title: PHASE 1/2, OPEN-LABEL, RANDOMIZED STUDY OF THE SAFETY, EFFICACY, AND PHARMACOKINETICS OF LETROZOLE PLUS PD 0332991 (ORAL CDK 4/6 INHIBITOR) AND LETROZOLE SINGLE AGENT FOR THE FIRST-LINE TREATMENT OF ER POSITIVE, HER2 NEGATIVE ADVANCED BREAST CANCER IN POSTMENOPAUSAL WOMEN

lead_sponsor: Pfizer

ReferenceCitation: Finn RS, Rugo HS, Gelmon KA, Cristofanilli M, Colleoni M, Loi S, Schnell P, Lu DR, Theall KP, Mori A, Gauthier E, Bananis E, Turner NC, Diéras V. Long-Term Pooled Safety Analysis of Palbociclib in Combination with Endocrine Therapy for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Updated Analysis with up to 5 Years of Follow-Up. Oncologist. 2021 May;26(5):e749-e755. doi: 10.1002/onco.13684. Epub 2021 Mar 10.

ReferenceCitation: Finn RS, Boer K, Bondarenko I, Patel R, Pinter T, Schmidt M, Shparyk YV, Thummala A, Voitko N, Bananis E, McRoy L, Wilner K, Huang X, Kim S, Slamon DJ, Ettl J. Overall survival results from the randomized phase 2 study of palbociclib in combination with letrozole versus letrozole alone for first-line treatment of ER+/HER2- advanced breast cancer (PALOMA-1, TRIO-18). Breast Cancer Res Treat. 2020 Sep;183(2):419-428. doi: 10.1007/s10549-020-05755-7. Epub 2020 Jul 18.

ReferenceCitation: Ettl J, Im SA, Ro J, Masuda N, Colleoni M, Schnell P, Bananis E, Lu DR, Cristofanilli M, Rugo HS, Finn RS. Hematologic adverse events following palbociclib dose reduction in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: pooled analysis from randomized phase 2 and 3 studies. Breast Cancer Res. 2020 Mar 12;22(1):27. doi: 10.1186/s13058-020-01263-0.

ReferenceCitation: Rugo HS, Turner NC, Finn RS, Joy AA, Verma S, Harbeck N, Masuda N, Im SA, Huang X, Kim S, Sun W, Iyer S, Schnell P, Bartlett CH, Johnston S. Palbociclib plus endocrine therapy in older women with HR+/HER2- advanced breast cancer: a pooled analysis of randomised PALOMA clinical studies. Eur J Cancer. 2018 Sep;101:123-133. doi: 10.1016/j.ejca.2018.05.017. Epub 2018 Jul 25.

ReferenceCitation: Diéras V, Rugo HS, Schnell P, Gelmon K, Cristofanilli M, Loi S, Colleoni M, Lu DR, Mori A, Gauthier E, Huang Bartlett C, Slamon DJ, Turner NC, Finn RS. Long-term Pooled Safety Analysis of Palbociclib in Combination With Endocrine Therapy for HR+/HER2- Advanced Breast Cancer. J Natl Cancer Inst. 2019 Apr 1;111(4):419-430. doi: 10.1093/jnci/djy109.

ReferenceCitation: Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R. US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments. J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9.

ReferenceCitation: Bell T, Crown JP, Lang I, Bhattacharyya H, Zanotti G, Randolph S, Kim S, Huang X, Huang Bartlett C, Finn RS, Slamon D. Impact of palbociclib plus letrozole on pain severity and pain interference with daily activities in patients with estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer as first-line treatment. Curr Med Res Opin. 2016 May;32(5):959-65. doi: 10.1185/03007995.2016.1157060. Epub 2016 Mar 2.

ReferenceCitation: Finn RS, Crown JP, Lang I, Boer K, Bondarenko IM, Kulyk SO, Ettl J, Patel R, Pinter T, Schmidt M, Shparyk Y, Thummala AR, Voytko NL, Fowst C, Huang X, Kim ST, Randolph S, Slamon DJ. The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study. Lancet Oncol. 2015 Jan;16(1):25-35. doi: 10.1016/S1470-2045(14)71159-3. Epub 2014 Dec 16.

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:
Spain
Ireland
Italy
Russian Federation
Canada
Ukraine
Hungary
Korea, Republic of
United States
France
South Africa
Germany

location_facility: Mutterhaus der Borromaeerinnen, Innere Medizin I

location_facility: Drug Management Only: UCLA West Medical Pharmacy

location_facility: Central Hematology Oncology Medical group Inc.

location_facility: Gwinnett Hospital System Inc.-d/b/a-The Center for Cancer Care

location_facility: Regulatory Office: Comprehensive Cancer Centers of Nevada

location_facility: Santa Monica-UCLA Medical Center and Orthopaedic Hospital

location_facility: UCLA West Medical Pharmacy (Drug Management Only)

location_facility: CSSS Champlain-Charles-Le Moyne Local HS-0054

location_facility: US Oncology Research and Clinical Pharmacy

location_facility: Markusovszky Egyetemi Oktatokorhaz, Onkoradiologiai Osztaly

location_facility: National Cancer Center, Center for Breast Cancer

location_facility: UCLA Hematology/Oncology - Santa Clarita

location_facility: Fovarosi Onkormanyzat Uzsoki Utcai Korhaz

location_facility: Frauenklinik und Poliklinik Klinikum rechts der Isar, Technische Universitaet Muenchen

location_facility: Department of Oncology and Medical Radiology, SI "DMA of MOH, Ukraine, "MI "Dnipropetrovsk City

location_facility: Azienda Unita Sanitaria Locale di Rimini, U.O. di Oncologia ed Oncoematologia Ospedale degli Infermi

location_facility: Westwood Bowyer Clinic, Peter Morton Medical Building

location_facility: Petz Aladar Megyei Oktato Korhaz, Onkoradiologia

location_facility: Municipal clinical treatment-and-propyilactic institution "Donetsk regional oncology center',

location_facility: Nationales Centrum fuer Tumorerkrankungen

location_facility: Department of Oncotherapy, National Hospital

location_facility: Frauenaerzte Pruener Gang Abts & Partner

location_facility: Municipal Treatment-and-Prophylactic Institution 'Donetsk City Oncological Dispensary' Radiology dep

location_facility: Republican Clinical Oncology Dispensary of the Ministry of Health of Bashkortostan Republic

location_facility: TORI Central Administration (Regulatory Management)

location_facility: Lviv State Oncologic Regional Treatment and Diagnostic Centre

location_facility: M.O. di Oncologia - Azienda USL di Rimini - Ospedale "Cervesi"

location_facility: Hospital General Universitario Vall D'Hebron

location_facility: TORI Central Administration (Regulatory Managment Only)

location_facility: CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center

location_facility: North Shore Oncology-Hematology Associates

location_facility: Szabolcs-Szatmar-Bereg Megyei Korhazak es

location_facility: Sansum Santa Barbara Medical Foundation Clinic

location_facility: Central Coast Medical Oncology Corporation

location_facility: Unita' Operativa di Oncologia, Ospedale Civile di Lugo

location_facility: Central Hematology Oncology Medical Group, Inc

location_facility: Divisione Oncologia Medica Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, IRST

location_facility: TORI -US Central Administration (Regulatory Management)

location_facility: Texas Oncology-Dallas Presbyterian Hospital

location_facility: Orszagos Onkologiai Intezet, Kemoterapia B

location_facility: Klinik und Poliklinik fuer Frauenheilkunde und Geburtshilfe Universitaetsklinik Mainz

location_facility: Universitaetsklinik und Poliklinik fuer Gynaekologie, Martin-Luther-Universitaet Halle-Wittenberg

location_facility: Torrance Health Association, DBA Torrance Memorial Physician Network/Cancer Care Associates

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz és Egyetemi Oktato Korhaz, Onkologia

location_facility: Gemeinschaftspraxis, Onkologischer Schwerpunkt am Oskar-Helene-Heim

location_facility: Federal State Budgetary Scientific Institution

location_facility: State Budgetary Healthcare Institution "Samara Regional Clinical Oncology Dispensary"

location_facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center

location_facility: Ospedale Civile di Faenza Centro Oncologico

summary: The study is aimed to confirm that letrozole + PD 0332991 is safe and tolerable and to assess the effect of the combination on advanced breast cancer


title: A Multi-center, Multi-regional Observational Study to Test the Responsiveness of the Validated MusiQoL (Multiple Sclerosis International Quality of Life Questionnaire) Instrument to EDSS Status Changes in Any Form of Multiple Sclerosis (MS) in Patients With or Without Treatment

acronym: MusiQoL

summary:
This is a multi-center, multi-regional observational,24 month study.

Health-related quality of life data from the MusiQoL instrument and SF-36 instrument will be collected at baseline, M6, M12, M18 and M24 in patients with MS. In addition, physical health outcomes such as expanded disability status scores (EDSS) will be collected every 6 months.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Auquier P, et al. Responsiveness of the Multiple Sclerosis International Quality of Life(MusiQoL) questionnaire to changes in disability in subjects with multiple sclerosis: 12-month results. Eur J Neurol 2010;17(Suppl 3):486

ReferenceCitation: Auquier P, et al. Responsiveness of the Multiple Sclerosis International Quality of Life and Short Form-36 questionnaires to Expanded Disability Status Scale score changes in subjects with multiple sclerosis: 12-month results of an international observational study. 26th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS): 13-16 October 2010, Gothenburg, Sweden; P650

ReferenceCitation: Auquier P, et al. Responsiveness of the Multiple Sclerosis International Quality of Life questionnaire to Expanded Disability Status Scale score changes in subjects with Multiple Sclerosis: Month 12 results from an international observational study. 13th Annual ISPOR Annual European Congress: November 2010, Prague, Czech Republic; P25667

ReferenceType: derived

ReferenceCitation: Baumstarck K, Pelletier J, Boucekine M, Auquier P; MusiQoL study group. Predictors of quality of life in patients with relapsing-remitting multiple sclerosis: a 2-year longitudinal study. Rev Neurol (Paris). 2015 Feb;171(2):173-80. doi: 10.1016/j.neurol.2014.09.005. Epub 2015 Jan 2.

ReferenceCitation: Boucekine M, Loundou A, Baumstarck K, Minaya-Flores P, Pelletier J, Ghattas B, Auquier P. Using the random forest method to detect a response shift in the quality of life of multiple sclerosis patients: a cohort study. BMC Med Res Methodol. 2013 Feb 15;13:20. doi: 10.1186/1471-2288-13-20.

lead_sponsor: EMD Serono

location_country:
Spain
Italy
Austria
Australia
United Kingdom
Argentina
United States
France
Israel
Turkey
Norway
Germany

location_facility:
Reseach Site
Research Site
Reseach site

lead_sponsor_type: industriel

status_simplified: Completed


title: Randomized, Controlled, Double-blind Multicenter Safety Study to Evaluate the Safety and Immunogenicity of Subcutaneous EPO HEXAL vs. ERYPO® in the Treatment of Anemia Associated With Chronic Renal Insufficiency in Predialysis Patients

summary:
This is a randomized, controlled, double-blind, multicenter multinational safety study involving about 300 predialysis patients aged 18 years or above suffering from anemia.

