title: An Open Label, Long-term, Safety, and Tolerability Extension Study Using the Pediatric Formulation of Bosentan in the Treatment of Children With Idiopathic or Familial Pulmonary Arterial Hypertension Who Completed FUTURE 1

acronym: FUTURE 2

summary: The main objective of the FUTURE 2 study was to assess the long-term safety and tolerability of the pediatric formulation of bosentan in children with idiopathic pulmonary arterial hypertension or familial pulmonary arterial hypertension who completed FUTURE 1 study.

ReferenceCitation: Berger RM, Haworth SG, Bonnet D, Dulac Y, Fraisse A, Galie N, Ivy DD, Jais X, Miera O, Rosenzweig EB, Efficace M, Kusic-Pajic A, Beghetti M. FUTURE-2: Results from an open-label, long-term safety and tolerability extension study using the pediatric FormUlation of bosenTan in pUlmonary arterial hypeRtEnsion. Int J Cardiol. 2016 Jan 1;202:52-8. doi: 10.1016/j.ijcard.2015.08.080. Epub 2015 Aug 9. Erratum In: Int J Cardiol. 2016 Nov 15;223:1072-1073.


title: Efficacy And Safety Study Of Brostallicin In Patients With Locally Advanced Or Metastatic Soft Tissue Sarcoma Failing One Prior Chemotherapy Treatment

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of brostallicin in treating patients who have locally advanced or metastatic soft tissue sarcoma that has not responded to one previous chemotherapy regimen.

status: Completed

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Leahy M, Ray-Coquard I, Verweij J, Le Cesne A, Duffaud F, Hogendoorn PC, Fowst C, de Balincourt C, di Paola ED, van Glabbeke M, Judson I, Blay JY; European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. Brostallicin, an agent with potential activity in metastatic soft tissue sarcoma: a phase II study from the European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. Eur J Cancer. 2007 Jan;43(2):308-15. doi: 10.1016/j.ejca.2006.09.014. Epub 2006 Nov 13.

ReferenceCitation: Leahy MG, Blay JY, Verweij J, et al.: EORTC 62011: phase II trial of brostallicin for soft tissue sarcoma. [Abstract] Eur J Cancer Suppl 1 (5): S209, A-694, 2003.

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

location_country:
Germany
United Kingdom
Netherlands
Belgium
France

location_facility: Klinikum Grosshadern der Ludwig-Maximilians Universitaet Muenchen

location_facility: Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

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

location_facility: Northern Centre for Cancer Treatment at Newcastle General Hospital

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Phase II Pilot Study Of Moderate Dose Radiotherapy For Inoperable Aggressive Fibromatoses

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.

PURPOSE: Phase II trial to study the effectiveness of radiation therapy in treating patients who have aggressive fibromatoses.

study_completion_date_type: Actual

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

location_country:
Germany
Poland
United Kingdom
Netherlands
Switzerland
Belgium
France

location_facility: Centre Hospitalier Universitaire Vaudois

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

location_facility: Mount Vernon Cancer Centre at Mount Vernon Hospital

location_facility: Cancer Research Centre at Weston Park Hospital

location_facility: Daniel Den Hoed Cancer Center at Erasmus Medical Center

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

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

intervention_type: Radiation


title: Open Label Phase II Study Of E7070 In Patients With Metastatic Melanoma (Stage IV)

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of E7070 in treating patients who have stage IV melanoma.

ReferenceCitation: Smyth JF, Aamdal S, Awada A, Dittrich C, Caponigro F, Schoffski P, Gore M, Lesimple T, Djurasinovic N, Baron B, Ravic M, Fumoleau P, Punt CJ; EORTC New Drug Development and Melanoma Groups. Phase II study of E7070 in patients with metastatic melanoma. Ann Oncol. 2005 Jan;16(1):158-61. doi: 10.1093/annonc/mdi016.

location_country:
Germany
Italy
Portugal
Norway
United Kingdom
Switzerland
Austria
Belgium
France

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

location_facility: Instituto Portugues de Oncologia de Francisco Gentil


title: Phase II Study of Oxaliplatin Single Agent in Patients With Metastatic Breast Cancer After Failure of Anthracycline/Taxane Based Chemotherapy

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating women who have advanced or metastatic breast cancer that has not responded to previous chemotherapy.

status: Terminated

location_country:
Germany
France
Slovenia
United Kingdom
Austria
Belgium
Israel

location_facility: Schneider Children's Medical Center of Israel

status_simplified: Unknown


type: EudraCT Number

title: A Controlled, Open-label PA Efficacy and Safety Study in Imlifidase Desensitised Kidney Tx Patients With Positive XM Against a Deceased Donor Prior to Imlifidase Treatment, Including Non-comparative Registry and Concurrent Reference Cohorts

acronym: PAES

summary: An open-label post authorization efficacy and safety study evaluating graft failure-free survival at 1-year in highly sensitized end-stage renal disease (ESRD) patients with positive crossmatch (XM) against a deceased donor prior to desensitized with imlifidase and subsequent kidney transplantation. Two non-comparative reference cohorts are included to assess the impact of differences in post-transplantation management and outcome in less sensitized patients.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Hansa Biopharma AB

location_country:
Italy
United Kingdom
Sweden
Netherlands
Austria
Belgium
Spain
Czechia
France

location_facility: Institut klinicke a experimentalni mediciny (IKEM)

location_facility: Hospital Clínic de Barcelona, Unidad de Trasplante Renal

location_facility: Vall d'Hebron University Hospital (HUVH)

location_facility: Hospital Del Mar, Servicio de Nefrología

location_facility: Centre Hospitalier Universitaire (CHU) de Rouen - Hôpital de Bois-Guillaume

status_simplified: Ongoing


title: Phase 2, Open-Label, Long-Term, Extension (OLE) Study of Infigratinib, an FGFR 1-3-Selective Tyrosine Kinase Inhibitor, in Children With Achondroplasia: PROPEL OLE

summary: This is a Phase 2, multicenter, open-label, extension (OLE) study to evaluate the long-term safety, tolerability, and efficacy of infigratinib, an FGFR 1-3-selective tyrosine kinase inhibitor, in subjects with ACH who previously completed a QED-sponsored interventional study, and potentially in additional subjects who are naïve to infigratinib treatment. Quality of Life assessments for this subject population will also be evaluated. Treatment-naïve subjects must have at least a 6-month period of growth assessment in the PROPEL study (Protocol QBGJ398 001) and will be enrolled in this OLE study only after a dose to be explored further is identified in Phase 2 Study QBGJ398-201.

lead_sponsor: QED Therapeutics, Inc.

location_country:
United Kingdom
Australia
United States
Spain
France

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Nemours Alfred I. Dupont Hospital for Children

location_facility: Manchester University Children's Hospital


lead_sponsor: EMD Serono Research & Development Institute, Inc.

summary: This study consists of 2 parts: Dose Escalation Part 1 and Dose Expansion Part 2. The Dose Escalation Part 1 will evaluate the safety and tolerability of Avelumab in combination with Lenvatinib and determine the recommended Avelumab and Lenvatinib dose for expansion. Dose Expansion Part 2 will assess the efficacy of Avelumab in combination with Lenvatinib by Progression-free Survival in participants with pre-defined primary central nervous system (CNS) tumors.

location_facility: Severance Hospital, Yonsei University Health System

location_facility: CHU Angers - Hôpital Hôtel Dieu - Service de Cancérologie Pédiatrique

location_facility: Institut Curie - Centre de Lutte Contre le Cancer (CLCC) de Paris

title: Single-arm, Multicenter Phase I/Ib Study of Avelumab + Lenvatinib in Children With Primary CNS Tumors

source: euctr

ipd_sharing_description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

location_country:
Germany
United States
Korea, Republic of
Canada
France


lead_sponsor: Galderma R&D

summary: The main objective of this study is to assess the long-term durability of response over a 24-week period following withdrawal of nemolizumab in participants with prurigo nodularis (PN) who previously responded to treatment in the Long-term-Extension (LTE) study RD.06.SPR.202699 (NCT05052983). The secondary objective of this study is to assess the safety of nemolizumab compared to placebo over a 24-week period in participants with PN who previously responded to treatment in the LTE study.

location_facility:
Galderma Investigational Site 5604
Galderma Investigational Site 5495
Galderma Investigational Site 5140
Galderma Investigational Site 6082
Galderma Investigational Site 5069
Galderma Investigational Site 6098
Galderma Investigational Site 6168
Galderma Investigational Site 6158
Galderma Investigational Site 5471
Galderma Investigational Site 6052
Galderma Investigational Site 5104
Galderma Investigational Site 6237
Galderma Investigational Site 6210
Galderma Investigational Site 8521

title: A Double-Blind, Placebo-Controlled, Randomized Study to Assess the Durability of Effect and Safety of Nemolizumab for 24 Weeks in Subjects With Prurigo Nodularis

design_allocation: Randomized

location_country:
Germany
Poland
Switzerland
Austria
United States
Korea, Republic of
France


title: Multi-centre Retrospective Study to Describe the Use and Outcomes of ECP in Combination With New Treatment Protocols in Acute and Chronic GvHD

summary:
Extracorporeal photopheresis (ECP) offers an alternative to standard immunosuppression and shows an immunomodulatory rather than an immunosuppressive effect, which is associated with less toxicities and side effects. Additionally ECP has been shown to allow tapering of steroids and immunosuppressant agents which should be a goal of GvHD therapy.

ECP has been used for the management of GvHD since first described in 1994 and as its use has continued over the decades. The treatment was incorporated into a number of guidelines as a second line therapy in steroid refractory or steroid dependent GvHD patients. As well as being used in addition and after steroids, it is also used in combination with CNI Inhibitors, MMF and other immunosuppressant agents.

However, despite the current widespread use of ECP in the treatment of patients with GvHD, clinical data from randomized studies is limited and small prospective and retrospective trials are the main evidence base .This is also the case for other commonly used immunosuppressant agents, which have been used in GvHD since ECP was introduced.

The systematic review concluded that ECP is an effective therapy for oral, skin, and liver SR-cGVHD, with modest activity in lung and gastrointestinal SR-cGVHD.

In the USA Ibrutinib is the only FDA approved agent for second line cGvHD therapy once steroid therapy has failed and Ruxolitinib had been approved in the USA for the treatment of steroid refractory GvHD.

While studies have shown the effectiveness and safety of ECP in GvHD treatment, there is limited data to show how it is being used in combination with the recently approved agents.

