title: Prospective Multi-country Observational Study to Investigate the Impact of Abiraterone Acetate and Enzalutamide on Health-related Quality of Life, Patient-reported Outcomes, and Medical Resource Use in Metastatic Castration-resistant Prostate Cancer Patients

acronym: AQUARiUS

summary: The purpose of this observational study of metastatic castration-resistant prostate cancer (mCRPC) participants is to explore whether or not there are differences between participants treated with abiraterone acetate and enzalutamide on the health-related quality of life (HRQoL), Fatigue, Pain, Cognitive function and medical resource use (MRU).

ReferenceCitation: Thiery-Vuillemin A, Poulsen MH, Lagneau E, Ploussard G, Birtle A, Dourthe LM, Beal-Ardisson D, Pintus E, Trepiakas R, Lefresne F, Lukac M, Van Sanden S, Pissart G, Reid A; AQUARiUS Investigators. Impact of Abiraterone Acetate plus Prednisone or Enzalutamide on Patient-reported Outcomes in Patients with Metastatic Castration-resistant Prostate Cancer: Final 12-mo Analysis from the Observational AQUARiUS Study. Eur Urol. 2020 Mar;77(3):380-387. doi: 10.1016/j.eururo.2019.09.019. Epub 2019 Oct 5.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inserm

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

repositories_institution: University of Southern Denmark - University of Southern Denmark Research Portal

lead_sponsor: Janssen Pharmaceutica N.V., Belgium

location_country:
Denmark
United Kingdom
France


type: Other Identifier

title: A Registry Study of Treatment With Bulevirtide in Participants With Chronic Hepatitis D Infection

summary: The main goal of this study is to collect post marketing data from patients with chronic hepatitis D virus (HDV) infection who are treated with bulevirtide to describe the long-term effects of bulevirtide treatment and evaluate the safety of participants treated with bulevirtide.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Other

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Gilead Sciences

location_country: Germany Romania Austria France

location_facility: Charité. Univeritätsmedizin Berlin, CMM & CVK, Department of Hepatology and Gastroenterology

location_facility: St Josephs-Hospital Wiesbaden, Med Klinik 2

location_facility: Hospital for Infectious Diseases St. Cuvioasa Paraschiva

location_facility: Centre Hospitalier Universitaire De Lille- Hôpital Huriez

location_facility: Universitätsklinikum Gießen und Marburg - Gießen, Medizinisch Klinik V

location_facility: Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I

location_facility: Clinical Hospital for Infectious Diseases and Pneumophthisiology Dr. Victor Babe

location_facility: National Institute of Infectious Diseases "Prof. Dr. Matei Balş"

location_facility: Prof. Dr. Agrippa Ionescu Emergency Clinical Hospital

location_facility: Universitätsklinik für Innere Medizin I Innsbruck

location_facility: Emergency County Clinical Hospital "Pius Brînzeu" Timişoara

location_facility: IFI- Institut für interdisziplinäre Medizin

location_facility: Universitätsklinikum Düsseldorf, Klinik für Gastroenterologie, Hepatologie und Infektiologie

location_facility: Centre Hospitalier Universitaire D'Angers

location_facility: Dr. Victor Babes Clinical Hospital for Infectious and Tropical Diseases

location_facility: Medizinische Universität Graz Universitätsklinik für Innere Medizin, Klinische Abteilung für Gastroenterologie und Hepatologie

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Phase II, Open-Label Study Evaluating Efficacy of Tafasitamab and Lenalinomide Associated to Rituximab in Frontline Diffuse Large B-Cell Lymphoma Patients of 80 y/o or Older

summary: This study evaluate the efficacy of Tafasitamab and Lenalinomide associated to Rituximab in elderly patients with frontline Diffuse Large B-Cell Lymphoma as assessed by the Overall Response Rate (ORR) after 3 cycles of treatment according to Lugano Response Criteria.

study_type: Interventional

primary_purpose: Treatment

lead_sponsor: The Lymphoma Academic Research Organisation

location_country: Belgium France

location_facility: Institut de Cancérologie de la Loire Lucien Neuwirth


title: A Phase Ib Study of Ibrutinib Combined With R-DHAP or R-DHAOx in Patients With B-cell Lymphomas

acronym: BIBLOS

summary:
This is an open label, multicenter, dose escalation, phase Ib study to determine the recommended dose by assessing the maximum tolerated dose (MTD), safety and efficacy of ibrutinib in combination with R-DHAP (Group A/Abis) or R-DHAOx (Group B/Bbis) for patients with B-cell malignancies. This dose escalation will be followed by an exploratory expansion phase in 3 groups of 12 patients each (Group A/Abis, Group B/B bis and Group C).

During Part 1 Dose Escalation, the "3+3" design will be applied. Three doses of ibrutinib (280, 420 and 560 mg) will be examined sequentially in each cohort by the Dose Escalation Committee. Dose escalation will begin at dose level 1 = 420 mg.

The dose escalation will be performed for two types of associations in five separate groups :

Group A : ibrutinib D1-D21+ R-DHAP
Group B : ibrutinib D1-D21 R-DHAOx
Group Abis : ibrutinib D5-D18+ R-DHAP
Group Bbis : ibrutinib D5-D18 R-DHAOx

This dose escalation will be followed by an exploratory expansion phase in the group Bbis plus a new group including only mantle cell lymphoma (MCL) in first line patients: group C. Patients included in the Group C will receive ibrutinib in combination with R-DHAP or R-DHAOx according to the choice of the local investigator at time of inclusion of each patient.

status: Terminated

study_completion_date_type: Actual

enrollment_type: Actual

sponsor_collaborators: The Lymphoma Academic Research Organisation

location_facility: Universite Catholique de Louvain Saint Luc

location_facility: Centre François Magendie - Hôpital du Haut Lévêque

status_simplified: Unknown


title: An Open-Label, Randomized Study to Evaluate the Radiographic Efficacy and Safety of Enbrel™ (Etanercept) Added to Methotrexate in Comparison With Usual Treatment in Subjects With Moderate Rheumatoid Arthritis Disease Activity

summary: To assess comparative radiographic efficacy, clinical efficacy and safety of etanercept (ETN) + methotrexate (MTX) with usual disease-modifying anti-rheumatic drug (DMARD) treatment in subjects with moderate RA who were treated with MTX monotherapy, but continue to have moderate disease activity.

design_allocation: Randomized

ReferenceType: derived

ReferenceCitation: Mandl P, Balint PV, Brault Y, Backhaus M, D'Agostino MA, Grassi W, van der Heijde D, de Miguel E, Wakefield RJ, Logeart I, Dougados M. Clinical and ultrasound-based composite disease activity indices in rheumatoid arthritis: results from a multicenter, randomized study. Arthritis Care Res (Hoboken). 2013 Jun;65(6):879-87. doi: 10.1002/acr.21913.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Wiley

ReferenceCitation: Mandl P, Balint PV, Brault Y, Backhaus M, D'Agostino MA, Grassi W, van der Heijde D, de Miguel E, Wakefield RJ, Logeart I, Dougados M. Metrologic properties of ultrasound versus clinical evaluation of synovitis in rheumatoid arthritis: results of a multicenter, randomized study. Arthritis Rheum. 2012 Apr;64(4):1272-82. doi: 10.1002/art.33491. Epub 2011 Nov 30.

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Spain
Turkey
Czech Republic
France


title: Phase III Randomized Clinical Trial for Stage III Epithelial Ovarian Cancer Randomizing Between Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy

summary: stage III epithelial ovarian cancer randomizing between primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy

ReferenceCitation: Koole S, van Stein R, Sikorska K, Barton D, Perrin L, Brennan D, Zivanovic O, Mosgaard BJ, Fagotti A, Colombo PE, Sonke G, Driel WJV; OVHIPEC-2 Steering Committee and the Dutch OVHIPEC group. Primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC) for FIGO stage III epithelial ovarian cancer: OVHIPEC-2, a phase III randomized clinical trial. Int J Gynecol Cancer. 2020 Jun;30(6):888-892. doi: 10.1136/ijgc-2020-001231. Epub 2020 Mar 23.

oa_host_type: repository

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

version: acceptedVersion

repositories_concat: PubMed Central

unpaywall_oa_status: green

publisher_dissemination: British Medical Journal

lead_sponsor: The Netherlands Cancer Institute

location_country:
Ireland
Italy
Denmark
Sweden
Netherlands
United States
France

location_facility: Mater Misericordiae University Hospital, Dublin

location_facility: Institut de Cancerologie de l'Ouest, ICO Nantes)

location_facility: Oncopole, Institute Universitaire du Cancer de Toulouse (IUCT Toulouse)


acronym: TPEx

intervention_type: Other

lead_sponsor: Groupe Oncologie Radiotherapie Tete et Cou

summary: PURPOSE: Cetuximab with platinum and 5FU is now the standard combination as first-line treatment in patients with metastatic or recurrent Head and Neck squamous cell carcinomas. Cetuximab and taxane combinations have demonstrated promising activity in Head and Neck cancer. This phase II trial is studying new cetuximab, docetaxel and cisplatin combination named TPEx as first-line treatment in this setting.

ReferenceCitation: Guigay J, Fayette J, Dillies AF, Sire C, Kerger JN, Tennevet I, Machiels JP, Zanetta S, Pointreau Y, Bozec Le Moal L, Henry S, Schilf A, Bourhis J. Cetuximab, docetaxel, and cisplatin as first-line treatment in patients with recurrent or metastatic head and neck squamous cell carcinoma: a multicenter, phase II GORTEC study. Ann Oncol. 2015 Sep;26(9):1941-1947. doi: 10.1093/annonc/mdv268. Epub 2015 Jun 24.

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: publisher-specific-oa

license_normalized: publisher-specific

version: publishedVersion

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

sponsor_collaborators: Gustave Roussy, Cancer Campus, Grand Paris

location_facility: Clinique universitaire de Mont Godinne UCL

status: Completed

title: Phase II Study of Cetuximab, Docetaxel and Cisplatin as First-line Treatment in Patients With Metastatic or Recurrent Head and Neck Squamous Cell Carcinomas - GORTEC 2008-03 TPEx

type: EudraCT Number

source: euctr

status_simplified: Completed


title: An Open Label Study Of Zonegran (Zonisamide) In Patients With Partial Onset Seizures

summary: To determine the efficacy and safety of adjunctive open label Zonegran treatment in patients with refractory partial seizures.

design_allocation: Non-Randomized

lead_sponsor: Eisai Limited

location_country:
Germany
Italy
Norway
United Kingdom
Denmark
Austria
France

location_facility: Avd. for nevrologi og klinisk nevrofysiologi

location_facility: Universitatsklinikum Campus Virchow-Klinikum Wedding

location_facility: Azienda Ospedaliero- Universitaria Policlinico di Catania

location_facility: University Hospital of North Staffordshire Royal Infirmary

location_facility: Istituto Nazionale Neurologico Carlo Besta di Milano


title: Randomized, Placebo-controlled, Double-blind Phase 2 Study of Patritumab (U3-1287) in Combination With Cetuximab Plus Platinum-based Therapy in First Line Setting in Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

summary: This study will test an investigational study drug called patritumab. It is a 'randomized study' which means participants have an equal chance of being assigned to receive the experimental medication (patritumab) or a substance that looks like the experimental product, but is not (placebo). Patritumab may work when combined with other medications that are approved for the treatment of head and neck cancer. They are called cetuximab, cisplatin or carboplatin. All participants will receive the other medications approved for treatment of head and neck cancer, even if they do not receive the experimental product.

