title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in Hematopoietic Cell Transplant (HCT) Recipients With Respiratory Syncytial Virus (RSV) Infection of the Upper Respiratory Tract

summary: The primary objective of this study is to evaluate the effect of presatovir on respiratory syncytial virus (RSV) viral load in autologous or allogeneic hematopoietic cell transplant (HCT) recipients with an acute RSV upper respiratory tract infection (URTI), the effect of presatovir on development of lower respiratory tract complication, being free of any supplemental oxygen progression to respiratory failure, and pharmacokinetics (PK), safety, and tolerability of presatovir.

ReferenceCitation: Chemaly RF, Dadwal SS, Bergeron A, Ljungman P, Kim YJ, Cheng GS, Pipavath SN, Limaye AP, Blanchard E, Winston DJ, Stiff PJ, Zuckerman T, Lachance S, Rahav G, Small CB, Mullane KM, Patron RL, Lee DG, Hirsch HH, Waghmare A, McKevitt M, Jordan R, Guo Y, German P, Porter DP, Gossage DL, Watkins TR, Marty FM, Chien JW, Boeckh M. A Phase 2, Randomized, Double-blind, Placebo-Controlled Trial of Presatovir for the Treatment of Respiratory Syncytial Virus Upper Respiratory Tract Infection in Hematopoietic-Cell Transplant Recipients. Clin Infect Dis. 2020 Dec 31;71(11):2777-2786. doi: 10.1093/cid/ciz1166.

name: Department of Infectious Diseases, Infection Control and Employee Health, University of Texas MD Anderson Cancer Center, Houston, Texas, USA

family: Chemaly

full_name: Roy F Chemaly

given: Roy F

name: Division of Infectious Disease, City of Hope National Medical Center, Duarte, California, USA

family: Dadwal

full_name: Sanjeet S Dadwal

given: Sanjeet S

name: Service de Pneumologie, Université Paris Diderot, Hôpital Saint Louis, Paris, France

family: Bergeron

full_name: Anne Bergeron

given: Anne

name: Department of Cellular Therapy and Allogeneic Stem Cell Transplantation, Karolinska University Hospital and Karolinska Institutet, Stockholm, Sweden

family: Ljungman

full_name: Per Ljungman

given: Per

name: Department of Pediatrics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea

family: Kim

full_name: Yae-Jean Kim

given: Yae-Jean

name: Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA

name: Department of Allergy and Infectious Diseases, University of Washington School of Medicine, Seattle, Washington, USA

family: Cheng

full_name: Guang-Shing Cheng

given: Guang-Shing

family: Pipavath

full_name: Sudhakar N Pipavath

given: Sudhakar N

family: Limaye

full_name: Ajit P Limaye

given: Ajit P

name: Department of Respiratory Diseases, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France

family: Blanchard

full_name: Elodie Blanchard

given: Elodie

name: Department of Medicine, University of California Los Angeles Ronald Reagan Medical Center, Los Angeles, California, USA

family: Winston

full_name: Drew J Winston

given: Drew J

name: Department of Hematology/Oncology, Loyola University Medical Center, Chicago, Illinois, USA

family: Stiff

full_name: Patrick J Stiff

given: Patrick J

name: Hematology Institute, Rambam Medical Health Care Campus, Haifa, Israel

family: Zuckerman

full_name: Tsila Zuckerman

given: Tsila

name: Hematology-Oncology Department, Hôpital Maisonneuve-Rosemont, Université de Montréal, Montréal, Québec, Canada

family: Lachance

full_name: Silvy Lachance

given: Silvy

name: Infectious Diseases Unit, Chaim Sheba Medical Center, Tel Hashomer and Sackler School of Medicine, Tel-Aviv University, Tel Aviv, Israel

family: Rahav

full_name: Galia Rahav

given: Galia

name: Department of Medicine/Division of Infectious Diseases, Weill Cornell Medicine, New York, New York, USA

family: Small

full_name: Catherine B Small

given: Catherine B

name: Section of Infectious Diseases, University of Chicago Medical Center, Chicago, Illinois, USA

family: Mullane

full_name: Kathleen M Mullane

given: Kathleen M

name: Department of Infectious Diseases, Mayo Clinic Arizona, Phoenix, Arizona, USA

family: Patron

full_name: Roberto L Patron

given: Roberto L

name: Department of Infectious Disease, College of Medicine, The Catholic University of Korea, Seoul, South Korea

