title: A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma

lead_sponsor: Kite, A Gilead Company

ReferenceCitation: Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, Lister TA; Alliance, Australasian Leukaemia and Lymphoma Group; Eastern Cooperative Oncology Group; European Mantle Cell Lymphoma Consortium; Italian Lymphoma Foundation; European Organisation for Research; Treatment of Cancer/Dutch Hemato-Oncology Group; Grupo Español de Médula Ósea; German High-Grade Lymphoma Study Group; German Hodgkin's Study Group; Japanese Lymphorra Study Group; Lymphoma Study Association; NCIC Clinical Trials Group; Nordic Lymphoma Study Group; Southwest Oncology Group; United Kingdom National Cancer Research Institute. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68.

ReferenceCitation: Swerdlow SH, Campo E, Pileri SA, Harris NL, Stein H, Siebert R, Advani R, Ghielmini M, Salles GA, Zelenetz AD, Jaffe ES. The 2016 revision of the World Health Organization classification of lymphoid neoplasms. Blood. 2016 May 19;127(20):2375-90. doi: 10.1182/blood-2016-01-643569. Epub 2016 Mar 15. Review.

ReferenceCitation: The Lancet Haematology. The role of conferences in tackling inequalities. Lancet Haematol. 2022 Feb;9(2):e81. doi: 10.1016/S2352-3026(22)00008-4.

ReferenceCitation: Del Pozo Martín Y. 2021 ASH annual meeting. Lancet Haematol. 2022 Feb;9(2):e92-e93. doi: 10.1016/S2352-3026(21)00384-7. Epub 2021 Dec 16.

ReferenceCitation: Locke FL, Miklos DB, Jacobson CA, Perales MA, Kersten MJ, Oluwole OO, Ghobadi A, Rapoport AP, McGuirk J, Pagel JM, Muñoz J, Farooq U, van Meerten T, Reagan PM, Sureda A, Flinn IW, Vandenberghe P, Song KW, Dickinson M, Minnema MC, Riedell PA, Leslie LA, Chaganti S, Yang Y, Filosto S, Shah J, Schupp M, To C, Cheng P, Gordon LI, Westin JR; All ZUMA-7 Investigators and Contributing Kite Members. Axicabtagene Ciloleucel as Second-Line Therapy for Large B-Cell Lymphoma. N Engl J Med. 2022 Feb 17;386(7):640-654. doi: 10.1056/NEJMoa2116133. Epub 2021 Dec 11.

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

ReferenceCitation: Kambhampati S, Hunter B, Varnavski A, Fakhri B, Kaplan L, Ai WZ, Pampaloni M, Huang CY, Martin T 3rd, Damon L, Andreadis CB. Ofatumumab, Etoposide, and Cytarabine Intensive Mobilization Regimen in Patients with High-risk Relapsed/Refractory Diffuse Large B-Cell Lymphoma Undergoing Autologous Stem Cell Transplantation. Clin Lymphoma Myeloma Leuk. 2021 Apr;21(4):246-256.e2. doi: 10.1016/j.clml.2020.11.005. Epub 2020 Nov 11.

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

location_facility: Washington University School of Medicine

location_facility: Centre Integre Universitaire de Sante et Services Sociaux de l'Est-de-l'lle-de-Montreal / Hopital Maisonneuve-Rosemont

location_facility: CHU de Quebec-Universite Laval, Hopital de L'Enfante-Jesus

location_facility: Instituto di Ematologia "L. e A. Seragnoli" - Dipartimento di Medicina Specialistica Diagnostica e Sperimentale

location_facility: University of Utah, Huntsman Cancer Institute

location_facility: The University of Texas, MD Anderson Cancer Center

location_facility: Medizinische Universitat Innsbruck, Innere Medizin V - Hamatologie und Onkologie

location_facility: Centre Hospitalier Lyon-Sud - Service d'Hematologie clinique

location_facility: IOSI, OSpedale Regionale Bellinzona e Valli

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Universitatsklinikum Graz, Division of Hematology

location_facility: University of Miami Hospital and Clinics/Sylvester Comprehensive Cancer Center

location_facility: University of Iowa Hospitals and Clinincs

location_facility: Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

location_facility: University of Maryland, Greenbaum Comprehensive Cancer Center

location_facility: Uninversity Health Network - Princess Margaret Cancer Center

location_facility: James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center

location_facility: University College London Hospitals NHS Foundation Trust

summary: The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).


status: Completed

primary_purpose: Treatment

intervention_type: Drug

title: A Multicenter, Double-Blind, Randomized, Parallel-Group, Active- and Placebo-Controlled Polysomnography Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42847922 in Subjects With Insomnia Disorder

study_completion_date_type: Actual

lead_sponsor: Janssen Research & Development, LLC

type: Other Identifier

type: EudraCT Number

source: euctr

design_allocation: Randomized

study_start_date_type: Actual

study_type: Interventional

enrollment_type: Actual

location_country:
Poland
United States
France
Belgium
Japan
Germany

location_facility: NZOZ Wielospecjalistyczna Poradnia Lekarska 'Synapsis'

location_facility: California Research Trials DBA Orange Country Research Institute

location_facility: Centrum Badań Klinicznych PI-House sp. z o.o.

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: Centre Hospitalier Specialisé de Rouffach

location_facility: CTI Clinical Trial and Consulting Services

location_facility: Kaiseikai Kita Shin Yokohama Internal Medicine Clinic

summary: The purpose of this 2 month phase 2b study is to investigate the dose response of 3 doses of JNJ-42847922 (Seltorexant) (5,10 and 20 mg) compared to placebo and zolpidem on sleep onset and maintenance and to further document safety and tolerability of JNJ-42847922 (Seltorexant) upon multiple (14 days) dose administration in participants with insomnia disorder.

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase 2a, Randomized, Partially-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Pharmacokinetics of Treatment With Multiple Doses of JNJ-56136379 as Monotherapy and in Combination With a Nucleos(t)Ide Analog in Subjects With Chronic Hepatitis B Virus Infection

summary: The main purpose of this study is to evaluate efficacy of 24 weeks of study treatment, in terms of changes in hepatitis B surface antigen (HBsAg) levels.

ReferenceType: derived

ReferenceCitation: Berke JM, Dehertogh P, Vergauwen K, Mostmans W, Vandyck K, Raboisson P, Pauwels F. Antiviral Properties and Mechanism of Action Studies of the Hepatitis B Virus Capsid Assembly Modulator JNJ-56136379. Antimicrob Agents Chemother. 2020 Apr 21;64(5). pii: e02439-19. doi: 10.1128/AAC.02439-19. Print 2020 Apr 21.

lead_sponsor: Janssen Sciences Ireland UC

location_country:
Poland
Taiwan
Hong Kong
Spain
Italy
Russian Federation
United Kingdom
Canada
Thailand
Ukraine
Korea, Republic of
United States
France
China
Malaysia
Belgium
Japan
Germany
Turkey

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Asklepios Klinik St. Georg, Haus Lifi - Studien und Projekte GmbH

location_facility: Queen Mary Hospital, University of Hong Kong

location_facility: Vancouver ID Research and Care Centre Society

location_facility: Ege University Medical of Faculty, Department of Gastroenterology

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Vinnytsia City Clinical Hospital #1, Department of Infectious Diseases #1

location_facility: Saglık Bilimleri University Şişli Trainig and Research Hospital,Department of Gastroenterology

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH

location_facility: Kharkiv National Medical University, Regional Clinical Infectious Hospital

location_facility: SGS Clinical Pharmacology Unit (located in ZNA Stuivenberg)

location_facility: Chang Gung Memorial Hospital Linkou Branch

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Karadeniz Teknik University Medical Faculty

location_facility: National Hospital Organization Nagasaki Medical Center

location_facility: Beiijing Friendship Hospital, Capital Medical University

location_facility: Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Universitätsklinikum Johann Wolfgang Goethe- Universität Frankfurt Medizinische Klinik 1

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: SE 'National institute therapy named L.T. Maloi NAMS of Ukraine'

location_facility: Sverdlovsk Regional Clinical Hospital #1


title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Sutimlimab in Patients With Primary Cold Agglutinin Disease Without a Recent History of Blood Transfusion

acronym: Cadenza

summary: The purpose of Part A is to determine whether sutimlimab administration results in a greater than or equal to (>=)1.5 gram per deciliter (g/dL) increase in hemoglobin (Hgb) level and avoidance of transfusion in participants with primary cold agglutinin disease (CAD) without a recent history of blood transfusion. The purpose of Part B is to evaluate the long-term safety and tolerability of sutimlimab in participants with primary CAD.

ReferenceCitation: Röth A, Berentsen S, Barcellini W, D'Sa S, Jilma B, Michel M, Weitz IC, Yamaguchi M, Nishimura JI, Vos JMI, Storek M, Wong N, Patel P, Jiang X, Vagge DS, Wardęcki M, Shafer F, Lee M, Broome CM. Sutimlimab in patients with cold agglutinin disease: results of the randomized placebo-controlled phase 3 CADENZA trial. Blood. 2022 Sep 1;140(9):980-991. doi: 10.1182/blood.2021014955.

ipd_sharing: Yes

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: Bioverativ, a Sanofi company

location_country:
Spain
Italy
Austria
Australia
Netherlands
Canada
United Kingdom
United States
France
Israel
Norway
Belgium
Japan
Germany

location_facility: Washington University School of Medicine

location_facility: New York Medical College at Westchester Medical Center

location_facility: Japanese Red Cross Society Himeji Hospital

location_facility: Hospital of the University of Pennsylvania

location_facility: St Olavs Hospital, Avdeling for blodsykdommer

location_facility: Hospital Clinci i Provincial de Barcelona

location_facility: U.O.C. Ematologia- Policlinico "A. Gemelli"

location_facility: Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Univ Ulm, Inst Klin. Transfusions. Immungen

location_facility: Imperial College Healthcare NHS Trust, Hammersmith Hospital


title: Open Label, Multi-center Roll-over Study to Assess Long Term Safety in Patients Who Have Completed a Global Novartis or GSK Sponsored Dabrafenib and/or Trametinib Study

summary: This study is to provide access for patients who are receiving treatment with dabrafenib and/or trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.

status: Recruiting

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: Novartis Pharmaceuticals

location_country:
Denmark
Spain
Austria
Netherlands
Argentina
Thailand
Hungary
United States
France
China
Japan
Germany

location_facility: James Cancer Hospital and Solove Research Institute Ohio State

status_simplified: Ongoing


title: A Phase 2, Prospective, Randomized, Open-Label Study on the Efficacy of Defibrotide Added to Standard of Care Immunoprophylaxis for the Prevention of Acute Graft-versus-Host-Disease in Adult and Pediatric Patients After Allogeneic Hematopoietic Stem Cell Transplant

summary: This is a study comparing the defibrotide prophylaxis arm vs standard of care arm for the prevention of aGvHD.

lead_sponsor: Jazz Pharmaceuticals

location_country:
Croatia
Poland
Portugal
Spain
Greece
Austria
Italy
United Kingdom
Canada
United States
France
Belgium
Germany
Bulgaria

location_facility: Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku

location_facility: University of North Carolina at Chapel Hill

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Hospital d Instructions des Armees Percy

location_facility: University of California, San Francisco Medical Center

location_facility: Klinikum Mannheim Universitätsklinikum gGmbH

location_facility: Specialized Hospital for Active Treatment of Haematological Diseases - Sofia

location_facility: Complejo Asistencial Universitario de Salamanca - H. Clinico

location_facility: Ordensklinikum Linz, Krankenhaus der Elisabethinen GmbH

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Penn State Milton S Hershey Medical Center

location_facility: Centrum Onkologii im. Marii Sklodowskiej-Curie

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden

location_facility: ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda


type: Registry Identifier

title: An Open-Label, Multi-Drug, Biomarker-Directed, Multi-Centre Phase II Umbrella Study in Patients With Non-Small Cell Lung Cancer, Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy (HUDSON).

acronym: HUDSON

summary: This is an open-label, multi-centre, umbrella Phase II study in patients with metastatic NSCLC who have progressed on an anti-PD-1/PD-L1 containing therapy. This study is modular in design, allowing initial assessment of the efficacy, safety, and tolerability of multiple treatment arms.

