title: An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab

summary:
This open-label, rater-blinded extension study enrolled participants who had relapsing-remitting multiple sclerosis (RRMS) and who participated in one of three prior Genzyme-sponsored studies of alemtuzumab (CAMMS223 [NCT00050778], CAMMS323 [NCT00530348] also known as CARE-MS I, or CAMMS324 [NCT00548405] also known as CARE-MS II). The purposes of this study were:

To examine the long term safety and efficacy of alemtuzumab treatment in participants who received alemtuzumab as their study treatment in one of the prior studies.
To examine the safety and efficacy of initial alemtuzumab treatment in this study for participants who received Rebif® (interferon beta-1a) as their study treatment in one of the prior studies.
To determine the safety and efficacy of additional "as needed" alemtuzumab treatment courses. This applied both to participants who received alemtuzumab for the first time in one of the prior studies or for the first time in this extension study.

ReferenceCitation: CAMMS223 Trial Investigators; Coles AJ, Compston DA, Selmaj KW, Lake SL, Moran S, Margolin DH, Norris K, Tandon PK. Alemtuzumab vs. interferon beta-1a in early multiple sclerosis. N Engl J Med. 2008 Oct 23;359(17):1786-801. doi: 10.1056/NEJMoa0802670.

ReferenceCitation: Cohen JA, Coles AJ, Arnold DL, Confavreux C, Fox EJ, Hartung HP, Havrdova E, Selmaj KW, Weiner HL, Fisher E, Brinar VV, Giovannoni G, Stojanovic M, Ertik BI, Lake SL, Margolin DH, Panzara MA, Compston DA; CARE-MS I investigators. Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a randomised controlled phase 3 trial. Lancet. 2012 Nov 24;380(9856):1819-28. doi: 10.1016/S0140-6736(12)61769-3. Epub 2012 Nov 1.

ReferenceCitation: Coles AJ, Twyman CL, Arnold DL, Cohen JA, Confavreux C, Fox EJ, Hartung HP, Havrdova E, Selmaj KW, Weiner HL, Miller T, Fisher E, Sandbrink R, Lake SL, Margolin DH, Oyuela P, Panzara MA, Compston DA; CARE-MS II investigators. Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial. Lancet. 2012 Nov 24;380(9856):1829-39. doi: 10.1016/S0140-6736(12)61768-1. Epub 2012 Nov 1.

ReferenceCitation: Coles AJ, Jones JL, Vermersch P, Traboulsee A, Bass AD, Boster A, Chan A, Comi G, Fernandez O, Giovannoni G, Kubala Havrdova E, LaGanke C, Montalban X, Oreja-Guevara C, Piehl F, Wiendl H, Ziemssen T. Autoimmunity and long-term safety and efficacy of alemtuzumab for multiple sclerosis: Benefit/risk following review of trial and post-marketing data. Mult Scler. 2022 Apr;28(5):842-846. doi: 10.1177/13524585211061335. Epub 2021 Dec 9.

repository_institution: University Library Bern - BORIS - Bern Open Repository and Information System

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

repository_institution: University of Cambridge - Apollo

ReferenceCitation: Kuhle J, Daizadeh N, Benkert P, Maceski A, Barro C, Michalak Z, Sormani MP, Godin J, Shankara S, Samad TA, Jacobs A, Chung L, Rӧsch N, Kaiser C, Mitchell CP, Leppert D, Havari E, Kappos L. Sustained reduction of serum neurofilament light chain over 7 years by alemtuzumab in early relapsing-remitting MS. Mult Scler. 2022 Apr;28(4):573-582. doi: 10.1177/13524585211032348. Epub 2021 Aug 11.

ReferenceCitation: Coles AJ, Arnold DL, Bass AD, Boster AL, Compston DAS, Fernandez O, Havrdova EK, Nakamura K, Traboulsee A, Ziemssen T, Jacobs A, Margolin DH, Huang X, Daizadeh N, Chirieac MC, Selmaj KW. Efficacy and safety of alemtuzumab over 6 years: final results of the 4-year CARE-MS extension trial. Ther Adv Neurol Disord. 2021 Apr 23;14:1756286420982134. doi: 10.1177/1756286420982134. eCollection 2021.

repositories_concat: PubMed Central;www.repository.cam.ac.uk

ReferenceCitation: Bass AD, Arroyo R, Boster AL, Boyko AN, Eichau S, Ionete C, Limmroth V, Navas C, Pelletier D, Pozzilli C, Ravenscroft J, Sousa L, Tintore M, Uitdehaag BMJ, Baker DP, Daizadeh N, Choudhry Z, Rog D; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ investigators. Alemtuzumab outcomes by age: Post hoc analysis from the randomized CARE-MS studies over 8 years. Mult Scler Relat Disord. 2021 Apr;49:102717. doi: 10.1016/j.msard.2020.102717. Epub 2020 Dec 24.

ReferenceCitation: Horakova D, Boster A, Bertolotto A, Freedman MS, Firmino I, Cavalier SJ, Jacobs AK, Thangavelu K, Daizadeh N, Poole EM, Baker DP, Margolin DH, Ziemssen T; CARE-MS I, CARE-MS II, and CAMMS03409 Investigators. Proportion of alemtuzumab-treated patients converting from relapsing-remitting multiple sclerosis to secondary progressive multiple sclerosis over 6 years. Mult Scler J Exp Transl Clin. 2020 Dec 18;6(4):2055217320972137. doi: 10.1177/2055217320972137. eCollection 2020 Oct-Dec.

ReferenceCitation: Ziemssen T, Bass AD, Berkovich R, Comi G, Eichau S, Hobart J, Hunter SF, LaGanke C, Limmroth V, Pelletier D, Pozzilli C, Schippling S, Sousa L, Traboulsee A, Uitdehaag BMJ, Van Wijmeersch B, Choudhry Z, Daizadeh N, Singer BA; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ investigators. Efficacy and Safety of Alemtuzumab Through 9 Years of Follow-up in Patients with Highly Active Disease: Post Hoc Analysis of CARE-MS I and II Patients in the TOPAZ Extension Study. CNS Drugs. 2020 Sep;34(9):973-988. doi: 10.1007/s40263-020-00749-x.

repositories_institution:
UHasselt - Document Server@UHasselt
University of Plymouth - PEARL

ReferenceCitation: Gilmore W, Lund BT, Li P, Levy AM, Kelland EE, Akbari O, Groshen S, Cen SY, Pelletier D, Weiner LP, Javed A, Dunn JE, Traboulsee AL. Repopulation of T, B, and NK cells following alemtuzumab treatment in relapsing-remitting multiple sclerosis. J Neuroinflammation. 2020 Jun 15;17(1):189. doi: 10.1186/s12974-020-01847-9.

ReferenceCitation: Comi G, Alroughani R, Boster AL, Bass AD, Berkovich R, Fernandez O, Kim HJ, Limmroth V, Lycke J, Macdonell RA, Sharrack B, Singer BA, Vermersch P, Wiendl H, Ziemssen T, Jacobs A, Daizadeh N, Rodriguez CE, Traboulsee A; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ Investigators. Efficacy of alemtuzumab in relapsing-remitting MS patients who received additional courses after the initial two courses: Pooled analysis of the CARE-MS, extension, and TOPAZ studies. Mult Scler. 2020 Dec;26(14):1866-1876. doi: 10.1177/1352458519888610. Epub 2019 Nov 25.

repository_institution: University of Melbourne - Minerva Access

repository_normalized: University of Melbourne - Minerva Access

repositories: University of Melbourne - Minerva Access

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;www.repositoriosalud.es

repositories_institution: University of Melbourne - Minerva Access

ReferenceCitation: Van Wijmeersch B, Singer BA, Boster A, Broadley S, Fernandez O, Freedman MS, Izquierdo G, Lycke J, Pozzilli C, Sharrack B, Steingo B, Wiendl H, Wray S, Ziemssen T, Chung L, Margolin DH, Thangavelu K, Vermersch P. Efficacy of alemtuzumab over 6 years in relapsing-remitting multiple sclerosis patients who relapsed between courses 1 and 2: Post hoc analysis of the CARE-MS studies. Mult Scler. 2020 Nov;26(13):1719-1728. doi: 10.1177/1352458519881759. Epub 2019 Nov 1.

repository_institution: Griffith University, Queensland, Australia - Griffith Research Online

ReferenceCitation: Okai AF, Amezcua L, Berkovich RR, Chinea AR, Edwards KR, Steingo B, Walker A, Jacobs AK, Daizadeh N, Williams MJ; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ Investigators. Efficacy and Safety of Alemtuzumab in Patients of African Descent with Relapsing-Remitting Multiple Sclerosis: 8-Year Follow-up of CARE-MS I and II (TOPAZ Study). Neurol Ther. 2019 Dec;8(2):367-381. doi: 10.1007/s40120-019-00159-2. Epub 2019 Oct 25.

ReferenceCitation: Arroyo R, Bury DP, Guo JD, Margolin DH, Melanson M, Daizadeh N, Cella D. Impact of alemtuzumab on health-related quality of life over 6 years in CARE-MS II trial extension patients with relapsing-remitting multiple sclerosis. Mult Scler. 2020 Jul;26(8):955-963. doi: 10.1177/1352458519849796. Epub 2019 May 30.

ReferenceCitation: Havrdova E, Arnold DL, Cohen JA, Hartung HP, Fox EJ, Giovannoni G, Schippling S, Selmaj KW, Traboulsee A, Compston DAS, Margolin DH, Thangavelu K, Rodriguez CE, Jody D, Hogan RJ, Xenopoulos P, Panzara MA, Coles AJ; CARE-MS I and CAMMS03409 Investigators. Alemtuzumab CARE-MS I 5-year follow-up: Durable efficacy in the absence of continuous MS therapy. Neurology. 2017 Sep 12;89(11):1107-1116. doi: 10.1212/WNL.0000000000004313. Epub 2017 Aug 23. Erratum In: Neurology. 2018 Apr 17;90(16):755.

repository_institution: University of Zurich - Zurich Open Repository and Archive

repositories_institution: University of Zurich - Zurich Open Repository and Archive

location_country:
Germany
Poland
Argentina
Australia
Brazil
Croatia
Czechia
Canada
Serbia
France
Denmark
United States
Ukraine
Belgium
Italy
United Kingdom
Sweden
Netherlands
Austria
Mexico
Spain
Russian Federation
Israel

location_facility: Hospital da Restauração, Neurology department

location_facility: Universitätsklinik Carl Gustav Carus Dresden

location_facility: AKH Wien-Universitätskliniken für Neurologie

location_facility: Wake Forest University Health Science Department of Neurology

location_facility: OMRF Multiple Sclerosis Center of Excellence

location_facility: University of South Florida College of Medicine

location_facility: Military Medical Academy, Institute of Neurology

location_facility: Emory University Department of Neurology

location_facility: Research Medical Complex "Your Health" Ltd

location_facility: St Petersburg State Pavlov Medical University, Dept of Neurology and Neurosurgery with a Hospital

location_facility: Shepherd Center Multiple Sclerosis Institute

location_facility: Institute of Psychiatry and Neurology/Instytut Psychiatrii i Neurologii

location_facility: University Hospital Leuven, Campus Gasthuisberg

location_facility: East Bay Physicians Medical Group/ Sutter East Bay Medical Foundation

location_facility: Klinik und Poliklinik für Neurologie, Universitätsklinikum Bonn

location_facility: Samodzielny Publiczny ZOZ, Uniwersytecki Szpital Kliniczny Nr1 im. Norberta Barlickiego

location_facility: Neurology Research Center under the Russian Academy of Medical Sciences

location_facility: The University of North Carolina at Chapel Hill

location_facility: Russian State Medical University, Department of Neurology and Neurosurgery

location_facility: SUNY Upstate Medical University, Department of Neurology

location_facility: St. Petersburg State Public Medical Institution: Nikolayevskaya Hospital

location_facility: Kiev Municipal Clinical Hospital #4, Department of Demyelinating Diseases of the Nervous System

