title: Long Term Follow-Up of Patients Exposed to Lentiviral-Based CAR T-Cell Therapy

acronym: PAVO

summary: Per Health Authorities guidelines for gene therapy medicinal products that utilize integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of treated patients is required. The purpose of this study is to monitor all patients exposed to CAR-T therapied for 15 years following their last CAR-T (e.g. CTL019) infusion to assess the risk of delayed adverse events (AEs), monitor for replication competent lentivirus (RCL) and assess long-term efficacy, including vector persistence.

status: Recruiting

primary_purpose: Other

enrollment_type: Anticipated

lead_sponsor: Novartis Pharmaceuticals

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

location_facility: Duke Unversity Medical Center SC - CTL019B2205J

location_facility: Stanford Universtiy Medical Center SC - CTL019B2205J - B2206

location_facility: Children's Healthcare of Atlanta SC CTL019

location_facility: University of Utah Clinical Trials Office

location_facility: University of Chicago Medical Center, Hematology & Oncology

location_facility: Ohio State Comprehensive Cancer Center/James Cancer Hospital Ohio State Univ.

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Mayo Clinic Arizona Mayo Clinic Building

location_facility: University of Wisconsin Hospital and Clinics

location_facility: University of Michigan Health System SC CTL019

location_facility: Emory University School of Medicine/Winship Cancer Institute

location_facility: The Childrens Hospital of Philadelphia CHOP

location_facility: Childrens Hospital Los Angeles SC CTL019

intervention_type: Genetic


type: Other Identifier

type: EudraCT Number

title: An Open-Label, Multicenter, Phase 1 Study of Ramucirumab Plus Pembrolizumab in Patients With Locally Advanced and Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma, Non-Small Cell Lung Cancer, Transitional Cell Carcinoma of the Urothelium, or Biliary Tract Cancer

summary: The main purpose of this study is to evaluate the safety and preliminary efficacy of the combination of the study drug known as ramucirumab plus pembrolizumab in participants with locally advanced and unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, non-small cell lung cancer (NSCLC), transitional cell carcinoma of the urothelium, or biliary tract cancer (BTC).

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Herbst RS, Arkenau HT, Bendell J, Arrowsmith E, Wermke M, Soriano A, Penel N, Santana-Davila R, Bischoff H, Chau I, Mi G, Wang H, Rasmussen E, Ferry D, Chao BH, Paz-Ares L. Phase 1 Expansion Cohort of Ramucirumab Plus Pembrolizumab in Advanced Treatment-Naive NSCLC. J Thorac Oncol. 2021 Feb;16(2):289-298. doi: 10.1016/j.jtho.2020.10.004. Epub 2020 Oct 15.

family: Herbst

full_name: Roy S. Herbst

given: Roy S.

sequence: first

family: Arkenau

full_name: Hendrik Tobias Arkenau

given: Hendrik Tobias

sequence: additional

family: Bendell

full_name: Johanna Bendell

given: Johanna

family: Arrowsmith

full_name: Edward Arrowsmith

given: Edward

family: Wermke

full_name: Martin Wermke

given: Martin

family: Soriano

full_name: Andres Soriano

given: Andres

family: Penel

full_name: Nicolas Penel

given: Nicolas

family: Santana-Davila

full_name: Rafael Santana-Davila

given: Rafael

family: Bischoff

full_name: Helge Bischoff

given: Helge

family: Chau

full_name: Ian Chau

given: Ian

family: Mi

full_name: Gu Mi

given: Gu

family: Wang

full_name: Hong Wang

given: Hong

family: Rasmussen

full_name: Erik Rasmussen

given: Erik

family: Ferry

full_name: David Ferry

given: David

family: Chao

full_name: Bo H. Chao

given: Bo H.

family: Paz-Ares

full_name: Luis Paz-Ares

given: Luis

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Thoracic Oncology

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

ReferenceCitation: Herbst RS, Arkenau HT, Santana-Davila R, Calvo E, Paz-Ares L, Cassier PA, Bendell J, Penel N, Krebs MG, Martin-Liberal J, Isambert N, Soriano A, Wermke M, Cultrera J, Gao L, Widau RC, Mi G, Jin J, Ferry D, Fuchs CS, Petrylak DP, Chau I. Ramucirumab plus pembrolizumab in patients with previously treated advanced non-small-cell lung cancer, gastro-oesophageal cancer, or urothelial carcinomas (JVDF): a multicohort, non-randomised, open-label, phase 1a/b trial. Lancet Oncol. 2019 Aug;20(8):1109-1123. doi: 10.1016/S1470-2045(19)30458-9. Epub 2019 Jul 10.

repository_institution: The University of Manchester - Research Explorer

ReferenceCitation: Arkenau HT, Martin-Liberal J, Calvo E, Penel N, Krebs MG, Herbst RS, Walgren RA, Widau RC, Mi G, Jin J, Ferry D, Chau I. Ramucirumab Plus Pembrolizumab in Patients with Previously Treated Advanced or Metastatic Biliary Tract Cancer: Nonrandomized, Open-Label, Phase I Trial (JVDF). Oncologist. 2018 Dec;23(12):1407-e136. doi: 10.1634/theoncologist.2018-0044. Epub 2018 May 31.

name: Drug Development Unit, Sarah Cannon Research Institute UKLondon United Kingdom

name: Cancer Institute, University College LondonLondon United Kingdom

name: Vall d'Hebron Institute of OncologyBarcelona Spain

name: Catalan Institute of Oncology (ICO)Barcelona Spain

name: Early Clinical Drug Development Program, START Madrid‐HM CIOCC, Centro Integral Oncológico Clara CampalMadrid Spain

name: The Christie NHS Foundation Trust and The University of ManchesterManchester United Kingdom

name: Yale University School of Medicine, Yale Cancer CenterNew Haven Connecticut USA

name: Eli Lilly and CompanyIndianapolis Indiana USA

name: Eli Lilly and CompanyNew York New York USA

name: Royal Marsden HospitalSutton United Kingdom

title: Ramucirumab Plus Pembrolizumab in Patients with Previously Treated Advanced or Metastatic Biliary Tract Cancer: Nonrandomized, Open‐Label, Phase I Trial (JVDF)

location_country:
United States
France
Japan
Spain
Germany
United Kingdom

location_facility: Florida Cancer Specialists and Research Institute

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


design_allocation: Randomized

intervention_type: Other

status: Completed

lead_sponsor: UCB BIOSCIENCES, Inc.

location_country:
Romania
Belgium
Australia
Russian Federation
Taiwan
France
Japan
Poland
Slovakia
Korea, Republic of
Bulgaria
Hungary
China
Portugal
Germany
United States
Italy
Brazil
Mexico
Czechia
Israel
Spain

acronym: VALOR

study_completion_date_type: Actual

source: euctr

title: A Double-blind, Randomized, Placebo-controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Lacosamide as Adjunctive Therapy for Uncontrolled Primary Generalized Tonic-Clonic Seizures in Subjects With Idiopathic Generalized Epilepsy

summary: Evaluating efficacy & safety of lacosamide versus Placebo in a blinded fashion as add-on Therapy for Primary Generalized Tonic-clonic (PGTC) seizures in subject 4 years of age or greater with idiopathic generalized epilepsy currently taking 1 to 3 antiepileptic drugs. Maximum duration of study drug administration is 28 weeks. Eligible subjects may choose to enter the open-label extension study after completion.

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects With Moderately to Severely Active Crohn's Disease

summary: This study will primarily evaluate the safety and efficacy of andecaliximab in adults with active Crohn's disease. The study will consist of a Double-Blind Phase of 8 weeks followed by an Open-Label Extension. Participants who complete the Double-Blind Phase will be eligible to enroll in the optional Open-Label Extension for an additional 44 weeks. Participants who complete Week 52 assessments will be eligible to enter the Extended Treatment Phase to continue treatment with andecaliximab for an additional 156 weeks.

status: Terminated

ReferenceType: result

ReferenceCitation: Schreiber S, Siegel CA, Friedenberg KA, Younes ZH, Seidler U, Bhandari BR, Wang K, Wendt E, McKevitt M, Zhao S, Sundy JS, Lee SD, Loftus EV. A Phase 2, Randomized, Placebo-Controlled Study Evaluating Matrix Metalloproteinase-9 Inhibitor, Andecaliximab, in Patients With Moderately to Severely Active Crohn's Disease. J Crohns Colitis. 2018 Aug 29;12(9):1014-1020. doi: 10.1093/ecco-jcc/jjy070.

name: Christian-Albrechts-University Kiel, UKSH, Kiel, Germany

family: Schreiber

full_name: Stefan Schreiber

given: Stefan

name: Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA

family: Siegel

full_name: Corey A Siegel

given: Corey A

name: Great Lakes Gastroenterology, Mentor, OH, USA

family: Friedenberg

full_name: Keith A Friedenberg

given: Keith A

family: Younes

full_name: Ziad H Younes

given: Ziad H

name: Hannover Medical School, Hannover, Germany

family: Seidler

full_name: Ursula Seidler

given: Ursula

name: Delta Research Partners, Monroe, LA, USA

family: Bhandari

full_name: Bal R Bhandari

given: Bal R

name: Gilead Sciences, Inc., Foster City, CA, USA

full_name: Ke Wang

given: Ke

family: Wendt

full_name: Emily Wendt

given: Emily

family: McKevitt

full_name: Matt McKevitt

given: Matt

family: Zhao

full_name: Sally Zhao

given: Sally

family: Sundy

full_name: John S Sundy

given: John S

name: University of Washington, Seattle, WA, USA

family: Lee

full_name: Scott D Lee

given: Scott D

family: Loftus

full_name: Edward V Loftus

given: Edward V

suffix: Jr

journal_name: Journal of Crohn's and Colitis

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: A Phase 2, Randomized, Placebo-Controlled Study Evaluating Matrix Metalloproteinase-9 Inhibitor, Andecaliximab, in Patients With Moderately to Severely Active Crohn’s Disease

lead_sponsor: Gilead Sciences

location_country:
Italy
United States
South Africa
Germany
France
Czechia
Poland
Hungary
Australia
New Zealand
Spain
Canada
United Kingdom

location_facility: Gastroenterology Associates Of Central Georgia, LLC

location_facility: Medical Diagnostic Center (MDC)-Indiana University (IU) Health University Hospital

location_facility: Gastroenterology/Colorectal Medicine & Genetics

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: The Medical University of Bialystok Clinical

location_facility: Ibd Clinical And Research Centre-Iscare Ivf

location_facility: Columbia University Medical Center/ New York Presbyterian

location_facility: Washington University School of Medicine

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Capital and Coast District Health board-Wellington hospital

location_facility: Digestive Health Specialists of The Southeast

location_facility: Gastroenterology Research of San Antonio

location_facility: Debreceni Egyeterm Orvos es Egeszsegtudomanyi Centrum

location_facility: Gastroenterology Associates Of Tidewater

location_facility: Ertan Digestive Disease Center of Excellence, UTH/MH-TMC

location_facility: Premier Medical Group Of The Hudson Valley

location_facility: Cotton-O'Neil Clinical Research Center, Digestive Health

location_facility: Norfolk and Norwich University Hospital Nhs Foundation Trust

location_facility: Clinical Research Institute of Michigan, LLC

intervention_type: Drug

status_simplified: Unknown


ReferenceCitation: Shemesh CS, Chan P, Legrand FA, Shames DS, Das Thakur M, Shi J, Bailey L, Vadhavkar S, He X, Zhang W, Bruno R. Pan-cancer population pharmacokinetics and exposure-safety and -efficacy analyses of atezolizumab in patients with high tumor mutational burden. Pharmacol Res Perspect. 2020 Dec;8(6):e00685. doi: 10.1002/prp2.685.

name: Clinical Pharmacology Genentech Inc. South San Francisco CA USA

family: Shemesh

full_name: Colby S. Shemesh

given: Colby S.

