title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Bosentan in Patients With Idiopathic Pulmonary Fibrosis, Open Label Extension

acronym: BUILD 1

summary:
Endothelin-1 (ET-1) is expressed in a variety of pulmonary pathological conditions including pulmonary vascular disease and pulmonary fibrosis.

Bosentan (an oral dual ET-1 receptor antagonist) could delay the progression of idiopathic pulmonary fibrosis (IPF), a condition for which no established treatment is available.

The present trial investigates a possible use of bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH) WHO class III and IV, to a new category of patients suffering from IPF.

It was decided to offer Open Label treatment (bosentan) for patients willing to continue in the BUILD 1 study.

ReferenceCitation: Raghu G, King TE Jr, Behr J, Brown KK, du Bois RM, Leconte I, Roux S, Swigris J. Quality of life and dyspnoea in patients treated with bosentan for idiopathic pulmonary fibrosis (BUILD-1). Eur Respir J. 2010 Jan;35(1):118-23. doi: 10.1183/09031936.00188108. Epub 2009 Aug 13.

ReferenceCitation: King TE Jr, Behr J, Brown KK, du Bois RM, Lancaster L, de Andrade JA, Stähler G, Leconte I, Roux S, Raghu G. BUILD-1: a randomized placebo-controlled trial of bosentan in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2008 Jan 1;177(1):75-81. Epub 2007 Sep 27.

lead_sponsor: Actelion

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

location_facility: University of Wisconsin Hospitals & Clinics - Section of Pulmonary and Critical Care Medicine

location_facility: Notre-Dame Hospital - Clinique du Thorax

location_facility: University of Iowa Hospitals & Clinics - Department of Internal Medicine

location_facility: Médecine Spécialisée Aigüe - CHU Grenoble

location_facility: University of Alabama at Birmingham - Pulmonary Division

location_facility: Abt. Pneumologie Medizinische Klinik Universitätsklinikum Freiburg

location_facility: University of Washington - Division of Pulmonary & Critical Care Medicine

location_facility: University of Michigan Health System - Division of Pulmonary & Critical Care Medicine

location_facility: National Jewish Medical and Research Center

location_facility: University of British Columbia - St. Paul's Hospital

location_facility: Section of Respiratory Diseases - Policlinico Le Scotte - Siena University

location_facility: University of California - Ambulatory Care Center

location_facility: Medizinische Klinik und Poliklinik I Klinikum der Universität München

location_facility: David Geffen School of Medicine at UCLA - Division of Pulmonary and Critical Care Medicine


title: The Van Gogh-extension Trial, a Multicenter, International, Randomized, Double-blind, Study Comparing the Efficacy and Safety of Once-weekly Subcutaneous SR34006 With Placebo in the Long-term Prevention of Symptomatic Venous Thromboembolism in Patients With Symptomatic Pulmonary Embolism or Deep-vein Thrombosis Who Completed 6 Months of Treatment With Vitamin K Antagonist or SR34006

summary:
Patients diagnosed with pulmonary embolism (blood clot in the lung) or deep vein thrombosis (blood clot in a leg vein) are at risk for these blood clots to reoccur. Anticoagulant (blood-thinning) drugs are normally given immediately after the clot is discovered and are continued for a period of 3 or 6 months during which time the risk for recurrence is highest. Research has shown that when oral anticoagulants are used appropriately during this period, patients are less at risk for a recurrent blood clot and this risk reduction outweighs the potential for bleeding to occur.

In this study, patients who had a blood clot in the lung or in a leg vein and completed 6 months of treatment with daily oral vitamin K antagonists (acenocoumarol or warfarin) or once-weekly injections of SR34006 (a new anticoagulant drug) will receive an additional 6 months of once-weekly SR34006 injections or injections of a solution containing no drug (placebo). This trial will evaluate whether patients treated for an additional 6 months with SR34006 have fewer recurrences of blood clots when compared to patients treated with placebo.

Assignment to either SR34006 or placebo will be purely by chance. Neither the patients nor their doctors will know which treatment is being given.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: van Gogh Investigators, Buller HR, Cohen AT, Davidson B, Decousus H, Gallus AS, Gent M, Pillion G, Piovella F, Prins MH, Raskob GE. Extended prophylaxis of venous thromboembolism with idraparinux. N Engl J Med. 2007 Sep 13;357(11):1105-12.

lead_sponsor: Sanofi

location_country:
Denmark
Poland
Brazil
Spain
Italy
Austria
Australia
Netherlands
Canada
Czech Republic
Finland
New Zealand
Sweden
United States
France
South Africa
United Kingdom
Belgium
Norway
Germany

location_facility: Pulmonary Associates of Fredericksburg, Inc.

location_facility: Pulmonary Specialists/Spokane Respiratory Consultants

location_facility: The University of Texas Health Center at Tyler

location_facility: Scott and White Memorial Hospital and Clinic

location_facility: Dr. Kiritkumar C. Patel's and Dr. Michele DeGregorio's Office

location_facility: Melbourne Internal Medical Associates (MIMA)

location_facility: Centre hospitalier de l'Universite Laval du Centre hospitalier universitaire de Quebec

location_facility: St. Joseph Mercy - Oakland Clinical Research Office

location_facility: Melbourne Internal Medicine Associates (MIMA)

location_facility: William Beaumont Hospital / Clinical Research Center

location_facility: Lovelace Sandia Health Systems, Clinical Thrombosis Center

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Randomized, Partially Blinded, Phase II Study to Assess the Safety, Tolerability and Efficacy of ZD6474 Alone or in Combination With Paclitaxel and Carboplatin in Subjects With Previously Untreated Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

summary:
The purpose of the run-in phase of this study is to determine the appropriate and tolerable dose of ZD6474 (200mg or 300mg) to be administered in combination with paclitaxel and carboplatin in subjects with previously untreated locally advanced or metastatic NSCLC. This phase of the trial is closed to enrollment.

The purpose of the randomized phase of this study is to determine the efficacy of ZD6474 alone versus that of ZD6474 in combination with paclitaxel and carboplatin versus that of paclitaxel and carboplatin alone in subjects with previously untreated locally advanced or metastatic NSCLC. This phase of the trial is closed to enrollment.

primary_purpose: Treatment

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Spain
Italy
Finland
Thailand
United States
India
France
South Africa
Germany


title: The AMADEUS Trial, A Multicenter, Randomized, Open-label, Assessor Blind, Non-inferiority Study Comparing the Efficacy and Safety of Once-weekly Subcutaneous Idraparinux (SR34006) With Adjusted-dose Oral Vitamin-K Antagonists in the Prevention of Thromboembolic Events in Patients With Atrial Fibrillation

summary:
This trial will include patients who have a heart condition called atrial fibrillation. Atrial fibrillation is an abnormal rhythm (irregular beat) in the heart. Patients with atrial fibrillation have an increased chance for a blood clot to form in the heart and move to other blood vessels in the body and cause obstruction. This obstruction may damage tissue. For example, a blood clot plugging a vessel in the brain could cause a stroke. Therefore, patients with atrial fibrillation may be given anticoagulant (blood-thinning) tablets such as warfarin or acenocoumarol.

The purpose of this study is to compare the safety and effectiveness of a new injectable anticoagulant drug that is administered once weekly, SR34006 with warfarin or acenocoumarol tablets.

Assignment to either SR34006 Injection or vitamin K antagonist (warfarin or acenocoumarol) tablets will be purely by chance and will be known by both patients and their doctors.

ReferenceCitation: Ding WY, Lip GYH, Shantsila A. Relationship between Chronic Kidney Disease, Time-in-Therapeutic Range, and Adverse Outcomes in Atrial Fibrillation: A post hoc Analysis from the AMADEUS Trial. Cerebrovasc Dis. 2022;51(1):29-35. doi: 10.1159/000517608. Epub 2021 Jul 28.

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

ReferenceCitation: Amadeus Investigators, Bousser MG, Bouthier J, Büller HR, Cohen AT, Crijns H, Davidson BL, Halperin J, Hankey G, Levy S, Pengo V, Prandoni P, Prins MH, Tomkowski W, Torp-Pedersen C, Wyse DG. Comparison of idraparinux with vitamin K antagonists for prevention of thromboembolism in patients with atrial fibrillation: a randomised, open-label, non-inferiority trial. Lancet. 2008 Jan 26;371(9609):315-21. doi: 10.1016/S0140-6736(08)60168-3. Erratum in: Lancet. 2008 Dec 13;372(9655):2022.. Thorp-Pedersen, C [corrected to Torp-Pedersen, C].

location_country:
Denmark
Poland
United Kingdom
Italy
Australia
New Zealand
Canada
United States
France
Netherlands

location_facility: Heart & Vascular Clinic/Advanced Medical Research

location_facility: The Clinic (Lake Charles Medical & Surgical Clinic)

location_facility: North Broward Hospital District Cardiovascular Research Institute

location_facility: Cardiovascular Research Institute of Dallas, Inc./Cardiology and Internal Medicine Associates

location_facility: Southern Arizona Veterans Affairs Health Care System

location_facility: Dr. M.P.J. Senaratne Professional Corporation

location_facility: Jacksonville Center for Clinical Research

location_facility: Denver Health and Hospital Authority Eastside Health Clinic

location_facility: Health Care Corporation of St. John's Health Sciences Centre

location_facility: Practice of James A. Underberg @ Murray Hill Medical Group

location_facility: Oracle Research, a Division of: The Heart Center, P.C.

location_facility: Denver Health and Hospital Authority Adult Medicine Clinic

location_facility: The Oregon Health and Science University


title: Continuous Fluorouracil Plus Mitomycin C Versus Mitomycin C Plus Cisplatin As Chemotherapy Combination In Combined Radiochemotherapy For Locally Advanced Anal Cancer. A Phase II-III Study

summary:
RATIONALE: Drugs used in chemotherapy, such as mitomycin, fluorouracil, and cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. It is not yet known whether radiation therapy and mitomycin are more effective when combined with fluorouracil or with cisplatin in treating anal cancer .

PURPOSE: This randomized phase II/III trial is studying how well giving radiation therapy and mitomycin together with fluorouracil works compared to radiation therapy, mitomycin, and cisplatin in treating patients with locally advanced anal cancer.

status: Terminated

ReferenceType: result

ReferenceCitation: Matzinger O, Roelofsen F, Mineur L, Koswig S, Van Der Steen-Banasik EM, Van Houtte P, Haustermans K, Radosevic-Jelic L, Mueller RP, Maingon P, Collette L, Bosset JF; EORTC Radiation Oncology and Gastrointestinal Tract Cancer Groups. Mitomycin C with continuous fluorouracil or with cisplatin in combination with radiotherapy for locally advanced anal cancer (European Organisation for Research and Treatment of Cancer phase II study 22011-40014). Eur J Cancer. 2009 Nov;45(16):2782-91. doi: 10.1016/j.ejca.2009.06.020. Epub 2009 Jul 28.

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

location_country: Serbia Italy Netherlands France Belgium Germany Egypt

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

location_facility: Ospedale Busonera - Divisione Oncologia Medica

location_facility: Robert Roessle Comprehensive Cancer Center - Charite Campus Buch

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

location_facility: Cazk Groeninghe - Campus Maria's Voorzienigheid

location_facility: Institute of Oncology and Radiology of Serbia

location_facility: Urologische Klinik - Universitaetsklinikum Aachen

intervention_type: Radiation

status_simplified: Unknown


title: Randomised Trial Of Single Agent Doxorubicin Versus Doxorubicin Plus Ifosfamide In The First Line Treatment Of Advanced Or Metastatic Soft Tissue Sarcoma

summary:
RATIONALE: Drugs used in chemotherapy such as doxorubicin and ifosfamide use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors, such as pegfilgrastim, cause the body to make blood cells. It is not yet known whether doxorubicin alone is more effective with or without ifosfamide and pegfilgrastim in treating soft tissue sarcoma.

PURPOSE: This randomized phase III trial is studying giving doxorubicin alone to see how well it works compared to giving doxorubicin together with ifosfamide and pegfilgrastim in treating patients with locally advanced or metastatic soft tissue sarcoma.