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

location_facility: Groupe Hospitalier Pitié-Salpêtrière, Fédération de Maladies du System Nerveux Central

location_facility: Ruan Neurology Clinic and Clinical Research Center, Mercy Medical Center

location_facility: Irmandade da Santa Casa de Misericórdio de São Paulo, Neurology department

location_facility: Medizinische Fakultät der Universität Rostock,Zentrum für Nervenheilkunde

location_facility: Baylor College of Medicine, Maxine Mesinger MS Clinic

location_facility: University of Maryland, Maryland Center for MS

location_facility: North Central Neurology Associates, P.C.

location_facility: Lehigh Valley Hospital Neurosciences and Pain Research

location_facility: Samara Regional Clinical Hospital n.a. Kalinin

location_facility: University of Colorado Health Science Center - Aurora

location_facility: Indiana University Multiple Sclerosis Center

location_facility: University of Calgary, Department of Neurology

location_facility: Hospital Clínico Universitario San Carlos

location_facility: Spectrum Health Medical Group, Neurology/Michigan Medical P.C., West Michigan MS Clinic

location_facility: Lviv National Medical University n.a. Danylo Galytsky, Department of Neurology

location_facility: Municipal Treatment and Prevention Institution, City Hospital #33

location_facility: Institute of Neurology, Psychiatry and Narcology under the AMS of Ukraine, Dep of Neuroinfection& MS

location_facility: Municipal Public Medical Institution: City Hospital #2 of Pyatigorsk, Neurology Department

location_facility: Universitätsklinikum Ulm, Klinik für Neurologie im RKU

location_facility: Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Med. im. Karola Marcinkowskiego w Poznaniu

location_facility: University of Florida Neuroscience Institute

location_facility: Wayne State University, The School of Medicine, Department of Neurology

location_facility: Winthrop University Hospital Multiple Sclerosis Treatment Center

location_facility: St. Petersburg General Hospital #2, Neurology Department #2

location_facility: The George Washington University Medical Faculty Associates

location_facility: Clinical Hospital Centre "Sestre Milosrdnice"

location_facility: Hospital das Clínicas da Faculdade de Medicina da USP, Neurology department

location_facility: Negroski, Stein, Sutherland and Hanes Neurology

location_facility: University of New Mexico, Dept. of Neurology

location_facility: Oberhavel Klinicum GmbH - Krankenhaus Hennigsdorf

location_facility: Clinical Centre Kragujevac, Clinic of Neurology

location_facility: The Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai

location_facility: Fachkrankenhaus Hubertusburg GmbH, Klinik für Neurologie und Neurologische Intensivmedizin

location_facility: General Hospital Varazdin, Department for Neurology

location_facility: Clinical Centre Serbia, Institute of Neurology,Dr.Subotica 6,Belgrade

location_facility: Clinical Centre Nis, Clinic of Neurology

location_facility: Moscow State Public Medical Institution Clinical Hospital #11, Neurology Department

location_facility: Universita Degli Studi di Roma "La Sapienza"

location_facility: Federal State Public Medical Institution: Siberian District Medical Center under the Federal Agency

location_facility: University Hospital of Wales, Dept of Neurology

location_facility: University of Southern California Keck School of Medicine/University of Southern California LAC & USC Medical Center

location_facility: St. Joseph's Hospital and Medical Center Barrow Neurology Clinics - Barrow Neurological Institute

location_facility: London Health Sciences Centre - University Hospital

location_facility: Hospital Teplice, Neurology Department, MS centrum

location_facility: Rhode Island Hospital MS Center - The Neurology Foundation, Inc

location_facility: Institute of Human Brain RAS, Laboratory of Neuroimmunology

location_facility: Hospital of Directorate of the Medical Corps within the Ukrainian Security Service, Neurology Dept.

location_facility: State Public Medical Institution: Republican Clinical Hospital n.a. G.G. Kuvatov

location_facility: University of Kansas Medical Center, Department of Neurology


intervention_type: Drug

lead_sponsor: Janssen Research & Development, LLC

summary: The purpose of this study is to compare the safety and effectiveness of JNJ-42160443 with placebo in the treatment of chronic, moderate to severe cancer-related pain in terminally ill patients with a diagnosis of active cancer.

status: Completed

title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 as Adjunctive Therapy in Subjects With Cancer-Related Pain, Followed by an Open-Label Extension Phase

primary_purpose: Treatment

type: Other Identifier

type: EudraCT Number

source: euctr

enrollment_type: Actual

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
Poland
Portugal
United States
Spain
France

study_type: Interventional

lead_sponsor_type: industriel

status_simplified: Completed


title: An Open-Label, Dose-Escalation, Phase I/II Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of the MEK Inhibitor GSK1120212 in Subjects With Relapsed or Refractory Leukemias

summary: MEK111759 is a dose-escalation, Phase I/II, open-label study to determine the recommended dose and regimen for the orally administered MEK inhibitor GSK1120212 in subjects with relapsed or refractory leukemias. The recommended dose and regimen will be selected based on the safety, pharmacokinetic, and pharmacodynamic profiles. This study will identify the maximum tolerated and recommended Phase II doses using a dose-escalation procedure. Dose escalations will continue based on predefined parameters until a maximum tolerated dose is established. In Phase II, the clinical efficacy of GSK1120212 in subjects with relapsed or refractory leukaemias (AML, MDS or CMML) will be determined.

design_allocation: Non-Randomized

lead_sponsor: GlaxoSmithKline

location_country:
United States
Germany
Belgium
France


study_start_date_type: Actual

lead_sponsor: Amgen

summary:
This is a phase 3, randomized, double-blind, placebo-controlled multi-center study evaluating the efficacy of pegfilgrastim to reduce the incidence of febrile neutropenia (FN) in patients with newly diagnosed, locally-advanced or metastatic colorectal cancer receiving first-line treatment with bevacizumab and either 5-fluorouracil, Oxaliplatin, Leucovorin (FOLFOX) or 5-fluorouracil, Irinotecan, Leucovorin (FOLFIRI).

This study will also investigate the effect of adding pegfilgrastim to bevacizumab and either FOLFOX or FOLFIRI by evaluating overall survival, progression-free survival, and overall response rate in each arm at regular intervals over a maximum of 60 months follow-up.

ReferenceType: background

ReferenceCitation: Pinter T, Klippel Z, Cesas A, Croitoru A, Decaestecker J, Gibbs P, Hotko Y, Jassem J, Kurteva G, Novotny J, O'Reilly S, Salek T, Reiner M, Morrow PK, Choi MR, Whittaker S, Blanke C. A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Pegfilgrastim in Patients Receiving First-Line FOLFOX/Bevacizumab or FOLFIRI/Bevacizumab for Locally Advanced or Metastatic Colorectal Cancer: Final Results of the Pegfilgrastim and Anti-VEGF Evaluation Study (PAVES). Clin Colorectal Cancer. 2017 Jun;16(2):103-114.e3. doi: 10.1016/j.clcc.2016.08.008. Epub 2016 Sep 7.

title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Pegfilgrastim Admininstered to Subjects With Newly Diagnosed, Locally-advanced or Metastatic Colorectal Cancer Treated With Bevacizumab & Either 5-fluorouracil, Oxaliplatin, Leucovorin (FOLFOX) or 5-fluorouracil, Irinotecan, Leucovorin (FOLFIRI)

primary_purpose: Supportive Care

location_country:
Ireland
Italy
Poland
Bulgaria
Slovakia
Hungary
Romania
Australia
Mexico
Belgium
United States
Latvia
Czechia
Canada
Ukraine
Russian Federation
France


title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis

acronym: ADVANCE

summary: The primary objective of this study is to determine the efficacy of peginterferon beta-1a in reducing the annualized relapse rate (ARR) in participants with relapsing multiple sclerosis (RMS) at 1 year. The secondary objectives of this study are to determine whether peginterferon beta-1a, at 1 year when compared with placebo, is effective in reducing the total number of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance imaging (MRI) scans, reducing the proportion of participants who relapse, and slowing the progression of disability.

ReferenceType: result

ReferenceCitation: Calabresi PA, Kieseier BC, Arnold DL, Balcer LJ, Boyko A, Pelletier J, Liu S, Zhu Y, Seddighzadeh A, Hung S, Deykin A; ADVANCE Study Investigators. Pegylated interferon beta-1a for relapsing-remitting multiple sclerosis (ADVANCE): a randomised, phase 3, double-blind study. Lancet Neurol. 2014 Jul;13(7):657-65. doi: 10.1016/S1474-4422(14)70068-7. Epub 2014 Apr 30.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

ReferenceType: derived

ReferenceCitation: Calabresi PA, Arnold DL, Sangurdekar D, Singh CM, Altincatal A, de Moor C, Engle B, Goyal J, Deykin A, Szak S, Kieseier BC, Rudick RA, Plavina T. Temporal profile of serum neurofilament light in multiple sclerosis: Implications for patient monitoring. Mult Scler. 2021 Sep;27(10):1497-1505. doi: 10.1177/1352458520972573. Epub 2020 Dec 14.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: SAGE Publications

ReferenceCitation: Cleanthous S, Cano S, Kinter E, Marquis P, Petrillo J, You X, Wakeford C, Sabatella G. Measuring the impact of multiple sclerosis: Enhancing the measurement performance of the Multiple Sclerosis Impact Scale (MSIS-29) using Rasch Measurement Theory (RMT). Mult Scler J Exp Transl Clin. 2017 Aug 15;3(3):2055217317725917. doi: 10.1177/2055217317725917. eCollection 2017 Jul-Sep.

oa_colors: green gold

evidence: oa journal (via doaj)

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

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

unpaywall_oa_status: gold

ReferenceCitation: Scott TF, Kieseier BC, Newsome SD, Arnold DL, You X, Hung S, Sperling B. Improvement in relapse recovery with peginterferon beta-1a in patients with multiple sclerosis. Mult Scler J Exp Transl Clin. 2016 Nov 15;2:2055217316676644. doi: 10.1177/2055217316676644. eCollection 2016 Jan-Dec.

ReferenceCitation: Newsome SD, Kieseier BC, Liu S, You X, Kinter E, Hung S, Sperling B. Peginterferon beta-1a reduces disability worsening in relapsing-remitting multiple sclerosis: 2-year results from ADVANCE. Ther Adv Neurol Disord. 2017 Jan;10(1):41-50. doi: 10.1177/1756285616676065. Epub 2016 Nov 16.

oa_colors: green other

evidence: open (via free pdf)

unpaywall_oa_status: bronze

ReferenceCitation: Arnold DL, Calabresi PA, Kieseier BC, Liu S, You X, Fiore D, Hung S. Peginterferon beta-1a improves MRI measures and increases the proportion of patients with no evidence of disease activity in relapsing-remitting multiple sclerosis: 2-year results from the ADVANCE randomized controlled trial. BMC Neurol. 2017 Feb 10;17(1):29. doi: 10.1186/s12883-017-0799-0.

ReferenceCitation: Newsome SD, Guo S, Altincatal A, Proskorovsky I, Kinter E, Phillips G, You X, Sabatella G. Impact of peginterferon beta-1a and disease factors on quality of life in multiple sclerosis. Mult Scler Relat Disord. 2015 Jul;4(4):350-7. doi: 10.1016/j.msard.2015.06.004. Epub 2015 Jun 14.