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.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

lead_sponsor: AstraZeneca

location_country:
Spain
Austria
Canada
Korea, Republic of
United States
France
Israel
Germany


title: A Randomized, Double-blind, Placebo-controlled, Adaptive Study to Evaluate Symptom Improvement and Metabolic Control Among Adult Subjects With Symptomatic Hypoparathyroidism Treated With Recombinant Human Parathyroid Hormone [rhPTH(1-84)]

summary:
Recombinant human parathyroid hormone, also known as if rhPTH(1-84), is a medicine to treat people with Hypothyroidism. The main aim of this study is to learn if rhPTH(1-84) can improve symptoms in adults with hypoparathyroidism.

In this study, participants will receive 1 of 2 treatments: rhPTH(1-84) or a placebo. A placebo looks like the medicine being studied but does not have medicine in it. In this study, the placebo will be a standard treatment which is either active Vitamin D, or active Vitamin D with calcium. Active Vitamin D is a form of vitamin D that has a faster effect on the body. These treatments will be given as a daily injection just under the skin. Participants will not know which treatment they received, nor will their study doctors. This is to help make sure the results are more reliable. All participants will also take active vitamin D and calcium supplements during treatment.

Participants will record their symptoms in a tool called the hypoparathyroidism symptom diary. This tool is used to assess symptoms and their impact and will give an overall score for each participant.

The study doctors will also check for side effects from the study treatments.

After treatment, researchers will check if there is any difference in the diary scores between the 2 treatment groups. A difference in score means there is a difference in symptoms and their impact. From this, researchers will learn if symptoms have improved for participants treated with rhPTH(1-84) compared with those treated with placebo.

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: Shire

location_country:
Denmark
Portugal
Spain
Italy
United Kingdom
Netherlands
Canada
Sweden
United States
France
Belgium
Norway
Germany

location_facility: Nova Scotia Health Authority (Capital District Health Authority)

location_facility: Oslo Universitetssykehus HF Rikshospitalet

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: Universita di Firenze, Dipartimento di Chirurgia e Medicina Traslazionale (DCMT)

location_facility: Eastern Health - Health Sciences Center- General Hospital

location_facility: Centro Hospitalar E Universitário de Coimbra EPE

location_facility: Ohio State University Wexner Medical Center

intervention_type: Biological


acronym: A multi-centre, open-label, long term safety study of mepolizumab in subjects with HSE.

title: A Multi-centre, Open-label Extension, Safety Study to Describe the Long-term Clinical Experience of Mepolizumab in Participants With Hypereosinophilic Syndrome (HES) From Study 200622

lead_sponsor: GlaxoSmithKline

ReferenceCitation: Gleich GJ, Roufosse F, Chupp G, Faguer S, Walz B, Reiter A, Yancey SW, Bentley JH, Steinfeld J; HES Mepolizumab Study Group. Safety and Efficacy of Mepolizumab in Hypereosinophilic Syndrome: An Open-Label Extension Study. J Allergy Clin Immunol Pract. 2021 Dec;9(12):4431-4440.e1. doi: 10.1016/j.jaip.2021.07.050. Epub 2021 Aug 10.

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

location_country:
Poland
Brazil
Romania
Spain
Italy
Russian Federation
Mexico
United Kingdom
Argentina
France
United States
Belgium
Germany

summary: This is an open-label extension study to Study 200622.In this study subjects from Study 200622 will be continued on 4-weekly dosing with open-label mepolizumab 300 milligram (mg) subcutaneously (SC) for an additional 20 Weeks after completing the 32 Week study assessments post-randomization, while they continue with their background HES therapy per standard of care (SoC). Subjects from study 200622 will participate in this extension study if they had completed the 32-Week treatment period in study 200622 or if they were withdrawn from the study pre-maturely, but were continued in the study per protocol until 32 Weeks from randomization. Data from this study (205203) and 200622 will be combined to provide up to 52-Week exposure data to further characterize the long-term safety profile of mepolizumab and provide additional data on the clinical benefit in HES subjects beyond 32 Weeks. The duration of the study participation will be 20 Weeks for subjects who continue with mepolizumab treatment via MHE104317/MHE112562 after this open-label extension study; and 28 Weeks for subjects who do not continue with MHE104317/MHE112562.


type: U.S. FDA Grant/Contract

title: A Randomized, Double Blind, Placebo Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients With C3 Glomerulopathy

acronym: ACCOLADE

summary: The aim of this trial is to evaluate the effect of avacopan treatment on renal disease activity in patients with complement component 3 glomerulopathy (C3G). Funding Source - FDA OOPD

ipd_sharing: No

lead_sponsor: ChemoCentryx

location_country:
Denmark
Spain
Ireland
Italy
Netherlands
United Kingdom
Canada
United States
France
Belgium
Germany

location_facility:
Clinical Trial Site
Clinical Site


title: A Multicenter, Open-Label, Longer-Term Study of AR101 Characterized Oral Desensitization Immunotherapy in Subjects Who Participated in a Prior AR101 Study

summary: The purpose of this study is to assess AR101's safety, tolerability and efficacy over an extended dosing period.

status: Enrolling by invitation

ReferenceCitation: Nilsson C, Scurlock AM, Dellon ES, Brostoff JM, Pham T, Ryan R, Brown KR, Adelman DC, Aceves SS. Onset of eosinophilic esophagitis during a clinical trial program of oral immunotherapy for peanut allergy. J Allergy Clin Immunol Pract. 2021 Dec;9(12):4496-4501. doi: 10.1016/j.jaip.2021.07.048. Epub 2021 Aug 11.

ReferenceCitation: Fernandez-Rivas M, Vereda A, Vickery BP, Sharma V, Nilsson C, Muraro A, Hourihane JO, DunnGalvin A, du Toit G, Blumchen K, Beyer K, Smith A, Ryan R, Adelman DC, Jones SM. Open-label follow-on study evaluating the efficacy, safety, and quality of life with extended daily oral immunotherapy in children with peanut allergy. Allergy. 2022 Mar;77(3):991-1003. doi: 10.1111/all.15027. Epub 2021 Sep 24.

lead_sponsor: Aimmune Therapeutics, Inc.

location_country:
Spain
Ireland
Italy
Netherlands
United Kingdom
Canada
Sweden
United States
France
Germany

location_facility: Children's Hospital Los Angeles, Division of Clinical Immunology and Allergy

location_facility: Jaffe Food Allergy Institute Icahn School of Medicine at Mount Sinai

location_facility: University of North Carolina at Chapel Hill, Clinical & Translational Research Center

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Medical Research of Arizona, Allergy, Asthma & Immunology Associates

location_facility: Service d'Allergologie Nouvel Hôpital Civil Hôpitaux Univesitaires de Strasbourg

location_facility: Children's Clinical Research Facility, Royal Manchester Children's Hospital

location_facility: Texas Children's Hospital, Baylor College of Medicine

location_facility: Univ. of Rochester Medical Center, Golisano Children's Hosp.

location_facility: Allergy & Asthma Associates of Santa Clara Valley Research Center

location_facility: Beatrix Children's Hospital, University Medical Center Groningen

location_facility: Le Bonheur Children's Hospital, Outpatient Bldg.

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Unité de dermatologie Pédiatrique, Hôpital Pellegrin-Enfants

location_facility: Madrid Hospital Clinico San Carlos, Servicio de Alergia

location_facility: Children's Hospital of Pittsburgh of UPMC

location_facility: Guy & St Thomas' NHS Foundation Trust, Children Allergies Department

location_facility: Allergy & Asthma Medical Group and Research Center

location_facility: Sean N. Parker Center for Allergy and Asthma Research LPCH El Camino Hospital

location_facility: Allergy & Asthma Associates of Southern California

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago

location_facility: Jeanne de Flandre Hospital -Paediatric Allergy and Pulmonology Center

location_facility: The University of Chicago Medicine, Comer Children's Hospital

location_facility: University Hospitals Southampton Foundation NHS Trust

location_facility: Specially for Children Allergy, Asthma and Immunology Clinic

location_facility: Rady Children's Hospital, Div. of Allergy & Immunology

location_facility: Family Allergy & Asthma Research Institute

location_facility: Hopital Saint Vincent de Paul- Service d'Allergologie

location_facility: UCSF, Benioff Children's Hospital - Allergy and Immunology

location_facility: H. Infantil Universitario Niño Jesús, Servicio de Alergia

location_facility: St Mary's Hospital - Paediatric Research Unit

location_facility: Cork University Hospital, UCC Department of Paediatrics and Child Health

location_facility: National Children's Research Centre, Our Lady's Children's Hospital Crumlin

location_facility: Oklahoma Institute of Allergy and Asthma Clinical Research

location_facility: Univ. of Michigan Health System, Div. of Allergy and Clinical Immunology

location_facility: Sher Allergy Specialists - Center for Cough

location_facility: National Allergy and Asthma Research, LLC

location_facility: University of South Florida, Asthma Allergy & Immunology Clinical Research Unit

location_facility: Johns Hopkins Hospital, Pediatric Clinical Research Unit

status_simplified: Unknown


primary_purpose: Prevention

acronym: NTHI MCAT-002

title: An Observer-blind Study to Evaluate the Efficacy, Safety, Reactogenicity and Immunogenicity of the GSK Biologicals' Investigational Vaccine GSK3277511A When Administered to COPD Patients

ReferenceCitation: Arora AK, Chinsky K, Keller C, Mayers I, Pascual-Guardia S, Vera MP, Lambert C, Lombardi S, Rondini S, Tian S, Ulloa-Montoya F, Moraschini L, Casula D; NTHi-Mcat-002 study group. A detailed analysis of possible efficacy signals of NTHi-Mcat vaccine against severe COPD exacerbations in a previously reported randomised phase 2b trial. Vaccine. 2022 Sep 29;40(41):5924-5932. doi: 10.1016/j.vaccine.2022.08.053. Epub 2022 Sep 6.