ReferenceCitation: Judson I, Verweij J, Gelderblom H, Hartmann JT, Schöffski P, Blay JY, Kerst JM, Sufliarsky J, Whelan J, Hohenberger P, Krarup-Hansen A, Alcindor T, Marreaud S, Litière S, Hermans C, Fisher C, Hogendoorn PC, dei Tos AP, van der Graaf WT; European Organisation and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. Doxorubicin alone versus intensified doxorubicin plus ifosfamide for first-line treatment of advanced or metastatic soft-tissue sarcoma: a randomised controlled phase 3 trial. Lancet Oncol. 2014 Apr;15(4):415-23. doi: 10.1016/S1470-2045(14)70063-4. Epub 2014 Mar 5.

location_country:
Denmark
Spain
United Kingdom
Austria
Netherlands
Canada
Switzerland
France
Belgium
Germany
Slovakia

location_facility: Klinikum der Universitaet Muenchen - Grosshadern Campus

location_facility: Cancer Research Centre at Weston Park Hospital

location_facility: University Medical Center Rotterdam at Erasmus Medical Center

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Medizinische Universitaetsklinik I at the University of Cologne

location_facility: Northern Centre for Cancer Treatment at Newcastle General Hospital

location_facility: McGill Cancer Centre at McGill University

location_facility: Edinburgh Cancer Centre at Western General Hospital

location_facility: Aarhus Universitetshospital - Aarhus Sygehus

location_facility: Universitair Medisch Centrum St. Radboud - Nijmegen

location_facility: Cross Cancer Institute at University of Alberta

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

location_facility: Margaret and Charles Juravinski Cancer Centre

location_facility: Leeds Cancer Centre at St. James's University Hospital

location_facility: Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

location_facility: Southwest German Cancer Center at Eberhard-Karls-University

location_facility: Copenhagen County Herlev University Hospital

intervention_type: Biological


title: A Phase III, Multicenter, Randomized, Double Masked, Active Treatment-Controlled Study of the Efficacy and Safety of rhuFab V2 (Ranibizumab) Compared With Verteporfin (Visudyne) Photodynamic Therapy in Subjects With Predominantly Classic Subfoveal Neovascular Age-Related Macular Degeneration

summary: This is a phase III, multicenter, randomized, double-masked, active treatment-controlled study of intravitreally administered ranibizumab compared with verteporfin (Visudyne) photodynamic therapy (PDT) in treating subfoveal neovascular mascular degeneration.

ReferenceCitation: Brown DM, Kaiser PK, Michels M, Soubrane G, Heier JS, Kim RY, Sy JP, Schneider S; ANCHOR Study Group. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1432-44.

ReferenceCitation: Kaiser PK, Brown DM, Zhang K, Hudson HL, Holz FG, Shapiro H, Schneider S, Acharya NR. Ranibizumab for predominantly classic neovascular age-related macular degeneration: subgroup analysis of first-year ANCHOR results. Am J Ophthalmol. 2007 Dec;144(6):850-857. Epub 2007 Oct 22.

ReferenceCitation: Brown DM, Michels M, Kaiser PK, Heier JS, Sy JP, Ianchulev T; ANCHOR Study Group. Ranibizumab versus verteporfin photodynamic therapy for neovascular age-related macular degeneration: Two-year results of the ANCHOR study. Ophthalmology. 2009 Jan;116(1):57-65.e5. doi: 10.1016/j.ophtha.2008.10.018.

ReferenceCitation: Suñer IJ, Kokame GT, Yu E, Ward J, Dolan C, Bressler NM. Responsiveness of NEI VFQ-25 to changes in visual acuity in neovascular AMD: validation studies from two phase 3 clinical trials. Invest Ophthalmol Vis Sci. 2009 Aug;50(8):3629-35. doi: 10.1167/iovs.08-3225. Epub 2009 Feb 28.

ReferenceCitation: Bressler NM, Chang TS, Fine JT, Dolan CM, Ward J; Anti-VEGF Antibody for the Treatment of Predominantly Classic Choroidal Neovascularization in Age-Related Macular Degeneration (ANCHOR) Research Group. Improved vision-related function after ranibizumab vs photodynamic therapy: a randomized clinical trial. Arch Ophthalmol. 2009 Jan;127(1):13-21. doi: 10.1001/archophthalmol.2008.562.

ReferenceCitation: Thach AB, Yau L, Hoang C, Tuomi L. Time to clinically significant visual acuity gains after ranibizumab treatment for retinal vein occlusion: BRAVO and CRUISE trials. Ophthalmology. 2014 May;121(5):1059-66. doi: 10.1016/j.ophtha.2013.11.022. Epub 2014 Jan 11.

ReferenceCitation: Weinberg DV, Shapiro H, Ehrlich JS. Ranibizumab treatment outcomes in phakic versus pseudophakic eyes: an individual patient data analysis of 2 phase 3 trials. Ophthalmology. 2013 Jun;120(6):1278-82. doi: 10.1016/j.ophtha.2012.11.042. Epub 2013 Feb 28.

ReferenceCitation: Bressler NM, Chang TS, Varma R, Suñer I, Lee P, Dolan CM, Ward J, Ianchulev T, Fine J. Driving ability reported by neovascular age-related macular degeneration patients after treatment with ranibizumab. Ophthalmology. 2013 Jan;120(1):160-8. doi: 10.1016/j.ophtha.2012.07.027. Epub 2012 Sep 23.

ReferenceCitation: Rosenfeld PJ, Shapiro H, Ehrlich JS, Wong P; MARINA and ANCHOR Study Groups. Cataract surgery in ranibizumab-treated patients with neovascular age-related macular degeneration from the phase 3 ANCHOR and MARINA trials. Am J Ophthalmol. 2011 Nov;152(5):793-8. doi: 10.1016/j.ajo.2011.04.025. Epub 2011 Jul 26.

ReferenceCitation: Rosenfeld PJ, Shapiro H, Tuomi L, Webster M, Elledge J, Blodi B; MARINA and ANCHOR Study Groups. Characteristics of patients losing vision after 2 years of monthly dosing in the phase III ranibizumab clinical trials. Ophthalmology. 2011 Mar;118(3):523-30. doi: 10.1016/j.ophtha.2010.07.011.

ReferenceCitation: Barbazetto IA, Saroj N, Shapiro H, Wong P, Ho AC, Freund KB. Incidence of new choroidal neovascularization in fellow eyes of patients treated in the MARINA and ANCHOR trials. Am J Ophthalmol. 2010 Jun;149(6):939-946.e1. doi: 10.1016/j.ajo.2010.01.007. Epub 2010 Apr 8.

ReferenceCitation: Bressler NM, Chang TS, Suñer IJ, Fine JT, Dolan CM, Ward J, Ianchulev T; MARINA and ANCHOR Research Groups. Vision-related function after ranibizumab treatment by better- or worse-seeing eye: clinical trial results from MARINA and ANCHOR. Ophthalmology. 2010 Apr;117(4):747-56.e4. doi: 10.1016/j.ophtha.2009.09.002. Epub 2010 Mar 2.

lead_sponsor: Genentech, Inc.

location_country:
Australia
Czech Republic
Hungary
United States
France
Germany

location_facility: Semmelweis University, 1st Ophthalmological Department

location_facility: No. California Retina-Vitreous Associates

location_facility: Retina-Vitreous Associates Medical Group

location_facility: University of Melbourne, Department of Ophthalmology

location_facility: California Vitreoretinal Research Center

location_facility: Cleveland Clinic Foundation/Cole Eye Institute

location_facility: Duke Univ Medical Center/Duke Eye Center


type: Other Identifier

title: A Multicenter Phase I Open-label Dose-escalation Vaccine Trial of dHER2 Protein With AS15 Adjuvant in HER2-overexpressing Patients With High-risk Breast Cancer

summary:
Treatment phase:

The purpose of this study is to evaluate the safety and the immune response elicited by a new anti-cancer therapy in patients with breast cancer in remission but who are at high risk of relapse. The study product is an immunotherapeutic consisting of the recombinant dHER2 protein combined with an immunostimulant called AS15. The study aims to determine the optimal of three different dose levels of dHER2 combined with the same fixed dose of AS15 by assessing the safety and the immune response elicited after a series of injections of the study product.

Five-year follow-up phase:

This part of the study aims to assess any late onset toxicity of the study treatment through yearly follow-up visits and to monitor the patients' survival and disease status up to five years after the last administration of the study treatment. The patients' immune response is also measured to assess the robustness of the immune response elicited by the study treatment.

study_start_date_type: Actual

design_allocation: Non-Randomized

ReferenceCitation: Limentani SA, Campone M, Dorval T, Curigliano G, de Boer R, Vogel C, White S, Bachelot T, Canon JL, Disis M, Awada A, Berlière M, Amant F, Levine E, Burny W, Callegaro A, de Sousa Alves PM, Louahed J, Brichard V, Lehmann FF. A non-randomized dose-escalation Phase I trial of a protein-based immunotherapeutic for the treatment of breast cancer patients with HER2-overexpressing tumors. Breast Cancer Res Treat. 2016 Apr;156(2):319-30. doi: 10.1007/s10549-016-3751-x. Epub 2016 Mar 18.

lead_sponsor: GlaxoSmithKline

location_country:
Italy
Australia
United States
France
Belgium


title: A Randomized, Double-blind, Placebo-controlled, Phase Lll Study in Patients With Metastatic Adenocarcinoma of the Colon or Rectum Who Are Receiving First-line Chemotherapy With Oxaliplatin/5-fluorouracil/Leucovorin With PTK787/ZK 222584 or Placebo

summary: To compare treatment with oxaliplatin/5-FU/leucovorin plus vatalanib versus oxaliplatin/5-FU/leucovorin plus placebo in patients with colorectal cancer that has spread to other organs and are seeking first chemotherapy treatment

ReferenceCitation: Hecht JR, Trarbach T, Hainsworth JD, Major P, Jäger E, Wolff RA, Lloyd-Salvant K, Bodoky G, Pendergrass K, Berg W, Chen BL, Jalava T, Meinhardt G, Laurent D, Lebwohl D, Kerr D. Randomized, placebo-controlled, phase III study of first-line oxaliplatin-based chemotherapy plus PTK787/ZK 222584, an oral vascular endothelial growth factor receptor inhibitor, in patients with metastatic colorectal adenocarcinoma. J Clin Oncol. 2011 May 20;29(15):1997-2003. doi: 10.1200/JCO.2010.29.4496. Epub 2011 Apr 4.

lead_sponsor: Novartis

location_country:
Taiwan
Brazil
Portugal
Spain
Italy
United Kingdom
Australia
Netherlands
Canada
New Zealand
Switzerland
Sweden
Hungary
United States
France
Belgium
Germany
Slovakia
Czechia

location_facility: Washington University School of Medicine

location_facility: Sansum Santa Barbara Foundation Medical Clinic

location_facility: Hematology Oncology Associates of Treasure

location_facility: California Oncology of the Central Valley

location_facility: Synergy Hematology-Oncology Medical Associates

location_facility: North Valley Hematology/Oncology Medical Group

location_facility: Hematology and Oncology Assoc. of Southern Mississippi

location_facility: University of Pennsylvania Abramson Cancer Center

location_facility: Center for Oncology Research & Treatment, PA

location_facility: Southern Oncology and Hematology Associates

location_facility: The Center for Cancer and Hematologic Disease

location_facility: Hematology-Oncology Associates of New Jersey

location_facility: George Washington University Medical Center

location_facility: Santa Barbara Hematology Oncology Medical Group, Inc.

location_facility: Heartland Hematology/Oncology Associates, Inc.

location_facility: Oncology Hematology Group of South Florida

location_facility: Ventura County Hematology-Oncology Specialists

location_facility: Associated Physicians & Surgeons Clinic, L.L.C.

location_facility: Oncology Hematology Associates of Central Illinois, PC

location_facility: Maine Center for Cancer Medicine & Blood Disorders

location_facility: Cancer Care Associates Medical Group, Inc.

location_facility: Tulane University Health Sciences Center

location_facility: North Central Montana Professional Building

location_facility: Innovative Medical Research of South Florida

location_facility: Kansas City Oncology and Hematology Group

location_facility: USC/Norris Comprehensive Cancer Care Center

location_facility: University of Tennessee Cancer Institute

location_facility: Glendale Adventist Medical Center Cancer Center

location_facility: Markey Clinical Oncology Research Program

location_facility: Compassionate Cancer Care Medical Group, Inc

location_facility: UW Health -- University of Wisconsin Comp


title: Gemtuzumab Ozogamicin (GO) Combined With Standard Intensive Chemotherapy Versus Standard Intensive Chemotherapy Alone For Induction/Consolidation In Patients 61-75 Years Old With Previously Untreated AML: A Randomized Phase III Trial (AML-17) Of The EORTC-LG and the GIMEMA-ALWP

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known if combining combination chemotherapy with monoclonal antibody therapy will kill more cancer cells.