ReferenceCitation: Forster MD, Dillon MT, Kocsis J, Remenar E, Pajkos G, Rolland F, Greenberg J, Harrington KJ. Patritumab or placebo, with cetuximab plus platinum therapy in recurrent or metastatic squamous cell carcinoma of the head and neck: A randomised phase II study. Eur J Cancer. 2019 Dec;123:36-47. doi: 10.1016/j.ejca.2019.08.017. Epub 2019 Oct 21.

oa_colors: green hybrid

oa_host_type: publisher;repository

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories_concat: UCL Discovery

ipd_sharing: Yes

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at http://www.clinicalstudydatarequest.com. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://www.clinicalstudydatarequest.com/Study-Sponsors-DS-Details.aspx

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
Germany
Poland
Hungary
United Kingdom
Romania
Belgium
France

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

location_facility: University College London Hospitals NHS Foundation Trust - University College Hospital

location_facility: Centre Hospitalier de Bordeaux - Hôpital Saint André

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy

location_facility: Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum

location_facility: Regionalny Osrodek Onkologiczny Szpital im. M. Kopernika w Lodzi

location_facility: Borsod Abauj Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

location_facility: The Shrewsbury and Telford Hospital NHS Trust

location_facility: Centre de Cancerologie du Grand Montpellier


title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating Epoetin Alfa Versus Placebo in Anemic Patients With IPSS Low- or Intermediate-1-Risk Myelodysplastic Syndromes

summary: The purpose of this study is to demonstrate that epoetin alfa works better than placebo in improving anemia in patients with lower-risk myelodysplastic syndromes (MDS). The safety of epoetin alfa will also be evaluated.

lead_sponsor: Janssen-Cilag International NV

location_country:
Germany
Greece
Bulgaria
Russian Federation
France


title: First Prospective Intergroup Translational Research Trial Assessing the Potential Predictive Value of p53 Using a Functional Assay in Yeast in Patients With Locally Advanced/Inflammatory or Large Operable Breast Cancer Prospectively Randomised to a Taxane Versus a Non Taxane Regimen

summary:
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Currently patients with breast cancer are treated with one of several very similar combinations of drugs. Analysis of biomarkers in tumor tissue may help doctors predict how well patients with breast cancer will respond to treatment and help doctors choose the best drug regimen to treat each patient.

PURPOSE: This randomized phase III trial is studying giving different regimens of chemotherapy and comparing how well they work in treating women with large operable or locally advanced or inflammatory breast cancer. This study is also looking at whether analyzing a specific biomarker (p53) in tumor tissue may help doctors predict how well patients will respond to treatment and help doctors choose the best drug to treat each patient.

ReferenceType: background

ReferenceCitation: Bonnefoi H, Potti A, Delorenzi M, Mauriac L, Campone M, Tubiana-Hulin M, Petit T, Rouanet P, Jassem J, Blot E, Becette V, Farmer P, Andre S, Acharya CR, Mukherjee S, Cameron D, Bergh J, Nevins JR, Iggo RD. Retraction--Validation of gene signatures that predict the response of breast cancer to neoadjuvant chemotherapy: a substudy of the EORTC 10994/BIG 00-01 clinical trial. Lancet Oncol. 2011 Feb;12(2):116. doi: 10.1016/S1470-2045(11)70011-0. No abstract available.

ReferenceCitation: Desmedt C, Di Leo A, de Azambuja E, Larsimont D, Haibe-Kains B, Selleslags J, Delaloge S, Duhem C, Kains JP, Carly B, Maerevoet M, Vindevoghel A, Rouas G, Lallemand F, Durbecq V, Cardoso F, Salgado R, Rovere R, Bontempi G, Michiels S, Buyse M, Nogaret JM, Qi Y, Symmans F, Pusztai L, D'Hondt V, Piccart-Gebhart M, Sotiriou C. Multifactorial approach to predicting resistance to anthracyclines. J Clin Oncol. 2011 Apr 20;29(12):1578-86. doi: 10.1200/JCO.2010.31.2231. Epub 2011 Mar 21.

ReferenceType: result

ReferenceCitation: Bonnefoi H, Piccart M, Bogaerts J, Mauriac L, Fumoleau P, Brain E, Petit T, Rouanet P, Jassem J, Blot E, Zaman K, Cufer T, Lortholary A, Lidbrink E, Andre S, Litiere S, Lago LD, Becette V, Cameron DA, Bergh J, Iggo R; EORTC 10994/BIG 1-00 Study Investigators. TP53 status for prediction of sensitivity to taxane versus non-taxane neoadjuvant chemotherapy in breast cancer (EORTC 10994/BIG 1-00): a randomised phase 3 trial. Lancet Oncol. 2011 Jun;12(6):527-39. doi: 10.1016/S1470-2045(11)70094-8. Epub 2011 May 11. Erratum In: Lancet Oncol. 2013 Feb;14(2):e47.

ReferenceCitation: Bonnefoi HR, Bogaerts J, Piccart M, et al.: Phase III trial (EORTC 10994/BIG 00-01) assessing the value of p53 using a functional assay to predict sensitivity to a taxane versus nontaxane primary chemotherapy in breast cancer: final analysis. [Abstract] J Clin Oncol 28 (Suppl 18): A-LBA503, 2010.

ReferenceCitation: Collingridge D. Expression of concern--validation of gene signatures that predict the response of breast cancer to neoadjuvant chemotherapy: a substudy of the EORTC 10994/BIG 00-01 clinical trial. Lancet Oncol. 2010 Sep;11(9):813-4. doi: 10.1016/S1470-2045(10)70185-6. Epub 2010 Jul 26. No abstract available.

ReferenceCitation: Bonnefoi H, Zimmer AS, Piccart M, et al.: P53 functional assay in yeast: evaluation in 1856 patients in a large prospective clinical trial: EORTC 10994/BIG 00-01. [Abstract] 31st Annual San Antonio Breast Cancer Symposium, December 10-14, 2008, San Antonio, Texas. A-1067, 2008.

ReferenceCitation: Bonnefoi H, Potti A, Delorenzi M, Mauriac L, Campone M, Tubiana-Hulin M, Petit T, Rouanet P, Jassem J, Blot E, Becette V, Farmer P, Andre S, Acharya CR, Mukherjee S, Cameron D, Bergh J, Nevins JR, Iggo RD. Validation of gene signatures that predict the response of breast cancer to neoadjuvant chemotherapy: a substudy of the EORTC 10994/BIG 00-01 clinical trial. Lancet Oncol. 2007 Dec;8(12):1071-1078. doi: 10.1016/S1470-2045(07)70345-5. Epub 2007 Nov 19.

RetractionSource: Bonnefoi H, Potti A, Delorenzi M, Mauriac L, Campone M, Tubiana-Hulin M, Petit T, Rouanet P, Jassem J, Blot E, Becette V, Farmer P, André S, Acharya CR, Mukherjee S, Cameron D, Bergh J, Nevins JR, Iggo RD. Lancet Oncol. 2011 Feb;12(2):116

ReferenceCitation: Karina M, Bogaerts J, Piccart M, et al.: Preliminary safety data of the EORTC 10994/BIG 00-01 neoadjuvant trial comparing 3 cycles of docetaxel followed by 3 cycles of epirubicin-docetaxel versus 6 cycles of FEC 100 in patients with locally advanced/inflammatory or large operable breast cancer. [Abstract] Breast Cancer Res Treat 100 (Suppl 1): A-3067, S146-7, 2006.

ReferenceCitation: Bonnefoi H, Farmer P, Delorenzi M, et al.: Is there a regimen-specific gene signature predicting for pathological complete response after neoadjuvant chemotherapy in hormone-negative breast cancer patients? A microarray substudy of 101 patients included in EORTC 10994/BIG 00-01 trial. [Abstract] Breast Cancer Research and Treatment 94 (Suppl 1): A-1040, 2005.

ReferenceCitation: Farmer P, Iggo R, Becette V, et al.: High quality gene expression microarray data from a multicentre prospective trial: results of the first microarray analysis in the EORTC 10994/ BIG 00-01 study. [Abstract] Eur J Cancer 2 (Suppl 3): A-155, 99, 2004.

ReferenceCitation: Chatzipli A, Bonnefoi H, MacGrogan G, Sentis J, Cameron D, Poncet C; EORTC 10994/BIG 1-00 Consortium; Iggo R. Patterns of genomic change in residual disease after neoadjuvant chemotherapy for estrogen receptor-positive and HER2-negative breast cancer. Br J Cancer. 2021 Nov;125(10):1356-1364. doi: 10.1038/s41416-021-01526-3. Epub 2021 Sep 3.

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

repository_institution: University of Edinburgh - Edinburgh Research Explorer

version: submittedVersion

repositories_concat: PubMed Central;pure.ed.ac.uk

publisher_dissemination: Springer-Nature

ReferenceCitation: Bonnefoi H, Litiere S, Piccart M, MacGrogan G, Fumoleau P, Brain E, Petit T, Rouanet P, Jassem J, Moldovan C, Bodmer A, Zaman K, Cufer T, Campone M, Luporsi E, Malmstrom P, Werutsky G, Bogaerts J, Bergh J, Cameron DA; EORTC 10994/BIG 1-00 Study investigators. Pathological complete response after neoadjuvant chemotherapy is an independent predictive factor irrespective of simplified breast cancer intrinsic subtypes: a landmark and two-step approach analyses from the EORTC 10994/BIG 1-00 phase III trial. Ann Oncol. 2014 Jun;25(6):1128-36. doi: 10.1093/annonc/mdu118. Epub 2014 Mar 11.

repository_institution: PubMed Central - Europe PMC

repository_institution: Université de Lausanne - SERVAL

repository_institution: reroDoc Digital Library

repositories_institution:
PubMed Central - Europe PMC
Université de Lausanne - SERVAL
reroDoc Digital Library

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

collaborators: Swiss Group for Clinical Cancer Research

location_country:
Slovenia
Poland
Portugal
United Kingdom
Sweden
Netherlands
Switzerland
Belgium
France

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

location_facility: Edinburgh Cancer Centre at Western General Hospital

location_facility: Hospitais da Universidade de Coimbra (HUC)

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

location_facility: Sahlgrenska University Hospital at Gothenburg University

location_facility: Northern Centre for Cancer Treatment at Newcastle General Hospital

location_facility: Sahlgrenska University Hospital - Molndal at Gothenburg University

location_facility: Swiss Institute for Applied Cancer Research

location_facility: Hopital Cantonal Universitaire de Geneve

location_facility: Karolinska University Hospital - Huddinge

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

location_facility: CHU Liege - Domaine Universitaire du Sart Tilman

location_facility: Daniel Den Hoed Cancer Center at Erasmus Medical Center

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


title: Setting a Benchmark for Resource Utilization and Quality of Care in Patients Undergoing Transcatheter Aortic Valve Implantation in Europe - The BENCHMARK Registry

acronym: BENCHMARK

summary:
Non-interventional, multi-center, international registry in patients with severe aortic stenosis (sAS) undergoing transcatheter aortic valve implantation (TAVI). The BENCHMARK Registry aims to implement standardized, reproducible and scalable quality improvement measures, which will help to reduce resource requirements, intensive care unit bed occupancy and overall length of hospitalization with uncompromised patient safety.