Using existing registry data targeting centres where the newer agents are being used and enhancing the capture of treatment data we believe we can undertake a larger scale study, which will include the new treatment protocols. The aim of the current study is to improve the evidence basis on the potential benefit of ECP use as treatment of GVHD.

status: Active, not recruiting

study_type: Observational

time_perspective: Retrospective

lead_sponsor: European Society for Blood and Marrow Transplantation

location_country:
Germany
Italy
Poland
Israel
United Kingdom
Denmark
Romania
Sweden
Belgium
Spain
Greece
Turkey
Russian Federation
France

location_facility: University Hospital Birmingham NHS Trust

location_facility: Institut de Cancerologie Lucien Neuwirth

location_facility: ICO-Hospital Universitari Germans Trias i Pujol

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: First State Pavlov Medical University of St. Petersburg


title: The "Global Paradise® System" Registry

acronym: GPS Registry

summary: The GPS Registry is a multi-centre, single-arm, non-interventional (observational) registry. In addition to collecting data from patients treated as per standard clinical practice, the Registry will also regularly collect telemetric Home Blood Pressure (HBP) measurements and Patient Reported Outcome (PRO) data via a standardized quality of life questionnaire. The objective of the GPS Registry is to document the long-term safety and effectiveness of the commercially available Paradise Ultrasound Renal Denervation System when used per its labelling in patients deemed to be candidates for RDN as per physician's assessment.

time_perspective: Other

lead_sponsor: ReCor Medical, Inc.

location_country:
Germany
United Kingdom
Netherlands
Switzerland
Belgium
Monaco
France

location_facility: Universitäts-Herzzentrum Freiburg Bad Krozingen

location_facility: Herzzentrum Dresden GmbH Universitätsklinik

location_facility: Centre Hospitalier Princesse Grace Monaco

location_facility: Cardiovasculäres Centrum (CVC) Frankfurt

location_facility: Hammersmith Hospital (Imperial College Healthcare NHS Trust)

location_facility: HEGP (Hôpital Européen Georges Pompidouv) Paris

location_facility: Heart Center Lucerne -Luzerner Kantonsspital

location_facility: Kent and Canterbury Hospital, Canterbury

location_facility: Charité Universitätsmedizin Berlin Campus Benjamin Franklin

intervention_type: Device


type: Other Identifier

type: Registry Identifier

title: A Phase 1 Study of JNJ-78278343, a T-Cell-Redirecting Agent Targeting Human Kallikrein 2 (KLK2), for Advanced Prostate Cancer

summary: The purpose of this study is to determine the recommended phase 2 dose(s) (RP2Ds) of JNJ-78278343 in Part 1 (Dose Escalation) and the safety at the RP2Ds in Part 2 (Dose Expansion).

ipd_sharing: Yes

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

location_country:
United States
Spain
Netherlands
France

location_facility: Columbia University Medical Center Herbert Irving Pavilion


lead_sponsor: Menarini Group

summary: Open-label, dose-confirmation and cohort expansion, multicentre, Phase Ib/II study to assess the anti-tumour activity and safety of MEN1611 in combination with cetuximab for the treatment of patients with PIK3CA mutated metastatic colorectal cancer.

location_facility: The Oncology Institute of Hope and Innovation

location_facility: MultiCare Health System Institute for Research and Innovation

location_facility: Azienda Ospedaliero Universitaria San Martino

location_facility: Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

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

location_facility: Klinikum der Universitaet Muenchen Campus Grosshadern

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Azienda Socio Sanitaria Territoriale Niguarda

title: Open-label, Multicentre, Phase Ib/II Study of MEN1611, a PI3K Inhibitor, and Cetuximab in Patients With PIK3CA Mutated Metastatic Colorectal Cancer Failing Irinotecan, Oxaliplatin, 5-FU and Anti-EGFR Containing Regimens

location_country:
Germany
Italy
Poland
Netherlands
United States
Spain
France


title: EP Device Registry

summary: This study will provide ongoing, high quality data on the safety, performance, and clinical benefits of Abbott's EP devices in a real-world setting.

time_perspective: Prospective

lead_sponsor: Abbott Medical Devices

location_country: Germany Italy India Portugal Hungary Netherlands Austria Spain Czechia France

location_facility: Herzzentrum Dresden GmbH Universitätsklinik

location_facility: Sree Chitra Tirunal Institute for Medical Sciences & tech.

location_facility: Deutsches Herzzentrum München des Freistaates Bayern

location_facility: Medizinische Einrichtungen der Universität zu Köln

location_facility: A. ö. Krankenhaus der Elisabethinen Linz

location_facility: Azienda Ospedaliero Universitaria Pisana

intervention_type: Other


lead_sponsor: Novartis Pharmaceuticals

summary: A double-blind, placebo controlled, randomized, phase II study evaluating the efficacy and safety of capmatinib (INC280) and spartalizumab (PDR001) combination therapy versus capmatinib and placebo as first line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with MET exon 14 skipping (METΔex14) mutations

location_facility: Massachusetts General Hospital Liver and Kidney TX

title: A Double-blind, Placebo Controlled, Randomized, Phase II Study Evaluating the Efficacy and Safety of Capmatinib and Spartalizumab vs Capmatinib and Placebo as 1st Line Treatment for Advanced NSCLC Patients With MET exon14 Skipping Mutations

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

location_country:
Germany
Italy
Japan
Belgium
United States
Korea, Republic of
Spain
Canada
France


title: Safety and Performance Evaluation of Seraph 100 Microbind Affinity Blood Filter (Seraph 100) in the Reduction of Pathogen Load From the Blood in Septic Patients With Suspected, Life-threatening Bloodstream Infection

summary: Safety and Performance Evaluation of Seraph 100 Microbind Affinity Blood Filter (Seraph 100) in the reduction of pathogen load from the blood in septic patients with suspected, life-threatening bloodstream infection

status: Unknown status

lead_sponsor: ExThera Medical Europe BV

sponsor_collaborators:
ExThera Medical Europe BV
ExThera Medical Corporation
Vivantes Clinic Neukölln

location_country:
Germany
Italy
Poland
United Kingdom
Netherlands
Austria
Belgium
Spain
France

location_facility:
Asklepios Hospital St. Georg
Städtisches Klinikum Braunschweig GmbH
Jagiellonia University
Medizinische Hochschule Hannover
Royal Surrey NHS Foundation Trust
Azienda Usl Toscana Centro
Universitätsmedizin Greifswald
Medisch Spectrum Twente
University Hospital Frankfurt
Universität Rostock
University Hospital, Pisa
Nouvel Hopital Civil
Universitätsklinikum Essen (AöR)
Ziekenhuis Gelderse Vallei
CHU Bocage Central
Hôpital Erasme
A.Gemelli University Hospital
Medical University of Innsbruck
Hospital Universitari Vall d'Hebron
Klinikum Aschaffenburg-Alzenau
Hospital Clinico San Carlos
Universität Witten-Herdecke
Hospices Civils de Lyon
Vivantes Klinikum Neukölln
Middelheim Hospital


title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study of Cemdisiran in Adult Patients With IgA Nephropathy

summary: The purpose of this study is to evaluate the effect of cemdisiran on proteinuria in adults with immunoglobulin A nephropathy (IgAN), who excrete >1 gram (gm) of protein per day despite standard of care, which includes treatment with angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARB). These participants are at high risk for progression of kidney disease, which can result in end-stage renal failure.

lead_sponsor: Alnylam Pharmaceuticals

location_country:
United Kingdom
Singapore
Sweden
Spain
Malaysia
Taiwan
Canada
Philippines
France


title: A Phase II Two Cohort Study Evaluating the Safety and Efficacy of Cobimetinib Plus Atezolizumab in BRAFV600 Wild-type Melanoma With Central Nervous System Metastases and Cobimetinib Plus Atezolizumab and Vemurafenib in BRAFV600 Mutation-positive Melanoma With Central Nervous System Metastases

summary: This study will evaluate the efficacy and safety of cobimetinib plus atezolizumab in participants with BRAFV600 wild-type melanoma with central nervous system (CNS) metastases and of cobimetinib plus atezolizumab and vemurafenib in BRAFV600 mutation-positive melanoma patients with CNS metastases.

ReferenceType: derived

ReferenceCitation: Dummer R, Queirolo P, Abajo Guijarro AM, Hu Y, Wang D, de Azevedo SJ, Robert C, Ascierto PA, Chiarion-Sileni V, Pronzato P, Spagnolo F, Mujika Eizmendi K, Liszkay G, de la Cruz Merino L, Tawbi H. Atezolizumab, vemurafenib, and cobimetinib in patients with melanoma with CNS metastases (TRICOTEL): a multicentre, open-label, single-arm, phase 2 study. Lancet Oncol. 2022 Sep;23(9):1145-1155. doi: 10.1016/S1470-2045(22)00452-1. Epub 2022 Aug 5.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

lead_sponsor: Hoffmann-La Roche

location_country: Germany Italy Hungary Brazil Switzerland Latvia Spain France

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: Universitätsspital Zürich; USZ Flughafen / H13-7-609

location_facility: Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik fur Dermatologie

location_facility: Riga East Clinical University Hospital Latvian Oncology Centre

location_facility: Onkologikoa - Instituto Oncológico de Donostia

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

location_facility: Azienda Ospedaliero - Universitaria Pisana U.O. Oncologia Medica 2 Universitaria - Polo Oncologico

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

location_facility: Hospital General Universitario de Valencia; Servicio de oncologia

location_facility: Hospital Universitario Virgen Macarena; Servicio de Oncologia

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

location_facility: Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

location_facility: Istituto Dermopatico dell'Immacolata (IDI)-IRCCS; IV Divisione Oncologica e Dermatologia Oncologica

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica B

location_facility: Orszagos Onkologiai Intezet; Borgyogyaszati Osztaly

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


title: An Open-label Phase I/IIa Study to Evaluate the Safety and Efficacy of CCS1477 as Monotherapy and in Combination, in Patients With Advanced Solid/Metastatic Tumours.

summary: A Phase 1/2a study to assess the safety, tolerability, PK and biological activity of CCS1477 in patients with metastatic castration resistant prostate cancer, metastatic breast cancer, non-small cell lung cancer or advanced solid tumours.

ReferenceCitation: Eickhoff N, Bergman AM, Zwart W. Homing in on a Moving Target: Androgen Receptor Cistromic Plasticity in Prostate Cancer. Endocrinology. 2022 Oct 11;163(11):bqac153. doi: 10.1210/endocr/bqac153.

oa_host_type: repository

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

host_type: repository

license: cc-by

license_normalized: cc-by

repository_institution: Eindhoven University of Technology - Eindhoven University of Technology Research Portal

version: publishedVersion

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

unpaywall_oa_status: green

publisher_dissemination: The Endocrine Society

lead_sponsor: CellCentric Ltd.

location_country:
France
United Kingdom
Netherlands
United States
Spain
Sweden

location_facility: Edinburgh Cancer Centre Western General Hospital

location_facility: Thomas Jefferson University, Sidney Kimmel Cancer Center

location_facility: The Beatson West of Scotland Cancer Centre

location_facility: New York-Presbyterian Hospital/Weill Cornell Medical Center


type: Other Grant/Funding Number

title: A Phase 2, Single-arm, Multi-center Trial to Determine the Efficacy and Safety of JCAR017 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma or With Other Aggressive B-Cell Malignancies

acronym: TRANSCENDWORLD

summary: The purpose of this study is to evaluate the efficacy and safety of JCAR017 in participants with aggressive B-cell non-Hodgkin lymphoma (B-NHL)

ReferenceCitation: Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.

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

license_normalized: no license

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repositories_concat: PubMed Central;ora.ox.ac.uk

publisher_dissemination: Wiley

lead_sponsor: Celgene

location_country:
Finland
Germany
Italy
United Kingdom
Japan
Netherlands
Austria
Belgium
Switzerland
Spain
France

location_facility:
Local Institution - 551
Local Institution - 351
Local Institution - 101
Local Institution - 154
Local Institution - 602
Local Institution - 501
Local Institution - 301
Local Institution - 251
Local Institution - 151
Local Institution - 202
Local Institution - 601
Local Institution - 155
Local Institution - 451
Local Institution - 401
Local Institution - 152
Local Institution - 153
Local Institution - 201
Local Institution - 502
Local Institution - 402
Local Institution - 203


title: Randomised Phase III Trial of Molecular Profile-based Versus Standard Recommendations for Adjuvant Radiotherapy for Women With Early Stage Endometrial Cancer: PORTEC-4a Trial

summary: This is prospective, multicenter, randomised phase III trial among women with endometrial cancer with high-intermediate risk features to investigate the role of an integrated clinicopathological and molecular risk profile to determine if participants should receive no adjuvant therapy, vaginal brachytherapy or external beam radiotherapy based on a favourable, intermediate or unfavourable profile as compared to standard adjuvant vaginal brachytherapy.