PURPOSE: Randomized phase III trial to determine the effectiveness of combination chemotherapy with or without gemtuzumab ozogamicin in treating patients who have acute myeloid leukemia.

ReferenceCitation: Amadori S, Suciu S, Stasi R, Salih HR, Selleslag D, Muus P, De Fabritiis P, Venditti A, Ho AD, Lübbert M, Thomas X, Latagliata R, Halkes CJ, Falzetti F, Magro D, Guimaraes JE, Berneman Z, Specchia G, Karrasch M, Fazi P, Vignetti M, Willemze R, de Witte T, Marie JP. Sequential combination of gemtuzumab ozogamicin and standard chemotherapy in older patients with newly diagnosed acute myeloid leukemia: results of a randomized phase III trial by the EORTC and GIMEMA consortium (AML-17). J Clin Oncol. 2013 Dec 10;31(35):4424-30. doi: 10.1200/JCO.2013.49.0771. Epub 2013 Oct 14.

location_country: Portugal Italy Austria Netherlands France Belgium Germany

location_facility: Istituto di Ematologia Universita - University di Sassari

location_facility: A. oe. Krankenhaus der Barmherzigen Schwestern Kinderabteilung

location_facility: Azienda Ospedale S. Luigi at University of Torino

location_facility: CHU Liege - Domaine Universitaire du Sart Tilman

location_facility: Azienda Ospedaliera Maggiore Della Carita

location_facility: Centre Hospitalier Universitaire Brugmann

location_facility: Klinikum der Albert - Ludwigs - Universitaet Freiburg

location_facility: Allgemeines Krankenhaus - Universitatskliniken

location_facility: Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore

location_facility: Universitair Medisch Centrum St. Radboud - Nijmegen

location_facility: Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi

location_facility: Azienda Ospedaliera Policlinico Paolo Giaccone

location_facility: Ruprecht - Karls - Universitaet Heidelberg

location_facility: Azienda Ospedaliera - Universitaria di Modena

location_facility: Libero Istituto Universitario Campus Bio-Medico

location_facility: Southwest German Cancer Center at Eberhard-Karls-University


title: A Phase II, Randomized, Open-Label Study of Single Agent CI-1033 in Patients With Metastatic Breast Cancer

summary: CI-1033 is an experimental drug that acts as an inhibitor of erbB (EGFR) receptors, which may be involved in tumor growth. The primary objective of this study is to assess the antitumor activity of CI-1033 in patients with metastatic breast cancer. Patients with histologically confirmed metastatic (Stage IV) breast cancer and who have received no more than 2 prior cytotoxic chemotherapy regimens are eligible for this study. CI-1033 is administered orally. Patients are required to have blood tests periodically while receiving treatment and will be closely monitored throughout the study for possible side effects and response to treatment. Patients may not have received any prior treatment with other agents that target erbB receptors, including Herceptin (trastuzumab) or Iressa (gefitinib).

lead_sponsor: Pfizer

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


title: A Randomized Three-Arm, Multicenter Comparison of 1 Year and 2 Years of Herceptin Versus No Herceptin in Women With HER2-Positive Primary Breast Cancer Who Have Completed Adjuvant Chemotherapy

acronym: HERA

summary: The purpose of this trial is to evaluate Herceptin treatment for 1 year and 2 years (versus observation/no Herceptin) in women with HER2-overexpressing primary breast cancer who have completed (neo-)adjuvant systemic chemotherapy, definitive surgery, and radiotherapy, if applicable. Efficacy and safety will be assessed for 10 years from randomization for each participant. All participants will continue to be followed for survival until 10 years after enrollment of the last participant.

ReferenceType: background

ReferenceCitation: Jahanzeb M. Adjuvant trastuzumab therapy for HER2-positive breast cancer. Clin Breast Cancer. 2008 Aug;8(4):324-33. doi: 10.3816/CBC.2008.n.037. Review.

ReferenceCitation: Shiroiwa T, Fukuda T, Shimozuma K, Ohashi Y, Tsutani K. The model-based cost-effectiveness analysis of 1-year adjuvant trastuzumab treatment: based on 2-year follow-up HERA trial data. Breast Cancer Res Treat. 2008 Jun;109(3):559-66. Epub 2007 Jul 28.

ReferenceCitation: Gianni L, Dafni U, Gelber RD, Azambuja E, Muehlbauer S, Goldhirsch A, Untch M, Smith I, Baselga J, Jackisch C, Cameron D, Mano M, Pedrini JL, Veronesi A, Mendiola C, Pluzanska A, Semiglazov V, Vrdoljak E, Eckart MJ, Shen Z, Skiadopoulos G, Procter M, Pritchard KI, Piccart-Gebhart MJ, Bell R; Herceptin Adjuvant (HERA) Trial Study Team. Treatment with trastuzumab for 1 year after adjuvant chemotherapy in patients with HER2-positive early breast cancer: a 4-year follow-up of a randomised controlled trial. Lancet Oncol. 2011 Mar;12(3):236-44. doi: 10.1016/S1470-2045(11)70033-X. Epub 2011 Feb 25.

ReferenceCitation: Procter M, Suter TM, de Azambuja E, Dafni U, van Dooren V, Muehlbauer S, Climent MA, Rechberger E, Liu WT, Toi M, Coombes RC, Dodwell D, Pagani O, Madrid J, Hall M, Chen SC, Focan C, Muschol M, van Veldhuisen DJ, Piccart-Gebhart MJ. Longer-term assessment of trastuzumab-related cardiac adverse events in the Herceptin Adjuvant (HERA) trial. J Clin Oncol. 2010 Jul 20;28(21):3422-8. doi: 10.1200/JCO.2009.26.0463. Epub 2010 Jun 7.

ReferenceCitation: Dowsett M, Procter M, McCaskill-Stevens W, de Azambuja E, Dafni U, Rueschoff J, Jordan B, Dolci S, Abramovitz M, Stoss O, Viale G, Gelber RD, Piccart-Gebhart M, Leyland-Jones B. Disease-free survival according to degree of HER2 amplification for patients treated with adjuvant chemotherapy with or without 1 year of trastuzumab: the HERA Trial. J Clin Oncol. 2009 Jun 20;27(18):2962-9. doi: 10.1200/JCO.2008.19.7939. Epub 2009 Apr 13.

ReferenceCitation: Untch M, Gelber RD, Jackisch C, Procter M, Baselga J, Bell R, Cameron D, Bari M, Smith I, Leyland-Jones B, de Azambuja E, Wermuth P, Khasanov R, Feng-Yi F, Constantin C, Mayordomo JI, Su CH, Yu SY, Lluch A, Senkus-Konefka E, Price C, Haslbauer F, Suarez Sahui T, Srimuninnimit V, Colleoni M, Coates AS, Piccart-Gebhart MJ, Goldhirsch A; HERA Study Team. Estimating the magnitude of trastuzumab effects within patient subgroups in the HERA trial. Ann Oncol. 2008 Jun;19(6):1090-6. doi: 10.1093/annonc/mdn005. Epub 2008 Feb 21.

ReferenceCitation: McCaskill-Stevens W, Procter M, Goodbrand J, et al.: Disease-free survival according to local immunohistochemistry for HER2 and central fluorescence in situ hydridization for patients treated with adjuvant chemotherapy with and without trastuzumab in the HERA (BIG 01-01) trial. [Abstract] Breast Cancer Res Treat 106 (1): A-71, S18, 2007.

ReferenceCitation: Smith I, Procter M, Gelber RD, Guillaume S, Feyereislova A, Dowsett M, Goldhirsch A, Untch M, Mariani G, Baselga J, Kaufmann M, Cameron D, Bell R, Bergh J, Coleman R, Wardley A, Harbeck N, Lopez RI, Mallmann P, Gelmon K, Wilcken N, Wist E, Sánchez Rovira P, Piccart-Gebhart MJ; HERA study team. 2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: a randomised controlled trial. Lancet. 2007 Jan 6;369(9555):29-36.

ReferenceCitation: Suter TM, Procter M, van Veldhuisen DJ, Muscholl M, Bergh J, Carlomagno C, Perren T, Passalacqua R, Bighin C, Klijn JG, Ageev FT, Hitre E, Groetz J, Iwata H, Knap M, Gnant M, Muehlbauer S, Spence A, Gelber RD, Piccart-Gebhart MJ. Trastuzumab-associated cardiac adverse effects in the herceptin adjuvant trial. J Clin Oncol. 2007 Sep 1;25(25):3859-65. Epub 2007 Jul 23.

ReferenceCitation: Piccart-Gebhart MJ, Procter M, Leyland-Jones B, Goldhirsch A, Untch M, Smith I, Gianni L, Baselga J, Bell R, Jackisch C, Cameron D, Dowsett M, Barrios CH, Steger G, Huang CS, Andersson M, Inbar M, Lichinitser M, Láng I, Nitz U, Iwata H, Thomssen C, Lohrisch C, Suter TM, Rüschoff J, Suto T, Greatorex V, Ward C, Straehle C, McFadden E, Dolci MS, Gelber RD; Herceptin Adjuvant (HERA) Trial Study Team. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med. 2005 Oct 20;353(16):1659-72.

ReferenceCitation: Yerushalmi R, Dong B, Chapman JW, Goss PE, Pollak MN, Burnell MJ, Levine MN, Bramwell VHC, Pritchard KI, Whelan TJ, Ingle JN, Shepherd LE, Parulekar WR, Han L, Ding K, Gelmon KA. Impact of baseline BMI and weight change in CCTG adjuvant breast cancer trials. Ann Oncol. 2017 Jul 1;28(7):1560-1568. doi: 10.1093/annonc/mdx152.

ReferenceCitation: Cameron D, Piccart-Gebhart MJ, Gelber RD, Procter M, Goldhirsch A, de Azambuja E, Castro G Jr, Untch M, Smith I, Gianni L, Baselga J, Al-Sakaff N, Lauer S, McFadden E, Leyland-Jones B, Bell R, Dowsett M, Jackisch C; Herceptin Adjuvant (HERA) Trial Study Team. 11 years' follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive early breast cancer: final analysis of the HERceptin Adjuvant (HERA) trial. Lancet. 2017 Mar 25;389(10075):1195-1205. doi: 10.1016/S0140-6736(16)32616-2. Epub 2017 Feb 17. Erratum in: Lancet. 2019 Mar 16;393(10176):1100.

ReferenceCitation: Loi S, Dafni U, Karlis D, Polydoropoulou V, Young BM, Willis S, Long B, de Azambuja E, Sotiriou C, Viale G, Rüschoff J, Piccart MJ, Dowsett M, Michiels S, Leyland-Jones B. Effects of Estrogen Receptor and Human Epidermal Growth Factor Receptor-2 Levels on the Efficacy of Trastuzumab: A Secondary Analysis of the HERA Trial. JAMA Oncol. 2016 Aug 1;2(8):1040-7. doi: 10.1001/jamaoncol.2016.0339.