The registry will consist of the following phases:

Retrospective phase (purpose: capture the status quo of each site prior to any Quality of Care improvement measures): The TAVI of patients being eligible for retrospective documentation must have been performed prior to the site's enrollment into the BENCHMARK prospective phase (follow-up: 30 days, 12 months).
Education phase: Each center will undergo an online BENCHMARK education. The contents of the education will be: Reflection on treatment pathways with the TAVI team, education on 8 defined Quality of Care improvement measures, followed by a center self-assessment (to self-assess the current alignment of hospital performance with the BENCHMARK Quality od Care measures).
Implementation phase: After having self-assessed the current alignment of hospital performance with the following BENCHMARK Quality of care measures, each center will start to introduce the tailored Quality of Care improvement measures to their hospital routine within a time frame of 2 months.
Prospective phase (purpose: to document the effects of defined quality of care improvement measure and to make sure patient safety is as least as good as in the retrospective phase. (8 months of recruitment, Follow-up: 30 days, 12 months)

status: Active, not recruiting

time_perspective: Prospective

ReferenceCitation: McCalmont G, Durand E, Lauck S, Muir DF, Spence MS, Vasa-Nicotera M, Wood D, Saia F, Chatel N, Luske CM, Kurucova J, Bramlage P, Frank D. Setting a benchmark for resource utilization and quality of care in patients undergoing transcatheter aortic valve implantation in Europe-Rationale and design of the international BENCHMARK registry. Clin Cardiol. 2021 Oct;44(10):1344-1353. doi: 10.1002/clc.23711. Epub 2021 Sep 9.

ipd_sharing_description: no individual participant data (IPD) will be shared

lead_sponsor: Institut für Pharmakologie und Präventive Medizin

location_country: Germany Italy Romania Austria Spain Czechia France

location_facility: L'Ospedale S.Giuseppe Moscati di Avellino

location_facility: Azienda Ospedaliera Ordine Mauriziano di Torino

location_facility: Institutul de Urgenta pentru Boli Cardiolvasculaire

location_facility: Hospital Regional Universitario de Málaga

location_facility: IMM (Institut Mutualiste Montsouris) Paris

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Centre Hospitalier Universitaire de Besancon


title: A Single-Arm, Multicenter, Phase 1b Study With an Expansion Cohort to Evaluate Safety and Efficacy of Necitumumab in Combination With Abemaciclib in Treatment of Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)

summary: This is medical research evaluating the safety and efficacy of two new medicines (necitumumab and abemaciclib), administered in combination in participants affected by a defined type of advanced lung cancer (stage IV non-small-cell lung cancer).

lead_sponsor: Eli Lilly and Company

location_country: Spain Belgium France

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

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


title: BIOTRONIK - Safety and Performance Registry for an All-comers Patient Population With the Limus Eluting Orsiro Stent System Within Daily Clinical Practice - III

acronym: BIOFLOW-III

summary: This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES).

status: Unknown status

ReferenceCitation: Toelg R, Slagboom T, Waltenberger J, Lefevre T, Saito S, Kandzari DE, Koolen J, Richardt G. Individual patient data analysis of the BIOFLOW study program comparing safety and efficacy of a bioresorbable polymer sirolimus eluting stent to a durable polymer everolimus eluting stent. Catheter Cardiovasc Interv. 2021 Nov 1;98(5):848-856. doi: 10.1002/ccd.29254. Epub 2020 Sep 5.

ReferenceCitation: Waltenberger J, Brachmann J, van der Heyden J, Richardt G, Frobert O, Seige M, Friedrich G, Erglis A, Winkens M, Hegeler-Molkewehrum C, Neef M, Hoffmann S; BIOFLOW-III Investigators. Five-Year Results of the Bioflow-III Registry: Real-World Experience with a Biodegradable Polymer Sirolimus-Eluting Stent. Cardiovasc Revasc Med. 2020 Jan;21(1):63-69. doi: 10.1016/j.carrev.2019.03.004. Epub 2019 Mar 15.

ReferenceCitation: Waltenberger J, Brachmann J, van der Heyden J, Richardt G, Frobert O, Seige M, Erglis A, Dewilde W, Winkens M, Hegeler-Molkewehrum C, Klein N, Hoffmann S; BIOFLOW-III Investigators. Real-world experience with a novel biodegradable polymer sirolimus-eluting stent: twelve-month results of the BIOFLOW-III registry. EuroIntervention. 2016 Feb;11(10):1106-10. doi: 10.4244/EIJY15M03_08.

publisher_dissemination: Europa Digital & Publishing

lead_sponsor: Biotronik AG

location_country:
Germany
Italy
Portugal
United Kingdom
Denmark
Sweden
Netherlands
Austria
Switzerland
Latvia
Spain
Chile
France

location_facility: Klinikum Landshut-Achdorf Medizinische Klinik I

location_facility: Universitetssjukhuset Oerebro, Kardiologiska Kliniken

location_facility: Riga Eastern Clinical University Hospital

location_facility: HZ Muenchen-Bogenhausen, Klinik fuer Kardiologie und Internistische Intensivmedizin

location_facility: Krankenhaus Martha Maria gGmbH, Klinik fuer Innere Medizin I

location_facility: Cattedra Universitaria, Divisione Cardiologia, Policlinico Tor Vergata

location_facility: Craigavon Area Hospital Lurgan Road Co. Armagh, Northern Ireland

location_facility: Uniklinik Heidelberg, Medizinische Uniklinik

location_facility: Pauls Stradins Clinical University Hospital


intervention_type: Biological

lead_sponsor: GlaxoSmithKline

summary: This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083 vaccine co-administered with Prevenar 13® at 2, 4 and 12 months of age and with Rotarix™ at 2 and 4 months of age.

title: Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 4 and 12 Months of Age

primary_purpose: Prevention

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

location_country: Germany Canada France


title: Molecular Genetic, Host-derived and Clinical Determinants of Long-term Survival in Glioblastoma

summary:
This pro - and retrospective multicenter clinical epidemiological study studies the molecular genetic, host-derived and clinical determinants of glioblastoma patients with an overall survival of more than 5 years. The different research focusses are:

Identification of clinical parameters and patient characteristics / host-related factors in long-term survivors (Focus 1)
Identification of molecular tumor characteristics in long-term survivors (Focus 2)
Assessment of therapy-related parameters, including neuro-toxicity (Focus 3)
Immunological studies (Focus 4)

time_perspective: Cross-Sectional

ipd_sharing: Undecided

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

location_country:
Germany
Italy
Netherlands
Austria
Belgium
Switzerland
United States
Greece
France

location_facility: Hopitaux de Marseille - Hôpital de La Timone (APHM)

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Giovanni

location_facility: Azienda Ospedaliera Di Padova - Istituto Oncologico Veneto IRCCS

location_facility: Technische Universitaet Muenchen - Klinikum Rechts Der Isar

location_facility: Hopitaux de Paris - La Pitie Salpetriere

location_facility: Dana-Farber Cancer Institute & Harvard Medical School

location_facility: Ludwig-Maximilians-Universitaet Muenchen - Campus Grosshadern

location_facility: Centre Hospitalier Universitaire Vaudois - Lausanne

location_facility: Universitaetsklinikum Wien - AKH uniklinieken

location_facility: CHU Lyon - Hopital neurologique Pierre Wertheimer

intervention_type: Procedure


acronym: FAIRPARKII

lead_sponsor: University Hospital, Lille

summary: This study evaluates the effect of iron chelation as a therapeutic strategy to slow the progression of Parkinson's disease. Half of participants will receive the deferiprone to 15 mg / kg twice daily morning and evening (30mg / kg per day), while the other half will receive a placebo. The treatment lasts nine months.

ReferenceCitation: Mahoney-Sanchez L, Bouchaoui H, Ayton S, Devos D, Duce JA, Devedjian JC. Ferroptosis and its potential role in the physiopathology of Parkinson's Disease. Prog Neurobiol. 2021 Jan;196:101890. doi: 10.1016/j.pneurobio.2020.101890. Epub 2020 Jul 26.

oa_colors: green other

evidence: open (via crossref license, author manuscript)

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

repository_normalized: HAL

repository_institution: Université de Lille (University Of Lille) - LillOA

repository_normalized: LillOA (Lille Open Archive)

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

repositories:
HAL
LillOA (Lille Open Archive)

repositories_concat: HAL;LillOA (Lille Open Archive)

ReferenceCitation: Moreau C, Duce JA, Rascol O, Devedjian JC, Berg D, Dexter D, Cabantchik ZI, Bush AI, Devos D; FAIRPARK-II study group. Iron as a therapeutic target for Parkinson's disease. Mov Disord. 2018 Apr;33(4):568-574. doi: 10.1002/mds.27275. Epub 2018 Jan 30. No abstract available.

repositories_concat: HAL;LillOA (Lille Open Archive);University of Melbourne - Minerva Access

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

sponsor_collaborators:
University Hospital, Lille
European Commission
ApoPharma

location_facility: CHU de Strasbourg, Hôpital de Hautepierre

location_facility: Centro Hospitalar e universitario de Coimbra

location_facility: Klinik und Poliklinik für Neurologie der Universitätsmedizin Rostock

location_facility: Hospital Clinic Universitari de Barcelona

location_facility: University Hospital, Saarland University

title: Conservative Iron Chelation as a Disease-modifying Strategy in Parkinson's Disease. European Multicentre, Parallel-group, Placebo-controlled, Randomized Clinical Trial of Deferiprone"

type: Other Grant/Funding Number

location_country:
Germany
Portugal
United Kingdom
Netherlands
Austria
Spain
Czechia
France

collaborators:
European Commission
ApoPharma

lead_sponsor_type: academique


acronym: SEQTOR

lead_sponsor: Grupo Espanol de Tumores Neuroendocrinos

summary: The purpose of this study is to compare STZ vs everolimus as first line treatment for advanced pNET and to elucidate which sequence of streptozotocin (STZ) based chemotherapy and the mammalian Target of Rapamycin (mTOR) inhibitor, everolimus, gives better results in terms of second Progression Free Survival (PFS) in well differentiated and advanced pancreatic NETs.

location_facility: Istituto Nazionale Tumori (Fondazione G Pascale)

location_facility: Aarhus Aarhus University Hospital NET Centre (AUH-NET)

location_facility: Instituto Catalán de Oncología de Hospitalet

location_facility: Clichy Neuroendocrine Tumor (NET) Center Hôpital Beaujon

location_facility: Hôpitaux Universitaires de Strasbourg Hôpital de Hautepierre

location_facility: UTTIOM Unité Transversale de Thérapeutiques Innovantes en Oncologie Médicale CHU Angers

location_facility: Interdisciplinary Center of Neuroendocrine Tumors of the GastroEnteroPancreatic System (GEPNET-KUM) at the University of Munich

location_facility: Magdeburg Universitätsklinikum Magdeburg A. ö. R

location_facility: Medizin II am Klinik und Poliklinik rechts der Isar

location_facility: University Hospital of Bordeaux Hôpital Saint-André

location_facility: Rigshospitalet NET CoE, University of Copenhagen

location_facility: UKM Facharzt für Innere Medizin Gastroenterologie, Onkologische Gastroenterologie (DGVS)

location_facility: Brest Hopital Augustin Morvan, Institut de Cancero-Hemato

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Medizinische Klinik und Poliklinik , Universitätsklinikum Hamburg-Eppendorf

location_facility: Marburg Universitätsklinikum Giessen und Marburg GmbH

title: Randomized Open Label Study to Compare the Efficacy and Safety of Everolimus Followed by Chemotherapy With Streptozotocin- Fluorouracilo (STZ-5FU) Upon Progression or the Reverse Sequence, in Advanced Progressive Pancreatic NETs (pNETs)

ipd_sharing_description: As per GETNE guidelines and local laws

location_country:
Germany
Italy
United Kingdom
Denmark
Sweden
Netherlands
Spain
France

collaborators:
European Neuroendocrine Tumor Society
Kantar Health
Novartis Pharmaceuticals


title: A Multi-center, Phase IB/II, Open Label, Single Arm Study of Inotuzumab Ozogamicin Plus Rituximab (R-CMC544) Alternating With Gemcitabine-oxaliplatin Plus Rituximab(R-GEMOX)in Patients Aged From 18 to 80 Years With CD20 and CD22 Positive Diffuse Large B-cell Lymphoma (DLBCL) in Relapse After/Refractory to 1ST or 2ND Line Treatment, Who Are no Candidates for Autologous Transplant.