Symptomatic anemia will be corrected by s.c. application of EPO HEXAL or ERYPO® in order to achieve a hemoglobin target range of 10.0 -12.0 g/dL.

status: Terminated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: Sandoz

location_country:
Poland
Austria
Russian Federation
France
India
Romania
Germany
Bulgaria
Slovakia
Czechia

location_facility: State Healthcare Institution "Kemerova Regional Clinical Hospital"

location_facility: Centrul Medical de Diagnostic si Tratament Ambulator si Medicina Preventiva Bucuresti

location_facility: Institutul National de DiabetNutritie si Boli Metabolice Paulescu

location_facility: KfH Kuratorium f. Dialyse und Nierentransplantation e.V.

location_facility: Nephrologische Gemeinschaftspraxis Dr. Rensinghoff & Dr. Becker

location_facility: State Healthcare Institution "Ryazan Regional Cardiological Dispensary"

location_facility: Specjalistyczne Centrum Diagnostyczno-Lecznicze Bamberski Dwor (Solumed SC)

location_facility: Gemeinschaftspraxis Dres. Leistikow, Hafezi und Sandner

location_facility: State Educational Institution of Higher Professional Education "Moscow State University of Medicine and dentistry of Federal Agency of health Care and Social Development", City Clinical Hospital #23

location_facility: State Educational Institution of Higher Professional Education "St. Petersburg State Medical Academy named after I.I. Mechnikov of Roszdrav"

location_facility: KfH Kuratorium für dialyse und Nierentransplantation e.V.

location_facility: Gemeinschaftspraxis Dr. Steffen & Dr. Perino

location_facility: Gemeinschaftspraxis Dr. med. Gert-Peter Dragoun, Dr. med Günther Hevendehl

location_facility: State healthcare Institution "Nizhegorodsky Regional Clinical Hospital named after NA Semashko"

location_facility: State Educational Institution of High Professional Education Saratov State Medical University of Roszdrav

location_facility: State Healthcare Institution of Yaroslavl region "Regional Clinical Hosptal"

location_facility: St. Petersburg State Healthcare Institution "City Outpatient Clinic #17"

location_facility: Specjalistyczna Przychodnia Lekarska Medikard

location_facility: State Educational Institution of Higher Professional Education "St. Petersburg State Medical Academy for Postgraduate studies of Roszdrav"

location_facility: Gemeinschaftspraxis Dr. Kirchner und Dr. Menge

location_facility: Municipal Healthcare Institution "City Clinical Hospital #2"

location_facility: Nephrologisches Zentrum an Stadtkrankenhaus

location_facility: Russian University of Peoples Frienship (clinical base: City clinical hospital #53)

location_facility: NZOZ NEFROLUX Sp. J. Lucjan Sobieraj, Wojciech Kaminski

location_facility: State Healthcare Institution "Reoublic Hospital named after VA Baranov"

location_facility: Szpital Praski p.w. Przemienienia Panskiego II Oddzia Chorob Wewnetrznych

location_facility: Studienzentrum Hämatologie / Onkologie / Diabetes

location_facility: Municipal medical Institution "City Hospital #1"

location_facility: State Institution Scientific Research Institute of Cardiology of Tomsk Research Center of Siberian Branch of Russian Academy of Medical Sciences

location_facility: Dialyseplaxis DR. Rieck, DR. Göbel, DR. Wagner

location_facility: St. Petersburg State Healthcare Institution "City Mariinsky Hospital"

location_facility: Gemeinschaftspraxis Dr. Spitthöver, Dr. Knee, Dr. Gröschel

location_facility: CHU de Rouen - Hopital de Bois Guillaume

location_facility: Sozialmedizinisches Zentrum Ost Donauspital

location_facility: Klinik für Nephrologie und Allgemeine Innere Medizin

location_facility: Praxis Dr. Rose, Pohlmeier und Dr. Lammers

location_facility: Wojewodzki Szpital Specjalistyczny nr. 1 im. Jozefa Gasinskiego

location_facility: State Healthcare Institution "Sverdlovsk Regional Clinical Hospital #1"

location_facility: State Institution "St. petersburg Clinical research Institute of Emergency Medical Care named after I.I. Dzhanelidze"

location_facility: State Educational Institution of Higher Professional Education "St. Petersburg State Medical Institute named after IP Pavlov of Roszdrav"

location_facility: Federal State Institution "National Medical Surgery center named after NI Pirogov of Federal Agency of Health Care and Social Development"

location_facility: Pulse Diagnostix Cardiac and Medical Center

location_facility: Diabetes- und Dialysezentrum Merker, Vogt

location_facility: Municipal Institution "City Clinical Hospital #40"

location_facility: Dialysepraxis Dipl. med. Gierak & Dipl. med. Rettig

location_facility: State Educational Institution of Higher Professional Education "Smolensk State Medical Academy of Federal Agency of Health Care and Social Development"

location_facility: State Health Care Institution City Clinical Hospital named after SP Botkin

location_facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V.

location_facility: Schwerpunktpraxis für Diabetologie und Nephrologie

location_facility: Municipal healthcare Institution "City Clinical Hospital #2"

intervention_type: Drug

status_simplified: Unknown


title: A Randomized, Open-label Study to Explore the Correlation of Biomarkers With Response Rate in Chemo-naive Patients With Advanced or Recurrent Non-squamous Non-small Cell Lung Cancer Who Receive Treatment With Avastin in Addition to Carboplatin-based Chemotherapy

summary: This study will explore the correlation of biomarkers with response rate, and the overall efficacy and safety, of Avastin in combination with carboplatin-based chemotherapy in patients with advanced or recurrent non-squamous non-small cell lung cancer. Patients will be randomized to one of 2 groups, to receive either Avastin 7.5mg/kg iv on day 1 of each 3 week cycle, or Avastin 15mg/kg iv on day 1 of each 3 week cycle; all patients will also receive treatment with carboplatin and either gemcitabine or paclitaxel for a maximum of 6 cycles. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

lead_sponsor: Hoffmann-La Roche

location_country:
Denmark
Poland
Taiwan
Hong Kong
Spain
Italy
Russian Federation
Australia
Netherlands
Canada
Czech Republic
United Kingdom
Hungary
France
Belgium
Germany


title: Randomized, Double-Blind, Placebo-Controlled Study of Efficacy and Safety of Donepezil Hydrochloride in Preadolescent and Adolescent Children With Attention Impairment Following Cancer Treatment

lead_sponsor: Eisai Inc.

type: Registry Identifier

type: EudraCT Number

source: euctr

study_start_date_type: Actual

location_country:
Spain
United Kingdom
Australia
Netherlands
Argentina
Canada
United States
Chile
France
Germany

summary: The purpose of this study is to evaluate the efficacy, safety and tolerability of donepezil in children with persistent attention impairment that is present at least 12 months after the completion of cancer treatment.


title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter, 36-Week Trial to Assess the Efficacy and Safety of Adjunct Mycophenolate Mofetil (MMF) to Maintain or Improve Symptom Control With Reduced Corticosteroid in Subjects With Myasthenia Gravis

summary: The efficacy and safety of CellCept (1g po, bid for 36 weeks) will be assessed in patients with myasthenia gravis receiving prednisone, or other corticosteroids. During the study, patients will undergo gradual corticosteroid dose reduction, if they respond to treatment. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

enrollment_type: Anticipated

ReferenceCitation: Sengupta M, Cheema A, Kaminski HJ, Kusner LL; Muscle Study Group. Serum metabolomic response of myasthenia gravis patients to chronic prednisone treatment. PLoS One. 2014 Jul 17;9(7):e102635. doi: 10.1371/journal.pone.0102635. eCollection 2014.

location_country:
Spain
Italy
Russian Federation
Netherlands
United Kingdom
Canada
Ukraine
Former Serbia and Montenegro
United States
France
India
Israel
Mexico
Germany


title: Efficacy and Safety of Oral Budesonide-MMX™ (CB-01-02) 6 mg and 9 mg Extended Release Tablets in Patients With Mild or Moderate Active Ulcerative Colitis. A Multicentre, Randomised, Double-Blind, Double-Dummy, Comparative Study Versus Placebo With an Additional Reference Arm Evaluating Entocort®EC

summary:
This will be a multicentre, randomised, double-blind, double-dummy, parallel group comparative study in patients with mild or moderate, active ulcerative colitis. The study will compare budesonide-MMX™ 6 mg and budesonide-MMX™ 9 mg tablets to placebo and to Entocort® 3 x 3 mg capsules, in four parallel groups of patients over an 8 week treatment period.

After the screening visit, patients will enter a washout period of 2 days, then they will be randomised to the following four treatment groups: budesonide-MMX™ tablets (6 mg), budesonide-MMX™ tablets (9 mg), Entocort® capsules (3 x 3 mg) and placebo (tablets and capsules), all administered once a day after breakfast. Hence, each patient will receive, in the morning after breakfast, either one budesonide-MMX™ 6 mg or budesonide MMX™ 9 mg tablet and 3 placebo Entocort® matching capsules, or three Entocort® 3 mg capsules and one placebo budesonide-MMX™ matching tablet, or one placebo budesonide-MMX™ matching tablet and three placebo Entocort® matching capsules.

ReferenceCitation: Travis SP, Danese S, Kupcinskas L, Alexeeva O, D'Haens G, Gibson PR, Moro L, Jones R, Ballard ED, Masure J, Rossini M, Sandborn WJ. Once-daily budesonide MMX in active, mild-to-moderate ulcerative colitis: results from the randomised CORE II study. Gut. 2014 Mar;63(3):433-41. doi: 10.1136/gutjnl-2012-304258. Epub 2013 Feb 22.

lead_sponsor: Bausch Health Americas, Inc.

location_country:
Poland
Romania
United Kingdom
Italy
Latvia
Estonia
Australia
Lithuania
Russian Federation
Ukraine
France
Israel
Belgium
Sweden
Slovakia

location_facility: NZOZ Centrum Leczenia Chorob Cywilizacyjnych, oddzial Gdynia, filia Fikakw

location_facility: Vilnius University Hospital Santariskiu Klinikos

location_facility: Szpital Uniwersytecki w Krakowie,Oddział Kliniczny Kliniki Gastroenterologii Hematologii i Chorób Zakaźnych

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska

location_facility: State Scientific Centre of Coloproctology of the Federal Agency for High-Technology Medical Care

location_facility: St. Petersburg State Medical Academy n.a. I.I. Mechnikov

location_facility: FGU North-West DIstrict Medical Center of Roszdrav

location_facility: Uzhgorod State Medical University, chair of therapy and family medicine, district clinical hospitalof station "Uzhgorod"

location_facility: Lviv National Medical University after name Danylo Halytsky based on Communal Clinical City hospital No 5, Department of Propedeutic of Internal Disease

location_facility: GUZ of Moscow "City Clinical Hospital #24"

location_facility: Dipartimento di Medicina Interna e Specialità Mediche (DIMI)

location_facility: FNsP Bratislava, Nemocnica Stare Mesto 1st Internal Clinic Mickiewiczova

location_facility: Paula Stradina Clinical University Hospital

location_facility: Spitalul Clinic Colentina Sectia Gastroenterologie

location_facility: Divisione di Gastroenterologia - Istituto Clinico Humanitas IRCCS in Gastroenterologia

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej POLIMEDICA

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED

location_facility: Box Hill Hospital, Department of Gastroenterology Clive Ward Centre,

location_facility: Gastroenterologické a Hepatologické centrum

location_facility: Gastromed S.C.Maciej Kralisz, Andrzej Penpicki, Jacek Romatowski, Gabinet, Gastrologiczny i Pracownia Endoskopowa

location_facility: FNsP Bratislava, Nemocnica Ruzinov V. Interna klinika, Gastroenterohepatologicke oddelenie Ruzinovska

location_facility: City Clinical Emergency Hospital named after O.I.Meschaninov,

location_facility: CRO - IRCCS - Struttura Operativa Complessa di Gastroenterologia Oncologica

location_facility: Federal State Institution ?National Medical Surgical Center

location_facility: GU research educational medical centre of the administration of the affairs of the president of Russian Federation on the basis of State Healthcare Institution "State Clinical Hospital # 51"

location_facility: Centrul de Gastroenterologie Dr. Goldis Adrian

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny Kliniki Gastroenterologii, Hepatologii i Chorob Zakaznych,

location_facility: University Hospital of Coventry and Warwickshire

location_facility: Saint-Petersburg GUZ City polyclinic #38 28

location_facility: Odessa city Polyclinic #20, Therapeutic Dept. 6

location_facility: Uzhgorod National University, Hospital surgery chair on the base of Uzhgorod Regional Clinical Hospital

location_facility: Chair of Gastroenterology and therapy of Dnipropetrovsk State Medical Academy based on Institute of gastroenterology

intervention_type: Procedure


title: A Phase 2, Multicenter, Open-label, Active Comparator-controlled, Extension Trial To Evaluate The Long-term Safety And Efficacy Of Cp-690,550 In Renal Allograft Recipients

summary: This is a study that will follow transplant patients from Study A3921030 to monitor for long term safety, tolerability and efficacy for 5 additional years, except in Portugal where the study will follow transplant patients through Month 36 posttransplant. Patients will continue their study medications that were previously assigned.