ReferenceCitation: O'Sullivan CC, Bradbury I, Campbell C, Spielmann M, Perez EA, Joensuu H, Costantino JP, Delaloge S, Rastogi P, Zardavas D, Ballman KV, Holmes E, de Azambuja E, Piccart-Gebhart M, Zujewski JA, Gelber RD. Efficacy of Adjuvant Trastuzumab for Patients With Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer and Tumors ≤ 2 cm: A Meta-Analysis of the Randomized Trastuzumab Trials. J Clin Oncol. 2015 Aug 20;33(24):2600-8. doi: 10.1200/JCO.2015.60.8620. Epub 2015 Jun 22.

ReferenceCitation: de Azambuja E, Procter MJ, van Veldhuisen DJ, Agbor-Tarh D, Metzger-Filho O, Steinseifer J, Untch M, Smith IE, Gianni L, Baselga J, Jackisch C, Cameron DA, Bell R, Leyland-Jones B, Dowsett M, Gelber RD, Piccart-Gebhart MJ, Suter TM. Trastuzumab-associated cardiac events at 8 years of median follow-up in the Herceptin Adjuvant trial (BIG 1-01). J Clin Oncol. 2014 Jul 10;32(20):2159-65. doi: 10.1200/JCO.2013.53.9288. Epub 2014 Jun 9.

ReferenceCitation: Zabaglo L, Stoss O, Rüschoff J, Zielinski D, Salter J, Arfi M, Bradbury I, Dafni U, Piccart-Gebhart M, Procter M, Dowsett M; HERA Trial Study Team. HER2 staining intensity in HER2-positive disease: relationship with FISH amplification and clinical outcome in the HERA trial of adjuvant trastuzumab. Ann Oncol. 2013 Nov;24(11):2761-6. doi: 10.1093/annonc/mdt275. Epub 2013 Jul 25.

ReferenceCitation: Goldhirsch A, Gelber RD, Piccart-Gebhart MJ, de Azambuja E, Procter M, Suter TM, Jackisch C, Cameron D, Weber HA, Heinzmann D, Dal Lago L, McFadden E, Dowsett M, Untch M, Gianni L, Bell R, Köhne CH, Vindevoghel A, Andersson M, Brunt AM, Otero-Reyes D, Song S, Smith I, Leyland-Jones B, Baselga J; Herceptin Adjuvant (HERA) Trial Study Team. 2 years versus 1 year of adjuvant trastuzumab for HER2-positive breast cancer (HERA): an open-label, randomised controlled trial. Lancet. 2013 Sep 21;382(9897):1021-8. doi: 10.1016/S0140-6736(13)61094-6. Epub 2013 Jul 18.

ReferenceCitation: Metzger-Filho O, Procter M, de Azambuja E, Leyland-Jones B, Gelber RD, Dowsett M, Loi S, Saini KS, Cameron D, Untch M, Smith I, Gianni L, Baselga J, Jackisch C, Bell R, Sotiriou C, Viale G, Piccart-Gebhart M. Magnitude of trastuzumab benefit in patients with HER2-positive, invasive lobular breast carcinoma: results from the HERA trial. J Clin Oncol. 2013 Jun 1;31(16):1954-60. doi: 10.1200/JCO.2012.46.2440. Epub 2013 Apr 15.

lead_sponsor: Hoffmann-La Roche

location_country:
Croatia
Spain
Italy
United Kingdom
Belgium
Japan
South Africa
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Singapore
Sweden
Brazil
Canada
Switzerland
Guatemala
Hungary
China
Germany
Denmark
Greece
Ireland
Thailand
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility: Cancer Research Centre at Weston Park Hospital

location_facility: Northern Centre for Cancer Treatment at Newcastle General Hospital

location_facility: Fovarosi Onkormanyzat Szent Margit Korhaz, Okologia

location_facility: Fraser Valley Cancer Centre at British Columbia Cancer Agency

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

location_facility: Centre Hospitalier Universitaire de Tivoli

location_facility: Centre Hospitalier Notre Dame - Reine Fabiola

location_facility: Hospital Universitario San Cecilio de Granada

location_facility: Hospital General Universitario De Guadalajara

location_facility: Centro Oncologico De Galicia Jose Antonio Quirogay Pineyro

location_facility: Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg

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

location_facility: Frauenklinik - Universitaetsklinikum Rostock am Klinikum Sudstadt

location_facility: P.A. Hertzen Research Oncology Institute

location_facility: University Hospital Schleswig-Holstein - Kiel Campus

location_facility: Istituto Nazionale per la Ricerca sul Cancro

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

location_facility: Universitaetsklinik fuer Innere Medizin I

location_facility: Prince Edward Island Cancer Centre at Queen Elizabeth Hospital

location_facility: Algoma Regional Cancer Program at Sault Area Hospital

location_facility: Karolinska University Hospital - Huddinge

location_facility: British Columbia Cancer Agency - Vancouver Cancer Centre

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel

location_facility: Johns Hopkins Singapore International Medical Centre

location_facility: Ospedale Ostetrico Ginecologica Sant Anna

location_facility: University of Modena Hospital and Reggio Emilia School of Medicine

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Hospitais da Universidade de Coimbra (HUC)

location_facility: Hotel Dieu Health Sciences Hospital - Niagara

location_facility: Saskatoon Cancer Centre at the University of Saskatchewan

location_facility: Cookridge Hospital at Leeds Teaching Hospital NHS Trust

location_facility: Allan Blair Cancer Centre at Pasqua Hospital

location_facility: Centro di Riferimento Oncologico - Aviano

location_facility: Centre Hospital Regional Universitaire de Limoges

location_facility: Windsor Regional Cancer Centre at Windsor Regional Hospital

location_facility: Yonsei Cancer Center at Yonsei University Medical Center

location_facility: Hospital Universitario Nuestra Senora de la Candelaria

location_facility: Kreiskrankenhaus Leonberg - Frauenklinik

location_facility: Trillium Health Centre - Mississauga Site

location_facility: Margaret and Charles Juravinski Cancer Centre

location_facility: Instituto Portugues de Oncologia, Centro Regional de Coimbra

location_facility: British Columbia Cancer Agency - Vancouver Island Cancer Centre

location_facility: Klinikum Rechts Der Isar - Technische Universitaet Muenchen

location_facility: Sahlgrenska University Hospital - Molndal at Gothenburg University


title: An Open Phase II, Multi Center Trial of BAY 59-8862 in Patients With Aggressive, Refractory Non-Hodgkin's Lymphoma

summary: Almost two-thirds of lymphoma cases are Non-Hodgkin's Lymphomas (NHL). NHL is a malignant process that affects lymphoid cells found both in the lymph nodes and extranodally. Incidence and mortality rates from NHL are highest in developed countries. While many patients with aggressive NHL are curable with initial anthracycline-containing regimens, the majority of patients will relapse or prove refractory to initial therapy. The prognosis of patients with disease recurrence following a multidrug regimen is also limited. The current protocol is designed to test the safety and efficacy of BAY 59-8862 in patients with Aggressive Refractory Non-Hodgkin's Lymphoma.

lead_sponsor: Bayer

location_country:
United Kingdom
Netherlands
Canada
United States
France
Germany


title: A Phase IIIb/IV, Randomized, Open Label, Multicenter, Pilot Trial to Explore the Safety and Tolerability of GW433908 +/- Ritonavir (1400mg Twice Daily or 700mg/100mg Twice Daily) When Used in Combination With a Zidovudine-containing Regimen (TRIZIVIR or COMBIVIR Twice Daily) Over a 24 Week Period in Antiretroviral Therapy Naive HIV-1 Infected Subjects.

summary: Antiretroviral Therapy (ART) naive subjects will be enrolled in this clinical research study to test the safety and tolerability of fosamprenavir with or without ritonavir in combination TRIZIVIR and COMBIVIR. Subjects will receive 24 weeks of therapy.

location_country:
United States
United Kingdom
France


title: Phase III Study of Tomudex and Cisplatin Versus Cisplatin in Malignant Pleural Mesothelioma

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether receiving cisplatin with raltitrexed is more effective than cisplatin alone for malignant mesothelioma.

PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin with or without raltitrexed in treating patients who have malignant mesothelioma of the pleura.

ReferenceCitation: Francart J, Legrand C, Sylvester R, Van Glabbeke M, van Meerbeeck JP, Robert A. Progression-free survival rate as primary end point for phase II cancer clinical trials: application to mesothelioma--The EORTC Lung Cancer Group. J Clin Oncol. 2006 Jul 1;24(19):3007-12.

ReferenceCitation: Bottomley A, Coens C, Efficace F, Gaafar R, Manegold C, Burgers S, Vincent M, Legrand C, van Meerbeeck JP; EORTC-NCIC. Symptoms and patient-reported well-being: do they predict survival in malignant pleural mesothelioma? A prognostic factor analysis of EORTC-NCIC 08983: randomized phase III study of cisplatin with or without raltitrexed in patients with malignant pleural mesothelioma. J Clin Oncol. 2007 Dec 20;25(36):5770-6.

ReferenceCitation: Bottomley A, Gaafar R, Manegold C, Burgers S, Coens C, Legrand C, Vincent M, Giaccone G, Van Meerbeeck J; EORTC Lung-Cancer Group; National Cancer Institute, Canada. Short-term treatment-related symptoms and quality of life: results from an international randomized phase III study of cisplatin with or without raltitrexed in patients with malignant pleural mesothelioma: an EORTC Lung-Cancer Group and National Cancer Institute, Canada, Intergroup Study. J Clin Oncol. 2006 Mar 20;24(9):1435-42. Epub 2006 Jan 30. Erratum in: J Clin Oncol. 2006 Jun 1;24(16):2601. Gaafa, Rabab [corrected to Gaafar, Rahab].

ReferenceCitation: van Meerbeeck JP, Gaafar R, Manegold C, Van Klaveren RJ, Van Marck EA, Vincent M, Legrand C, Bottomley A, Debruyne C, Giaccone G; European Organisation for Research and Treatment of Cancer Lung Cancer Group; National Cancer Institute of Canada. Randomized phase III study of cisplatin with or without raltitrexed in patients with malignant pleural mesothelioma: an intergroup study of the European Organisation for Research and Treatment of Cancer Lung Cancer Group and the National Cancer Institute of Canada. J Clin Oncol. 2005 Oct 1;23(28):6881-9.

ReferenceCitation: Van Meerbeeck JP, Manegold C, Gaafar R, et al.: A randomized phase III study of cisplatin with or without raltitrexed in patients (pts) with malignant pleural mesothelioma (MPM): an intergroup study of the EORTC Lung Cancer Group and NCIC. [Abstract] J Clin Oncol 22 (Suppl 14): A-7021, 622s, 2004.

location_country:
Poland
United Kingdom
Italy
Netherlands
Canada
Switzerland
France
Peru
Belgium
Germany
Egypt

location_facility: University Hospital - Rotterdam Dijkzigt

location_facility: Istituto Nazionale per la Ricerca sul Cancro

location_facility: Cancer Care Ontario-London Regional Cancer Centre

location_facility: Cancer Care Ontario-Hamilton Regional Cancer Centre

location_facility: Assistance Publique Hopitaux de Marseille Hopitaux Sud


title: A Strategic Study to Determine the Optimal Moment to Initiate Systemic Antifungal Therapy With Ambisome in Granulocytopenic Cancer Patients With Unexplained Fever Refractory to Empirical Antibacterials

summary:
RATIONALE: Liposomal amphotericin B may be effective in controlling fever and granulocytopenia. It is not yet known which regimen of liposomal amphotericin B is more effective in treating cancer patients who have these conditions.

PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of liposomal amphotericin B in treating granulocytopenia and fever in cancer patients.

primary_purpose: Supportive Care

location_country:
Portugal
Spain
Greece
Italy
Netherlands
Czech Republic
Sweden
Hungary
France
Israel
Turkey
Belgium
Germany
Slovakia
United Arab Emirates

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Virchow Klinikum Humboldt Universitaet Berlin

location_facility: Athens University-Laikon General Hospital


title: Randomized Phase II/III Study of Taxol/Paclitaxel-BEP Versus BEP in Patients With Intermediate Prognosis Germ Cell Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy may be more effective for germ cell cancer.