family: Chan

full_name: Phyllis Chan

given: Phyllis

name: Clinical Science Genentech Inc. South San Francisco CA USA

family: Legrand

full_name: Fatema A. Legrand

given: Fatema A.

name: Biomarkers Genentech Inc. South San Francisco CA USA

family: Shames

full_name: David S. Shames

given: David S.

family: Das Thakur

full_name: Meghna Das Thakur

given: Meghna

name: Safety Science F. Hoffmann‐La Roche Ltd. Shanghai China

family: Shi

full_name: Jane Shi

given: Jane

name: Safety Science Roche Products Ltd. Welwyn Garden City United Kingdom

family: Bailey

full_name: Lorna Bailey

given: Lorna

family: Vadhavkar

full_name: Shweta Vadhavkar

given: Shweta

name: Biometrics Genentech Inc. South San Francisco CA USA

family: He

full_name: Xian He

given: Xian

family: Zhang

full_name: Wei Zhang

given: Wei

name: Clinical Pharmacology Genentech‐Roche Marseille France

family: Bruno

full_name: René Bruno

given: René

currency_apc_doaj: USD

journal_name: Pharmacology Research & Perspectives

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Pan‐cancer population pharmacokinetics and exposure‐safety and ‐efficacy analyses of atezolizumab in patients with high tumor mutational burden

ReferenceCitation: Chalabi M, Cardona A, Nagarkar DR, Dhawahir Scala A, Gandara DR, Rittmeyer A, Albert ML, Powles T, Kok M, Herrera FG; imCORE working group of early career investigators. Efficacy of chemotherapy and atezolizumab in patients with non-small-cell lung cancer receiving antibiotics and proton pump inhibitors: pooled post hoc analyses of the OAK and POPLAR trials. Ann Oncol. 2020 Apr;31(4):525-531. doi: 10.1016/j.annonc.2020.01.006. Epub 2020 Jan 16.

family: Chalabi

full_name: M. Chalabi

given: M.

family: Cardona

full_name: A. Cardona

given: A.

family: Nagarkar

full_name: D.R. Nagarkar

family: Dhawahir Scala

full_name: A. Dhawahir Scala

family: Gandara

full_name: D.R. Gandara

family: Rittmeyer

full_name: A. Rittmeyer

family: Albert

full_name: M.L. Albert

family: Powles

full_name: T. Powles

given: T.

family: Kok

full_name: M. Kok

ReferenceCitation: Fehlings M, Jhunjhunwala S, Kowanetz M, O'Gorman WE, Hegde PS, Sumatoh H, Lee BH, Nardin A, Becht E, Flynn S, Ballinger M, Newell EW, Yadav M. Late-differentiated effector neoantigen-specific CD8+ T cells are enriched in peripheral blood of non-small cell lung carcinoma patients responding to atezolizumab treatment. J Immunother Cancer. 2019 Sep 12;7(1):249. doi: 10.1186/s40425-019-0695-9.

ReferenceCitation: Fehrenbacher L, Spira A, Ballinger M, Kowanetz M, Vansteenkiste J, Mazieres J, Park K, Smith D, Artal-Cortes A, Lewanski C, Braiteh F, Waterkamp D, He P, Zou W, Chen DS, Yi J, Sandler A, Rittmeyer A; POPLAR Study Group. Atezolizumab versus docetaxel for patients with previously treated non-small-cell lung cancer (POPLAR): a multicentre, open-label, phase 2 randomised controlled trial. Lancet. 2016 Apr 30;387(10030):1837-46. doi: 10.1016/S0140-6736(16)00587-0. Epub 2016 Mar 10.

location_country:
Italy
United States
Sweden
Germany
France
Poland
Thailand
Belgium
Spain
Turkey
Canada
United Kingdom
Korea, Republic of

location_facility: Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii

location_facility: Centre Hospitalier de Saint Brieuc - Hôpital Yves Le Foll; Pneumologie

location_facility: Akdeniz University Medical Faculty; Medical Oncology Department

location_facility: Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

location_facility: Comprehensive Cancer Centers of Nevada - Eastern Avenue

location_facility: Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii

location_facility: Northwest Cancer Specialists - Vancouver

location_facility: Rocky Mountain Cancer Centers - Colorado Springs (Circle)

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: Citta Ospedaliera; Divisione Oncologia Medica

location_facility: Irccs Ospedale San Raffaele;Oncologia Medica

location_facility: National Cancer Center; Medical Oncology

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Cite de La Sante de Laval; Hemato-Oncologie

location_facility: Providence St. Mary Regional Cancer Center

location_facility: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

location_facility: Samsung Medical Centre; Division of Hematology/Oncology

location_facility: Hopital Gabriel Montpied; Service de Pneumologie

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie

location_facility: Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II

location_facility: Willamette Valley Cancer Ctr - 520 Country Club

location_facility: Guys and St Thomas NHS Foundation Trust, Guys Hospital

location_facility: Charing Cross Hospital; Medical Oncology.

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii

location_facility: Centre D'Oncologie de Gentilly; Oncology

location_facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

location_facility: Rajavithi Hospital; Division of Medical Oncology

title: A Phase II, Open-label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of MPDL3280A (Anti-PD-L1 Antibody) Compared With Docetaxel in Patients With Non-Small Cell Lung Cancer After Platinum Failure

summary: This multicenter, open-label, randomized study will evaluate the efficacy and safety of Atezolizumab compared with docetaxel in participants with advanced or metastatic non-small cell lung cancer after platinum failure. Participants will be randomized to receive either Atezolizumab 1200 milligram (mg) intravenously every 3 weeks or docetaxel 75 milligram per meter square (mg/m^2) intravenously every 3 weeks. Treatment with Atezolizumab may be continued as long as participants are experiencing clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.


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

lead_sponsor: Pfizer

location_country:
Peru
Finland
Belgium
Australia
Russian Federation
Ukraine
India
France
Japan
Poland
Thailand
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Chile
Hong Kong
Netherlands
Singapore
Hungary
China
United States
United Kingdom
Italy
Brazil
Spain
Turkey
Latvia

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Wits Clinical Research-Chris Hani Baragwanath Hospital

location_facility: Universidade Estadual de Campinas / Centro de Hematologia e Hemoterapia

location_facility: Hudson Valley Hematology and Oncology Associates

location_facility: Ruijin Hospital- Shanghai Jiaotong University School of Medicine

location_facility: University Medical Center Groningen, Department of Hematology

location_facility: MI "Dnipropetrovsk City Multi-field Clinical Hospital #4" of DRC Hematology Center

location_facility: Division of Hematology, Department of Medicine, Faculty of Medicine, Siriraj Hospital,

location_facility: Kyiv City Clinical Hospital #9, SI "Institute of Hematology and Transfusiology of NAMS of Ukraine"

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Faculdade de Medicina do ABC - Centro de Estudos e Pesquisa em Hematologia e Oncologia (CEPHO)

location_facility: Indiana Blood and Marrow Transplantation

location_facility: Hospital Clinico Universitario De Valencia (CHUV)

location_facility: Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointezet

location_facility: Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

location_facility: Siouxland Hematology-Oncology Associates, LLP

location_facility: Hamamatsu University School of Medicine University Hospital

location_facility: State Budgetary Educational Institution of Higher Professional Education

location_facility: Municipal Institution "Cherkasy Regional Oncology Dispensary"

location_facility: Federal State Budgetary Institution "Federal Almazov Medical Research Centre"

location_facility: Pamela Youde Nethersole Eastern Hospital

location_facility: State Institution "Institute of Blood Pathology and Transfusion Medicine of

location_facility: Northside Hospital, Inc. - Central Research Department

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Helsingin Yliopistollinen Keskussairaala, Hematologian poliklinikka

location_facility: Alberta Health Services - Department of Medical Oncology - Cross Cancer Institute

location_facility: State Budgetary Institution of Healthcare Samara Regional Clinical Hospital n.a. V.D. Seredavin

location_facility: Chinese People's Liberation Army General Hospital

location_facility: Blood Disease Hospital, Chinese Academy of Medical Science & Peking Union Medical College

location_facility: Winship Cancer Institute, Emory University

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

location_facility: State Institution "National Research Center for Radiation Medicine of the National Academy of

location_facility: Unidad de Investigacion de Hematologia - Hospital Nacional Edgardo Rebagliati Martins

location_facility: State Budgetary Institution of Healthcare - Leningrad Regional Clinical Hospital

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

location_facility: Gaziantep Universitesi Tip Fakultesi Sahinbey Uygulama ve Arastirma Hastanesi

location_facility: Department of Medicine & Therapeutics, Prince of Wales Hospital

location_facility: State Budgetary Institution of Rostov Region - Rostov Regional Clinical Hospital

location_facility: State Budgetary Institution of Healthcare of Sverdlovsk Region

location_facility: Hospital Universitario Madrid Sanchinarro, Centro Integral Oncologico Clara Campal

location_facility: Clinic "Institute of Pediatric Oncology, Hematology and Transplantation n.a. R.M. Gorbachova"

location_facility: The First affiliated Hospital of College of Medicine, Zhejiang University

location_facility: Federal State-Funded Institution National Research Center of Hematology of the Ministry of

location_facility: The University of Texas, MD Anderson Cancer Center

location_facility: Northside Hospital Inc., - GCS/Northside

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Sir Mortimer B. Davis-Jewish General Hospital

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Strasbourg Oncologie Liberale -Centre de Radiotherapie, Clinique Ste Anne

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz, Belgyogyaszati Osztaly

ipd_sharing: No

title: AN OPEN-LABEL BOSUTINIB TREATMENT EXTENSION STUDY FOR SUBJECTS WITH CHRONIC MYELOID LEUKEMIA (CML) WHO HAVE PREVIOUSLY PARTICIPATED IN BOSUTINIB STUDIES B1871006 OR B1871008

summary: The objective of the study is to provide long term access to bosutinib treatment and assess long term safety, tolerability and duration of clinical benefit, without any formal hypothesis testing; therefore, there is no formal primary endpoint.


title: A 2 Year, Double-blind, Randomized, Multicenter, Active-controlled Core Phase to Evaluate Safety & Efficacy of Daily Fingolimod vs Weekly Interferon β-1a im in Pediatric Patients With Multiple Sclerosis and 5 Year Fingolimod Extension Phase

summary: To evaluate the safety and efficacy of fingolimod vs. interferon beta-1a i.m. in pediatric patients with multiple sclerosis (MS)

ReferenceCitation: Deiva K, Huppke P, Banwell B, Chitnis T, Gärtner J, Krupp L, Waubant E, Stites T, Pearce GL, Merschhemke M. Consistent control of disease activity with fingolimod versus IFN β-1a in paediatric-onset multiple sclerosis: further insights from PARADIGMS. J Neurol Neurosurg Psychiatry. 2020 Jan;91(1):58-66. doi: 10.1136/jnnp-2019-321124. Epub 2019 Aug 29.

family: Deiva

full_name: Kumaran Deiva

given: Kumaran

family: Huppke

full_name: Peter Huppke

given: Peter

family: Banwell

full_name: Brenda Banwell

given: Brenda

family: Chitnis

full_name: Tanuja Chitnis

given: Tanuja

family: Gärtner

full_name: Jutta Gärtner

given: Jutta

family: Krupp

full_name: Lauren Krupp

given: Lauren

family: Waubant

full_name: Emmanuelle Waubant

given: Emmanuelle

family: Stites

full_name: Tracy Stites

given: Tracy

family: Pearce

full_name: Gregory Lewis Pearce

given: Gregory Lewis

family: Merschhemke

full_name: Martin Merschhemke

given: Martin

journal_name: Journal of Neurology, Neurosurgery & Psychiatry

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Chitnis T, Arnold DL, Banwell B, Brück W, Ghezzi A, Giovannoni G, Greenberg B, Krupp L, Rostásy K, Tardieu M, Waubant E, Wolinsky JS, Bar-Or A, Stites T, Chen Y, Putzki N, Merschhemke M, Gärtner J; PARADIGMS Study Group. Trial of Fingolimod versus Interferon Beta-1a in Pediatric Multiple Sclerosis. N Engl J Med. 2018 Sep 13;379(11):1017-1027. doi: 10.1056/NEJMoa1800149.

name: From the Partners Pediatric Multiple Sclerosis Center, Massachusetts General Hospital, Boston (T.C.); Montreal Neurological Institute, McGill University, and NeuroRx Research — both in Montreal (D.L.A.); Children’s Hospital of Philadelphia (B.B.) and the Center for Neuroinflammation and Experimental Neurotherapeutics and the Department of Neurology (A.B.-O.), Perelman School of Medicine, University of Pennsylvania — all in Philadelphia; the Department of Neuropathology (W.B.) and the Department of...

family: Arnold

full_name: Douglas L. Arnold

given: Douglas L.

family: Brück

full_name: Wolfgang Brück

given: Wolfgang

family: Ghezzi

full_name: Angelo Ghezzi

given: Angelo

family: Giovannoni

full_name: Gavin Giovannoni

given: Gavin

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:
Romania
Australia
Russian Federation
Ukraine
Spain
Croatia
France
Lithuania
Poland
Slovakia
Canada
Turkey
Sweden
Netherlands
Bulgaria
Puerto Rico
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Mexico
Belarus
Estonia
Latvia


title: A Phase 2 Study of Duvelisib in Subjects With Refractory Indolent Non-Hodgkin Lymphoma (DYNAMO)

summary: Phase 2 clinical trial to evaluate the safety and efficacy of duvelisib as a monotherapy in subjects with iNHL (Follicular Lymphoma, Marginal Zone Lymphoma, or Small Lymphocytic Lymphoma) that is refractory to rituximab and to either chemotherapy or RIT.