summary: The purpose of this study is to determine the recommended dose of CMC544 administered in combination with rituximab (R-CMC544), and in alternance with rituximab, gemcitabine and oxaliplatin (R-GEMOX) in the first phase of the study. After that, efficacy and safety of this combination will be evaluated preliminarily in patients with DLBCL in relapse or refractory, who are no candidates for autologous transplant.

location_facility:
Hôpital Henri Mondor
CHU Brabois
CHU de Dijon
Centre Henri Becquerel
CHU Lyon - Sud
CHRU de Lille
CHU Pontchaillou
CHU Hôtel Dieu
AZ Sint Jan
CHU Mont-Godinne
University Hospital Gent


title: PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post- Approval Surveillance Study To Evaluate Real World Clinical Outcomes Data for the TAXUS® Element™ Coronary Stent System in Unselected Patients in Routine Clinical Practice

acronym: TE-Prove

summary: The goal of the TAXUS™ Element™ Paclitaxel-Eluting Coronary Stent System European Post-Approval Surveillance Study is to evaluate real world clinical outcomes data for the TAXUS™ Element™ Coronary Stent System in unselected patients in routine clinical practice.

ReferenceCitation: Tamburino C, Capodanno D, Erglis A, Menown IB, Horvath IG, Moreno R, Gilbert TJ, Crowley JJ, Calabria P, Allocco DJ, Dawkins KD. One-year outcomes in unselected patients treated with a thin-strut, platinum-chromium, paclitaxel-eluting stent: primary endpoint results from the TAXUS Element European post-approval surveillance study (TE-PROVE). EuroIntervention. 2015 Mar;10(11):1261-6. doi: 10.4244/EIJY15M01_01.

ipd_sharing_description: Primary endpoint data presented at TCT 2014.

lead_sponsor: Boston Scientific Corporation

sponsor_collaborators:
Boston Scientific Corporation
Pharmaceutical Research Associates

location_country:
Germany
Ireland
Italy
Poland
Hungary
United Kingdom
Belgium
Latvia
Spain
France

location_facility: Samodzielny Publiczny Specjalistyczny Szpital Zachodni im. Jana Pawla II

location_facility: Centre Hospitalier Privé Saint Martin gds

location_facility: Zentrum für klinische Prüfungen in der Facharztzentrum Dresden-Neustadt GbR

location_facility: Norfolk and Norwich University Hospital NHS Trust


title: A Prospective, Multi-centre, Randomized, Open-label, Parallel, Comparative Study to Evaluate Effects of AQUACEL® Ag Dressing and Urgotul® Silver Dressing on Healing of Chronic Venous Leg Ulcers

summary: A prospective, comparative, randomised study to compare the effects on ulcer healing of AQUACEL® Ag dressing when used for 4 weeks followed by treatment with AQUACEL® for 4 weeks to Urgotul® Silver dressing followed by Urgotul® for 4 weeks on subjects with venous leg ulcers.

lead_sponsor: ConvaTec Inc.

location_country:
Germany
Poland
United Kingdom
Denmark
France

location_facility: Poradnia Chirurgiczna Szpital, Specjalistyczny nr.2 (#50)

location_facility: Distric Nurses, The Wilson Practice, Alton Health Centre (#9)

location_facility: Fareham College Specialist Leg Care Centre (#13)

location_facility: Tissue Viability Service, The Willows, Centre for Health Care (#11)

location_facility: Tissue Viability Service NHS Harrow PCT (#26)

location_facility: Chalfont and Gerrards Cross Hospital (#14)

location_facility: Mayday University Hospital Wound Clinic (#10)

location_facility: Poradnia Medycyny Paliatywnej, Hospicjum Palium, SK im. Przemienienia Panskiego nr.1(#49)

intervention_type: Device


title: Study of GSK2130579A Tumor-Antigen-Specific Cancer Immunotherapeutic in Adult Acute Myeloid Leukemia Patients With a Suboptimal Clinical Response to Induction Chemotherapy

summary: The purpose of this study is to evaluate the clinical activity and safety of a WT1 Antigen-Specific Cancer Immunotherapeutic (WT1 ASCI) as post-induction therapy in adult patients with WT1-positive AML presenting a suboptimal clinical response to induction chemotherapy. The study will also assess whether this treatment induces a specific immune response to the malignancy.

location_country:
United States
Germany
France


title: Renal Safety Evaluation After Dotarem®-Enhanced MRI Compared With Non-enhanced MRI in Patients at High Risk of Developing Contrast Medium Induced Nephropathy

acronym: RESCUE

summary: Although there is a well documented risk of acute renal failure with the iodinated contrast agents, the implication of intravenous gadolinium-based contrast agents in nephrotoxicity remains controversial. The aim of this study was to evaluate the safety profile of gadoterate meglumine (Dotarem®) in patients with chronic renal insufficiency by evaluating the rate of patients experiencing contrast-induced nephrotoxicity following the injection of gadoterate meglumine.

primary_purpose: Diagnostic

lead_sponsor: Guerbet

location_country: Italy Spain Belgium France

location_facility: Azienda Ospedaliera Universitaria di Ferrara


title: An International, Multicentre, Randomized, Parallel Group, Double Blind, Placebo Controlled, Flexible Dose Study to Evaluate Self-esteem and Relationships in Males With Erectile Dysfunction Treated With Sildenafil Citrate

summary: To determine the improvement in the self-esteem domain score of the Self-Esteem/Overall Relationship (SEAR) questionnaire and the improvement in erectile function (obtained from the Erectile Function [EF] domain of the International Index of Erectile Function [IIEF]). Furthermore, to determine if the improvement obtained in self-esteem was related to the main erectile dysfunction (ED) co-morbidities type and/or number.

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

location_country:
Finland
Italy
Poland
United Kingdom
Sweden
Spain
Russian Federation
France


title: A Multicenter Randomized Trial, With Direct Individual Benefit, to Determine the Optimal Circadian Time of Vinorelbine Administration Combined With Chronomodulated Infusion of 5-Fluorouracil in Previously Treated Patients With Metastatic Breast 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.

PURPOSE: Randomized clinical trial to study the effectiveness of vinorelbine plus fluorouracil in treating women who have metastatic breast cancer that has been previously treated with at least one regimen of chemotherapy.

ReferenceCitation: Coudert B, Focan C, Genet D, Giacchetti S, Cvickovic F, Zambelli A, Fillet G, Chollet P, Amoroso D, Van Der Auwera J, Lentz MA, Marreaud S, Baron B, Gorlia T, Biville F, Levi F. A randomized multicenter study of optimal circadian time of vinorelbine combined with chronomodulated 5-fluorouracil in pretreated metastatic breast cancer patients: EORTC trial 05971. Chronobiol Int. 2008 Sep;25(5):680-96. doi: 10.1080/07420520802384036.

location_country: Italy Greece Belgium France

location_facility: Azienda Ospedale S. Luigi - Universita Di Turin

location_facility: Istituti Fisioterapici Ospitalieri - Roma

location_facility: CHU Liege - Domaine Universitaire du Sart Tilman

location_facility: Centre Hospital Regional Universitaire de Limoges

location_facility: Istituto per la Ricerca e Cura del Cancro

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


title: A Single Arm, Open-label Phase 3b Study to Describe the Safety and Tolerability of Ivosidenib in Combination With Azacitidine in Adult Patients Newly Diagnosed With IDH1m Acute Myeloid Leukemia (AML) Ineligible for Intensive Induction Chemotherapy

summary: The purpose of this study is to learn more about the safety and efficacy of ivosidenib taken with azacitidine to treat adult patients with acute myeloid leukemia (AML) who are presenting a gene mutation called IDH1 (isocitrate dehydrogenase1 mutation-positive [IDH1m]) and cannot receive treatment with intensive chemotherapy (IC).

ipd_sharing_description:
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

sponsored by Servier
with a first patient enrolled as of 1 January 2004 onwards
for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

lead_sponsor: Servier Affaires Médicales

location_country: Italy Netherlands Austria France

location_facility: IRCCS Istituto Scientifico Romagnolo Per Lo Studio Dei Tumori "Dino Amadori" - IRST

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

location_facility: Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia


title: A Phase I, Randomised, Open-Label, Single-Dose, Two-Treatment, Two-Way Crossover, Two-Stage Study to Evaluate the Bioequivalence of Onivyde (Irinotecan Liposome Injection) Manufactured at Two Different Sites Administered in Combination With Anti-Cancer Agents in Adult Participants With Metastatic Pancreatic Adenocarcinoma

acronym: SIRACUSA

summary:
The aim of this study is to compare Onivyde manufactured at two different production sites in adult participants with advanced cancer in the pancreas.

Adult participants with metastatic pancreatic adenocarcinoma will receive Test Product (TP) and Reference Product (RP) Onivyde in line with its approved indication. The order in which they receive them depends on the group to which they are randomly assigned, this will be referred to as the crossover phase.

The average study duration for each participant until end of crossover phase is estimated to be approximately 3 months. After completion of the crossover phase, participants who in the opinion of the investigator will benefit from the treatment will be offered to enter the extension phase where they will receive the commercial Onivyde (RP) until disease progression, withdrawal, unacceptable toxicity or death. Metastatic pancreatic adenocarcinoma is a cancer that has spread (metastasized) beyond the area of the pancreas to other organs of the body.