ReferenceCitation: Nero C, Ciccarone F, Pietragalla A, Duranti S, Daniele G, Scambia G, Lorusso D. Adjuvant Treatment Recommendations in Early-Stage Endometrial Cancer: What Changes With the Introduction of The Integrated Molecular-Based Risk Assessment. Front Oncol. 2021 Sep 1;11:612450. doi: 10.3389/fonc.2021.612450. eCollection 2021.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

repository_institution: PubMed Central - Europe PMC

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Frontiers

ReferenceCitation: van den Heerik ASVM, Horeweg N, Nout RA, Lutgens LCHW, van der Steen-Banasik EM, Westerveld GH, van den Berg HA, Slot A, Koppe FLA, Kommoss S, Mens JWM, Nowee ME, Bijmolt S, Cibula D, Stam TC, Jurgenliemk-Schulz IM, Snyers A, Hamann M, Zwanenburg AG, Coen VLMA, Vandecasteele K, Gillham C, Chargari C, Verhoeven-Adema KW, Putter H, van den Hout WB, Wortman BG, Nijman HW, Bosse T, Creutzberg CL. PORTEC-4a: international randomized trial of molecular profile-based adjuvant treatment for women with high-intermediate risk endometrial cancer. Int J Gynecol Cancer. 2020 Dec;30(12):2002-2007. doi: 10.1136/ijgc-2020-001929. Epub 2020 Oct 12.

oa_colors: green hybrid

evidence: open (via page says license)

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: Erasmus University Rotterdam - EUR Research Repository

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

repository_institution: Radboud University - Radboud Repository

repository_institution: Dr Steevens Hospital Library - Lenus, The Irish Health Repository

repositories_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

ReferenceCitation: Wortman BG, Bosse T, Nout RA, Lutgens LCHW, van der Steen-Banasik EM, Westerveld H, van den Berg H, Slot A, De Winter KAJ, Verhoeven-Adema KW, Smit VTHBM, Creutzberg CL; PORTEC Study Group. Molecular-integrated risk profile to determine adjuvant radiotherapy in endometrial cancer: Evaluation of the pilot phase of the PORTEC-4a trial. Gynecol Oncol. 2018 Oct;151(1):69-75. doi: 10.1016/j.ygyno.2018.07.020. Epub 2018 Aug 3.

ipd_sharing_description: Specifics will be decided and made public on website at a later stage, most probably from 5 years after final publication onwards

collaborators: Comprehensive Cancer Centre The Netherlands

location_country: Germany Ireland Netherlands Austria Belgium Switzerland Czechia France

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Lübeck

location_facility: CEEGOG, General Faculty Hospital and First Faculty of Medicine, Charles University, Prague

location_facility: CancerTrials Ireland - St Luke's Hospital (SLRON SLH)

location_facility: CancerTrials Ireland - St James Hospital (SLRON SJH)

titre: PORTEC  4a : Postoperative Radiation Therapy for Endometrial Carcinoma  4a


title: TransCatheter Aortic Valve Implantation and Fractional Flow Reserve-Guided Percutaneous Coronary Intervention Versus Conventional Surgical Aortic Valve Replacement and Coronary By-Pass Grafts for Treatment of Patients With Coronary MultiVessel Disease and Aortic Valve Stenosis

acronym: TCW

summary: The trial objective is to investigate whether Fractional Flow Reserve (FFR)-Guided Percutaneous Coronary Intervention (PCI) and TransCatheter Aortic Valve Implantation (TAVI) strategy for treatment of multivessel disease and aortic stenosis will be non-inferior to Coronary Artery By-pass Grafting (CABG) and Surgical Aortic Valve Replacement (SAVR) for a composite primary endpoint of all-cause mortality, stroke, myocardial infarction, coronary or valve re-intervention and life-threatening or disabling bleeding at one year.

ipd_sharing: Undecided

lead_sponsor: Maatschap Cardiologie Zwolle

sponsor_collaborators:
Maatschap Cardiologie Zwolle
Medtronic

location_country: Germany Poland Portugal Slovakia Denmark Netherlands Austria Spain Greece France

location_facility: Hospital Clinico Universitario San Carlos

location_facility: Rigshospitalet, Copenhagen University Hospital

location_facility: Universitäres Herz- und Gefäßzentrum UKE Hamburg GmbH

location_facility: University Hospital Frankfurt - Goethe University


title: Post-Market Clinical Investigation of the Clareon® IOL

summary: The primary purpose of this study is to evaluate the long-term (3 years) visual acuity and adverse event outcomes for the Clareon® Intraocular Lens (IOL). A comparison to historical safety and performance endpoint (SPE) rates as reported in the European Standard International Organization for Standardization (EN ISO) 11979-7:2014 will be conducted at one year. The secondary purpose of this study is to evaluate the visual acuity outcomes with the Clareon IOL at Years 2 and 3.

lead_sponsor: Alcon Research

location_country:
Germany
Italy
United Kingdom
Australia
Netherlands
Spain
France


lead_sponsor: Iltoo Pharma

summary: The purpose of this study is to evaluate the efficacy and safety of ILT-101 (human recombinant interleukin 2 (IL-2)) in patients with moderate to severe systemic lupus erythematosus.

ReferenceCitation: Humrich JY, Cacoub P, Rosenzwajg M, Pitoiset F, Pham HP, Guidoux J, Leroux D, Vazquez T, Riemekasten G, Smolen JS, Tsokos G, Klatzmann D. Low-dose interleukin-2 therapy in active systemic lupus erythematosus (LUPIL-2): a multicentre, double-blind, randomised and placebo-controlled phase II trial. Ann Rheum Dis. 2022 Dec;81(12):1685-1694. doi: 10.1136/ard-2022-222501. Epub 2022 Aug 16.

publisher_dissemination: British Medical Journal

location_facility: University Multiprofile Hospital for Active Treatment

location_facility: Klinikum der Johann Wolfgang Goethe-Universität

location_facility: Centro Integral en Reumatología S.A. de C.V.

location_facility: Azienda Osp. Univ. Seconda Università di Napoli

location_facility: Hospital Universitario y Politécnico La Fe

location_facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

title: A Phase II, Multi-centre, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of ILT-101 in Patients With Active Moderate to Severe Systemic Lupus Erythematosus (SLE)

location_country: Germany Italy Portugal Romania Austria Mexico Spain Mauritius Bulgaria France


title: Trial on Radical Upfront Surgery in Advanced Ovarian Cancer

acronym: TRUST

summary:
This study consists of three parts, whereas Part 1 and Part 2 are performed in Germany only, and Part 3 is a multinational trial.

All patients with suspicion of advanced ovarian cancer are detected in the participating study centers in a pre-screening. The study centers will register all patients with suspected ovarian cancer in a screening log. After the patients have given informed consent, they can be enrolled in different parts of the study.

TRUST-Trial: This part compares two strategies in the therapy of advanced ovarian cancer. En detail, this part of the trial will evaluate if one of two strategies of timing surgery within the therapeutic procedures may show any significant advances in terms of overall survival over the other.

ReferenceCitation: Reuss A, du Bois A, Harter P, Fotopoulou C, Sehouli J, Aletti G, Guyon F, Greggi S, Mosgaard BJ, Reinthaller A, Hilpert F, Schade-Brittinger C, Chi DS, Mahner S. TRUST: Trial of Radical Upfront Surgical Therapy in advanced ovarian cancer (ENGOT ov33/AGO-OVAR OP7). Int J Gynecol Cancer. 2019 Oct;29(8):1327-1331. doi: 10.1136/ijgc-2019-000682. Epub 2019 Aug 15.

lead_sponsor: AGO Study Group

location_country:
Germany
Italy
United Kingdom
Denmark
Sweden
Austria
United States
France

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

location_facility: Fondazione IRCCS Istituto Nazionale Tumori - Milan

location_facility: Klinikum rechts der Isar, Frauen- und Poliklinik

location_facility: Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Klinik für Gynäkologie

location_facility: Imperial College London, Hammersmith Hospital, Surgery&Cancer

location_facility: Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Klinikum der Universität München

location_facility: Hôpital Européen Georges Pompidou (HEGP)

location_facility: Kliniken Essen-Mitte, Evang. Huyssens-Stiftung, Klinik für Gynäkologie und gyn. Onkologie

location_facility: Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Gynäkologie

location_facility: Universitätsklinikum Carl Gustav Carus Dresden, Klinik & Poliklinik f. Frauenheilkunde & Geburtshilfe

location_facility: European Institute of Oncology; Gynecologic Cancer Surgery

intervention_type: Procedure


title: A Phase II Multicenter Study Comparing the Efficacy of the Oral Angiogenesis Inhibitor Nintedanib With the Intravenous Cytotoxic Compound Ifosfamide for Treatment of Patients With Advanced Metastatic Soft Tissue Sarcoma After Failure of Systemic Non-oxazaphosporine-based First Line Chemotherapy for Inoperable Disease "ANITA"

acronym: ANITA

summary:
This is a prospective, multicentric, randomized, open label Phase II trial investigating whether the oral angiogenesis inhibitor nintedanib, as compared to the intravenous cytotoxic compound ifosfamide, given for patients with advanced, inoperable and/or metastatic STS after failure of first line chemotherapy prolongs progression-free survival.

The primary objective of the trial is to evaluate whether nintedanib given as second-line therapy for advanced, inoperable and/or metastatic STS prolongs progression-free survival when compared with ifosfamide.

Secondary objectives are to evaluate the efficacy of nintedanib as compared to ifosfamide in terms of progression-free survival rate at 12 weeks, overall survival, objective response rate, patient benefit rate, response duration, total duration of treatment with nintedanib safety, Health related Quality of Life and Health Economics.

Exploratory objectives include an analysis of putative predictive biomarkers for the anti-tumor effects of the investigational agent nintedanib.treatment.

ReferenceCitation: Schoffski P, Toulmonde M, Estival A, Marquina G, Dudzisz-Sledz M, Brahmi M, Steeghs N, Karavasilis V, de Haan J, Wozniak A, Cousin S, Domenech M, Bovee JVMG, Charon-Barra C, Marreaud S, Litiere S, De Meulemeester L, Olungu C, Gelderblom H. Randomised phase 2 study comparing the efficacy and safety of the oral tyrosine kinase inhibitor nintedanib with single agent ifosfamide in patients with advanced, inoperable, metastatic soft tissue sarcoma after failure of first-line chemotherapy: EORTC-1506-STBSG "ANITA". Eur J Cancer. 2021 Jul;152:26-40. doi: 10.1016/j.ejca.2021.04.015. Epub 2021 May 29.

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repository_institution: Leiden University - Leiden Repository

repositories_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

unpaywall_oa_status: hybrid

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

location_country:
Lithuania
Poland
United Kingdom
Netherlands
Belgium
Spain
France

location_facility: Maria Sklodowska-Curie Memorial Cancer Centre

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

location_facility: Cliniques Universitaires Saint-Luc (121)

location_facility: Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet

location_facility: The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis (301)

location_facility: Royal Marsden Hospital - Chelsea, London (613)

location_facility: Vilnius University Hospital Santariskiu Santaros Clinics Klinikos (9453)


summary: The purpose of the Valiant Evo International Clinical Trial is to demonstrate the safety and effectiveness of the Valiant Evo Thoracic Stent Graft System in subjects with a descending thoracic aortic aneurysm (DTAA) who are candidates for endovascular repair.