ReferenceCitation: Arnold DL, Calabresi PA, Kieseier BC, Sheikh SI, Deykin A, Zhu Y, Liu S, You X, Sperling B, Hung S. Effect of peginterferon beta-1a on MRI measures and achieving no evidence of disease activity: results from a randomized controlled trial in relapsing-remitting multiple sclerosis. BMC Neurol. 2014 Dec 31;14:240. doi: 10.1186/s12883-014-0240-x.

ReferenceCitation: Kieseier BC, Arnold DL, Balcer LJ, Boyko AA, Pelletier J, Liu S, Zhu Y, Seddighzadeh A, Hung S, Deykin A, Sheikh SI, Calabresi PA. Peginterferon beta-1a in multiple sclerosis: 2-year results from ADVANCE. Mult Scler. 2015 Jul;21(8):1025-35. doi: 10.1177/1352458514557986. Epub 2014 Nov 28.

ReferenceCitation: Hu X, Cui Y, White J, Zhu Y, Deykin A, Nestorov I, Hung S. Pharmacokinetics and pharmacodynamics of peginterferon beta-1a in patients with relapsing-remitting multiple sclerosis in the randomized ADVANCE study. Br J Clin Pharmacol. 2015 Mar;79(3):514-22. doi: 10.1111/bcp.12521.

location_country:
Germany
Poland
New Zealand
Croatia
Chile
Canada
Serbia
France
Czech Republic
Colombia
United States
Latvia
Ukraine
India
Romania
Belgium
Peru
Estonia
United Kingdom
Netherlands
Mexico
Spain
Greece
Bulgaria
Georgia
Russian Federation


title: Effect of Passive Immunization on the Progression of Alzheimer's Disease: LY2062430 Versus Placebo

summary:
Alzheimer's disease (AD) is an age-related degenerative disorder of the brain, characterized by progressive decline in cognitive function and ability to perform activities of daily living, and ultimately can lead to death due to complications of the disease. AD is thought to be caused by an excess of A-Beta amyloid, a sticky protein in the brain that forms amyloid plaques. Treatments that slow the synthesis or deposition of A-Beta amyloid, or that increase clearance, might be expected to slow the progression of AD.

LY2062430 (solanezumab) is a humanized anti-A Beta peptide immunoglobulin G-1 (IgG1) monoclonal antibody being developed for the treatment of AD. The primary hypothesis being tested is that LY2062430 will slow cognitive and functional decline in AD as compared with placebo. Each patient's participation will last approximately 19 months. Patients taking approved AD medications may participate in this study and continue taking these medications during the study.

ReferenceCitation: Reed C, Belger M, Dell'Agnello G, Kahle-Wrobleski K, Sethuraman G, Hake A, Raskin J, Henley D. Representativeness of European clinical trial populations in mild Alzheimer's disease dementia: a comparison of 18-month outcomes with real-world data from the GERAS observational study. Alzheimers Res Ther. 2018 Apr 3;10(1):36. doi: 10.1186/s13195-018-0360-4.

publisher_dissemination: Springer-Nature

ReferenceCitation: Liu-Seifert H, Siemers E, Price K, Han B, Selzler KJ, Henley D, Sundell K, Aisen P, Cummings J, Raskin J, Mohs R; Alzheimer's Disease Neuroimaging Initiative. Cognitive Impairment Precedes and Predicts Functional Impairment in Mild Alzheimer's Disease. J Alzheimers Dis. 2015;47(1):205-14. doi: 10.3233/JAD-142508.

evidence: open (via page says Open Access)

license: unspecified-oa

license_normalized: unspecified-oa

repository_institution: Indiana University - Purdue University Indianapolis - IUPUI ScholarWorks

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

repository_institution: Indiana University - IUScholarWorks

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher_dissemination: IOS Press

ReferenceCitation: Henley DB, Dowsett SA, Chen YF, Liu-Seifert H, Grill JD, Doody RS, Aisen P, Raman R, Miller DS, Hake AM, Cummings J. Alzheimer's disease progression by geographical region in a clinical trial setting. Alzheimers Res Ther. 2015 Jun 25;7(1):43. doi: 10.1186/s13195-015-0127-0. eCollection 2015.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: California Digital Library - eScholarship

ReferenceCitation: Liu-Seifert H, Siemers E, Sundell K, Price K, Han B, Selzler K, Aisen P, Cummings J, Raskin J, Mohs R. Cognitive and functional decline and their relationship in patients with mild Alzheimer's dementia. J Alzheimers Dis. 2015;43(3):949-55. doi: 10.3233/JAD-140792.

ReferenceCitation: Doody RS, Thomas RG, Farlow M, Iwatsubo T, Vellas B, Joffe S, Kieburtz K, Raman R, Sun X, Aisen PS, Siemers E, Liu-Seifert H, Mohs R; Alzheimer's Disease Cooperative Study Steering Committee; Solanezumab Study Group. Phase 3 trials of solanezumab for mild-to-moderate Alzheimer's disease. N Engl J Med. 2014 Jan 23;370(4):311-21. doi: 10.1056/NEJMoa1312889.

location_country:
Germany
Italy
Poland
United Kingdom
Australia
Japan
Sweden
United States
Korea, Republic of
Spain
Taiwan
Russian Federation
France

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


title: A Randomized, Double Blind, Parallel Group, Placebo Controlled 28 Day Study to Investigate the Safety, Tolerability and Pharmacodynamics of SB-656933 in Patients With Cystic Fibrosis.

summary: The purpose of this study is to determine whether the safety, tolerability and pharmacodynamics of SB656933 in patients that have cystic fibrosis

ReferenceCitation: Moss RB, Mistry SJ, Konstan MW, Pilewski JM, Kerem E, Tal-Singer R, Lazaar AL; CF2110399 Investigators. Safety and early treatment effects of the CXCR2 antagonist SB-656933 in patients with cystic fibrosis. J Cyst Fibros. 2013 May;12(3):241-8. doi: 10.1016/j.jcf.2012.08.016. Epub 2012 Sep 17.

oa_host_type: publisher

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

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.

location_country:
Germany
France
United States
Canada
Israel


lead_sponsor: Bristol-Myers Squibb

summary: The purpose of this study is to determine the safety and tolerability of BMS-708163 in patients with Prodromal Alzheimer's disease over a treatment period of a minimum of 104-weeks. In addition patients will be seen for safety visits at 4 and 12 weeks post treatment.

ReferenceCitation: Coric V, Salloway S, van Dyck CH, Dubois B, Andreasen N, Brody M, Curtis C, Soininen H, Thein S, Shiovitz T, Pilcher G, Ferris S, Colby S, Kerselaers W, Dockens R, Soares H, Kaplita S, Luo F, Pachai C, Bracoud L, Mintun M, Grill JD, Marek K, Seibyl J, Cedarbaum JM, Albright C, Feldman HH, Berman RM. Targeting Prodromal Alzheimer Disease With Avagacestat: A Randomized Clinical Trial. JAMA Neurol. 2015 Nov;72(11):1324-33. doi: 10.1001/jamaneurol.2015.0607.

publisher_dissemination: American Medical Association

location_facility: California Neuroscience Research Medical Group, Inc.

location_facility: Wake Forest University School Of Medicine

location_facility: Collaborative Neuroscience Network, Inc.

location_facility: Dean Foundation For Health Research & Education

location_facility: Memory Enhancement Center Of Amercia, Inc.

location_facility: Robert Wood Johnson Medical School, Umdnj

location_facility: Washington University School Of Medicine

location_facility: Cleveland Clinic Lou Ruvo Center For Brain Health

status: Terminated

title: Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, Pharmacodynamic and Pharmacokinetic Effects of BMS-708163 in the Treatment of Patients With Prodromal Alzheimer's Disease

location_country:
Finland
Denmark
Sweden
United States
Canada
France

status_simplified: Unknown


title: A Multicenter, Double-Blind, Placebo-Controlled, Randomized Withdrawal, Parallel Group Study To Evaluate The Efficacy And Safety Of 50 mg/Day Of DVS SR In Adult Outpatients With Major Depressive Disorder

summary:
The primary purpose of this study is to compare the long-term efficacy and safety of desvenlafaxine succinate sustained release versus placebo in adults with Major Depressive Disorder, using a randomized withdrawal design. Randomized withdrawal means that after receiving desvenlafaxine succinate sustained release for a predetermined period of time, subjects will be selected by chance to either continue receiving the study drug or to be withdrawn from the study drug and receive placebo for the remainder of their participation in the trial. Subjects will not know to which group they have been assigned.

The study consists of an up to 14-day screening period followed by an 8-week open-label period in which subjects will knowingly receive 50 mg/day of desvenlafaxine succinate sustained release. Subjects who do not respond to treatment, demonstrating no significant change in their depressive symptoms, will be withdrawn from participation at the end of this period. Responding subjects will receive an additional 3 months of open-label desvenlafaxine succinate sustained release at the same dose. Subjects with stable response to treatment at the conclusion of this 3 month period will be randomized to either desvenlafaxine succinate sustained release at 50 mg/day or placebo in a blinded manner for an additional 6 months or until symptoms of depression return. Following discontinuation at any point after enrollment in the study, subjects will receive two weeks of follow-up monitoring, including one week of blinded taper with 25 mg/day of desvenlafaxine succinate sustained release treatment for any subjects who have been taking desvenlafaxine succinate sustained release prior to discontinuation. Subjects assigned to placebo will receive a blinded placebo taper. Following taper, subjects will be evaluated for one additional week to monitor safety.

ReferenceCitation: Boyer P, Vialet C, Hwang E, Tourian KA. Efficacy of Desvenlafaxine 50 mg/d Versus Placebo in the Long-Term Treatment of Major Depressive Disorder: A Randomized, Double-Blind Trial. Prim Care Companion CNS Disord. 2015 Aug 27;17(4):10.4088/PCC.14m01711. doi: 10.4088/PCC.14m01711. eCollection 2015.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: Physicians Postgraduate Press, Inc

ReferenceCitation: McIntyre RS, Fayyad RS, Guico-Pabia CJ, Boucher M. A Post Hoc Analysis of the Effect of Weight on Efficacy in Depressed Patients Treated With Desvenlafaxine 50 mg/d and 100 mg/d. Prim Care Companion CNS Disord. 2015 Jun 4;17(3):10.4088/PCC.14m01741. doi: 10.4088/PCC.14m01741. eCollection 2015.

ReferenceCitation: McIntyre RS, Fayyad RS, Guico-Pabia CJ, Boucher M. An Analysis of Relapse Rates and Predictors of Relapse in 2 Randomized, Placebo-Controlled Trials of Desvenlafaxine for Major Depressive Disorder. Prim Care Companion CNS Disord. 2015 Feb 26;17(1):10.4088/PCC.14m01681. doi: 10.4088/PCC.14m01681. eCollection 2015.

ReferenceCitation: Thase ME, Fayyad R, Cheng RF, Guico-Pabia CJ, Sporn J, Boucher M, Tourian KA. Effects of desvenlafaxine on blood pressure in patients treated for major depressive disorder: a pooled analysis. Curr Med Res Opin. 2015 Apr;31(4):809-20. doi: 10.1185/03007995.2015.1020365. Epub 2015 Mar 26.

publisher_dissemination: Informa

ReferenceCitation: Rosenthal JZ, Boyer P, Vialet C, Hwang E, Tourian KA. Efficacy and safety of desvenlafaxine 50 mg/d for prevention of relapse in major depressive disorder:a randomized controlled trial. J Clin Psychiatry. 2013 Feb;74(2):158-66. doi: 10.4088/JCP.12m07974.

lead_sponsor: Pfizer

location_country:
Finland
Lithuania
Poland
Colombia
Slovakia
Romania
United States
Latvia
South Africa
Croatia
Chile
Canada
Estonia
France


acronym: TENERE

lead_sponsor: Sanofi

summary:
Primary objective was to assess the effectiveness evaluated by the time to failure of two doses of teriflunomide in comparison to interferon beta-1a in participants with relapsing Multiple Sclerosis [MS].