Onivyde is approved for the treatment of metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy, in combination with 5-fluorouracil (5-FU) and leucovorin (LV).

lead_sponsor: Ipsen

location_country: Germany Italy Portugal Hungary Australia Spain France

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Peninsula and Southeast Oncology - Frankston Private Hospital

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS

location_facility: Institut BERGONIE Centre de Lutte Contre le Cancer

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E

location_facility: Azienda Ospedaliero Universitaria Modena

location_facility: Caritasklinikum Saarbruecken St Theresia

location_facility: Hospital Universitari de Lleida Arnaud de Villanova

location_facility: Centro Hospitalar Lisboa Norte - Hospital de Santa Maria

location_facility: Complejo Hospitalario Universitario de Santiago de Compostela -Chus

location_facility: AOU-S.Orsola-Malpighi - Universita degli Studi di Bologna

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I

location_facility: Universitätsklinikum Ulm -Zentrum Für Innere Medizin


title: Computed Tomography-Guided Catheter Ablation for Ventricular Tachycardia (InEurHeart Study)

acronym: InEurHeart

summary: This double arm randomized study will compare 2 ventricular tachycardia ablation strategies: the standard strategy based on invasive substrate and VT mapping with 3D electro-anatomical system vs a tailored strategy which identifies targets based on pre-procedural CT-scan imaging. The primary endpoint will be procedure duration and secondary endpoints will include safety and efficacy criteria as well as medico-economic evaluation.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: University Hospital, Bordeaux

sponsor_collaborators:
University Hospital, Bordeaux
EIT Health

location_country: Germany Switzerland Austria France

location_facility:
Rhön-Klinikum AG
Inuversitäres Herzzentrum Leipzig
Inselspital, Universitätsspital Bern
Medical University of Graz
CHU de Clermont-Ferrand
APHP Salpétrière
CHU de Limoges
CHU de Toulouse
Evangelisches Krankenhaus Düsseldorf
Asklepios Klinik St. Georg Hamburg
Vaudois University Hospital, Lausanne
Public Hospital Elisabethinen Linz
Luzerner Kantonsspital
Deutsches Herzzentrum München
CHU de Bordeaux


title: Safe Anastomosis Feasibility Study: a Study to Investigate the Efficacy, Mechanism of Action and Safety of the Colovac+ Colorectal Anastomosis Protection Device

summary: A clinical trial to assess the efficacy, mechanism of action and safety of the Colovac+ Colorectal Anastomosis Protection Device in providing temporary protection of the anastomosis in subjects undergoing lower anterior resection for colorectal cancer

lead_sponsor: SafeHeal Inc

location_country: Belgium France

location_facility: Centre Hospitalier Universitaire St Pierre


title: A Prospective, Multinational Study of Real-Life Current Standards of Care in Patients With Relapsed and/or Refractory Multiple Myeloma

acronym: MoMMent

summary: The purpose of this study is to assess in real-life clinical practice, over a 24-month period, the effectiveness and safety of current standard of care (SOC) antimyeloma treatments in participants with previously treated relapsed and/or refractory multiple myeloma.

lead_sponsor: Janssen Pharmaceutica N.V., Belgium

location_country:
Germany
Italy
United Kingdom
Netherlands
Belgium
Spain
France

location_facility: Nottingham University Hospitals NHS Trust

location_facility: U.O. Ematologia Istituto Tumori Giovanni Paolo II

location_facility: Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: Universita degli Studi di Padova - Azienda Ospedaliera di Pa

location_facility: Fondazione Policlinico Universitario A. Gemelli IRCCS

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

location_facility: Klinikum der Eberhard-Karls-Universität/Abt. für innere Med. II/Hämatologie/Onkologie-Germany

location_facility: IRCCS Azienda Ospedaliera San Martino - IST

location_facility: Universitätsklinik Hamburg-Eppendorf - Orthopädische Universitätsklinik und Poliklinik

location_facility: Universitatsklinikum Carl Gustvav Carus Dresden an der Technischen Universitat Dresden

location_facility: Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza


lead_sponsor: Alexion Pharmaceuticals, Inc.

summary: This study is being conducted to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics of ALXN1840 versus standard of care in pediatric participants with Wilson disease (WD).

location_facility:
Clinical Trial Site
Clinical Trial Site 2
Clinical Trial Site3

title: A Multicenter, Randomized, Controlled, Open-label, Rater-blinded Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of ALXN1840 Versus Standard of Care in Pediatric Participants With Wilson Disease

location_country:
Germany
Poland
United Kingdom
Australia
Japan
Korea, Republic of
Spain
France


title: BoStOn SCientific Rhythm MAnagemenT REgiStry

acronym: SOCRATES

summary: SOCRATES is part of Boston Scientific's (BSC) Post-market surveillance system. The implementation of such systems is mandatory per local regulations such as the Regulation '(EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices' or short Medical Device Regulation (MDR). The SOCRATES design is therefore based on the BSC's commitment as well as external regulatory requirements to proactively and systematically gather, record and analyze relevant data on the quality, performance and safety of devices throughout their entire lifetime.

location_country:
Germany
Ireland
Italy
Israel
United Kingdom
Belgium
Spain
Greece
France

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Hospital Nuestra Señora de La Candelaria

location_facility: General Hospital of Athens "G. Gennimatas"

location_facility: CHRU de Brest, Hôpital de la Cavale Blanche

location_facility: Ospedale S.G. Calibita Fatebenefratelli - Isola Tiberina


acronym: CYCLONE 1

summary: The study will evaluate how safe and effective abemaciclib is when given to participants whose metastatic prostate cancer progresses after they had received several previous treatments.

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: University of Utah - Huntsman Cancer Institute

title: CYCLONE 1: A Phase 2 Study of Abemaciclib in Metastatic Castration-Resistant Prostate Cancer Patients Previously Treated With a Novel Hormonal Agent and Taxane-based Chemotherapy

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

location_country:
United States
Spain
France


title: POLARx Cardiac Cryoablation System Post Market Clinical Follow-up Study

acronym: POLAR ICE

summary: This is a Post Market Clinical Follow-up (PMCF) study designed to establish the continued safety and effectiveness profile of the Boston Scientific Cardiac Cryoablation System after receiving CE mark.

location_country:
Germany
Italy
United Kingdom
Netherlands
Belgium
Croatia
France

location_facility: CHU De Brest - Hopital de la Cavale Blanche


title: Safety and Effectiveness of SOFIA™/SOFIA™ PLUS When Used for Direct Aspiration as a First Line Treatment Technique in Patients Suffering an Acute Ischemic Stroke in the Anterior Circulation

acronym: SESAME

summary:
Sesame is a European, multi-center, single arm, prospective, observational registry.

Sesame aims to demonstrate that use of SOFIA™/SOFIA™ PLUS catheter for direct aspiration as a first line treatment technique is fast, safe and effective in patients suffering an Acute Ischemic Stroke when assessed at 24 hours, discharge and 90 days after treatment. 250 patients will be enrolled. All patients will be followed for 90 days or until death.

lead_sponsor: Dr. Markus Alfred Möhlenbruch

sponsor_collaborators:
Dr. Markus Alfred Möhlenbruch
Microvention-Terumo, Inc.
Eppdata Hamburg

location_country: Germany Italy Netherlands Austria France

location_facility: Groupe Hospitalier Universitaire Pitié Salpêtrière

location_facility: Le Centre Hospitalier Universitaire de Bordeaux

location_facility: Centre Hospitalier Régional Universitaire de Lille


title: Effectiveness of a Personalized Neurofeedback Training Device (ADHD@Home) as Compared With Methylphenidate in the Treatment of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder: A Multicentre Randomized Clinical Study

acronym: Newrofeed

summary: The main objective of the study is to demonstrate the non-inferiority of the personalized Neurofeedback Training device versus Methylphenidate in the treatment of children and adolescents with Attention-Deficit/Hyperactivity Disorder.

ReferenceCitation: Purper-Ouakil D, Blasco-Fontecilla H, Ros T, Acquaviva E, Banaschewski T, Baumeister S, Bousquet E, Bussalb A, Delhaye M, Delorme R, Drechsler R, Goujon A, Hage A, Kaiser A, Mayaud L, Mechler K, Menache C, Revol O, Tagwerker F, Walitza S, Werling AM, Bioulac S, Brandeis D. Personalized at-home neurofeedback compared to long-acting methylphenidate in children with ADHD: NEWROFEED, a European randomized noninferiority trial. J Child Psychol Psychiatry. 2022 Feb;63(2):187-198. doi: 10.1111/jcpp.13462. Epub 2021 Jun 24.

ReferenceCitation: Bioulac S, Purper-Ouakil D, Ros T, Blasco-Fontecilla H, Prats M, Mayaud L, Brandeis D. Personalized at-home neurofeedback compared with long-acting methylphenidate in an european non-inferiority randomized trial in children with ADHD. BMC Psychiatry. 2019 Aug 1;19(1):237. doi: 10.1186/s12888-019-2218-0.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: University of Zurich - Zurich Open Repository and Archive

repository_institution: ETH Zurich - Repository for Publications and Research Data

unpaywall_oa_status: gold

lead_sponsor: Mensia Technologies SA

sponsor_collaborators:
Mensia Technologies SA
European Union H2020 SME Instrument

location_country: Germany Switzerland Belgium Spain France

location_facility: CHRU de Lille - Hôpital Fontan - Service de psychiatrie de l'enfant et de l'adolescent

location_facility: Hospice Civil de Lyon - Hôpital Neurologique Service de Neuro-Psychiatrie de l'Enfant

location_facility: PSY Pluriel Centre europeen de psychologie medicale

location_facility: Medical faculty of Mannheim/Heidelberg university

location_facility: Puerta de Hierro Hospital - Department of Psychiatry

location_facility: Hôpital Erasme - Cliniques universitaires de Bruxelles

location_facility: Psychiatric Hospital, University of Zürich


title: A Randomized, Double-masked, Placebo-controlled Exploratory Study to Evaluate Pharmacodynamics, Safety and Tolerability of Orally Administered BI 1026706 for 12 Weeks in Patients With Mild Visual Impairment Due to Center-involved Diabetic Macular Edema (DME)

summary: This is a proof of mechanism trial to explore the effect of BI 1026706 on the central retinal thickness and to evaluate safety and tolerability of BI 1026706 administered orally for 12 weeks in patients with mild vision impairment due to center-involved DME

lead_sponsor: Boehringer Ingelheim

location_country:
Germany
Portugal
Hungary
United Kingdom
Belgium
Spain
Greece
France

location_facility: University General Hospital of Heraklion

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Augenarzt Dr. Dunker und Kollegen, Troisdorf

location_facility: AIBILI - Association for Innovation and Biomedical Research on Light and Image

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: BAZ County Hospital, Ophtalmology Department, Miskolc

location_facility: Attikon, Panepistimiako Geniko Nosokomeio


title: A Phase 1b-2, Open-Label, Dose Escalation and Expansion Study Evaluating the Safety and Efficacy of Entospletinib (ENTO [GS-9973]) Combined With Vincristine (VCR) in Adult Subjects With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (NHL)

summary: The primary objective of this study is to evaluate the safety of ENTO with VCR in participants with relapsed or refractory B-cell NHL.

lead_sponsor: Gilead Sciences

location_country:
United States
France

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

location_facility: Centre Hospitalier Universitaire de Dijon Hôpital du Bocage


title: INtegratioN of Trastuzumab, With or Without Pertuzumab, Into periOperatiVe chemotherApy of HER-2 posiTIve stOmach caNcer: the INNOVATION-TRIAL

acronym: INNOVATION

summary: The purpose of this study is to find out whether either trastuzumab or the combination of trastuzumab and pertuzumab with standard chemotherapy shows more activity against gastro-oesophageal adenocarcinoma than standard chemotherapy given before and after surgery and it can be safely administered.