ReferenceCitation: Andreas S, Testa M, Boyer L, Brusselle G, Janssens W, Kerwin E, Papi A, Pek B, Puente-Maestu L, Saralaya D, Watz H, Wilkinson TMA, Casula D, Di Maro G, Lattanzi M, Moraschini L, Schoonbroodt S, Tasciotti A, Arora AK, Maltais F; NTHi-Mcat-002 study group. Non-typeable Haemophilus influenzae-Moraxella catarrhalis vaccine for the prevention of exacerbations in chronic obstructive pulmonary disease: a multicentre, randomised, placebo-controlled, observer-blinded, proof-of-concept, phase 2b trial. Lancet Respir Med. 2022 May;10(5):435-446. doi: 10.1016/S2213-2600(21)00502-6. Epub 2022 Jan 10. Erratum in: Lancet Respir Med. 2022 Aug;10(8):e77.

location_country:
Spain
Italy
United Kingdom
Canada
United States
France
Belgium
Germany

summary:
The purpose of this study is to test if the vaccine is working well in COPD patients aged 40 to 80 years old to reduce episodes of worsening symptoms ("exacerbations") and to gather further information on safety and immune response.

In the current study, COPD patients with a history of acute exacerbations will receive 2 doses of the investigational vaccine or placebo intramuscularly according to a 0, 2 month vaccination schedule, in addition to standard care.

The effect of vaccination against two pathogens known to cause exacerbations (Non-typeable Haemophilus influenza [NTHi] and Moraxella catarrhalis [Mcat]) will be evaluated at pre-defined timepoints (scheduled study visits).

In addition to the scheduled study visits, additional study visit(s) and/ or phone contact(s) will take place for each acute exacerbation of COPD occurring from first vaccination up to study conclusion.


title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 986 in Healthy Subjects and Heart Failure Patients

summary: To evaluate the safety and tolerability of ascending single (Part A) and ascending multiple (Part B) doses of AMG 986 in healthy adults and of ascending multiple oral doses of AMG 986 in heart failure patients (Part C).

status: Terminated

ReferenceCitation: Winkle P, Goldsmith S, Koren MJ, Lepage S, Hellawell J, Trivedi A, Tsirtsonis K, Abbasi SA, Kaufman A, Troughton R, Voors A, Hulot JS, Donal E, Kazemi N, Neutel J. A First-in-Human Study of AMG 986, a Novel Apelin Receptor Agonist, in Healthy Subjects and Heart Failure Patients. Cardiovasc Drugs Ther. 2022 Apr 23. doi: 10.1007/s10557-022-07328-w. [Epub ahead of print]

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

lead_sponsor: Amgen

location_country:
Poland
Australia
Netherlands
Canada
New Zealand
United States
France
Singapore
Germany


title: HEMOglobin Transfusion Threshold in Traumatic Brain Injury OptimizatioN: The HEMOTION Trial

acronym: HEMOTION

summary: Most trauma deaths are related to traumatic brain injury (TBI). Although the management of patients has improved, mortality remains unacceptably high, and half of survivors of moderate and severe TBI are left with major functional impairment. Current management guidelines are based on limited evidence and practice is highly variable. Most acutely ill patients with TBI will develop anemia, which may decrease oxygen delivery to a fragile brain. While clinical practice is moving towards transfusing at low hemoglobin (Hb) levels, experts have expressed concerns regarding restrictive strategies, which may adversely affect clinical outcomes in TBI. Our primary objective is to evaluate the effect of red blood cell (RBC) transfusion thresholds on neurological functional outcome. We hypothesize that a liberal transfusion strategy improves outcomes compared to a restrictive strategy.

ReferenceCitation: Turgeon AF, Fergusson DA, Clayton L, Patton MP, Zarychanski R, English S, Docherty A, Walsh T, Griesdale D, Kramer AH, Scales D, Burns KEA, Boyd JG, Marshall JC, Kutsogiannis DJ, Ball I, Hébert PC, Lamontagne F, Costerousse O, St-Onge M, Lessard Bonaventure P, Moore L, Neveu X, Rigamonti A, Khwaja K, Green RS, Laroche V, Fox-Robichaud A, Lauzier F; HEMOTION Trial Team, the Canadian Critical Care Trials Group, the Canadian Perioperative Anesthesia Clinical Trials Group and the Canadian Traumatic Brain Injury Research Consortium. Haemoglobin transfusion threshold in traumatic brain injury optimisation (HEMOTION): a multicentre, randomised, clinical trial protocol. BMJ Open. 2022 Oct 10;12(10):e067117. doi: 10.1136/bmjopen-2022-067117.

lead_sponsor: CHU de Quebec-Universite Laval

location_country:
Canada
Brazil
United Kingdom
France

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: CHU de Québec-Université Laval (Hôpital de l'Enfant-Jésus), Université Laval

location_facility: Centre Hospitalier de l'Université de Montréal

location_facility: St. Mary's Hospital (Imperial College Healthcare)

location_facility: The Hospital das Clinicas da Facudade de Medicina da USP

intervention_type: Procedure

lead_sponsor_type: academique


title: A Phase 2 Open-Label Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination With Ruxolitinib in Subjects With Myelofibrosis (REFINE)

acronym: REFINE

summary: This is a Phase 2 open-label, multicenter study evaluating tolerability and efficacy of navitoclax alone or when added to ruxolitinib in participants with myelofibrosis.

status: Active, not recruiting

ReferenceCitation: Pemmaraju N, Garcia JS, Potluri J, Harb JG, Sun Y, Jung P, Qin QQ, Tantravahi SK, Verstovsek S, Harrison C. Addition of navitoclax to ongoing ruxolitinib treatment in patients with myelofibrosis (REFINE): a post-hoc analysis of molecular biomarkers in a phase 2 study. Lancet Haematol. 2022 Jun;9(6):e434-e444. doi: 10.1016/S2352-3026(22)00116-8. Epub 2022 May 13.

ReferenceCitation: Harrison CN, Garcia JS, Somervaille TCP, Foran JM, Verstovsek S, Jamieson C, Mesa R, Ritchie EK, Tantravahi SK, Vachhani P, O'Connell CL, Komrokji RS, Harb J, Hutti JE, Holes L, Masud AA, Nuthalapati S, Potluri J, Pemmaraju N. Addition of Navitoclax to Ongoing Ruxolitinib Therapy for Patients With Myelofibrosis With Progression or Suboptimal Response: Phase II Safety and Efficacy. J Clin Oncol. 2022 May 20;40(15):1671-1680. doi: 10.1200/JCO.21.02188. Epub 2022 Feb 18.

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications

lead_sponsor: AbbVie

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
United States
Belgium
Japan
Poland
Russian Federation
Australia
Puerto Rico
Israel
Turkey
Canada
Hungary
Bulgaria
Taiwan
Greece
Korea, Republic of
France

location_facility: Belfast Health and Social Care Trust /ID# 216991

location_facility: Mid Illinois Hematology & Oncology Associates, Ltd /ID# 230536

location_facility: Medical University of South Carolina /ID# 222597

location_facility: Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 230318

location_facility: Grande Ospedale Metropolitano-Bianchi-Melacrino /ID# 230011

location_facility: VA Caribbean Healthcare System /ID# 222416

location_facility: Juntendo University Hospital /ID# 221484

location_facility: St Joseph Heritage Healthcare /ID# 230936

location_facility: Hospital Clinic de Barcelona /ID# 231538

location_facility: Princess Margaret Cancer Centre /ID# 214483

location_facility: A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 214549

location_facility: Guy's and St Thomas' NHS Foundation Trust /ID# 164110

location_facility: Weill Cornell Medical College /ID# 162679

location_facility: University of Massachusetts Wo /ID# 222547

location_facility: Southeastern Medical Oncology Center /ID# 230954

location_facility: Seoul National University Hospital /ID# 230380

location_facility: A.O.U. Policlinico S.Orsola-Malpighi /ID# 230012

location_facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 230393

location_facility: Klinicka bolnica Dubrava Zagreb /ID# 230504

location_facility: New Jersey Cancer Care & Blood Disorders /ID# 230925

location_facility: Hospital Universitario Germans Trias i Pujol /ID# 214704

location_facility: Leningrad Regional Clinical Hospital /ID# 230507

location_facility: General Hospital of Athens Laiko /ID# 230394

location_facility: Comprehensive Cancer Centers of Nevada /ID# 230916

location_facility: Cancer Specialists of North Florida /ID# 230917

location_facility: Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet /ID# 230306

location_facility: Long Beach Memorial Medical Ct /ID# 230148

location_facility: Dokuz Eylul University Medical Faculty /ID# 231321

location_facility: Clin Hosp Ctr Bezanijska Kosa /ID# 230681

location_facility: City Clinical Hospital named after S.P. Botkin /ID# 230508

location_facility: Capital Region Medical Center /ID# 232627

location_facility: Memorial Hospital of South Bend /ID# 230912

location_facility: University of Texas Health San Antonio MD Anderson Cancer Center /ID# 164094

location_facility: ASST Spedali civili di Brescia /ID# 230420

location_facility: Hospital General Universitario Gregorio Maranon /ID# 214676

location_facility: Dokkyo Medical University Saitama Medical Center /ID# 222332

location_facility: Ondokuz mayis University Facul /ID# 230314

location_facility: CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 230718

location_facility: Dana-Farber Cancer Institute /ID# 162675

location_facility: Tel Aviv Sourasky Medical Center /ID# 230311

location_facility: Klinicki bolnicki centar Zagreb /ID# 230602

location_facility: Ocala Oncology Florida Cancer Affiliates /ID# 230927

location_facility: Nippon Medical School Hospital /ID# 222692

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 214553

location_facility: McGill University Health Center Research Institute /ID# 223976

location_facility: Moore UC San Diego Cancer Center /ID# 164084

location_facility: Hospital Universitario 12 de Octubre /ID# 214710

location_facility: Kansai Medical University Hospital /ID# 222690

location_facility: Hospital Universitario Central de Asturias /ID# 230884

location_facility: University of Chicago Medicine /ID# 164115

location_facility: Hospital Universitario Virgen de la Victoria /ID# 214709

location_facility: Univ Hosp Cleveland: Seidman Cancer Center /ID# 230938

location_facility: Klinicki bolnicki centar Split /ID# 230601

location_facility: Azienda Ospedaliero Universitaria Careggi /ID# 214555

location_facility: University General Hospital Attikon /ID# 230395

location_facility: Ascension Providence Southfield Cancer Center /ID# 223876

location_facility: Kaohsiung Chang Gung Memorial Hospital /ID# 230371

location_facility: Aneurin Bevan University Health Board /ID# 230332

location_facility: Colorado Blood Cancer Institute /ID# 224250

location_facility: Fujita Health University Hospital /ID# 221539

location_facility: Hospital Universitario Vall d'Hebron /ID# 222415

location_facility: St. Joseph Heritage Healthcare /ID# 230935

location_facility: Universtiy of Southern California /ID# 164095

location_facility: Hadassah Medical Center-Hebrew University /ID# 230310

location_facility: MD Anderson Cancer Center at Texas Medical Center /ID# 162683

location_facility: Hematology Oncology Associates of Fredericksburg /ID# 231372

location_facility: Assuta Ashdod Medical Center /ID# 230396

location_facility: Prairie Lakes Healthcare System /ID# 224358

location_facility: Szabolcs - Szatmar - Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras /ID# 230585

