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

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

lead_sponsor: Gilead Sciences

location_country:
United States
France

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

location_facility: Centre Hospitalier Universitaire de Dijon Hôpital du Bocage


type: EudraCT Number

type: Other Grant/Funding Number

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

acronym: INNOVATION

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

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ReferenceType: derived

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

ReferenceCitation: Integration of Trastuzumab, with or without Pertuzumab, into Perioperative Chemotherapy of HER2- Positive Stomach Cancer: The INNOVATION Trial (EORTC-1203-GITCG). Oncol Res Treat. 2016;39(3):153-4; discussion 155.

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

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

location_facility: Hospital Clinico Universitario De Valencia (ES 372)

location_facility: Centre Hospitalier Universitaire Vaudois (CH 457)

location_facility: Royal Marsden Hospital - site: Sutton, Surrey (UK 616)

location_facility: The Catholic University of Korea-St. Vincent's Hospital (KR 1189)

location_facility: Ludwig-Maximilians-Universitaet München - Campus Grosshadern

location_facility: Hôpitaux universitaires de Genève - HUG (CH 451)

location_facility: Asklepios Kliniken GmbH - Asklepios Klinik Barmbek

location_facility: Universitaetsmedizin Goettingen - Georg-August Universitaet

location_facility: Instituto Portugues De Oncologia - Centro Do Porto (PT 804)

location_facility: Royal Marsden Hospital - site: London Chelsea (UK 613)

location_facility: Hospital General Vall D'Hebron - Institut Oncologia (ES 371)

location_facility: Azienda Ospedaliera Ordine Mauriziano di Torino (IT 3902)

location_facility: Johannes Gutenberg Universitaetskliniken - Mainz University Medical Center

location_facility: Hallym University Sacred Heart Hospital (KR 1286)

location_facility: ICO Girona - Hospital Dr Josep Trueta (Institut Catala d'Oncologia) (ES 6282)

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

location_facility: University Hospitals Birmingham NHS - UHB-Queen Elisabeth MC (UK 629)

location_facility: ICO Badalona (Institut Catala d'Oncologia) - Hospital Germans Trias i Pujol (ES 381)

location_facility: National Cancer Centre Singapore (SG 8600)

location_facility: Academisch Medisch Centrum - UMC Universiteit van Amsterdam - site: VUMC (NL 308)

location_facility: Oslo University Hospital - Radiumhospitalet (NO 845)

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

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

location_facility: University College London Hospitals NHS Foundation Trust (UK 622)

location_facility: Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum

location_facility: Hospital Universitario Ramon y Cajal (ES 360)

location_facility: Institut Catala d'Oncologia - ICO L'Hospitalet (ES 6225)

location_facility: Technische Universität München - Klinikum Rechts der Isar

location_facility: Leiden University Medical Centre (NL 310)

location_facility: Azienda Ospedaliera Papa Giovanni XXIII (IT 882)

intervention_type: Procedure

lead_sponsor_type: industriel

status_simplified: Ongoing


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

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

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

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

enrollment_type: Actual

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

ipd_sharing: Yes

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

lead_sponsor: AstraZeneca

location_country:
Spain
Korea, Republic of
United States
France
Belgium


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

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

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

status: Completed

study_completion_date_type: Actual

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

lead_sponsor: Vaxon Biotech

location_country: Poland Spain Italy Greece France Romania Germany Czechia

location_facility: University General Hospital Papageorgiou

location_facility: Chirurgische Klinik-Inderdisziplinäre Thorakale Oncologie

location_facility: Oddział Onkologii z Pododdziałem Chemioterapii Nowotworów Płuc

location_facility: Seconda Universita degli Studi Napoli Hospital

location_facility: Specjalistyczny Szpital im. prof.Alfreda Sokołowskiego

location_facility: Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy w Otwocku

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

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

location_facility: Spitalul Clinic Judetean de Urgenta Sibiu

location_facility: Mathias Spital Rheine Medizinische Klinik V

location_facility: General hospital of thoracic diseases Sotiria

location_facility: Mühlenkreiskliniken (AöR) Johannes Wesling Klinikum Minden

location_facility: Fundacja Hospicjum Onkologiczne św. Krzysztofa

location_facility: Oncomed SRL, Department of Medical Oncology

location_facility: General Oncology Hospital of Kifissia Agioi Anargyroi

location_facility: Spitalul Universitar de Urgenta Bucuresti

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

intervention_type: Drug

status_simplified: Completed


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

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

study_type: Observational

time_perspective: Prospective

lead_sponsor: Shire

location_country:
Spain
Italy
United Kingdom
France
Belgium
Germany

location_facility: Klinikum rechts der Isar der technischen Universität München


acronym: CREATE

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

source: euctr

design_allocation: Non-Randomized

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

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

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

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

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

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

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

location_facility: Nottingham University Hospitals NHS Trust - City Hospital

location_facility: Radboud University Nijmegen Medical Centre

location_facility: Maria Sklodowska-Curie Memorial Cancer Centre

location_facility: Hôpitaux Universitaires Bordet-Erasme - Institut Jules Bordet

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Oslo University Hospital - Radiumhospitalet

location_facility: Klinikum Grosshadern Ludwig-Maximilians Univ. Muenchen

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


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

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

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

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

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

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

lead_sponsor: Hoffmann-La Roche

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Centre Leon Berard; Departement Oncologie Medicale


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

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

lead_sponsor: Kythera Biopharmaceuticals


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

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

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

lead_sponsor: GlaxoSmithKline

location_country: Denmark Sweden France Norway Germany


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

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country: Poland Spain Italy France Belgium Germany


acronym: CERTAIN

intervention_type: Biological

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

lead_sponsor: UCB Pharma

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

location_country: Poland Italy Austria France Germany

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


type: Other Identifier

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

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

lead_sponsor: Centocor, Inc.

location_country:
Netherlands
France
Czech Republic
United Kingdom


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

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

time_perspective: Retrospective

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

location_country:
Brazil
United Kingdom
Thailand
France
South Africa
Norway
Sweden


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

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

lead_sponsor: Bayer

location_country: Poland Portugal Spain Italy France Belgium Netherlands


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

acronym: INTEGRATED

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

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

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

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

lead_sponsor: Takeda

location_country: Austria Germany France Greece

location_facility: Klinikum rechts der Isa der Technischen Universitaet Muenchen

location_facility: Centre Hospitalier Universitaire Hopitaux de Rouen

location_facility: Medizinische Universitat Wien (Medical University of Vienna)


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

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

status: Recruiting

ipd_sharing: No

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

location_country:
United States
Italy
Spain
France

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

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

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

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

location_facility: Hospital Universitario La Fe; Servicio de Farmacia

location_facility: Azienda Ospedaliero Universitaria Pisana-Ospedale Santa Chia

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

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

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


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

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

lead_sponsor: Spyryx Biosciences, Inc.

location_country:
Portugal
United Kingdom
Italy
Canada
France

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

location_facility: Liverpool Heart and Chest Hospital NHS Foundation Trust

location_facility: University Hospitals Bristol NHS Foundation Trust

location_facility: Assistance Publique-Hôpitaux de Paris Hôpital Cochin

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Royal Devon and Exeter NHS Foundation Trust

location_facility: University of Calgary Heritage Medical Research Center

location_facility: University Hospital of South Manchester NHS Foundation Trust

location_facility: Royal Brompton and Harefield NHS Foundation Trust

location_facility: Istituto Giannina Gaslini Ospedale Pediatrico

location_facility: Barts Health NHS Trust Saint Bartholomews Hospital


primary_purpose: Prevention

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

lead_sponsor: Janssen Vaccines & Prevention B.V.

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

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


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

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

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

ReferenceType: background

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

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

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

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

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

location_country:
Spain
Italy
United States
France
Germany

location_facility: Midway Immunology & Research Center, LLC

location_facility: Hospital Universitario 12 de Octubre - Hospital

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Fondazione IRCCS San Raffaele del Monte Tabor

location_facility: Comprensorio Amedeo Di Savoia Birago Di Vische

location_facility: ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco

location_facility: CHU Tours Service de Médecine Internes et Maladies Infectieuses


title: A Phase 2, Open-label Study to Investigate the Efficacy and Safety of the Combination of Simeprevir and Daclatasvir in Chronic Hepatitis C Genotype 1b-Infected Subjects

acronym: COMMIT

summary: The purpose of this study is to determine the efficacy of a 12- or 24-week treatment regimen of simeprevir in combination with daclatasvir, as measured by sustain virologic response 12 (SVR12), in treatment-naive, chronic hepatitis C virus (HCV) genotype 1b-infected participants who have advanced fibrosis or compensated cirrhosis (METAVIR F3/F4).