ReferenceCitation: Wagner AD, Grabsch HI, Mauer M, Marreaud S, Caballero C, Thuss-Patience P, Mueller L, Elme A, Moehler MH, Martens U, Kang YK, Rha SY, Cats A, Tokunaga M, Lordick F. EORTC-1203-GITCG - the "INNOVATION"-trial: Effect of chemotherapy alone versus chemotherapy plus trastuzumab, versus chemotherapy plus trastuzumab plus pertuzumab, in the perioperative treatment of HER2 positive, gastric and gastroesophageal junction adenocarcinoma on pathologic response rate: a randomized phase II-intergroup trial of the EORTC-Gastrointestinal Tract Cancer Group, Korean Cancer Study Group and Dutch Upper GI-Cancer group. BMC Cancer. 2019 May 24;19(1):494. doi: 10.1186/s12885-019-5675-4.

repositories_institution:
PubMed Central - Europe PMC
Université de Lausanne - SERVAL

ReferenceCitation: Integration of Trastuzumab, with or without Pertuzumab, into Perioperative Chemotherapy of HER2- Positive Stomach Cancer: The INNOVATION Trial (EORTC-1203-GITCG). Oncol Res Treat. 2016;39(3):153-4; discussion 155. doi: 10.1159/000444702. No abstract available.

publisher_dissemination: S. Karger AG

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

location_country:
Germany
Italy
Portugal
Norway
Singapore
United Kingdom
Netherlands
Switzerland
Belgium
Korea, Republic of
Spain
Estonia
France

location_facility: Centre Hospitalier Universitaire Vaudois

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

location_facility: University Hospitals Birmingham NHS - UHB-Queen Elisabeth MC

location_facility: Academisch Medisch Centrum - UMC Universiteit van Amsterdam - site: VUMC

location_facility: Technische Universität München - Klinikum Rechts der Isar

location_facility: The Catholic University of Korea-St. Vincent's Hospital

location_facility: ICO Girona - Hospital Dr Josep Trueta (Institut Catala d'Oncologia)

location_facility: Hospital Clinico Universitario De Valencia

location_facility: Asklepios Kliniken GmbH - Asklepios Klinik Barmbek

location_facility: Universitaetsmedizin Goettingen - Georg-August Universitaet

location_facility: The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis

location_facility: Royal Marsden Hospital - site: Sutton, Surrey

location_facility: Kliniken Essen-Mitte - Evang. Huyssens-Stiftung

location_facility: Johannes Gutenberg Universitaetskliniken - Mainz University Medical Center

location_facility: Institut Catala d'Oncologia - ICO L'Hospitalet

location_facility: Oslo University Hospital - Radiumhospitalet

location_facility: Instituto Portugues De Oncologia - Centro Do Porto

location_facility: Ludwig-Maximilians-Universitaet München - Campus Grosshadern

location_facility: University College London Hospitals (UCLH) - NHS Foundation Trust

location_facility: Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum

location_facility: Royal Marsden Hospital - site: London Chelsea

location_facility: Hospital Universitari Vall d'Hebron - Institut Oncologia

location_facility: CHU de Bordeaux - Group Hospitalier Sud - Hopital Haut-Lévêque


title: A Phase I, Open-Label, Non-Randomised, Multicentre Study to Assess the Effect of AZD9291 on the Pharmacokinetics of Simvastatin (a Sensitive CYP3A4 Substrate) in Patients With EGFRm Positive NSCLC Whose Disease Has Progressed on an EGFR TKI

summary:
This is a Phase I, open-label, 2-part study in patients with a confirmed diagnosis of epidermal growth factor receptor (EGFR) mutation positive (EGFRm+) non-small cell lung cancer (NSCLC), who have progressed following prior therapy with an approved EGFR tyrosine kinase inhibitor (TKI) agent.

Part A will assess the effect of AZD9291 on the pharmacokinetic (PK) parameters of simvastatin and simvastatin acid, following multiple oral dosing of AZD9291 in a fasted state.

Part B will allow patients further access to AZD9291 after the PK phase (Part A) and will provide for additional safety data collection. All patients from Part A who completed treatment may continue to receive AZD9291 80 mg once daily until: disease progression; they are no longer deriving clinical benefit; or any other reason.

ReferenceCitation: Harvey RD, Aransay NR, Isambert N, Lee JS, Arkenau T, Vansteenkiste J, Dickinson PA, Bui K, Weilert D, So K, Thomas K, Vishwanathan K. Effect of multiple-dose osimertinib on the pharmacokinetics of simvastatin and rosuvastatin. Br J Clin Pharmacol. 2018 Dec;84(12):2877-2888. doi: 10.1111/bcp.13753. Epub 2018 Oct 10.

evidence: open (via free article)

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central
UCL Discovery

repositories_concat: LIRIAS (KU Leuven);PubMed Central;UCL Discovery

repositories_institution: University College London - UCL Discovery

unpaywall_oa_status: bronze

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

lead_sponsor: AstraZeneca

location_country:
Belgium
United States
Spain
Korea, Republic of
France


title: Phase II Study of Vx001 Vaccine in HLA-A*0201 Positive Patients With TERT Positive Stage IV or Recurrent Stage I-III NSCLC

summary:
Patients with stage IV or recurrent stage I-III NSCLC with documented disease control (objective response or stable disease) within 3 weeks after platinum based 1st line chemotherapy; only HLA-A*0201 positive patients with TERT expressing tumors will be included.

The objective of the trial is survival rate at 12 months.

ReferenceCitation: Gridelli C, Ciuleanu T, Domine M, Szczesna A, Bover I, Cobo M, Kentepozidis N, Zarogoulidis K, Kalofonos C, Kazarnowisz A, Korozan M, de Las Penas R, Majem M, Chella A, Griesinger F, Bournakis E, Sadjadian P, Kotsakis A, Chinet T, Syrigos KN, Correale P, Gallou C, Jamet JM, Vetsika EK, Kosmatopoulos K, Georgoulias V; Vx-001-201 trial team. Clinical activity of a htert (vx-001) cancer vaccine as post-chemotherapy maintenance immunotherapy in patients with stage IV non-small cell lung cancer: final results of a randomised phase 2 clinical trial. Br J Cancer. 2020 May;122(10):1461-1466. doi: 10.1038/s41416-020-0785-y. Epub 2020 Mar 25.

repository_institution: Conselleria de Salut i Consum del Govern de les Illes Balears - Docusalut

lead_sponsor: Vaxon Biotech

location_country: Germany Italy Poland Romania Spain Greece Czechia France

location_facility: Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy w Otwocku

location_facility: University General Hospital Papageorgiou

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

location_facility: Mathias Spital Rheine Medizinische Klinik V

location_facility: Oncomed SRL, Department of Medical Oncology

location_facility: Chirurgische Klinik-Inderdisziplinäre Thorakale Oncologie

location_facility: Spitalul Universitar de Urgenta Bucuresti

location_facility: Oddział Onkologii z Pododdziałem Chemioterapii Nowotworów Płuc

location_facility: Specjalistyczny Szpital im. prof.Alfreda Sokołowskiego

location_facility: Spitalul Clinic Judetean de Urgenta Sibiu

location_facility: General hospital of thoracic diseases Sotiria

location_facility: Institutului Oncologic "Prof. Dr. I. Chiricuţă" Cluj-Napoca

location_facility: Seconda Universita degli Studi Napoli Hospital

location_facility: Fundacja Hospicjum Onkologiczne św. Krzysztofa

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

location_facility: Mühlenkreiskliniken (AöR) Johannes Wesling Klinikum Minden

location_facility: General Oncology Hospital of Kifissia Agioi Anargyroi


title: A European Multi-Center, Multi-Country, Post-Authorisation, Observational Study (Registry) Of Patients With Hereditary Angioedema (HAE) Who Are Administered CINRYZE® (C1 Inhibitor [Human]) For The Treatment Or Prevention Of HAE Attacks

summary: This observational (non-interventional) study is being conducted to characterize the safety and use of CINRYZE in routine clinical practice when administered for (1) routine prevention of angioedema attacks, (2) pre-procedure prevention of angioedema attacks, and/or (3) treatment of angioedema attacks.

lead_sponsor: Shire

location_country:
Germany
Italy
United Kingdom
Belgium
Spain
France

location_facility: Klinikum rechts der Isar der technischen Universität München


acronym: CREATE

summary: The study will primarily assess the antitumor activity of crizotinib in a variety of tumors with alterations in ALK and/or MET pathways. The targeted patient population will include patients with tumors harboring specific alterations leading to ALK and/or MET activation, where tyrosine kinase inhibitors against these targets have not yet been adequately explored.

ReferenceCitation: Schoffski P, Kubickova M, Wozniak A, Blay JY, Strauss SJ, Stacchiotti S, Switaj T, Bucklein V, Leahy MG, Italiano A, Isambert N, Debiec-Rychter M, Sciot R, Lee CJ, Speetjens FM, Nzokirantevye A, Neven A, Kasper B. Long-term efficacy update of crizotinib in patients with advanced, inoperable inflammatory myofibroblastic tumour from EORTC trial 90101 CREATE. Eur J Cancer. 2021 Oct;156:12-23. doi: 10.1016/j.ejca.2021.07.016. Epub 2021 Aug 13.

ReferenceCitation: Schoffski P, Sufliarsky J, Gelderblom H, Blay JY, Strauss SJ, Stacchiotti S, Rutkowski P, Lindner LH, Leahy MG, Italiano A, Isambert N, Debiec-Rychter M, Sciot R, Van Cann T, Marreaud S, Nzokirantevye A, Collette S, Wozniak A. Crizotinib in patients with advanced, inoperable inflammatory myofibroblastic tumours with and without anaplastic lymphoma kinase gene alterations (European Organisation for Research and Treatment of Cancer 90101 CREATE): a multicentre, single-drug, prospective, non-randomised phase 2 trial. Lancet Respir Med. 2018 Jun;6(6):431-441. doi: 10.1016/S2213-2600(18)30116-4. Epub 2018 Apr 15.

ReferenceCitation: Schoffski P, Wozniak A, Leahy MG, Aamdal S, Rutkowski P, Bauer S, Richter S, Grunwald V, Debiec-Rychter M, Sciot R, Geoerger B, Marreaud S, Collette S, Nzokirantevye A, Strauss SJ. The tyrosine kinase inhibitor crizotinib does not have clinically meaningful activity in heavily pre-treated patients with advanced alveolar rhabdomyosarcoma with FOXO rearrangement: European Organisation for Research and Treatment of Cancer phase 2 trial 90101 'CREATE'. Eur J Cancer. 2018 May;94:156-167. doi: 10.1016/j.ejca.2018.02.011. Epub 2018 Mar 20.

ReferenceCitation: Schoffski P, Wozniak A, Kasper B, Aamdal S, Leahy MG, Rutkowski P, Bauer S, Gelderblom H, Italiano A, Lindner LH, Hennig I, Strauss S, Zakotnik B, Anthoney A, Albiges L, Blay JY, Reichardt P, Sufliarsky J, van der Graaf WTA, Debiec-Rychter M, Sciot R, Van Cann T, Marreaud S, Raveloarivahy T, Collette S, Stacchiotti S. Activity and safety of crizotinib in patients with alveolar soft part sarcoma with rearrangement of TFE3: European Organization for Research and Treatment of Cancer (EORTC) phase II trial 90101 'CREATE'. Ann Oncol. 2018 Mar 1;29(3):758-765. doi: 10.1093/annonc/mdx774.