location_facility: University of Yamanashi Hospital /ID# 221700

location_facility: University of Alberta Hospital - Division of Hematology /ID# 217698

location_facility: Eastern Connecticut Hematology and Oncology Associates /ID# 230918

location_facility: Community Cancer Trials of Utah /ID# 230914

location_facility: University Cancer & Blood Center /ID# 230939

location_facility: Utah Cancer Specialists Salt Lake Clinic /ID# 222806

location_facility: The Center for Cancer and Blood Disorders a division of American Oncology Partners of Maryland, PA /ID# 231299

location_facility: Ankara Universitesi Fakultesi /ID# 230317

location_facility: Tennessee Oncology-Nashville Centennial /ID# 221410

location_facility: National Cheng Kung University Hospital /ID# 230372

location_facility: Baptist MD Anderson Cancer Center - Jacksonville /ID# 222548

location_facility: UAB Comprehensive Cancer Cente /ID# 165464

location_facility: Northwest Medical Specialties /ID# 230926

location_facility: CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 230719

location_facility: Hospital del Centro Comprensivo de Cancer de la UPR /ID# 222544

location_facility: Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 225159

location_facility: Indiana Blood & Marrow Transpl /ID# 165075

location_facility: Southcoast Health Cancer Center /ID# 230934

location_facility: A.O.U. di Bologna Policlinico S.Orsola-Malpighi /ID# 230012

location_facility: Aomori Prefectural Central Hospital /ID# 221773

location_facility: Mary Crowley Cancer Research /ID# 230923

location_facility: Heart Blood and Endocrinology Federal Center n.a. V.A. Almazov /ID# 230506

location_facility: Centre Hospitalier de CHAMBERY /ID# 230889

location_facility: University Clinical Center Serbia /ID# 230629

location_facility: Heartland Regional Medical Center, St.Joseph Mosaic Life Care Cancer Care / ID# 230924

location_facility: University Clinical Center Kragujevac /ID# 230550


title: A Single Arm, Open Label, Multicenter Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment Naïve Adults With Chronic Hepatitis C Virus (HCV) Genotypes 1 - 6 Infection and Aspartate Aminotransferase to Platelet Ratio Index (APRI) ≤ 1

summary: A study to evaluate the efficacy and safety of glecaprevir(GLE)/pibrentasvir(PIB) in treatment-naïve participants with chronic hepatitis C virus (HCV) genotypes 1-6 infection and with an aspartate aminotransferase to platelet ratio index (APRI) of less than or equal to 1.

ReferenceCitation: Fontana RJ, Lens S, McPherson S, Elkhashab M, Ankoma-Sey V, Bondin M, Dos Santos AGP, Xue Z, Trinh R, Porcalla A, Zeuzem S. Efficacy and Safety of 8 Weeks of Glecaprevir/Pibrentasvir in Treatment-Naïve, HCV-Infected Patients with APRI ≤ 1 in a Single-Arm, Open-Label, Multicenter Study. Adv Ther. 2019 Dec;36(12):3458-3470. doi: 10.1007/s12325-019-01123-0. Epub 2019 Oct 23.

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

location_country:
Poland
Spain
United Kingdom
Russian Federation
Canada
Puerto Rico
United States
France
Germany
Bulgaria

location_facility: University of Vermont Medical Center /ID# 161263

location_facility: University of Michigan Hospitals /ID# 161265

location_facility: Charité Universitätsmedizin Campus Mitte /ID# 161395

location_facility: Digestive Disease Associates - Baltimore /ID# 161260

location_facility: Hosp Uni Virgen de la Victoria /ID# 164383

location_facility: Universitaetsmedizin der Johannes-Gutenberg Universität Mainz /ID# 161396

location_facility: Uniwersytecki Szpital Kliniczn /ID# 162216

location_facility: A.I. Evdokimov Moscow State Un /ID# 163162

location_facility: Universitätsklinikum Frankfurt /ID# 161397

location_facility: Digestive and Liver Disease Sp /ID# 161259

location_facility: Northwest Gastroenterology Cli /ID# 161257

location_facility: Complexo Hospitalario universi /ID# 165603

location_facility: A. F. Agafonov Republican Clin /ID# 163164

location_facility: CHU de Rennes - PONTCHAILLOU /ID# 161492

location_facility: CHU de Besancon - Jean Minjoz /ID# 161485

location_facility: HepID - Diagnostyka I Terapia /ID# 162219

location_facility: Liver Associates of Texas, P.A /ID# 161262

location_facility: South Ural State Medical univ /ID# 163163

location_facility: Hospital Clinic de Barcelona /ID# 161437

location_facility: Univ Maryland School Medicine /ID# 161157

location_facility: ICH Study Center GmbH & Co KG /ID# 161394


title: A Multicenter, Double-Blind, Randomized, Comparative Study of the Safety, Tolerability, Efficacy, and Pharmacokinetics of CF-301 vs. Placebo in Addition to Standard-of-Care Antibacterial Therapy for the Treatment of Adult Patients With Staphylococcus Aureus Bloodstream Infections (Bacteremia) Including Endocarditis

summary:
The purpose of this study is to evaluate the safety, tolerability, efficacy and pharmacokinetics (PK) of CF-301 in addition to background standard of care (SOC) antibacterial therapy for the treatment of Staphylococcus aureus (S. aureus) bloodstream infections (bacteremia), including endocarditis in adults. Patients will be randomized to receive a single intravenous dose of CF-301 or placebo in addition to SOC antibacterial therapy. Patients will be prescribed standard of care antibiotics selected by the investigators based on their professional experience, practice guidelines and local antibiotic susceptibility information for the treatment of S. aureus bacteremia.

CF-301 is a lysin and member of a new class of targeted protein-based antimicrobials that has demonstrated activity against S. aureus in laboratory (in vitro) and animal studies, alone and in addition to conventional antibiotics.

ReferenceCitation: Fowler VG Jr, Das AF, Lipka-Diamond J, Schuch R, Pomerantz R, Jáuregui-Peredo L, Bressler A, Evans D, Moran GJ, Rupp ME, Wise R, Corey GR, Zervos M, Douglas PS, Cassino C. Exebacase for patients with Staphylococcus aureus bloodstream infection and endocarditis. J Clin Invest. 2020 Jul 1;130(7):3750-3760. doi: 10.1172/JCI136577.

lead_sponsor: ContraFect

location_country:
Spain
Greece
Italy
Russian Federation
United Kingdom
Guatemala
United States
Chile
France
Israel
Belgium
Germany
Bulgaria
Czechia

location_facility:
CF0301-102 Study Site
CF301-102 Study Site
Cf-301-102
Cf301-102
CF-301-102 Study Site
CF301-102 Study Site #2
CF-301-102 Study Site #2
CF-301 Study Site
Study Site #2
CF301-102 Study Site #3
CF301-102 Study site


title: An International, Multi-centre Prospective Pharmacokinetic Evaluation of Antifungal Drug Exposure in Intensive Care Unit Patients Receiving Conventional Dosing Regimens

acronym: SAFE-ICU

summary:
Adequate antifungal therapy is a critical determinant of survival in patients admitted to an Intensive Care Unit (ICU) with suspected or proven fungal infections. Critical illness can alter the way human body handles antifungal agents, i.e. how the drugs are distributed in the body and removed from the body. Consequently, these changes can increase the risk of inappropriate antifungal exposure that may lead to adverse consequence on patients' outcome. Developing an evidence-based antifungal dosing guideline is of global significance and should be considered a priority to improving clinical outcomes for patients receiving antifungal agents

The aim of the SAFE-ICU Study is to develop optimised antibiotic dosing guidelines for ICU patients with life-threatening infections that account for patient characteristics. This will be achieved through completion of the following aims:

i) Describe detailed demographic, clinical and plasma antibiotic concentration-time data in a large ICU patient cohort; ii) Perform a robust statistical analysis of the data collected in Aim 1 to develop an enhanced preliminary prediction algorithm for antifungal dosing.

This is a multi-national study and will enrol ICU patients who are prescribed an antifungal agent (fluconazole, voriconazole, posaconazole, isavuconazole, caspofungin, anidulafungin, micafungin or amphotericin B). A minimum of 12 patients per drug will be enrolled across at least 15 countries and up to 80 ICUs.

Eligible patients are those admitted to the ICU, who are prescribed an antifungal agent (fluconazole, voriconazole, posaconazole, isavuconazole, caspofungin, anidulafungin, micafungin or amphotericin B). Blood samples will be taken to measure drug concentration. Sampling will occur on two occasions, first during study days 1-3 and then a second time between days 4-7, each over an 8-24 hour period. Blood samples will be taken from a vascular access device already inserted for ICU patient care. Abdominal samples from abdominal indwelling drains already inserted peri operatively will also be collected on these two occasions in the subgroup of patients with intra-abdominal infection. Data on infection, various blood tests and patient specific data will be collected using a structured case report form (CRF). Patients will also be followed up 30 days after enrolment into the study to evaluate 30-day mortality.

Collected samples will be frozen and stored locally and then shipped in large batches for processing at Burns Trauma and Critical Care Research Centre, The University of Queensland, Australia. Data analysis for development of antifungal dosing algorithms will also be undertaken at The University of Queensland, Australia.

status: Unknown status

study_type: Observational

time_perspective: Prospective

lead_sponsor: The University of Queensland

location_country:
Hong Kong
Portugal
Spain
Greece
Italy
Australia
Netherlands
Finland
Canada
United States
France
Belgium
Malaysia

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau

location_facility: APHP Hôpital Bichat - Réanimation médicale et Maladies infectieuses

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: International Islamic University Malaysia Medical Center

location_facility: Instituto Português de Oncologia do Porto Francisco Gentil

location_facility: Radboud University Nijmegen Medical Centre

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Chu de BORDEAUX Hôpital Haut-Leveque - Réanimation

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino

location_facility: Centro Hospitalar Universitario de coimbra

location_facility: The Health Sciences Center University of Manitoba


acronym: SELECT - PsA 2

title: A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD) - SELECT - PsA 2

ReferenceType: result

ReferenceCitation: Mease PJ, Lertratanakul A, Anderson JK, Papp K, Van den Bosch F, Tsuji S, Dokoupilova E, Keiserman M, Wang X, Zhong S, McCaskill RM, Zueger P, Pangan AL, Tillett W. Upadacitinib for psoriatic arthritis refractory to biologics: SELECT-PsA 2. Ann Rheum Dis. 2021 Mar;80(3):312-320. doi: 10.1136/annrheumdis-2020-218870. Epub 2020 Dec 3.