PURPOSE: This randomized phase II/III trial is studying two different regimens of combination chemotherapy and comparing how well they work in treating men with germ cell cancer.

status: Unknown status

enrollment_type: Anticipated

location_country:
Denmark
Poland
Spain
Italy
Austria
Netherlands
United Kingdom
Hungary
France
Israel
Belgium
Norway
Germany
Slovakia

location_facility: Klinikum der Stadt Ludwigshafen am Rhein

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg

location_facility: Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster

location_facility: Cancer Research Centre at Weston Park Hospital

location_facility: St. Johannes Hospital - Medical Klinik II

location_facility: University Medical Center Rotterdam at Erasmus Medical Center

location_facility: Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: Academisch Medisch Centrum at University of Amsterdam

location_facility: Rosemere Cancer Centre at Royal Preston Hospital

location_facility: Daniel Den Hoed Cancer Center at Erasmus Medical Center

location_facility: Gloucestershire Oncology Centre at Cheltenham General Hospital

location_facility: Aarhus Universitetshospital - Aarhus Sygehus

location_facility: Universitair Medisch Centrum St. Radboud - Nijmegen

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

location_facility: Southend University Hospital NHS Foundation Trust

location_facility: University Medical Center Hamburg - Eppendorf

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Berkshire Cancer Centre at Royal Berkshire Hospital

location_facility: Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet

location_facility: Leeds Cancer Centre at St. James's University Hospital

location_facility: Rigshospitalet - Copenhagen University Hospital

location_facility: Universitaetsklinikum Giessen und Marburg GmbH - Marburg

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

location_facility: Southwest German Cancer Center at Eberhard-Karls-University

location_facility: Velindre Cancer Center at Velindre Hospital


title: RANDOMISED TRIAL OF ADJUVANT CHEMOTHERAPY WITH HIGH-DOSE DOXORUBICIN, IFOSFAMIDE AND LENOGRASTIM IN HIGH GRADE SOFT TISSUE SARCOMA

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether giving chemotherapy after surgery is more effective than surgery alone in treating soft tissue sarcoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without chemotherapy in treating patients who have soft tissue sarcoma.

ReferenceCitation: Le Cesne A, Van Glabbeke M, Woll PJ, et al.: The end of adjuvant chemotherapy (adCT) era with doxorubicin-based regimen in resected high-grade soft tissue sarcoma (STS): pooled analysis of the two STBSG-EORTC phase III clinical trials. [Abstract] J Clin Oncol 26 (Suppl 15): A-10525, 2008.

ReferenceCitation: Woll PJ, Reichardt P, Le Cesne A, Bonvalot S, Azzarelli A, Hoekstra HJ, Leahy M, Van Coevorden F, Verweij J, Hogendoorn PC, Ouali M, Marreaud S, Bramwell VH, Hohenberger P; EORTC Soft Tissue and Bone Sarcoma Group and the NCIC Clinical Trials Group Sarcoma Disease Site Committee. Adjuvant chemotherapy with doxorubicin, ifosfamide, and lenograstim for resected soft-tissue sarcoma (EORTC 62931): a multicentre randomised controlled trial. Lancet Oncol. 2012 Oct;13(10):1045-54. doi: 10.1016/S1470-2045(12)70346-7. Epub 2012 Sep 4.

location_country:
Denmark
Portugal
Spain
Italy
Austria
Netherlands
United Kingdom
Canada
Switzerland
France
Belgium
Germany
Slovakia

location_facility: Middlesex Hospital- Meyerstein Institute

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Daniel Den Hoed Cancer Center at Erasmus University Medical Center

location_facility: Cancer Care Ontario-London Regional Cancer Centre

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori

location_facility: Cancer Care Ontario-Hamilton Regional Cancer Centre

location_facility: British Columbia Cancer Agency - Vancouver Island Cancer Centre

location_facility: Instituto Portugues de Oncologia de Francisco Gentil - Centro de Lisboa


type: EudraCT Number

title: An Open-Label, Safety, Tolerability, and Proof-of-Concept Study of Oral BCX9930 Therapy in Subjects With C3G, IgAN, or PMN

summary: The purpose of this study is to determine the safety and therapeutic potential of BCX9930 in participants with C3G, IgAN, or PMN.

status: Recruiting

study_completion_date_type: Anticipated

ipd_sharing: No

lead_sponsor: BioCryst Pharmaceuticals

location_country:
United Kingdom
France
Spain
Italy

location_facility:
Investigative Site #2
Investigative Site
Investigative Site #1

status_simplified: Ongoing


title: An Open-label Multicenter Phase 2 Clinical Safety Investigation of the EndoArt® Implantation in Subjects With Chronic Corneal Edema

summary:
The EndoArt® is intended to be used as an endothelial prosthesis in patients with chronic corneal edema.The EndoArt® (Artificial Endothelial layer) is a permanent implant, constructed of a clear, transparent, foldable, biologically compatible copolymer of hydroxyethyl methacrylate and methyl methacrylate. The peripheral surface of the EndoArt® has either one or more marks, to ensure the correct orientation of the implant. The device serves as a physical barrier blocking the influx of water from the AC of the eye into the cornea due to dysfunctional corneal endothelial layer. Together with evaporation from the anterior surface of the cornea it maintains corneal hydration and clarity.

The EndoArt® device is CE marked approved (approved for marketing by the European regulatory authority).

primary_purpose: Other

lead_sponsor: Eye-yon Medical

location_country: Georgia Netherlands France Israel India Germany

location_facility: Centre Hospitalier Régional Universitaire de Brest (CHRU Brest)

location_facility: International Vision Correction Research Centre (IVCRC) Universitätsklinikum Heidelberg

location_facility: High Technology Medical Center, University Clinic

intervention_type: Device


title: A Phase Ib Dose Finding Study Assessing Safety and Activity of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Glioblastoma in Combination With Radiotherapy With or Without Temozolomide and in Recurrent Glioblastoma as Single Agent

summary: This study aims to establish the recommended dose of [177Lu]Lu-DOTA-TATE in combination with the standard of care or as single agent in three different groups of participants with Glioblastoma. In addition, this study will investigate the safety of [68Ga]Ga-DOTA-TATE and describe its uptake characteristics in participants with Glioblastoma.

lead_sponsor: Novartis Pharmaceuticals

location_country: France Portugal Switzerland Spain

intervention_type: Other


title: Performance, Safety and Clinical Benefits of a Noble Metal Alloy-coated Intramedullary Nail: a Multicenter, Prospective Trial With a Retrospective Control

summary:
Primary objective of this study is to compare fracture related infection (FRI) rates of ZNN Bactiguard Tibia to conventional uncoated titanium-alloy nails 12 months after tibia fracture fixation.

The secondary objectives are confirmation of safety, performance and clinical benefits of ZNN Bactiguard implant and related instrumentation12 months after fracture fixation.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Zimmer Biomet

location_country:
Spain
Italy
United Kingdom
France
South Africa
Germany

location_facility: AOUC Azienda Ospedaliero-Universitaria Careggi

location_facility: Hôpitaux Universitaires de Marseille Nord


title: Randomized Open Label, Phase 3 Study to Compare the Efficacy and Safety of Lerodalcibep (LIB003) to Inclisiran in Patients at Very High or High Risk for CVD, on Stable Lipid-Lowering Therapy Requiring Additional LDL-C Reduction

acronym: LIBerate-VI

summary: Comparison of LDL-C reductions of lerodalcibep (LIB003) 300 mg to inclisiran (Leqvio®) 284 in patients at very-high risk or high-risk for CVD on stable diet and oral LDL-C-lowering drug therapy

status: Enrolling by invitation

lead_sponsor: LIB Therapeutics LLC

location_country:
Spain
United Kingdom
France
Norway
Germany

location_facility: Oak Tree Surgery and Pensilva Health Centre

location_facility: Universitätsklinikum Heidelberg - Medizinische Klinik

location_facility: The Lipid Clinic (Oslo University Hospital)


title: European Hypotension Prediction Index Real World Experience Using AcumenTM Hypotension Prediction Index Software to Prevent Intraoperative Hypotension: the Multicentre Prospective Observational Registry

summary: European, multicenter, prospective, observational registry in patients undergoing elective major non-cardiac surgery

lead_sponsor: Edwards Lifesciences

location_country:
United Kingdom
Spain
Italy
France
Germany

location_facility: Les Hôpitaux Universitaires de Strasbourg

location_facility: York and Scarborough Teaching Hospitals NHS Foundation Trust

location_facility: Justus Liebig University Giessen, University Hospital of Giessen and Marburg

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Azienda Ospedaliero-Universitaria Ospedali Riuniti "Umberto I° General

location_facility: University Medical Center Hamburg Eppendorf

location_facility: Azienda Ospedaliero-Universitaria Ospedali Riuniti di Ancona

location_facility: University Hospital Philipps-Universität Marburg, University Hospital of Giessen and Marburg

location_facility: Hospital Universitario Infanta Leonor, Madrid

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Marien Hospital Herne, University Hospital Ruhr-University Bochum


title: A Retrospective Mapping of Health Care Utilisation and Current Quality of Life Status in Adult Subjects With a History of Chronic Otitis Media With or Without Cholesteatoma Who Have Undergone a Primary Tympanoplasty

summary: The objective of this multicentre study is to evaluate the standard of care of participants diagnosed with Chronic Otitis Media that have already gone through a first middle ear surgery but still have at least a moderate hearing loss. The study has a retrospective part (extraction of medical chart data) and a prospective part with a survey and three questionnaires collecting data on the use of health care services, on health related quality of life and hearing performance.

time_perspective: Other

ipd_sharing_description: Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.

lead_sponsor: Cochlear

location_country: Germany France Spain

location_facility: Universitätsklinik für Hals-, Nasen und Ohrenheilkunde

location_facility: ENT department - Bâtiment Pierre Paul Riquet - Hôpital Purpan

location_facility: Hôpital Bicêtre, Hôpitaux universitaires Paris Sud AP-HP

location_facility: Hals-, Nasen- und Ohrenklinik, Universitätsklinikum Heidelberg


title: A Phase Ib/II, Multicentre, Double-blind, Randomised, Placebo-controlled, Dose Escalation and Dose-finding Study to Evaluate the Safety and Efficacy of IPN10200 in Improving the Appearance of Moderate to Severe Upper Facial Lines in Adults

acronym: LANTIC

summary:
The purpose of this study is to assess the safety and efficacy profile of increasing doses of IPN10200 in comparison to placebo, with the aim to discover the doses(s) that offer the best efficacy/safety profile when used for the treatment of moderate to severe Upper Facial Lines.

This study will be conducted in three stages. The full study (including all stages) will have a maximum 448 participants. The protocol is currently approved up to stage 1, step 1 and stage 1/ step 2.