ReferenceCitation: Verzini F, Cieri E, Kahlberg A, Sternbach Y, Heijmen R, Ouriel K, Robaina S, Azizzadeh A. A preliminary analysis of late structural failures of the Navion stent graft in the treatment of descending thoracic aortic aneurysms. J Vasc Surg. 2021 Oct;74(4):1125-1134.e2. doi: 10.1016/j.jvs.2021.04.018. Epub 2021 Apr 20.

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

ReferenceCitation: Azizzadeh A, Desai N, Arko FR 3rd, Panneton JM, Thaveau F, Hayes P, Dagenais F, Lei L, Verzini F. Pivotal results for the Valiant Navion stent graft system in the Valiant EVO global clinical trial. J Vasc Surg. 2019 Nov;70(5):1399-1408.e1. doi: 10.1016/j.jvs.2019.01.067. Epub 2019 May 21.

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

repositories_concat: Zenodo

lead_sponsor: Medtronic Cardiovascular

location_country:
Italy
United Kingdom
Denmark
Netherlands
Canada
France

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)

location_facility: Maastricht Universitair Medisch Centrum (MUMC)

location_facility: Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital

location_facility: Imperial College Healthcare NHS Trust - St Mary's Hospital

location_facility: London Health Sciences Centre - Victoria Hospital

location_facility: CHU de Montpellier - Hôpital Arnaud de Villeneuve

location_facility: IRCCS Ca' Granda Ospendale Maggiore Policlinico

location_facility: Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil

location_facility: Università di Perugia - Ospedale S.M. Della Misericordia


acronym: ICONIC

lead_sponsor: Mirum Pharmaceuticals, Inc.

summary: This is a long-term, open-label study with a double-blind, placebo-controlled, randomized drug withdrawal period in children with Alagille Syndrome (ALGS) designed to evaluate the safety and efficacy of LUM001 (Also known as maralixibat or MRX).

ReferenceCitation: Kamath BM, Goldstein A, Howard R, Garner W, Vig P, Marden JR, Billmyer E, Anderson A, Kirson N, Jacquemin E, Gonzales E. Maralixibat Treatment Response in Alagille Syndrome is Associated with Improved Health-Related Quality of Life. J Pediatr. 2023 Jan;252:68-75.e5. doi: 10.1016/j.jpeds.2022.09.001. Epub 2022 Sep 10.

oa_host_type: publisher

ReferenceCitation: Gonzales E, Hardikar W, Stormon M, Baker A, Hierro L, Gliwicz D, Lacaille F, Lachaux A, Sturm E, Setchell KDR, Kennedy C, Dorenbaum A, Steinmetz J, Desai NK, Wardle AJ, Garner W, Vig P, Jaecklin T, Sokal EM, Jacquemin E. Efficacy and safety of maralixibat treatment in patients with Alagille syndrome and cholestatic pruritus (ICONIC): a randomised phase 2 study. Lancet. 2021 Oct 30;398(10311):1581-1592. doi: 10.1016/S0140-6736(21)01256-3. Epub 2021 Oct 28.

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

location_facility: Paediatric Liver Center, Kings College Hospital

location_facility: Hospital Universitario La Paz- Hospital Materno Infantil

location_facility: The Children's Memorial Health Institute

title: Long-Term, Open-Label Study With a Double-Blind, Placebo-Controlled, Randomized Drug Withdrawal Period of LUM001 (Maralixibat), an Apical Sodium-Dependent Bile Acid Transporter Inhibitor (ASBTi), in Patients With Alagille Syndrome

location_country:
Poland
United Kingdom
Australia
Belgium
Spain
France


summary: The primary purpose of the study is to determine the safety and efficacy and to generate PK and biomarker data for the combination of Pomalidomide and low-dose Dexamethasone in patients with relapsed or refractory multiple myeloma, with moderate or severe renal impairment.

ReferenceType: background

ReferenceCitation: Li Y, Wang X, O'Mara E, Dimopoulos MA, Sonneveld P, Weisel KC, Matous J, Siegel DS, Shah JJ, Kueenburg E, Sternas L, Cavanaugh C, Zaki M, Palmisano M, Zhou S. Population pharmacokinetics of pomalidomide in patients with relapsed or refractory multiple myeloma with various degrees of impaired renal function. Clin Pharmacol. 2017 Nov 8;9:133-145. doi: 10.2147/CPAA.S144606. eCollection 2017.

ReferenceCitation: Dimopoulos M, Weisel K, van de Donk NWCJ, Ramasamy K, Gamberi B, Streetly M, Offidani M, Bridoux F, de la Rubia J, Mateos MV, Ardizzoia A, Kueenburg E, Collins S, Di Micco A, Rosettani B, Li Y, Bacon P, Sonneveld P. Pomalidomide Plus Low-Dose Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma and Renal Impairment: Results From a Phase II Trial. J Clin Oncol. 2018 Jul 10;36(20):2035-2043. doi: 10.1200/JCO.2017.76.1742. Epub 2018 Feb 2.

location_facility: Alexandra Hospital, University of Athens

location_facility: CEIC Hospital Universitario de Salamanca

location_facility: Queen Elizabeth Hospital UHB NHS Foundation Trust

location_facility: Daniel den Hoed Kliniek Medical Oncology, Erasmus MC

location_facility: Krankenhaus der Elisabethinen Linz, I Interne Abteilung

location_facility: Ospedale Maggiore Policlinico Mangiagalli Regina Elena

location_facility: St Thomas' HospitalGuy's Hospital Dept. of Haematology

location_facility: VU University Medical Center VU Medisch Centrum

location_facility: Azienda Ospedaliero Universitaria Ospedali

location_facility: Oxford Radcliffe Hospital ICRF Medical Oncology Unit

location_facility: Medizinische Klinik und Poliklinik V Hamatologie, Onkologie und Rheumatologie

title: A Phase 2 Multicenter, Open-label Study to Determine the Efficacy and Safety of Pomalidomide (CC-4047) in Combination With Low-Dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma and Moderate or Severe Renal Impairment Including Subjects Undergoing Hemodialysis

location_country:
Germany
Italy
United Kingdom
Netherlands
Austria
Spain
Greece
France


title: A Multicenter Postmarketing Study to Evaluate the Placental Transfer of Certolizumab Pegol in Pregnant Women Receiving Treatment With Cimzia® (Certolizumab Pegol)

acronym: CRIB

summary: The primary purpose is to assess whether there is transfer of Certolizumab Pegol (CZP) from pregnant women receiving treatment with Cimzia® across the placenta to infants by evaluating the concentration of CZP in the plasma of infants at birth.

primary_purpose: Other

ReferenceCitation: Mariette X, Forger F, Abraham B, Flynn AD, Molto A, Flipo RM, van Tubergen A, Shaughnessy L, Simpson J, Teil M, Helmer E, Wang M, Chakravarty EF. Lack of placental transfer of certolizumab pegol during pregnancy: results from CRIB, a prospective, postmarketing, pharmacokinetic study. Ann Rheum Dis. 2018 Feb;77(2):228-233. doi: 10.1136/annrheumdis-2017-212196. Epub 2017 Oct 13.

license: cc-by-nc

license_normalized: cc-by-nc

lead_sponsor: UCB BIOSCIENCES, Inc.

collaborators: PPD Parexel

sponsor_collaborators:
UCB BIOSCIENCES, Inc.
PPD
Parexel

location_country:
United States
Netherlands
Switzerland
France


title: An Exploratory, Blinded, Randomized, Placebo-controlled Study in Subjects With Depressive Disorder to Investigate the Effect of Minocycline on Relapse After Successful Intravenous Ketamine/Minocycline-induced (Partial) Symptoms Response

summary: The purpose of this study is to assess whether the antidepressant effect from intravenous (IV) ketamine treatment can be maintained by minocycline compared to placebo after IV ketamine treatment is stopped.

lead_sponsor: Janssen Research & Development, LLC

location_country: Spain Netherlands Belgium France


summary:
The purpose of this study was to determine if AUY922 had superior efficacy when compared to chemotherapy agents docetaxel or pemetrexed in patients whose tumor had EGFR mutations.

The primary purpose of this study was to compare the efficacy of AUY922, when administered i.v. on a once-weekly schedule at 70 mg/m2, versus docetaxel or pemetrexed in adult patients with advanced NSCLC, whose tumors harbored EGFR activating mutations, and had developed resistance to EGFR TKI.

location_facility: University of Wisconsin / Paul P. Carbone Comp Cancer Center Univ Wisc 5

location_facility: Cedars Sinai Medical Center Dept.of Cedars-Sinai Med. Ctr.

title: A Multicenter, Open-label, Randomized Phase II Study to Evaluate the Efficacy of AUY922 vs Pemetrexed or Docetaxel in NSCLC Patients With EGFR Mutations Who Have Progressed on Prior EGFR TKI Treatment

location_country:
Italy
Poland
Norway
Hong Kong
United Kingdom
Japan
Netherlands
United States
Korea, Republic of
Spain
Taiwan
France


title: An Open Label, International, Multicenter, Dose Escalating Phase I/II Trial Investigating the Safety of Daratumumab in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed or Relapsed and Refractory Multiple Myeloma

summary: The purpose of this study is to establish the safety profile of daratumumab when given in combination with Lenalidomide and dexamethasone in participants with relapsed or relapsed and refractory Multiple Myeloma (MM).

ReferenceCitation: Krejcik J, Frerichs KA, Nijhof IS, van Kessel B, van Velzen JF, Bloem AC, Broekmans MEC, Zweegman S, van Meerloo J, Musters RJP, Poddighe PJ, Groen RWJ, Chiu C, Plesner T, Lokhorst HM, Sasser AK, Mutis T, van de Donk NWCJ. Monocytes and Granulocytes Reduce CD38 Expression Levels on Myeloma Cells in Patients Treated with Daratumumab. Clin Cancer Res. 2017 Dec 15;23(24):7498-7511. doi: 10.1158/1078-0432.CCR-17-2027. Epub 2017 Oct 12.

oa_colors: green other

evidence: open (via free pdf)

unpaywall_oa_status: bronze

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Plesner T, Arkenau HT, Gimsing P, Krejcik J, Lemech C, Minnema MC, Lassen U, Laubach JP, Palumbo A, Lisby S, Basse L, Wang J, Sasser AK, Guckert ME, de Boer C, Khokhar NZ, Yeh H, Clemens PL, Ahmadi T, Lokhorst HM, Richardson PG. Phase 1/2 study of daratumumab, lenalidomide, and dexamethasone for relapsed multiple myeloma. Blood. 2016 Oct 6;128(14):1821-1828. doi: 10.1182/blood-2016-07-726729. Epub 2016 Aug 16.

evidence: open (via free article)

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

version: submittedVersion

repositories:
PubMed Central
UCL Discovery

repositories_concat: PubMed Central;UCL Discovery

publisher_dissemination: American Society of Hematology

location_country:
United Kingdom
Denmark
Netherlands
United States
France


lead_sponsor: Bayer

summary:
This is the first study where BAY1000394 is given in combination with chemotherapy: cisplatin / etoposide or carboplatin / etoposide. Patients with small cell lung cancer will be treated. Every patient will receive drug treatment, there is no placebo group. Different groups of patients will receive different dosages of BAY1000394 to determine the safety and maximum tolerated dose (MTD) of BAY1000394 in combination with chemotherapy. The dose of chemotherapy is the standard dose usually administered and will not change.