ReferenceCitation: Flinn IW, Miller CB, Ardeshna KM, Tetreault S, Assouline SE, Mayer J, Merli M, Lunin SD, Pettitt AR, Nagy Z, Tournilhac O, Abou-Nassar KE, Crump M, Jacobsen ED, de Vos S, Kelly VM, Shi W, Steelman L, Le N, Weaver DT, Lustgarten S, Wagner-Johnston ND, Zinzani PL. DYNAMO: A Phase II Study of Duvelisib (IPI-145) in Patients With Refractory Indolent Non-Hodgkin Lymphoma. J Clin Oncol. 2019 Apr 10;37(11):912-922. doi: 10.1200/JCO.18.00915. Epub 2019 Feb 11. Erratum in: J Clin Oncol. 2019 Jun 1;37(16):1448.

name: Sarah Cannon Research Institute, Nashville, TN

family: Flinn

full_name: Ian W. Flinn

given: Ian W.

name: Saint Agnes Cancer Center, Baltimore, MD

family: Miller

full_name: Carole B. Miller

given: Carole B.

name: University College London Hospitals National Health Service Foundation Trust, London, United Kingdom

family: Ardeshna

full_name: Kirit M. Ardeshna

given: Kirit M.

name: Florida Cancer Specialists, Tallahassee, FL

family: Tetreault

full_name: Scott Tetreault

given: Scott

name: McGill University, Montreal, Quebec, Canada

family: Assouline

full_name: Sarit E. Assouline

given: Sarit E.

name: Fakultní Nemocnice Brno, Brno, Czech Republic

family: Mayer

full_name: Jiri Mayer

given: Jiri

name: Ospedale di Circolo e Fondazione Macchi, Varese, Italy

family: Merli

full_name: Michele Merli

given: Michele

family: Lunin

full_name: Scott D. Lunin

given: Scott D.

name: University of Liverpool, Liverpool, United Kingdom

family: Pettitt

full_name: Andrew R. Pettitt

given: Andrew R.

family: Nagy

full_name: Zoltan Nagy

given: Zoltan

name: Centre Hospitalier Universitaire Estaing, Clermont-Ferrand, France

family: Tournilhac

full_name: Olivier Tournilhac

given: Olivier

name: Centre intégré de santé et de services sociaux de l’Outaouais, Gatineau, Quebec, Canada

family: Abou-Nassar

full_name: Karem-Etienne Abou-Nassar

given: Karem-Etienne

name: Princess Margaret Cancer Centre, Toronto, Ontario, Canada

family: Crump

full_name: Michael Crump

given: Michael

name: Dana-Farber Cancer Institute, Boston, MA

family: Jacobsen

full_name: Eric D. Jacobsen

given: Eric D.

name: Ronald Reagan University of California, Los Angeles, Medical Center, Los Angeles, CA

family: de Vos

full_name: Sven de Vos

given: Sven

family: Kelly

full_name: Virginia M. Kelly

given: Virginia M.

family: Shi

full_name: Weiliang Shi

given: Weiliang

family: Steelman

full_name: Lori Steelman

given: Lori

family: Le

full_name: NgocDiep Le

given: NgocDiep

family: Weaver

full_name: David T. Weaver

given: David T.

family: Lustgarten

full_name: Stephanie Lustgarten

given: Stephanie

name: Washington University in St Louis, St Louis, MO

family: Wagner-Johnston

full_name: Nina D. Wagner-Johnston

given: Nina D.

family: Zinzani

full_name: Pier Luigi Zinzani

given: Pier Luigi

publisher: American Society of Clinical Oncology (ASCO)

location_country:
Italy
United States
Spain
France
Bulgaria
Czechia
Georgia
Hungary
Belgium
Belarus
Canada
United Kingdom


lead_sponsor: Genzyme, a Sanofi Company

location_country:
Italy
Brazil
Sweden
Spain
France
Czechia
Japan
Poland
Russian Federation
China
Denmark
United States

acronym: VERIFY

location_facility:
Research Site
Washington University

title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Phase III Study to Assess the Efficacy and Safety of Vandetanib (CAPRELSA™; SAR390530 (Formerly AstraZeneca ZD6474)) 300 mg in Patients With Differentiated Thyroid Cancer That Is Either Locally Advanced or Metastatic Who Are Refractory or Unsuitable for Radioiodine (RAI) Therapy.

summary:
Primary Objective:

To determine the efficacy (as assessed by progression-free survival [PFS]) of vandetanib when compared to placebo in participants with differentiated thyroid cancer that is either locally advanced or metastatic who are refractory or unsuitable for radioiodine therapy.

Secondary Objectives:

To determine the efficacy of vandetanib when compared to placebo in this participant population as assessed by efficacy variables including duration of response (DOR), objective response rate (ORR), change in tumour size (TS) and overall survival (OS).
To evaluate the pharmacokinetics (PK) of vandetanib in this participant population and potentially investigate any influence of participant demography and pathophysiology on vandetanib PK.
To demonstrate an improvement in time to worsening of pain (TWP) in participants treated with vandetanib when compared to placebo in this participant population.
To evaluate the safety and tolerability of vandetanib treatment in this participant population.

status_simplified: Ongoing


title: A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Safety and Efficacy of Different Oral Doses of BAY94-8862 in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy

acronym: ARTS-DN

summary: To assess a new drug, BAY94-8862 given orally at different doses, to evaluate whether it was safe and can help the well being of patients with type 2 diabetes and diabetic nephropathy. These treatment doses were compared to placebo.

ReferenceCitation: Bakris GL, Agarwal R, Chan JC, Cooper ME, Gansevoort RT, Haller H, Remuzzi G, Rossing P, Schmieder RE, Nowack C, Kolkhof P, Joseph A, Pieper A, Kimmeskamp-Kirschbaum N, Ruilope LM; Mineralocorticoid Receptor Antagonist Tolerability Study-Diabetic Nephropathy (ARTS-DN) Study Group. Effect of Finerenone on Albuminuria in Patients With Diabetic Nephropathy: A Randomized Clinical Trial. JAMA. 2015 Sep 1;314(9):884-94. doi: 10.1001/jama.2015.10081.

name: University of Chicago Medicine, Chicago, Illinois

family: Bakris

full_name: George L. Bakris

given: George L.

name: Richard L. Roudebush VA Medical Center and Indiana University, Indianapolis

family: Agarwal

full_name: Rajiv Agarwal

given: Rajiv

name: Department of Medicine and Therapeutics, Chinese University of Hong Kong, Hong Kong, China

family: Chan

full_name: Juliana C. Chan

given: Juliana C.

name: Baker IDI Heart and Diabetes Institute, Melbourne, Australia

family: Cooper

full_name: Mark E. Cooper

given: Mark E.

name: Department of Nephrology, University Medical Center Groeningen, Groeningen, the Netherlands

family: Gansevoort

full_name: Ron T. Gansevoort

given: Ron T.

name: Departments of Nephrology and Hypertension, Hannover Medical School, Hannover, Germany

family: Haller

full_name: Hermann Haller

given: Hermann

name: Istituto di Ricerche Farmacologiche Mario Negri, Clinical Research Center for Rare Diseases “Aldo e Cele Daccò,” Ranica (Bergamo), Italy8Unit of Nephrology and Dialysis, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy

family: Remuzzi

full_name: Giuseppe Remuzzi

given: Giuseppe

name: Steno Diabetes Center, Gentofte, Denmark10University of Copenhagen, Copenhagen, Denmark11Aarhus University, Aarhus, Denmark

family: Rossing

full_name: Peter Rossing

given: Peter

name: Department of Nephrology and Hypertension, University Hospital Erlangen, Erlangen, Germany

family: Schmieder

full_name: Roland E. Schmieder

given: Roland E.

name: Global Clinical Development, Bayer HealthCare AG, Wuppertal, Germany

family: Nowack

full_name: Christina Nowack

given: Christina

name: Heart Diseases Research, Global Drug Discovery, Bayer HealthCare AG, Wuppertal, Germany

family: Kolkhof

full_name: Peter Kolkhof

name: Global Clinical Development, Bayer PLC, Newbury, England

family: Joseph

full_name: Amer Joseph

given: Amer

family: Pieper

full_name: Alexander Pieper

given: Alexander

name: Global Research and Development Statistics, Bayer HealthCare AG, Leverkusen, Germany

family: Kimmeskamp-Kirschbaum

full_name: Nina Kimmeskamp-Kirschbaum

given: Nina

name: Institute of Investigation and Hypertension Unit, Hospital 12 de Octubre, Madrid, Spain

family: Ruilope

full_name: Luis M. Ruilope

given: Luis M.

journal_name: JAMA

oa_colors: green other

evidence: open (via free pdf)

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

ReferenceCitation: Snelder N, Heinig R, Drenth HJ, Joseph A, Kolkhof P, Lippert J, Garmann D, Ploeger B, Eissing T. Population Pharmacokinetic and Exposure-Response Analysis of Finerenone: Insights Based on Phase IIb Data and Simulations to Support Dose Selection for Pivotal Trials in Type 2 Diabetes with Chronic Kidney Disease. Clin Pharmacokinet. 2020 Mar;59(3):359-370. doi: 10.1007/s40262-019-00820-x.

family: Snelder

full_name: Nelleke Snelder

given: Nelleke

family: Heinig

full_name: Roland Heinig

given: Roland

family: Drenth

full_name: Henk-Jan Drenth

title: Population Pharmacokinetic and Exposure–Response Analysis of Finerenone: Insights Based on Phase IIb Data and Simulations to Support Dose Selection for Pivotal Trials in Type 2 Diabetes with Chronic Kidney Disease

ReferenceCitation: Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10:CD007004. doi: 10.1002/14651858.CD007004.pub4.

name: Department of Medicine; Royal North Shore Hospital; Sydney Australia

name: Sydney School of Public Health; The University of Sydney; Sydney Australia

name: Department of Emergency and Organ Transplantation; University of Bari; Bari Italy

name: Institute of Clinical Physiology; CNR - Italian National Council of Research; Reggio Calabria Italy

name: Baylor College of Medicine; Houston Texas USA

name: Department of Medicine; University of Otago Christchurch; Christchurch New Zealand

name: Cochrane Kidney and Transplant, Centre for Kidney Research; The Children's Hospital at Westmead; Westmead Australia