family: Lee

full_name: Dong-Gun Lee

given: Dong-Gun

name: Department of Biomedicine, University Hospital Basel, Basel, Switzerland

family: Hirsch

full_name: Hans H Hirsch

given: Hans H

family: Waghmare

full_name: Alpana Waghmare

given: Alpana

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

family: McKevitt

full_name: Matt McKevitt

given: Matt

family: Jordan

full_name: Robert Jordan

given: Robert

family: Guo

full_name: Ying Guo

given: Ying

name: Department of Infectious Disease, Dana-Farber Cancer Institute and Brigham and Women’s Hospital, Boston, Massachusetts, USA

location_country:
Brazil
United States
Sweden
Switzerland
Netherlands
Germany
France
Israel
Singapore
Australia
Spain
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: Fundação Antonio Prudente - Hospital do Câncer AC Camargo

location_facility: Institut Universitaire du Cancer Oncopole

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Chang Gung Medical Foundation-LinKou Branch

location_facility: Fundacao Faculdade Regional Medicina de Sao Jose do Rio Preto

location_facility: Instituto Brasileiro de Controle do Câncer-IBCC

location_facility: New York Presbyterian Hospital Cornell Medical Center

location_facility: University of Massachusetts Memorial Cancer Center


title: Interventional, Prospective, Multicenter, Randomized, Parallel-arm Study to Compare the Effectiveness of Peripheral Nerve Stimulation (PNS) Utilizing a Subcutaneous Lead Implant Technique (SQS) Plus Optimized Medical Management (OMM) Versus OMM Alone in Patients Suffering From Back Pain Due to Failed Back Surgery Syndrome (FBSS)

summary: The purpose of this study is to compare the effectiveness of peripheral nerve stimulation utilizing a subcutaneous lead implant technique (SQS) plus optimized medical management (OMM) versus OMM alone in patients suffering from back pain due to Failed Back Surgery Syndrome (FBSS).

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Eldabe S, Kern M, Peul W, Green C, Winterfeldt K, Taylor RS. Assessing the effectiveness and cost effectiveness of subcutaneous nerve stimulation in patients with predominant back pain due to failed back surgery syndrome (SubQStim study): study protocol for a multicenter randomized controlled trial. Trials. 2013 Jun 25;14:189. doi: 10.1186/1745-6215-14-189.

family: Eldabe

full_name: Sam Eldabe

given: Sam

sequence: first

family: Kern

full_name: Michael Kern

given: Michael

sequence: additional

family: Peul

full_name: Wilco Peul

given: Wilco

family: Green

full_name: Colin Green

given: Colin

family: Winterfeldt

full_name: Kristi Winterfeldt

given: Kristi

family: Taylor

full_name: Rod S Taylor

given: Rod S

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Trials

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_institution: The University of Glasgow - Enlighten: Publications

version: acceptedVersion

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

lead_sponsor: MedtronicNeuro

location_country:
Austria
Switzerland
Netherlands
France
Israel
Australia
Belgium
Spain
Germany
United Kingdom

location_facility: Clinique Mutualiste de la porte de l'Orient

location_facility: Märkische Kliniken GmbH / Marienhospital Letmathe

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Unknown


ReferenceCitation: Chitnis T, Banwell B, Kappos L, Arnold DL, Gücüyener K, Deiva K, Skripchenko N, Cui LY, Saubadu S, Hu W, Benamor M, Le-Halpere A, Truffinet P, Tardieu M; TERIKIDS Investigators. Safety and efficacy of teriflunomide in paediatric multiple sclerosis (TERIKIDS): a multicentre, double-blind, phase 3, randomised, placebo-controlled trial. Lancet Neurol. 2021 Dec;20(12):1001-1011. doi: 10.1016/S1474-4422(21)00364-1.