The study will also assess how the drug is metabolized by the body and changes in tumor size.

BAY1000394 will be given per mouth, twice a day for three days every week. Treatment will stop if the tumor continues to grow, if side effects occur which the patient can not tolerate or if the patients decides to exit treatment.

title: Phase Ib / II Study of BAY 1000394 in Combination With Cisplatin / Etoposide or Carboplatin / Etoposide as First-line Therapy in Subjects With Extensive Disease Small Cell Lung Cancer

location_country:
United States
Korea, Republic of
France


title: A Randomized, Double-Blind, Placebo-Controlled, Repeat-Dose Study of the Efficacy, Safety, Tolerability, and Pharmacodynamics of Subcutaneously-Administered REGN668 in Adult Patients With Extrinsic Moderate-to-Severe Atopic Dermatitis

summary: The primary objective was to assess the clinical efficacy of repeated subcutaneous (SC) doses of Dupilumab in adult participants with moderate-to-severe atopic dermatitis (AD).

ReferenceCitation: Beck LA, Thaci D, Hamilton JD, Graham NM, Bieber T, Rocklin R, Ming JE, Ren H, Kao R, Simpson E, Ardeleanu M, Weinstein SP, Pirozzi G, Guttman-Yassky E, Suarez-Farinas M, Hager MD, Stahl N, Yancopoulos GD, Radin AR. Dupilumab treatment in adults with moderate-to-severe atopic dermatitis. N Engl J Med. 2014 Jul 10;371(2):130-9. doi: 10.1056/NEJMoa1314768.

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Tsianakas A, Luger TA, Radin A. Dupilumab treatment improves quality of life in adult patients with moderate-to-severe atopic dermatitis: results from a randomized, placebo-controlled clinical trial. Br J Dermatol. 2018 Feb;178(2):406-414. doi: 10.1111/bjd.15905. Epub 2018 Jan 11.

publisher_dissemination: Oxford University Press

lead_sponsor: Regeneron Pharmaceuticals

sponsor_collaborators:
Regeneron Pharmaceuticals
Sanofi

location_country: Germany Poland Hungary Czechia France


lead_sponsor: Shire

summary: The purpose of this trial is to investigate the pharmacodynamic effect on reflux parameters of SPD557 tablets (0.5 mg t.i.d., on top of PPI treatment) in patients with Gastroesophageal Reflux Disease (GERD) with persistent symptoms despite taking a stable dose of proton pump inhibitors. Additionally the effect on symptoms will be explored and safety and tolerability will be evaluated.

ReferenceCitation: Tack J, Zerbib F, Blondeau K, des Varannes SB, Piessevaux H, Borovicka J, Mion F, Fox M, Bredenoord AJ, Louis H, Dedrie S, Hoppenbrouwers M, Meulemans A, Rykx A, Thielemans L, Ruth M. Randomized clinical trial: effect of the 5-HT4 receptor agonist revexepride on reflux parameters in patients with persistent reflux symptoms despite PPI treatment. Neurogastroenterol Motil. 2015 Feb;27(2):258-68. doi: 10.1111/nmo.12484. Epub 2014 Dec 21.

repository_institution: University of Zurich - Zurich Open Repository and Archive

repositories:
LIRIAS (KU Leuven)
PubMed Central
www.zora.uzh.ch

repositories_concat: LIRIAS (KU Leuven);PubMed Central;www.zora.uzh.ch

location_facility: Queen's Medical Center (Nottingham University Hospital)

location_facility: Wingate Institute of Neurogastroenterology

location_facility: Inselspital Bern (Bern University Hopsital)

location_facility: CHU de Lyon - Groupement Hospitalier Edouard Herriot

title: An Explorative, Randomized, Placebo-controlled, DB, Parallel-group Trial, to Evaluate the Pharmacodynamic Effect of SPD557 on Reflux Parameters in Subjects With GERD & With Persistent Symptoms Despite Taking a Stable Dose of PPIs

location_country:
Germany
United Kingdom
Switzerland
Netherlands
Belgium
France


title: A Phase I, Open, Dose Escalation Trial With BI 836826 in Patients With Advanced Chronic Lymphocytic Leukaemia

summary: Adult patients with chronic lymphocytic leukaemia who experience a relapse after at least two prior treatment regimens may be enrolled in this trial. The trial will examine whether monotherapy with BI 836826 is safe and tolerable at escalating dose levels.

lead_sponsor: Boehringer Ingelheim

location_country: Germany Belgium France

location_facility: CTR Investigation Clinique, onco, Montpellier


title: A Phase IIIb/IV, Multi-centre, Double-blind, Randomised, Placebo-controlled Parallel Group Study to Compare the Efficacy and Safety of Movicol® With Placebo in Patients With Constipation Associated With Irritable Bowel Syndrome (IBS)

summary: Multi-centre, double-blind, randomised, placebo-controlled, parallel group study.

ReferenceCitation: Attar A, Lemann M, Ferguson A, Halphen M, Boutron MC, Flourie B, Alix E, Salmeron M, Guillemot F, Chaussade S, Menard AM, Moreau J, Naudin G, Barthet M. Comparison of a low dose polyethylene glycol electrolyte solution with lactulose for treatment of chronic constipation. Gut. 1999 Feb;44(2):226-30. doi: 10.1136/gut.44.2.226.

lead_sponsor: Norgine

location_country:
Germany
Italy
Poland
United Kingdom
Sweden
Czech Republic
France

location_facility: Katedra i Klinika Gastroenterologii i Hepatologii


title: An Open Label, Non Comparative, Phase III Study of the Raf Kinase Inhibitor BAY 43-9006 as a Subsequent to First Line Therapy in Patients With Advanced Renal Cell Carcinoma

summary:
Purpose of the study:

The purpose of this study is to make sorafenib available for patients with advanced Renal Cell Carcinoma, who have failed prior systemic therapy for advanced disease (i.e. requiring second line treatment), and who do not have access to or are not eligible for other clinical trials with sorafenib and who may benefit from treatment with sorafenib.

Patients will be treated orally with 400 mg bid sorafenib on a continuous basis and as a single agent. Patients may continue treatment until Disease Progression, intolerable toxicity, the patients chooses to withdraw consent or the patient is unlikely to benefit any further from treatment.

Overall, participation in the study will help determine the following:

Find out if patients receiving Sorafenib will live longer
Find out if Sorafenib helps to slow the worsening of kidney cancer
Find out if Sorafenib has an effect on the tumours

location_country:
Germany
Italy
Poland
United Kingdom
Denmark
Sweden
Netherlands
Switzerland
Belgium
Spain
France


title: A Non-Invasive Evaluation of Bone Microarchitecture Modification in Osteopenic Postmenopausal Women by 3D-Peripheral Quantitative Computed Tomography (3D-pQCT)

summary: The primary purpose of the protocol is to evaluate the sensitivity of 3D-pQCT (3D-Peripheral Quantitative Computed Tomography) technology to detect minute changes in bone microarchitecture.

primary_purpose: Prevention

lead_sponsor: Warner Chilcott

location_country:
Germany
United Kingdom
Argentina
Australia
Switzerland
Canada
France


title: An Open, Randomised, Multicentre Clinical Study to Investigate the Safety and Efficacy of Steroid Withdrawal With Tacrolimus, Mycophenolate Mofetil and Daclizumab Against Tacrolimus, Mycophenolate Mofetil and Steroids in Children After Kidney Transplantation

acronym: TWIST

summary: The primary objective of this study is to investigate the impact of early corticosteroid withdrawal in paediatric renal transplant patients on growth expressed as change in height standard deviation score (SDS) from baseline to end of study as the primary endpoint. The expected advantages are reduced growth suppression, lower incidence of arterial hypertension and post transplant diabetes mellitus (PTDM) and improved lipid metabolism, expressed by lower serum lipid values.

lead_sponsor: Astellas Pharma Inc

location_country:
Germany
Italy
Poland
Hungary
Israel
Romania
United Kingdom
Sweden
Belgium
South Africa
Turkey
Taiwan
Czech Republic
France


title: Phase 2 Clinical Trial of Bi-weekly Dosing of Irofulven Plus Capecitabine in Patients With Anaplastic or Locally Advanced/Metastatic Differentiated Thyroid Cancer

summary: Irofulven is an investigational chemotherapeutic agent being studied in a variety of solid tumors. The purpose of this study is to assess the efficacy and safety of irofulven/capecitabine combination therapy in patients with anaplastic, medullary, or locally advanced/metastatic differentiated thyroid cancer.

lead_sponsor: Eisai Inc.

location_country:
Argentina
United States
Peru
Ukraine
Russian Federation
France


title: A Multi-Center Study Comparing the Effects of Two Glucose Control Regimens by Insulin in Intensive Care Unit Patients

summary:
Glucontrol is a prospective, randomized, controlled, multi-centric study. The present study will compare the effects of two regimens of insulin therapy, respectively titrated to achieve a blood sugar level between 4.4 and 6.1 mmol/l (80 and 110 mg/dl, respectively) and between 7.8 and 10.0 mmol/l (140 and 180 mg/dl, respectively).

This project aims at defining whether a tight glucose control by insulin improves the vital outcome in a mixed population of critically ill patients (around 3000 patients).

Secondary outcome variables will include in-hospital and 28-day mortality, lengths of stays in the Intensive Care Unit (ICU) and in the hospital, length of ICU stay without life-support therapy, number and clinical signs of episodes of hypoglycemia, rates of infections and organ failures, and number of red-cell transfusions.

ReferenceCitation: Crosara IC, Melot C, Preiser JC. A J-shaped relationship between caloric intake and survival in critically ill patients. Ann Intensive Care. 2015 Dec;5(1):37. doi: 10.1186/s13613-015-0079-3. Epub 2015 Nov 5.

repository_institution: RePEc: Research Papers in Economics - RePEc

repository_normalized: RePEc

repositories:
PubMed Central
RePEc

repositories_concat: PubMed Central;RePEc

publisher_dissemination: Springer-Nature

ReferenceCitation: Preiser JC, Devos P, Ruiz-Santana S, Melot C, Annane D, Groeneveld J, Iapichino G, Leverve X, Nitenberg G, Singer P, Wernerman J, Joannidis M, Stecher A, Chiolero R. A prospective randomised multi-centre controlled trial on tight glucose control by intensive insulin therapy in adult intensive care units: the Glucontrol study. Intensive Care Med. 2009 Oct;35(10):1738-48. doi: 10.1007/s00134-009-1585-2. Epub 2009 Jul 28.

lead_sponsor: University of Liege

sponsor_collaborators:
University of Liege
Belgian Government

location_country: Germany France Netherlands Switzerland Belgium Spain Israel

location_facility: Centre Hospitalier Universitaire de Liège

lead_sponsor_type: academique


title: A Phase I Study On The Feasibility Of High Dose Three Dimensional Conformal Radiotherapy In Patients With Inoperable And Locally Advanced Non Small Cell Lung Cancer

summary:
RATIONALE: Using computer systems that create a 3-dimensional picture of the tumor to plan treatment may enable doctors to provide more effective radiation therapy that will cause less damage to normal tissue.