ReferenceCitation: Hézode C, Almasio PL, Bourgeois S, Buggisch P, Brown A, Diago M, Horsmans Y, Serfaty L, Szalay F, Gaeta GB, Planas R, Schlag M, Lonjon-Domanec I, Omoruyi E, DeMasi R, Zeuzem S. Simeprevir and daclatasvir for 12 or 24 weeks in treatment-naïve patients with hepatitis C virus genotype 1b and advanced liver disease. Liver Int. 2017 Sep;37(9):1304-1313. doi: 10.1111/liv.13376. Epub 2017 Mar 13.

lead_sponsor: Janssen-Cilag International NV

location_country:
Spain
United Kingdom
Hungary
France
Belgium
Germany


acronym: PRAME-AS15-MEL-001 (MET)

title: Study of GSK2302025A Antigen-Specific Cancer Immunotherapeutic in Patients With Metastatic Melanoma

ReferenceCitation: Gutzmer R, Rivoltini L, Levchenko E, Testori A, Utikal J, Ascierto PA, Demidov L, Grob JJ, Ridolfi R, Schadendorf D, Queirolo P, Santoro A, Loquai C, Dreno B, Hauschild A, Schultz E, Lesimple TP, Vanhoutte N, Salaun B, Gillet M, Jarnjak S, De Sousa Alves PM, Louahed J, Brichard VG, Lehmann FF. Safety and immunogenicity of the PRAME cancer immunotherapeutic in metastatic melanoma: results of a phase I dose escalation study. ESMO Open. 2016 Aug 8;1(4):e000068. eCollection 2016.

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

location_country:
Poland
Italy
Russian Federation
France
Germany
Czechia

summary: The purpose of this clinical study is to examine the safety, immunogenicity and clinical activity of the immunotherapeutic product GSK2302025A (also referred to as recPRAME + AS15 Antigen-Specific Cancer Immunotherapeutic [ASCI]) administered as a first line treatment in patients with unresectable and progressive metastatic cutaneous melanoma.


title: Randomised, Double-blind, Placebo-controlled, Phase II Study to Assess the Safety and Efficacy of Different Doses of Intravenous APD405 for the Prevention of Post-operative Nausea and Vomiting

summary: To assess the efficacy and safety of different doses of APD405 in the prevention of post-operative nausea and vomiting (PONV) in adult patients at moderate to high-risk of PONV. Patients must be undergoing elective surgery under general anaesthesia (hysterectomy (any surgical technique), cholecystectomy (any surgical technique) or "other" elective surgery scheduled to last at least one hour from induction of anaesthesia), requiring at least one overnight stay in hospital, and have at least 2 of the following risk factors for PONV: Past history of PONV and/or motion sickness; Non-smoking status; Female gender; Planned opiate use for post-operative analgesia.

ReferenceCitation: Kranke P, Röhm KD, Diemunsch P, Gan TJ, Apfel CC, Eberhart L, Minkowitz HS, Wallenborn J, Chassard D, Lebuffe G, Fox GM, Tramèr MR. Intravenous buspirone for the prevention of postoperative nausea and vomiting. Eur J Clin Pharmacol. 2012 Nov;68(11):1465-72. doi: 10.1007/s00228-012-1284-8. Epub 2012 May 1.

lead_sponsor: Acacia Pharma Ltd

location_country:
Germany
United States
Switzerland
France

location_facility: Centre Hospitalier Universitaire Vaudois


title: An Open-Label Multi-center, Multiple Dose Study to Determine the Optimum Starting Dose of Intravenous MIRCERA for Maintenance Treatment of Anemia in Pediatric Participants With Chronic Kidney Disease on Hemodialysis

location_country:
Poland
Romania
Spain
Italy
Russian Federation
Australia
Thailand
Ukraine
Hungary
France
Belgium
Germany

location_facility: Instytut "Centrum Zdrowia Matki Polki; Klinika Nefrologii i Dializoterapii

location_facility: Kiev city childrens nephrological center of hospital #1; Nephrology and RRT

location_facility: Hopital Timone Enfants; Nephrologie Hemodialyse

location_facility: Semmelweis University; 1st Department of Pediatrics, Pediatric Nephrology Center

location_facility: Hospital Universitario La Paz: Nefrologia Pediatrica

location_facility: Dzieciecy Szpital Kliniczny; Klinika Nefrologii Dzieciecej

location_facility: Hopital Femme Mere Enfant; Ped Nephrologie Rhumatologie

location_facility: Chulalongkorn university Faculty of Medicine;Department of Pediatrics

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Nefrologia

location_facility: KfH-Nierenzentrum für Kinder und Jugendliche

location_facility: SPSZOZ Zdroje Oddzial Pediatrii; Nefrologii i Toksykologii ze Stacja Dializ

location_facility: Ospedale Pediatrico Bambino Gesu; U.O. Di Nefrologia E Dialisi

location_facility: Siriraj Hospital, Faculty of Medicine; Department of Pediatrics

location_facility: St. Maria Emergency Clinical Hospital for Children

location_facility: Hospital Universitario la Fe; Servicio de Nefrologia Pediatrica

location_facility: DGCB St. Vladimir; Pediatric nephrologist

location_facility: Hopital Armand Trousseau; Pediatrie Nephrologie

location_facility: KfH Nierenzentrum für Kinder und Jugendliche

location_facility: Instytut Pomnik-Centrum Zdrowia Dziecka, Klinika Nefrologii, Transp. Nerek i Nadcisnienia Tetniczego

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Nefrologia Pediatrica

location_facility: Hopital Arnaud De Villeneuve; Pediatrie I

location_facility: Hôpital Robert Debré; Nephrologie pediatrique

location_facility: Akademia Medyczna im. Piastow Slaskich; Katedra i Klinika Nefrologii Pediatrycznej

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Chorob Nerek i Nadciśnienia Dzieci i Mlodziezy

location_facility: Hopital Jeanne De Flandre; Cons Pediatrie

location_facility: KfH-Nierenzentrum fur Kinder und Jugendliche

location_facility: Wojewodzki Szpital Dzieciecy; Osrodek Chorob Nerek i Dializoterapii

location_facility: Royal Children'S Hospital; Department of Nephrology

location_facility: IRCCS G. Gaslini; U.O. Nefrologia, Dialisi e Trapianto

location_facility: Ospedale Infantile Regina Margherita; U.O. Autonoma di Nefrologia, Dialisi e Trapianto

location_facility: Public Institution Zaporizhzhia City Multispecialty Children's Hospital #5; Allergologic

location_facility: SBIH Children City Hospital #1; Dialysis department

location_facility: A.O. Di Padova; Dipartimento Di Pediatria U.O. Di Nefrologia Pediatrica, Dialisi e Trapianto

summary: This sequential study will assess the efficacy and safety of multiple doses of intravenous (IV) methoxy polyethylene glycol-epoetin beta (MIRCERA), and will determine the optimum starting dose for maintenance treatment of anemia in children with chronic kidney disease on hemodialysis. Pediatric participants will remain on epoetin alfa, epoetin beta or darbepoetin alfa during the screening period, after which they will receive IV MIRCERA monthly, at a starting dose related to the previous weekly epoetin or darbepoetin alfa dose. Depending on the response achieved, another group may be selected to receive a higher or a lower dose.


title: A Randomized, Open Label Study to Evaluate the Effect of Subcutaneous Mircera, Versus no ESA Therapy, on Hemoglobin Levels in Chronic Kidney Disease Patients With Anemia After Kidney Transplant.

summary: This 2 arm study will assess the efficacy, safety and tolerability of subcutaneous Mircera, versus no ESA therapy, in chronic kidney disease patients with anemia after kidney transplant, not currently treated with ESA. Patients will be randomized to receive a)subcutaneous Mircera at a recommended starting dose of 0.6 micrograms/kg every 2 weeks, switching to monthly treatment at week 16 or b)supportive treatment (eg. iron supplementation) for management of low hemoglobin concentrations. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

status: Terminated

location_country:
Spain
Italy
United Kingdom
France
Belgium
Germany

status_simplified: Unknown


title: A Randomized, Open-label Study Comparing the Anti-tumor Effect of Treatment With Tarceva Plus Avastin Versus Chemotherapy Plus Avastin in Patients With Advanced Non-small Cell Lung Cancer

summary: This 2 arm study will compare the efficacy and safety of Tarceva plus Avastin, and chemotherapy plus Avastin, in the first-line treatment of patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva 150mg p.o. daily plus Avastin 15mg/kg i.v. every 3 weeks, or standard platinum-based chemotherapy (4-6 cycles) plus Avastin. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