ReferenceCitation: Erraez S, López-Mesa M, Gómez-Fernández P. [Mineralcorticoid receptor blockers in chronic kidney disease]. Nefrologia (Engl Ed). 2021 May-Jun;41(3):258-275. doi: 10.1016/j.nefro.2020.10.001. Epub 2020 Dec 24. Review. English, Spanish.

title: Bloqueantes del receptor mineralcorticoide en la enfermedad renal crónica

location_country:
Finland
Australia
Denmark
Taiwan
France
Poland
Norway
Canada
Korea, Republic of
South Africa
Sweden
Hong Kong
Netherlands
Bulgaria
Hungary
Portugal
United States
Germany
Italy
Austria
Czechia
Israel
Spain


lead_sponsor: Hoffmann-La Roche

location_country:
Italy
United States
Peru
Mexico
Germany
France
Japan
Poland
Belgium
Australia
Spain
Canada
United Kingdom

location_facility: Ospedale Morgagni-Pierantoni; U.O. Pneumologia

location_facility: Ruhrlandklinik Lungenzentrum der UNI Essen Abt.Pneumologie-Allergologie

location_facility: Lawson Health Research Institute a joint venture of LHSC Research Inc and Lawson Research Institute

location_facility: North Manchester Hospital; Respiratory Department

location_facility: Hopital de Pontchaillou; Service de Pneumologie

location_facility: Ms Clinsearch Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej

location_facility: Hospital General Del Estado De Sonora "Dr. Ernesto Ramos Bours"; Servicio De Neumologia

location_facility: A.O. Universitaria San Luigi Gonzaga di Orbassano; Ambulatorio per le Malattie Rare del Polmone

location_facility: Royal Prince Alfred Hospital; Department of Respiratory Medicine

location_facility: Mt Sinai School Medical Pulmo And Critical Care Med

location_facility: Southern Arizona Veterans Administration Healthcare Systems

location_facility: Johns Hopkins Bayview Medical Center - Johns Hopkins Asthma & Allergy Center

location_facility: Box Hill Hospital; Eastern Clinical Research Unit

location_facility: University of British Columbia - Vancouver Coastal Health Authority

location_facility: University of Minnesota Hospital & Clinic

location_facility: Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional

location_facility: Southmead Hospital; Respiratory Department

location_facility: University of Utah Health Sciences Center, Lung Health Research Center

location_facility: Institut universitaire de cardiologie et de pneumologie de Québec (Hôpital Laval)

location_facility: Ospedale San Giuseppe; U.O. di Pneumologia

location_facility: University of Pittsburgh Med Cen; Dorothy P And Richard P Simmons Cen For Interstitial Lung Disease

location_facility: University Wisconsin Hospitals and Clinics

location_facility: Rocky Mountain Center For Clinical Research

location_facility: Hopital Bichat Claude Bernard ; Service de Pneumologie

location_facility: Hospital Universitari de Bellvitge ; Servicio de Neumologia

location_facility: Cardiopulmonary Associates LLC Cardiopulmonary Research

location_facility: Instituto Nacional De Enfermedades Respiratorias;Unidad de Investigación

location_facility: A.O.U. Policlinico Vittorio Emanuele; Centro per la cura delle Malattie Rare del Polmone

location_facility: Royal Brompton Hospital; Respiratory Department

location_facility: St James University Hospital; Respiratory Department

location_facility: Piedmont Healthcare Pulmonary and Critical Care Research

location_facility: Case Western Research University; University Hospitals Case Medical Center

location_facility: Maine Medical Center -Division of Pulmomary and Critical Care Medicine

location_facility: Hospital General Universitario De Valencia; Servicio de Neumologia

location_facility: Papworth Hospital NHS Foundation Trust; Respiratory Department

location_facility: CPC Comprehensive Pneumology Center / Forschungsambulanz, Helmholtz Zentrum

location_facility: Unidad de Investigacion Clinica En Medicina (Udicem) S.C.

location_facility: Southampton General Hospital; Respiratory Department

location_facility: Highland Hospital-University of Rochester Medical Center

location_facility: Inova Transplant Center Fairfax Hospital

location_facility: A.O. Univ. Senese Policlinico S. Maria alle Scotte; UOC Malattie Resepiratorie e Trapianto Polmonare

location_facility: Via Christi Hospital Inc. DBA Via Christi Research; Research Dept.

location_facility: University Vermont College Medicine Fletcher Allen Health Care

location_facility: Hospital Clínico San Carlos - Servicio de Neumologia

location_facility: Klinika Pulmonologii, Alergologii i Onkologii Pulmonologicznej Uniwersytet Medyczny w Poznaniu

location_facility: Universidad Autonoma De Nuevo Leon, Hospital Universitario Doctor Jose Eleuterio Gonzalez

location_facility: Hospital Universitario La Princesa; Servicio de Neumologia

location_facility: Klinika Chorob Pluc i Gruzlicy w Zabrzu; Slaski Uniwersytet Medyczny

location_facility: Weill Medical College of Cornell University

location_facility: ST VINCENT'S HOSPITAL; Thoracic Medicine

location_facility: Oklahoma University Health Sciences Center

location_facility: Policlinico Tor Vergata; UO Mal. Respiratorie; Centro Malattie rare polmone

location_facility: Universitätsklinikum Standort Gießen Medizinische Klinik II u. Poliklinik Innere Med./Pneumologie

location_facility: Uniwersytecki Szpital Kliniczny Nr 1 im.N.Barlickiego Oddzial Kliniczny Pneumonologii i Alergologii

location_facility: Respiratory research department clinical science building

location_facility: Kanagawa Cardiovascular and Respiratory Center; Respiratory Medicine

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Neumologia

location_facility: University of Chicago; Pulmonary and Critical Care

location_facility: Penn State University College Medical Allergy And Care Med

location_facility: Temple Lung Center, Temple Universtiy-Of the Commomwealth System of Higher Education

title: A Phase II, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Idiopathic Pulmonary Fibrosis

summary: This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of lebrikizumab as monotherapy in the absence of background IPF therapy and as combination therapy with pirfenidone background therapy in participants with IPF. Participants will be randomized to receive either lebrikizumab or placebo subcutaneously every 4 weeks.


title: MGuard™ Prime Stent System Clinical Trial in Patients With Acute ST Elevation Myocardial Infarction

acronym: MASTER-II

summary: To evaluate the safety and efficacy of the MGuard™ Prime stent in the treatment of blocked arteries in coronary arteries in patients undergoing a stenting procedure due to having a heart attack. The MGuard Prime stent wil be compared to other FDA approved bare-metal (BMS) or drug-eluting (DES) coronary stents. The hypotheses are that (1) the MGuard Prime stent will achieve a higher rate of complete ST-segment resolution as seen on the post-procedure ECG as compared to the comparator stent, and will have a similar effect on the rate of all-cause death or recurrent target vessel myocardial infarction at 365 days post-procedure.

lead_sponsor: InspireMD

location_country:
United Kingdom
Netherlands
Germany
Finland
France
Poland
Israel
Belgium
Spain
Estonia
United States
Czech Republic

location_facility: Krakowskie Centrum Kardiologii Inwazyjnej

location_facility: Klinika Kardiologii i Angiologii Interwencyjnej

location_facility: MedStar Southern Maryland Hospital Center

location_facility: Katedra i Klinika Kardiologii Uniwersytetu Medycznego w Łodzi

location_facility: Cardiology Associates of North Mississippi

location_facility: Charité Universitätsklinikum Berlin Campus Benjamin Franklin

location_facility: University Hospitals Case Medical Center

location_facility: Hospital Universitario Madrid Montepríncipe

location_facility: Charité Universitätsklinikum Berlin Campus Virchow

location_facility: University Hospitals Southampton NHS Foundation Trust

location_facility: Hospital Clinic, University of Barcelona

intervention_type: Device


title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication

summary: This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of lebrikizumab in participants with asthma whose disease remains uncontrolled despite daily treatment with inhaled corticosteroid (ICS) therapy and at least one second controller medication. Participants will be randomized in 1:1:1 ratio to receive double-blind treatment with either lebrikizumab ("high" or "low") or placebo, administered subcutaneously (SC) every 4 weeks for 52 weeks, in addition to their standard-of-care therapy. This will be followed by a 52-week double-blind active treatment extension. During double-blind active treatment extension period, all participants will receive SC injection of lebrikizumab from Week 53 to Week 104. The anticipated time on study treatment is 104 weeks. After study treatment, all participants will complete a 20-week safety follow-up.

ReferenceCitation: Chen M, Shepard K 2nd, Yang M, Raut P, Pazwash H, Holweg CTJ, Choo E. Overlap of allergic, eosinophilic and type 2 inflammatory subtypes in moderate-to-severe asthma. Clin Exp Allergy. 2021 Apr;51(4):546-555. doi: 10.1111/cea.13790. Epub 2021 Jan 7.

name: Southwest Asthma and Allergy Associates Houston TX USA

family: Chen

full_name: Meng Chen

given: Meng

name: University of South Florida Tampa FL USA

family: Shepard

full_name: Kirk Shepard

given: Kirk

suffix: II

name: Genentech, Inc. South San Francisco CA USA

family: Yang

full_name: Ming Yang

given: Ming

family: Raut

full_name: Pranil Raut

given: Pranil

family: Pazwash

full_name: Hooman Pazwash

given: Hooman

family: Holweg

full_name: Cecile T.J. Holweg

given: Cecile T.J.

name: University of California San Francisco CA USA

family: Choo

full_name: Eugene Choo

given: Eugene

journal_name: Clinical & Experimental Allergy

title: Overlap of allergic, eosinophilic and type 2 inflammatory subtypes in moderate‐to‐severe asthma

ReferenceCitation: N Bauer R, Yang X, L Staton T, Olsson J, Holweg CTJ, R Arron J, Matthews JG, Choy DF. Seasonal variability of lung function and Asthma Quality of Life Questionnaire Scores in adults with uncontrolled asthma. BMJ Open Respir Res. 2019 Nov 11;6(1):e000406. doi: 10.1136/bmjresp-2019-000406. eCollection 2019.

family: Bauer

full_name: Rebecca N Bauer

given: Rebecca N

full_name: Xiaoying Yang

given: Xiaoying

family: Staton

full_name: Tracy L Staton

given: Tracy L

family: Olsson

full_name: Julie Olsson

given: Julie

full_name: Cecile T J Holweg

given: Cecile T J

family: Arron

full_name: Joseph R Arron

given: Joseph R

family: Matthews

full_name: John G Matthews

given: John G

family: Choy

full_name: David F Choy

given: David F

currency_apc_doaj: GBP

journal_name: BMJ Open Respiratory Research

ReferenceCitation: Hanania NA, Korenblat P, Chapman KR, Bateman ED, Kopecky P, Paggiaro P, Yokoyama A, Olsson J, Gray S, Holweg CT, Eisner M, Asare C, Fischer SK, Peng K, Putnam WS, Matthews JG. Efficacy and safety of lebrikizumab in patients with uncontrolled asthma (LAVOLTA I and LAVOLTA II): replicate, phase 3, randomised, double-blind, placebo-controlled trials. Lancet Respir Med. 2016 Oct;4(10):781-796. doi: 10.1016/S2213-2600(16)30265-X. Epub 2016 Sep 5.

location_country:
Romania
Belgium
Australia
Russian Federation
Ukraine
France
Japan
Poland
Slovakia
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Chile
Hungary
United States
Germany
United Kingdom
Italy
Serbia
Mexico
Czechia
Israel
New Zealand
Spain
Turkey

location_facility: Allergy & Asthma Care of FL; Clinical Research

location_facility: St.-Petersburg SMU n. a. Academician I.P.Pavlov; Therapy Department

location_facility: A.o. Universitaria Pisana; Dipartimento Cardio Toracico

location_facility: Barzilai Medical Center; Pulmonary Inst.

location_facility: Danylo Halytskyy National Medical University; Lviv

location_facility: Public Institution City Clinical Hospital # 6 of Dnipropetrovsk Regional Board

location_facility: Tehelná Clinic, Inc; IMUNO-ALERGO, s. r.o.