PURPOSE: This phase I trial is studying the side effects and best dose of high-dose 3-dimensional conformal radiation therapy in treating patients with inoperable stage I, stage II, or stage IIIA non-small cell lung cancer.

location_country: Switzerland Belgium France

location_facility: Centre Hospitalier Universitaire Vaudois

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

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel


title: A Parallel-group Treatment, Proof-of-concept Phase 2, Multicenter, Double-blind, Randomized Two-arm Clinical Trial to Investigate the Efficacy and Safety of Subcutaneous NT 201 Injections Compared With Placebo Injections in Decreasing Pain Intensity in Male and Female Participants Aged 18 Years and Older With Moderate to Severe Chronic Peripheral Neuropathic Pain Due to Postherpetic Neuralgia or Peripheral Nerve Injury

acronym: PaiNT

summary:
In this clinical trial, participants with nerve pain after shingles or nerve injury will receive injections with NT 201 or placebo. The purpose is to measure the decrease of nerve pain with NT 201 compared to placebo.

Trial details include:

Trial duration: 22-23 weeks;
Treatment duration: 1 injection visit with a 20-week follow-up period;
Visit frequency: 2 remote visits by phone/video call (1 week and 12 weeks after the injection); 2 on-site visits (6 weeks and 20 weeks after the injection).

lead_sponsor: Merz Therapeutics GmbH

location_country: Germany Poland Hungary Spain Bulgaria France

location_facility:
Merz Investigational Site #0360022
Merz Investigational Site #0480112
Merz Investigational Site #0480110
Merz Investigational Site #0490386
Merz Investigational Site #0480107
Merz Investigational Site #0480109
Merz Investigational Site #0360021
Merz Investigational Site #0480111
Merz Investigational Site #0360020
Merz Investigational Site #0490387
Merz Investigational Site #0490389
Merz Investigational Site #0490219
Merz Investigational Site #0480114
Merz Investigational Site #3590004
Merz Investigational Site #0330065
Merz Investigational Site #0340043
Merz Investigational Site #0340044
Merz Investigational Site #0480113
Merz Investigational Site #0340042
Merz Investigational Site #0480115
Merz Investigational Site #3590003
Merz Investigational Site #3590002
Merz Investigational Site #0330067
Merz Investigational Site #3590005
Merz Investigational Site #0330066
Merz Investigational Site #0490174
Merz Investigational Site #0480059
Merz Investigational Site #0480108
Merz Investigational Site #0490388
Merz Investigational Site #0340041

intervention_type: Biological


title: International Registry of Congenital Portosystemic Shunts (IRCPSS) - A Multi-centre, Retrospective and Prospective Registry of Neonates, Children and Adults With Congenital Portosystemic Shunts

acronym: IRCPSS

summary:
Congenital Portosystemic Shunt (CPSS) is a rare condition important by the multiplicity and severity of associated complications.

CPSS is venous anomaly in which blood coming from the intestines only partially passes through the liver.

This leads to the accumulation of potentially toxic factors that cause systemic effects.

Complications vary among the individuals, and currently, it is challenging to predict which individuals will develop severe complications.

The IRCPSS registry is established with the aim of centralizing detailed clinical follow-up and biological information from participants around the world who suffer from Congenital Portosystemic Shunt (CPSS). A multidisciplinary consortium of experts is collaborating to enhance our understanding of the prevalence, natural history, individual risks, and physiopathology of the disease through the IRCPSS registry.

status: Enrolling by invitation

ReferenceCitation: Hanquinet S, Morice C, Courvoisier DS, Cousin V, Anooshiravani M, Merlini L, McLin VA. Globus pallidus MR signal abnormalities in children with chronic liver disease and/or porto-systemic shunting. Eur Radiol. 2017 Oct;27(10):4064-4071. doi: 10.1007/s00330-017-4808-x. Epub 2017 Apr 6.

ReferenceCitation: Cudalbu C, McLin VA, Lei H, Duarte JM, Rougemont AL, Oldani G, Terraz S, Toso C, Gruetter R. The C57BL/6J mouse exhibits sporadic congenital portosystemic shunts. PLoS One. 2013 Jul 23;8(7):e69782. doi: 10.1371/journal.pone.0069782. Print 2013.

ReferenceCitation: Joye R, Lador F, Aggoun Y, Farhat N, Wacker J, Wildhaber BE, Vallee JP, Hachulla AL, McLin VA, Beghetti M. Outcome of paediatric portopulmonary hypertension in the modern management era: A case report of 6 patients. J Hepatol. 2021 Mar;74(3):742-747. doi: 10.1016/j.jhep.2020.11.039. Epub 2020 Dec 1.

ReferenceCitation: McLin V, Beghetti M, D'Antiga L, Franchi-Abella S; International Registry of Congenital Porto-Systemic Shunts (IRCPSS). Current Quandaries in the Management of Congenital Portosystemic Shunts. Liver Transpl. 2021 Aug;27(8):1212-1213. doi: 10.1002/lt.26055. Epub 2021 Jul 20. No abstract available.

ReferenceCitation: Korff S, Mostaguir K, Beghetti M, D'Antiga L, Debray D, Franchi-Abella S, Gonzales E, Guerin F, Hachulla AL, Lambert V, Makrythanasis P, Roduit N, Savale L, Senat MV, Spaltenstein J, van Steenbeek F, Wildhaber BE, Zwahlen M, McLin VA. International registry of congenital porto-systemic shunts: a multi-centre, retrospective and prospective registry of neonates, children and adults with congenital porto-systemic shunts. Orphanet J Rare Dis. 2022 Jul 19;17(1):284. doi: 10.1186/s13023-022-02412-8.

ReferenceCitation: Lambert V, Ladarre D, Fortas F, Durand P, Herve P, Gonzales E, Guerin F, Savale L, McLin VA, Ackermann O, Franchi-Abella S; International Registry of Congenital Portosystemic Shunts (IRCPSS). Cardiovascular disorders in patients with congenital portosystemic shunts: 23 years of experience in a tertiary referral centre. Arch Cardiovasc Dis. 2021 Mar;114(3):221-231. doi: 10.1016/j.acvd.2020.10.003. Epub 2020 Dec 3.

ReferenceCitation: McLin VA, D'Antiga L. The current pediatric perspective on type B and C hepatic encephalopathy. Anal Biochem. 2022 Apr 15;643:114576. doi: 10.1016/j.ab.2022.114576. Epub 2022 Jan 29.

ReferenceCitation: McLin VA, Franchi Abella S, Debray D, Guerin F, Beghetti M, Savale L, Wildhaber BE, Gonzales E; Members of the International Registry of Congenital Porto-Systemic Shunts. Congenital Portosystemic Shunts: Current Diagnosis and Management. J Pediatr Gastroenterol Nutr. 2019 May;68(5):615-622. doi: 10.1097/MPG.0000000000002263.

ReferenceCitation: Bahadori A, Kuhlmann B, Debray D, Franchi-Abella S, Wacker J, Beghetti M, Wildhaber BE, McLin VA, On Behalf Of The Ircpss. Presentation of Congenital Portosystemic Shunts in Children. Children (Basel). 2022 Feb 11;9(2):243. doi: 10.3390/children9020243.

ReferenceCitation: Guerin F, Franchi Abella S, McLin V, Ackermann O, Girard M, Cervoni JP, Savale L, Hernandez-Gea V, Valla D, Hillaire S, Dutheil D, Bureau C, Gonzales E, Plessier A. Congenital portosystemic shunts: Vascular liver diseases: Position papers from the francophone network for vascular liver diseases, the French Association for the Study of the Liver (AFEF), and ERN-rare liver. Clin Res Hepatol Gastroenterol. 2020 Sep;44(4):452-459. doi: 10.1016/j.clinre.2020.03.004. Epub 2020 Apr 9. No abstract available.

ReferenceCitation: Rock NM, Beghetti M, Tissot C, Willi JP, Bouhabib M, McLin VA, Maggio ABR. Reliable Detection of Intrapulmonary Shunts Using Contrast-Enhanced Echocardiography in Children With Portal Hypertension or Portosystemic Shunt. J Pediatr Gastroenterol Nutr. 2021 Jul 1;73(1):73-79. doi: 10.1097/MPG.0000000000003079.

ipd_sharing_description: undecided

lead_sponsor: Prof. Valérie Mc Lin

collaborators: European Society of Pediatric Gastroenterology, Hepatology and Nutrition

collaborators: European Association for the Study of the Liver (EASL)

location_country:
Germany
Italy
India
Hungary
Israel
United Kingdom
Australia
Japan
Netherlands
Switzerland
Belgium
United States
Spain
Greece
Turkey
Canada
France

location_facility: National Center for Child Health and Development

location_facility: Royal Hospital for Children and Young People

location_facility: First Department of Pediatrics, Semmelweis University

location_facility: Schneider Children's Medical Center of Israel

location_facility: Istituto di Ricovero e Cura a Carattere Scientifico (ISMETT)

location_facility: Hôpital Bicêtre-Hôpitaux Universitaires Paris-Sud- Assistance Publique Hôpitaux de Paris.

location_facility: Department of Pediatric Hepatology Institute of Liver and Biliary Sciences


title: An Open-label, Multicenter, Single-arm, Post-marketing Trial (in Select Countries) to Evaluate Efficacy and Safety and the Impact of Immunogenicity on Efficacy, Safety, and Pharmacokinetics of Spesolimab i.v. in Treatment of Patients With Generalized Pustular Psoriasis Presenting With a Recurrent Flare Following Their Initial GPP Flare Treatment With Spesolimab i.v.

summary:
This study is open to adults with a serious skin disease called generalized pustular psoriasis (GPP) who have repeated flares of GPP. The purpose of this study is to find out whether a medicine called spesolimab helps people with repeated flares of GPP.

Participants are given a single dose of spesolimab as an infusion into a vein on the first day of an outbreak of GPP. They may be given a second dose 1 week later if doctors think it is helpful. They are also treated for additional GPP flares.

During the time of the study, doctors regularly examine participants' skin for signs of GPP to see how well the treatment works and take blood samples. The doctors also regularly check participants' health and take note of any unwanted effects.

ipd_sharing_description:
Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

location_country:
Germany
Italy
Singapore
Australia
Belgium
Korea, Republic of
China
Spain
Thailand
Malaysia
Taiwan
France

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Southern Medical University Dermatology Hospital


title: A Randomized, Open-labelled, Crossover Study Confirming Performance of a New Single-use Compact Intermittent Catheter in a Population of Adult Female Intermittent Catheter Users

summary: A multi-centre, open-labelled, randomised, crossover design. The total study duration for the individual subject will be approximately 4 weeks, consisting of four site visits and two 2-week test periods at home. Visits 0 and 1 can be performed on the same day. For visit 2 and 3, 2 catheterisations will be performed in a hospital setting (one HCP catheterisation and one self-catheterisation) for bladder emptying and user experience assessments. Visit 1 and 2 are followed by a home-use test period, followed by visit 3 which terminates the study.

lead_sponsor: Coloplast A/S

location_country:
Denmark
United Kingdom
France

location_facility:
Addenbrookes
CHU Toulouse Rangueil
North Bristol NHS Trust
Hôpital Tenon
Odense Universitetshospital
Rigshopsitalet
Synexus Birmingham
Sanos Clinic Vejle
Hôpital Saint- Philibert
Sanos Clinic
Synexus Merseyside


title: Ground-Breaking Electroporation-based Intervention for PERSistent Atrial Fibrillation Treatment (BEAT PERS-AF)

acronym: BEAT PERS-AF

summary: BEAT AF is a randomized controlled trial aiming to assess the efficacy and the safety of pulsed field energy in persistent AF ablation