ReferenceCitation: Ciuleanu T, Tsai CM, Tsao CJ, Milanowski J, Amoroso D, Heo DS, Groen HJ, Szczesna A, Chung CY, Chao TY, Middleton G, Zeaiter A, Klingelschmitt G, Klughammer B, Thatcher N. A phase II study of erlotinib in combination with bevacizumab versus chemotherapy plus bevacizumab in the first-line treatment of advanced non-squamous non-small cell lung cancer. Lung Cancer. 2013 Nov;82(2):276-81. doi: 10.1016/j.lungcan.2013.08.002. Epub 2013 Aug 13.

location_country:
Poland
Taiwan
Romania
Spain
Italy
United Kingdom
Australia
Lithuania
Korea, Republic of
France
Singapore
Belgium
Netherlands


title: A Randomized, Controlled, Open-Label Study of the Long-Term Impact on Functioning Using Atomoxetine Hydrochloride Compared to Other Early Standard Care in the Treatment of Attention-Deficit/Hyperactivity Disorder in Treatment-Naïve Children and Adolescents

acronym: ADHD LIFE

summary: The purpose of this study is to demonstrate that atomoxetine is superior to other early standard therapy (any treatment that investigator considers is appropriate to initiate for the treatment of Attention-Deficit/Hyperactivity Disorder [ADHD]) on the long term functioning in approximately 400 children and adolescents with ADHD. Patients will be pharmacological naïve prior to entry into the study.

lead_sponsor: Eli Lilly and Company

location_country:
Belgium
Spain
Ireland
Italy
United Kingdom
France
Turkey
Mexico
Norway

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


type: Registry Identifier

title: Controlled Study of Immunogenicity and Safety of the Investigational vYF Candidate Vaccine in Comparison to Stamaril in Adults

summary:
VYF03 is a phase II, randomized, parallel-group prevention study with 2 arms, active-controlled (Stamaril), observer-blind, multi-center study to assess the non-inferiority of the immune response, in terms of seroconversion rates of the investigational vaccine candidate vYF to the licensed Stamaril, in adults aged 18 years up to 60 years in Europe (EU).

The safety and immunogenicity profile of vYF in a cohort of Asian population of Chinese origin outside of China will also be described. The study will also assess the immunogenicity profiles and the safety profiles of vYF and Stamaril.

Participants will be randomized in a 2:1 ratio to receive a single subcutaneous injection of either the vYF vaccine (380 participants in EU and 80 participants of Chinese origin in Asia) or Stamaril (190 participants in EU and 40 participants of Chinese origin in Asia), on Day 01.

The duration of each participant's participation will be approximately 5 years.

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

lead_sponsor: Sanofi Pasteur, a Sanofi Company

location_country: Spain Finland Thailand Singapore France Germany

location_facility:
Investigational Site Number :7020003
Investigational Site Number :2500006
Investigational Site Number :7240003
Investigational Site Number :2760002
Investigational Site Number :7640001
Investigational Site Number :7020001
Investigational Site Number :7240002
Investigational Site Number :2500008
Investigational Site Number :7020002
Investigational Site Number :2760004
Investigational Site Number :7640003
Investigational Site Number :2760001
Investigational Site Number :2460002
Investigational Site Number :7240001
Investigational Site Number :2760003
Investigational Site Number :2500004
Investigational Site Number :2460003
Investigational Site Number :7240004
Investigational Site Number :2500001
Investigational Site Number :7640002
Investigational Site Number :2500007
Investigational Site Number :2460001
Investigational Site Number :2500009

lead_sponsor_type: academique


title: A Phase 2, Randomized, Open-Label Study of Nivolumab Combined With Ipilimumab Versus Standard of Care in Subjects With Previously Untreated and Advanced (Unresectable or Metastatic) Non-clear Cell Renal Cell Carcinoma (nccRCC)

summary: SUNNIFORECAST (Standard of Care vs. Nivolumab + Ipilimumab as First line treatment of renal cell cancer of non-clear cell subtypes) is a Phase II, randomized, open-label investigator initiated trial (IIT) of Nivolumab (BMS-936558) combined with Ipilimumab vs standard of care in subjects with previously untreated and advanced (unresectable or metastatic) non-clear cell renal cell carcinoma (nccRCC).

ReferenceCitation: Motzer RJ, Escudier B, McDermott DF, George S, Hammers HJ, Srinivas S, Tykodi SS, Sosman JA, Procopio G, Plimack ER, Castellano D, Choueiri TK, Gurney H, Donskov F, Bono P, Wagstaff J, Gauler TC, Ueda T, Tomita Y, Schutz FA, Kollmannsberger C, Larkin J, Ravaud A, Simon JS, Xu LA, Waxman IM, Sharma P; CheckMate 025 Investigators. Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma. N Engl J Med. 2015 Nov 5;373(19):1803-13. doi: 10.1056/NEJMoa1510665. Epub 2015 Sep 25.

ReferenceCitation: Armstrong AJ, Halabi S, Eisen T, Broderick S, Stadler WM, Jones RJ, Garcia JA, Vaishampayan UN, Picus J, Hawkins RE, Hainsworth JD, Kollmannsberger CK, Logan TF, Puzanov I, Pickering LM, Ryan CW, Protheroe A, Lusk CM, Oberg S, George DJ. Everolimus versus sunitinib for patients with metastatic non-clear cell renal cell carcinoma (ASPEN): a multicentre, open-label, randomised phase 2 trial. Lancet Oncol. 2016 Mar;17(3):378-388. doi: 10.1016/S1470-2045(15)00515-X. Epub 2016 Jan 13.

ReferenceCitation: Vera-Badillo FE, Templeton AJ, Duran I, Ocana A, de Gouveia P, Aneja P, Knox JJ, Tannock IF, Escudier B, Amir E. Systemic therapy for non-clear cell renal cell carcinomas: a systematic review and meta-analysis. Eur Urol. 2015 Apr;67(4):740-9. doi: 10.1016/j.eururo.2014.05.010. Epub 2014 Jun 2. Review.

ReferenceCitation: Ahrens M, Scheich S, Hartmann A, Bergmann L; IAG-N Interdisciplinary Working Group Kidney Cancer of the German Cancer Society. Non-Clear Cell Renal Cell Carcinoma - Pathology and Treatment Options. Oncol Res Treat. 2019;42(3):128-135. doi: 10.1159/000495366. Epub 2019 Feb 23. Review.

ReferenceCitation: Motzer RJ, Tannir NM, McDermott DF, Arén Frontera O, Melichar B, Choueiri TK, Plimack ER, Barthélémy P, Porta C, George S, Powles T, Donskov F, Neiman V, Kollmannsberger CK, Salman P, Gurney H, Hawkins R, Ravaud A, Grimm MO, Bracarda S, Barrios CH, Tomita Y, Castellano D, Rini BI, Chen AC, Mekan S, McHenry MB, Wind-Rotolo M, Doan J, Sharma P, Hammers HJ, Escudier B; CheckMate 214 Investigators. Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma. N Engl J Med. 2018 Apr 5;378(14):1277-1290. doi: 10.1056/NEJMoa1712126. Epub 2018 Mar 21.

lead_sponsor: Goethe University

location_country:
Spain
United Kingdom
Netherlands
France
Belgium
Germany
Czechia

location_facility: Gent University Hospital (Universitair Ziekenhuis Gent)

location_facility: Charite Berlin (Campus Virchow-Klinikum)

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Les Hoptaux Universitaires de Strasbourg

location_facility: Centre Hospitalier Départemental de Vendée

location_facility: Nationales Zentrum für Tumorerkrankungen (NCT)


title: Phase IIIb, Randomized, Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Previously Untreated Unresectable or Metastatic Melanoma

summary: This is a safety and efficacy study of different administration regimens of nivolumab plus Ipilimumab in subjects with previously untreated, unresectable or metastatic melanoma.

lead_sponsor: Bristol-Myers Squibb

location_country: Australia France Spain Italy

location_facility: Istituto Scientifico Romagnolo Per Lo Studio E Cura Tumori

location_facility: Istituto Nazionale Per La Ricerca Sul Cancro - Oncologia Med

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza


title: An Open-Label, Multicenter, Phase 1b Study With an Expansion Cohort to Evaluate Safety and Efficacy of the Combination of Necitumumab With Pembrolizumab in Patients With Stage IV Non-Small Cell Lung Cancer

summary: The main purpose of this study is to evaluate the safety and efficacy of the combination of necitumumab with pembrolizumab in participants with stage IV non-small cell lung cancer (NSCLC).

location_country:
Japan
United States
Spain
France

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


title: Reporting Patterns and Results of Initial Antibiotic Treatment in Patients With Complicated Urinary Tract Infection,Complicated Intra-abdominal Infection and Nosocomial Pneumonia Including Ventilator-associated Pneumonia.

acronym: RECOMMEND

summary: Reporting patterns and results of initial antibiotic treatment in patients with complicated urinary tract infection (cUTI), complicated intra-abdominal infection (cIAI) and nosocomial pneumonia (NP) including ventilator-associated pneumonia (VAP) - RECOMMEND Study

ReferenceCitation: Ryan K, Karve S, Peeters P, Baelen E, Potter D, Rojas-Farreras S, Pascual E, Rodríguez-Baño J. The impact of initial antibiotic treatment failure: Real-world insights in healthcare-associated or nosocomial pneumonia. J Infect. 2018 Jul;77(1):9-17. doi: 10.1016/j.jinf.2018.04.002. Epub 2018 May 6.