Secondary objectives were:

To assess the effect of the two doses in comparison to interferon beta-1a on:

Frequency of relapses,
Fatigue,
Participant's satisfaction with treatment.
To evaluate the safety and tolerability of the two doses in comparison to interferon beta-1a.

The study consisted of a core treatment period with a common end date defined as 48 weeks after randomization of the last participant, followed by an optional long-term extension treatment period until teriflunomide is commercially available in accordance with local regulations.

ReferenceCitation: Vermersch P, Czlonkowska A, Grimaldi LM, Confavreux C, Comi G, Kappos L, Olsson TP, Benamor M, Bauer D, Truffinet P, Church M, Miller AE, Wolinsky JS, Freedman MS, O'Connor P; TENERE Trial Group. Teriflunomide versus subcutaneous interferon beta-1a in patients with relapsing multiple sclerosis: a randomised, controlled phase 3 trial. Mult Scler. 2014 May;20(6):705-16. doi: 10.1177/1352458513507821. Epub 2013 Oct 14.

ReferenceCitation: Comi G, Freedman MS, Meca-Lallana JE, Vermersch P, Kim BJ, Parajeles A, Edwards KR, Gold R, Korideck H, Chavin J, Poole EM, Coyle PK. Prior treatment status: impact on the efficacy and safety of teriflunomide in multiple sclerosis. BMC Neurol. 2020 Oct 6;20(1):364. doi: 10.1186/s12883-020-01937-4.

repository_institution: University of Ottawa - uO Research

repositories_concat: PubMed Central;ruor.uottawa.ca

location_facility:
Investigational Site Number 380007
Investigational Site Number 276005
Investigational Site Number 348001
Investigational Site Number 348005
Investigational Site Number 276009
Investigational Site Number 056002
Investigational Site Number 380010
Investigational Site Number 124004
Investigational Site Number 250002
Investigational Site Number 724002
Investigational Site Number 348003
Investigational Site Number 300001
Investigational Site Number 250004
Investigational Site Number 203004
Investigational Site Number 276003
Investigational Site Number 276010
Investigational Site Number 616004
Investigational Site Number 756002
Investigational Site Number 724007
Investigational Site Number 276002
Investigational Site Number 616001
Investigational Site Number 276006
Investigational Site Number 380003
Investigational Site Number 276012
Investigational Site Number 250001
Investigational Site Number 380008
Investigational Site Number 348002
Investigational Site Number 380001
Investigational Site Number 250005
Investigational Site Number 380004
Investigational Site Number 124002
Investigational Site Number 348004
Investigational Site Number 826002
Investigational Site Number 826003
Investigational Site Number 724001
Investigational Site Number 124003
Investigational Site Number 276007
Investigational Site Number 788002
Investigational Site Number 203002
Investigational Site Number 348007
Investigational Site Number 276001
Investigational Site Number 276011
Investigational Site Number 203003
Investigational Site Number 276004
Investigational Site Number 616002
Investigational Site Number 724003
Investigational Site Number 380002
Investigational Site Number 380006
Investigational Site Number 250003
Investigational Site Number 300002
Investigational Site Number 380005
Investigational Site Number 056001
Investigational Site Number 056003
Investigational Site Number 616003

title: A Multi-center, Randomized, Parallel-group, Rater-blinded Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis Plus a Long Term Extension Period

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Switzerland
Tunisia
Belgium
Spain
Greece
Canada
Czech Republic
France


lead_sponsor: Novartis Pharmaceuticals

summary: This study was to evaluate the efficacy and safety of single agent oral panobinostat in patients who have refractory de novo or refractory secondary AML.

location_facility: University of Chicago Medical Center Dept. of U. of Chicago Hosp(3)

location_facility: North Shore University Hospital North Shore Univ

location_facility: Oregon Health Sciences University Dept. of OHSU (2)

location_facility: University of Texas Southwestern Medical Center Dept of Simmons Cancer Center

location_facility: Memorial Sloan Kettering Cancer Center Dept. of MSKCC (2)

location_facility: University of Texas/MD Anderson Cancer Center Dept of MD Anderson (14)

location_facility: Nebraska Methodist Hospital Nebraska Methodist Hospital(2)

title: A Phase II Study of Oral Single Agent Panobinostat in Patients With Refractory de Novo or Secondary Acute Myelogenous Leukemia (AML)

location_country:
Germany
Italy
United Kingdom
Australia
Switzerland
Belgium
United States
Korea, Republic of
Spain
Turkey
Peru
France


title: A Randomized Double-Blinded Phase II Study of Carboplatin/Paclitaxel/CT-322 Versus Carboplatin/Paclitaxel/Bevacizumab as First-Line Treatment for Recurrent or Advanced Non-Small Cell Lung Cancer With Non-Squamous Histology

summary: The purpose of this study is to determine the efficacy of CT-322 comparative to bevacizumab, both in combination with carboplatin and paclitaxel in the treatment of chemonaive subjects with recurrent or advanced non-squamous NSCLC

location_country:
Italy
Poland
United Kingdom
Brazil
United States
South Africa
Russian Federation
France

location_facility: Acrc/Arizona Clinical Research Center, Inc.

location_facility: University Of Tennessee Cancer Institute

location_facility: North Mississippi Hematology And Oncology Associates, Ltd

location_facility: Cancer Center At Cookeville Regional Medical Center

location_facility: Charleston Hematology Oncology Associates, Pa

location_facility: Piedmont Hematology Oncology Associates, Pllc


lead_sponsor: Morphotek

summary: This research is being done to find out if Carboplatin and Taxane works better alone or when given with an experimental drug called MORAb-003(farletuzumab) in subjects with first platinum sensitive relapsed ovarian cancer.

sponsor_collaborators:
Morphotek
Eisai Europe Ltd. (United Kingdom)

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Oncology-Hematology Associates of W. Broward P.A.

location_facility: Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház

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

location_facility: Clínica de Oncologia de Porto Alegre S/S Ltda

location_facility: Azienda Ospedaliera Santi Antonio, Biagio e Cesare Arrigo

location_facility: MNJ Institute of Oncology and Regional Cancer Centre

location_facility: Republican Clinical Oncology Center of Bashkortostan Republic Ministry of Healthcare

location_facility: Harrison Bremerton Hematology and Oncology

location_facility: Peninsula Cancer Institute - Riverside Gynecology Oncology

location_facility: St. Joseph's Hospital, Barrow Neurology Clinics

location_facility: Instituto Ribeirãopretano de Combate ao Câncer

location_facility: Fondazione Centro San Raffaele del Monte Tabor

location_facility: Azienda Ospedaliero-Universitaria di Udine

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: Centrum Onkologii, Instytut im. M. Sklodowskiej-Curie oddzial w Gliwicach

location_facility: Bhagwan Mahaveer Cancer Hospital and Research Centre

location_facility: Fundación Instituto Valenciano de Oncología

location_facility: M.S Ramaiah Medical College and Teaching Hospital Ethical Review Board

location_facility: Gainsville Hematology Oncology Associates

location_facility: Ospedale Santa Maria della Misericordia di Perugia

location_facility: General Oncology Hospital Kifissias "Oi Agioi Anargyroi"

location_facility: Severance Hospital, Yonsei University College of Medicine

location_facility: Instituto de Pesquisas Clínicas para Estudos Multicêntricos

location_facility: International Beneficence Clinical Research, L.L.C.

location_facility: Northern Virginia Pelvic Surgery Associates

location_facility: Instituto Portugues de Oncologia de Lisboa Francisco Gentil (IPOLFG, EPE)

location_facility: Veszprém Megyei Önkormányzat Csolnoky Ferenc Kórház-Rendelöintézet

location_facility: Centre Régional de lutte contre le cancer Paul Papin

location_facility: SPZOZ Wojewodzki Szpital Specjalistyczny nr 3

location_facility: Ryazan Regional Clinical Oncology Dispensary

location_facility: AZ Groeninge - Campus Maria's Voorzienigheid

location_facility: Kaiser Permanente - Moanalua Medical Center

location_facility: Istituto Nazionale per lo studio e la cura dei tumori "Fondazione Giovanni Pascale"

location_facility: Institut Jean Godinot - Centre de lutte contre le cancer

location_facility: Olsztynski Osrodek Onkologiczny "Kopernik" Sp. z o.o.

location_facility: Istituto Ospedaliero Fondazione Poliambulanza

location_facility: Centro di Ricerca e Formazione ad Alta Tecnologia nelle Scienze Biomediche

location_facility: Irmandade Santa Casa de Misericórdia de Porto Alegre

location_facility: Instituto do Câncer Arnaldo Vieira de Carvalho

location_facility: University of California Los Angeles Medical Center

location_facility: Chernivtsi Regional Clinical Oncology Dispansery

location_facility: Chattanooga's Program in Women's Oncology

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Pozna

location_facility: Cheil General Hospital & Women's Healthcare Center

location_facility: National Kidney and Transplant Institute

location_facility: Zaklad Opieki Zdrowotnej MSWiA z Warminsko-Mazurskim Centrum Onkologii

location_facility: Kapi'olani Medical Center for Women and Children

location_facility: Russian Oncology Research Center named after N.N. Blokhin

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

location_facility: Ospedale Mater Salutis ULSS 21 della regione Veneto

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: Jupiter Medical center Physician's Group

location_facility: Frauenarztpraxis Dr. med. Gröll de Rivera

location_facility: Memorial Health University Medical Center

location_facility: Palm Beach Institute of Hematology and Oncology

location_facility: Fundação Pio XII - Hospital de Câncer de Barretos

location_facility: Clínica AMO - Assistência Multidiciplinar em Oncologia

location_facility: Instituto Português de Oncologia Francisco Gentil, Centro Regional de Oncologia de Coimbra, EPE

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi

location_facility: Moscow Research Oncology Institute n.a. P.A.Gertsen

location_facility: Jawaharlal Nehru Cancer Hospital & Research Centre

location_facility: University of California Davis Cancer Center

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 2 PAM w Szczecinie

location_facility: Medical Radiology Research Center of RAMS

location_facility: Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelöintézet

location_facility: Instituto Portugues de Oncologia do Porto Francisco Gentil (IPOPFG, EPE)

location_facility: Signal Point Clinical Research Center, LLC

location_facility: Amrita Institute of Medical Sciences and Research Centre

location_facility: Hospital Santa Izabel - Santa Casa de Misericordia da Bahia

location_facility: Triva Investigaciones Medicas Sociedad Anónima de Capital Variable

location_facility: University of Texas Health Science Center at Houston Medical School

location_facility: Municipal Institution of Cherkasy Regional Counsil "Cherkasy Regional Oncology Dispensary"

location_facility: Linn Medical Center, Clalit Health Services

location_facility: The Center for Cancer and Hematologic Disease

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Hospital Zonal Especializado en Oncología de Lanús

location_facility: Weinberg Cancer Institute at Franklin Square

location_facility: Klinikum der Universität München - Innenstadt

location_facility: University General Hospital of Heraklion

location_facility: John Theurer Cancer Center at Hackensack University MC

location_facility: Arizona Hematology & Oncology Associates

location_facility: Saúde ABC Serviços Médicos Hospitalares Ltda

title: A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Weekly Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Subjects With Platinum-sensitive Ovarian Cancer in First Relapse

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Chile
Canada
France
Portugal
Hungary
Hong Kong
Switzerland
United States
Ukraine
India
Belgium
Philippines
Italy
United Kingdom
Singapore
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel


acronym: GRIP

lead_sponsor: Bayer

summary:
Patients with moderate to severe renal impairment scheduled for a magnetic resonance imaging (MRI) scan and injection with a contrast agent, Gadovist, will be asked to participate.