family: Chitnis

full_name: Tanuja Chitnis

given: Tanuja

family: Banwell

full_name: Brenda Banwell

given: Brenda

family: Kappos

full_name: Ludwig Kappos

given: Ludwig

family: Arnold

full_name: Douglas L Arnold

given: Douglas L

family: Gücüyener

full_name: Kivilcim Gücüyener

given: Kivilcim

family: Deiva

full_name: Kumaran Deiva

given: Kumaran

family: Skripchenko

full_name: Natalia Skripchenko

given: Natalia

family: Cui

full_name: Li-Ying Cui

given: Li-Ying

family: Saubadu

full_name: Stephane Saubadu

given: Stephane

family: Hu

full_name: Wenruo Hu

given: Wenruo

family: Benamor

full_name: Myriam Benamor

given: Myriam

family: Le-Halpere

full_name: Annaig Le-Halpere

given: Annaig

family: Truffinet

full_name: Philippe Truffinet

given: Philippe

family: Tardieu

full_name: Marc Tardieu

given: Marc

family: Dubois

full_name: Benedicte Dubois

given: Benedicte

family: Verhelst

full_name: Helene Verhelst

given: Helene

family: Bojinova-Tchamova

full_name: Veneta Bojinova-Tchamova

given: Veneta

family: Mah

full_name: Jean Mah

given: Jean

family: Fang

full_name: Fang Fang

given: Fang

family: Hao

full_name: Yunpeng Hao

given: Yunpeng

family: Jiang

full_name: Li Jiang

given: Li

family: Li

full_name: Ling Li

given: Ling

family: Mao

full_name: Ding'An Mao

given: Ding'An

family: Qiu

full_name: Wei Qiu

given: Wei

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

location_country:
Greece
Belgium
Russian Federation
Ukraine
Morocco
France
Lithuania
Canada
Turkey
Netherlands
Bulgaria
China
Portugal
United States
United Kingdom
Serbia
Lebanon
Israel
Tunisia
Spain
Estonia

location_facility:
Investigational Site Number :376001
Investigational Site Number :620001
Investigational Site Number :504005
Investigational Site Number :724002
Investigational Site Number :100001
Investigational Site Number :792006
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Investigational Site Number :056001
Investigational Site Number :300001
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Investigational Site Number :804002
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Investigational Site Number :840012
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Investigational Site Number :643004
Investigational Site Number :826003
Investigational Site Number :643005
Investigational Site Number :792008
Investigational Site Number :156002
Investigational Site Number :156005
Investigational Site Number :156009
Investigational Site Number :528001
Investigational Site Number :300002
Investigational Site Number :792007
Investigational Site Number :804001
Investigational Site Number :643001
Investigational Site Number :840003
Investigational Site Number :156006
Investigational Site Number :788001
Investigational Site Number :840002
Investigational Site Number :792002
Investigational Site Number :250001
Investigational Site Number :792003
Investigational Site Number :788004
Investigational Site Number :504004
Investigational Site Number :156010
Investigational Site Number :156012
Investigational Site Number :643002
Investigational Site Number :250003
Investigational Site Number :156007
Investigational Site Number :056002
Investigational Site Number :788002
Investigational Site Number :250002
Investigational Site Number :156011
Investigational Site Number :376003
Investigational Site Number :156003
Investigational Site Number :840004
Investigational Site Number :422001
Investigational Site Number :643003
Investigational Site Number :124001
Investigational Site Number :233001
Investigational Site Number :688002
Investigational Site Number :826001
Investigational Site Number :156001
Investigational Site Number :156004

title: A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients With Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension

summary:
Primary Objective:

To assess the effect of teriflunomide in comparison to placebo on disease activity measured by time to first clinical relapse after randomization in children and adolescents 10 to 17 years of age with relapsing forms of multiple sclerosis (MS).

Secondary Objective:

To assess the effect of teriflunomide in comparison to placebo on disease activity/progression measured by brain magnetic resonance imaging (MRI) and on cognitive function.
To evaluate the safety and tolerability of teriflunomide in comparison to placebo.
To evaluate the pharmacokinetics (PK) of teriflunomide.


ReferenceCitation: Cortés J, Diéras V, Lorenzen S, Montemurro F, Riera-Knorrenschild J, Thuss-Patience P, Allegrini G, De Laurentiis M, Lohrisch C, Oravcová E, Perez-Garcia JM, Ricci F, Sakaeva D, Serpanchy R, Šufliarský J, Vidal M, Irahara N, Wohlfarth C, Aout M, Gelmon K. Efficacy and Safety of Trastuzumab Emtansine Plus Capecitabine vs Trastuzumab Emtansine Alone in Patients With Previously Treated ERBB2 (HER2)-Positive Metastatic Breast Cancer: A Phase 1 and Randomized Phase 2 Trial. JAMA Oncol. 2020 Aug 1;6(8):1203-1209. doi: 10.1001/jamaoncol.2020.1796.