ReferenceCitation: Karve S, Ryan K, Peeters P, Baelen E, Rojas-Farreras S, Potter D, Rodríguez-Baño J. The impact of initial antibiotic treatment failure: Real-world insights in patients with complicated urinary tract infection. J Infect. 2018 Feb;76(2):121-131. doi: 10.1016/j.jinf.2017.11.001. Epub 2017 Nov 8.

lead_sponsor: Pfizer

location_country:
Brazil
Spain
Italy
Russian Federation
Greece
France


title: A Phase 2a, Randomized, Placebo Controlled, Proof of Mechanism Study to Evaluate the Safety and Efficacy of AMG 557/MEDI5872 in Subjects With Primary Sjögren's Syndrome

summary: A Phase 2a study to evaluate the efficacy and safety of AMG 557/MEDI5872 in Primary Sjögren's Syndrome

lead_sponsor: MedImmune LLC

location_country:
Sweden
United States
United Kingdom
France


acronym: Balise

title: A Randomized, Controlled Phase 2 Study Evaluating LY2875358 Plus Erlotinib Versus Erlotinib as First-Line Treatment in Metastatic Non-Small Cell Lung Cancer Patients With Activating EGFR Mutations Who Have Disease Control After an 8-Week Lead-In Treatment With Erlotinib

location_country:
Denmark
Taiwan
Spain
Italy
United Kingdom
Netherlands
Korea, Republic of
France
Germany

summary: The primary purpose of this study is to compare the efficacy of the study drug LY2875358, given together with erlotinib, against erlotinib, alone. Participants will have Non-Small Cell Lung Cancer (NSCLC) that has advanced to Stage IV. Participants should not have been treated with drugs for Stage IV NSCLC, previously. All participants will get erlotinib alone, for approximately 8 weeks. Participants with radiographic disease control at the end of the erlotinib lead-in study period will be randomly assigned to receive LY2875358 plus erlotinib or erlotinib alone. Participants, who were chosen to receive erlotinib, alone, may cross over to the combination treatment at the time of progression.


title: An Observational Study to Assess Persistence, Adherence, Quality of Life, and Treatment Satisfaction in Patients Beginning Therapy With the Avonex® PEN™.

acronym: PERSIST

summary: The primary objective of the study is to determine physician reported persistence with the Avonex PEN at Month 12/End of Study as well as determining factors associated with persistence. The secondary objectives for this study are as follows: To evaluate the tolerability for treatment administration of the Avonex PEN at Months 3, 6, and 12; To evaluate patient quality of life (QoL) while using the Avonex PEN for treatment administration at Months 3, 6, and 12; To evaluate clarity of directions for use of the Avonex PEN at Month 3; To evaluate ease of use and the patient's assessment of the injection procedure with the Avonex PEN at Months 3, 6, and 12; To evaluate patient reported adherence at Months 6 and 12; To evaluate physician reported persistence at Month 6; To evaluate overall patient satisfaction with the use of the Avonex PEN for treatment administration at Months 3, 6, and 12; To evaluate patient reported fear of injection at Months 3, 6, and 12; and To evaluate the percentage of patients switching from caregiver to self-injection at Months 3, 6, and 12.

ReferenceCitation: Hupperts R, Becker V, Friedrich J, Gobbi C, Salgado AV, Sperling B, You X. Multiple sclerosis patients treated with intramuscular IFN-β-1a autoinjector in a real-world setting: prospective evaluation of treatment persistence, adherence, quality of life and satisfaction. Expert Opin Drug Deliv. 2015 Jan;12(1):15-25. doi: 10.1517/17425247.2015.989209. Epub 2014 Nov 28.

lead_sponsor: Biogen

location_country:
Denmark
Portugal
United Kingdom
Netherlands
Switzerland
Sweden
France
Norway
Germany
Slovakia

intervention_type: Other


title: A Prospective, Randomized, Double-blind, Double-dummy, Placebo- and Active Controlled, Multicenter Study Assessing the Efficacy and Safety of the Combination BAY60-4552 / Vardenafil Compared to Vardenafil (20 mg) for the Treatment of Erectile Dysfunction Not Sufficiently Responsive to Standard Therapy With PDE5 (Phosphodiesterase 5) Inhibitors

location_country: Spain Italy Netherlands Finland Sweden France Germany

summary:
This study examines the efficacy and safety of the combination treatment BAY60-4552 plus vardenafil in patients with erectile dysfunction, who do not sufficiently respond to therapy with PDE5 (Phosphodiesterase 5) inhibitors.

Patients meeting the entry criteria, will receive vardenafil alone in the first four weeks of the study to assess the effect of PDE5 inhibitor therapy given alone.

Patients with an insufficient therapeutic response to vardenafil alone will enter the next part of the study, and will be randomly assigned to one of 3 treatments. There is a 1 in 3 chance of receiving either the combination BAY60-4552 plus vardenafil, or vardenafil alone, or placebo. Neither patient nor the treating physician will know which treatment is given (double-blinded design).This part of the study will last four weeks Patients will have to go to the clinic/hospital for 7 visits during the 8 weeks.


title: A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn's Disease.

summary: The study aims to evaluate the safety and clinical effect of daily oral treatment of Laquinimod capsules in active moderate to severe Crohn's disease. This study will assess Laquinimod doses of 0.5mg /day to 2 mg/day in sequential dose groups (cohorts). Laquinimod is a novel immunomodulating drug which is currently in advanced stages of development by Teva Pharmaceuticals Ltd. for Multiple Sclerosis.

ReferenceCitation: D'Haens G, Sandborn WJ, Colombel JF, Rutgeerts P, Brown K, Barkay H, Sakov A, Haviv A, Feagan BG; Laquinimod for Crohn's Disease Investigators. A phase II study of laquinimod in Crohn's disease. Gut. 2015 Aug;64(8):1227-35. doi: 10.1136/gutjnl-2014-307118. Epub 2014 Oct 3.

lead_sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

location_country:
Poland
Spain
Italy
United Kingdom
France
Israel
South Africa
Belgium
Netherlands

location_facility:
Teva Investigational Site 3711
Teva Investigational Site 3070
Teva Investigational Site 8048
Teva Investigational Site 3164
Teva Investigational Site 3428
Teva Investigational Site 3069
Teva Investigational Site 5362
Teva Investigational Site 3820
Teva Investigational Site 9013
Teva Investigational Site 3429
Teva Investigational Site 9009
Teva Investigational Site 8046
Teva Investigational Site 3158
Teva Investigational Site 5361
Teva Investigational Site 5360
Teva Investigational Site 8051
Teva Investigational Site 5355
Teva Investigational Site 8047
Teva Investigational Site 3430
Teva Investigational Site 3712
Teva Investigational Site 5352
Teva Investigational Site 3432
Teva Investigational Site 3713
Teva Investigational Site 5363
Teva Investigational Site 5354
Teva Investigational Site 5350
Teva Investigational Site 8049
Teva Investigational Site 5353
Teva Investigational Site 5351
Teva Investigational Site 9017
Teva Investigational Site 3160
Teva Investigational Site 3819
Teva Investigational Site 3072
Teva Investigational Site 8050


title: A Phase II Study Of Su011248 In Patients With Recurrent And/Or Metastatic Squamous Head And Neck Carcinoma.

summary: Preclinical studies as well as phase I and II trials have demonstrated that SU11248 has antitumor activity in renal cell carcinoma, breast cancer, neuroendocrine tumor and GIST. So at the light of these pre-clinical and clinical data, it seems interesting and promising to test SU011248 in these poor prognosis patients.