Stage 1 (phase Ib & II)

Step 1 (Phase Ib): a dose-escalation first-in-human step in participants with moderate to severe Glabellar Lines (GL)
Step 2 (Phase II): dose finding step in participants with moderate to severe GL as compared with Dysport

Stage 2 (phase II)

- An evaluation of efficacy and safety of IPN10200 in one of the following regions: GL + forehead lines (FHL) or lateral canthal lines (LCL)

Stage 3 (phase II)

- A safety and efficacy evaluation of IPN10200 in all three regions (GL, FHL and LCL)

status: Active, not recruiting

lead_sponsor: Ipsen

location_country: Germany France

location_facility: CRS Clinical Research Services Berlin GMBH

location_facility: Fachbereich Chemie Institut für Biologie und Molekularbiologie Studiengang Kosmetikwissenschaft


title: Double-blind, Placebo-controlled, Randomized Pilot Clinical Trial to Evaluate the Efficacy and Safety of the Probiotic Strains Limosilactocillus Reuteri DSM 32910 and Lacticaseibacillus Paracasei DSM 32851 on Glucose Homeostatis in Prediabetic Adults

acronym: NOVOGLUCOSE

summary: The aim of this international, randomized, parallel arms, double-blind, placebo-controlled clinical trial is to investigate the safety and efficacy of a combination of the two Lactobacillus strains (NZ-GHMH-01) on glucose and insulin metabolism, in prediabetic subjects. This trial will include prediabetic (insulin resistant) subjects with excessive body weight (over-weight or obese, showing abdominal or visceral obesity) to be able to investigate the effect of the probiotic NZ-GHMH-01 on glycaemic control.

primary_purpose: Prevention

lead_sponsor: Novozymes A/S

location_country:
France
United Kingdom
Romania

location_facility: Military Hospital- Spitalul Militar Central Dr "Carol Davila"

location_facility: Suceava County Hospital - Spitalul Județean de Urgență "Sfântul Ioan cel Nou"

location_facility: Parhon Institute- Institutul National de Endocrinologie C.I. Parhon

intervention_type: Dietary Supplement


title: A Phase Ib/II, Open Label Study of Sabatolimab as a Treatment for Patients With Acute Myeloid Leukemia and Presence of Measurable Residual Disease After Allogeneic Stem Cell Transplantation

summary: The primary purpose of this study is to test the hypothesis that preemptive treatment with sabatolimab, alone or in combination with azacitidine, when administered to participants with AML/secondary AML who are in complete remission with positive measurable residual disease post-allogeneic hematopoietic stem cell transplantation (MRD+ post-aHSCT), can enhance the graft versus leukemia (GvL) response and prevent or delay hematologic relapse without an unacceptable level of treatment-emergent toxicities, including clinically significant acute and/or chronic graft-versus-host disease (GvHD) and immune-related adverse events

ipd_sharing: Yes

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

This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

location_country: Germany France Spain Italy


title: A First-in-human, Open-label Dose Escalation Followed by Dose Expansion Phase I/IIa Trial to Evaluate the Safety, Preliminary Efficacy and Pharmacokinetics of Intratumoral CyPep-1 Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Solid Cancers.

acronym: CICILIA

summary: This Phase I/IIa trial is designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of CyPep-1 when administered directly into malignant tumors in monotherapy and in combination with anti-PD-1 antibody pembrolizumab. Additionally, the trial will monitor anti-tumor effects on both injected lesions and distant non-injected deposits.

ReferenceCitation: Gibney GT, Weiner LM, Atkins MB. Predictive biomarkers for checkpoint inhibitor-based immunotherapy. Lancet Oncol. 2016 Dec;17(12):e542-e551. doi: 10.1016/S1470-2045(16)30406-5. Review.

ReferenceCitation: Herbst RS, Soria JC, Kowanetz M, Fine GD, Hamid O, Gordon MS, Sosman JA, McDermott DF, Powderly JD, Gettinger SN, Kohrt HE, Horn L, Lawrence DP, Rost S, Leabman M, Xiao Y, Mokatrin A, Koeppen H, Hegde PS, Mellman I, Chen DS, Hodi FS. Predictive correlates of response to the anti-PD-L1 antibody MPDL3280A in cancer patients. Nature. 2014 Nov 27;515(7528):563-7. doi: 10.1038/nature14011.

ReferenceCitation: Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-55.

ReferenceCitation: Samstein RM, Lee CH, Shoushtari AN, Hellmann MD, Shen R, Janjigian YY, Barron DA, Zehir A, Jordan EJ, Omuro A, Kaley TJ, Kendall SM, Motzer RJ, Hakimi AA, Voss MH, Russo P, Rosenberg J, Iyer G, Bochner BH, Bajorin DF, Al-Ahmadie HA, Chaft JE, Rudin CM, Riely GJ, Baxi S, Ho AL, Wong RJ, Pfister DG, Wolchok JD, Barker CA, Gutin PH, Brennan CW, Tabar V, Mellinghoff IK, DeAngelis LM, Ariyan CE, Lee N, Tap WD, Gounder MM, D'Angelo SP, Saltz L, Stadler ZK, Scher HI, Baselga J, Razavi P, Klebanoff CA, Yaeger R, Segal NH, Ku GY, DeMatteo RP, Ladanyi M, Rizvi NA, Berger MF, Riaz N, Solit DB, Chan TA, Morris LGT. Tumor mutational load predicts survival after immunotherapy across multiple cancer types. Nat Genet. 2019 Feb;51(2):202-206. doi: 10.1038/s41588-018-0312-8. Epub 2019 Jan 14.

ReferenceCitation: Schumacher TN, Schreiber RD. Neoantigens in cancer immunotherapy. Science. 2015 Apr 3;348(6230):69-74. doi: 10.1126/science.aaa4971. Review.

ReferenceCitation: Snyder A, Makarov V, Merghoub T, Yuan J, Zaretsky JM, Desrichard A, Walsh LA, Postow MA, Wong P, Ho TS, Hollmann TJ, Bruggeman C, Kannan K, Li Y, Elipenahli C, Liu C, Harbison CT, Wang L, Ribas A, Wolchok JD, Chan TA. Genetic basis for clinical response to CTLA-4 blockade in melanoma. N Engl J Med. 2014 Dec 4;371(23):2189-2199. doi: 10.1056/NEJMoa1406498. Epub 2014 Nov 19. Erratum in: N Engl J Med. 2018 Nov 29;379(22):2185.

ReferenceCitation: Szczepanski C, Tenstad O, Baumann A, Martinez A, Myklebust R, Bjerkvig R, Prestegarden L. Identification of a novel lytic peptide for the treatment of solid tumours. Genes Cancer. 2014 May;5(5-6):186-200.

ReferenceCitation: Vesely MD, Schreiber RD. Cancer immunoediting: antigens, mechanisms, and implications to cancer immunotherapy. Ann N Y Acad Sci. 2013 May;1284:1-5. doi: 10.1111/nyas.12105.

ReferenceCitation: Zappasodi R, Merghoub T, Wolchok JD. Emerging Concepts for Immune Checkpoint Blockade-Based Combination Therapies. Cancer Cell. 2018 Apr 9;33(4):581-598. doi: 10.1016/j.ccell.2018.03.005. Review. Erratum in: Cancer Cell. 2018 Oct 8;34(4):690.

ReferenceCitation: Seymour L, Bogaerts J, Perrone A, Ford R, Schwartz LH, Mandrekar S, Lin NU, Litière S, Dancey J, Chen A, Hodi FS, Therasse P, Hoekstra OS, Shankar LK, Wolchok JD, Ballinger M, Caramella C, de Vries EGE; RECIST working group. iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics. Lancet Oncol. 2017 Mar;18(3):e143-e152. doi: 10.1016/S1470-2045(17)30074-8. Epub 2017 Mar 2. Review. Erratum in: Lancet Oncol. 2019 May;20(5):e242.

ipd_sharing_description: De-identified data for all primary and secondary outcomes will be made available.

lead_sponsor: Cytovation AS

location_country: Netherlands France Spain

location_facility:
EMC
Institue Curie
UMCU
START
Vall d'Hebron (VHIO)
Institute Gustave Roussy
LUMC
NKI/AvL


title: Retrospective Chart Review to Evaluate the Safety Profile of Ceftobiprole in Patients With Impaired Hepatic or Renal Function or Immunosuppression

acronym: RETRACE

summary: In this observational study, data from patients treated with the antibiotic ceftobiprole in the past will be collected. The sponsor of the study is Correvio International Sárl, based in Switzerland. Correvio has committed to the health authorities to obtain further information on possible side effects especially in patients suffering from impaired liver or renal function or immune system deficiency and compare these effects to the ones observed in patients without these health problems. Patient data are collected from historic patient charts, patients will not be treated for the purpose of this data collection. All efforts are being made to capture the data of all patients who meet the inclusion criteria and have received at least one dose of ceftobiprole since this drug was first prescribed at the site.

time_perspective: Retrospective

lead_sponsor: Advanz Pharma

location_country: Germany France Italy

location_facility: ASST Settelaghi - Ospedale di Circolo e Fondazione Macchi

location_facility: AO di Perugia -Ospedale Santa Maria della Misericordia

location_facility: AORN Ospedali dei Colli - Ospedale 'V. Monaldi

location_facility: AOU Città della Salute e della Scienza Torino - Presidio Molinette

location_facility: AAS n 5 "Friuli Occidentale - Ospedale Santa Maria degli Angeli


title: An Open-label Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of Patisiran-LNP in Patients With Hereditary Transthyretin-mediated Amyloidosis (hATTR Amyloidosis) With Disease Progression Post-Orthotopic Liver Transplant

lead_sponsor: Alnylam Pharmaceuticals

source: euctr

ReferenceCitation: Schmidt HH, Wixner J, Planté-Bordeneuve V, Muñoz-Beamud F, Lladó L, Gillmore JD, Mazzeo A, Li X, Arum S, Jay PY, Adams D; Patisiran Post-LT Study Group. Patisiran treatment in patients with hereditary transthyretin-mediated amyloidosis with polyneuropathy after liver transplantation. Am J Transplant. 2022 Jun;22(6):1646-1657. doi: 10.1111/ajt.17009. Epub 2022 Mar 26.

ReferenceCitation: Seibert K, Wlodarski R, Sarswat N, Appelbaum D, Issa NP, Soliven B, Rezania K. Progressive Multiple Mononeuropathy in a Patient With Familial Transthyretin Amyloidosis After Liver Transplantation. J Clin Neuromuscul Dis. 2022 Mar 1;23(3):143-147. doi: 10.1097/CND.0000000000000368.

location_country:
Portugal
Spain
Italy
United Kingdom
Sweden
France
Germany

summary: The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of patisiran in participants with hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) with disease progression after liver transplant.


title: A Randomized, Open-label, Multi-center, Controlled Clinical Study to Compare MAR-CUTIS With Dermabond Advanced in Closure of Surgical Incisions and Lacerations up to 15 Centimeters

summary: This was a randomized, open-label, multicenter, comparator-controlled clinical study to compare MAR-CUTIS with Dermabond Advanced in closure of surgical incisions and lacerations less than or equal to (<=)15 centimeter (cm). Eligible participants were randomized 2:1 to MAR-CUTIS or Dermabond Advanced.

lead_sponsor: Grünenthal GmbH

location_country:
Germany
France
Spain
United Kingdom

location_facility: 001 - Hospital Universitari Vall d'Hebron

location_facility: 003 - University Hospital Virgen del Rocío

location_facility: 018 - Bristol Royal Hospital for Children

location_facility: 014 - Queen Elizabeth the Queen Mother Hospital

location_facility: 022 - Hospital General Universitario Gregorio Maranon


title: A Prospective, Open, Multicentre Clinical Trial With One Cohort Analysing the Efficacy and Safety of MINIject in European Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications

acronym: STAR-II

summary: The study will evaluate the efficacy and safety of the MINIject glaucoma implant and Intraocular Pressure (IOP) lowering effects with or without glaucoma medications. The procedure will be a stand-alone surgery. Overall, the patient will be asked to perform several examinations up to 24 months after surgery.

ReferenceCitation: García Feijoó J, Denis P, Hirneiß C, Aptel F, Perucho González L, Hussain Z, Lorenz K, Pfeiffer N; STAR-II Investigators. A European Study of the Performance and Safety of MINIject in Patients With Medically Uncontrolled Open-angle Glaucoma (STAR-II). J Glaucoma. 2020 Oct;29(10):864-871. doi: 10.1097/IJG.0000000000001632.

lead_sponsor: iSTAR Medical

location_facility: Center Hospotalier Universitaire Genoble Alpes


title: Tamoxifen in Duchenne Muscular Dystrophy: A Multicenter, Randomised, Double-blind, Placebo-controlled, Phase 3 Safety and Efficacy 48-week Trial

acronym: TAMDMD

summary:
A randomised, double blind, placebo controlled, 48-week clinical trial with a core population (group A) of 79 ambulant 6.5 to 12 years old Duchenne's muscular dystrophy (DMD) patients that are under stable standard treatment of care with glucocorticoids. Furthermore, the investigators plan to include 6-20 non-ambulant patients who do not receive glucocorticoids (as parallel group B), 10 to 16 years old, to obtain efficacy and safety data in a broader DMD population. All patients will receive 20 mg of tamoxifen (TAM) or placebo once daily during 48 weeks.

An open label extension (OLE) trial for participants of the TAMDMD main study will be performed. All TAMDMD patients on TAM or placebo are offered to enter this OLE.