primary_purpose: Prevention

location_country:
Poland
Brazil
Portugal
Spain
Italy
Australia
Netherlands
Canada
Korea, Republic of
United States
France
Belgium
Norway
Germany
Czechia

location_facility: Istituto di Clinica Chirurgica, Universita Cattolica del Sacro Cuore

location_facility: Washington University School of Medicine

location_facility: UNC Department of Surgery/Abdominal Transplant Division

location_facility: Division of Pharmacotherapy, School of Pharmacy, University of North Carolina at Chapel Hill

location_facility: Hospitais da Universidade de Coimbra, EPE

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: California Pacific Medical Center - Pacific Campus

location_facility: Department of Surgery, Yonsei University College of Medicine Severance Hospital

location_facility: Medical University of South Carolina, Department of Transplantation Surgery

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: Westmead Hospital, Department of Renal Medicine

location_facility: Ambulatorio Pos Transplante do Hospital do Rim a Hipertensao

location_facility: Investigational Drug Services (IDS) / UNC Healthcare

location_facility: Annette C. and Harold C. Simmons Transplant Institute at Baylor University Medical Center

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

location_facility: UNC Department of Surgery, Clinical Trials Consortium

location_facility: USCF Medical Center - Connie Frank Transplant Center

location_facility: Institut Klinicke a Experimentalni Mediciny

location_facility: Oslo universitetssykehus HF- Rikshospitalet

location_facility: Asan Medical Center, Department of Surgery

location_facility: University of North Carolina, Department of Medicine/Nephrology

location_facility: Central Northern Adelaide Renal and Transplantation Service

location_facility: Drexel University College of Medicine - Hahnemann University Hospital

location_facility: CHRU de Nancy-Brabois - Service de Nephrologie

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Akademicki Szpital Kliniczny im. J. Mikulicza - Radeckiego we Wroclawiu


title: A Four-Arm Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Study to Evaluate the Safety, Tolerability and Efficacy as Assessed by Frequent MRI Measures of 3 Doses of Atacicept Monotherapy in Subjects With Relapsing Multiple Sclerosis (RMS) Over a 36 Week Treatment Course

acronym: ATAMS

summary: To evaluate the safety and tolerability of atacicept and to explore if atacicept reduces central nervous system inflammation in subjects with relapsing multiple sclerosis (RMS) as assessed by frequent magnetic resonance imaging (MRI). This study is randomised. Study medication is administered via subcutaneous (under the skin) injections.

ReferenceCitation: Kappos L, Hartung HP, Freedman MS, Boyko A, Radü EW, Mikol DD, Lamarine M, Hyvert Y, Freudensprung U, Plitz T, van Beek J; ATAMS Study Group. Atacicept in multiple sclerosis (ATAMS): a randomised, placebo-controlled, double-blind, phase 2 trial. Lancet Neurol. 2014 Apr;13(4):353-63. doi: 10.1016/S1474-4422(14)70028-6. Epub 2014 Mar 6.

location_country:
Spain
United Kingdom
Austria
Australia
Lebanon
Canada
Czech Republic
Lithuania
Netherlands
Russian Federation
Sweden
Switzerland
Ukraine
United States
France
Belgium
Germany


title: Safety of Sports for Patients With Implantable Cardioverter-Defibrillators: A Multi-Center Registry

summary: The registry will obtain information to determine the safety of sports participation for patients with defibrillators (ICDs).

ReferenceCitation: Saarel EV, Law I, Berul CI, Ackerman MJ, Kanter RJ, Sanatani S, Cohen MI, Berger S, Fischbach PS, Burton DA, Dziura J, Brandt C, Simone L, Li F, Olshansky B, Cannom DS, Lampert RJ. Safety of Sports for Young Patients With Implantable Cardioverter-Defibrillators: Long-Term Results of the Multinational ICD Sports Registry. Circ Arrhythm Electrophysiol. 2018 Nov;11(11):e006305. doi: 10.1161/CIRCEP.118.006305.

lead_sponsor: Yale University

location_country:
Poland
Spain
United Kingdom
Australia
Netherlands
Canada
Czech Republic
Switzerland
United States
France
Israel
Belgium
Norway
Germany

location_facility: The Ohio State University Research Foundation

location_facility: Arizona Pediatric Cardiology Consultants

location_facility: Legacy Cllinical Research & Tech Center (Good Samaritan Hospital_

location_facility: London Health Sciences Centre University Hospital

location_facility: Midatlantic Cardiovascular Associates, PA

location_facility: Foundation for the Advancement of Cardiovascular Therapy

location_facility: Children's Hospital and Clinics of Minnesota

lead_sponsor_type: academique


title: A Randomized Discontinuation Study of Brivanib Alaninate (BMS-582664) Versus Placebo in Subjects With Advanced Tumors

summary: The purpose of this study is to determine if gastric/esophageal, lung, pancreatic, bladder and sarcoma patients show benefit from brivanib treatment. Patients who clearly do, stay on treatment. Those in which it is unclear will be randomized to continue or withdraw treatment to determine whether that benefit is related to brivanib

lead_sponsor: Bristol-Myers Squibb

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

location_facility: Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins


title: A Phase 2 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis

summary: Study will evaluate the safety and potential benefit of recombinant human talactoferrin as an addition to the standard care of severe sepsis.

ReferenceCitation: Guntupalli K, Dean N, Morris PE, Bandi V, Margolis B, Rivers E, Levy M, Lodato RF, Ismail PM, Reese A, Schaumberg JP, Malik R, Dellinger RP; TLF LF-0801 Investigator Group. A phase 2 randomized, double-blind, placebo-controlled study of the safety and efficacy of talactoferrin in patients with severe sepsis. Crit Care Med. 2013 Mar;41(3):706-16. doi: 10.1097/CCM.0b013e3182741551. Erratum in: Crit Care Med. 2014 May;42(5):e390. multiple investigator names added.

lead_sponsor: Agennix

location_country:
Spain
Canada
United States
France
Germany

location_facility: Wake Forest University Baptist Medical Center

location_facility: University of Oklahoma Health Science Center

location_facility: Floyd Memorial Hospital and Health Services

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: The George Washington University Hospital

location_facility: University of Pittsburgh Medical Center Presbyterian Hospital

location_facility: Texas Tech University Health Sciences Center


title: The Atrial High Rate Episodes (A-HIRATE) in Pacemaker Patients

summary: Prospective study assessing the incidence of atrial high rate episodes (AHRE) in pacemaker patients with and without previously diagnosed AT.

ReferenceType: background

ReferenceCitation: Ghali JK, Orlov MV, Araghi-Niknam M, Sherfesee L, Hettrick DA. The influence of symptoms and device detected atrial tachyarrhythmias on medical management: insights from A-HIRATE. Pacing Clin Electrophysiol. 2007 Jul;30(7):850-7.

ReferenceCitation: Orlov MV, Ghali JK, Araghi-Niknam M, Sherfesee L, Sahr D, Hettrick DA; Atrial High Rate Trial Investigators. Asymptomatic atrial fibrillation in pacemaker recipients: incidence, progression, and determinants based on the atrial high rate trial. Pacing Clin Electrophysiol. 2007 Mar;30(3):404-11.

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
Australia
United States
France


title: A 52-Week, Multinational, Multi-Centre, Open-Labelled Extension Trial of Insulin Detemir in Children and Adolescents 3-17 Years With Type 1 Diabetes on a Basal-Bolus Regimen With Insulin Aspart as Bolus Insulin

lead_sponsor: Novo Nordisk A/S

design_allocation: Non-Randomized

ReferenceCitation: Thalange N, Bereket A, Jensen LB, Hiort LC, Peterkova V. Development of Insulin Detemir/Insulin Aspart Cross-Reacting Antibodies Following Treatment with Insulin Detemir: 104-week Study in Children and Adolescents with Type 1 Diabetes Aged 2-16 Years. Diabetes Ther. 2016 Dec;7(4):713-724. Epub 2016 Sep 6.

location_country: Macedonia, The Former Yugoslav Republic of

summary: This trial is conducted in Europe. The aim of this research is to assess the safety of continuous treatment with insulin detemir following participation in trial NN304-1689 (NCT00435019) on antibody development.


title: Two-year Study to Determine the Efficacy and Safety of Risedronate Therapy Administered 35 mg Once A Week in Men With Osteoporosis for 2 Years Followed by a 2 Year Open Label Study

summary: Two year study to determine the safety and efficacy of weekly 35 mg Risedronate doses in men with osteoporosis followed by a two year follow-up study.

ReferenceCitation: Boonen S, Lorenc RS, Wenderoth D, Stoner KJ, Eusebio R, Orwoll ES. Evidence for safety and efficacy of risedronate in men with osteoporosis over 4 years of treatment: Results from the 2-year, open-label, extension study of a 2-year, randomized, double-blind, placebo-controlled study. Bone. 2012 Sep;51(3):383-8. doi: 10.1016/j.bone.2012.06.016. Epub 2012 Jun 30.

lead_sponsor: Warner Chilcott

location_country:
Poland
United Kingdom
Australia
Lebanon
Czech Republic
Hungary
United States
France
Belgium
Netherlands

location_facility:
Research Facility
Research Site


title: A Study of INT-747 (6-ECDCA) Monotherapy in Patients With Primary Biliary Cirrhosis

lead_sponsor: Intercept Pharmaceuticals

ReferenceCitation: Kowdley KV, Luketic V, Chapman R, Hirschfield GM, Poupon R, Schramm C, Vincent C, Rust C, Parés A, Mason A, Marschall HU, Shapiro D, Adorini L, Sciacca C, Beecher-Jones T, Böhm O, Pencek R, Jones D; Obeticholic Acid PBC Monotherapy Study Group. A randomized trial of obeticholic acid monotherapy in patients with primary biliary cholangitis. Hepatology. 2018 May;67(5):1890-1902. doi: 10.1002/hep.29569. Epub 2018 Jan 29.

location_country:
Spain
United Kingdom
Austria
Canada
United States
France
Germany

location_facility: Centre de Recherche du CHUM / University of Montreal

location_facility: University Medical Centre Hamburg-Eppendorf

summary: The primary hypothesis was that obeticholic acid (OCA) will cause a reduction in alkaline phosphatase levels in PBC participants, over a 12-week treatment period, as compared to placebo.


title: Open Label, Parallel Group, Multicenter Study of Two Intravenous (IV) Ibandronate Dose Regimens (2 mg Every 2 Months and 3 mg Every 3 Months) in Women With Postmenopausal Osteoporosis Who Completed Trial BM16550

summary: This 2-arm study was designed to assess the long-term safety and tolerability of intravenous (IV) treatment with 2 mg or 3 mg Bonviva in women with post-menopausal osteoporosis who had previously completed Bonviva study BM16550 (DIVA study; NCT00048074). Patients received Bonviva either 2 mg IV every 2 months, or 3 mg IV every 3 months. Patients also received daily supplementation with vitamin D and calcium. The anticipated time on study treatment was 2+ years, and the target sample size was 500+ individuals.

location_country:
Denmark
Poland
Spain
Italy
United Kingdom
Australia
Mexico
Czech Republic
Hungary
United States
France
South Africa
Belgium
Norway
Germany


title: A Multi-center, Open-label, follow-on Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy Including a Double-blind, Randomized Time Point Withdrawal Subtrial.

summary: SP746 (NCT00546351) is a multi-center, open-label, follow-on trial. The purpose of this trial is to assess safety and tolerability of long-term exposure of lacosamide (previously referred to as SPM 927) in subjects with painful distal diabetic neuropathy.

lead_sponsor: UCB Pharma

location_country:
Poland
Romania
Serbia
Spain
Italy
Austria
Russian Federation
United Kingdom
Finland
Hungary
France
Belgium
Germany
Bulgaria
Czechia


title: A Randomized, Double-Blind, Parallel-Group Multi-Center Comparative Flexible-Dose Study Of Pregabalin Versus Levetiracetam As Adjunctive Therapy To Reduce Seizure Frequency In Subjects With Partial Seizures

summary: This study will compare pregabalin and levetiracetam in patients with partial seizures. It will also evaluate the safety and tolerability of pregabalin and levetiracetam in these patients.