lead_sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

location_country: France Belgium

location_facility: Clinique universiataire de Mont Godinnes UCL


title: A Multi-centre, Randomized, Double Blind, Placebo-controlled, Parallel Group Study to Investigate Efficacy and Safety of ONO-2506PO Compared to Placebo, in the Presence of Riluzole, to Patients Diagnosed With Amyotrophic Lateral Sclerosis (ALS), Who Have Had Onset of Muscle Weakness Within 14 Months of Randomization

summary: The purpose of this study is to determine if oral treatment with ONO-2506PO in patients diagnosed with ALS, who have had onset of muscle weakness within 14 months of randomization, could lead to the slowing of decline in respiratory function, functional status, muscle strength, quality of life and survival compared with placebo group.

lead_sponsor: Ono Pharmaceutical Co. Ltd

location_country:
United Kingdom
Italy
Austria
Netherlands
Switzerland
France
Belgium
Germany

location_facility: Academic Medical Centre (AMC) Amsterdam - Dept of Neurology

location_facility: University of Sheffield - Academic Neurology Unit

location_facility: L. Boltzmann Forschungsinstitut, Neurologische Abteilung, Kaiser Franz Josef Hospital, Wien

location_facility: Dipartimento di Neurologia e Laboratorio di Neuroscienze - Universita di Milano - IRCCS - Istituto Auxologico Italiano

location_facility: Medizinische Hochschule Hannover, Neurologische Klinik

location_facility: Deutsche Klinik fur Diagnostik, Fachbereich Neurologie

location_facility: Hopital Roger Salengro - Clinique Neurologique, Neurologie A

location_facility: Poliklinik der Universitat Erlangen-Nurnberg, Neurologische Klinik

location_facility: Dipartimento di Neuroscienze - Divisione di Neurologia II - Azienda Ospedaliera S. Giovanni Battista - Molinette

location_facility: Interdisziplinares Zentrum fur Palliativmedizin

location_facility: Kantonsspital St. Gallen, Muskelzentrum/ALS Clinic

location_facility: Martin-Luther-Universitat Halle-Wittenberg, Klinikum der Medizinischen Fakultat, Universitatsklinik und Poliklinik fur Neurologie

location_facility: Divisione di Neuroriabilitazione II - Fondazione Salvatore Maugeri - IRCCS

location_facility: Klinik und Poliklinik fur Neurologie der Universitat Ulm-Universitatsklinikum Ulm


title: First Line Chemotherapy With Temozolomide in Recurrent Oligodendroglial Tumors, a Phase II Trial

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 temozolomide in treating patients with recurrent oligodendroglial tumors.

ReferenceCitation: Kouwenhoven MC, Kros JM, French PJ, Biemond-ter Stege EM, Graveland WJ, Taphoorn MJ, Brandes AA, van den Bent MJ. 1p/19q loss within oligodendroglioma is predictive for response to first line temozolomide but not to salvage treatment. Eur J Cancer. 2006 Oct;42(15):2499-503. Epub 2006 Aug 17.

ReferenceType: result

ReferenceCitation: van den Bent MJ, Taphoorn MJ, Brandes AA, Menten J, Stupp R, Frenay M, Chinot O, Kros JM, van der Rijt CC, Vecht ChJ, Allgeier A, Gorlia T; European Organization for Research and Treatment of Cancer Brain Tumor Group. Phase II study of first-line chemotherapy with temozolomide in recurrent oligodendroglial tumors: the European Organization for Research and Treatment of Cancer Brain Tumor Group Study 26971. J Clin Oncol. 2003 Jul 1;21(13):2525-8.

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

location_country:
Portugal
United Kingdom
Italy
Netherlands
Switzerland
France
Belgium
Germany
Slovakia

location_facility: Instituto Portugues de Oncologia de Francisco Gentil

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Istituti Fisioterapici Ospitalieri - Roma

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel


title: A Phase 3b, Multicenter, Open-label, Daratumumab Long-term Extension Study

summary: The purpose of this study is to provide ongoing access to study treatments for participants with multiple myeloma who are actively receiving daratumumab in a Janssen Research and Development (R&D)-sponsored daratumumab study which has reached clinical cutoff for final analysis and who continue to benefit from study treatment. Certain long-term safety data will continue to be collected from study participants.

study_start_date_type: Anticipated

status: Not yet recruiting

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:
Spain
Korea, Republic of
United States
France
Germany

location_facility: Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,

location_facility: Seoul National University Bundang Hospital

location_facility: Chonnam National University Hwasun Hospital


title: A Phase 1b Study in Patients With Acromegaly or Functioning Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) to Characterize the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Debio 4126, a 12-week Prolonged-release Octreotide Formulation

summary: This is an open-label, single treatment arm, multicenter study to assess the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of Debio 4126 in the treatment of participants with Acromegaly or Functioning Gastroenteropancreatic Neuroendocrine tumors (GEP-NETs).

lead_sponsor: Debiopharm International SA

location_country:
Denmark
Poland
Portugal
Spain
Italy
Russian Federation
United Kingdom
Sweden
Hungary
France
Israel
Germany

location_facility: Universitaetsklinikum Bonn, Medizinische Klinik und Poliklinik I,

location_facility: AP-HM - Hôpital de la Conception, Service d'Endocrinologie et Centre de Référence des Maladies Rares de l'hypophyse

location_facility: Rabin Medical Center, Beilinson Hospital, Clalit Health Services by Rabin Medical Center, Beilinson Hospita

location_facility: Universitätsklinikum München - Medizinische Klinik und Poliklinik IV, Medizinische Klinik und Poliklinik IV Department of Nephrology

location_facility: Medicover Praxis fur Neuroendokrinologie

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

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

location_facility: Royal Free London NHS Foundation Trust, Royal Free Hospital

location_facility: Novosibirsk State Regional Clinical Hospital

location_facility: Semmelweis Egyetem - II. Belgyogyaszati Klinika (Internal Medicine), Klinikai Farmakológiai Részleg

location_facility: University Hospital Coventry, WISDEM Centre, UHCW NHS Trust

location_facility: Cancer Research UK - Christie Hospital Foundation NHS Trust - Endocrinology Department, Endocrinology department, The Christie

location_facility: Centro Hospitalar Universitário São João, EPE, Departamento de Endocrinologia, Diabetes e Metabolismo

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Oddzial Gliwice, Zaklad Medycyny Nuklearnej i Endokrynologii Onkologicznej

location_facility: Tel Aviv Sourasky Medical Center, Institute of Endocrinology, metabolism and hypertension

location_facility: Hospital de la Santa Creu i Sant Pau Barcelon

location_facility: Sheba Medical Center, Endocrine institute

location_facility: Mazowiecki Szpital Brodnowski - Zespol Oddzialow Chorob Wewnetrznych, Endokrynologii i Diabetologii

location_facility: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori

location_facility: Instituto Português de Oncologia de Lisboa Francisco Gentil

location_facility: Szpital Uniwersytecki Krakow - Oddzial Kliniczny Endokrynologii,

location_facility: Uniwersyteckie Centrum Kliniczne im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach

location_facility: Scientific and Research Medical complex Vashe Zdorovie, LLC, State Autonomous Healthcare Institution, Interregional Clinical Diagnostic Cente

location_facility: Debreceni Egyetem Klinikai Kozpont, Klinikai Farmakológiai részleg

location_facility: Cancer Research UK - Christie Hospital Foundation NHS Trust - Dept of Medical Oncology, Christie Hospital NHS Foundation Trust


title: A Multicenter, Open-Label, Single- and Multiple-Dose, Dose-Finding Study, With an Optional Open-Label Extension to Assess the Safety, Tolerability, and Pharmacokinetics of Obeticholic Acid in Pediatric Subjects With Biliary Atresia

acronym: CARE

summary: This is a Phase 2, multicenter, open-label, single dose and multi-dose, dose-finding study with an optional open-label extension (OLE) to assess the safety, tolerability, and pharmacokinetics of obeticholic acid (OCA) in pediatric subjects with biliary atresia with successful hepatoportoenterostomy (HPE, also known as a Kasai portoenterosomy). The OLE will continue to evaluate safety, tolerability, pharmacodynamics, and efficacy of OCA. In addition, a change in vitamin A and D levels, and where possible the degree of change in liver stiffness, will be assessed during the OLE.

lead_sponsor: Intercept Pharmaceuticals

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

location_facility: University Medical Center Gröningen-Beatrix, children's Hospital

location_facility: CHU de Toulouse Purpan-Hopital des Enfants

location_facility: Hannover Medical School, Children's Hospital, Paediatric Gastroenterology and Hepatology,


title: A Case-control Study on Risk Factors, Timing, and PCR Use, for Pneumocystis Pneumonia (PcP) After Allogeneic HSCT

summary:
The fungus Pneumocystis jirovecii is responsible for pneumocystosis (PcP), a life threatening pneumonia in patients undergoing HSCT. The spontaneous attack rate of 16% within the first 6 months following allogeneic HSCT reported in the 1980's has considerably decreased with prophylaxis. However, PcP still remains a concern in the transplant ward with an incidence rate up to 2.5% in allo- and 1.4% in autologous HSCT but up to 7.2% on low dose of Dapsone. The mortality of PcP is especially high in HSCT recipients. One of the main factors of PcP after HSCT seems to be either the lack of TMP-SMX prophylaxis (all the other prophylactic drugs being inferior to TMP-SMX), or poor compliance to prophylaxis. Due to the rarity of the disease after HSCT, it is impossible to study it in monocenter studies, except on very long periods of time which may not reflect current practice. Several questions deserve investigations in a multicenter study, about timing, risk factors, and outcome.