The administration of contrast agents that contain gadolinium such as Gadovist might increase a potential risk to develop a rare condition called nephrogenic systemic fibrosis (NSF) in patients with renal impairment. This study is to assess the potential risk to develop NSF in patients with renal impairment after the administration of Gadovist. Patients who are enrolled in this study will receive a Gadovist enhanced MRI scan which was prescribed by the referring doctor. After the MRI scan the patient will be included in a two year follow-up period to assess if signs or symptoms suggestive of NSF have appeared.

title: Prospective Non-randomized (Pharmacoepidemiologic) Cohort Study (Open-label, Multicenter) to Assess the Magnitude of Potential Risk With the Administration of Gadovist in Patients With Moderate to Severe Renal Impairment for the Development of Nephrogenic Systemic Fibrosis (NSF) Based on Diagnostically Specific Clinical and Histopathologic Information

location_country:
Germany
Italy
Australia
Switzerland
Austria
Korea, Republic of
Spain
Thailand
Canada
France


summary: The purpose of this study is to determine whether tanezumab is effective in the treatment of pain associated with chronic prostatitis.

location_facility: Atlantic Urological Medical Group Incorporated

location_facility: Prostate Cancer Centre / Urology Research

location_facility: Los Angeles Infertility and Prostatitis Medical Group

location_facility: Temple University of the Commonwealth System of Higher Education

location_facility: The Male/Female Health and Research Centre

location_facility: Tri-State Urologic Services PSC, Inc. dba The Urology Group

location_facility: Urology Associates / Urologic Medical Research

location_facility: Klinik und Poliklinik fuer Urologie, Inselspital

location_facility: Universitaetsspital Basel, Urologische Klinik

location_facility: Skaraborgs Sjukhus, FoU-centrum och urologkliniken

location_facility: Centre Hospitalier Universitaire de NANTES (CHU)

title: A PHASE 2, 16 WEEK, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED, PARALLEL GROUP PROOF-OF-CONCEPT STUDY EVALUATING THE EFFICACY AND SAFETY OF TANEZUMAB FOR THE TREATMENT OF PAIN ASSOCIATED WITH CHRONIC ABACTERIAL PROSTATITIS

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

location_country:
France
Switzerland
United States
Canada
Sweden


title: A Multicenter, Randomized, Double Blind, Sham Control, Parallel Arm Trial to Assess Effectiveness and Safety of the Ischemic Stroke System ISS, as an Adjunct to Standard of Care in Subjects With Acute Ischemic Stroke

summary: The primary objective of the study is to assess the safety and effectiveness of SPG stimulation with the ISS in patients with an acute ischemic stroke in the anterior circulation initiated within 24 hours from stroke onset.

ReferenceCitation: Bornstein NM, Saver JL, Diener HC, Gorelick PB, Shuaib A, Solberg Y, Thackeray L, Savic M, Janelidze T, Zarqua N, Yarnitsky D, Molina CA; ImpACT-24B investigators. An injectable implant to stimulate the sphenopalatine ganglion for treatment of acute ischaemic stroke up to 24 h from onset (ImpACT-24B): an international, randomised, double-blind, sham-controlled, pivotal trial. Lancet. 2019 Jul 20;394(10194):219-229. doi: 10.1016/S0140-6736(19)31192-4. Epub 2019 May 24.

lead_sponsor: BrainsGate

location_country:
Finland
Germany
Italy
North Macedonia
Poland
Portugal
Slovakia
Israel
Hong Kong
Denmark
United States
Spain
Czechia
Ukraine
Canada
Georgia
Serbia
France

location_facility: Special Hospital for Cerebrovascular Disease Sveti Sava

location_facility: Center for Stroke Research at Charite University of Berlin

location_facility: Vitkovicka nemocnice a.s. Ostrava Vitkovice

location_facility: Complejo Hospitalarion Univiersitario de Santiago

location_facility: University of Toledo Medical Center- Campus 1

location_facility: University of Toledo Medical Center- Campus 2

location_facility: Neurologické Oddelenie, Nemocnica s Poliklinikou Spišská

location_facility: Neurologické Oddelenie FN Trnava, Fakultná Nemocnica

location_facility: University Hospital of Ostrava, Ostrava Poruba

location_facility: Department of Medicine, Stroke Program, University of Alberta Hospital

location_facility: Emergency Neurology Clinic Neurology Ltd.

location_facility: Unidade de AVC Centro Hospitalar São João

location_facility: Foothills Medical Centre/University of Calgary, Department of Clinical Neurosciences

location_facility: Centro Hospitalar de Douro e Vouga, EPE - Hospital de São Sebastião

location_facility: High Technology Medical Center University Clinic LTD.

intervention_type: Device


title: Shockless Implant Evaluation

acronym: SIMPLE

summary:
This trial will assess the safety of defibrillator testing and the influence of defibrillation testing on the efficacy of clinical shocks.

The trial will test the hypothesis that implantable cardioverter defibrillator (ICD) implantation without defibrillation testing (DT) is non-inferior to implantation with testing against the composite endpoint of ineffective first appropriate clinical shock or arrhythmic death.

It will also test the hypothesis, that defibrillation testing increases the peri-operative (30 days) complication rate of ICD implantation.

ReferenceCitation: Vamos M, Healey JS, Wang J, Connolly SJ, Mabo P, Van Erven L, Kautzner J, Glikson M, Neuzner J, O'Hara G, Vinolas X, Gadler F, Hohnloser SH. Implantable cardioverter-defibrillator therapy in hypertrophic cardiomyopathy: A SIMPLE substudy. Heart Rhythm. 2018 Mar;15(3):386-392. doi: 10.1016/j.hrthm.2017.11.020. Epub 2017 Nov 20.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

repository_normalized: HAL

repositories_concat: HAL

ReferenceCitation: Vamos M, Healey JS, Wang J, Duray GZ, Connolly SJ, van Erven L, Vinolas X, Neuzner J, Glikson M, Hohnloser SH. Troponin levels after ICD implantation with and without defibrillation testing and their predictive value for outcomes: Insights from the SIMPLE trial. Heart Rhythm. 2016 Feb;13(2):504-10. doi: 10.1016/j.hrthm.2015.11.009. Epub 2015 Nov 11.

ReferenceCitation: Healey JS, Hohnloser SH, Glikson M, Neuzner J, Mabo P, Vinolas X, Kautzner J, O'Hara G, VanErven L, Gadler F, Pogue J, Appl U, Gilkerson J, Pochet T, Stein KM, Merkely B, Chrolavicius S, Meeks B, Foldesi C, Thibault B, Connolly SJ; Shockless IMPLant Evaluation [SIMPLE] investigators. Cardioverter defibrillator implantation without induction of ventricular fibrillation: a single-blind, non-inferiority, randomised controlled trial (SIMPLE). Lancet. 2015 Feb 28;385(9970):785-91. doi: 10.1016/S0140-6736(14)61903-6. Epub 2015 Feb 23.

lead_sponsor: Boston Scientific Corporation

sponsor_collaborators:
Boston Scientific Corporation
Guidant Corporation

location_country:
Finland
Germany
Poland
Hungary
Hong Kong
Israel
Australia
Norway
Netherlands
Austria
Sweden
United Kingdom
Spain
Thailand
Malaysia
Czechia
Canada
France

location_facility: Hadassh University Hospital, Mount Scopus

location_facility: Queen Elizabeth II Health Sciences Center

location_facility: Medisch Centrum Haaglanden (MCH) - locatie Westeinde

location_facility: IKEM - Institut klinicke a experimentalni mediciny

location_facility: Allami Egeszsegugyi Kozpont (AEK) Hospital

location_facility: Semmelweis University, Cardiovascular Center

location_facility: Institut universitaire de Cardiologie et de Pneumologie de Quebec

location_facility: Sunnybrook & Women's College Health Sciences Centre

location_facility: University Hospital Bochum Bergmannsheil


lead_sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

summary: The purpose of this study is to evaluate the efficacy and safety of trabectedin compared to standard doxorubicin in participants with advanced translocation-related sarcomas (cancer of connective tissue cells) (TRS).

ReferenceCitation: Blay JY, Leahy MG, Nguyen BB, Patel SR, Hohenberger P, Santoro A, Staddon AP, Penel N, Piperno-Neumann S, Hendifar A, Lardelli P, Nieto A, Alfaro V, Chawla SP. Randomised phase III trial of trabectedin versus doxorubicin-based chemotherapy as first-line therapy in translocation-related sarcomas. Eur J Cancer. 2014 Apr;50(6):1137-47. doi: 10.1016/j.ejca.2014.01.012. Epub 2014 Feb 7.

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

repositories_concat: Zenodo

title: A Randomized, Multicenter, Phase III Trial of Trabectedin (Yondelis) Versus Doxorubicin-based Chemotherapy as First-Line Therapy in Patients With Translocation-Related Sarcomas (TRS)

location_country:
Germany
United Kingdom
United States
Spain
France


summary: Comparison of Nexavar with a placebo as maintenance therapy for patients with advanced Ovarian or primary Peritoneal cancers in complete remission following surgery and one regimen of chemotherapy.

ReferenceCitation: Herzog TJ, Scambia G, Kim BG, Lhomme C, Markowska J, Ray-Coquard I, Sehouli J, Colombo N, Shan M, Petrenciuc O, Oza A. A randomized phase II trial of maintenance therapy with Sorafenib in front-line ovarian carcinoma. Gynecol Oncol. 2013 Jul;130(1):25-30. doi: 10.1016/j.ygyno.2013.04.011. Epub 2013 Apr 13.

title: A Double-Blind, Randomized Phase II Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Ovarian Epithelial Cancer or Primary Peritoneal Cancer Patients Who Have Achieved a Complete Clinical Response After Standard Platinum/Taxane Containing Chemotherapy

location_country:
Finland
Germany
Italy
Poland
Hong Kong
Singapore
Japan
Netherlands
Belgium
United States
Korea, Republic of
Spain
Canada
France


title: A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Main Treatment Period and an Extension Assessing the Efficacy and Safety of AVE0010 on Top of Pioglitazone in Patients With Type 2 Diabetes Not Adequately Controlled With Pioglitazone

acronym: GETGOAL-P

summary:
The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to pioglitazone with or without metformin, over a period of 24 weeks of treatment, followed by an extension.

The primary objective is to assess the effects of lixisenatide when added to pioglitazone on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24.

Secondary objectives are to assess the effects of lixisenatide when added to pioglitazone on the percentage of patients reaching HbA1c less than 7 percent (%) and less than or equal to 6.5%, fasting plasma glucose (FPG), body weight, beta-cell function (assessed by homeostatic model assessment of beta-cell function [HOMA-beta]), and on fasting plasma insulin (FPI), to assess the safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.