ReferenceCitation: Zaccara G, Almas M, Pitman V, Knapp L, Posner H. Efficacy and safety of pregabalin versus levetiracetam as adjunctive therapy in patients with partial seizures: a randomized, double-blind, noninferiority trial. Epilepsia. 2014 Jul;55(7):1048-57. doi: 10.1111/epi.12679. Epub 2014 Jun 5.

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

location_country:
Spain
Italy
Lithuania
Venezuela
Costa Rica
Peru
Belgium
Philippines
Czechia
Russian Federation
India
Panama
Turkey
Mexico
Germany
Bulgaria
Taiwan
Greece
Korea, Republic of
France
Colombia


title: A Double Blind, Randomized, Placebo Controlled, Parallel Group Dose-range Exploration Study of Sativex® in Relieving Pain in Patients With Advanced Cancer, Who Experience Inadequate Analgesia During Optimized Chronic Opioid Therapy.

acronym: SPRAY

summary: The purpose of this study is to determine the effective dose range and to demonstrate a non-effective dose range of Sativex in patients with advanced cancer, who experience inadequate pain relief even though they are on optimized chronic opioid therapy.

primary_purpose: Supportive Care

ReferenceCitation: Portenoy RK, Ganae-Motan ED, Allende S, Yanagihara R, Shaiova L, Weinstein S, McQuade R, Wright S, Fallon MT. Nabiximols for opioid-treated cancer patients with poorly-controlled chronic pain: a randomized, placebo-controlled, graded-dose trial. J Pain. 2012 May;13(5):438-49. doi: 10.1016/j.jpain.2012.01.003. Epub 2012 Apr 5.

lead_sponsor: Jazz Pharmaceuticals

location_country:
Poland
Romania
Spain
Italy
United Kingdom
Mexico
Canada
Czech Republic
Finland
United States
Chile
France
India
Belgium
South Africa
Germany

location_facility: Indo-American Cancer Institute and Research Center

location_facility: Spitalul Judetean de Urgenta "Constantin Opris"

location_facility: ARO, Krajská zdravotni, K.Z. a.s, Nemocnice

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika

location_facility: Dir. S.C.D.U. Psicologia Clinica ed Oncologica

location_facility: FN Hradec Králové - Klinika onkologie a radioterapie

location_facility: Pacific Coast Hematology/Oncology Medical Group, Inc.

location_facility: Beskidzkie Centrum Onkologii im. Jana Pawla

location_facility: CHU Charleroi (Hôpital civil de Charleroi)

location_facility: FN a LF UP Olomouc - Ambulance pro lécbu bolesti

location_facility: AR klinika FN Plzen -Ambulance pro lécbu bolesti

location_facility: Meenakshi Mission Hospital & Research Centre

location_facility: Spitalul Clinic Judetean Sibiu Oncologie

location_facility: UZ Leuven - Algologisch Centrum Anesthesiologie

location_facility: The Center for Clinical Research - Washington County Hospital

location_facility: S.C. IanuliMed S.R.L. Oncologie Medicala

location_facility: Jehangir Clinical Development Centre Pvt. Ltd.

location_facility: Trialtech Research - Embassy Drive Medical Centre

location_facility: Instituto Radio-oncológico Santiago (INRAD)

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

location_facility: Spitalul Judetean de Urgenta "Sf. Ioan cel Nou"

location_facility: Center of Hope for Cancer and Blood Disorders

location_facility: International Observatory on End of Life Care

location_facility: Bhagwaan Mahaveer Cancer Hospital and Research Centre

location_facility: Deenanath Mangeshkar Hospital and Research Center

location_facility: Basingstoke & North Hampshire NHS Foundation Trust

location_facility: District Hospital Dr. Alexandru Simionescu

location_facility: Capital Comprehensive Cancer Care Clinic


title: A Prospective, Randomized, Double-dummy, Double-blind, Multicenter Trial Comparing the Safety and Efficacy of Intravenous Moxifloxacin 400 mg IV QD 24 Hours to That of Ertapenem 1.0 g IV QD 24 Hours for 5 to 14 Days for the Treatment of Subjects With Complicated Intra-abdominal Infections (PROMISE Study)

summary: A study to compare the safety and efficacy of moxifloxacin to ertapenem in patients with intra-abdominal infections.

ReferenceCitation: De Waele JJ, Tellado JM, Alder J, Reimnitz P, Jensen M, Hampel B, Arvis P. Randomised clinical trial of moxifloxacin versus ertapenem in complicated intra-abdominal infections: results of the PROMISE study. Int J Antimicrob Agents. 2013 Jan;41(1):57-64. doi: 10.1016/j.ijantimicag.2012.08.013. Epub 2012 Nov 13.

lead_sponsor: Bayer

location_country:
Romania
Spain
Greece
Latvia
Estonia
Russian Federation
Argentina
Lithuania
France
Israel
South Africa
Belgium
Germany
Bulgaria


type: Other Identifier

title: A Randomized, Double-Blind, Active- and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Extended-Release Paliperidone as Maintenance Treatment After an Acute Manic or Mixed Episode Associated With Bipolar I Disorder

summary: The purpose of this study is to evaluate the effectiveness and safety of oral extended-release (ER) paliperidone compared with placebo in the prevention of the recurrence of mood symptoms in patients with Bipolar I Disorder who initially respond to treatment of an acute manic or mixed episode with paliperidone ER. Olanzapine was included as an active control arm, although the study is not designed to allow for a direct comparison of olanzapine with paliperidone.

ReferenceCitation: Berwaerts J, Melkote R, Nuamah I, Lim P. A randomized, placebo- and active-controlled study of paliperidone extended-release as maintenance treatment in patients with bipolar I disorder after an acute manic or mixed episode. J Affect Disord. 2012 May;138(3):247-58. doi: 10.1016/j.jad.2012.01.047. Epub 2012 Feb 27.

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

location_country:
Poland
Romania
Serbia
Turkey
Russian Federation
Ukraine
United States
Costa Rica
China
France
India
Malaysia
Germany
Panama
Bulgaria
South Africa


title: Clinical Study on Tacrolimus Ointment Over the Long-term. "CONTROL Study - Adults"

summary: Long-term tacrolimus ointment based regimen comprising of up to 6 weeks of initial twice daily treatment and subsequent twice weekly prophylactic application can effectively treat active lesions of atopic dermatitis and prevent delay & reduce flares

ReferenceCitation: Wollenberg A, Reitamo S, Girolomoni G, Lahfa M, Ruzicka T, Healy E, Giannetti A, Bieber T, Vyas J, Deleuran M; European Tacrolimus Ointment Study Group. Proactive treatment of atopic dermatitis in adults with 0.1% tacrolimus ointment. Allergy. 2008 Jul;63(7):742-50.

ReferenceCitation: Wollenberg A, Sidhu MK, Odeyemi I, Dorsch B, Koehne-Volland R, Schaff M, Ehlken B, Berger K. Economic evaluation of maintenance treatment with tacrolimus 0.1% ointment in adults with moderate to severe atopic dermatitis. Br J Dermatol. 2008 Dec;159(6):1322-30. doi: 10.1111/j.1365-2133.2008.08807.x. Epub 2008 Sep 6.

lead_sponsor: Astellas Pharma Inc

location_country:
Denmark
Portugal
Spain
Italy
Austria
Netherlands
United Kingdom
Finland
Czech Republic
Switzerland
France
Belgium
Germany


title: Randomized, Double-blind, Placebo-controlled, Parallel Group Study of Vardenafil 10 mg Twice Daily to Assess the Effect on Urodynamics in Patients With Overactive Bladder (Detrusor Overactivity)

location_country:
Poland
Portugal
Spain
Russian Federation
Netherlands
Canada
Czech Republic
Switzerland
Hungary
France
Israel
Belgium
Germany

summary: The purpose of this study is to assess if the study drug, Vardenafil (approved by Health Authorities is available on the market for treatment of erectile dysfunction) has an effect on bladder function and micturition frequency. The study drug is to be taken in the form of tablets twice a day, one tablet in the morning and one tablet in the evening. A non-active treatment (placebo), a sugar pill, will be used as a comparator to see if the new study drug works better than no drug. The timing of visits for the study is as follows: the 1st visit (screening visit) at beginning of run-in-assessment with qualifying tests for patients: electrocardiogram (ECG), safety laboratory and residual urine (by ultrasonography: a non-invasive examination using ultrasound for the assessment of the bladder). 2nd visit (randomization visit). During visit this should be performed: urodynamic measurements (filling cystometry and pressure flow investigations), ECG and safety laboratory. 3rd visit (safety visit) takes place at two up to three weeks of randomized treatment. 4th visit (final visit)-following test should be done: urodynamic measurements (filling cystometry and pressure flow investigations), ECG, safety laboratory and residual urine (by ultrasonography); A phone call 24 hours after visit 4 to assess any SAEs.


type: Other Grant/Funding Number

title: A Randomised Phase III Study of Radiation Doses and Fractionation Schedules in Non-low Risk Ductal Carcinoma In Situ (DCIS) of the Breast

acronym: DCIS

summary:
Hypotheses:

The addition of tumour bed boost after BCS in women with non-low risk DCIS reduces the risk of local recurrence (invasive or intraductal recurrence in the ipsilateral breast).
The risk of local recurrence in the shorter fractionation arm is not worse than that for the standard fractionation arm.
A molecular signature predictive of invasive recurrence of DCIS will be detectable and the molecular signature may eventually have clinical utility for therapy individualization.

Overall Objectives:

To improve the outcome of women with non-low risk DCIS treated with breast conserving therapy.
To individualize treatment selection for women with DCIS to achieve long term disease control with minimal toxicity.

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Chua BH, Link EK, Kunkler IH, Whelan TJ, Westenberg AH, Gruber G, Bryant G, Ahern V, Purohit K, Graham PH, Akra M, McArdle O, O'Brien P, Harvey JA, Kirkove C, Maduro JH, Campbell ID, Delaney GP, Martin JD, Vu TTT, Muanza TM, Neal A, Olivotto IA; BIG 3-07/TROG 07.01 trial investigators. Radiation doses and fractionation schedules in non-low-risk ductal carcinoma in situ in the breast (BIG 3-07/TROG 07.01): a randomised, factorial, multicentre, open-label, phase 3 study. Lancet. 2022 Aug 6;400(10350):431-440. doi: 10.1016/S0140-6736(22)01246-6.

ReferenceCitation: King MT, Link EK, Whelan TJ, Olivotto IA, Kunkler I, Westenberg AH, Gruber G, Schofield P, Chua BH; BIG 3-07/TROG 07.01 trial investigators. Quality of life after breast-conserving therapy and adjuvant radiotherapy for non-low-risk ductal carcinoma in situ (BIG 3-07/TROG 07.01): 2-year results of a randomised, controlled, phase 3 trial. Lancet Oncol. 2020 May;21(5):685-698. doi: 10.1016/S1470-2045(20)30085-1. Epub 2020 Mar 20.

lead_sponsor: Trans Tasman Radiation Oncology Group

location_country:
United Kingdom
Ireland
Italy
Australia
New Zealand
Canada
Switzerland
France
Singapore
Belgium
Netherlands

location_facility: Genesis Cancer Care (previously Premion) - Nambour

location_facility: William Buckland Radiotherapy Centre, Alfred Hospital

location_facility: Maastricht Radiation Oncology Maastro Clinic

location_facility: Sandwell and West Birmingham Hospitals NHS Trust

location_facility: Thunder Bay Regional Health Sciences Centre

location_facility: Centro Di Riferimento Oncologico - Aviano

location_facility: McGill University Department of Oncology

location_facility: Barwon Health - Andrew Love Cancer Care Centre, Geelong Hospital

location_facility: The Shrewsbury and Telford Hospital NHS Trust

location_facility: The Beatson West of Scotland Cancer Centre

location_facility: Cancer Institute Antoni Van Leeuwenhoekziekenhuis

location_facility: Gloucestershire Royal & Cheltenham General Hospitals

location_facility: AZ Groeninghe - Campus Maria's Voorzienigheid

location_facility: Genesis Cancer Care (previously Premion) - Tugun

location_facility: Imperial College Healthcare Charing Cross

intervention_type: Radiation

status_simplified: Ongoing


title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Treatment-withdrawal Study to Evaluate the Efficacy and Safety of Esomeprazole for the Treatment of Gastroesophageal Reflux (GERD) in Infants Aged 1 to 11 Months, Inclusive

summary: The purpose of this study is to look at the improvement of a once a day dose of esomeprazole for reducing the signs and symptoms of infants with gastroesophageal reflux disease (GERD). This research study consists of a screening, open-label, and double-blind treatment withdrawal phase. The screening phase ensures the patient eligibility. No study medication is dispensed during the screening phase. During the open-label phase, patients are administered esomeprazole 2.5mg, 5.0mg or 10.0mg based on his/her weight. During the double-blind phase, the patients are administered either his/her open-label dose or placebo. Double-blind means neither the physician, parent, or patient will know if patient is taking esomeprazole or placebo. The patient will have an equal chance of receiving esomeprazole or placebo.