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: University Hospital, Bordeaux

sponsor_collaborators:
University Hospital, Bordeaux
Horizon 2020 - European Commission

location_country: Germany Austria Belgium Czechia France

location_facility: Institute for Clinical and Experimental Medicine


title: Ground-Breaking Electroporation-based Intervention for PAROXysmal Atrial Fibrillation Treatment (BEAT PAROX-AF)

acronym: BEAT PAROX-AF

summary: BEAT AF is a randomized controlled trial aiming to demonstrate that pulsed field energy is faster, more effective and safer (tissue selectivity) than RF for paroxysmal AF ablation

sponsor_collaborators:
University Hospital, Bordeaux
Funding: European Commission (H2020)


title: Prospective Longitudinal Study of Neurological Disease Trajectory in Children Living With Late-Infantile or Juvenile Onset of GM1 or GM2 Gangliosidosis

acronym: PRONTO

summary: The study aims to characterize prospectively longitudinal progression of neurological domains in GM1 and GM2 Gangliosidosis patients with high-quality standards (GCP compliant).

lead_sponsor: Azafaros A.G.

location_country:
Germany
Italy
United Kingdom
Brazil
United States
France

location_facility: Universtitäsklinikum Giessen und Marburg

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta

location_facility: Armand-Trousseau Children's Hospital - CHU Paris Est

location_facility: Hôpital des Enfants - CHU Toulouse Purpan

location_facility: LMU - Klinikum der Universitaet Muenchen - Neurologische Klinik und Poliklinik


title: A Phase II Study of Intratumoral Injection of LTX-315 in Combination With Pembrolizumab in Patients With Percutaneously Accessible Lesions With Advanced Melanoma Refractory to Pembrolizumab

summary: ATLAS-IT-05 is an open-label, single-arm study in patients with advanced melanoma accessible for injections (cutaneous, subcutaneous, lymph node, or intramuscular tumors) and who have either exhausted treatment options or are not eligible for, suitable for, or willing to undergo such treatments.

ReferenceCitation: Camilio KA, Rekdal O, Sveinbjornsson B. LTX-315 (Oncopore): A short synthetic anticancer peptide and novel immunotherapeutic agent. Oncoimmunology. 2014 Jun 25;3:e29181. doi: 10.4161/onci.29181. eCollection 2014.

ReferenceCitation: Sveinbjornsson B, Camilio KA, Haug BE, Rekdal O. LTX-315: a first-in-class oncolytic peptide that reprograms the tumor microenvironment. Future Med Chem. 2017 Aug;9(12):1339-1344. doi: 10.4155/fmc-2017-0088. Epub 2017 May 11.

ReferenceCitation: Jebsen NL, Apelseth TO, Haugland HK, Rekdal O, Patel H, Gjertsen BT, Jossang DE. Enhanced T-lymphocyte infiltration in a desmoid tumor of the thoracic wall in a young woman treated with intratumoral injections of the oncolytic peptide LTX-315: a case report. J Med Case Rep. 2019 Jun 10;13(1):177. doi: 10.1186/s13256-019-2088-6.

repository_institution: University of Oslo - Duo Research Archive

repositories_concat: PubMed Central;munin.uit.no

ReferenceCitation: Spicer J, Marabelle A, Baurain JF, Jebsen NL, Jossang DE, Awada A, Kristeleit R, Loirat D, Lazaridis G, Jungels C, Brunsvig P, Nicolaisen B, Saunders A, Patel H, Galon J, Hermitte F, Camilio KA, Mauseth B, Sundvold V, Sveinbjornsson B, Rekdal O. Safety, Antitumor Activity, and T-cell Responses in a Dose-Ranging Phase I Trial of the Oncolytic Peptide LTX-315 in Patients with Solid Tumors. Clin Cancer Res. 2021 May 15;27(10):2755-2763. doi: 10.1158/1078-0432.CCR-20-3435. Epub 2021 Feb 4.

evidence: oa repository (via page says license)

lead_sponsor: Lytix Biopharma AS

collaborators:
Laboratory Corporation of America
OWL

sponsor_collaborators:
Lytix Biopharma AS
Laboratory Corporation of America
OWL

location_country:
United States
Spain
Norway
France

location_facility: University of Pittsburgh Medical Center (UPMC) Hilman Cancer Center

location_facility: Centre Hospitalier Regional Universitaire De Lille

intervention_type: Combination Product


title: An Open-Label, Randomized, Phase 2, Umbrella Study to Investigate the Biological Rational of Various Neoadjuvant Therapies for Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Cisplatin-Ineligible or Refuse Cisplatin Therapy and Undergoing Radical Cystectomy

acronym: Optimus

summary: This is a multicenter, open-label, randomized, Phase 2 umbrella study of various neoadjuvant treatment combinations in participants who have muscle-invasive urothelial carcinoma of the bladder and are cisplatin-ineligible or refusing cisplatin therapy and awaiting radical cystectomy.

ipd_sharing_description:
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

lead_sponsor: Incyte Corporation

location_country:
United States
Italy
France

location_facility: Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele

location_facility: Hopital Europeen Georges Pompidou (Hegp)

location_facility: Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari

location_facility: Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma)

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

location_facility: Ohio State University Medical Center Division of H


acronym: ESsCOVID

lead_sponsor: Biotest

summary:
The objectives of the trial are to evaluate the efficacy and safety of trimodulin as add-on therapy to standard of care (SoC) compared to placebo treatment in adult hospitalized subjects with severe COVID-19.

Additionally, pharmacodynamic (PD) and pharmacokinetic (PK) properties of trimodulin will be evaluated in all subjects.

location_facility:
Investigational site # 5505
Investigational Site # 3301
Investigational site # 0707
Investigational Site # 3401
Investigational site # 3304
Investigational site # 5503
Investigational site # 0702
Investigational site # 0711
Investigational site # 0709
Investigational site # 5502
Investigational Site # 3402
Investigational site # 3305
Investigational site # 0706
Investigational Site # 0704
Investigational site # 0701
Investigational site # 5501
Investigational site # 0708

title: A Randomized, Placebo-controlled, Double-blind, Multi-center, Phase II Trial Investigating the Efficacy and Safety of Trimodulin (BT588) as add-on Therapy to Standard of Care in Adult Subjects With Severe COVID-19

location_country:
Spain
Brazil
Russian Federation
France


title: An Open-Label, Multicenter, Phase I Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of Forimtamig (RO7425781) in Participants With Relapsed or Refractory Multiple Myeloma

summary: This is a first-in-human, open-label, uncontrolled, multi-center, monotherapy, dose-escalation and dose expansion study. Forimtamig will be administered to participants with r/r MM for whom no standard-of-care treatment exists or who are intolerant to those established therapies. The study consists of two parts: dose-escalation of forimtamig (Part 1) and a randomized dose expansion of forimtamig (Part 2).

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).

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
New Zealand
United Kingdom
Denmark
Australia
Belgium
Korea, Republic of
Spain
France

location_facility: Hospital Clinico Universitario de Salamanca;Servicio de Hematologia

location_facility: New Zealand Clinical Research - Auckland

location_facility: Rigshospitalet; Hæmatologisk Klinik, Klinisk Afprøvnings Team KAT

location_facility: Odense Universitetshospital; Hæmatologisk Afdeling

location_facility: University College London Hospitals NHS Foundation Trust; NIHR UCLH Clinical Research Facility

location_facility: IRCCS Istituto Nazionale dei Tumori di Napoli - Pascale Ematologia Oncologica

location_facility: Policlinico S.Orsola-Malpighi;Istituto di Ematologia "Seragnoli"

location_facility: Hopital De Haut Leveque; Hematologie Clinique

location_facility: CHRU Lille - Hôpital Claude Huriez; Service des Maladies du Sang

location_facility: Clinica Universitaria de Navarra; Servicio de Hematologia

location_facility: St James University Hospital; Institute of Oncology

location_facility: Fond. IRCCS Istituto Nazionale Tumori; S. C. Ematologia

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Hematologia

location_facility: Instituto Clinico Humanitas; Med Onc & Hemat

location_facility: CHU NANTES - Hôtel Dieu; Service d'Hematologie Clinique


title: A Phase 1b/2 Clinical Study of Intratumoral Administration of V937 in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors

summary: The purpose of this study is to evaluate the safety, tolerability, and efficacy in participants with advanced/metastatic or recurrent malignancies who receive gebasaxturev (V937) in combination with pembrolizumab (MK-3475). The primary objective for Part 1 is to evaluate the objective response rate, and the primary objective for Part 2 is to determine the safety and tolerability of gebasaxturev administered in combination with pembrolizumab. With Amendment 4, this study will be terminated once all participants who have completed or discontinued gebasaxturev treatment and are only receiving pembrolizumab may be enrolled in a pembrolizumab extension study, if available, to continue pembrolizumab monotherapy for up to 35 cycles from first pembrolizumab dose on V937-013.

ReferenceCitation: Deng JZ, Rustandi RR, Barbacci D, Swartz AR, Gulasarian A, Loughney JW. Reverse-Phase Ultra-Performance Chromatography Method for Oncolytic Coxsackievirus Viral Protein Separation and Empty to Full Capsid Quantification. Hum Gene Ther. 2022 Jul;33(13-14):765-775. doi: 10.1089/hum.2022.013. Epub 2022 Jun 1.

publisher_dissemination: Mary Ann Liebert Inc

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Germany
Italy
Poland
Portugal
Hungary
Israel
Norway
Japan
United States
Spain
Taiwan
Peru
Canada
France

location_facility: Istituto Europeo di Oncologia IRCCS-Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative (

location_facility: Chang Gung Memorial Hospital - Linkou Branch ( Site 0146)

location_facility: Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria ( Site 0192)

location_facility: Hadassah Medical Center. Ein Kerem ( Site 0072)

location_facility: Clinica Universitaria de Navarra ( Site 0122)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0032)

location_facility: Centre Hospitalier Lyon-Sud ( Site 0055)

location_facility: Providence Portland Medical Center ( Site 0001)

location_facility: National Cancer Center Hospital East ( Site 0166)

location_facility: Chang Gung Medical Foundation - Kaohsiung ( Site 0145)

location_facility: Helse Bergen HF - Haukeland Universitetssykehus ( Site 0162)

location_facility: Princess Margaret Cancer Centre ( Site 0031)

location_facility: Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 0191)

location_facility: Oslo Universitetssykehus Radiumhospitalet ( Site 0161)

location_facility: Universitaetsklinikum Heidelberg-Nationales Centrum für Tumorerkrankungen ( Site 0172)

location_facility: China Medical University Hospital ( Site 0144)

location_facility: National Taiwan University Hospital ( Site 0141)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 0181

location_facility: Universitaetsklinikum Tuebingen ( Site 0171)

location_facility: National Cheng Kung University Hospital ( Site 0142)

location_facility: Hospital Universitari Vall d Hebron ( Site 0121)

location_facility: Orszagos Onkologiai Intezet ( Site 0070)


title: A Phase I Open Label Followed by a Phase II Randomized, Controlled Study to Assess the Efficacy and Safety of ABTL0812 in Combination With FOLFIRINOX for First-line Treatment of Metastatic Pancreatic

acronym: PanC-ASAP

summary: A Phase I open label followed by a Phase II randomized, controlled study to assess the efficacy and safety of ABTL0812 in combination with FOLFIRINOX for first-line treatment of metastatic pancreatic. Funded by: FDA OOPD (Grant #FD-R-006817-01), H2020 EIC Accelerator (Grant #954825) and Ability Pharmaceuticals SL.