ReferenceCitation: Pinget M, Goldenberg R, Niemoeller E, Muehlen-Bartmer I, Guo H, Aronson R. Efficacy and safety of lixisenatide once daily versus placebo in type 2 diabetes insufficiently controlled on pioglitazone (GetGoal-P). Diabetes Obes Metab. 2013 Nov;15(11):1000-7. doi: 10.1111/dom.12121. Epub 2013 May 26.

publisher_dissemination: Wiley

location_country:
Germany
Guatemala
India
Romania
Austria
Mexico
United States
Greece
Turkey
Peru
Canada
Puerto Rico
France

location_facility: Sanofi-Aventis Investigational Site Number 840865

location_facility: Sanofi-Aventis Investigational Site Number 124704

location_facility: Sanofi-Aventis Investigational Site Number 840775

location_facility: Sanofi-Aventis Investigational Site Number 840745

location_facility: Sanofi-Aventis Investigational Site Number 320702

location_facility: Sanofi-Aventis Investigational Site Number 840744

location_facility: Sanofi-Aventis Investigational Site Number 124710

location_facility: Sanofi-Aventis Investigational Site Number 840729

location_facility: Sanofi-Aventis Investigational Site Number 840774

location_facility: Sanofi-Aventis Investigational Site Number 840755

location_facility: Sanofi-Aventis Investigational Site Number 604705

location_facility: Sanofi-Aventis Investigational Site Number 840795

location_facility: Sanofi-Aventis Investigational Site Number 840757

location_facility: Sanofi-Aventis Investigational Site Number 840701

location_facility: Sanofi-Aventis Investigational Site Number 840779

location_facility: Sanofi-Aventis Investigational Site Number 124713

location_facility: Sanofi-Aventis Investigational Site Number 250702

location_facility: Sanofi-Aventis Investigational Site Number 840868

location_facility: Sanofi-Aventis Investigational Site Number 840730

location_facility: Sanofi-Aventis Investigational Site Number 840798

location_facility: Sanofi-Aventis Investigational Site Number 840780

location_facility: Sanofi-Aventis Investigational Site Number 840751

location_facility: Sanofi-Aventis Investigational Site Number 840723

location_facility: Sanofi-Aventis Investigational Site Number 840770

location_facility: Sanofi-Aventis Investigational Site Number 840851

location_facility: Sanofi-Aventis Investigational Site Number 840763

location_facility: Sanofi-Aventis Investigational Site Number 840879

location_facility: Sanofi-Aventis Investigational Site Number 840727

location_facility: Sanofi-Aventis Investigational Site Number 604703

location_facility: Sanofi-Aventis Investigational Site Number 840743

location_facility: Sanofi-Aventis Investigational Site Number 840877

location_facility: Sanofi-Aventis Investigational Site Number 124708

location_facility: Sanofi-Aventis Investigational Site Number 840716

location_facility: Sanofi-Aventis Investigational Site Number 840855

location_facility: Sanofi-Aventis Investigational Site Number 484703

location_facility: Sanofi-Aventis Investigational Site Number 276706

location_facility: Sanofi-Aventis Investigational Site Number 276701

location_facility: Sanofi-Aventis Investigational Site Number 840704

location_facility: Sanofi-Aventis Investigational Site Number 840792

location_facility: Sanofi-Aventis Investigational Site Number 840741

location_facility: Sanofi-Aventis Investigational Site Number 840709

location_facility: Sanofi-Aventis Investigational Site Number 356703

location_facility: Sanofi-Aventis Investigational Site Number 604701

location_facility: Sanofi-Aventis Investigational Site Number 840769

location_facility: Sanofi-Aventis Investigational Site Number 840717

location_facility: Sanofi-Aventis Investigational Site Number 840863

location_facility: Sanofi-Aventis Investigational Site Number 840785

location_facility: Sanofi-Aventis Investigational Site Number 040705

location_facility: Sanofi-Aventis Investigational Site Number 792705

location_facility: Sanofi-Aventis Investigational Site Number 040706

location_facility: Sanofi-Aventis Investigational Site Number 250705

location_facility: Sanofi-Aventis Investigational Site Number 840872

location_facility: Sanofi-Aventis Investigational Site Number 840871

location_facility: Sanofi-Aventis Investigational Site Number 124716

location_facility: Sanofi-Aventis Investigational Site Number 840857

location_facility: Sanofi-Aventis Investigational Site Number 840767

location_facility: Sanofi-Aventis Investigational Site Number 840782

location_facility: Sanofi-Aventis Investigational Site Number 840739

location_facility: Sanofi-Aventis Investigational Site Number 840711

location_facility: Sanofi-Aventis Investigational Site Number 484704

location_facility: Sanofi-Aventis Investigational Site Number 642702

location_facility: Sanofi-Aventis Investigational Site Number 642707

location_facility: Sanofi-Aventis Investigational Site Number 840867

location_facility: Sanofi-Aventis Investigational Site Number 840752

location_facility: Sanofi-Aventis Investigational Site Number 642706

location_facility: Sanofi-Aventis Investigational Site Number 040707

location_facility: Sanofi-Aventis Investigational Site Number 840760

location_facility: Sanofi-Aventis Investigational Site Number 840853

location_facility: Sanofi-Aventis Investigational Site Number 840708

location_facility: Sanofi-Aventis Investigational Site Number 642715

location_facility: Sanofi-Aventis Investigational Site Number 840875

location_facility: Sanofi-Aventis Investigational Site Number 840707

location_facility: Sanofi-Aventis Investigational Site Number 276702

location_facility: Sanofi-Aventis Investigational Site Number 840765

location_facility: Sanofi-Aventis Investigational Site Number 124705

location_facility: Sanofi-Aventis Investigational Site Number 300703

location_facility: Sanofi-Aventis Investigational Site Number 604702

location_facility: Sanofi-Aventis Investigational Site Number 040701

location_facility: Sanofi-Aventis Investigational Site Number 840773

location_facility: Sanofi-Aventis Investigational Site Number 356701

location_facility: Sanofi-Aventis Investigational Site Number 642711

location_facility: Sanofi-Aventis Investigational Site Number 840858

location_facility: Sanofi-Aventis Investigational Site Number 840740

location_facility: Sanofi-Aventis Investigational Site Number 840874

location_facility: Sanofi-Aventis Investigational Site Number 840789

location_facility: Sanofi-Aventis Investigational Site Number 840735

location_facility: Sanofi-Aventis Investigational Site Number 840766

location_facility: Sanofi-Aventis Investigational Site Number 276707

location_facility: Sanofi-Aventis Investigational Site Number 840712

location_facility: Sanofi-Aventis Investigational Site Number 642714

location_facility: Sanofi-Aventis Investigational Site Number 276703

location_facility: Sanofi-Aventis Investigational Site Number 840776

location_facility: Sanofi-Aventis Investigational Site Number 124703

location_facility: Sanofi-Aventis Investigational Site Number 642708

location_facility: Sanofi-Aventis Investigational Site Number 642703

location_facility: Sanofi-Aventis Investigational Site Number 840720

location_facility: Sanofi-Aventis Investigational Site Number 356702

location_facility: Sanofi-Aventis Investigational Site Number 642710

location_facility: Sanofi-Aventis Investigational Site Number 484701

location_facility: Sanofi-Aventis Investigational Site Number 840721

location_facility: Sanofi-Aventis Investigational Site Number 840862

location_facility: Sanofi-Aventis Investigational Site Number 320701

location_facility: Sanofi-Aventis Investigational Site Number 840761

location_facility: Sanofi-Aventis Investigational Site Number 840777

location_facility: Sanofi-Aventis Investigational Site Number 840728

location_facility: Sanofi-Aventis Investigational Site Number 840854

location_facility: Sanofi-Aventis Investigational Site Number 840796

location_facility: Sanofi-Aventis Investigational Site Number 300701

location_facility: Sanofi-Aventis Investigational Site Number 630715

location_facility: Sanofi-Aventis Investigational Site Number 630714

location_facility: Sanofi-Aventis Investigational Site Number 300705

location_facility: Sanofi-Aventis Investigational Site Number 124711

location_facility: Sanofi-Aventis Investigational Site Number 840791

location_facility: Sanofi-Aventis Investigational Site Number 840733

location_facility: Sanofi-Aventis Investigational Site Number 276704

location_facility: Sanofi-Aventis Investigational Site Number 792702

location_facility: Sanofi-Aventis Investigational Site Number 356704

location_facility: Sanofi-Aventis Investigational Site Number 840772

location_facility: Sanofi-Aventis Investigational Site Number 250707

location_facility: Sanofi-Aventis Investigational Site Number 840799

location_facility: Sanofi-Aventis Investigational Site Number 840764

location_facility: Sanofi-Aventis Investigational Site Number 840866

location_facility: Sanofi-Aventis Investigational Site Number 840726

location_facility: Sanofi-Aventis Investigational Site Number 250704

location_facility: Sanofi-Aventis Investigational Site Number 840724

location_facility: Sanofi-Aventis Investigational Site Number 300704

location_facility: Sanofi-Aventis Investigational Site Number 840753

location_facility: Sanofi-Aventis Investigational Site Number 642709

location_facility: Sanofi-Aventis Investigational Site Number 642713

location_facility: Sanofi-Aventis Investigational Site Number 124712

location_facility: Sanofi-Aventis Investigational Site Number 840784

location_facility: Sanofi-Aventis Investigational Site Number 642712

location_facility: Sanofi-Aventis Investigational Site Number 840758

location_facility: Sanofi-Aventis Investigational Site Number 840762

location_facility: Sanofi-Aventis Investigational Site Number 840738

location_facility: Sanofi-Aventis Investigational Site Number 320703

location_facility: Sanofi-Aventis Investigational Site Number 840722

location_facility: Sanofi-Aventis Investigational Site Number 276708

location_facility: Sanofi-Aventis Investigational Site Number 840794

location_facility: Sanofi-Aventis Investigational Site Number 040704

location_facility: Sanofi-Aventis Investigational Site Number 840747

location_facility: Sanofi-Aventis Investigational Site Number 642701

location_facility: Sanofi-Aventis Investigational Site Number 840864

location_facility: Sanofi-Aventis Investigational Site Number 642705

location_facility: Sanofi-Aventis Investigational Site Number 250701

location_facility: Sanofi-Aventis Investigational Site Number 124701

location_facility: Sanofi-Aventis Investigational Site Number 840756

location_facility: Sanofi-Aventis Investigational Site Number 040702

location_facility: Sanofi-Aventis Investigational Site Number 840850

location_facility: Sanofi-Aventis Investigational Site Number 320704


lead_sponsor: Hoffmann-La Roche

summary: This 4 arm study in patients with advanced Stage IIIb/IV non-small cell cancer (NSCLC) who failed at least one standard chemotherapy regimen will determine the proportion of patients with progression-free survival at 12 weeks following combination therapy with R1507 and Tarceva or placebo and Tarceva. Patients will be randomized to one of four treatment arms to receive R1507 (9mg/kg iv) or placebo weekly or R1507 (16mg/kg iv) or placebo every 3 weeks. Tarceva (150mg oral daily) will be administered in all treatment arms. Other disease-related endpoints including overall survival, objective response rate, time to response, time to progressive disease and duration of response will also be evaluated. The anticipated time on study treatment is 1-2 years, and the target sample size is <500 individuals.

ReferenceCitation: Ramalingam SS, Spigel DR, Chen D, Steins MB, Engelman JA, Schneider CP, Novello S, Eberhardt WE, Crino L, Habben K, Liu L, Janne PA, Brownstein CM, Reck M. Randomized phase II study of erlotinib in combination with placebo or R1507, a monoclonal antibody to insulin-like growth factor-1 receptor, for advanced-stage non-small-cell lung cancer. J Clin Oncol. 2011 Dec 1;29(34):4574-80. doi: 10.1200/JCO.2011.36.6799. Epub 2011 Oct 24.

location_facility: Arcispedale Santa Maria Nuova; Oncologia

location_facility: Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico

location_facility: Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin I

location_facility: Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii

location_facility: Wythenshawe Hospital; North West Lung Centre

location_facility: Fondation Hopital Saint Joseph; Pole Cancerologie, Imagerie Medicale Service d'Oncologie

location_facility: Hopital de La Croix Rousse; Service de Pneumologie

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

location_facility: Hopital Albert Michallon; Medecine Aigue Specialisee Pneumologie

location_facility: Chattanooga Oncology and Hematology Associates, PC

location_facility: IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A

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

location_facility: Zentralklinik Bad Berka GmbH; Pneumologie

location_facility: Ludwig-Maximilians Uni Klinik Innenstadt; Medizinische Klinik

location_facility: Joliet Oncology Hematology Associates, Ltd.

location_facility: Hospital de Cruces; Servicio de Oncologia

location_facility: Hopital Larrey; Clinique Des Voies Respiratoires

location_facility: Klinikum Leverkusen; Med. Klinik III / Onkologie

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

location_facility: Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

location_facility: University of Chicago Medical Center; Dept. of Medicine/Section of Nephrology

location_facility: SK Przemienienia Panskiego UM im.K.Marcinkowskiego

location_facility: Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia

location_facility: Specjalistyczny Szpital Im. Prof. A. Sokolowskiego; Oddziall Chemioterapii

location_facility: Stiftung Kathol. Krankenhaus Marienhospital Herne Klinik Mitte Frauenklinik

location_facility: Carolina Oncology Specialists, PA - Hickory

location_facility: Flinders Medical Center; Medical Oncology

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia

title: A Randomized, Placebo Controlled Study to Determine the Effect of Two Dose Schedules of R1507 or Placebo, Both in Combination With Erlotinib (Tarceva®), on Progression-free Survival in Patients With Advanced Non-small Cell Lung Cancer With Disease Progression After First or Second Line Chemotherapy

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

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


summary: The primary goal of this study was to determine the rate of confirmed best cumulative complete molecular response (CMR) within the first year of study therapy with imatinib or nilotinib. The study also explored the impact and significance of the achieved CMR on patient outcomes (progression free survival (PFS), event free survival (EFS) and overall survival (OS), characterized the kinetics of CMR achieved in both treatment arms and after the cross-over.