ReferenceCitation: Winter H, Gunasekaran T, Tolia V, Gottrand F, Barker PN, Illueca M. Esomeprazole for the Treatment of GERD in Infants Ages 1-11 Months. J Pediatr Gastroenterol Nutr. 2015 Jul;60 Suppl 1:S9-15. doi: 10.1097/MPG.0b013e3182496b35.

ReferenceCitation: Winter H, Gunasekaran T, Tolia V, Gottrand F, Barker PN, Illueca M. Esomeprazole for the treatment of GERD in infants ages 1-11 months. J Pediatr Gastroenterol Nutr. 2012 Jul;55(1):14-20. doi: 10.1097/MPG.0b013e3182496b35.

lead_sponsor: AstraZeneca

location_country:
Germany
Poland
United States
France


title: A Combined Phase 1 and 2 Study Investigating the Combination of RAD001 and Erlotinib in Patients With Advanced NSCLC Previously Treated Only With Chemotherapy

lead_sponsor: Novartis Pharmaceuticals

location_country:
Denmark
Russian Federation
Canada
United States
France

summary: This study aims to assess the value of combined treatment with RAD001 and erlotinib in patients with advanced Non Small Cell Lung Cancer treated only with chemotherapy as systemic therapy.


title: A Randomized Phase II Biomarker Neoadjuvant Study of Sequential AC Followed by Ixabepilone Compared to Sequential AC Followed by Paclitaxel in Women With Early Stage Breast Cancer

summary: The study will evaluate the effectiveness of ixabepilone when given after doxorubicin plus cyclophosphamide (AC) compared to standard treatment of paclitaxel given after doxorubicin plus cyclophosphamide in patients with early stage breast cancer. In addition the study will verify predefined biomarkers as well as discover new biomarkers that could identify patients who are more likely to respond to ixabepilone than standard paclitaxel based therapy.

ReferenceCitation: Abdel-Fatah TMA, Agarwal D, Liu DX, Russell R, Rueda OM, Liu K, Xu B, Moseley PM, Green AR, Pockley AG, Rees RC, Caldas C, Ellis IO, Ball GR, Chan SYT. SPAG5 as a prognostic biomarker and chemotherapy sensitivity predictor in breast cancer: a retrospective, integrated genomic, transcriptomic, and protein analysis. Lancet Oncol. 2016 Jul;17(7):1004-1018. doi: 10.1016/S1470-2045(16)00174-1. Epub 2016 Jun 14.

location_country:
Taiwan
Spain
Italy
Austria
Russian Federation
United Kingdom
Argentina
Korea, Republic of
United States
France
India
Peru
Singapore
Philippines
Germany

location_facility: Northwest Oncology & Hematology Associates


title: A Randomized Phase 3 Study of Pemetrexed in Combination With Cisplatin Versus Cisplatin Monotherapy in Patients With Recurrent or Metastatic Head and Neck Cancer

summary: This study will compare the effects of pemetrexed plus cisplatin versus cisplatin alone in head and neck cancer patients.

lead_sponsor: Eli Lilly and Company

location_country:
Spain
Italy
United States
Romania
Belgium
South Africa
Poland
Russian Federation
Argentina
Puerto Rico
India
Mexico
Brazil
Hungary
China
Germany
Denmark
Taiwan
Korea, Republic of
France
Netherlands

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 Phase III, Double-blind, Randomized Study to Evaluate the Safety and Efficacy of BAL8557 Versus a Caspofungin Followed by Voriconazole Regimen in the Treatment of Candidemia and Other Invasive Candida Infections

summary: The purpose of the study is to compare the safety and efficacy of isavuconazole versus caspofungin followed by voriconazole in the treatment of candidemia and other invasive Candida infections.

ReferenceCitation: Kullberg BJ, Viscoli C, Pappas PG, Vazquez J, Ostrosky-Zeichner L, Rotstein C, Sobel JD, Herbrecht R, Rahav G, Jaruratanasirikul S, Chetchotisakd P, Van Wijngaerden E, De Waele J, Lademacher C, Engelhardt M, Kovanda L, Croos-Dabrera R, Fredericks C, Thompson GR. Isavuconazole Versus Caspofungin in the Treatment of Candidemia and Other Invasive Candida Infections: The ACTIVE Trial. Clin Infect Dis. 2019 May 30;68(12):1981-1989. doi: 10.1093/cid/ciy827.

ReferenceCitation: McCormack PL. Isavuconazonium: first global approval. Drugs. 2015 May;75(7):817-22. doi: 10.1007/s40265-015-0398-6. Review.

ipd_sharing: Yes

ipd_sharing_description: Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

location_country:
Spain
Italy
United States
Belgium
Philippines
South Africa
Russian Federation
Australia
Argentina
India
Israel
Mexico
Malaysia
Singapore
Brazil
Lebanon
Canada
Switzerland
Hungary
China
Germany
New Zealand
Thailand
France
Chile

location_facility: Regional Infection Diseases Infusion Center Inc.

location_facility: University of California at San Francisco

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Azienda Ospedaliera di Verona-Ospedale Civile Maggiore

location_facility: Hadassah Universtiy Hospital - Ein Kerem

location_facility: Universidade Federal de Sao Paulo - UNIFESP

location_facility: Hospital Civil de Guadalajara Dr Juan I Menchaca

location_facility: Hamilton Health Sciences - Henderson Site

location_facility: De La Salle Health Sciences Institute- DLSUMC

location_facility: Deenanath Mangeshkar Hospital and Research Centre

location_facility: S.I. Russian Oncological Research Center n.a. N.N. Blokhin

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre

location_facility: Pusat Perubatan Universiti Kebangsaan Malaysia

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: University of California Davis Health System

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez

location_facility: Azienda Ospedaliero Universitaria San Martino

location_facility: Hospital Universitario Clementino Fraga Filho

location_facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Ma

location_facility: Hospital General de Agudos Dr. Carlos G. Durand

location_facility: University of Maryland School of Medicine

location_facility: Kasturba Medical College K. M. C. Hospital

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador

location_facility: Apollo Hospitals Educational & Research Foundation

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Hospital General de Agudos Dr. Cosme Argerich

location_facility: State Institution "Hematology Research Center" RAMS

location_facility: West China Hospital of Sichuan University

location_facility: Santa Casa de Misericordia de Belo Horizonte

location_facility: Hospital das Clinicas da Universidade Federal de Minas Gerai

location_facility: University Health Network - Toronto General Hospital


intervention_type: Biological

title: A Multi-Center, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease

lead_sponsor: Abbott

ReferenceCitation: Horneff G, Seyger MMB, Arikan D, Kalabic J, Anderson JK, Lazar A, Williams DA, Wang C, Tarzynski-Potempa R, Hyams JS. Safety of Adalimumab in Pediatric Patients with Polyarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, Psoriasis, and Crohn's Disease. J Pediatr. 2018 Oct;201:166-175.e3. doi: 10.1016/j.jpeds.2018.05.042. Epub 2018 Jul 25.

ReferenceCitation: Ruemmele FM, Rosh J, Faubion WA, Dubinsky MC, Turner D, Lazar A, Eichner S, Maa JF, Alperovich G, Robinson AM, Hyams JS. Efficacy of Adalimumab for Treatment of Perianal Fistula in Children with Moderately to Severely Active Crohn's Disease: Results from IMAgINE 1 and IMAgINE 2. J Crohns Colitis. 2018 Nov 9;12(10):1249-1254. doi: 10.1093/ecco-jcc/jjy087.

ReferenceCitation: Hyams JS, Griffiths A, Markowitz J, Baldassano RN, Faubion WA Jr, Colletti RB, Dubinsky M, Kierkus J, Rosh J, Wang Y, Huang B, Bittle B, Marshall M, Lazar A. Safety and efficacy of adalimumab for moderate to severe Crohn's disease in children. Gastroenterology. 2012 Aug;143(2):365-74.e2. doi: 10.1053/j.gastro.2012.04.046. Epub 2012 May 2.

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

location_facility:
Site Reference ID/Investigator# 5109
Site Reference ID/Investigator# 6182
Site Reference ID/Investigator# 6798
Site Reference ID/Investigator# 3734
Site Reference ID/Investigator# 5904
Site Reference ID/Investigator# 6354
Site Reference ID/Investigator# 4983
Site Reference ID/Investigator# 5222
Site Reference ID/Investigator# 4984
Site Reference ID/Investigator# 5901
Site Reference ID/Investigator# 7640
Site Reference ID/Investigator# 6700
Site Reference ID/Investigator# 14750
Site Reference ID/Investigator# 4912
Site Reference ID/Investigator# 4317
Site Reference ID/Investigator# 10287
Site Reference ID/Investigator# 3826
Site Reference ID/Investigator# 5223
Site Reference ID/Investigator# 6071
Site Reference ID/Investigator# 6073
Site Reference ID/Investigator# 6065
Site Reference ID/Investigator# 5676
Site Reference ID/Investigator# 6430
Site Reference ID/Investigator# 8801
Site Reference ID/Investigator# 4950
Site Reference ID/Investigator# 4914
Site Reference ID/Investigator# 4911
Site Reference ID/Investigator# 4909
Site Reference ID/Investigator# 7742
Site Reference ID/Investigator# 5102
Site Reference ID/Investigator# 6072
Site Reference ID/Investigator# 10284
Site Reference ID/Investigator# 4916
Site Reference ID/Investigator# 5169
Site Reference ID/Investigator# 16501
Site Reference ID/Investigator# 8391
Site Reference ID/Investigator# 5892
Site Reference ID/Investigator# 13622
Site Reference ID/Investigator# 4316
Site Reference ID/Investigator# 6257
Site Reference ID/Investigator# 5570
Site Reference ID/Investigator# 4285
Site Reference ID/Investigator# 7744
Site Reference ID/Investigator# 4913
Site Reference ID/Investigator# 6428

summary: The purpose of this study is to determine Efficacy, Pharmacokinetics, and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease


title: A Double-Masked, Placebo-Controlled, Multi-Center, Parallel-Group, Dose-Ranging Study With an Optional Extension to Assess the Efficacy and Safety of LX211 as Therapy in Subjects With Clinically Quiescent Sight Threatening, Non-infectious Intermediate, Anterior and Intermediate, Posterior or Pan-Uveitis

acronym: LUMINATE

summary: The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in subjects with clinically quiescent non-infectious uveitis

lead_sponsor: Lux Biosciences, Inc.

location_country:
United Kingdom
Austria
Canada
United States
France
India
Germany

location_facility: Klinik für Augenheilkunde, Dept. of Ophthalmology

location_facility: Aravind Eye Hospitals and Postgraduate Institute of Ophthalmology

location_facility: Massachusetts Eye Research and Surgery Institute

location_facility: Consultant, Retina and Vitreous Services, Bhubaneswar L V Prasad Eye Institute

location_facility: UMDNJ-New Jersey Medical School, Ophthalmology Dept.

location_facility: Dr. R. P. Centre for Ophthalmic Sciences, All India Institute of Medical Sciences

location_facility: Vittala International Institute of Ophthalmology

location_facility: Department of Opthalmology, Sankara Nethralaya, Medical Research Foundation,

location_facility: Bristol Eye Hospital and University of Bristol

location_facility: Center Hospitalier Universitaire d' Angers, Service d'Opthalmologie

location_facility: Hôpital Pitié Salpétrière, Service d'Ophtalmologie

location_facility: Advanced Eye Centre, Postgraduate Institute of Medical Education and Research (PGIMER)


title: A Double-Masked, Placebo-Controlled, Parallel Group, Multi-Center, Dose-Ranging Study With an Optional Extension to Assess the Efficacy and Safety of LX211 as Therapy in Subjects With Active Sight Threatening, Non-infectious Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-Uveitis

summary: The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in subjects with active non-infectious uveitis


acronym: REFLEX

title: A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial of Rebif New Formulation (44 Microgram [Mcg] Three Times Weekly [Tiw] and 44 Mcg Once Weekly [ow]) in Subjects at High Risk of Converting to Multiple Sclerosis (REFLEX)

lead_sponsor: Merck KGaA, Darmstadt, Germany

ReferenceCitation: Battaglini M, Vrenken H, Tappa Brocci R, Gentile G, Luchetti L, Versteeg A, Freedman MS, Uitdehaag BMJ, Kappos L, Comi G, Seitzinger A, Jack D, Sormani MP, Barkhof F, De Stefano N. Evolution from a first clinical demyelinating event to multiple sclerosis in the REFLEX trial: Regional susceptibility in the conversion to multiple sclerosis at disease onset and its amenability to subcutaneous interferon beta-1a. Eur J Neurol. 2022 Jul;29(7):2024-2035. doi: 10.1111/ene.15314. Epub 2022 Apr 4.