ReferenceCitation: Nagy S, Hafner P, Schmidt S, Rubino-Nacht D, Schädelin S, Bieri O, Fischer D. Tamoxifen in Duchenne muscular dystrophy (TAMDMD): study protocol for a multicenter, randomized, placebo-controlled, double-blind phase 3 trial. Trials. 2019 Nov 21;20(1):637. doi: 10.1186/s13063-019-3740-6.

lead_sponsor: University Hospital, Basel, Switzerland

location_country:
Spain
United Kingdom
Netherlands
Switzerland
France
Germany

location_facility:
Royal Hospital for Children
Hôpitaux Raymond Poincaré
Radboud umc
University Children's Hospital Basel
Hospital Universitario Virgen del Rocío
DRK Klinik Berlin Westend
Universitätsklinikum Essen
The Leeds Teaching Hospitals NHS Trust
Hôpital de Hautepierre
Alder Hey Children's Hospital
Hospital Sant Joan de Déu. UB

lead_sponsor_type: academique


title: Renoir: A Randomised, Double-blind, Controlled Trial to Evaluate the Effects of a New Human Milk Fortifier on Growth and Tolerance in Preterm Infants.

acronym: Renoir

summary:
Preterm birth (birth before start of the 37th week of gestation) is a major determinant of neonatal morbidity and mortality and has long-term adverse consequences for health and neurodevelopment.

Preterm infants have much higher nutrient requirements than term infants. The preferred nutrition for all infants including preterm infants is human milk from the infant's own mother, or alternatively donor human milk, provided it is fortified with several nutrients as human milk alone does not sufficiently meet the nutritional needs of preterm infants.

Human milk fortifiers (HMFs) are multicomponent enrichments that can be added to human milk (own mother´s milk or donor milk) to meet the increased nutritional needs of preterm infants. The current Nutricia HMF (control product) has been available in its current composition since 2010. It is a multicomponent HMF providing protein, energy, minerals, and vitamins in accordance with the ESPGHAN recommendations.

Recent investigation suggests positive effects on growth and development of preterm infants when lipids are added to their nutrition. Therefore, Nutricia has added lipids to their HMF (test product) for a nutritionally more complete fortification of human milk aiming for optimal growth and optimal cognitive and brain development.

The Renoir study will investigate the difference between both HMFs with regards to the growth velocity as well as the safety and tolerance of the new HMF.

lead_sponsor: Nutricia Research

location_country:
Germany
France
Netherlands
United Kingdom

location_facility: Universitätskinderklinik der Otto-v.-Guericke Universität

location_facility: CHRU Nancy - Maternité regionale Universitaire A. Pinard

location_facility: Saint-Peter's Hospital NHS Foundation Trust

location_facility: Norfolk and Norwich NHS Foundation Trust


title: A Randomised, Open-label, Phase I Study to Determine the Effect of Food on the Pharmacokinetics of AZD1775 After Oral Dosing of a Capsule Formulation in Patients With Advanced Solid Tumours

summary: The purpose of this study is to assess the effect of food on the pharmacokinetics (PK) of a single dose of AZD1775 (printed capsules) in patients with advanced solid tumours.

lead_sponsor: AstraZeneca

location_country:
Netherlands
France
United Kingdom


title: Observational Registry Characterizing the Performance and Feature Use of the GORE® TAG® Conformable Thoracic Stent Graft Featuring ACTIVE CONTROL System

acronym: SURPASS

summary: Collect real-world clinical and device-specific outcomes of the GORE® TAG® Conformable Thoracic Stent Graft featuring ACTIVE CONTROL System (CTAG Device with ACTIVE CONTROL) in the treatment of aortic disease as part of routine clinical practice.

ReferenceCitation: Torsello GF, Argyriou A, Stavroulakis K, Bosiers MJ, Austermann M, Torsello GB; SURPASS Registry Collaborators. One-Year Results From the SURPASS Observational Registry of the CTAG Stent-Graft With the Active Control System. J Endovasc Ther. 2020 Jun;27(3):421-427. doi: 10.1177/1526602820913007. Epub 2020 Mar 20.

lead_sponsor: W.L.Gore & Associates

location_country:
Spain
Italy
United Kingdom
Netherlands
Sweden
France
Germany

location_facility: Azienda Ospedaliers San Camilla Forlanni

location_facility: Hospital Universitario Central de Asturias


title: A Randomized, Controlled, Double-blind, Multicenter Clinical Trial on Home Parenteral Nutrition Using an Omega-3 Fatty Acid Enriched MCT/LCT Lipid Emulsion

acronym: HOME

summary: The aim of the trial is to investigate safety and tolerability of an Omega-3-FA-enriched lipid emulsion in adult patients with chronic intestinal failure in need of long-term HPN. It is aimed to show non-inferiority of the lipid emulsion Lipidem (investigational test product) in comparison to the lipid emulsion Lipofundin MCT (investigational reference product) with regard to liver function.

ReferenceCitation: Klek S, Chambrier C, Cooper SC, Gabe S, Kunecki M, Pironi L, Rahman F, Sobocki J, Szczepanek K, Wanten G, Lincke N, Glotzbach B, Forbes A. Home parenteral nutrition with an omega-3-fatty-acid-enriched MCT/LCT lipid emulsion in patients with chronic intestinal failure (the HOME study): study protocol for a randomized, controlled, multicenter, international clinical trial. Trials. 2019 Dec 30;20(1):808. doi: 10.1186/s13063-019-3994-z.

lead_sponsor: B. Braun Melsungen AG

location_country:
Poland
United Kingdom
Italy
France
Netherlands

location_facility: Samodzielny Publiczny Szpital Kliniczny, im. prof. dr W. Orlowskiego, Centrum Medycznego Ksztalcenia Podyplomowego, Oddzial Kliniczny Zywienia i Chirurgii

location_facility: Department of Medical and Surgical Science, University of Bologna, Center for Chronic Intestinal Failure, Department of Digestive System, St. Orsola-Malpighi Hospital

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Wojewódzkim Specjalistycznym Szpitalem im. M. Pirogowa w Łodzi , Oddział Chirurgii Ogólnej i Naczyniowej

location_facility: Hôpital Archet 2 - Unité de support nutritionnel

location_facility: Hospices Civiles de Lyon - Centre hospitalier Lyon Sud


acronym: COMPOSER

title: An Adaptive Phase I/II Study to Assess Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Crovalimab in Healthy Volunteers and Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

lead_sponsor: Hoffmann-La Roche

ReferenceCitation: Röth A, Nishimura JI, Nagy Z, Gaàl-Weisinger J, Panse J, Yoon SS, Egyed M, Ichikawa S, Ito Y, Kim JS, Ninomiya H, Schrezenmeier H, Sica S, Usuki K, Sicre de Fontbrune F, Soret J, Sostelly A, Higginson J, Dieckmann A, Gentile B, Anzures-Cabrera J, Shinomiya K, Jordan G, Biedzka-Sarek M, Klughammer B, Jahreis A, Bucher C, Peffault de Latour R. The complement C5 inhibitor crovalimab in paroxysmal nocturnal hemoglobinuria. Blood. 2020 Mar 19;135(12):912-920. doi: 10.1182/blood.2019003399.

location_country:
Italy
Netherlands
Hungary
Korea, Republic of
France
Japan
Germany

location_facility: Elblandklinikum Riesa; Klinik fuer Haematologie Onkologie und Gastroenterologie

location_facility: Universitätsklinikum Ulm; Institut für Klinische Transfusionsmedizin

location_facility: Universitätsklinikum Essen; Klinik für Hämatologie

location_facility: Uniklinik RWTH Aachen; Klinik IV; Klinik Hämatologie, Onkologie, Hämostaseologie und Stamm.

location_facility: Semmelweis Egyetem, 1. Szamu Belgyogyaszati Klinika, Diabetologia

location_facility: Kaposi Mor Teaching Hospital, Dept of Internal Medicine/Hematology

location_facility: A.O. UNIVERSITARIA FEDERICO II DI NAPOLI;Dipartimento di Medicina Clinica e Chirurgia

location_facility: Institut hematologie Centre Hayem CHU paris Saint-Louis Lariboisiere F Widal Hopital St Louis

location_facility: Osaka University Hospital; Hematology and Oncology

location_facility: Ospedale Di Vicenza; Nefrologia, Ematologia

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: University of Tsukuba Hospital; Hematology

location_facility: Seoul National University Hosp; Dept Internal Med Hem Onc

location_facility: Severance Hospital, Yonsei University Health System

summary: This is a Phase I/II, first-in-human study consisting of four sequential parts and an open-label extension (OLE). The safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single doses of crovalimab will be evaluated in healthy volunteers (HV) during part 1. The safety, tolerability, PK and PD of multiple doses of crovalimab will be evaluated in participants with paroxysmal nocturnal hemoglobinuria (PNH) in parts 2, 3, 4, and OLE of the study. Efficacy of crovalimab will be evaluated in Parts 2, 3, and 4.


title: Phase II Trial of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Multiple Myeloma Patients Double Refractory to Bortezomib and Lenalidomide

lead_sponsor: PharmaMar

location_country: France Spain Italy

location_facility: Hospital General Universitario J.M. Morales Meseguer

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino

location_facility: Institut Català d´Oncologia L´Hospitalet

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

location_facility: Complejo Hospitalario Regional Virgen Del Rocio

location_facility: Complexo Hospitalario Universitario de Santiago

location_facility: Hospital Universitario Germans Trias i Pujol

summary: This is a multi-center, open-label, single arm, non-comparative phase II trial, designed to evaluate the efficacy of plitidepsin in combination with bortezomib and dexamethasone in patients with Multiple Myeloma (MM) double refractory to bortezomib and lenalidomide.


title: Cochlear Implant and Healthy Aging: A Multinational, Multicentre Observational Study

summary: The purpose of this study is to show that cochlear implant treatment improves the overall health related quality of life and general well-being in elderly individuals.

ReferenceCitation: Marx M, Mosnier I, Belmin J, Wyss J, Coudert-Koall C, Ramos A, Manrique Huarte R, Khnifes R, Hilly O, Martini A, Cuda D. Healthy aging in elderly cochlear implant recipients: a multinational observational study. BMC Geriatr. 2020 Jul 23;20(1):252. doi: 10.1186/s12877-020-01628-2.

location_country: France Israel Spain Italy

location_facility: ENT Otosurgery Department-Azienda Ospedaliera di Padova

location_facility: ENT Department Ospedale Guglielmo da Saliceto

location_facility: Groupe Hospitalier de La Pitié Salpétrière

location_facility: Complejo Hospitalario Universitario Insular Materno Infantil


title: RE-SPECT CVT: a Randomised, Open-label, Exploratory Trial With Blinded Endpoint Adjudication (PROBE), Comparing Efficacy and Safety of Oral Dabigatran Etexilate Versus Oral Warfarin in Patients With Cerebral Venous and Dural Sinus Thrombosis Over a 24-week Period

summary: This is a multi-center, prospective, international, randomized (1:1), open-label study with two parallel groups. This phase III study is planned to investigate the efficacy and safety of dabigatran etexilate versus dose-adjusted warfarin on a net clinical benefit endpoint of major bleeding (ISTH criteria) and new venous thrombotic event (VTE) (primary endpoint) with blinded endpoint adjudication.

ReferenceCitation: Ferro JM, Bendszus M, Jansen O, Coutinho JM, Dentali F, Kobayashi A, Aguiar de Sousa D, Neto LL, Miede C, Caria J, Huisman H, Diener HC; RE-SPECT CVT Study Group. Recanalization after cerebral venous thrombosis. A randomized controlled trial of the safety and efficacy of dabigatran etexilate versus dose-adjusted warfarin in patients with cerebral venous and dural sinus thrombosis. Int J Stroke. 2022 Feb;17(2):189-197. doi: 10.1177/17474930211006303. Epub 2021 Apr 4.

ReferenceCitation: Ferro JM, Coutinho JM, Jansen O, Bendszus M, Dentali F, Kobayashi A, van der Veen B, Miede C, Caria J, Huisman H, Diener HC; RE-SPECT CVT Study Group. Dural Arteriovenous Fistulae After Cerebral Venous Thrombosis. Stroke. 2020 Nov;51(11):3344-3347. doi: 10.1161/STROKEAHA.120.031235. Epub 2020 Sep 25.