Moreover, some European laboratories involved in the diagnosis of PcP have already given up to classical diagnostic methods and switched to qPCR. This implies that lower fungal burden can be detected and the clinical pertinence of such a diagnostic strategy deserves to be assessed.

ipd_sharing: Undecided

lead_sponsor: European Society for Blood and Marrow Transplantation

location_country: Hungary France Israel Belgium Norway Germany

location_facility: Oslo University Hospital, Rikshospitalet

location_facility: United St. Istvan and St. Laszlo Hospital


title: Biomarker- Guided Intervention to Prevent Acute Kidney Injury After Major Surgery. A Prospective Randomized Controlled Multicenter Trial (BigpAK-2)

summary:
There is no specific therapy for acute kidney injury. It is presumed that supportive measures improve the care and outcome of patients with acute kidney injury. The investigators hypothesize that the implementation of a bundle of supportive measures adapted to patients undergoing major surgery reduces the occurrence of AKI.

This randomized prospective multicenter trial is needed to investigator whether the implementation of the bundle of measures is effective to prevent AKI in high risk patients undergoing major surgery.

primary_purpose: Supportive Care

lead_sponsor: University Hospital Muenster

location_country:
Spain
Italy
United Kingdom
Netherlands
Switzerland
France
Belgium
Germany

location_facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna

location_facility: Department of Translational Medicine and for Romagna, St. Anne's Archbishop Hospital, University of Ferrara

location_facility: Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Knappschaftskrankenhaus, Ruhr University Bochum

location_facility: Department of Anesthesiology, University Hospital Düsseldorf, Heinrich-Heine-University Duesseldorf

location_facility: Department of Anesthesiology, Department of Anesthesiology and Critical Care, Franziskus Hospital Münster

location_facility: Servicio de Anestesiologia, Hospital Universitario y Politécnico La Fe

location_facility: Department of Anesthesiology and Intensive Care Medicine, University Hospital Augsburg

location_facility: Department of Anesthesiology, Hospital Universitario Ramón y Cajal

location_facility: Department of Anesthesiology, Heidelberg University Hospital

location_facility: Department of Anaesthesiology and Intensive Care Medicine, Klinikum Bayreuth GmbH

location_facility: Centre for Experimental Medicine, School of Medicine, Dentistry, and Biomedical Sciences, Queen's University Belfast

location_facility: Department of Critical Care, King's College London, Guy's & St Thomas' Hospital

location_facility: Service d´Anesthésie-Réanimation, Hôpital Edouard Herriot, Hospices Civils de Lyon

location_facility: Department of Anaesthesiology, Intensive Care and Pain Medicine, University Hospital

location_facility: Intensive Care Unit, Royal Liverpool University Hospital

location_facility: Department of Anesthesiology and Intensive Care Medicine, University Hospital "Carl Gustav Carus", Technische Universität Dresden

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Centre Hospitalier Universitaire de Reims

location_facility: Centre Hospitalier Universitaire de Angers

location_facility: Department of Anesthesiology and Intensive Care Medicine, University Hospital Tübingen, Eberhard Karls University Tübingen

location_facility: Department of Anesthesiology and Critical Care, University Hospital Vall d'Hebron

location_facility: Department of Anaesthesiology and Intensive Care Medicine, Parc de Salut Mar

location_facility: Department of Anesthesia, Hospital Juan Ramon Jimenez

location_facility: Department of Anesthesiology and Intensive Care, San Bortolo Hospital

location_facility: Department of Anesthesiology, University Medical Center, Georg-August-University

location_facility: Department of Anesthesiology, Intensive Care and Pain Medicine, Klinikum Dortmund

location_facility: Department of Anesthesiology and Intensive Care Medicine, Philipps-University

location_facility: Department of Anesthetics, King's College Hospital, Denmark Hill

location_facility: Department of Nephrology, Heidelberg University Hospital

location_facility: Adult Intensive Care Unit, Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: Clinical Research Department, Centre Hospitalier Universitaire Brugmann

location_facility: Department of Anesthesiology and Intensive Care Medicine, University Hospital Essen, University Duisburg-Essen

location_facility: Department of Health Sciences, Section of Anesthesiology, Intensive Care and Pain Medicine, University of Florence; Department of Anesthesia and Intensive Care, Section of Oncological Anesthesia and Intensive care, Azienda Ospedaliero Careggi

location_facility: Department of Anesthesiology and Intensive Care, IRCCS Humanitas Clinical and Research Hospital

location_facility: Intensive Care Unit, Royal Surrey County Hospital

location_facility: Department of Anaesthesiology and Surgical Critical Care, Hospital Universitario Marqués de Valdecilla

location_facility: Department of Anaesthetics and Critical Care, Harefield Hospital

location_facility: Department of Anesthesia and Perioperative Care, Infanta Leonor University Hospital

location_facility: Department of Anesthesiology and Intensive Care Medicine, Medical Faculty and University Hospital Cologne, University of Cologne

location_facility: Department of Anesthesiology and Intensive Care Medicine, University Hospital Bonn

location_facility: Department of Anaesthesiology, Laboratory of Experimental Intensive Care and Anaesthesiology (L.E.I.C.A.), Amsterdam UMC, Location Academic Medical Centre (AMC), Amsterdam, University of Amsterdam


title: A Phase II, Open Label Study to Investigate the Efficacy and Safety of Domatinostat in Combination With Avelumab in Patients With Advanced Unresectable/Metastatic Merkel Cell Carcinoma Progressing on Anti-PD-(L)1 Antibody Therapy

lead_sponsor: 4SC AG

location_country: Spain Italy Netherlands France Belgium Germany

location_facility: Instituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari

location_facility: Hôpital Ambroise Paré - Boulogne-Billancourt

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Lübeck

location_facility: Istituto Nazionale Tumori Fondazione G.Pascale

summary: This phase II trial studies how well domatinostat (4SC-202) works in combination with avelumab in adult patients with advanced unresectable and/or metastatic Merkel Cell Carcinoma that have progressed on a previous therapy with an anti-PD-(L)1 antibody


title: Outcome of COVID-19 Patients After Extracorporeal Membrane Oxygenation for Acute Respiratory Distress Syndrome: A Multicenter European Study

summary: This study aims to investigate outcomes and predictors of outcome after extracorporeal membrane oxygenation (ECMO) therapy for severe acute respiratory syndrome (ARDS) in COVID-19 patients.

ReferenceCitation: Biancari F, Mariscalco G, Dalén M, Settembre N, Welp H, Perrotti A, Wiebe K, Leo E, Loforte A, Chocron S, Pacini D, Juvonen T, Broman LM, Perna DD, Yusuff H, Harvey C, Mongardon N, Maureira JP, Levy B, Falk L, Ruggieri VG, Zipfel S, Folliguet T, Fiore A. Six-Month Survival After Extracorporeal Membrane Oxygenation for Severe COVID-19. J Cardiothorac Vasc Anesth. 2021 Jul;35(7):1999-2006. doi: 10.1053/j.jvca.2021.01.027. Epub 2021 Jan 19.

lead_sponsor: Helsinki University Central Hospital

location_country:
United Kingdom
Italy
Finland
Sweden
France
Germany

location_facility:
Robert Debré University Hospital
Karolinska University Hospital
S. Orsola Hospital
Helsinki University Hospital
Henri Mondon Unoversity Hospital
University Hospitals of Leicester
University Hospital Jean Minjoz
Münster University Hospital
Hamburg University Heart Center
Lecco Hospital
Nancy University Hospital

intervention_type: Device


title: Response to CFTR-modulators in Intestinal Organoids of Patients With CF Having at Least One R334W Mutation

summary: In contrary to what is seen in FRT cells, rectal organoids of patients with a R334W mutation do respond to CFTR modulators ivacaftor and lumacaftor. The present study will investigate the response to modulators in organoids of 30 patients with CF and a R334W mutation, to allow further stratificaton for a future clinical trial assessing the clinical effect of ivacaftor/tezacaftor in patients with CF and a R334W mutation.