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Grazyna Pulka Specjalistyczny Ośrodek ALL-MED

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi Di Ancona

location_facility: Small Business Private Enterprise Medical Centre Pulse

location_facility: Japan Community Health Care Organization Hokkaido Hospital

location_facility: National Hospital Organization Mito Medical Center

location_facility: Box Hill Hospital; Eastern Clinical Research Unit

location_facility: Turgut Ozal Universitesi Tip Fakultesi Bestepe Hastanesi

location_facility: National Hospital Organization Asahikawa Medical Center

location_facility: Canakkale Onsekiz Mart Universitesi Tip Fakultesi Hastanesi

location_facility: Grand View Hospital; Clinical Research Department

location_facility: Lady Davis Carmel Medical Center; Cardiovascular Medicine

location_facility: St. Francis Sleep; Allergy & Lung Institute

location_facility: St. Petersburg State Budget Medical Institution Pokrovskaya City Hospital

location_facility: Tosei General Hospital; Respiratory and Allergy Medicine

location_facility: Dr. Victor Babes Pneumology and Infectious Diseases Clinical Hospital

location_facility: Laporte County Institute For Clinical Research

location_facility: Florida Pulmonary Research Institute, LLC

location_facility: Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi

location_facility: Educational Scientific Medical Centre of Donetsk National Medical University;

location_facility: National Hospital Organization Tokyo National Hospital

location_facility: Northeast Medical Research Associates, Inc

location_facility: Allergy & Asthma Diagnostic; Treatment Center

location_facility: Centrum Medycyny Oddechowej Robert M. Mróz

location_facility: Klinika Chorób Wewnetrznych i Alergologii MSW

location_facility: Centro de Investigaciones Medicas Respiratorias

location_facility: Medical and Sanitary Unit of OJSC "Kharkiv Tractor Plant n.a. Ordzhonikidze"; Department of Therapy

location_facility: St. Paul's Hospital, The Catholic University of Korea, College of Medicine

location_facility: Hospital Dr Angel Leaño universidad Autonoma de Guadalajara AC

location_facility: Dokkyo Medical University Koshigaya Hospital

location_facility: St James University Hospital; Respiratory Department

location_facility: Instituto Jalisciense de Investigacion Clinica S.A. de C.V.

location_facility: Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital

location_facility: Nouvel Hôpital Civil; Pôle de Pathologie Thoracique

location_facility: Central Clinical Hospital #1 of RZhD JCS

location_facility: Yanovskyy Inst of Phth. & Pulm; Clinical-functional

location_facility: Fondazione Salvatore Maugeri. IRCCS - Divisione di Pneumologia

location_facility: Niepubliczny Specjalistyczny ZOZ Puls-Med s.c.

location_facility: Central PA Asth & Allergy Care; Research Division

location_facility: CHU Nantes - Hôpital Laennec; Service de Pneumologie

location_facility: Seoul National University Bundang Hospital

location_facility: Ninewells Hospital; Asthma and Allergy Research Group

location_facility: Municipal Institution of Health Care "Yevpatoriya City Hospital №1

location_facility: Regional Phthisiology and Pulmonology Center

location_facility: SI Dept. Clin. Hospital of Zaporizhzhia-2 Railway Station of SE Prydniprovska Zaliznytsia

location_facility: Pharmaceutical Research & Consulting, Inc.

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne ProMiMed sp z o.o. sp.k.

location_facility: Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny

location_facility: Atatürk Göğüs Hastalıkları ve Göğüs Cerrahisi Eğitim ve Araştırma Hastanesi

location_facility: Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Victor Babes Craiova

location_facility: Allergy & Asthma Research Center of El Paso

location_facility: Centre d'investigation Clinique Mauricie

location_facility: Castle Hill Hospital; Respiratory Medicine

location_facility: The Lung Institute of Western Australia; Sir Charles Gairdner Hospital

location_facility: Allergy & Asthma Medical Group & Research Center, Pc

location_facility: Prof.Dr.Octavian Fodor Emergency Clinical Hospital

location_facility: Clinical Research Inst. of Southern Oregon, Pc

location_facility: Uludag University; Pulmonology and Allergy Department

location_facility: Investigaciones en Patologias Respiratorias

location_facility: Russian Uni of People'S Friendship, Med. Faculty; City Clinical Hospital No 64, Internal Diseases

location_facility: Novosibirsk Municipal Clinical Hospital For Emergency Medicine #2

location_facility: St-Petersburg Diagnostic Ctr#1; Pulmonology

location_facility: Specjalistyczne Centrum Medyczne NOWOMED

location_facility: Clinical Hospital Center ''Bezanijska Kosa''; Department of Pulmology

location_facility: Kirikkale Universitesi Tip Fakultesi Hastanesi

location_facility: Central Outpatient Hospital of Desnyansky District


location_country:
Italy
United Kingdom
France
Czechia
Israel
Romania
Belgium
Australia
Spain
United States
Latvia
Korea, Republic of
Taiwan

location_facility: Hosp. Regional Univ. de Malaga - Hospital Materno Infantil; Hospital Materno Infantil de Malaga

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

location_facility: Organización Sanitaria Integrada Bilbao Basurto

location_facility: Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer

location_facility: St John of God Murdoch Hospital; Oncology West

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology

location_facility: Azienda Ospedaliero Universitaria Seconda Università Degli Studi Di Napoli

location_facility: National Cancer Center; Medical Oncology

location_facility: Centro Di Riferimento Oncologico; SOC Oncologia Medica C

location_facility: Yonsei University Health System/Severance Hospital

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Hospital Universitario Infanta Cristina; Servicio de Oncologia

location_facility: Nottingham University Hospitals City Campus

location_facility: Riga East Clinical University Hospital Latvian Oncology Centre

location_facility: Prof. Dr. I. Chiricuta Institute of Oncology

location_facility: A.O.U Policlinico S. Orsola Malpighi di Bologna U.O di Medicina Interna Borghi - Pad.2

location_facility: Fundacion Jimenez Diaz; Servicio de Oncologia

location_facility: Mercy Hospital, a Campus of Plantation General Hospital

location_facility: Hospital Clinico San Carlos; Servicio de Nefrologia

location_facility: Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque

location_facility: Peter MacCallum Cancer Centre; Medical Oncology

title: A Multistage, Phase II Study Evaluating the Safety and Efficacy of Cobimetinib Plus Paclitaxel, Cobimetinib Plus Atezolizumab Plus Paclitaxel, or Cobimetinib Plus Atezolizumab Plus Nab-Paclitaxel as First-Line Treatment for Patients With Metastatic Triple-Negative Breast Cancer

summary: This three-cohort, multi-stage, randomized, Phase II, multicenter trial will evaluate the safety and tolerability and estimate the efficacy of cobimetinib plus paclitaxel versus placebo plus paclitaxel in Cohort I, of cobimetinib plus atezolizumab plus paclitaxel in Cohort II, and of cobimetinib plus atezolizumab plus nab-paclitaxel in Cohort III in participants with metastatic or locally advanced, triple-negative adenocarcinoma of the breast who have not received prior systemic therapy for metastatic breast cancer (MBC). Participants may continue on study treatment until the development of progressive disease (PD) or the loss of clinical benefit, unacceptable toxicity, and/or consent withdrawal. The Cohort I target sample size is 12 participants for the safety run-in stage and approximately 90 participants in the expansion stage. Each of Cohorts II and III will consist of a safety run-in stage of approximately 15 participants followed by an expansion stage of approximately 15 participants.


title: A STUDY OF NERATINIB PLUS CAPECITABINE VERSUS LAPATINIB PLUS CAPECITABINE IN PATIENTS WITH HER2+ METASTATIC BREAST CANCER WHO HAVE RECEIVED TWO OR MORE PRIOR HER2-DIRECTED REGIMENS IN THE METASTATIC SETTING (NALA)

acronym: NALA

summary: This is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of neratinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2+ MBC patients who have received two or more prior HER2 directed regimens in the metastatic setting.

ReferenceCitation: Dai MS, Feng YH, Chen SW, Masuda N, Yau T, Chen ST, Lu YS, Yap YS, Ang PCS, Chu SC, Kwong A, Lee KS, Ow S, Kim SB, Lin J, Chung HC, Ngan R, Kok VC, Rau KM, Sangai T, Ng TY, Tseng LM, Bryce R, Bebchuk J, Chen MC, Hou MF. Analysis of the pan-Asian subgroup of patients in the NALA Trial: a randomized phase III NALA Trial comparing neratinib+capecitabine (N+C) vs lapatinib+capecitabine (L+C) in patients with HER2+metastatic breast cancer (mBC) previously treated with two or more HER2-directed regimens. Breast Cancer Res Treat. 2021 Oct;189(3):665-676. doi: 10.1007/s10549-021-06313-5. Epub 2021 Sep 23.

family: Dai

full_name: Ming Shen Dai

given: Ming Shen

family: Feng

full_name: Yin Hsun Feng

given: Yin Hsun

full_name: Shang Wen Chen

given: Shang Wen

family: Masuda

full_name: Norikazu Masuda

given: Norikazu

family: Yau

full_name: Thomas Yau

given: Thomas

full_name: Shou Tung Chen

given: Shou Tung

family: Lu

full_name: Yen Shen Lu

given: Yen Shen

family: Yap

full_name: Yoon Sim Yap

given: Yoon Sim

family: Ang

full_name: Peter C. S. Ang

given: Peter C. S.

family: Chu

full_name: Sung Chao Chu

given: Sung Chao

family: Kwong

full_name: Ava Kwong

given: Ava

family: Lee

full_name: Keun Seok Lee

given: Keun Seok

family: Ow

full_name: Samuel Ow

given: Samuel

family: Kim

full_name: Sung Bae Kim

given: Sung Bae

family: Lin

full_name: Johnson Lin

given: Johnson

family: Chung

full_name: Hyun Cheol Chung

given: Hyun Cheol

family: Ngan

full_name: Roger Ngan

given: Roger

family: Kok

full_name: Victor C. Kok

given: Victor C.

family: Rau

full_name: Kun Ming Rau

given: Kun Ming

family: Sangai

full_name: Takafumi Sangai

given: Takafumi

family: Ng

full_name: Ting Ying Ng

given: Ting Ying

family: Tseng

full_name: Ling Ming Tseng

given: Ling Ming

family: Bryce

ReferenceCitation: Saura C, Oliveira M, Feng YH, Dai MS, Chen SW, Hurvitz SA, Kim SB, Moy B, Delaloge S, Gradishar W, Masuda N, Palacova M, Trudeau ME, Mattson J, Yap YS, Hou MF, De Laurentiis M, Yeh YM, Chang HT, Yau T, Wildiers H, Haley B, Fagnani D, Lu YS, Crown J, Lin J, Takahashi M, Takano T, Yamaguchi M, Fujii T, Yao B, Bebchuk J, Keyvanjah K, Bryce R, Brufsky A; NALA Investigators. Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in HER2-Positive Metastatic Breast Cancer Previously Treated With ≥ 2 HER2-Directed Regimens: Phase III NALA Trial. J Clin Oncol. 2020 Sep 20;38(27):3138-3149. doi: 10.1200/JCO.20.00147. Epub 2020 Jul 17.

name: Vall d’Hebron University Hospital, Vall d’Hebron Institute of Oncology (VHIO), SOLTI Breast Cancer Cooperative Group, Barcelona, Spain

name: Chi Mei Medical Centre, Liouying, Tainan, Taiwan and Tri-Service General Hospital, Taipei, Taiwan

name: University of California Los Angeles/Jonsson Comprehensive Cancer Center, Los Angeles, CA

name: University of Ulsan College of Medicine, Seoul, Republic of Korea

name: Massachusetts General Hospital Cancer Center, Boston, MA

name: Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL

name: National Hospital Organization, Osaka National Hospital, Osaka, Japan

name: Masaryk Memorial Cancer Institute, Brno, Czech Republic

name: Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

name: Helsinki University Hospital Comprehensive Cancer Center, Helsinki, Finland

name: National Cancer Centre Singapore, Singapore

name: Kaohsiung Medical University Hospital, Kaohsiung, Taiwan

name: National Cancer Institute Fondazione Pascale, Napoli, Italy

name: National Cheng Kung University, Tainan, Taiwan

name: Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan

name: Li Ka Shing Faculty of Medicine, University of Hong Kong, Hong Kong

name: University Hospitals Leuven, Leuven, Belgium

name: Department of Oncology, KU Leuven, Leuven, Belgium

name: UT Southwestern Medical Center, Dallas, TX

name: National Taiwan University Hospital, Taipei City, Taiwan

name: St Vincent’s University Hospital, Dublin, Ireland

name: MacKay Memorial Hospital, Taipei, Taiwan

name: National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan

name: Department of Breast Surgery, JCHO Kurume General Hospital, Kurume, Japan

name: Graduate School of Medicine, Gunma University, Gunma, Japan

name: Magee-Womens Hospital of UPMC, Pittsburgh, PA

repository_institution: University of California - eScholarship University of California

repository_normalized: California Digital Library - eScholarship

repositories: California Digital Library - eScholarship

publisher_dissemination: American Society of Clinical Oncology (ASCO)

publisher_group: American Society of Clinical Oncology (ASCO)

publisher_normalized: American Society of Clinical Oncology (ASCO)

ipd_sharing_description:
Puma Biotechnology is committed to sharing clinical trial data and information to help physicians and patients make informed treatment decisions, and to help qualified researchers advance scientific knowledge.