ReferenceCitation: Schoffski P, Wozniak A, Stacchiotti S, Rutkowski P, Blay JY, Lindner LH, Strauss SJ, Anthoney A, Duffaud F, Richter S, Grunwald V, Leahy MG, Reichardt P, Sufliarsky J, van der Graaf WT, Sciot R, Debiec-Rychter M, van Cann T, Marreaud S, Lia M, Raveloarivahy T, Collette L, Bauer S. Activity and safety of crizotinib in patients with advanced clear-cell sarcoma with MET alterations: European Organization for Research and Treatment of Cancer phase II trial 90101 'CREATE'. Ann Oncol. 2017 Dec 1;28(12):3000-3008. doi: 10.1093/annonc/mdx527. Erratum In: Ann Oncol. 2019 Feb 1;30(2):344.

location_facility: Assistance Publique - Hôpitaux de Marseille - Hôpital de La Timone

location_facility: Nottingham University Hospitals NHS Trust - City Hospital

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Hôpitaux Universitaires Bordet-Erasme - Institut Jules Bordet

location_facility: Maria Sklodowska-Curie Memorial Cancer Centre

location_facility: Oslo University Hospital - Radiumhospitalet

location_facility: Klinikum Grosshadern Ludwig-Maximilians Univ. Muenchen

location_facility: Radboud University Nijmegen Medical Centre

title: Cross-tumoral Phase 2 Clinical Trial Exploring Crizotinib (PF-02341066) in Patients With Advanced Tumors Induced by Causal Alterations of ALK and/or MET ("CREATE")

location_country:
Germany
Italy
Poland
Slovenia
Slovakia
Norway
United Kingdom
Netherlands
Belgium
France


title: Open-Label, Multicenter, Dose Escalation Phase Ia/Ib Study With Expansion Phase to Evaluate Safety, Pharmacokinetics and Activity of RO5509554, Administered as an Intravenous Infusion as Monotherapy and in Combination With Paclitaxel in Patients With Advanced Solid Tumors

summary: This open-label, multicenter, dose-escalation study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of RO5509554 in participants with advanced solid tumors which are not amenable to standard treatment. In Part I (Dose Escalation), multiple ascending doses of RO5509554 will be administered as monotherapy in participants with solid tumors. Participants with locally advanced and/or metastatic ovarian (including fallopian tube) and breast carcinoma will receive multiple ascending doses of RO5509554 in combination with paclitaxel. In Part II (Expansion Cohort), RO5509554 will be administered as monotherapy to participants with locally advanced and/or metastatic Pigmented Villonodular Synovitis (PVNS)/Tenosynovial Giant Cell Tumor (TGCT), soft tissue sarcoma or malignant mesothelioma, ovarian (including fallopian tube), endometrial or breast cancer and pancreatic cancer. Participants with Human Epidermal Growth Factor Receptor 2 (HER2)/neu negative breast cancer will receive RO5509554 in combination with paclitaxel. Anticipated time on study treatment is until disease progression, unacceptable toxicity, death or participant refusal, whichever occurs first.

ReferenceCitation: Cassier PA, Italiano A, Gomez-Roca C, Le Tourneau C, Toulmonde M, D'Angelo SP, Weber K, Loirat D, Jacob W, Jegg AM, Michielin F, Christen R, Watson C, Cannarile M, Klaman I, Abiraj K, Ries CH, Weisser M, Ruttinger D, Blay JY, Delord JP. Long-term clinical activity, safety and patient-reported quality of life for emactuzumab-treated patients with diffuse-type tenosynovial giant-cell tumour. Eur J Cancer. 2020 Dec;141:162-170. doi: 10.1016/j.ejca.2020.09.038. Epub 2020 Nov 5.

ReferenceCitation: Gomez-Roca CA, Italiano A, Le Tourneau C, Cassier PA, Toulmonde M, D'Angelo SP, Campone M, Weber KL, Loirat D, Cannarile MA, Jegg AM, Ries C, Christen R, Meneses-Lorente G, Jacob W, Klaman I, Ooi CH, Watson C, Wonde K, Reis B, Michielin F, Ruttinger D, Delord JP, Blay JY. Phase I study of emactuzumab single agent or in combination with paclitaxel in patients with advanced/metastatic solid tumors reveals depletion of immunosuppressive M2-like macrophages. Ann Oncol. 2019 Aug 1;30(8):1381-1392. doi: 10.1093/annonc/mdz163.

ReferenceCitation: Cassier PA, Italiano A, Gomez-Roca CA, Le Tourneau C, Toulmonde M, Cannarile MA, Ries C, Brillouet A, Muller C, Jegg AM, Broske AM, Dembowski M, Bray-French K, Freilinger C, Meneses-Lorente G, Baehner M, Harding R, Ratnayake J, Abiraj K, Gass N, Noh K, Christen RD, Ukarma L, Bompas E, Delord JP, Blay JY, Ruttinger D. CSF1R inhibition with emactuzumab in locally advanced diffuse-type tenosynovial giant cell tumours of the soft tissue: a dose-escalation and dose-expansion phase 1 study. Lancet Oncol. 2015 Aug;16(8):949-56. doi: 10.1016/S1470-2045(15)00132-1. Epub 2015 Jul 12.

ReferenceCitation: Ries CH, Cannarile MA, Hoves S, Benz J, Wartha K, Runza V, Rey-Giraud F, Pradel LP, Feuerhake F, Klaman I, Jones T, Jucknischke U, Scheiblich S, Kaluza K, Gorr IH, Walz A, Abiraj K, Cassier PA, Sica A, Gomez-Roca C, de Visser KE, Italiano A, Le Tourneau C, Delord JP, Levitsky H, Blay JY, Ruttinger D. Targeting tumor-associated macrophages with anti-CSF-1R antibody reveals a strategy for cancer therapy. Cancer Cell. 2014 Jun 16;25(6):846-59. doi: 10.1016/j.ccr.2014.05.016. Epub 2014 Jun 2.

lead_sponsor: Hoffmann-La Roche

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Centre Leon Berard; Departement Oncologie Medicale


title: Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of ATX-101 (Sodium Deoxycholate Injection) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area

summary: To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).

lead_sponsor: Kythera Biopharmaceuticals

sponsor_collaborators:
Kythera Biopharmaceuticals
Bayer


title: A Randomised, Double Blind Study to Evaluate the Safety and Efficacy of the p38 Kinase Inhibitor, GW856553, in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy

summary: This study will be a double-blind, placebo-controlled, parallel group study. After enrolment and initial assessments, subjects will receive 35 days of study medication. During this treatment period, they will be randomised to either oral GW856553 7.5mg BID or matching placebo in a 1:1 ratio. Sufficient numbers of subjects will be recruited to obtain 128 evaluable subjects.

lead_sponsor: GlaxoSmithKline

location_country: Germany France Norway Denmark Sweden


title: A Single Arm, Multicenter Phase II Trial of RAD001 as Monotherapy in the Treatment of Advanced Papillary Renal Cell Cancer

summary: To evaluate the preliminary efficacy and safety of RAD001 as monotherapy for first-line treatment of patients with metastatic papillary carcinoma of the kidney.

ReferenceCitation: Escudier B, Molinie V, Bracarda S, Maroto P, Szczylik C, Nathan P, Negrier S, Weiss C, Porta C, Grunwald V, Albiges L. Open-label phase 2 trial of first-line everolimus monotherapy in patients with papillary metastatic renal cell carcinoma: RAPTOR final analysis. Eur J Cancer. 2016 Dec;69:226-235. doi: 10.1016/j.ejca.2016.08.004. Epub 2016 Sep 24.

lead_sponsor: Novartis Pharmaceuticals

location_country: Germany Italy Poland Belgium Spain France


acronym: CERTAIN

lead_sponsor: UCB Pharma

summary: To assess the clinical efficacy and safety of certolizumab pegol as add-on therapy with stable-dose disease-modifying antirheumatic drugs (DMARDs) for achieving clinical remission in patients with moderate to low disease activity rheumatoid arthritis

ReferenceCitation: Smolen JS, Emery P, Ferraccioli GF, Samborski W, Berenbaum F, Davies OR, Koetse W, Purcaru O, Bennett B, Burkhardt H. Certolizumab pegol in rheumatoid arthritis patients with low to moderate activity: the CERTAIN double-blind, randomised, placebo-controlled trial. Ann Rheum Dis. 2015 May;74(5):843-50. doi: 10.1136/annrheumdis-2013-204632. Epub 2014 Jan 15.

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: Goethe University Frankfurt - Publication Server of Goethe University Frankfurt am Main

title: A Phase IIIB, Multi-center, Double-blind, Placebo-controlled, Parallel Group, 52-week Study to Evaluate the Safety and Efficacy of Certolizumab Pegol, Administered With DMARDs, in Patients With Low to Moderate Disease Activity Rheumatoid Arthritis

location_country: Germany Italy Poland Austria France


title: A Phase I/II Study of a Chimeric Antibody Against Interleukin-6 (CNTO 328) in Subjects With Metastatic Renal Cell Carcinoma

summary: The purpose of this study is to better understand the safety, tolerability and distribution of CNTO 328 in the bloodstream.

lead_sponsor: Centocor, Inc.

location_country:
France
United Kingdom
Netherlands
Czech Republic


title: Retrospective Case-control Study of Risk Factors for Anti-erythropoietin Antibody Positive Pure Red Cell Aplasia Among Patients With Chronic Kidney Disease Receiving Epoetin Alfa

summary: The purpose of this study is to collect historical occurrences of risk factors that are potentially associated with the development of anti-erythropoietin (EPO) antibody positive pure red cell aplasia (PRCA) in participants with chronic kidney disease who have been recently treated with epoetin alfa (EPREX).

time_perspective: Retrospective

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

location_country:
France
Norway
United Kingdom
Brazil
Thailand
South Africa
Sweden


title: Open-label, Uncontrolled, Long-term Surveillance Study of Iloprost Aerosol Inhalation Therapy in the Treatment of Patients With Primary or Secondary Pulmonary Hypertension. Follow-up Program for Patients Who Completed 12 Weeks in Study ME97218/300180.

summary: The aim of this study is to monitor long-term safety and tolerability of iloprost aerosol inhalation therapy in patients suffering from pulmonary hypertension.

lead_sponsor: Bayer

location_country: Italy Poland Portugal Netherlands Belgium Spain France


title: A Phase 3, Randomized, Double-blind, Study to Assess Efficacy and Safety of Ianalumab (VAY736) Versus Placebo in Warm Autoimmune Hemolytic Anemia (wAIHA) Patients Who Failed at Least One Line of Treatment

acronym: VAYHIA

summary: The purpose of this study is to evaluate efficacy and safety of ianalumab compared to placebo in patients with warm autoimmune hemolytic anemia, who failed at least one line of treatment.

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 available according to the process described on www.clinicalstudydatarequest.com.

location_country:
Germany
Italy
Hungary
Singapore
Romania
Australia
Japan
United Kingdom
China
Spain
Thailand
Malaysia
France


title: Retrospective, Observational Chart Review Study Evaluating Clinical Effectiveness and Disease/Treatment Management Among Patients Who Initiated Long-term Prophylaxis With Takhzyro® in a Real-world Setting

acronym: INTEGRATED

summary:
The main aims of this study are to learn how many people with HAE Type I or Type II are attack-free when treated with lanadelumab in real life. This includes the number of people that are attack-free when lanadelumab is given every 2 and every 4 weeks.

This study is about collecting existing data only; participants will not receive lanadelumab as part of this study. No new information will be collected during this study. Only data already available at the participant's doctor's office will be reviewed and collected for this study.

Participants do not need to visit their doctor in addition to their normal visits.

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

lead_sponsor: Takeda

location_country: Germany Greece Austria France

location_facility: Klinikum rechts der Isa der Technischen Universitaet Muenchen

location_facility: Medizinische Universitat Wien (Medical University of Vienna)

location_facility: Centre Hospitalier Universitaire Hopitaux de Rouen


title: A Phase Ib Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Venetoclax in Combination With Polatuzumab Vedotin Plus Rituximab (R) and Cyclophosphamide, Doxorubicin, Prednisone (CHP) in Patients With Untreated BCL-2 Immunohistochemistry (IHC)-Positive Diffuse Large B-Cell Lymphoma

summary: This Phase Ib, open-label, multicenter study evaluates the safety, efficacy, and pharmacokinetics of venetoclax in combination with Pola + R-CHP in previously untreated participants with BCL-2 IHC-positive DLBCL. Approximately 50 participants will be enrolled in this study in five consecutive cohorts each consisting of approximately 10 participants.