status: Unknown status

primary_purpose: Other

lead_sponsor: Universitaire Ziekenhuizen KU Leuven

location_country: Portugal Spain Italy France Belgium

location_facility: Fondazione Ospedale Maggiore Policlinico

location_facility: Centre Hospitalier Régional Universitaire Montpellier

location_facility: Sapienza university - Centra Fibrosi Cistica Regione Lazio

location_facility: Azieda Ospedaliera Universitaria Integrata


title: A Post-Authorisation Safety Study Patient Registry of Patients With High-risk Neuroblastoma Being Treated With the Monoclonal Antibody Dinutuximab Beta

summary: This is a non-interventional, multi-national, observational, prospective patient registry to further evaluate the effectiveness and safety of dinutuximab beta - a monoclonal immunoglobulin G 1 (IgG1) antibody, to obtain information on survival, pain severity and incidence of neuro-toxicity, visual impairment, capillary leak syndrome, cardiovascular events, hypersensitivity reactions and long-term safety.

lead_sponsor: EusaPharma (UK) Limited

location_country:
Poland
Spain
Italy
Austria
United Kingdom
France
Germany

location_facility: Hospital Universitario y Politecnico La Fe Avenida Fernando Abril Martorell

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: Hôpital de la Timone, Hôpital des Enfants


acronym: TUDCA-ALS

lead_sponsor: Humanitas Mirasole SpA

ReferenceCitation: Albanese A, Ludolph AC, McDermott CJ, Corcia P, Van Damme P, Van den Berg LH, Hardiman O, Rinaldi G, Vanacore N, Dickie B; TUDCA-ALS Study Group. Tauroursodeoxycholic acid in patients with amyotrophic lateral sclerosis: The TUDCA-ALS trial protocol. Front Neurol. 2022 Sep 27;13:1009113. doi: 10.3389/fneur.2022.1009113. eCollection 2022.

ipd_sharing_description:
Once the dataset has been analysed, a complete, cleaned, anonymized copy of the final data used in conducting the final analyses will be made available to be used in further studies by the research partners or by other research groups and clinicians.

To prevent misuse and misinterpretation, relevant study metadata (such as the study protocol, case report forms, documentation providing information about the methodology and procedures used to collect the data, definition of variables and statistical code) will be shared in a data repository with a stable URL. Patient anonymity and legal compliance will be assured throughout all the steps of data transfer.

location_country:
United Kingdom
Italy
Ireland
Netherlands
France
Belgium
Germany

location_facility: AOU Città della Salute e della Scienza di Torino

location_facility: Lancashire Teaching Hospitals NHS Foundation Trust

location_facility: Centre Hospitalier Regional Universitaire de Tours

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Azienda Ospedaliera Santa Maria di Terni

location_facility: Centre Hospitalier Universitaire Limoges

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: NEuroMuscular Omnicentre. Fondazione Serena Onlus

location_facility: AOU Università degli Studi della Campania "Luigi Vanvitelli"

summary: This is a Phase III, multi-centre, randomized, double-blind, placebo-controlled, parallel-group study to evaluate Safety and Efficacy of Tauroursodeoxycholic (TUDCA) as add-on Treatment in Patients Affected by Amyotrophic Lateral Sclerosis (ALS).


title: A Prospective Multinational European Study on Evaluation of Practices and Prognostic Factors of Percutaneous Coronary Interventions (PCI) of Calcified Complex Lesions Using Rotational Atherectomy Device.

acronym: Eurotaclub

summary:
In spite of technological advances, PCI of complex calcified coronary lesions remain a challenge.

Observational studies demonstrate that moderate or severe calcifications in lesions to treat are associated with an increase in mortality, in myocardial infarctions, in stent thrombosis, and in complementary revascularizations. Rotational atherectomy is now part of therapeutic armamentarium of interventional cardiologists for the treatment of some complex calcified coronary lesions. Last recommendations of the European Society of Cardiology about revascularizations indicate that rotational atherectomy should be used for "the preparation of calcified or massive fibrotic lesions that cannot be crossed by a balloon or for an optimal dilatation before stenting". However, this technique is not frequently used and limited to high-volume PCI centers. Even though rotational atherectomy demonstrated an improvement in immediate success of complex lesions, the longterm reduction of cardiovascular events after active stenting has not been proved. In observational studies, the results are not consistent because of many selection biases that influence the choice of an angioplasty with rotational atherectomy device (calcifications, severity of the disease). Furthermore, this technique needs operators with a certain amount of experience. The fundamentals of an optimal use of rotational atherectomy remain to be defined (duration and speed of burr, anti-platelet treatments...).

lead_sponsor: University Hospital, Toulouse

location_country:
Poland
Spain
Italy
Austria
Greece
Russian Federation
France
Germany

location_facility: Interventional Cardiology Clinic, Jagiellonina University

location_facility: Hospital Universitario Central de la Defensa "Gomez Ulla"

location_facility: Azienda Sanitaria Universitaria Integrata di Udine


title: Effects of Two Different Doses of Rec 0/0438 Administered by Intravesical Instillation in Patients With Neurogenic Detrusor Overactivity Due to Spinal Cord Injury: a Repeated Doses, Double-blind, Placebo Controlled Study

lead_sponsor: RECORDATI GROUP

location_country: Poland France Portugal Czechia

location_facility: Centre Hospitalier Lyon Sud Unité de Pharmacie Clinique Oncologique (essai clinique) Pavillon Marcel Bérard - Bât. 1G

location_facility: Department of Urology, Academic hospital Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris, Pierre et Marie Curie Medical School, Sorbonne Universités

summary: Study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of Rec 0/0438 in subjects with neurogenic detrusor overactivity due to spinal cord injury


title: Validation of Fenestrations Positioning by Numerical Simulation in Fenestrated Endovascular Repair of Abdominal Aortic Aneurysms

acronym: FenSim

summary: Fenestrated endovascular repair (FEVAR) is nowadays a recognized option to treat juxtarenal, pararenal or suprarenal abdominal aortic aneurysms in patients at high risk for conventional repair. The technique consists in deploying a custom-made stent-graft (SG) inside the patient aorta. Part of the customization involves cauterizing a hole in SG fabric and reinforcing it with a Nitinol stent ring, thereby creating a fenestration for each corresponding collateral artery. For this reason, preoperative planning is crucial to determine adequate positions of fenestrations, in order to obtain perfect alignment with the collateral arteries of the patient. Inadequate positioning may result in failure to catheterize a collateral artery and subsequent organ damage, increased catheterizing time, increased irradiation dose, endoleaks… The current process of fenestrations positioning for fenestrated anacondaTM SG involves: (i) anatomical measurements on patient preoperative CT-scan by case planners using dedicated sizing software; (ii) designing an initial custom device scheme with its positioned fenestrations, created by engineers with CAD software using the above cited measurements and (iii) validation of fenestrations position by in vitro testing using a SG prototype deployed inside a transparent anatomy model (3D-printed model of patient aorta and collateral arteries). The main limitations of this process are the costs and long SG delivery time.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_country:
United Kingdom
Austria
Netherlands
France
Germany

location_facility: University Hospital, Campus Benjamin Franklin


title: Comparison of Amplatzer Amulet vs Watchman Device in Patients Undergoing Left Atrial Appendage Closure: the SWISS-APERO Randomized Clinical Trial

acronym: SWISS-APERO

summary: Left atrial appendage closure (LAAC) is an emerging therapeutic option in non-valvular atrial fibrillation (NVAF) patients with high thromboembolic and bleeding risks. In Europe the devices most frequently utilized for LAAC are Amplatzer Amulet (St. Jude Medical-Abbott) and Watchman (Boston Scientific) system. However there are currently no randomized controlled trials assessing the degree of LAA closure between the two devices. The main purpose of this trial is to evaluate the feasibility and the efficacy of the devices in terms of LAA complete occlusion with a non-invasive imaging technique such as cardiac computed tomography angiography (CCTA).

ReferenceCitation: Galea R, De Marco F, Meneveau N, Aminian A, Anselme F, Gräni C, Huber AT, Teiger E, Iriart X, Babongo Bosombo F, Heg D, Franzone A, Vranckx P, Fischer U, Pedrazzini G, Bedogni F, Räber L, Valgimigli M. Amulet or Watchman Device for Percutaneous Left Atrial Appendage Closure: Primary Results of the SWISS-APERO Randomized Clinical Trial. Circulation. 2022 Mar 8;145(10):724-738. doi: 10.1161/CIRCULATIONAHA.121.057859. Epub 2021 Nov 6.