In accordance with legal and regulatory requirements, Puma publishes study protocol information and clinical study results on clinical trial registries, including ClinicalTrials.gov and EU Clinical Trials Register. Puma also publishes information about clinical studies in peer-reviewed scientific journals and shares data in scientific meetings.

Puma commits to safeguarding confidentiality and patient privacy throughout the clinical trial data and information sharing process. Any patient-level data will be anonymized to protect personally identifiable information.

Qualified researchers and study participants may submit requests for other study documentation and clinical trial data to clinicaltrials@pumabiotechnology.com for consideration.

location_country:
Finland
Australia
Belgium
Russian Federation
Denmark
Taiwan
France
Japan
Argentina
Canada
Korea, Republic of
Sweden
Hong Kong
Netherlands
Switzerland
Singapore
Ireland
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Czechia
Israel
Spain
Turkey

location_facility: National Cancer Institute - IRCCS "Fondazione G. Pascale"

location_facility: Hospital de Cancer de Barretos - Hospital

location_facility: University of California San Diego Moores Cancer Center

location_facility: Maastricht University Medical Centre (MUMC)

location_facility: Gustave Roussy Oncology Institute, Department of Medicine

location_facility: Hospital Clinico Universitario de Valencia, Servicio de Oncologia

location_facility: CBCC Global Research, Inc. at Comprehensive Blood and Caner Center

location_facility: IRCCS - Hospital San Raffaele, Department of Medical Oncology

location_facility: Nottingham City Hospital Campus, Department of Oncology

location_facility: Otto von Guericke University of Magdeburg

location_facility: University of Texas Southwestern Medical Center at Dallas

location_facility: Maroondah Hospital, Maroondah Breast Clinic

location_facility: Hospital Araújo Jorge, Associação de Combate ao Câncer em Goiás

location_facility: Hakuaikai Medical Corporation Sagara Hospital

location_facility: Cancer Care Associates Medical Group, Inc

location_facility: Hospital Clinico Universitario Lozano Blesa, Servicio de Oncologia

location_facility: Queen Mary Hospital, Department of Surgery

location_facility: Hospital Infermi Rimini, Unit of Oncology

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

location_facility: Instituto de Pesquisas Clinicas para Estudos Multicentricos Hospital Geral de Caxias do Sul, Universidade de Caxias do Sul (IPCEM)

location_facility: Hospital Cervesi di Cattolica, Department of Oncology

location_facility: University Hospital Virgen del Rocio, Servicio de Oncologia

location_facility: Abbotsford Regional Hospital and Cancer Care Centre

location_facility: University of California San Diego Medical Center

location_facility: Chi Mei Medical Center - LiouYing Branch

location_facility: South Lyon Hospital Center, Department of Clinical Hematology and Medical Oncology

location_facility: University Hospital Cologne, Breast Center, Clinic of Obstetrics and Gynecology

location_facility: Queen Mary Hospital, Department of Oncology

location_facility: Cancer Center of Santa Barbara Sansum Clinic

location_facility: University Hospital Quiron Madrid, Department of Oncology

location_facility: Complejo Hospitalario Universitario Insular-Materno Infantil

location_facility: North Shore Oncology-Hematology Associates, Ltd.

location_facility: Centre hospitalier affilié universitaire de Québec - Hôpital du Saint-Sacrement

location_facility: University Hospital Innsbruck - Tyrolean Hospital, Department of Gynecology

location_facility: Gleneagles Medical Centre, Center for Medical Oncology

location_facility: Hospital Do Cancer A C Camargo - Hospital

location_facility: Hospital Desio and Vimercate, Department of Medical Oncology

location_facility: Instituto Brasileiro de Controle Do Câncer IBCC

location_facility: Sidney Kimmel Comprehensive Cancer Center at John Hopkins at Greenspring Station

location_facility: Federal State Government-Financed Institution: City Clinical Hospital #40

location_facility: National Hospital Organization Osaka National Hospital

location_facility: Queen Mary Hospital, Department of Clinical Oncology

location_facility: Clinic Sainte Anne, Center for Radiotherapy

location_facility: Centro de Investigação Clinica, Hospital da Luz

location_facility: University Hospitals Case Medical Center

location_facility: Scientific Institute of Romagna of the Study and Treatment of Cancer

location_facility: Calderdale Royal Hospital, Macmillan Unit

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital

location_facility: Sourasky Medical Center, Department of Oncology

location_facility: The Cancer Institute at University of Maryland St. Joseph Medical Center

location_facility: University Hospital Motol, Comprehensive Oncology Center

location_facility: Orebro University Hospital, Department of Oncology

location_facility: Kaplan Medical Center, Department of Oncology

location_facility: North Shore Hematology Oncology Association PC

location_facility: Russian Oncological Research Center n.a. N.N. Blokhin Russian Academy of Medical Sciences

location_facility: Helsinki University Central Hospital, Department of Oncology

location_facility: AZ Damiaan General Hospital, Sint-Jozef Oncology Center

location_facility: Instituto Joinvillense de Hematologia e Oncologia

location_facility: Compassionate Cancer Care Medical Group Inc.

location_facility: Institut Jules Bordet - Medical Oncology

location_facility: University Hospital Clinic San Carlos, Servicio de Oncologia Medica

location_facility: Emory University Winship Cancer Institute

location_facility: University of California San Diego Medical Center - Hillcrest

location_facility: Hospital Sacro Cuore Don Calabria, Department of Medical Oncology

location_facility: Liga Paranaense de Combate ao Cancer, Hospital Erasto Gaertner

location_facility: Taichung Veterans General Hospital, Breast Center

location_facility: COIBA Centro de Oncología e Investigación Buenos Aires

location_facility: Kobe City Medical Center General Hospital

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Icon Singapore Oncology Consultants Farrer Park Medical Clinic

location_facility: Hospital Universitario Virgen de la Arrixaca, Servicio de Oncologia

location_facility: Hospital Papa Giovanni XXIII, Department of Medical Oncology

location_facility: Instituto Ribeiraopretano de Combate Ao Cancer - Clinic/Outpatient Facility

location_facility: Johns Hopkins Singapore International Medical Center

location_facility: Institute of Cancer Research and Treatment

location_facility: Consorcio Hospitalario Provincial de Castellon

location_facility: Hospital Universitari de Girona Dr. Josep Trueta (ICO Girona), Servicio de Oncologia

location_facility: University Hospital 12 de Octubre, Servicio de Oncologia - Edificio Maternidad, 2ª planta

location_facility: Uppsala University Hospital, Department of Oncology

location_facility: National Cancer Centre Singapore, Department of Medical Oncology

location_facility: University Hospitals Cleveland Medical Center

location_facility: Sunnybrook Health Sciences Center, Odette Cancer Center

location_facility: Ensino E Terapia de Inovação Clínica Assistência Multidiciplinar Em Oncologia Ética

location_facility: Queen Elizabeth Hospital, Department of Clinical Oncology

location_facility: Hospital Son Llatzer, Servicio de Oncologia

location_facility: University of Texas Southwestern Medical Center

location_facility: Instituto Portugues de Oncologia de Lisboa Francisco Gentil, EPE

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


title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Assess the Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis

summary: This study is designed to assess the efficacy and safety of etelcalcetide compared with placebo in the treatment of SHPT in patients with chronic kidney disease (CKD) receiving hemodialysis.

ReferenceType: background

ReferenceCitation: Block GA, Bushinsky DA, Cunningham J, Drueke TB, Ketteler M, Kewalramani R, Martin KJ, Mix TC, Moe SM, Patel UD, Silver J, Spiegel DM, Sterling L, Walsh L, Chertow GM. Effect of Etelcalcetide vs Placebo on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism: Two Randomized Clinical Trials. JAMA. 2017 Jan 10;317(2):146-155. doi: 10.1001/jama.2016.19456.

ReferenceCitation: Kroenke MA, Weeraratne DK, Deng H, Sloey B, Subramanian R, Wu B, Serenko M, Hock MB. Clinical immunogenicity of the d-amino acid peptide therapeutic etelcalcetide: Method development challenges and anti-drug antibody clinical impact assessments. J Immunol Methods. 2017 Jun;445:37-44. doi: 10.1016/j.jim.2017.03.005. Epub 2017 Mar 6.

ReferenceCitation: Stollenwerk B, Iannazzo S, Akehurst R, Adena M, Briggs A, Dehmel B, Parfrey P, Belozeroff V. A Decision-Analytic Model to Assess the Cost-Effectiveness of Etelcalcetide vs. Cinacalcet. Pharmacoeconomics. 2018 May;36(5):603-612. doi: 10.1007/s40273-017-0605-2.

ReferenceCitation: Stollenwerk B, Iannazzo S, Cooper K, Belozeroff V. Exploring the potential value of improved care for secondary hyperparathyroidism with a novel calcimimetic therapy. J Med Econ. 2017 Oct;20(10):1110-1115. doi: 10.1080/13696998.2017.1360309. Epub 2017 Aug 14.

ReferenceCitation: Chen P, Narayanan A, Wu B, Gisleskog PO, Gibbs JP, Chow AT, Melhem M. Population Pharmacokinetic and Pharmacodynamic Modeling of Etelcalcetide in Patients with Chronic Kidney Disease and Secondary Hyperparathyroidism Receiving Hemodialysis. Clin Pharmacokinet. 2018 Jan;57(1):71-85. doi: 10.1007/s40262-017-0550-4.

ReferenceCitation: Block GA, Chertow GM, Sullivan JT, Deng H, Mather O, Tomlin H, Serenko M. An integrated analysis of safety and tolerability of etelcalcetide in patients receiving hemodialysis with secondary hyperparathyroidism. PLoS One. 2019 Mar 15;14(3):e0213774. doi: 10.1371/journal.pone.0213774. eCollection 2019.

ReferenceCitation: Cunningham J, Block GA, Chertow GM, Cooper K, Evenepoel P, Iles J, Sun Y, Ureña-Torres P, Bushinsky DA. Etelcalcetide Is Effective at All Levels of Severity of Secondary Hyperparathyroidism in Hemodialysis Patients. Kidney Int Rep. 2019 Apr 16;4(7):987-994. doi: 10.1016/j.ekir.2019.04.010. eCollection 2019 Jul.