ReferenceCitation: Mease P, Kavanaugh A, Gladman D, FitzGerald O, Soriano ER, Nash P, Feng D, Lertratanakul A, Douglas K, Lippe R, Gossec L. Disease Control with Upadacitinib in Patients with Psoriatic Arthritis: A Post Hoc Analysis of the Randomized, Placebo-Controlled SELECT-PsA 1 and 2 Phase 3 Trials. Rheumatol Ther. 2022 Aug;9(4):1181-1191. doi: 10.1007/s40744-022-00449-6. Epub 2022 May 23.

ReferenceCitation: Burmester GR, Winthrop K, Blanco R, Nash P, Goupille P, Azevedo VF, Salvarani C, Rubbert-Roth A, Lesser E, Lippe R, Lertratanakul A, Mccaskill RM, Liu J, Ruderman EM. Safety Profile of Upadacitinib up to 3 Years in Psoriatic Arthritis: An Integrated Analysis of Two Pivotal Phase 3 Trials. Rheumatol Ther. 2022 Apr;9(2):521-539. doi: 10.1007/s40744-021-00410-z. Epub 2021 Dec 30.

ReferenceCitation: Nash P, Richette P, Gossec L, Marchesoni A, Ritchlin C, Kato K, McDearmon-Blondell EL, Lesser E, McCaskill R, Feng D, Anderson JK, Ruderman EM. Upadacitinib as monotherapy and in combination with non-biologic disease-modifying antirheumatic drugs for psoriatic arthritis. Rheumatology (Oxford). 2022 Aug 3;61(8):3257-3268. doi: 10.1093/rheumatology/keab905.

ReferenceCitation: Strand V, Van den Bosch F, Ranza R, Leung YY, Drescher E, Zueger P, Saffore CD, Lertratanakul A, Lippe R, Nash P. Patient-Reported Outcomes in Psoriatic Arthritis Patients with an Inadequate Response to Biologic Disease-Modifying Antirheumatic Drugs: SELECT-PsA 2. Rheumatol Ther. 2021 Dec;8(4):1827-1844. doi: 10.1007/s40744-021-00377-x. Epub 2021 Oct 18.

ReferenceCitation: Muensterman E, Engelhardt B, Gopalakrishnan S, Anderson JK, Mohamed MF. Upadacitinib pharmacokinetics and exposure-response analyses of efficacy and safety in psoriatic arthritis patients - Analyses of phase III clinical trials. Clin Transl Sci. 2022 Jan;15(1):267-278. doi: 10.1111/cts.13146. Epub 2021 Oct 27.

ReferenceCitation: Mease PJ, Lertratanakul A, Papp KA, van den Bosch FE, Tsuji S, Dokoupilova E, Keiserman MW, Bu X, Chen L, McCaskill RM, Zueger P, McDearmon-Blondell EL, Pangan AL, Tillett W. Upadacitinib in Patients with Psoriatic Arthritis and Inadequate Response to Biologics: 56-Week Data from the Randomized Controlled Phase 3 SELECT-PsA 2 Study. Rheumatol Ther. 2021 Jun;8(2):903-919. doi: 10.1007/s40744-021-00305-z. Epub 2021 Apr 28.

location_country:
Brazil
Portugal
Spain
Greece
Italy
New Zealand
United Kingdom
Canada
Hungary
Puerto Rico
United States
Chile
France
Belgium
Japan
Netherlands
Czechia

location_facility: USF Health Morsani Center for /ID# 161291

location_facility: Clinical Investigation Specialists - Skokie /ID# 160068

location_facility: General Hospital of Athens Laiko /ID# 163474

location_facility: Diagnostic Group Integrated He /ID# 161406

location_facility: Deerbrook Medical Associates /ID# 159815

location_facility: National Hospital Organization Osaka Minami Medical Center /ID# 162589

location_facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HC /ID# 161793

location_facility: Groupe de Recherche en Maladies Osseuses Inc /ID# 157836

location_facility: Centro Inter Estud Clin CIEC /ID# 169543

location_facility: Gulf Region Clinical Res Inst /ID# 159860

location_facility: Centro Hospitalar de Vila Nova Gaia/Espinho, EPE /ID# 165897

location_facility: Nippon Life Saiseikai Public Interest Foundation Nippon Life Hospital /ID# 161773

location_facility: International Medical Research - Daytona /ID# 160051

location_facility: Inland Rheum Clin Trials Inc. /ID# 159839

location_facility: Kitakyushu Municipal Medical Center /ID# 163516

location_facility: Arthritis & Osteoporosis Clinic /ID# 161400

location_facility: CIP - Centro Internacional de Pesquisa /ID# 161808

location_facility: AZ Arthritis and Rheumotology Research, PLLC /ID# 160006

location_facility: Adriana Pop-Moody MD Clinic PA /ID# 160009

location_facility: Instituto Portugues De Reumatologia /ID# 165894

location_facility: Ctr. de Recherche Musculo-Sque /ID# 163557

location_facility: Azienda Ospedaliera Universitaria Policlinico "G. Rodolico - San Marco" /Id# 164126

location_facility: PMG Research of Wilmington LLC /ID# 161403

location_facility: Juntendo University Hospital /ID# 162089

location_facility: Hospital Universitario Reina Sofia /ID# 170764

location_facility: Azienda Unita Sanitaria Locale/IRCCS c/o Arcispedale Santa Maria Nuova /ID# 162751

location_facility: The Center for Rheumatology & Bone Research /ID# 159900

location_facility: Revita Reumatologiai Rendelo /ID# 162575

location_facility: Clinical Res of West FL, Inc. /ID# 159840

location_facility: Centro Hospitalar Lisboa Ocidental, EPE /ID# 165896

location_facility: Centro Hospitalar Lisboa Norte, EPE /ID# 165895

location_facility: Unidade Local De Saude Do Alto Minho /ID# 165898

location_facility: Faculdade de Medicina do ABC /ID# 163489

location_facility: C.V. Mehta MD, Med Corporation /ID# 161192

location_facility: Care Access Research, Huntingt /ID# 160049

location_facility: MAV Korhaz ess Rendelointezet /ID# 162574

location_facility: Clinical Research of West Florida, Inc /ID# 160069

location_facility: Nagoya City University Hospital /ID# 162563

location_facility: SunValley Arthritis Center, Lt /ID# 161203

location_facility: Oribe Clinic of Rheumatism and Medicine /ID# 163704

location_facility: Percuro Clinical Research, Ltd /ID# 157835

location_facility: Kansai Medical University Hospital /ID# 162081

location_facility: Trinity Health Med Arts Clinic /ID# 159811

location_facility: Asahikawa Medical University Hospital /ID# 200684

location_facility: Hospital de Clínicas da Universidade Federal de Uberlândia /ID# 161794

location_facility: Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP /ID# 163317

location_facility: Betegapolo Irgalmas Rend - Budai Irgalmasrendi Korhaz /ID# 170911

location_facility: Hospital de Clinicas de Porto Alegre /ID# 161795

location_facility: AZ Arthritis & Rheum Research /ID# 160047

location_facility: Rheumatology Consultants, PLLC /ID# 161408

location_facility: Atlanta Research Center for Rheumatology /ID# 161201

location_facility: The Arthritis & Diabetes Clinic, Inc. /ID# 161294

location_facility: Vital Medical Center Orvosi-es Fogaszati Kozpont /ID# 162571

location_facility: Luton & Dunstable University Hospital /ID# 162713

location_facility: Hospital Universitario A Coruña - CHUAC /ID# 161019

location_facility: Arthritis & Rheumatic Disease Specialties /ID# 161409

location_facility: Osaka City University Hospital /ID# 162082

location_facility: Debreceni Egyetem Kenezy Gyula /ID# 162572

location_facility: St.Luke's International Hospital /ID# 162013

location_facility: Stanford University School of Med /ID# 161402

location_facility: Hospital Clinico Universitario Virgen de la Arrixaca /ID# 163138

location_facility: Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 163462

summary:
The study objectives of Period 1 are to compare the efficacy, safety, and tolerability of upadacitinib 15 mg once daily (QD) and 30 mg QD versus placebo for the treatment of signs and symptoms in adults with moderately to severely active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to biologic disease-modifying anti-rheumatic drug (bDMARD).

The objective of Period 2 is to evaluate the long-term safety, tolerability and efficacy of upadacitinib 15 mg QD and 30 mg QD in participants who have completed Period 1.


title: An Open Label, Phase Ib, Dose-escalation Study Evaluating the Safety and Tolerability of Xentuzumab and Abemaciclib in Patients With Locally Advanced or Metastatic Solid Tumours and in Combination With Endocrine Therapy in Patients With Locally Advanced or Metastatic Hormone Receptor-positive, HER2-, Breast Cancer, Followed by Expansion Cohorts.

summary:
This is a study in adult patients with different types of cancer. The purpose of this study is to find a safe dose of:

Xentuzumab in combination with abemaciclib
Xentuzumab in combination with abemaciclib and hormonal therapies The study also tests whether these medicines make tumours shrink in participants with lung and breast cancer.

Participants can stay in the study as long as they benefit from and can tolerate treatment. All participants get xentuzumab infusions and abemaciclib tablets. Participants who have breast cancer get different types of hormonal therapies in addition to xentuzumab and abemaciclib.

For all participants, the size of the tumour is measured regularly. Doctors also regularly check the general health of the participants."

ipd_sharing_description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets

lead_sponsor: Boehringer Ingelheim

location_country:
Denmark
Spain
Finland
Korea, Republic of
United States
France
Japan

location_facility: The University of North Carolina at Chapel Hill

location_facility: Copenhagen University Hospital, Rigshospitalet


acronym: EMPHENE

title: A Double-blind, Placebo-controlled, Randomized Dose Ranging Trial to Determine the Safety and Efficacy of Three Dose Levels of EMA401 in Reducing 24-hour Average Pain Intensity Score in Patients With Post-herpetic Neuralgia

ReferenceCitation: Rice ASC, Dworkin RH, Finnerup NB, Attal N, Anand P, Freeman R, Piaia A, Callegari F, Doerr C, Mondal S, Narayanan N, Ecochard L, Flossbach Y, Pandhi S. Efficacy and safety of EMA401 in peripheral neuropathic pain: results of 2 randomised, double-blind, phase 2 studies in patients with postherpetic neuralgia and painful diabetic neuropathy. Pain. 2021 Oct 1;162(10):2578-2589. doi: 10.1097/j.pain.0000000000002252.