ReferenceCitation: Freedman MS, De Stefano N, Barkhof F, Polman CH, Comi G, Uitdehaag BM, Casset-Semanaz F, Hennessy B, Lehr L, Stubinski B, Jack DL, Kappos L. Patient subgroup analyses of the treatment effect of subcutaneous interferon β-1a on development of multiple sclerosis in the randomized controlled REFLEX study. J Neurol. 2014 Mar;261(3):490-9. doi: 10.1007/s00415-013-7222-6. Epub 2014 Jan 12.

ReferenceCitation: De Stefano N, Comi G, Kappos L, Freedman MS, Polman CH, Uitdehaag BM, Hennessy B, Casset-Semanaz F, Lehr L, Stubinski B, Jack DL, Barkhof F. Efficacy of subcutaneous interferon β-1a on MRI outcomes in a randomised controlled trial of patients with clinically isolated syndromes. J Neurol Neurosurg Psychiatry. 2014 Jun;85(6):647-53. doi: 10.1136/jnnp-2013-306289. Epub 2013 Nov 29.

ReferenceCitation: Comi G, De Stefano N, Freedman MS, Barkhof F, Polman CH, Uitdehaag BM, Casset-Semanaz F, Hennessy B, Moraga MS, Rocak S, Stubinski B, Kappos L. Comparison of two dosing frequencies of subcutaneous interferon beta-1a in patients with a first clinical demyelinating event suggestive of multiple sclerosis (REFLEX): a phase 3 randomised controlled trial. Lancet Neurol. 2012 Jan;11(1):33-41. doi: 10.1016/S1474-4422(11)70262-9. Epub 2011 Dec 4. Erratum in: Lancet Neurol. 2012 Feb;11(2):125.

location_country:
Croatia
Serbia
Saudi Arabia
Italy
Spain
Romania
Belgium
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Slovakia
Lebanon
Canada
Germany
Bulgaria
Greece
Latvia
Estonia
Finland
Czech Republic
France
Morocco

summary:
The study is a 24 months randomized, double-blind, Placebo-controlled, multi-center clinical trial with an optional 12 months open label extension.

The primary objective of the study is to evaluate the effect of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN] beta-1a (RNF) 44 microgram (three times weekly and once weekly) versus placebo on the time to conversion to McDonald multiple sclerosis (MS) criteria (2005) in subjects with a first clinical demyelinating event at high risk of converting to MS.

The main secondary objective of study is to evaluate the effect of RNF 44 microgram (three times weekly and once weekly) versus placebo on the "Time to conversion to clinically definite MS (CDMS)" in subjects with a first clinical demyelinating event at high risk of converting to MS.

At the end of 24 month double-blind core REFLEX trial, subjects who will not convert to CDMS and decide to receive open-label (OL) treatment will be enrolled into an open-label, 12 month extension period to evaluate the effect of RNF 44 mcg three times weekly treatment on the time to conversion to McDonald MS and time to conversion to CDMS.


title: Belatacept Conversion Trial in Renal Transplantation

summary: The purpose of this study is to learn if conversion to belatacept from cyclosporine or tacrolimus will preserve kidney function in people who have had a kidney transplant. The safety and tolerability of this treatment will also be studied

ReferenceCitation: Rostaing L, Massari P, Garcia VD, Mancilla-Urrea E, Nainan G, del Carmen Rial M, Steinberg S, Vincenti F, Shi R, Di Russo G, Thomas D, Grinyó J. Switching from calcineurin inhibitor-based regimens to a belatacept-based regimen in renal transplant recipients: a randomized phase II study. Clin J Am Soc Nephrol. 2011 Feb;6(2):430-9. doi: 10.2215/CJN.05840710. Epub 2010 Nov 4.

lead_sponsor: Bristol-Myers Squibb

location_country:
Poland
Brazil
Spain
Australia
Mexico
Argentina
Canada
United States
France
India
Belgium
Germany

location_facility: University Of North Carolina School Of Medicine


title: A Phase I/II Study of HKI-272 in Combination With Trastuzumab (Herceptin) in Subjects With Advanced Breast Cancer

lead_sponsor: Puma Biotechnology, Inc.

location_country:
United States
Switzerland
China
France

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Cancer Hospital, Academy of Med Science and Peking Union Med

location_facility: University of Maryland, University of Maryland Medical Center

location_facility: Duke University, Duke University Medical Center

location_facility: 307 Hospital of Chinese People's Liberation Army

location_facility: LAC/USC Medical Center, USC/Norris Comprehensive Cancer Center

summary: The purpose of this study is to determine the safety and efficacy of HKI-272 (neratinib) in combination with trastuzumab in patients with advanced breast cancer.


title: A Phase 2, Multicenter, Double-Blind, Randomized, Stratified, Controlled, Efficacy, Safety and Feasibility Study of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)/Calcium Phosphate Matrix (CPM) as an Adjuvant Therapy in Closed Fractures of the Humerus

summary: The primary objective of this study is to assess whether fracture union is accelerated in subjects with humeral fractures (proximal,diaphyseal) treated with conservative therapy (standard of care) and a single dose of rhBMP-2/CPM compared to subjects who receive standard of care alone.

ReferenceCitation: Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6:CD000434. doi: 10.1002/14651858.CD000434.pub5. Review.

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

location_country:
Brazil
Romania
Australia
Finland
Canada
Sweden
United States
France
Mexico
Norway
Germany


title: A Phase 2, Multicenter, Single-Blind, Randomized, Stratified, Standard-Of-Care Controlled, Feasibility And Safety Study Of rhBMP-2/CPM As An Adjuvant Therapy For Fractures Of The Proximal Femur

summary: The primary objective of this study is to assess the safety of administering rhBMP-2/CPM as an adjuvant to internal fixation in subjects with fractures of the proximal femur.

location_country:
United Kingdom
Australia
Finland
Canada
Sweden
Hungary
United States
France
Norway
Germany

intervention_type: Other


title: A Phase III, Randomized, Double Blind, Placebo Controlled, Multi-Center Study of Epratuzumab in Patients With Active Systemic Lupus Erythematosus.

summary: The purpose of this study is to evaluate the safety and efficacy of Epratuzumab with standard treatments for patients with SLE.

ReferenceCitation: Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3:CD007478. doi: 10.1002/14651858.CD007478.pub2.

location_country:
Brazil
Spain
Italy
United Kingdom
Netherlands
Canada
Czech Republic
United States
France
Belgium
Germany


title: A Phase III Multi-Center, OpenLabel, Follow-Up Study to Assess the Safety & Efficacy of Epratuzumab in Patients With Acute Severe SLE Flares Excluding the Renal or Neurologic Systems

summary: Epratuzumab is an investigational antibody designed to help treat SLE. The purpose is to evaluate safety and long term efficacy in concert with standard SLE treatments

status: Withdrawn

location_country:
Brazil
Spain
Italy
United Kingdom
Netherlands
Canada
Czech Republic
Hungary
United States
France
Belgium
Germany
Slovakia


title: A Randomized Placebo-Controlled Trial Of The Efficacy And Tolerability Of Flexibly Dosed Pregabalin In The Treatment Of Cancer-Induced Bone Pain

acronym: COPE

summary: The purpose of this study is to assess the analgesic efficacy of flexibly-dosed pregabalin in the adjunctive treatment of subjects with cancer-induced bone pain.

ReferenceCitation: Sjölund KF, Yang R, Lee KH, Resnick M. Randomized study of pregabalin in patients with cancer-induced bone pain. Pain Ther. 2013 Jun;2(1):37-48. doi: 10.1007/s40122-013-0009-8. Epub 2013 Feb 26.

location_country:
Poland
Taiwan
Spain
Italy
Russian Federation
Finland
Canada
Thailand
Venezuela
Hungary
Korea, Republic of
United States
France
Peru
Mexico
Philippines
Sweden
Czechia
Egypt


title: A Prospective, Multi-center Trial of NovoTTF-100A Compared to Best Standard of Care in Patients With Progressive or Recurrent GBM

summary: The study is a randomized, controlled trial, designed to test the efficacy and safety of a new medical device, the NovoTTF-100A. The device is an experimental, portable, battery operated device for chronic treatment of patients with recurrent or progressive glioblastoma multiforme (GBM) using alternating electric fields (termed TTFields).

ReferenceCitation: Kirson ED, Gurvich Z, Schneiderman R, Dekel E, Itzhaki A, Wasserman Y, Schatzberger R, Palti Y. Disruption of cancer cell replication by alternating electric fields. Cancer Res. 2004 May 1;64(9):3288-95.

ReferenceCitation: Kirson ED, Dbalý V, Tovarys F, Vymazal J, Soustiel JF, Itzhaki A, Mordechovich D, Steinberg-Shapira S, Gurvich Z, Schneiderman R, Wasserman Y, Salzberg M, Ryffel B, Goldsher D, Dekel E, Palti Y. Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors. Proc Natl Acad Sci U S A. 2007 Jun 12;104(24):10152-7. Epub 2007 Jun 5.

ReferenceCitation: Salzberg M, Kirson E, Palti Y, Rochlitz C. A pilot study with very low-intensity, intermediate-frequency electric fields in patients with locally advanced and/or metastatic solid tumors. Onkologie. 2008 Jul;31(7):362-5. doi: 10.1159/000137713. Epub 2008 Jun 24.

ReferenceCitation: Stupp R, Wong ET, Kanner AA, Steinberg D, Engelhard H, Heidecke V, Kirson ED, Taillibert S, Liebermann F, Dbalý V, Ram Z, Villano JL, Rainov N, Weinberg U, Schiff D, Kunschner L, Raizer J, Honnorat J, Sloan A, Malkin M, Landolfi JC, Payer F, Mehdorn M, Weil RJ, Pannullo SC, Westphal M, Smrcka M, Chin L, Kostron H, Hofer S, Bruce J, Cosgrove R, Paleologous N, Palti Y, Gutin PH. NovoTTF-100A versus physician's choice chemotherapy in recurrent glioblastoma: a randomised phase III trial of a novel treatment modality. Eur J Cancer. 2012 Sep;48(14):2192-202. doi: 10.1016/j.ejca.2012.04.011. Epub 2012 May 18.

lead_sponsor: NovoCure Ltd.

location_country:
Austria
Czech Republic
Switzerland
United States
France
Israel
Germany

location_facility: University Medical Center Hamburg-Eppendorf

location_facility: NJ Neuroscience Institute - JFK Medical Center

location_facility: Hospital of Neurology Lyon - University Claude Bernard Lyon 1

location_facility: University of Pittsburgh Medical Center (UPMC)

location_facility: University Hospital of Schleswig-Holstein

intervention_type: Device


title: A Randomized, Double-blind, Parallel Group, Placebo and Active Controlled, Multicenter Dose Ranging Study With the Beta-3 Agonist YM178 in Patients With Symptomatic Overactive Bladder

summary: The study will examine which dose of YM178 is best in terms of efficacy, safety and tolerability compared to placebo and compared to tolterodine, a marketed product.

location_country:
Denmark
Poland
Spain
Greece
Italy
Netherlands
Russian Federation
United Kingdom
Czech Republic
Sweden
Hungary
France
Belgium
Norway
Germany

location_facility:
3 Sites
2 Sites
7 Sites


title: Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Evaluating the Safety, Tolerability and Effect on MRI Lesion Parameters of FTY720 vs Placebo in Patients With Relapsing Multiple Sclerosis Including 18 Month Extension Phase

summary: This study evaluated the safety, tolerability and effect on MRI lesion parameters of FTY720 in patients with relapsing multiple sclerosis.