ReferenceCitation: Erazo T, Lorente M, Lopez-Plana A, Munoz-Guardiola P, Fernandez-Nogueira P, Garcia-Martinez JA, Bragado P, Fuster G, Salazar M, Espadaler J, Hernandez-Losa J, Bayascas JR, Cortal M, Vidal L, Gascon P, Gomez-Ferreria M, Alfon J, Velasco G, Domenech C, Lizcano JM. The New Antitumor Drug ABTL0812 Inhibits the Akt/mTORC1 Axis by Upregulating Tribbles-3 Pseudokinase. Clin Cancer Res. 2016 May 15;22(10):2508-19. doi: 10.1158/1078-0432.CCR-15-1808. Epub 2015 Dec 15.

ReferenceCitation: Munoz-Guardiola P, Casas J, Megias-Roda E, Sole S, Perez-Montoyo H, Yeste-Velasco M, Erazo T, Dieguez-Martinez N, Espinosa-Gil S, Munoz-Pinedo C, Yoldi G, Abad JL, Segura MF, Moran T, Romeo M, Bosch-Barrera J, Oaknin A, Alfon J, Domenech C, Fabrias G, Velasco G, Lizcano JM. The anti-cancer drug ABTL0812 induces ER stress-mediated cytotoxic autophagy by increasing dihydroceramide levels in cancer cells. Autophagy. 2021 Jun;17(6):1349-1366. doi: 10.1080/15548627.2020.1761651. Epub 2020 May 25.

ReferenceCitation: Felip I, Moiola CP, Megino-Luque C, Lopez-Gil C, Cabrera S, Sole-Sanchez S, Munoz-Guardiola P, Megias-Roda E, Perez-Montoyo H, Alfon J, Yeste-Velasco M, Santacana M, Dolcet X, Reques A, Oaknin A, Rodriguez-Freixinos V, Lizcano JM, Domenech C, Gil-Moreno A, Matias-Guiu X, Colas E, Eritja N. Therapeutic potential of the new TRIB3-mediated cell autophagy anticancer drug ABTL0812 in endometrial cancer. Gynecol Oncol. 2019 May;153(2):425-435. doi: 10.1016/j.ygyno.2019.03.002. Epub 2019 Mar 7.

ReferenceCitation: Lopez-Plana A, Fernandez-Nogueira P, Munoz-Guardiola P, Sole-Sanchez S, Megias-Roda E, Perez-Montoyo H, Jauregui P, Yeste-Velasco M, Gomez-Ferreria M, Erazo T, Ametller E, Recalde-Percaz L, Moragas-Garcia N, Noguera-Castells A, Mancino M, Moran T, Nadal E, Alfon J, Domenech C, Gascon P, Lizcano JM, Fuster G, Bragado P. The novel proautophagy anticancer drug ABTL0812 potentiates chemotherapy in adenocarcinoma and squamous nonsmall cell lung cancer. Int J Cancer. 2020 Aug 15;147(4):1163-1179. doi: 10.1002/ijc.32865. Epub 2020 Feb 6.

ReferenceCitation: Vidal L, Victoria I, Gaba L, Martin MG, Brunet M, Colom H, Cortal M, Gomez-Ferreria M, Yeste-Velasco M, Perez A, Rodon J, Sohal DPS, Lizcano JM, Domenech C, Alfon J, Gascon P. A first-in-human phase I/Ib dose-escalation clinical trial of the autophagy inducer ABTL0812 in patients with advanced solid tumours. Eur J Cancer. 2021 Mar;146:87-94. doi: 10.1016/j.ejca.2020.12.019. Epub 2021 Feb 12.

ReferenceCitation: Paris-Coderch L, Soriano A, Jimenez C, Erazo T, Munoz-Guardiola P, Masanas M, Antonelli R, Boloix A, Alfon J, Perez-Montoyo H, Yeste-Velasco M, Domenech C, Roma J, Sanchez de Toledo J, Moreno L, Lizcano JM, Gallego S, Segura MF. The antitumour drug ABTL0812 impairs neuroblastoma growth through endoplasmic reticulum stress-mediated autophagy and apoptosis. Cell Death Dis. 2020 Sep 17;11(9):773. doi: 10.1038/s41419-020-02986-w.

ReferenceCitation: Mancini A, Colapietro A, Cristiano L, Rossetti A, Mattei V, Gravina GL, Perez-Montoyo H, Yeste-Velasco M, Alfon J, Domenech C, Festuccia C. Anticancer effects of ABTL0812, a clinical stage drug inducer of autophagy-mediated cancer cell death, in glioblastoma models. Front Oncol. 2022 Nov 2;12:943064. doi: 10.3389/fonc.2022.943064. eCollection 2022.

ReferenceCitation: Polonio-Alcala E, Sole-Sanchez S, Munoz-Guardiola P, Megias-Roda E, Perez-Montoyo H, Yeste-Velasco M, Alfon J, Lizcano JM, Domenech C, Ruiz-Martinez S, Puig T. ABTL0812 enhances antitumor effect of paclitaxel and reverts chemoresistance in triple-negative breast cancer models. Cancer Commun (Lond). 2022 Jun;42(6):567-571. doi: 10.1002/cac2.12282. Epub 2022 Mar 16. No abstract available.

repository_institution: Universitat de Girona - Universitat de Girona Digital Repository

repositories_concat: PubMed Central;dugi-doc.udg.edu

lead_sponsor: Ability Pharmaceuticals SL

location_country:
United States
Israel
Spain
France

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Hospital General Universitario Dr. Balmis


title: An Evaluation of Effectiveness and Safety of the CorPath® GRX System in Endovascular Embolization Procedures of Cerebral Aneurysms

summary: The primary objective of this study is to evaluate the effectiveness and safety of robotic-assisted endovascular embolization procedures compared to objective performance criteria for traditional, manual operation based on the scientific literature.

ReferenceCitation: Lawton MT, Vates GE. Subarachnoid Hemorrhage. N Engl J Med. 2017 Jul 20;377(3):257-266. doi: 10.1056/NEJMcp1605827. No abstract available.

ReferenceCitation: Lantigua H, Ortega-Gutierrez S, Schmidt JM, Lee K, Badjatia N, Agarwal S, Claassen J, Connolly ES, Mayer SA. Subarachnoid hemorrhage: who dies, and why? Crit Care. 2015 Aug 31;19(1):309. doi: 10.1186/s13054-015-1036-0.

ReferenceCitation: Connolly ES Jr, Rabinstein AA, Carhuapoma JR, Derdeyn CP, Dion J, Higashida RT, Hoh BL, Kirkness CJ, Naidech AM, Ogilvy CS, Patel AB, Thompson BG, Vespa P; American Heart Association Stroke Council; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular Nursing; Council on Cardiovascular Surgery and Anesthesia; Council on Clinical Cardiology. Guidelines for the management of aneurysmal subarachnoid hemorrhage: a guideline for healthcare professionals from the American Heart Association/american Stroke Association. Stroke. 2012 Jun;43(6):1711-37. doi: 10.1161/STR.0b013e3182587839. Epub 2012 May 3.

ReferenceCitation: Steiner T, Juvela S, Unterberg A, Jung C, Forsting M, Rinkel G; European Stroke Organization. European Stroke Organization guidelines for the management of intracranial aneurysms and subarachnoid haemorrhage. Cerebrovasc Dis. 2013;35(2):93-112. doi: 10.1159/000346087. Epub 2013 Feb 7.

ReferenceCitation: Keedy A. An overview of intracranial aneurysms. Mcgill J Med. 2006 Jul;9(2):141-6.

ipd_sharing_description: No plan to share IPD.

lead_sponsor: Corindus Inc.

location_country: Australia Switzerland Austria Spain Canada France

location_facility: CHU Montpellier - Hôpital Gui de Chauliac

location_facility: University Clinical Hospital of Valladolid


title: A Phase I Open Label First in Human Dose Escalation of the Immunoproteasome Inhibitor M3258 as a Single Agent and Expansion Study of M3258 in Combination With Dexamethasone in Participants With Relapsed Refractory Multiple Myeloma

summary: The purpose of this study was to determine the safety, tolerability, pharmacokinetics, pharmacodynamics and early efficacy signs of M3258 as a single agent and co-administered with dexamethasone in participants with Relapsed Refractory Multiple Myeloma (RRMM).

ReferenceCitation: Sanderson MP, Friese-Hamim M, Walter-Bausch G, Busch M, Gaus S, Musil D, Rohdich F, Zanelli U, Downey-Kopyscinski SL, Mitsiades CS, Schadt O, Klein M, Esdar C. M3258 Is a Selective Inhibitor of the Immunoproteasome Subunit LMP7 (beta5i) Delivering Efficacy in Multiple Myeloma Models. Mol Cancer Ther. 2021 Aug;20(8):1378-1387. doi: 10.1158/1535-7163.MCT-21-0005. Epub 2021 May 27.

ipd_sharing_description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website http://bit.ly/IPD21

lead_sponsor: EMD Serono Research & Development Institute, Inc.

location_country:
United States
France

location_facility: Centre Hospitalier Regional Universitaire de Lille

location_facility: Georgetown University Medical Center- Research Parent


title: A First-in-Human Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of JNJ-74699157 in Participants With Advanced Solid Tumors Harboring the KRAS G12C Mutation

summary: The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of JNJ-74699157 in participants with advanced solid tumors harboring a kirsten rat sarcoma virus homolog (KRAS) glycine-to-cysteine (G12C) mutation (Part 1: Dose escalation) and to determine the safety and preliminary antitumor activity of JNJ-74699157 at the RP2D regimen in participants with advanced solid tumors harboring a KRAS G12C mutation (Part 2: Dose expansion).

ReferenceCitation: Wang J, Martin-Romano P, Cassier P, Johnson M, Haura E, Lenox L, Guo Y, Bandyopadhyay N, Russell M, Shearin E, Lauring J, Dahan L. Phase I Study of JNJ-74699157 in Patients with Advanced Solid Tumors Harboring the KRAS G12C Mutation. Oncologist. 2022 Jul 5;27(7):536-e553. doi: 10.1093/oncolo/oyab080.

ipd_sharing_description:
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

location_facility: H. Lee Moffitt Cancer & Research Institute


title: International, Non-interventional, Post-Authorization Long-Term Safety Study of Lutathera, in Patients With Unresectable or Metastatic, Well-Differentiated, Somatostatin Receptor Positive, Gastroenteropancreatic Neuroendocrine Tumours

acronym: SALUS

summary: Study to assess the long-term safety of LUTATHERA for the labeled indication (SmPC/USPI).

lead_sponsor: Advanced Accelerator Applications

location_country:
Portugal
United Kingdom
United States
Spain
France

location_facility: Oregon Health & Sciences University Hospital

location_facility: The Ohio State University Wexner Medical Center


title: An International Phase Ib Multicentre Study to Characterize the Safety and Tolerability of Intravenously Administered S64315, a Selective Mcl-1 Inhibitor, in Combination With Orally Administered Venetoclax, a Selective Bcl-2 Inhibitor in Patients With Acute Myeloid Leukaemia (AML).

summary: The purpose of this study is to determine the safety profile, tolerability and the Recommended Phase 2 Dose of the combination S64315 with venetoclax in patients with Acute Myeloid Leukaemia.

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: Institut de Recherches Internationales Servier

location_country:
United States
Australia
France

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole

location_facility: The Alfred Hospital Department of Haematology

location_facility: The University of Texas MD Anderson Cancer Center, Houston, TX