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

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Denmark
Poland
Taiwan
Portugal
Spain
Italy
Austria
Australia
United Kingdom
Canada
Hungary
Korea, Republic of
France
Norway
Belgium
Japan
Germany
Slovakia
Czechia

summary: This study was designed to characterize dose response, and evaluate safety and efficacy of three different doses of EMA401 compared to placebo in patients with post-herpetic neuralgia (PHN).


acronym: Clover

title: A PHASE 3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF A CLOSTRIDIUM DIFFICILE VACCINE IN ADULTS 50 YEARS OF AGE AND OLDER

lead_sponsor: Pfizer

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

location_country:
Spain
United Kingdom
United States
Peru
Belgium
Japan
Czechia
Poland
Portugal
Australia
Argentina
Sweden
Slovakia
Canada
Hungary
Germany
Bulgaria
Taiwan
Finland
Korea, Republic of
France
Chile
Colombia

location_facility: Washington University School of Medicine

location_facility: Centre Integre Universitaire de Santé et de Services Sociaux de la Mauricie et du Centre du Québec

location_facility: Synexus Polska Sp. z o.o. Oddział w Poznaniu

location_facility: St. Vincent Hospital and Health Care Center

location_facility: Fleming Island Center for Clinical Research

location_facility: Central Kentucky Research Associates, LLC

location_facility: Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, I. Belgyogyaszati Osztaly

location_facility: Frandsen Family Medicine DBA Sound Medical Research

location_facility: Krajska zdravotni, a.s., Masarykova nemocnice Usti nad Labem

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz, Infektologiai Osztaly

location_facility: SPAOLO s.r.o., Ambulancia vnutorneho lekarstva

location_facility: Ocean Blue Medical Research Center, Inc.

location_facility: MultiCare Institute for Research & Innovation

location_facility: Universitaetsklinikum Essen, Klinik fuer Infektiologie

location_facility: Kaiser Permanente Northwest Center for Health Research

location_facility: Alliance for Multispecialty Research, LLC

location_facility: Luminis Health Anne Arundel Medical Center Infusion Center

location_facility: North Texas Infectious Diseases Consultants, P.A.

location_facility: Veterans Affairs Palo Alto Health Care System

location_facility: Slezska Nemocnice v Opave, prispevkova organizace

location_facility: "Acibadem City Clinic University Hospital" EOOD

location_facility: Louis Stokes Cleveland VA Medical Center

location_facility: Vancouver Coastal Health Research Institution-clinical research unit-Diamond Health Care Centre

location_facility: J. Lewis Research, Inc. - Jordan River Family Medicine

location_facility: Florida Sleep Disorder Center of Brandon

location_facility: University Of Cincinnati-Internal Medicine Division of Digestive Diseases

location_facility: Diabetologische Gemeinschaftspraxis Dr. Schaper & Dr. Faulmann

location_facility: Clinical Alliance for Research & Education - Infectious Diseases, LLC

location_facility: Synexus Polska Sp. z o.o Oddzial w Gdansku

location_facility: University of Colorado Clinical & Translational Research Center Clinic

location_facility: Gastroenterology Center of Connecticut, PC

location_facility: Alliance for Multispecialty Reseach, LLC

location_facility: Centro de Investigaciones Biomédicas - CIBIOM/Clinica Peruano Americana S.A

location_facility: Medical Affiliated Research Center, Inc.

location_facility: CHU de Liège - Domaine universitaire du Sart Tilman

location_facility: Centro de Investigaciones - MedPlus Centro de Recuperación Integral S.A.S.

location_facility: Hospital Senhora de Oliveira - Guimaraes, E.P.E.

location_facility: Lehigh Valley Health Network/Network Office of Research and Innovation

location_facility: Clinical Trial Center University of Colorado Denver, School of Medicine

location_facility: Mater Misericordiae Ltd & Mater Medical Research Institute Ltd

location_facility: PULMO-MEDIK s.r.o., Pneumologicko-ftizeologicka ambulancia

location_facility: Duke University Hospital Investigational Drug Services (IDS) Pharmacy

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

location_facility: South Texas Veterans Healthcare System, Audie L Murphy Hospital

location_facility: PMG Research,Inc. d/b/a PMG Research of Knoxville

location_facility: Long Beach Clinical Trials Services, Inc.

location_facility: University of North Texas Health Science Center at Fort Worth

location_facility: Avdelningen for kliniska provningar, S-huset

location_facility: SHATPPD Dr. Dimitar Gramatikov - Ruse EOOD

location_facility: Paradigm Clinical Research Centers, Inc.

location_facility: Semmelweis Egyetem III. Sz. Belgyogyaszati Klinika

location_facility: Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

location_facility: Hospital Nuestra Senora de la Misericordia

location_facility: VA Loma Linda Healthcare System Research Pharmacy

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Luminis Health Research Institute: Research Office

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Fundacion Centro de Investigacion Clinica - CIC

location_facility: Mayo Clinic Rochester, Methodist Hospital Campus

location_facility: Hallym University Kangdong Sacred Heart Hospital

location_facility: Lawrence J. Ellison Ambulatory Care Center

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: J. Lewis Research Inc. / Foothill Family Clinic Draper

location_facility: University of California, Davis Medical Center

location_facility: Accel Research Sites - DeLand Clinical Research Unit

location_facility: University Hospitals of Leicester NHS Trust

location_facility: Luminis Health Anne Arundel Medical Center

location_facility: Social Medical Care Corporation Hose-kai Marunouchi Hospital

location_facility: Baptist Health Center for Clinical Research

location_facility: Hallym University Kangnam Sacred Heart Hospital

location_facility: Orszagos Koranyi Pulmonologiai Intezet, VI. Osztaly

location_facility: ClinTrial Audit Kft., Klinikai Farmakologiai Intezet, Vedooltasi Ambulancia

location_facility: Nemocnice Kyjov, prispevkova organizace, Infekcni oddeleni

location_facility: Bajai Szent Rokus Korhaz, II Belgyogyaszat

location_facility: MHAT "Sveta Anna - Sofia" AD, Clinic of Internal Diseases

location_facility: Multi-Specialty Research Associates, Inc.

location_facility: Ochsner Center for Primary Care and Wellness

location_facility: Newcastle upon Tyne Hospitals NHS Foundation trust

location_facility: Gemeinschaftspraxis Dr. med. Heidrun Taeschner und Dr. med. Susanne Bonigut

location_facility: Hospital Nacional Adolfo Guevara Velasco

location_facility: The Alverton Practise, St Clare Medical Centre

location_facility: KM Management spol. s.r.o., Gastroenterologicke a hepatologicke centrum Nitra

location_facility: University of Colorado Department of AIP 2. Pharmacy Bulk Storage

location_facility: CHU DIJON BOURGOGNE- Hopital Francois Mitterrand

location_facility: Gothia Forum CTC/Sahlgrenska Universitetssjukhuset

location_facility: Malcom Randall VA Medical Center Investigational Drug Services

location_facility: Sahlgrenska Universitetssjukhuset - Ostra Sjukhuset

location_facility: University of Colorado Denver, School of Medicine

location_facility: Internal Medicine and Pediatric Associates of Bristol, PC

location_facility: SYNEXUS Polska Sp. z o.o. Oddzial w Katowicach

location_facility: Coastal Clinical Research, LLC, An AMR Company

location_facility: VA Loma Linda Healthcare System Ambulatory Care System

location_facility: Clinical Research Institute of Arizona, LLC

location_facility: Medak s.r.o., Gastroenterologicka ambulancia

location_facility: Synexus Polska Sp. z o.o. Oddzial we Wroclawiu

location_facility: PMG Research of Raleigh, LLC d/b/a PMG Research of Cary

location_facility: Advanced Clinical Research/Gut Whisperer

location_facility: Asociación IPS Médicos Internistas de Caldas

location_facility: Bozeman Health Deaconess Hospital d/b/a Bozeman Health Clinical Research

location_facility: Synexus Polska Sp. z o.o. Oddzial w Gdyni

location_facility: Karolinska Trial Alliance, KTA Prim Sabbatsbergs sjukhus

location_facility: Centre de recherche du CHU de Quebec-Universite Laval

location_facility: Centre Integre de Sante et de Services Sociaux de la Monteregie- Center- Hopital Charles LeMoyne

location_facility: J. Lewis Research, Inc./Foothill Family Clinic

location_facility: University Hospitals Cleveland Medical Center

location_facility: Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E.

location_facility: VA Northern California Health Care System

location_facility: MHAT ''Sv.Ivan Rilski-Kozloduy'' EOOD; Internal Department

location_facility: Waterway Primary Care LLC DBA Tabor City Family Medicine

location_facility: Budapesti Szent Ferenc Korhaz, Kardiologiai Rehabilitacios Osztaly

location_facility: PMG Research, Inc. d/b/a PMG Research of Knoxville

location_facility: University of Colorado Clinical & Translational Research Center Outpatient Clinic

location_facility: Centro Hospitalar do Baixo Vouga, E.P.E.

location_facility: Medical Corporation Tokushukai Koga General Hospital

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: St. Vincent Hospital & Health Care Center

location_facility: Synexus Polska Sp. z o.o. Oddzial w Warszawie

location_facility: UMHAT "Dr. Georgi Stranski" EAD, Second Psychiatric Clinic of general psychiatry and dependence

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Salmed S. C.

location_facility: Medical Research Center of Connecticut, LLC

summary:
The Clover trial is evaluating an investigational vaccine that may help to prevent Clostridium difficile infection. Participants in the study are adults 50 years of age and older, who are at risk of developing Clostridium difficile infection. The study will assess whether the vaccine prevents the disease, and whether it is safe and well tolerated.

Each subject will receive 3 doses of Clostridium difficile vaccine or placebo and be followed for up to 3 years after vaccination for potential Clostridium difficile infection.


acronym: RESILIENT

title: RESILIENT: A Randomized, Open Label Phase 3 Study of Irinotecan Liposome Injection (ONIVYDE®) Versus Topotecan in Patients With Small Cell Lung Cancer Who Have Progressed on or After Platinum-based First-Line Therapy

lead_sponsor: Ipsen

ReferenceCitation: Paz-Ares L, Spigel DR, Chen Y, Jove M, Juan-Vidal O, Rich P, Hayes T, Calderón VG, Caro RB, Navarro A, Dowlati A, Zhang B, Moore Y, Yao X, Kokhreidze J, Ponce S, Bunn PA. RESILIENT part 1: a phase 2 dose-exploration and dose-expansion study of second-line liposomal irinotecan in adults with small cell lung cancer. Cancer. 2022 May 1;128(9):1801-1811. doi: 10.1002/cncr.34123. Epub 2022 Feb 23.

location_country:
Poland
Taiwan
Brazil
Romania
Serbia
Italy
Russian Federation
Australia
Spain
Ukraine
Hungary
Korea, Republic of
United States
France
China
Turkey
Belgium
Germany

location_facility: Szpitale Pomorskie spółka z ograniczoną odpowiedzialnością

location_facility: The First Affiliated Hospital of Bengbu Medical College

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza

location_facility: Florida Cancer Specialists (South Region)

location_facility: CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

location_facility: SBIH of Yaroslavl region "Regional Clinical Oncological Hospital"