ReferenceCitation: Zarbin MA, Jampol LM, Jager RD, Reder AT, Francis G, Collins W, Tang D, Zhang X. Ophthalmic evaluations in clinical studies of fingolimod (FTY720) in multiple sclerosis. Ophthalmology. 2013 Jul;120(7):1432-9. doi: 10.1016/j.ophtha.2012.12.040. Epub 2013 Mar 24.

ReferenceCitation: Kappos L, Antel J, Comi G, Montalban X, O'Connor P, Polman CH, Haas T, Korn AA, Karlsson G, Radue EW; FTY720 D2201 Study Group. Oral fingolimod (FTY720) for relapsing multiple sclerosis. N Engl J Med. 2006 Sep 14;355(11):1124-40.

lead_sponsor: Novartis

location_country:
Denmark
Poland
Portugal
Spain
Italy
United Kingdom
Finland
Canada
Switzerland
France
Germany


title: Prospective, International, Multi-centre Study on ASAS Classification Criteria for SpA

summary:
Background:

Existing criteria for AS/SpA such as mod. New York, ESSG, or Amor criteria for classification and/or diagnosis of spondyloarthritis have limitations when applied to early disease. Moreover, MRI is not part of any of the established criteria and the precise role of MRI in early axial disease has not been fully defined yet. Even less is known about sacroiliac (SI) changes in SpA patients with peripheral symptoms. A pilot study using data from 'paper patients' led to new candidate criteria for early spondyloarthritis. Subsequently, the members of the ASAS International Working Group decided to conduct a prospective multi-centre study to evaluate (validate) the new candidate criteria, and to assess their performance as diagnostic criteria.

Aims of the study:

To evaluate the new candidate criteria for axial SpA in a multi-centre setting.
To assess the potential role of the new candidate criteria to be used as diagnostic criteria. To accomplish this, inclusion of consecutive and undiagnosed patients is mandatory as are longer periods of follow-up .
To compare criteria encompassing the whole group of SpA such as ESSG and Amor criteria against criteria which are tailored to either predominant axial disease or predominant peripheral disease. To accomplish this, both patients with predominant axial disease (back pain) but also patient with predominant peripheral disease (arthritis/enthesitis) will be included.

status: Unknown status

ReferenceCitation: Rudwaleit M, Metter A, Listing J, Sieper J, Braun J. Inflammatory back pain in ankylosing spondylitis: a reassessment of the clinical history for application as classification and diagnostic criteria. Arthritis Rheum. 2006 Feb;54(2):569-78.

ReferenceCitation: Rudwaleit M, Sieper J. Positive and negative predictive values from published studies can be misleading for decision-making in clinical practice. Rheumatology (Oxford). 2006 Jun;45(6):779-80; author reply 780-1. Epub 2006 Apr 4.

ReferenceCitation: Rudwaleit M, van der Heijde D, Landewé R, Listing J, Akkoc N, Brandt J, Braun J, Chou CT, Collantes-Estevez E, Dougados M, Huang F, Gu J, Khan MA, Kirazli Y, Maksymowych WP, Mielants H, Sørensen IJ, Ozgocmen S, Roussou E, Valle-Oñate R, Weber U, Wei J, Sieper J. The development of Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis (part II): validation and final selection. Ann Rheum Dis. 2009 Jun;68(6):777-83. doi: 10.1136/ard.2009.108233. Epub 2009 Mar 17. Erratum in: Ann Rheum Dis. 2019 Jun;78(6):e59.

lead_sponsor: Charite University, Berlin, Germany

location_country:
Denmark
Taiwan
Brazil
Spain
Colombia
Ireland
Italy
Mexico
Canada
Netherlands
Indonesia
Switzerland
United Kingdom
Hungary
United States
France
China
Turkey
Belgium
Germany

location_facility: Glasgow Royal Infirmary, Queen Elizabeth Building

location_facility: Case Western Reserve University at MetroHealth Medical Centre

location_facility: Third Affiliated Hospital of Sun Yat-sen University

location_facility: Hvidovre Hospital, University of Copenhagen

location_facility: Universitaetsmedizin Berlin, Charité Campus Benjamin-Franklin, Med. Clinic I, Rheumatology, Hindenburgdamm 30


title: Long-term Bosentan Open Label Extension of the AC-052-331 Study in Systemic Sclerosis Patients With Ischemic Digital Ulcers

acronym: RAPIDS 2 OL

summary: The aim of the study is to collect long-term efficacy, tolerability and safety data of bosentan in Systemic Sclerosis (SSc) patients suffering from ischemic digital ulcers (DUs).

lead_sponsor: Actelion

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

location_facility:
AKH Universitatsklinik
Murray Baron, MD
Nadera Sweiss, MD
Naomi Rothfield, MD
Vivien Hsu, MD - UMDNJ
Selly Oak Hospital
Freeman Hospital
Universitatsklinik
Centre Hospitalier Universitaire
Edwin Smith, MD
Maureen Mayes, MD
Inselspital, Universitatspital Bern
Howard Kenney, MD
Bashar Kahaleh, MD
Thomas Osborn, MD
Avram Goldberg, MD
Policlinico Umberto 1
Daniel Furst, MD
Ospedale Maggiore
Peter Merkel, MD
CHRU Claude Huriez
David Collier, MD
Barri Fessler, MD
Thomas Medsger, MD
Eric Rich, MD
Jerry Molitor, MD
Mary Ellen Csuka, MD
Mittie Doyle, MD
Medical Universtiy of South Carolina
Instituto di Clinica, Villa Monna Tessa
Frederick Wigley, MD
Janet Pope, MD
Royal Free Hospital
Peter Lee, MD
Universitatsklinikum


title: Long-term Open-label Extension Study in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Who Completed Protocol AC-052-366 (BENEFIT, NCT00313222)

acronym: BENEFIT OL

summary: The present trial investigates the long-term safety, tolerability and efficacy of bosentan in patients with inoperable CTEPH.

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

location_facility: Centre de Pneumologie de L'Hopital Laval

location_facility: Mayo Clinic, Division of Cardiovascular Diseases and Internal Medicine

location_facility: Charles University, Internal Medicine Department, (PAH unit)


title: Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

summary: The present trial investigates a possible use of oral bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH), to patients suffering from inoperable chronic thromboembolic pulmonary hypertension (CTEPH) because of (i) peripheral localization of thrombotic material or (ii) persistent or recurrent pulmonary hypertension after pulmonary endarterectomy.

ReferenceCitation: Jaïs X, D'Armini AM, Jansa P, Torbicki A, Delcroix M, Ghofrani HA, Hoeper MM, Lang IM, Mayer E, Pepke-Zaba J, Perchenet L, Morganti A, Simonneau G, Rubin LJ; Bosentan Effects in iNopErable Forms of chronIc Thromboembolic pulmonary hypertension Study Group. Bosentan for treatment of inoperable chronic thromboembolic pulmonary hypertension: BENEFiT (Bosentan Effects in iNopErable Forms of chronIc Thromboembolic pulmonary hypertension), a randomized, placebo-controlled trial. J Am Coll Cardiol. 2008 Dec 16;52(25):2127-34. doi: 10.1016/j.jacc.2008.08.059.

location_facility: Toronto General Hospital Pulmonary & Critical Care Medicine

location_facility: Centre de Pneumonologie de L'Hospital Laval


title: A Randomised Study Examining the Effect of Different Diuretics on Fluid Balance in Diabetics Treated With Avandia

summary: Study examining the effect of different diuretics on fluid retention in diabetics treated with rosiglitazone.

ReferenceCitation: Karalliedde J. Abstract (oral presentation). Management of Rosiglitazone Related Fluid Retention. Diabetes 2005; Vol 54, (suppl 1):Abstract number 81-OR

ReferenceCitation: Karalliedde J, Buckingham R, Starkie M, Lorand D, Stewart M, Viberti G; Rosiglitazone Fluid Retention Study Group. Effect of various diuretic treatments on rosiglitazone-induced fluid retention. J Am Soc Nephrol. 2006 Dec;17(12):3482-90. Epub 2006 Nov 8.

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

lead_sponsor: GlaxoSmithKline

location_country:
Denmark
Poland
Spain
Greece
Italy
Netherlands
United Kingdom
Canada
France
Israel
Belgium
Norway
Germany
Slovakia


title: A Phase 2B, Randomized, Multicenter, Dose-Ranging Study Assessing the Safety and Efficacy of PD 0348292 in the Prevention of Venous Thromboembolic Events (VTE) in Subjects Undergoing an Elective, Unilateral Total Knee Replacement

summary: To study the safety and effectiveness of several doses of PD 0348292 compared to enoxaparin in preventing blood clots in the lungs or deep leg veins of patients after knee surgery

lead_sponsor: Pfizer

location_country:
Denmark
Poland
Portugal
Spain
Italy
Russian Federation
Australia
United Kingdom
Canada
Czech Republic
United States
Chile
France
South Africa
Colombia
Slovakia


title: A Multi-center, Randomized, Double Blind, Placebo Controlled Study to Investigate the Efficacy and Safety of Aprotinin on Transfusion Requirements in Patients With Bladder Cancer Undergoing Radical or Total Cystectomy.

summary: The purpose of this study is to assess if aprotinin (BAYA0128), given intravenously during your surgery, is safe and can help reduce the need for a blood transfusion during bladder surgery.

lead_sponsor: Bayer

location_country:
United Kingdom
Netherlands
Sweden
United States
France
Belgium
Germany


title: A Phase IIB Study to Assess the Efficacy of GSK 249553 as Adjuvant Therapy Given to MAGE-3-Positive Patients With Non-Small-Cell Lung Cancer in Stage IB (T2/N0) or II (T1/N1 or T2/N1 or T3/N0), Who Have Had Complete Surgical Resection

summary: Patients will receive injections of GSK 249553 vaccine . Appropriate tests will be performed to assess the safety of the treatment and its ability to induce an immune response.

ReferenceCitation: Passlick B et al. MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI) as adjuvant therapy in resected stage IB/II Non-Small Cell Lung Cancer (NSCLC): from proof-of-concept to Phase III trial (MAGRIT). Abstract presented at the European Multidisciplinary Conference in Thoracic Oncology (EMCTO), Lugano, Switzerland. 1-3 May 2009; 64 (suppl. 1):S45 (102PD).

ReferenceCitation: Vansteenkiste J et al. Activity of MAGE-A3 cancer immunotherapeutic as adjuvant therapy in stage IB/II Non-Small Cell Lung Cancer (NSCLC): Final results of a multi-center, double-blind, randomized, placebo-controlled Phase II study. Abstract presented at the 12th Conference on Lung Cancer (WCLC), Seoul, Korea. 2-6 September 2007.

ReferenceCitation: Vansteenkiste J et al. Adjuvant therapy in stage IB/II Non-Small Cell Lung Cancer (NSCLC): Final results of a multi-center, double-blind, randomized, placebo-controlled Phase II study evaluating the MAGE-A3 cancer immunotherapeutic. Abstract presented at The 14th European Cancer Conference (ECCO) (formerly ECCO14/ESTRO 26), Barcelona, Spain. 23-27 September 2007.