ReferenceCitation: Hughes TP, Lipton JH, Spector N, Cervantes F, Pasquini R, Clementino NC, Dorlhiac Llacer PE, Schwarer AP, Mahon FX, Rea D, Branford S, Purkayastha D, Collins L, Szczudlo T, Leber B. Deep molecular responses achieved in patients with CML-CP who are switched to nilotinib after long-term imatinib. Blood. 2014 Jul 31;124(5):729-36. doi: 10.1182/blood-2013-12-544015. Epub 2014 Jun 19.

publisher_dissemination: American Society of Hematology

title: An Open Label, Randomized Study of Nilotinib vs. Standard Imatinib (400/600 mg QD) Comparing the Kinetics of Complete Molecular Response for CML-CP Patients With Evidence of Persistent Leukemia by RQ-PCR.

location_country: Argentina Australia Brazil Spain Canada France


title: A Multicenter, Randomized, Double-dummy, Placebo and Active-controlled Study to Assess the Safety, Tolerability and Effect of Taspoglutide on Glycemic Control Compared to Sitagliptin and Placebo in Patients With Type II Diabetes Mellitus Inadequately Controlled With Metformin.

summary: This 4 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to sitagliptin and placebo in patients with type 2 diabetes mellitus inadequately controlled with metformin. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly), sitagliptin 100mg once daily or placebo, in a ratio of 2:2:2:1, in addition to their continued prestudy metformin treatment. After 24 weeks of treatment, patients on active treatment will continue on the same treatment and patients on placebo will be switched to taspoglutide 10mg once weekly or taspoglutide 20mg once weekly (after 4 weeks of taspoglutide 10mg once weekly). The anticipated time on study treatment is 2+ years, and the target sample size is 500+ individuals.

location_country:
Germany
Poland
Argentina
Australia
Thailand
Turkey
Canada
France
Slovakia
Switzerland
United States
Romania
Peru
Puerto Rico
Norway
United Kingdom
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Sweden


title: A Multi-center, Open-label, Follow-up Study to Assess the Long-term Safety of 125 mg Per Day of Oral Azimilide Dihydrochloride in Patients With an Implantable Cardioverter Defibrillator

summary: This is an open-label, multi-center, long-term, (open-ended) safety study with 125 mg per day of azimilide in patients who completed protocol 2000098.

lead_sponsor: Forest Laboratories

location_country:
Germany
Poland
Belgium
United States
Spain
Canada
France

location_facility:
Research Facility
Research Site


title: A Double-Blind, Randomized, Parallel Two-Arm Phase II Trial of BMS-690514 Versus Erlotinib in Previously Treated NSCLC Patients

summary: The purpose of this study is to improve disease control and survival for patients who were treated with chemotherapy using BMS-690514 over erlotinib

location_country:
Poland
Argentina
United States
Korea, Republic of
Spain
Taiwan
Canada
France

location_facility: Piedmont Hematology Oncology Associates, Pllc


lead_sponsor: Eisai Inc.

summary: The purpose of this study was to evaluate the safety and tolerability of perampanel (up to 12 mg/day) given as adjunctive treatment in subjects with refractory partial seizures and to evaluate the maintenance of effect of perampanel for the control of refractory partial seizures.

ReferenceCitation: Maguire M. Response to "Perampanel and pregnancy: Could experience be a gloomy lantern that does not even illuminate its bearer?". Epilepsy Behav. 2022 Apr;129:108654. doi: 10.1016/j.yebeh.2022.108654. Epub 2022 Mar 16. No abstract available.

ReferenceCitation: Krauss GL, Perucca E, Kwan P, Ben-Menachem E, Wang XF, Shih JJ, Patten A, Yang H, Williams B, Laurenza A. Final safety, tolerability, and seizure outcomes in patients with focal epilepsy treated with adjunctive perampanel for up to 4 years in an open-label extension of phase III randomized trials: Study 307. Epilepsia. 2018 Apr;59(4):866-876. doi: 10.1111/epi.14044. Epub 2018 Mar 25.

ReferenceCitation: Rosenfeld W, Conry J, Lagae L, Rozentals G, Yang H, Fain R, Williams B, Kumar D, Zhu J, Laurenza A. Efficacy and safety of perampanel in adolescent patients with drug-resistant partial seizures in three double-blind, placebo-controlled, phase III randomized clinical studies and a combined extension study. Eur J Paediatr Neurol. 2015 Jul;19(4):435-45. doi: 10.1016/j.ejpn.2015.02.008. Epub 2015 Mar 5.

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

ReferenceCitation: Krauss GL, Perucca E, Ben-Menachem E, Kwan P, Shih JJ, Clement JF, Wang X, Bagul M, Gee M, Zhu J, Squillacote D. Long-term safety of perampanel and seizure outcomes in refractory partial-onset seizures and secondarily generalized seizures: results from phase III extension study 307. Epilepsia. 2014 Jul;55(7):1058-68. doi: 10.1111/epi.12643. Epub 2014 May 27.

repositories_concat: PubMed Central;University of Melbourne - Minerva Access

title: An Open-Label Extension Phase of the Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Studies to Evaluate the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures

location_country:
Finland
Germany
Poland
Argentina
Australia
Thailand
Chile
Canada
Serbia
France
Czech Republic
Lithuania
Portugal
Hungary
Hong Kong
United States
Latvia
Ukraine
India
Romania
Belgium
China
Malaysia
Estonia
Philippines
Italy
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


lead_sponsor: Acrotech Biopharma Inc.

summary: The purpose of this study is to determine whether pralatrexate, given with vitamin B12 and folic acid, is effective in the treatment of advanced or metastatic bladder cancer. The study will also investigate the safety of pralatrexate with vitamin B12 and folic acid in this patient population. Additionally, this study includes the collection of blood samples to investigate the pharmacokinetics (PK) of pralatrexate in this patient population (PK is the activity of a drug in the body over a period of time, including how the drug is absorbed, distributed in the body, localized in the tissues, and excreted from the body).

location_facility: The University of Arizona Health Sciences Center

location_facility: University of Utah, Huntsman Cancer Institute

location_facility: CHU Zagreb University Hospital Center Rebro in Zagreb

location_facility: CH Split Clinic of Oncology and Radiotherapy

location_facility: Clinic of Oncology and Nuclear Medicine, CH "Sestre Milosrdnice"

location_facility: Centro de Terapia Radiante Cumbres (CAICI)

title: A Phase 2, Single-Arm Study of Pralatrexate in Patients With Advanced or Metastatic Relapsed Transitional Cell Carcinoma of the Urinary Bladder

location_country:
Argentina
Belgium
United States
Spain
Croatia
France


title: A Multicenter Open Label Phase II Study of the Efficacy and Safety of AMG 479, a Fully Human Monoclonal Antibody Against Insulin-like Growth Factor Type 1 Receptor (IGF-1R) as Second Line Therapy in Patients With Recurrent Platinum Sensitive Ovarian Cancer

summary: The purpose of this study is to obtain an estimate of the objective response rate (ORR) of AMG 479 in patients with recurrent platinum-sensitive ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma failing frontline chemotherapy.

lead_sponsor: Translational Research in Oncology

location_country:
Ireland
Germany
Israel
United States
Spain
Canada
France

location_facility: Ventura County Hematology Oncology Specialists

location_facility: Centre Hospitalier Départemental Les Oudairies

location_facility: University of Southern California/ Norris Comprehensive Cancer Center

location_facility: Central Hematology Oncology Medical Group Inc.

location_facility: Hospital Universitario Virgen Macarena de Sevilla

location_facility: North Valley Hematology/ Oncology Medical Group

intervention_type: Biological


title: A 12-week, Open Label, Multicenter, Titration Study, With a 9-month Maintenance Treatment Extension, to Demonstrate Efficacy of SBR759 Compared to Sevelamer HCl in Lowering Serum Phosphate Levels in Chronic Kidney Disease Patients on Hemodialysis

summary: This study will evaluate the efficacy of SBR759 compared to sevelamer HCl in lowering serum phosphate levels in Chronic Kidney Disease patients on hemodialysis

ReferenceCitation: Chen JB, Chiang SS, Chen HC, Obayashi S, Nagasawa M, Hexham JM, Balfour A, Junge G, Akiba T, Fukagawa M. Efficacy and safety of SBR759, a novel calcium-free, iron(III)-based phosphate binder, in Asian patients undergoing hemodialysis: A 12-week, randomized, open-label, dose-titration study versus sevelamer hydrochloride. Nephrology (Carlton). 2011 Nov;16(8):743-50. doi: 10.1111/j.1440-1797.2011.01509.x.

location_country:
Finland
Germany
Italy
Norway
United Kingdom
Australia
Sweden
Switzerland
Belgium
United States
Canada
Puerto Rico
France

location_facility:
Novartis Investigative Site
Novarits
Novartis


lead_sponsor: Novo Nordisk A/S

summary: This trial was conducted in Europe,Asia and Africa. Study participants were randomised evenly to treatment with semaglutide (0.1 mg QW - 1.6 mg QW, 6 treatment arms, placebo or liraglutide (1.2 mg QD, or 1.8 mg QD).Treatment allocation to semaglutide or placebo was double-blind, whereas liraglutide treatment was administered open-label.Primary efficacy parameter was HbA1c and the treatment duration was 12 weeks.

ReferenceCitation: Nauck MA, Petrie JR, Sesti G, Mannucci E, Courreges JP, Lindegaard ML, Jensen CB, Atkin SL; Study 1821 Investigators. A Phase 2, Randomized, Dose-Finding Study of the Novel Once-Weekly Human GLP-1 Analog, Semaglutide, Compared With Placebo and Open-Label Liraglutide in Patients With Type 2 Diabetes. Diabetes Care. 2016 Feb;39(2):231-41. doi: 10.2337/dc15-0165. Epub 2015 Sep 10.

publisher_dissemination: American Diabetes Association

title: Investigation of Safety and Efficacy of Five Doses of Semaglutide Versus Placebo and Open-label Liraglutide, as Add on Therapy, in Subjects Diagnosed With Type 2 Diabetes Currently Treated With Metformin or Controlled With Diet and Exercise A 12 Week Multi-centre, Multi National, Double-blind, Placebo-controlled, Randomised, Nine Armed Parallel Group, Dose Finding Trial

location_country:
Finland
Former Serbia and Montenegro
Germany
Italy
India
Hungary
United Kingdom
Switzerland
Austria
Spain
South Africa
Turkey
Bulgaria
France


title: An Open-Label, Multi-center Study to Evaluate the Safety and Tolerability of Intramuscular Administration of Alefacept (LFA-3/IgG1 Fusion Protein) in Subjects With Chronic Plaque Psoriasis Who Have Completed Studies C99-717 or C99-712

summary: An extension study to evaluate safety and tolerability of up to 3 additional courses of IM alefacept in patients with chronic plaque psoriasis who have been previously treated with 1 or 2 courses of IM alefacept.