ReferenceCitation: Wolf M, Block GA, Chertow GM, Cooper K, Fouqueray B, Moe SM, Sun Y, Tomlin H, Vervloet M, Oberbauer R. Effects of etelcalcetide on fibroblast growth factor 23 in patients with secondary hyperparathyroidism receiving hemodialysis. Clin Kidney J. 2019 Apr 26;13(1):75-84. doi: 10.1093/ckj/sfz034. eCollection 2020 Feb.

ReferenceCitation: Hain D, Tomlin H, Gibson C. Administration of Etelcalcetide for the Treatment of Secondary Hyperparathyroidism in Patients with CKD-MBD on Hemodialysis: A Nephrology Nursing Perspective. Nephrol Nurs J. 2019 May-Jun;46(3):315-290.

lead_sponsor: Amgen

location_country:
Italy
Austria
United States
Germany
France
Czechia
Poland
Israel
Hungary
Australia
Belgium
Russian Federation
Spain
Canada
United Kingdom


title: An Adaptive Phase II Study to Evaluate the Efficacy, Pharmacodynamics, Safety and Tolerability of GSK2586184 in Patients With Mild to Moderate Systemic Lupus Erythematosus

summary:
This is an adaptive, dose ranging, Phase II study to investigate the relationship between repeat doses of GSK2586184 and the pharmacodynamic effect and clinical efficacy in patients with active systemic lupus erythematosus (SLE). This study will also investigate the safety and tolerability of repeat doses of GSK2586184. During the study, up to 3 Interim Analyses will be conducted. These are to monitor the pharmacodynamic effect and safety following 2 weeks of therapy (Interim Analysis 1); and the clinical efficacy and safety of GSK2586184 following 12 weeks of therapy (Interim Analyses 2 and 3). Subjects who meet the entry criteria (approximately 150 to 250) will be randomized in a 1:1:1:1:1 ratio to receive GSK2586184 at doses of 50 milligram (mg) twice daily (b.i.d), 100 mg b.i.d, 200 mg b.i.d, 400 mg b.i.d or Placebo b.i.d. GSK2586184 tablets available in 50 and 200 mg dose strength will be administered orally up to 12 weeks.

Subjects who complete the study will participate in the study for approximately 21 weeks.

ReferenceCitation: Kahl L, Patel J, Layton M, Binks M, Hicks K, Leon G, Hachulla E, Machado D, Staumont-Sallé D, Dickson M, Condreay L, Schifano L, Zamuner S, van Vollenhoven RF; JAK115919 Study Team. Safety, tolerability, efficacy and pharmacodynamics of the selective JAK1 inhibitor GSK2586184 in patients with systemic lupus erythematosus. Lupus. 2016 Nov;25(13):1420-1430. doi: 10.1177/0961203316640910. Epub 2016 Jul 11.

name: Clinical Development in Infectious Diseases, GSK, Uxbridge, UK

family: Kahl

full_name: L Kahl

given: L

name: Immuno-Inflammation Therapeutic Area Unit, GSK, Stevenage, UK

family: Patel

full_name: J Patel

given: J

family: Layton

full_name: M Layton

given: M

name: Worldwide Research and Development, Pfizer Inc., Cambridge, MA, USA

family: Binks

full_name: M Binks

name: Clinical Statistics Medicines Research Centre, GSK, Stevenage, UK

family: Hicks

full_name: K Hicks

given: K

name: Instituto de Ginecologia y Reproduccion, Lima, Peru

family: Leon

full_name: G Leon

given: G

name: Claude Huriez Hospital, University of Lille, FHU IMMINeNT, Lille, France

family: Hachulla

full_name: E Hachulla

given: E

name: Instituto Centralizado de Asistencia e Investigacion Clinica Integral, CAICI, Rosario, Santa Fe, Argentina

family: Machado

full_name: D Machado

given: D

family: Staumont-Sallé

full_name: D Staumont-Sallé

family: Dickson

full_name: M Dickson

family: Condreay

full_name: L Condreay

family: Schifano

full_name: L Schifano

name: Clinical Pharmacology Modelling and Simulation Department, GSK, Uxbridge, UK

family: Zamuner

full_name: S Zamuner

given: S

name: Unit for Clinical Therapy Research, Inflammatory Diseases (ClinTRID), The Karolinska Institute, Stockholm, Sweden

family: van Vollenhoven

full_name: R F van Vollenhoven

given: R F

journal_name: Lupus

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

ipd_sharing: Yes

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

lead_sponsor: GlaxoSmithKline

location_country:
South Africa
Chile
Peru
Sweden
Hong Kong
France
Czechia
Greece
Poland
Romania
Hungary
Argentina
Spain
Estonia
Germany
Korea, Republic of


type: Other Grant/Funding Number

type: U.S. NIH Grant/Contract

type: Registry Identifier

title: A Phase II/III Randomized, Double-Blind, Placebo-Controlled, Cognitive Endpoint, Multi-Center Study of Potential Disease Modifying Therapies in Individuals at Risk for and With Dominantly Inherited Alzheimer's Disease

acronym: DIAN-TU

summary: The purpose of this study is to assess the safety, tolerability, biomarker and cognitive efficacy of investigational products in subjects who are known to have an Alzheimer's disease-causing mutation by determining if treatment with the study drug slows the rate of progression of cognitive impairment and improves disease-related biomarkers.

ReferenceCitation: Bateman RJ, Xiong C, Benzinger TL, Fagan AM, Goate A, Fox NC, Marcus DS, Cairns NJ, Xie X, Blazey TM, Holtzman DM, Santacruz A, Buckles V, Oliver A, Moulder K, Aisen PS, Ghetti B, Klunk WE, McDade E, Martins RN, Masters CL, Mayeux R, Ringman JM, Rossor MN, Schofield PR, Sperling RA, Salloway S, Morris JC; Dominantly Inherited Alzheimer Network. Clinical and biomarker changes in dominantly inherited Alzheimer's disease. N Engl J Med. 2012 Aug 30;367(9):795-804. doi: 10.1056/NEJMoa1202753. Epub 2012 Jul 11. Erratum in: N Engl J Med. 2012 Aug 23;367(8):780.

ReferenceCitation: Farlow M, Arnold SE, van Dyck CH, Aisen PS, Snider BJ, Porsteinsson AP, Friedrich S, Dean RA, Gonzales C, Sethuraman G, DeMattos RB, Mohs R, Paul SM, Siemers ER. Safety and biomarker effects of solanezumab in patients with Alzheimer's disease. Alzheimers Dement. 2012 Jul;8(4):261-71. doi: 10.1016/j.jalz.2011.09.224. Epub 2012 Jun 5.

ReferenceCitation: Bateman RJ, Benzinger TL, Berry S, Clifford DB, Duggan C, Fagan AM, Fanning K, Farlow MR, Hassenstab J, McDade EM, Mills S, Paumier K, Quintana M, Salloway SP, Santacruz A, Schneider LS, Wang G, Xiong C; DIAN-TU Pharma Consortium for the Dominantly Inherited Alzheimer Network. The DIAN-TU Next Generation Alzheimer's prevention trial: Adaptive design and disease progression model. Alzheimers Dement. 2017 Jan;13(1):8-19. doi: 10.1016/j.jalz.2016.07.005. Epub 2016 Aug 29.

ReferenceCitation: Mills SM, Mallmann J, Santacruz AM, Fuqua A, Carril M, Aisen PS, Althage MC, Belyew S, Benzinger TL, Brooks WS, Buckles VD, Cairns NJ, Clifford D, Danek A, Fagan AM, Farlow M, Fox N, Ghetti B, Goate AM, Heinrichs D, Hornbeck R, Jack C, Jucker M, Klunk WE, Marcus DS, Martins RN, Masters CM, Mayeux R, McDade E, Morris JC, Oliver A, Ringman JM, Rossor MN, Salloway S, Schofield PR, Snider J, Snyder P, Sperling RA, Stewart C, Thomas RG, Xiong C, Bateman RJ. Preclinical trials in autosomal dominant AD: implementation of the DIAN-TU trial. Rev Neurol (Paris). 2013 Oct;169(10):737-43. doi: 10.1016/j.neurol.2013.07.017. Epub 2013 Sep 6. Review.

ReferenceCitation: Wang G, Berry S, Xiong C, Hassenstab J, Quintana M, McDade EM, Delmar P, Vestrucci M, Sethuraman G, Bateman RJ; Dominantly Inherited Alzheimer Network Trials Unit. A novel cognitive disease progression model for clinical trials in autosomal-dominant Alzheimer's disease. Stat Med. 2018 Sep 20;37(21):3047-3055. doi: 10.1002/sim.7811. Epub 2018 May 14.

ReferenceCitation: Weninger S, Carrillo MC, Dunn B, Aisen PS, Bateman RJ, Kotz JD, Langbaum JB, Mills SL, Reiman EM, Sperling R, Santacruz AM, Tariot PN, Welsh-Bohmer KA. Collaboration for Alzheimer's Prevention: Principles to guide data and sample sharing in preclinical Alzheimer's disease trials. Alzheimers Dement. 2016 May;12(5):631-2. doi: 10.1016/j.jalz.2016.04.001.

ReferenceCitation: Grill JD, Bateman RJ, Buckles V, Oliver A, Morris JC, Masters CL, Klunk WE, Ringman JM; Dominantly Inherited Alzheimer's Network. A survey of attitudes toward clinical trials and genetic disclosure in autosomal dominant Alzheimer's disease. Alzheimers Res Ther. 2015 Jul 22;7(1):50. doi: 10.1186/s13195-015-0135-0. eCollection 2015.

ReferenceCitation: McDade E, Bateman RJ. Stop Alzheimer's before it starts. Nature. 2017 Jul 12;547(7662):153-155. doi: 10.1038/547153a.

ReferenceCitation: McDade E, Wang G, Gordon BA, Hassenstab J, Benzinger TLS, Buckles V, Fagan AM, Holtzman DM, Cairns NJ, Goate AM, Marcus DS, Morris JC, Paumier K, Xiong C, Allegri R, Berman SB, Klunk W, Noble J, Ringman J, Ghetti B, Farlow M, Sperling RA, Chhatwal J, Salloway S, Graff-Radford NR, Schofield PR, Masters C, Rossor MN, Fox NC, Levin J, Jucker M, Bateman RJ; Dominantly Inherited Alzheimer Network. Longitudinal cognitive and biomarker changes in dominantly inherited Alzheimer disease. Neurology. 2018 Oct 2;91(14):e1295-e1306. doi: 10.1212/WNL.0000000000006277. Epub 2018 Sep 14.

ReferenceCitation: Ryman DC, Acosta-Baena N, Aisen PS, Bird T, Danek A, Fox NC, Goate A, Frommelt P, Ghetti B, Langbaum JB, Lopera F, Martins R, Masters CL, Mayeux RP, McDade E, Moreno S, Reiman EM, Ringman JM, Salloway S, Schofield PR, Sperling R, Tariot PN, Xiong C, Morris JC, Bateman RJ; Dominantly Inherited Alzheimer Network. Symptom onset in autosomal dominant Alzheimer disease: a systematic review and meta-analysis. Neurology. 2014 Jul 15;83(3):253-60. doi: 10.1212/WNL.0000000000000596. Epub 2014 Jun 13. Review.