ReferenceCitation: Vansteenkiste J et al. Multi-center, double-blind, randomized, placebo-controlled Phase II study to assess the efficacy of recombinant MAGE-A3 vaccine as adjuvant therapy in stage IB/II MAGE-A3-positive, completely resected, Non-Small Cell Lung Cancer (NSCLC). Abstract presented at the 43rd Annual Meeting American Society of Clinical Oncology (ASCO), Chicago, IL. 1-5 June 2007.

ReferenceCitation: Vansteenkiste J et al. Multi-center, double-blind, randomized, placebo-controlled phase II study to assess the efficacy of recombinant MAGE-A3 vaccine as adjuvant therapy in stage IB/II MAGE-A3-positive, completely resected, non-small-cell lung cancer (NSCLC). Abstract presented at the 42nd Annual Meeting American Society of Clinical Oncology (ASCO), Atlanta, GA. 2-6 June 2006.

ReferenceCitation: Vansteenkiste J et al. Phase II randomized study of MAGE-A3 immunotherapeutic as adjuvant therapy in stage IB/II Non-Small Cell Lung Cancer (NSCLC): 44 month follow-up, humoral and cellular immune response data. European Society for Medical Oncology (IASLC-ESMO) Abstract presented at the 1st European Lung Cancer Conference (ELCC), Geneva, Switzerland. 23-26 April 2008; 3 (4 suppl.1):S55-56.

ReferenceCitation: Zielinski M et al. MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI) as adjuvant therapy in resected stage IB/II Non-Small Cell Lung Cancer (NSCLC): from proof-of-concept to Phase III trial (MAGRIT). Abstract presented at the 17th European Conference on General Thoracic Surgery (ECGTS), Krakow, Poland. 31 May-3 June 2009.

ReferenceCitation: Zhu J, Yuan Y, Wan X, Yin D, Li R, Chen W, Suo C, Song H. Immunotherapy (excluding checkpoint inhibitors) for stage I to III non-small cell lung cancer treated with surgery or radiotherapy with curative intent. Cochrane Database Syst Rev. 2021 Dec 6;12(12):CD011300. doi: 10.1002/14651858.CD011300.pub3.

ReferenceCitation: Vansteenkiste J, Zielinski M, Linder A, Dahabreh J, Gonzalez EE, Malinowski W, Lopez-Brea M, Vanakesa T, Jassem J, Kalofonos H, Perdeus J, Bonnet R, Basko J, Janilionis R, Passlick B, Treasure T, Gillet M, Lehmann FF, Brichard VG. Adjuvant MAGE-A3 immunotherapy in resected non-small-cell lung cancer: phase II randomized study results. J Clin Oncol. 2013 Jul 1;31(19):2396-403. doi: 10.1200/JCO.2012.43.7103. Epub 2013 May 28.

ReferenceCitation: Ulloa-Montoya F, Louahed J, Dizier B, Gruselle O, Spiessens B, Lehmann FF, Suciu S, Kruit WH, Eggermont AM, Vansteenkiste J, Brichard VG. Predictive gene signature in MAGE-A3 antigen-specific cancer immunotherapy. J Clin Oncol. 2013 Jul 1;31(19):2388-95. doi: 10.1200/JCO.2012.44.3762. Epub 2013 May 28.

ipd_sharing_description: IPD is available via the Clinical Study Data Request site (click on the link provided below)

location_country:
Poland
Spain
Greece
Italy
Estonia
Latvia
Finland
Lithuania
Netherlands
United Kingdom
France
Belgium
Norway
Germany


title: A Randomized, Controlled, Parallel-Group, Multicenter Study of Extracorporeal Photoimmune Therapy With THERAKOS* UVADEX* for the Treatment of Patients With Newly Diagnosed Acute Graft Versus-Host Disease

summary: The purpose of this study is to compare the safety and efficacy of ECP treatment combined with high dose corticosteroids versus high dose corticosteroids alone, in the treatment of patients with newly diagnosed acute GvHD (Grades II to III) that developed within 100 days following an allo HPCT.

lead_sponsor: Mallinckrodt

location_country:
United Kingdom
Italy
Austria
Australia
Netherlands
Canada
Switzerland
United States
France
Belgium
Germany

location_facility: Centre Hopitalier Universitaire Sart Tilman Liege

location_facility: Universita di Siena Policlinico Le Scotte

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Weill Medical College of Cornell University

location_facility: Centre Hospitalier Universitaire Hospital Bordeaux

location_facility: Leukemia and Bone Marrow Transplant Center - Avera Cancer Institute

location_facility: Stammzelltransplantationzentrum der Universitat Wurzbrug

location_facility: Klinikum der Universitat Erlangen-Nurnberg


title: MVP Trial (Managed Ventricular Pacing ("MVP") Versus Backup Ventricular Pacing at a Rate of 40 Beats Per Minute ("VVI 40") Pacing Trial)

acronym: MVP

summary: The purpose of the study is to compare two device settings (sets of instructions) used by the ICD. The Implantable Cardiac Defibrillator ("ICD") can be set to use one wire (top or bottom of the heart) or two wires (top and bottom). The study will compare how much time either ICD wire is used by the ICD and the status of congestive heart failure.

ReferenceCitation: Sweeney MO, Ellenbogen KA, Tang AS, Whellan D, Mortensen PT, Giraldi F, Sandler DA, Sherfesee L, Sheldon T; Managed Ventricular Pacing Versus VVI 40 Pacing Trial Investigators. Atrial pacing or ventricular backup-only pacing in implantable cardioverter-defibrillator patients. Heart Rhythm. 2010 Nov;7(11):1552-60. doi: 10.1016/j.hrthm.2010.05.038. Epub 2010 Jun 4.

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
Denmark
Spain
Italy
Austria
United Kingdom
Canada
Switzerland
United States
France
Israel
Norway
Germany


title: A Study to Compare the Efficacy of AZD2171 in Combination With 5-fluorouracil, Leucovorin, and Oxaliplatin (FOLFOX) and the Efficacy of Bevacizumab in Combination With FOLFOX in the Second-line Treatment of Patients With Metastatic Colorectal Cancer

acronym: HORIZON I

summary: The primary purpose of this study is to compare the efficacy of AZD2171 in combination with FOLFOX to the efficacy of bevacizumab in combination with FOLFOX, in the second-line treatment of patients with metastatic colorectal cancer

lead_sponsor: AstraZeneca

location_country:
Spain
Italy
Austria
United Kingdom
Canada
Czech Republic
France
Belgium
Germany

location_facility:
Ressearch Site
Research Site


title: A Phase II Clinical Trial of PXD101 in Patients With Recurrent or Refractory Cutaneous and Peripheral T-Cell Lymphomas

summary: Open-label, non-randomized trial to assess the effectiveness of PXD101 in patients with recurrent or refractory cutaneous or peripheral and other types of T-cell lymphomas. PXD101 is a new, potent histone deacetylase (HDAC) inhibitor. Patients are treated with belinostat(PXD101) 1000 mg/m2 on days 1-5 of a 21 day cycle.

ReferenceCitation: Foss F, Advani R, Duvic M, Hymes KB, Intragumtornchai T, Lekhakula A, Shpilberg O, Lerner A, Belt RJ, Jacobsen ED, Laurent G, Ben-Yehuda D, Beylot-Barry M, Hillen U, Knoblauch P, Bhat G, Chawla S, Allen LF, Pohlman B. A Phase II trial of Belinostat (PXD101) in patients with relapsed or refractory peripheral or cutaneous T-cell lymphoma. Br J Haematol. 2015 Mar;168(6):811-9. doi: 10.1111/bjh.13222. Epub 2014 Nov 17.

lead_sponsor: Onxeo

location_country:
Thailand
United States
Israel
France
Germany

location_facility: Songklanagarind Hospital, Prince of Songkla University


title: An International, Multicenter, Randomized, Placebo-controlled, Parallel-group, 1 Year Treatment, Integrated Biomarkers and Imaging Study in Subjects With Angiographically Documented Coronary Heart Disease (CHD) to Examine the Effects of the Novel Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Inhibitor SB-480848 on Intermediate Cardiovascular Endpoints, Patient Safety and Tolerability

summary: IBIS-2 is a study using SB-480848 versus placebo in subjects with angiographically documented coronary heart disease. Endpoints include coronary imaging, endothelial function, biomarkers, safety and tolerability.

ReferenceCitation: Serruys PW, García-García HM, Buszman P, Erne P, Verheye S, Aschermann M, Duckers H, Bleie O, Dudek D, Bøtker HE, von Birgelen C, D'Amico D, Hutchinson T, Zambanini A, Mastik F, van Es GA, van der Steen AF, Vince DG, Ganz P, Hamm CW, Wijns W, Zalewski A; Integrated Biomarker and Imaging Study-2 Investigators. Effects of the direct lipoprotein-associated phospholipase A(2) inhibitor darapladib on human coronary atherosclerotic plaque. Circulation. 2008 Sep 9;118(11):1172-82. doi: 10.1161/CIRCULATIONAHA.108.771899. Epub 2008 Sep 1.

location_country: Denmark Poland Spain Austria Netherlands Switzerland France Belgium Norway Germany Czechia


title: Cyclophosphamide, Doxorubicin, Vincristine, Prednisone Plus Rituximab (CHOP-R) and Cyclophosphamide, Pixantrone, Vincristine, Prednisone Plus Rituximab (CPOP-R) in Patients With Diffuse Large-B-cell Lymphoma: A Phase II, Randomized, Multicenter, Comparative Trial

acronym: RAPID

summary: The purpose of this study is to compare the standard CHOP-R regimen of Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, and Rituximab to CPOP-R (same regimen, but substituting Doxorubicin with Pixantrone). The objective is to show that CPOP-R is not inferior to CHOP-R.

ReferenceCitation: Herbrecht R, Cernohous P, Engert A, Le Gouill S, Macdonald D, Machida C, Myint H, Saleh A, Singer J, Wilhelm M, van der Jagt R. Comparison of pixantrone-based regimen (CPOP-R) with doxorubicin-based therapy (CHOP-R) for treatment of diffuse large B-cell lymphoma. Ann Oncol. 2013 Oct;24(10):2618-2623. doi: 10.1093/annonc/mdt289. Epub 2013 Aug 14.

lead_sponsor: CTI BioPharma

location_country:
Italy
Canada
United States
France
Germany

location_facility: The Center for Cancer and Blood Disorders

location_facility: Mid-Illinois Hematology & Oncology Associates

location_facility: Multicare Oncology Hematology Specialists

location_facility: Farmacia Osepdaliera, Odpedale Umberto I

location_facility: Consultants in Blood Disorders and Cancer

location_facility: Tufts-New England Medical Center-The Neely Ctr for Clinical Cancer Research

location_facility: Oncology Hematology of Northern Illinois

location_facility: Oncology Hematology Associates of West Broward

location_facility: Hopitaux Universitaires de Strabourg - Hopital Hautepierre

location_facility: Watson Clinic for Cancer Care and Research

location_facility: Western Kentucky Hematology/Oncology Group

location_facility: Maryland Hematology/Oncology Associates, PA

location_facility: North Missssppi Hematology Oncology Associates

location_facility: Hazel Hawkins Hospital, Dept. of Medical Oncology

location_facility: UCSD Moore's Cancer Center-Blood & Marrow Transplantation Division

location_facility: London Health Science Center Regional Care Program

location_facility: Hematology Oncology Associates of the Treasure Coast

location_facility: New Mexico Hematology/Oncology Consultants

location_facility: Cancer Treatment & Research Mid-Dakota Clinic

location_facility: Southeast Nebraska Hematology and Oncology Consultants, P.C.

location_facility: Hematology/Oncology Group of Orange County

location_facility: Center for Cancer and Blood Disorders, P.C.

location_facility: Brody School of Medicine at East Carolina University - Leo W. Jenkins Cancer Center

location_facility: Berks Hematology-Oncology Associates Ltd.

location_facility: Instituto di Ematologia "Lorenzo e Ariosto"

location_facility: Frederick Memorial Hospital Cancer Center

location_facility: Our Lady of the Lake Regional Medial Center, Hematology Oncology