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet

location_facility: HGB - Hospital Giovanni Battista - Mãe de Deus Center

location_facility: CI Kryvyi Rih Oncological Dispensary of DRC

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

location_facility: Communal Non-profit Enterprise Regional Center of Oncology

location_facility: Tri County Hematology & Oncology Associates, Inc

location_facility: Hospital de Cancer de Barretos, Fundacoa Pio X II

location_facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto

location_facility: CCCH City Oncological Center SHEI Uzhgorod NU

location_facility: North Shore Hematology Oncology Associates, PC

location_facility: Cancer & Hematology Centers of Western Michigan

location_facility: SPb SBIH "City Clinical Oncological Dispensary"

location_facility: University of Oklahoma Health Sciences Center

location_facility: Greenville Hospital System University Medical Center

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital

location_facility: Hospital General Universitario de Alicante

location_facility: Communal Enterprise Kremenchuk Regional Oncology Dispensary of Poltava Regional Council

location_facility: RCI Sumy Regional Clinical Oncological Dispensary

location_facility: BHI of Omsk region "Clinical Oncology Dispensary"

location_facility: Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca

location_facility: Baskent University Adana Application and Research Center

location_facility: Charleston Hematology Oncology Associates, PA

location_facility: Azienda Sanitaria Universitaria Integrata di Udine

location_facility: S.C Centrul de Oncologie Sf. Nectarie S.R.L

location_facility: CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: Cancer Treatment Centers of America-Georgia

location_facility: SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"

location_facility: SP Zespol Gruzlicy i Chorob Pluc w Olsztynie

location_facility: SBHI of Kaluga Region "Kaluga regional clinical oncology dispensary"

location_facility: Hospital Regional Universitario de Malaga

location_facility: Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego

location_facility: MultiCare Health System Institute for Research and Innovation

location_facility: Treatment-Prevention Institution Volyn Regional Oncological Dispensary

location_facility: Institute for Pulmonary Diseases of Vojvodina

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Istanbul Medeniyet Uni Goztepe Training&Res Hosp

location_facility: Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

summary:
A Randomized, Open Label Phase 3 Study of Irinotecan Liposome Injection (ONIVYDE®) versus Topotecan in Patients with Small Cell Lung Cancer Who Have Progressed on or after Platinum-based First-Line Therapy

The study will be conducted in two parts:

Dose determination of irinotecan liposome injection
A randomized, efficacy study of irinotecan liposome injection versus topotecan


acronym: HERO

title: HERO: A Multinational Phase 3 Randomized, Open-label, Parallel Group Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer

lead_sponsor: Myovant Sciences GmbH

ReferenceType: background

ReferenceCitation: Shore ND, Saad F, Cookson MS, George DJ, Saltzstein DR, Tutrone R, Akaza H, Bossi A, van Veenhuyzen DF, Selby B, Fan X, Kang V, Walling J, Tombal B; HERO Study Investigators. Oral Relugolix for Androgen-Deprivation Therapy in Advanced Prostate Cancer. N Engl J Med. 2020 Jun 4;382(23):2187-2196. doi: 10.1056/NEJMoa2004325. Epub 2020 May 29.

ReferenceCitation: Shore ND, Sutton J. Plain language summary of the HERO study comparing relugolix with leuprolide for men with advanced prostate cancer. Future Oncol. 2022 Jul;18(21):2575-2584. doi: 10.2217/fon-2022-0172. Epub 2022 May 19. Review.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Poland
Austria
Australia
Sweden
Slovakia
Brazil
Canada
China
Germany
Denmark
Taiwan
New Zealand
Finland
Korea, Republic of
France
Netherlands

location_facility:
Salvador
Candiolo
Syracuse
Stockholm
Chongqing
Beijing Shi
Troy
Middleburg Heights
Albany
Arezzo
Scunthorpe
Hamilton
Nanchang
Exeter
Tokyo
Suita
Southport
Eindhoven
Vancouver
Greensboro
Emmendingen
Pompano Beach
Trencin
Barcelona
Braunschweig
Quebec
Sherbrooke
Lubeck
Strasbourg
Lanzhou
Goyang-Si
Des Moines
Nanjing
Nitra
Poughkeepsie
Sneek
Montreal
Warszawa
São José Do Rio Preto
San Antonio
Poprad
Martin
Camperdown
Seoul
Oviedo
Osaka-sayama
Tucson
Garden City
Kyoto
Lublin
Malmo
Wahroonga
Taiyuan
Wichita
Hwasun
Linz
Plainview
Vejle
Omaha
Siedlce
Passo Fundo
Orange
Las Vegas
Redcliffe
Suzhou
Curitiba
Orebro
A Coruna
Shanghai
Helsinki
Tauranga
Munster
Orbassano
Albuquerque
Presov
Seinajoki
Uppsala
Alborg
Turku
Dunedin
Sala
Cremona
Amsterdam
Ijuí
Lyon
Ube
Busan
Yokohama
Nottingham
Lancaster
Oklahoma City
Gent
Milano
Herlev
Taipei
Gdynia
Creteil
Kita-gun
Rhyl
Sumida-ku
Brussels
Calgary
Aarhus
Myrtle Beach
Durham
Chiba
Joinville
Salamanca
Kortrijk
Planegg
Beijing
Katowice
Teresina
Dresden
Sapporo
Porto Alegre
Halifax
Osaka
Kaohsiung City
Nashville
London
Hiroshima
Nakano-ku
Christchurch
Itabuna
Maebashi
Rome
Valencia
Daegu
Pierre Benite
Tweed Heads
Madrid
Nagasaki
Tampere
Jeffersonville
Baltimore
Meldola
Brick
Kosice
Sendai
Changchun
Denver
Hangzhou
Bunkyō-Ku
Fukuoka
Bratislava
Natal
Kanazawa-shi
Cincinnati

summary: The purpose of this study is to determine the efficacy and safety of relugolix 120 milligrams (mg) orally once daily for 48 weeks on maintaining serum testosterone suppression to castrate levels (< 50 nanograms/deciliter [ng/dL]) in participants with androgen-sensitive advanced prostate cancer.


acronym: ASPEN

title: A Phase 3, Randomized, Open-Label, Multicenter Study Comparing the Efficacy and Safety of the Bruton's Tyrosine Kinase (BTK) Inhibitors BGB-3111 and Ibrutinib in Subjects With Waldenström's Macroglobulinemia (WM)

lead_sponsor: BeiGene

ReferenceCitation: Tam CS, LeBlond V, Novotny W, Owen RG, Tedeschi A, Atwal S, Cohen A, Huang J, Buske C. A head-to-head Phase III study comparing zanubrutinib versus ibrutinib in patients with Waldenström macroglobulinemia. Future Oncol. 2018 Sep;14(22):2229-2237. doi: 10.2217/fon-2018-0163. Epub 2018 Jun 5.

location_country:
Poland
Spain
Greece
Italy
Australia
Netherlands
United Kingdom
Sweden
United States
France
Belgium
Germany
Czechia

location_facility: Azienda Ospedaliera Spedali Civili Di Brescia

location_facility: University of California San Diego (UCSD) - Moores Cancer Center

location_facility: Università degli Studi di Roma "La Sapienza"

location_facility: Academisch Medisch Centrum Universiteit van Amsterdam

location_facility: Complejo Asistencial Universitario de Salamanca

location_facility: Szpitale Pomorskie Sp. z o.o., Szpital Morski im. PCK Gdansk

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Szpital Specjalist. w Brzozowie,Podkarpacki Ośrodek Onkologiczny

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Azienda Ospedaliera "Maggiore della Carità" di Novara

location_facility: Germans Trias i Pujol University Hospital

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Desert Hematology Oncology Medical Group Inc.

location_facility: The Royal Bournemouth and Christchurch Hospitals NHS Foundation

location_facility: Barwon Health, University Hospital Geelong

location_facility: Niguarda Cancer Center Division of Hematology

location_facility: Instytut Hematologii i Transfuzjologii w Warszawie

location_facility: PU A. Gemelli, Universität Cattolica del Sacro Cuore

location_facility: AZ Sint-Jan Brugge - Oostende - Campus Sint-Jan

location_facility: PO A.Ferrarotto, AOU Policlinico-Vittorio Emanuele Catania

location_facility: Uniwersytecki Szpital Kliniczny w Białymstoku

location_facility: Hospital Duran i Reynals, Instituto Catalán de Oncología

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino

location_facility: Universitätsklinikum Münster Hämatologie und Onkologie

summary: This study is to evaluate the safety, efficacy and clinical benefit of BGB-3111 (Zanubrutinib) vs ibrutinib in participants with MYD88 Mutation Waldenström's Macroglobulinemia.


title: A Randomized, Double Blind, Placebo-Controlled, Study to Assess the Efficacy, Safety, and Tolerability of RO7239361 in Ambulatory Boys With Duchenne Muscular Dystrophy

lead_sponsor: Hoffmann-La Roche

location_country:
Spain
Italy
United Kingdom
Australia
Netherlands
Argentina
Canada
Sweden
United States
France
Belgium
Japan
Germany

location_facility: Universitatsklinikum Essen; Innere Klinik

location_facility: Cincinnati Childrens Hospital Medical Center;Investigational Pharmacy

location_facility: London Health Sciences Centre; Children's Hospital; Pediatrics

location_facility: UCL Institute of Child Health & Great Ormond Street Hospital for Children

location_facility: Nationwide Childrens Hospital; Research Institute at Nationwide Childrens Hospital

location_facility: Drottning Silvias Barn- och ungdomssjukhus; Kliniken for barnmedicin

location_facility: Hopital Armand Trousseau; centre reference Maladies Neuro-musculaires Est parisien Neuropediatrie

location_facility: Hospital Universitari i Politecnic La Fe de Valencia; Servicio de Farmacia

location_facility: National Center of Neurology and Psychiatry

location_facility: Yale University School of Medicine ; Pulmonary & Critical Care

location_facility: Children's Hospital Westmead; Paediatrics & Child Health

location_facility: University of California Davis Medical Center

location_facility: Lady Cilento Children's Hospital; Neurosciences Department

location_facility: Fondazione Policlinico Universitario A Gemelli; Servizio di Farmacia

location_facility: Alder Hey Children s Hospital; Department of Pediatrics

location_facility: Hotel Dieu; Service Pharmacie Essais Cliniques

location_facility: National Hospital Organization Osaka Toneyama Medical Center

location_facility: University of Massachusetts Memorial Childrens Medical Center; Department of Neurology

location_facility: Az. Osp. Universitaria Pol. G. Martino; Dip. Neuroscienze, Scienze Psichiatriche e Anest.

location_facility: Radboud University Nijmegen Medical Centre; Ophthalmology

location_facility: Fondazione Serena Onlus - CENTRO CLINICO NEMO

summary: This is a multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy, safety and tolerability of two different weekly doses of RO7239361 in ambulatory boys with Duchenne Muscular Dystrophy (DMD).


title: A 24-week Treatment, Multi-center, Randomized, Double-blind, Double-dummy, Parallel Group Study to Compare Umeclidinium/Vilanterol, Umeclidinium, and Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

ReferenceCitation: Maltais F, Bjermer L, Kerwin EM, Jones PW, Watkins ML, Tombs L, Naya IP, Boucot IH, Lipson DA, Compton C, Vahdati-Bolouri M, Vogelmeier CF. Efficacy of umeclidinium/vilanterol versus umeclidinium and salmeterol monotherapies in symptomatic patients with COPD not receiving inhaled corticosteroids: the EMAX randomised trial. Respir Res. 2019 Oct 30;20(1):238. doi: 10.1186/s12931-019-1193-9.