ReferenceCitation: Galea R, De Marco F, Aminian A, Meneveau N, Anselme F, Gräni C, Huber AT, Teiger E, Iriart X, Angelillis M, Brugger N, Spirito A, Corpataux N, Franzone A, Vranckx P, Fischer U, Pedrazzini G, Bedogni F, Windecker S, Räber L, Valgimigli M. Design and Rationale of the Swiss-Apero Randomized Clinical Trial: Comparison of Amplatzer Amulet vs Watchman Device in Patients Undergoing Left Atrial Appendage Closure. J Cardiovasc Transl Res. 2021 Oct;14(5):930-940. doi: 10.1007/s12265-020-10095-4. Epub 2021 Apr 21.

lead_sponsor: University Hospital Inselspital, Berne

location_country: France Italy Switzerland Belgium

location_facility: Hopital cardiologique Haut Lévêque CHU de Bordeaux

location_facility: Hôpital Hôpitaux Universitaires Henri-Mondor

location_facility: Department of Cardiology, Cardiocentro Ticino

location_facility: Centre Hospitalier Universitaire Hôpitaux De Rouen

location_facility: Centre Hospitalier Régional Universitaire Hôpital Jean Minjoz

location_facility: Centre Hospitalier Universitaire de Charleroi


title: Safety and Efficacy Comparison Of Two TAVI Systems in a Prospective Randomized Evaluation II: A Randomized, Controlled, Non-inferiority Trial Evaluating Safety and Clinical Efficacy of the Symetis ACURATE Neo Compared to the Medtronic Evolut R Bioprosthesis in Transfemoral Transcatheter Aortic Valve Implantation

acronym: SCOPE II

summary: Current care randomized clinical trial comparing the CE marked Symetis ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System with the CE marked Medtronic CoreValve Evolut R TAVI system (or any future CE-marked CoreValve versions).

ReferenceCitation: Tamburino C, Bleiziffer S, Thiele H, Scholtz S, Hildick-Smith D, Cunnington M, Wolf A, Barbanti M, Tchetchè D, Garot P, Pagnotta P, Gilard M, Bedogni F, Van Belle E, Vasa-Nicotera M, Chieffo A, Deutsch O, Kempfert J, Søndergaard L, Butter C, Trillo-Nouche R, Lotfi S, Möllmann H, Joner M, Abdel-Wahab M, Bogaerts K, Hengstenberg C, Capodanno D. Comparison of Self-Expanding Bioprostheses for Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis: SCOPE 2 Randomized Clinical Trial. Circulation. 2020 Dec 22;142(25):2431-2442. doi: 10.1161/CIRCULATIONAHA.120.051547. Epub 2020 Oct 15.

lead_sponsor: Ceric Sàrl

location_country:
Denmark
Spain
Italy
United Kingdom
France
Germany

location_facility: Deutsches Herzzentrum München des Freistaates Bayern

location_facility: Brighton and sussex University hospital NHS trust

location_facility: University of Catania, Ferrarotto Hospital

location_facility: Centre Hospitalier Universitaire de Lille

location_facility: Complejo Hospitalario Universitario de Santiago de Compostela

location_facility: Herzzentrum Leipzig - Universitätsklinik

location_facility: Klinik für Herz- & Kreislauferkrankungen - Deutsches Herzzentrum München

location_facility: Herzzentrum Brandenburg, Immanuel Klinikum Bernau

location_facility: Heart Center, Rigshospitalet, University of Copenhagen


acronym: Safety and Efficacy of Nemolizumab in PN

title: A Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis (PN)

lead_sponsor: Galderma R&D

ReferenceCitation: Ständer S, Yosipovitch G, Legat FJ, Lacour JP, Paul C, Narbutt J, Bieber T, Misery L, Wollenberg A, Reich A, Ahmad F, Piketty C. Trial of Nemolizumab in Moderate-to-Severe Prurigo Nodularis. N Engl J Med. 2020 Feb 20;382(8):706-716. doi: 10.1056/NEJMoa1908316.

location_country: Austria Germany Poland France

location_facility: Centre-Hospitalier Universitaire (CHU) - Hopital Morvan - Br

location_facility: Dermoklinika Centrum Medyczne s.c. M.Kierstan, J.Narbutt, A.Lesiak

location_facility: Centre Hospitalier Universitaire De Toulouse

location_facility: Klinikum der Johann-Wolfgang Goethe-Universität

location_facility: Eberhard-Karls Universitaet Tuebingen - Universitaets Hautkl

location_facility: Kliniczny Szpital Wojew. nr 1 im. F.Chopina w Rzeszowie

location_facility: Klinikum Der Universität München - Campus Innenstadt - Dermatologie und Allergologie

location_facility: Charite - Campus Charite Mitte (CCM) - Dermatologie & Allergologie - Dermatologie & Allergologie

summary: The aim of this study is to assess the safety and efficacy of nemolizumab in subjects with prurigo nodularis.


acronym: LUX-Lung-IO

title: LUX-Lung IO: A Phase II, Open Label, Non-randomised Study of Afatinib in Combination With Pembrolizumab in Patients With Locally Advanced or Metastatic Squamous Cell Carcinoma of the Lung

lead_sponsor: Boehringer Ingelheim

ReferenceCitation: Levy B, Barlesi F, Paz-Ares L, Bennouna J, Erman M, Felip E, Isla D, Ryun Kim H, Kim SW, Madelaine J, Molinier O, Özgüroğlu M, Rodríguez Abreu D, Adeniji A, Lorence RM, Voccia I, Chisamore MJ, Riess JW. Phase II study of afatinib plus pembrolizumab in patients with squamous cell carcinoma of the lung following progression during or after first-line chemotherapy (LUX-Lung-IO). Lung Cancer. 2022 Apr;166:107-113. doi: 10.1016/j.lungcan.2022.01.023. Epub 2022 Feb 3.

ReferenceCitation: Levy B, Paz-Ares L, Bennouna J, Felip E, Abreu DR, Isla D, Barlesi F, Molinier O, Madelaine J, Audigier-Valette C, Kim SW, Kim HR, Ozguroglu M, Erman M, Badin FB, Mekhail TM, Scheff R, Chisamore MJ, Sadrolhefazi B, Riess JW. Afatinib With Pembrolizumab for Treatment of Patients With Locally Advanced/Metastatic Squamous Cell Carcinoma of the Lung: The LUX-Lung IO/KEYNOTE 497 Study Protocol. Clin Lung Cancer. 2019 May;20(3):e407-e412. doi: 10.1016/j.cllc.2018.12.022. Epub 2019 Jan 4.

location_country:
Spain
Korea, Republic of
Turkey
United States
France

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi

location_facility: Hospital Clínico Universitario Lozano Blesa

location_facility: Hacettepe Universitesi Tip Fakultesi, Onkoloji ABD

location_facility: Complejo Hospitalario Universitario Insular - Materno Infantil

summary:
The main objective is to assess the efficacy of afatinib in combination with pembrolizumab, as measured by objective response (OR) in patients with locally advanced or metastatic squamous NSCLC who progressed during or after first line platinum-based treatment.

The secondary objectives are to confirm the RP2D, assess the safety profile, and the secondary measures of clinical efficacy including disease control (DC), duration of objective response (DoR), progression-free survival (PFS), overall survival (OS), and tumour shrinkage.


title: Phase I Dose-escalation Study of Oral Administration of the Selective Bcl2 Inhibitor S 55746 in Patients With Refractory or Relapsed Chronic Lymphocytic Leukaemia and B-Cell Non-Hodgkin Lymphoma

summary: The purpose of this study is to determine the safety profile and tolerability of S 55746 in patients with CLL, B-Cell NHL and MM, in terms of Dose-Limiting Toxicities (DLTs), Maximum Tolerated Dose (MTD) and determine the Recommended Phase 2 Dose (RP2D) through safety profile (DLT, MTD), PK profile, PD profile and preliminary efficacy.

ipd_sharing_description:
Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs).

They can ask all interventional clinical studies:

submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.

lead_sponsor: Institut de Recherches Internationales Servier

location_country:
Poland
United Kingdom
Australia
Hungary
Korea, Republic of
France
Singapore
Germany

location_facility: The Alfred Hospital Malignant Haematology & Stem Cell Transplantation Services

location_facility: National University Cancer Institute Singapore


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

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

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

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

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

lead_sponsor: AstraZeneca

location_country:
United Kingdom
United States
Spain
France