ReferenceCitation: Ferro JM, Coutinho JM, Dentali F, Kobayashi A, Alasheev A, Canhão P, Karpov D, Nagel S, Posthuma L, Roriz JM, Caria J, Frässdorf M, Huisman H, Reilly P, Diener HC; RE-SPECT CVT Study Group. Safety and Efficacy of Dabigatran Etexilate vs Dose-Adjusted Warfarin in Patients With Cerebral Venous Thrombosis: A Randomized Clinical Trial. JAMA Neurol. 2019 Dec 1;76(12):1457-1465. doi: 10.1001/jamaneurol.2019.2764.

ReferenceCitation: Ferro JM, Dentali F, Coutinho JM, Kobayashi A, Caria J, Desch M, Fraessdorf M, Huisman H, Diener HC. Rationale, design, and protocol of a randomized controlled trial of the safety and efficacy of dabigatran etexilate versus dose-adjusted warfarin in patients with cerebral venous thrombosis. Int J Stroke. 2018 Oct;13(7):766-770. doi: 10.1177/1747493018778125. Epub 2018 May 18.

lead_sponsor: Boehringer Ingelheim

location_country:
Poland
Portugal
Spain
Italy
Russian Federation
Netherlands
France
India
Germany

location_facility: Reg.State Budget Hlthcare,City Hosp#5,Neurology Dept,Barnaul

location_facility: Nuovo Ospedale Civile S. Agostino-Estense

location_facility: Independent Public Clin.Hospital No.4,Neurol.Dept,Lublin

location_facility: St.Petersb,State Hlthcare Instit. Elisabeth Hosp,Neurol.dept

location_facility: Fondazione Centro San Raffaele del Monte Tabor

location_facility: Umberto I Pol. di Roma-Università di Roma La Sapienza

location_facility: Interreg. Clinical & Diagnostic Center, Neurol. Dept., Kazan

location_facility: Centro Hospitalar de Entre o Douro e Vouga, E.P.E. - Hospital de São Sebastião


acronym: MESOS

title: A Randomised Phase II Open-label Study With a Phase Ib Safety lead-in Cohort of ONCOS-102, an Immune-priming GM-CSF Coding Oncolytic Adenovirus, and Pemetrexed/Cisplatin in Patients With Unresectable Malignant Pleural Mesothelioma

lead_sponsor: Targovax Oy

location_country: France Spain

location_facility: Hospital Universitari de Girona Doctor Josep Trueta - Institut Català d'Oncologia

summary: The trial is an open-label, parallel group, multicentre trial that will recruit a total of 30 patients with malignant pleural mesothelioma. The trial will be conducted in 2 phases: a non-randomised safety phase and a randomised phase. The safety phase will consist of a lead-in cohort of 6 patients treated with ONCOS 102 and pemetrexed/cisplatin. The randomised phase will not commence until the DSMB has deemed the safety lead-in data appropriate for continuation. A total of 24 patients will be included in the randomised phase; 14 patients will be randomised to receive ONCOS 102 and pemetrexed/cisplatin, and 10 patients will receive pemetrexed/cisplatin alone. If cisplatin is seen to be too toxic after one or more cycles, the patient may change to carboplatin during the study. Furthermore, if treatment with cisplatin is deemed to be too toxic by the investigator due to age, presence of neurological toxicities or other relevant medical conditions, carboplatin can be administered from start of study. The trial's main objectives are determination of safety, immune activation, clinical response and the correlation between clinical outcome and the immunological data.


title: Substantially Improving the Cure Rate of High-risk BRCA1-like Breast Cancer Patients With Personalized Therapy (SUBITO) - an International Randomized Phase III Trial

acronym: Subito

summary: Investigator-initiated, international, multicentre, randomized, open-label, (neo)adjuvant phase III study in target population (stage III, HER2-negative, BRCA1-like breast cancer patients) comparing optimized standard-dose chemotherapy with intensified, alkylating chemotherapy with stem cell rescue.

ipd_sharing: Undecided

lead_sponsor: The Netherlands Cancer Institute

location_country: Netherlands France

location_facility:
Hopital Tenon, University Marie-Curie
Radboud UMC
Medical spectrum Twente
Institut Paoli Calmettes
Antoni van Leeuwenhoek
University Medical Center Utrecht
Maastricht University Medical Center
Erasmus Medical Center Cancer Institute
University Medical Center Groningen
LUMC
AZVU


title: A Phase II Study of the Anti-PDL1 Antibody Atezolizumab, Bevacizumab and Acetylsalicylic Acid to Investigate Safety and Efficacy of This Combination in Recurrent Platinum-resistant Ovarian, Fallopian Tube or Primary Peritoneal Adenocarcinoma

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

location_country:
Spain
United Kingdom
Switzerland
France
Netherlands

location_facility: Centre Hospitalier Universitaire Vaudois - Lausanne

location_facility: Royal Marsden Hospital - Chelsea, London

location_facility: Guy's and St Thomas' NHS - Guy s and St Thomas' NHS - Guy's Hospital

location_facility: Academisch Medisch Centrum - Universiteit van Amsterdam

location_facility: Radboudumc - Radboud University Medical Center Nijmegen

location_facility: Assistance Publique - Hopitaux de Paris - Hopital Europeen Georges Pompidou

location_facility: Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)

summary: This is a randomized phase II study, aimed at evaluating the efficacy (through progression free survival at 6 months) and safety of 5 different treatments involving atezolizumab, bevacizumab and/or acetylsalicylic acid in advanced recurrent platinum-resistant ovarian cancer patients in order to select the optimal treatments for further development in Phase III.


title: A PHASE IIA PROSPECTIVE, OPEN-LABEL, MULTICENTER STUDY TO DETERMINE THE PHARMACOKINETICS (PK) AND SAFETY AND TOLERABILITY OF AZTREONAM-AVIBACTAM (ATM-AVI) FOR THE TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTIONS (CIAIS) IN HOSPITALIZED ADULTS

summary: Determine the PK and safety and tolerability of aztreonam-avibactam (ATM-AVI) in the treatment of hospitalized adults with cIAI

ReferenceCitation: Jimenez-Rodriguez RM, Martín-Gutiérrez G, Jiménez-Jorge S, Rosso-Fernández CM, Tallón-Aguilar L, Roca-Oporto C, Padillo J, Luckey A, Cano A, López-Ruiz J, Gómez-Zorrilla S, Bonnín-Pascual J, Boix-Palop L, Montejo JM, Torre-Cisneros J, Cisneros JM. Factors associated with recruitment success in the phase 2a study of aztreonam-avibactam development programme: a descriptive qualitative analysis among sites in Spain. BMJ Open. 2022 Feb 3;12(2):e051187. doi: 10.1136/bmjopen-2021-051187.

ReferenceCitation: Cornely OA, Cisneros JM, Torre-Cisneros J, Rodriguez-Hernandez MJ, Tallon-Aguilar L, Calbo E, Horcajada JP, Queckenberg C, Zettelmeyer U, Arenz D, Rosso-Fernandez CM, Jimenez-Jorge S, Turner G, Raber S, O'Brien S, Luckey A; COMBACTE-CARE consortium/REJUVENATE Study Group. Pharmacokinetics and safety of aztreonam/avibactam for the treatment of complicated intra-abdominal infections in hospitalized adults: results from the REJUVENATE study. J Antimicrob Chemother. 2020 Mar 1;75(3):618-627. doi: 10.1093/jac/dkz497.

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.

lead_sponsor: Pfizer

location_country: Germany France Spain

location_facility: Universitaetsklinikum Koeln Innere Medizin I

location_facility: Universitaetsklinikum Schleswig-Holstein, Klinik fuer Infektiologie und Mikrobiologie, DZIF-CTU


title: Evaluation of the Effectiveness of the Abatacept (Orencia®) IV and SC Patient Alert Cards in Patients With Rheumatoid Arthritis in European Economic Area Countries

summary: The purpose of the study is to determine a) if the implementation of abatacept (Orencia®) patient alert card (PAC) resulted in effective understanding of key safety messages and b) if the degree of understanding of key safety messages is associated with improved clinical and safety outcomes.

time_perspective: Cross-Sectional

lead_sponsor: Bristol-Myers Squibb

location_country:
United Kingdom
Spain
Sweden
France
Germany

location_facility: APHM - Hopital Sainte-Marguerite, Marseille


title: A Multicenter, Single-blind, Randomized, Controlled Study of the Safety and Effectiveness of VYC-25L Hyaluronic Acid Injectable Gel for Restoration and Creation of Facial Volume in the Chin and Jaw

summary: This study will evaluate the safety and performance of VYC-25L hyaluronic acid injectable gel for the restoration and creation of facial volume in participants seeking to increase projection of the chin and/or jaw.

lead_sponsor: Allergan

location_country: Germany France Netherlands

location_facility: Hautzentrum Altenbochum - RuhrDERM Gemeinschaftspraxis Dr. med. Ardabili - Dr. med. Niesmann

location_facility: Praxisgemeinschaft Theatiner46 Dres. Ogilvie und Dr. Bernd Schuster

location_facility: Rotes Kreuz Krankenhaus Kassel Gemeinnützige GmbH Klinik für Plastische, Rekonstruktive und Ästhetische Chirurgie

location_facility: Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH

location_facility: Dermatogische Privatpraxis CentroDerm GmbH


title: SECURE - A poSt-market Registry in Patients With infrarEnal aortiC Aneurysm Undergoing endovasculaR Stenting With the New E-tegra Stent Graft System

acronym: SECURE

summary: The purpose of this study is to evaluate clinical and technical success as well as safety and feasibility of the E-tegra Stent Graft System used in endovascular treatment of infrarenal aortic aneurysm.

lead_sponsor: JOTEC GmbH

location_country: Poland Spain Switzerland France Germany

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny

location_facility: Hospital Clinico Universitario Valladolid

location_facility: Szpital Uniwersytecki im. dr. Antoniego Jurasza

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1


title: An Open Label, Phase II, Multicenter Study to Evaluate the Efficacy and Safety of a Recombinant Humanized Antibody to HER2 (Pertuzumab) Administered Every 3 Weeks to Patients With Hormone-Refractory Prostate Cancer Who Have Not Been Treated With Chemotherapy

summary: This study will evaluate the efficacy and safety of intravenous (IV) pertuzumab in participants with hormone-refractory prostate cancer who have had no previous chemotherapy. Participants will be enrolled in two stages, the first (Cohort A) at a lower 420-mg dose and the second (Cohort B) at a higher 1050-mg dose based upon observations in Cohort A. Up to 50 participants may enter either cohort, for a total enrollment between 46 and 73 participants across 9 study centers.

location_country:
Spain
Italy
United Kingdom
Netherlands
France
Germany


title: A Phase II, Open-label, Multicentre, Randomised Study of the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of CAM2029 in Patients With Acromegaly and Neuroendocrine Tumours (NETs) Previously Treated With Sandostatin® LAR®

summary: This is a Phase II, open-label multicentre, randomised study to assess the PK, PD, efficacy, and safety of two dosing regimens of CAM2029 in adult patients with acromegaly or a functional, well-differentiated NET, with carcinoid symptoms.

ReferenceCitation: Pavel M, Borson-Chazot F, Cailleux A, Hörsch D, Lahner H, Pivonello R, Tauchmanova L, Darstein C, Olsson H, Tiberg F, Ferone D. Octreotide SC depot in patients with acromegaly and functioning neuroendocrine tumors: a phase 2, multicenter study. Cancer Chemother Pharmacol. 2019 Feb;83(2):375-385. doi: 10.1007/s00280-018-3734-1. Epub 2018 Dec 8.

ipd_sharing_description: No plan to share IPD

lead_sponsor: Camurus AB

location_country: Germany Sweden France Italy

location_facility: Università degli Studi di Napoli Federico II

location_facility: RCCS Azienda Ospedaliera Universitaria San Martino IST