ReferenceCitation: Bjermer LH, Boucot IH, Vogelmeier CF, Maltais F, Jones PW, Tombs L, Compton C, Lipson DA, Kerwin EM. Efficacy and Safety of Umeclidinium/Vilanterol in Current and Former Smokers with COPD: A Prespecified Analysis of The EMAX Trial. Adv Ther. 2021 Sep;38(9):4815-4835. doi: 10.1007/s12325-021-01855-y. Epub 2021 Aug 4.

ReferenceCitation: Maltais F, Naya IP, Vogelmeier CF, Boucot IH, Jones PW, Bjermer L, Tombs L, Compton C, Lipson DA, Kerwin EM. Salbutamol use in relation to maintenance bronchodilator efficacy in COPD: a prospective subgroup analysis of the EMAX trial. Respir Res. 2020 Oct 22;21(1):280. doi: 10.1186/s12931-020-01451-8.

ReferenceCitation: Kerwin EM, Boucot IH, Vogelmeier CF, Maltais F, Naya IP, Tombs L, Jones PW, Lipson DA, Keeley T, Bjermer L. Early and sustained symptom improvement with umeclidinium/vilanterol versus monotherapy in COPD: a post hoc analysis of the EMAX randomised controlled trial. Ther Adv Respir Dis. 2020 Jan-Dec;14:1753466620926949. doi: 10.1177/1753466620926949.

location_country:
Spain
Italy
Australia
Netherlands
Argentina
Canada
Sweden
United States
France
South Africa
Mexico
Germany

summary:
COPD is characterized by an airflow limitation, which is not fully reversible, usually progressive and accompanied by chronic cough, sputum production and dyspnea, which can be a major cause of disability and anxiety associated with the disease. In addition, COPD is associated with poor health-related quality of life (HRQoL). Pharmacologic therapy is used to improve lung function, reduce symptoms, reduce the frequency and severity of exacerbations, and also to improve health status and exercise tolerance.

This is a multi-center, randomized, double blind, double dummy, 3-arm parallel group study to compare umeclidinium/vilanterol (62.5/25 microgram [mcg], once daily), umeclidinium (62.5 mcg, once daily), and salmeterol (50 mg, twice daily) in male and female subjects with COPD. The primary purpose of this study is to demonstrate improvements in lung function for subjects treated with UMEC/VI compared with UMEC for 24 weeks.

Approximately 2424 subjects will be randomized across 3 parallel arms in 1:1:1 ratio. Subjects will be stratified based on long-acting bronchodilator usage during the run-in period (none, one or 2 long-acting bronchodilators per day). Subjects will receive either UMEC/VI inhalation powder (62.5/25 microgram [mcg] once daily) administered via the ELLIPTA® dry powder inhaler (DPI) and placebo twice daily via DISKUS® DPI; or UMEC (62.5 mcg once daily) administered via the ELLIPTA DPI and placebo twice daily via DISKUS DPI or salmeterol (50 mcg twice daily [BID]) administered via the DISKUS DPI and placebo once daily via ELLIPTA DPI. The duration of the study will be 29 to 31 weeks including a pre-screening period of 2 weeks, run-in period of 4 weeks, treatment period of 24 weeks and follow-up period of 1 week.

ELLIPTA and DISKUS are trademarks of GSK group of companies.


title: A Phase 2, Open-Label, Monotherapy, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203)

summary: The purpose of this study is to evaluate the efficacy and safety of pemigatinib (INCB054828) in subjects with myeloid/lymphoid neoplasms with fibroblast growth factor receptor (FGFR) 1 rearrangement.

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

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

lead_sponsor: Incyte Corporation

location_country:
Spain
Italy
Austria
United Kingdom
Canada
Switzerland
United States
France
Belgium
Japan
Germany

location_facility: Washington University School of Medicine

location_facility: Azienda Ospedaliero-Universitaria Careggi (Aouc)

location_facility: Oxford University Hospitals Nhs Foundation Trust

location_facility: Emory University - Winship Cancer Institute

location_facility: Iii Med. Abteilung For Hematologie and Onkologie Hanuscfhkrankenhaus

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Ordensklinikum Krankenhaus Der Barmherzigen Schwestern Linz

location_facility: Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole


title: An Open-Label Phase 1b Trial of Lenvatinib Plus Pembrolizumab in Subjects With Hepatocellular Carcinoma

summary: This is an open-label Phase 1b study designed to evaluate the tolerability and safety of lenvatinib in combination with pembrolizumab in participants with hepatocellular carcinoma (HCC). The study will evaluate objective response rate and duration of response by modified Response Evaluation Criteria In Solid Tumors (mRECIST) for HCC and Response Evaluation Criteria In Solid Tumors (RECIST 1.1) based on independent imaging review (IIR).

ReferenceCitation: Finn RS, Ikeda M, Zhu AX, Sung MW, Baron AD, Kudo M, Okusaka T, Kobayashi M, Kumada H, Kaneko S, Pracht M, Mamontov K, Meyer T, Kubota T, Dutcus CE, Saito K, Siegel AB, Dubrovsky L, Mody K, Llovet JM. Phase Ib Study of Lenvatinib Plus Pembrolizumab in Patients With Unresectable Hepatocellular Carcinoma. J Clin Oncol. 2020 Sep 10;38(26):2960-2970. doi: 10.1200/JCO.20.00808. Epub 2020 Jul 27.

lead_sponsor: Eisai Co., Ltd.

location_country:
Spain
Italy
Russian Federation
United Kingdom
United States
France
Japan

location_facility: California Pacific Medical Center (CPMC)

location_facility: Hôpital Haut-Levêque Centre médico-chirurgical Magellan

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

location_facility: St. Petersburg City Clinical Oncology Dispansery

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

location_facility: Hospital Universitario Marqués de Valdecilla


title: An Exploratory Study of the Biologic Effects and Biomarkers of Nivolumab in Combination With Ipilimumab in Subjects With Treatment-Naive Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)

acronym: CheckMate 592

summary: The purpose of this study is to explore the possible links between participant characteristics and their cancer, with how effective the combination of nivolumab with ipilimumab is, in participants with Stage IV or recurrent Non-Small Cell Lung Cancer (NSCLC).

lead_sponsor: Bristol-Myers Squibb

location_country:
Romania
Spain
Italy
Netherlands
United States
France
Belgium
Germany

location_facility: Prof Dr I Chiricuta Institute of Oncology

location_facility: Washington University School Of Medicine

location_facility: Montefiore - Einstein Center for Cancer Care

location_facility: Winship Cancer Institute, Emory University

location_facility: Groupe Jolimont-SEREC - SERVICE DE RECHERCHE CLINIQUE


title: A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of ABBV-181 as Monotherapy and in Combination With Another Anti-Cancer Therapy in Subjects With Advanced Solid Tumors

summary: This is an open-label, Phase I, dose-escalation study to determine the recommended Phase 2 dose (RPTD), maximum tolerated dose (MTD), and evaluate the safety and pharmacokinetic (PK) profile of budigalimab. This study will also evaluate the safety and tolerability of budigalimab in combination with Rovalpituzumab Tesirine and budigalimab in combination with venetoclax. The study will consist of 3 parts: budigalimab monotherapy dose escalation and expansion, budigalimab in combination with Rovalpituzumab Tesirine and budigalimab in combination with venetoclax.

ReferenceCitation: Lambert SL, Zhang C, Guo C, Turan T, Masica DL, Englert S, Fang Y, Sheridan J, McLaughlin RT, Tribouley C, Vosganian G, Afar D. Association of Baseline and Pharmacodynamic Biomarkers With Outcomes in Patients Treated With the PD-1 Inhibitor Budigalimab. J Immunother. 2022 Apr 1;45(3):167-179. doi: 10.1097/CJI.0000000000000408.

ReferenceCitation: Calvo E, Spira A, Miguel M, Kondo S, Gazzah A, Millward M, Prenen H, Rottey S, Warburton L, Alanko T, Cassier PA, Yoh K, Italiano A, Moreno V, Peltola K, Seto T, Toyozawa R, Afar DE, Englert S, Komarnitsky P, Lambert S, Parikh A, Vosganian G, Gao B. Safety, pharmacokinetics, and efficacy of budigalimab with rovalpituzumab tesirine in patients with small cell lung cancer. Cancer Treat Res Commun. 2021;28:100405. doi: 10.1016/j.ctarc.2021.100405. Epub 2021 May 25.

ReferenceCitation: Italiano A, Cassier PA, Lin CC, Alanko T, Peltola KJ, Gazzah A, Shiah HS, Calvo E, Cervantes A, Roda D, Tosi D, Gao B, Millward M, Warburton L, Tanner M, Englert S, Lambert S, Parikh A, Afar DE, Vosganian G, Moreno V. First-in-human phase 1 study of budigalimab, an anti-PD-1 inhibitor, in patients with non-small cell lung cancer and head and neck squamous cell carcinoma. Cancer Immunol Immunother. 2022 Feb;71(2):417-431. doi: 10.1007/s00262-021-02973-w. Epub 2021 Jul 3.

ReferenceCitation: Powderly J, Spira A, Kondo S, Doi T, Luke JJ, Rasco D, Gao B, Tanner M, Cassier PA, Gazzah A, Italiano A, Tosi D, Afar DE, Parikh A, Engelhardt B, Englert S, Lambert SL, Kasichayanula S, Mensing S, Menon R, Vosganian G, Tolcher A. Model Informed Dosing Regimen and Phase I Results of the Anti-PD-1 Antibody Budigalimab (ABBV-181). Clin Transl Sci. 2021 Jan;14(1):277-287. doi: 10.1111/cts.12855. Epub 2020 Dec 26.

location_country:
Taiwan
Spain
Austria
Australia
Canada
Finland
United States
France
Belgium
Japan

location_facility: Carolina BioOncology Institute /ID# 157376

location_facility: South Texas Accelerated Research Therapeutics /ID# 157378

location_facility: Hospital Universitario HM Sanchinarro /ID# 163861

location_facility: National Taiwan University Hospital /ID# 163997

location_facility: Moores Cancer Center at UC San Diego /ID# 157374

location_facility: National Cancer Center Hospital East /ID# 166433

location_facility: National Hospital Organization Kyushu Cancer Center /ID# 206229

location_facility: Taipei Medical University Hospital /ID# 163998

location_facility: Virginia Cancer Specialists - Fairfax /ID# 157377

location_facility: Hospital Clinico Universitario de Valencia /ID# 163925

location_facility: Universitair Ziekenhuis Antwerpen /ID# 170702

location_facility: The University of Chicago Medical Center /ID# 157375

location_facility: National Cancer Center Hospital /ID# 166279

location_facility: Medizinische Universitaet Graz /ID# 168752

location_facility: St Vincent's Hospital Melbourne /ID# 167552

location_facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 163862

location_facility: Institut du Cancer de Montpellier - Val d'Aurelle /ID# 163999