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

location_country:
United States
Italy
Spain
France

location_facility: NYU Langone Hospitals, NYU Langone Rusk Ambulatory Surgical Pharmacy

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

location_facility: Hospital Universitario La Fe; Servicio de Farmacia

location_facility: Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez

location_facility: Azienda Ospedaliero-Universitaria Policlinico S. Orsola Malpighi; Dip. Scienze Mediche e Chirurgiche

location_facility: SARAH CANNON RESEARCH INST.; Tennessee Oncology, PLLC

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

location_facility: Azienda Ospedaliero Universitaria Pisana-Ospedale Santa Chia

location_facility: Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica

location_facility: Centre Hospitalier Lyon Sud; Service d'Oncologie Médicale


type: Registry Identifier

title: Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn's Disease and Complex Perianal Fistula

acronym: EMPIRE

summary: The main aim is to check the long term side effects of a repeat treatment of darvadstrocel and to see if that treatment improves symptoms of Crohn's disease and complex perianal fistula. Participants will attend 8 clinic visits and will receive 1 treatment of darvadstrocel at the third visit. A magnetic resonance imaging (MRI) will be performed several times during the study.

collaborators: Takeda Development Center Americas, Inc.

location_country: Germany France Austria Spain Czechia Israel

location_facility: CHU AMIENS PICARDIE Site SUD Hepato-Gastroenterology

location_facility: Hadassah Medical Organization, Hadassah Medical Center, Ein-Karem

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Hospital Universitario Nuestra Senora de la Candelaria

location_facility: Rabin Medical Center, Beilinson Hospital

location_facility: Klinikum Dresden, University Hospital Dresden

location_facility: CHRU de Lille - Hopital Claude Huriez - Gastroenterologie

location_facility: Groupe Hospitalier Diaconesses Croix Saint Simon

location_facility: CHU de Nice - Hopital de l'Archet II - Gastro-Enterologie, Hepatologi

location_facility: Centre Hospitalier Lyon Sud - Gastroenterology

location_facility: CHRU Hopital de Pontchaillou - Maladies De L'Appareil Digesti


title: Comparison of Quantitative Flow Ratio (QFR) and Conventional Pressure-wire Based Functional Evaluation for Guiding Coronary Intervention. A Randomized Clinical Non-inferiority Trial

acronym: FAVOR III EJ

summary: Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of coronary stenosis. QFR is estimated based on two angiographic projections. Studies have shown a good correlation with the present wire-based standard approach Fractional Flow Reserve (FFR) for assessment of intermediate coronary stenosis. The purpose of the FAVOR III Europe Japan study is to investigate if a QFR-based diagnostic strategy will results in non-inferior clinical outcome after 12 months compared to a standard pressure-wire guided strategy in evaluation of patients with chest pain (stable angina pectoris) and intermediate coronary stenosis.

ReferenceCitation: Tu S, Westra J, Yang J, von Birgelen C, Ferrara A, Pellicano M, Nef H, Tebaldi M, Murasato Y, Lansky A, Barbato E, van der Heijden LC, Reiber JHC, Holm NR, Wijns W; FAVOR Pilot Trial Study Group. Diagnostic Accuracy of Fast Computational Approaches to Derive Fractional Flow Reserve From Diagnostic Coronary Angiography: The International Multicenter FAVOR Pilot Study. JACC Cardiovasc Interv. 2016 Oct 10;9(19):2024-2035. doi: 10.1016/j.jcin.2016.07.013.

ReferenceCitation: Westra J, Andersen BK, Campo G, Matsuo H, Koltowski L, Eftekhari A, Liu T, Di Serafino L, Di Girolamo D, Escaned J, Nef H, Naber C, Barbierato M, Tu S, Neghabat O, Madsen M, Tebaldi M, Tanigaki T, Kochman J, Somi S, Esposito G, Mercone G, Mejia-Renteria H, Ronco F, Botker HE, Wijns W, Christiansen EH, Holm NR. Diagnostic Performance of In-Procedure Angiography-Derived Quantitative Flow Reserve Compared to Pressure-Derived Fractional Flow Reserve: The FAVOR II Europe-Japan Study. J Am Heart Assoc. 2018 Jul 6;7(14):e009603. doi: 10.1161/JAHA.118.009603.

repository_institution: University of Ferrara - Institutional Research Information System University of Ferrara

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

repository_normalized: dnet

evidence: oa repository (semantic scholar lookup)

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Westra J, Tu S, Winther S, Nissen L, Vestergaard MB, Andersen BK, Holck EN, Fox Maule C, Johansen JK, Andreasen LN, Simonsen JK, Zhang Y, Kristensen SD, Maeng M, Kaltoft A, Terkelsen CJ, Krusell LR, Jakobsen L, Reiber JHC, Lassen JF, Bottcher M, Botker HE, Christiansen EH, Holm NR. Evaluation of Coronary Artery Stenosis by Quantitative Flow Ratio During Invasive Coronary Angiography: The WIFI II Study (Wire-Free Functional Imaging II). Circ Cardiovasc Imaging. 2018 Mar;11(3):e007107. doi: 10.1161/CIRCIMAGING.117.007107.

ReferenceCitation: Xu B, Tu S, Qiao S, Qu X, Chen Y, Yang J, Guo L, Sun Z, Li Z, Tian F, Fang W, Chen J, Li W, Guan C, Holm NR, Wijns W, Hu S. Diagnostic Accuracy of Angiography-Based Quantitative Flow Ratio Measurements for Online Assessment of Coronary Stenosis. J Am Coll Cardiol. 2017 Dec 26;70(25):3077-3087. doi: 10.1016/j.jacc.2017.10.035. Epub 2017 Oct 31.

lead_sponsor: Aarhus University Hospital Skejby

sponsor_collaborators:
Aarhus University Hospital Skejby
Medis Medical Imaging Systems

location_country: Germany Italy Lithuania Poland Denmark Sweden Netherlands Switzerland Latvia Spain France

location_facility: Azienda Ospedaliero Universitaria Federico II di Napoli

location_facility: Azienda Ospedaliera Universitaria integrata Verona

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: San Luigi Gonzaga University Hospital, Turin

location_facility: Arcispedale S. Maria Nuova di Reggio Emilia

location_facility: Institut Cardiovasculaire Paris Sud (ICPS), Hopital Jacques Cartier

location_facility: Hospital Clinico Universitario Virgen de la Arrixaca

location_facility: Azienda Ospedaliero-Universitaria di Ferrara, University of Ferrara

location_facility: Hospital of Lithuanian University of Health Sciences Kauno Klinikos

intervention_type: Diagnostic Test


title: A Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis (HOPE-1 Study: Hydration for Optimal Pulmonary Effectiveness)

summary: 28-Day double-blinded efficacy and safety trial of SPX-101 Inhalation Solution in adult subjects with cystic fibrosis.

lead_sponsor: Spyryx Biosciences, Inc.

location_country:
Italy
Portugal
United Kingdom
Canada
France

location_facility: University Hospitals Bristol NHS Foundation Trust

location_facility: Barts Health NHS Trust Saint Bartholomews Hospital

location_facility: Royal Devon and Exeter NHS Foundation Trust

location_facility: University Hospital of South Manchester NHS Foundation Trust

location_facility: Liverpool Heart and Chest Hospital NHS Foundation Trust

location_facility: University of Calgary Heritage Medical Research Center

location_facility: Ottawa Hospital Research Institute/Institut de Recherche de l'Hospital d'Ottawa

location_facility: Istituto Giannina Gaslini Ospedale Pediatrico

location_facility: Assistance Publique-Hôpitaux de Paris Hôpital Cochin

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Royal Brompton and Harefield NHS Foundation Trust


lead_sponsor: Janssen Vaccines & Prevention B.V.

summary: The purpose of the study is to assess the long-term safety profile of Ad26.ZEBOV and MVA-BN-Filo in participants previously exposed to these vaccines in Phase 1, 2, or 3 clinical studies.

sponsor_collaborators:
Janssen Vaccines & Prevention B.V.
Bavarian Nordic GmbH

title: A Multi-country, Prospective, Clinical Safety Study of Subjects Exposed to the Candidate Ebola Vaccines Ad26.ZEBOV and/or MVA-BN-Filo

location_country:
Uganda
United Kingdom
Burkina Faso
Tanzania
United States
Kenya
France


title: A Phase 3b Open-Label Pilot Study to Evaluate Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) in Virologically-Suppressed HIV-1 Infected Adult Subjects Harboring the Archived Isolated NRTI Resistance Mutation M184V/M184I

summary:
The primary objective of the study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) after switching from a stable regimen consisting of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC) plus a third antiretroviral (ARV) agent in participants harboring the archived nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) resistance mutation M184V and/or M184I in human immunodeficiency virus (HIV) -1 reverse transcriptase.

This is a two part study. If the rate of virologic failure in Part 1 is deemed acceptable, once the internal data monitoring committee officially completes the interim review, the study will continue to Part 2.

ReferenceCitation: Perez-Valero I, Llibre JM, Lazzarin A, di Perri G, Pulido F, Molina JM, Esser S, Margot N, Shao Y, Piontkowsky D, Das M, McNicholl IR, Haubrich R. A Phase 3b Open-Label Pilot Study to Evaluate Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) in Virologically-Suppressed HIV-1 Infected Adults Harboring the NRTI Resistance Mutation M184V/I (GS-US-292-1824): Week 24 Results [Poster PE13/20]. 17th European AIDS Conference (EACS), 6-9 November 2019, Basel, Switzerland.

ReferenceCitation: Perez-Valero I, Llibre JM, Lazzarin A, di Perri G, Pulido F, Molina JM, Esser S, McNicholl IR, Lorgeoux RP, Margot N, Shao Y, Piontkowsky D, Das M, Haubrich R. A Phase 3b Open-Label Pilot Study to Evaluate Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single-Tablet Regimen in Virologically-Suppressed HIV-1 Infected Adults Harboring the NRTI Resistance Mutation M184V and/or M184I (GS-US-292-1824): Week 24 Results [Oral abstract]. 22nd International AIDS Conference, 23-27 July 2018, Amsterdam, The Netherlands.

ReferenceCitation: Perez-Valero I, Llibre JM, Lazzarin A, di Perri G, Pulido F, Molina JM, Esser S, McNicholl IR, Lorgeoux RP, Margot N, Shao Y, Piontkowsky D, Das M, Haubrich R. A Phase 3b Open-Label Pilot Study to Evaluate Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen in Virologically-Suppressed HIV-1 Infected Adults Harboring the NRTI Resistance Mutation M184V and/or M184I (GS-US-292-1824): Week 12 Results [Poster]. XXVI International Workshop on HIV Drug Resistance and Treatment Strategies, 6-8 November 2017, Johannesburg, South Africa.

ReferenceCitation: Perez-Valero I, Llibre JM, Castagna A, Pulido F, Molina JM, Esser S, Margot N, Shao Y, Temme L, Piontkowsky D, McNicholl IR, Haubrich R. Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in Adults With HIV and M184V/I Mutation. J Acquir Immune Defic Syndr. 2021 Apr 1;86(4):490-495. doi: 10.1097/QAI.0000000000002595.

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.

lead_sponsor: Gilead Sciences

location_country:
Germany
Italy
United States
Spain
France

location_facility: CHU Tours Service de Médecine Internes et Maladies Infectieuses

location_facility: Hospital Universitario 12 de Octubre - Hospital

location_facility: Comprensorio Amedeo Di Savoia Birago Di Vische

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Fondazione IRCCS San Raffaele del Monte Tabor

location_facility: ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco

location_facility: Midway Immunology & Research Center, LLC