ReferenceCitation: Roberts JL, Ortonne JP, Tan JK, Jaracz E, Frankel E; Alefacept Clinical Study Group. The safety profile and sustained remission associated with response to multiple courses of intramuscular alefacept for treatment of chronic plaque psoriasis. J Am Acad Dermatol. 2010 Jun;62(6):968-78. doi: 10.1016/j.jaad.2009.07.032. Epub 2010 Apr 14.

lead_sponsor: Astellas Pharma Inc

sponsor_collaborators:
Astellas Pharma Inc
Biogen

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


title: Cetrorelix Pamoate (AEZS-102) in Patients With Symptomatic BPH: a Double-blind Placebo-controlled Efficacy Study

summary:
Benign Prostatic Hypertrophy (BPH) is a common and bothersome condition of aging men. It is characterized by an enlargement of the prostate occurring in human male over the age of 50 which increases in prevalence with age, and among those aged 50 to 80, about 40% report moderate or severe urinary symptoms of prostatism. The aim of treatment is to improve patients' quality of life which primarily depends on the severity of the symptoms of BPH. Current treatments of BPH have a benefit / risk ratio which leaves room for improvement.

For this study, study medication (Cetrorelix pamoate or placebo) is administered by injection in the buttocks (Intramuscular). All patients completing the double-blind portion (Week 0 to 52) are eligible to receive the active drug during the open-label part of the study (Week 52 to 90).

lead_sponsor: AEterna Zentaris

location_country: Macedonia, The Former Yugoslav Republic of

location_facility: Spitalul Clinic de Urgenta "Sf. Ioan", Clinica Urologie

location_facility: Minsk Regional Clinical Hospital, Clinic of Urology

location_facility: University of Bari, Department of Urology

location_facility: Policlinic Pod Marjánkou 12, Urological Department

location_facility: University multiprofil Hospital of Active Treatment "Sveti Georgi", Urology Department

location_facility: Aleksandrovska Hospital, Oncourology Department

location_facility: Aleksandrovska Hospital, Kidney Transplantation Department

location_facility: 19th Central Regional Policlinic, Urology department

location_facility: Multiprofil Hospital "Sveta Anna", Urology Department

location_facility: Urocentrum Prague, Out-Patient Clinic of Urology

location_facility: 1st Medical Faculty of Charles University, Deputy Department and Clinic of Urology

location_facility: Klinikum Offenbach GmbH, Klinik für Urologie

location_facility: Urologische Klinik, Ev. Krankenhaus Oberhausen

location_facility: Irccs Ospedale San Raffaele Milano, Università Vita Salute-San Raffaele

location_facility: Clinica Chirurgie Urologica si Transplant Renal

location_facility: Bristol Royal Infirmary, Urology Research Unit

location_facility: Spitalul Clinic de Urologie "Prof. Dr. Th. Burghele"

location_facility: National Central Hospital for Active Treatment of Oncology JSC

location_facility: Leicester General Hospital, Urology Section

location_facility: Urologische Praxisgemeinschaft Frankfurt Höchst

location_facility: Leighton Hospital, Clinical Trials Dept., Michael Heal Unit

location_facility: University of Padova, Department of Urology


title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Randomized, Phase 2/3 Trial to Evaluate the Glycemic Efficacy, Renal Safety, Pharmacokinetics, and Pharmacodynamics of Dapagliflozin in Subjects With Type 2 Diabetes Mellitus and Moderate Renal Impairment Who Have Inadequate Glycemic Control

summary: The purpose of this study is to determine whether dapagliflozin is effective in the treatment of type 2 diabetes in subjects with poor blood sugar control and moderate renal impairment

ReferenceCitation: Fioretto P, Stefansson BV, Johnsson E, Cain VA, Sjostrom CD. Dapagliflozin reduces albuminuria over 2 years in patients with type 2 diabetes mellitus and renal impairment. Diabetologia. 2016 Sep;59(9):2036-9. doi: 10.1007/s00125-016-4017-1. Epub 2016 Jun 15. No abstract available.

repositories_concat: PubMed Central;www.research.unipd.it

ReferenceCitation: Kohan DE, Fioretto P, Tang W, List JF. Long-term study of patients with type 2 diabetes and moderate renal impairment shows that dapagliflozin reduces weight and blood pressure but does not improve glycemic control. Kidney Int. 2014 Apr;85(4):962-71. doi: 10.1038/ki.2013.356. Epub 2013 Sep 25.

lead_sponsor: AstraZeneca

sponsor_collaborators:
AstraZeneca
Bristol-Myers Squibb

location_country:
Italy
India
Argentina
Denmark
Australia
Singapore
Mexico
United States
Spain
Peru
Canada
Puerto Rico
France

location_facility: University Of Medicine And Dentistry Of New Jersey

location_facility: Zablocki Veterans Affairs Medical Center

location_facility: Center For Thyroid Diseases And Endocrinology

location_facility: Va Nebraska-Western Iowa Health Care System (Nwihcs)


acronym: Not applicable

summary: The purpose of this study is to determine the safety and efficacy of Rabeprazole extended release (ER) 50 mg versus Esomeprazole 40 mg for healing and symptomatic relief among subjects with erosive gastroesophageal reflux disease (GERD).

ReferenceCitation: Laine L, Katz PO, Johnson DA, Ibegbu I, Goldstein MJ, Chou C, Rossiter G, Lu Y. Randomised clinical trial: a novel rabeprazole extended release 50 mg formulation vs. esomeprazole 40 mg in healing of moderate-to-severe erosive oesophagitis - the results of two double-blind studies. Aliment Pharmacol Ther. 2011 Jan;33(2):203-12. doi: 10.1111/j.1365-2036.2010.04516.x. Epub 2010 Nov 30.

title: A Randomized Double-Blind Parallel Study of Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD)

location_country:
Germany
India
Hungary
Argentina
Australia
Estonia
United States
Latvia
Croatia
Chile
Bulgaria
Canada
France


title: A Randomized, Open-label, Dose-escalation to Rash Study to Assess the Effect of Tarceva in Combination With Gemcitabine on Overall Survival in Patients With Metastatic Pancreatic Cancer.

summary: This study will compare the efficacy and safety of escalating versus standard doses to rash of Tarceva, in combination with gemcitabine, in patients with metastatic pancreatic cancer. During a 4 week run-in period, all patients will receive Tarceva 100mg/day po plus gemcitabine 1000mg/m2 iv on days 1, 8,15 and 22. After 4 weeks, patients who have not developed rash, or only develop grade 1 rash, will be randomized to one of 2 groups. Group 1 will receive a starting dose of Tarceva 150mg po daily, increased in steps of 50mg every 2 weeks up to a maximum of 250mg/day po, until development of grade 2 rash or other dose-limiting toxicity. Group 2 will continue to receive Tarceva 100mg/day po. All patients will continue to receive gemcitabine 1000mg/m2 iv on days 1, 8 and 15 of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

location_country:
Germany
Poland
Argentina
Australia
Brazil
Croatia
Canada
Serbia
France
Lithuania
Hong Kong
Denmark
Romania
Belgium
Italy
United Kingdom
Singapore
Austria
Mexico
Spain
Greece
Taiwan
Israel


title: A Prospective Randomized Open-label 6-Month Head-To-Head Trial to Compare Metabolic Effects of Paliperidone ER and Olanzapine in Subjects With Schizophrenia

summary: The purpose of this 6 month study is to compare the metabolic effects of paliperidone ER and olanzapine in patients with schizophrenia, using the ratio of the concentration of lipids (triglycerides (TG)) in the blood to the concentration of good cholesterol (high density lipoproteins (HDL)) in the blood as the primary parameter. Approximately 456 adult patients will participate in this study.

lead_sponsor: Janssen-Cilag International NV

location_country:
Lithuania
Slovakia
Argentina
Romania
Lebanon
Latvia
Spain
Greece
South Africa
Turkey
Jordan
Estonia
Egypt
France


summary: The study was primarily designed to determine objective response, progression-free survival (PFS), and the safety and tolerability of R1507 in participants with recurrent or refractory Ewing's sarcoma, osteosarcoma, synovial sarcoma, rhabdomyosarcoma and other sarcomas including alveolar soft part sarcoma, desmoplastic small round cell tumor, extraskeletal myxoid chondrosarcoma, clear cell sarcoma, and myxoid liposarcoma.

ReferenceCitation: Asmane I, Watkin E, Alberti L, Duc A, Marec-Berard P, Ray-Coquard I, Cassier P, Decouvelaere AV, Ranchere D, Kurtz JE, Bergerat JP, Blay JY. Insulin-like growth factor type 1 receptor (IGF-1R) exclusive nuclear staining: a predictive biomarker for IGF-1R monoclonal antibody (Ab) therapy in sarcomas. Eur J Cancer. 2012 Nov;48(16):3027-35. doi: 10.1016/j.ejca.2012.05.009. Epub 2012 Jun 7.

ReferenceCitation: Pappo AS, Patel SR, Crowley J, Reinke DK, Kuenkele KP, Chawla SP, Toner GC, Maki RG, Meyers PA, Chugh R, Ganjoo KN, Schuetze SM, Juergens H, Leahy MG, Geoerger B, Benjamin RS, Helman LJ, Baker LH. R1507, a monoclonal antibody to the insulin-like growth factor 1 receptor, in patients with recurrent or refractory Ewing sarcoma family of tumors: results of a phase II Sarcoma Alliance for Research through Collaboration study. J Clin Oncol. 2011 Dec 1;29(34):4541-7. doi: 10.1200/JCO.2010.34.0000. Epub 2011 Oct 24.

location_facility: Washington Cancer Institute; Washington Hospital Center

location_facility: Institut Gustave Roussy; Service Pediatrique

location_facility: University of Texas M.D. Anderson Cancer Center

location_facility: Erasmus Mc - Daniel Den Hoed Kliniek; Medical Oncology

location_facility: Peter Maccallum Cancer Institute; Medical Oncology

location_facility: Uniklinik Mannheim; Sektion Chirurgische Onkologie & Thoraxchirurgie

location_facility: HELIOS Klinikum Bad Saarow; Klinik für Innere Medizin III

location_facility: Huntsman Cancer Institute; Orthopedic Center

location_facility: Oregon Health and Science University Cancer Institute

location_facility: Massachusetts General Hospital; Dana Farber Partnes Cancer Center

location_facility: UCLA School Of Medicine Mattel's Children's Hospital At UCLA; Division Of Hematology-Oncology

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Skånes University Hospital, Skånes Department of Onclology

location_facility: Centre Oscar Lambret; Chir Cancerologie General

location_facility: Albert Einstein College of Medical Pediatrics; Department of Pediatrics

location_facility: Nebraska Methodist Hospital; Onc Hem West

location_facility: Carolinas Hematology Oncology Associates; Investigational Drug Services - Pharmacy

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Texas Children's Cancer Center; Baylor College of Medicine

title: A Phase II Trial of R1507, a Recombinant Human Monoclonal Antibody to the Insulin-Like Growth Factor-1 Receptor for the Treatment of Participants With Recurrent or Refractory Ewing's Sarcoma, Osteosarcoma, Synovial Sarcoma, Rhabdomyosarcoma and Other Sarcomas.

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