ReferenceCitation: Weng H, Bateman R, Morris JC, Xiong C. Validity and power of minimization algorithm in longitudinal analysis of clinical trials. Biostat Epidemiol. 2017;1(1):59-77. doi: 10.1080/24709360.2017.1331822. Epub 2017 Jun 13.

ipd_sharing_description: Access to DIAN-TU trial data will follow the DIAN-TU data access policy, which complies with the guidelines established by the Collaboration for Alzheimer's Prevention [CAP REF].

lead_sponsor: Washington University School of Medicine

location_country:
Italy
Brazil
United States
Mexico
Netherlands
Germany
France
Japan
Ireland
Argentina
Australia
Puerto Rico
Spain
Canada
United Kingdom
Colombia

location_facility: University of California San Diego Medical Center

location_facility: Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

location_facility: The National Hospital for Neurology and Neurosurgery

location_facility: CHU de Quebec - Hôpital de l' Enfant Jésus

location_facility: Hospital das Clínicas da Faculdade de Medicina da USP

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: University of Puerto Rico, School of Medicine

location_facility: Hospital Clínic I Provincial de Barcelona

location_facility: The McCuster Foundation of Alzheimer's Disease Research

location_facility: IRCCS Centro San Giovanni di Dio Fatebenefratelli

location_facility: Grupo de Neurociencias Sede de la Universidad de Antioquia

location_facility: Instituto de Investigaciones Neurologicas Raul Carrea, FLENI

lead_sponsor_type: academique


title: A Pivotal Phase 2b/3, Multicentre, Randomised, Open, Controlled Study on the Efficacy and Safety of Autologous Osteoblastic Cells (PREOB®) Implantation in Non-Infected Hypotrophic Non-Union Fractures

summary:
Fracture healing is a complex physiological process caused by interaction of cellular elements, cytokines and signaling proteins, which results in the formation of new bone (Gerstenfeld et al., 2003). Depending on fracture site, complexity, co-morbidities and other factors, 10% of all fractures will eventually fail to unite.

Non-union fractures are defined as fractures that are at least six to nine months old and in which there have been no signs of healing for the last three months. Various causes have been evoked for impaired healing in hypotrophic (atrophic and oligotrophic) non-unions, including poor fracture stabilization, local infection and failure of the osteoblastic cells to multiply. Currently the treatment of choice for non-unions, particularly atrophic non-unions, is bone autograft (or allograft), combined or not with intramedullary nailing, plating, and external fixation devices (Kanakaris et al., 2007). This procedure produces good results but requires an invasive surgery of several hours under general anesthesia and a few days of hospitalization. Because of this, major complications have been reported in up to 20-30% of patients (Pieske et al., 2009, Zimmerman et al., 2009).

This Phase 2b/3 study aims at demonstrating the safety and efficacy of PREOB®, a proprietary population of autologous osteoblastic cells, in the treatment of hypotrophic non-union fractures of long bones. PREOB® will be compared to Bone Autograft in a non-inferiority design.

lead_sponsor: Bone Therapeutics S.A

location_country: Belgium France Netherlands

location_facility:
Investigating site BE08
Investigating site BE05
Investigating site FR02
Investigating site BE09
Investigating site BE02
Investigating site FR01
Investigating site BE03
Investigating site NL02
Investigating site BE07
Investigating site FR03
Investigating site NL01
Investigating site BE04
Investigating site FR04
Investigating site BE06
Investigating site FR06
Investigating site BE01

intervention_type: Procedure


title: Study NOG112264, a Phase II Study of Ozanezumab (GSK1223249) Versus Placebo in the Treatment of Amyotrophic Lateral Sclerosis

summary: This is a 48-week, randomised, multi-centre, double-blind, placebo-controlled, parallel group investigation of the efficacy and safety of intravenous (IV) ozanezumab (GSK1223249) compared to placebo in subjects with Amyotrophic Lateral Sclerosis (ALS). Following a screening period of up to four weeks, eligible subjects will be randomised (1:1) to receive IV placebo or 15 milligram (mg)/ kilogram (kg) IV ozanezumab every 2 weeks for a period of 48 weeks with a follow-up visit around 14 weeks after the last infusion. A total of approximately 294 eligible subjects will be randomised from approximately 37 centers worldwide. The primary objective is to assess the effect of ozanezumab on the physical function and survival of ALS subjects over a treatment period of 48 weeks. Function will be measured using the ALS Functional Rating Scale - Revised (ALSFRS-R). Secondary objectives include the evaluation of other clinical outcomes associated with ALS (respiratory function, muscle strength, progression free survival and overall survival) in support of the primary objective. Quality of life, safety, tolerability, immunogenicity and pharmacokinetics (ozanezumab and riluzole) will also be assessed.

ReferenceCitation: Meininger V, Genge A, van den Berg LH, Robberecht W, Ludolph A, Chio A, Kim SH, Leigh PN, Kiernan MC, Shefner JM, Desnuelle C, Morrison KE, Petri S, Boswell D, Temple J, Mohindra R, Davies M, Bullman J, Rees P, Lavrov A; NOG112264 Study Group. Safety and efficacy of ozanezumab in patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Neurol. 2017 Mar;16(3):208-216. doi: 10.1016/S1474-4422(16)30399-4. Epub 2017 Jan 28.

family: Meininger

full_name: Vincent Meininger

given: Vincent

family: Genge

full_name: Angela Genge

given: Angela

family: van den Berg

full_name: Leonard H van den Berg

given: Leonard H

family: Robberecht

full_name: Wim Robberecht

given: Wim

family: Ludolph

full_name: Albert Ludolph

given: Albert

family: Chio

full_name: Adriano Chio

given: Adriano

family: Kim

full_name: Seung H Kim

given: Seung H

family: Leigh

full_name: P Nigel Leigh

given: P Nigel

family: Kiernan

full_name: Matthew C Kiernan

given: Matthew C

family: Shefner

full_name: Jeremy M Shefner

given: Jeremy M

family: Desnuelle

full_name: Claude Desnuelle

given: Claude

family: Morrison

full_name: Karen E Morrison

given: Karen E

family: Petri

full_name: Susanne Petri

given: Susanne

family: Boswell

full_name: Diane Boswell

given: Diane

family: Temple

full_name: Jane Temple

given: Jane

family: Mohindra

full_name: Rajat Mohindra

given: Rajat

family: Davies

full_name: Matt Davies

given: Matt

family: Bullman

full_name: Jonathan Bullman

given: Jonathan

family: Rees

full_name: Paul Rees

given: Paul

family: Lavrov

full_name: Arseniy Lavrov

given: Arseniy

family: Abdulla

full_name: Susanne Abdulla

family: Alsop

full_name: Cathy Alsop

given: Cathy

family: Barbieri

full_name: Francesca Barbieri

given: Francesca

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

repository_institution: University of Southampton - ePrints Soton

location_country:
Italy
United States
Netherlands
Germany
France
Japan
Belgium
Australia
Canada
United Kingdom
Korea, Republic of


title: Phase 1b/2, Multicenter, Open-label Trial to Evaluate the Safety and Efficacy of Talimogene Laherparepvec and Ipilimumab Compared to Ipilimumab Alone in Subjects With Unresected, Stage IIIB-IV Melanoma

summary: Phase 1b of the study will evaluate the safety of talimogene laherparepvec in combination with ipilimumab. Phase 2 is a randomized study that will evaluate the safety and efficacy of talimogene laherparepvec in combination with ipilimumab versus ipilumumab alone.

ReferenceCitation: Chesney J, Puzanov I, Collichio F, Singh P, Milhem MM, Glaspy J, Hamid O, Ross M, Friedlander P, Garbe C, Logan TF, Hauschild A, Lebbé C, Chen L, Kim JJ, Gansert J, Andtbacka RHI, Kaufman HL. Randomized, Open-Label Phase II Study Evaluating the Efficacy and Safety of Talimogene Laherparepvec in Combination With Ipilimumab Versus Ipilimumab Alone in Patients With Advanced, Unresectable Melanoma. J Clin Oncol. 2018 Jun 10;36(17):1658-1667. doi: 10.1200/JCO.2017.73.7379. Epub 2017 Oct 5.

ReferenceCitation: Dummer R, Hoeller C, Gruter IP, Michielin O. Combining talimogene laherparepvec with immunotherapies in melanoma and other solid tumors. Cancer Immunol Immunother. 2017 Jun;66(6):683-695. doi: 10.1007/s00262-017-1967-1. Epub 2017 Feb 25. Review.

ReferenceCitation: Puzanov I, Milhem MM, Minor D, Hamid O, Li A, Chen L, Chastain M, Gorski KS, Anderson A, Chou J, Kaufman HL, Andtbacka RH. Talimogene Laherparepvec in Combination With Ipilimumab in Previously Untreated, Unresectable Stage IIIB-IV Melanoma. J Clin Oncol. 2016 Aug 1;34(22):2619-26. doi: 10.1200/JCO.2016.67.1529. Epub 2016 Jun 13.

ReferenceCitation: Chesney J, Puzanov I, Collichio F, Milhem MM, Hauschild A, Chen L, Sharma A, Garbe C, Singh P, Mehnert JM. Patterns of response with talimogene laherparepvec in combination with ipilimumab or ipilimumab alone in metastatic unresectable melanoma. Br J Cancer. 2019 Aug;121(5):417-420. doi: 10.1038/s41416-019-0530-6. Epub 2019 Jul 29.

family: Chesney

full_name: Jason Chesney

given: Jason

family: Puzanov

full_name: Igor Puzanov

given: Igor

family: Collichio

full_name: Frances Collichio

given: Frances

family: Milhem

full_name: Mohammed M. Milhem

given: Mohammed M.

family: Hauschild

full_name: Axel Hauschild

given: Axel

family: Chen

full_name: Lisa Chen

given: Lisa

family: Sharma

full_name: Anjali Sharma

given: Anjali

family: Garbe

full_name: Claus Garbe

given: Claus

family: Singh

full_name: Parminder Singh

given: Parminder

family: Mehnert

full_name: Janice M. Mehnert

given: Janice M.

journal_name: British Journal of Cancer

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

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

location_country:
Germany
United States
France


title: A Randomized, Open-label, Active-controlled Multi-center Study to Assess Safety of Uninterrupted Rivaroxaban vs. Usual Care in Subjects Undergoing Catheter Ablation Therapy for Atrial Fibrillation

acronym: VENTURE-AF

summary: The purpose of this exploratory study is to evaluate the safety of rivaroxaban and uninterrupted vitamin K antagonist (VKA) in adult participants with non-valvular atrial fibrillation (NVAF) who undergo catheter ablation as measured by post-procedure major bleeding events.

ReferenceCitation: Cappato R, Marchlinski FE, Hohnloser SH, Naccarelli GV, Xiang J, Wilber DJ, Ma CS, Hess S, Wells DS, Juang G, Vijgen J, Hügl BJ, Balasubramaniam R, De Chillou C, Davies DW, Fields LE, Natale A; VENTURE-AF Investigators. Uninterrupted rivaroxaban vs. uninterrupted vitamin K antagonists for catheter ablation in non-valvular atrial fibrillation. Eur Heart J. 2015 Jul 21;36(28):1805-11. doi: 10.1093/eurheartj/ehv177. Epub 2015 May 14.

family: Cappato

full_name: Riccardo Cappato

given: Riccardo

family: Marchlinski

full_name: Francis E. Marchlinski

given: Francis E.

family: Hohnloser

full_name: Stefan H. Hohnloser

given: Stefan H.

family: Naccarelli

full_name: Gerald V. Naccarelli

given: Gerald V.

family: Xiang

full_name: Jim Xiang

given: Jim

family: Wilber

full_name: David J. Wilber

given: David J.

family: Ma

full_name: Chang-Sheng Ma

given: Chang-Sheng

family: Hess

full_name: Susanne Hess

given: Susanne

family: Wells

full_name: Darryl S. Wells

given: Darryl S.

family: Juang

full_name: George Juang

given: George

family: Vijgen

full_name: Johan Vijgen

given: Johan

family: Hügl

full_name: Burkhard J. Hügl

given: Burkhard J.

family: Balasubramaniam

full_name: Richard Balasubramaniam

given: Richard

family: De Chillou

full_name: Christian De Chillou

given: Christian

family: Davies

full_name: D. Wyn Davies

given: D. Wyn

family: Fields

full_name: L. Eugene Fields

given: L. Eugene

family: Natale

full_name: Andrea Natale

given: Andrea

journal_name: European Heart Journal

evidence: open (via page says Open Access)

license: implied-oa

license_normalized: implied-oa

location_country:
United States
France
Belgium
Germany
United Kingdom