name: Quirónsalud Group, IOB Institute of Oncology, Madrid, Spain

name: Quirónsalud Group, IOB Institute of Oncology, Barcelona, Spain

name: Vall d’Hebron Institute of Oncology, Barcelona, Spain

family: Cortés

full_name: Javier Cortés

given: Javier

family: Diéras

full_name: Véronique Diéras

given: Véronique

name: Hematology/Medical Oncology, 3rd Department of Internal Medicine, Klinikum rechts der Isar, Technische Universität München, Munich, Germany

family: Lorenzen

full_name: Sylvie Lorenzen

given: Sylvie

name: Multidisciplinary Oncology Outpatient Clinic, Candiolo Cancer Institute, FPO-IRCCS, Candiolo, Italy

family: Montemurro

full_name: Filippo Montemurro

given: Filippo

name: Klinik für Hämatologie, Onkologie und Immunologie, Universitätsklinikum Gießen und Marburg, Standort Marburg, Philipps-Universität Marburg, Baldingerstraße, Marburg, Germany

family: Riera-Knorrenschild

full_name: Jorge Riera-Knorrenschild

given: Jorge

name: Department of Haematology, Oncology and Tumorimmunology, Campus Virchow-Klinikum, Charité–University Medicine Berlin, Berlin, Germany

family: Thuss-Patience

full_name: Peter Thuss-Patience

given: Peter

name: Division of Medical Oncology, Department of Oncology, Pontedera Hospital, Azienda L Toscana Nord Ovest, Pisa, Italy

family: Allegrini

full_name: Giacomo Allegrini

given: Giacomo

name: Division of Breast Medical Oncology, Istituto Nazionale Tumori IRCCS “Fondazione G. Pascale”, Napoli, Italy

family: De Laurentiis

full_name: Michelino De Laurentiis

given: Michelino

name: BC Cancer, Vancouver Cancer Centre, Vancouver, British Columbia, Canada

family: Lohrisch

full_name: Caroline Lohrisch

given: Caroline

name: 2nd Department of Oncology, Faculty of Medicine, Comenius University, Bratislava, Slovak Republic

family: Oravcová

full_name: Eva Oravcová

given: Eva

family: Perez-Garcia

full_name: Jose M. Perez-Garcia

given: Jose M.

family: Ricci

full_name: Francesco Ricci

given: Francesco

name: Department of Chemotherapy, Republican Clinical Oncology Center, Ufa, Russia

family: Sakaeva

full_name: Dina Sakaeva

given: Dina

family: Serpanchy

full_name: Rosanne Serpanchy

given: Rosanne

name: National Cancer Institute, Bratislava, Slovak Republic

family: Šufliarský

full_name: Jozef Šufliarský

given: Jozef

name: Translational Genomics and Targeted Therapeutics in Solid Tumors Group, IDIBAPS, Barcelona, Spain

family: Vidal

full_name: Maria Vidal

given: Maria

name: F. Hoffmann-La Roche Ltd, Basel, Switzerland

family: Irahara

full_name: Natsumi Irahara

given: Natsumi

family: Wohlfarth

full_name: Christine Wohlfarth

given: Christine

family: Aout

full_name: Mounir Aout

given: Mounir

name: University of British Columbia, Vancouver, British Columbia, Canada

family: Gelmon

full_name: Karen Gelmon

given: Karen

journal_name: JAMA Oncology

oa_colors: green hybrid

evidence: open (via free pdf)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

location_country:
Italy
Brazil
Serbia
Spain
Germany
France
Greece
Slovakia
Argentina
Russian Federation
Portugal
Canada

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Blokhin Cancer Research Center; Combined Treatment

location_facility: Faculdade de Medicina de Sao Jose do Rio Preto - FAMERP*X*

location_facility: Fakultna nemocnica Trencín; Onkologicke odd.

location_facility: Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica

location_facility: Philipps-Universität Marburg; Klinik für Innere Med.; Schwerpunkt Hämatologie/Onkologie/Immunologie

location_facility: Charité-Universitätsm. Berlin; Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunolo.

location_facility: Narodny Onkologicky Ustav; Oddelenie klinickej onkologie A

location_facility: Institut Paoli Calmettes; Oncologie Medicale

location_facility: S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Onkologische Schwerpunktpraxis Bielefeld; Haemotologie & Internistische onkologie

location_facility: Instituto Oncologico de Ribeirao Preto - INORP

location_facility: Hospital da Luz; Departamento de Oncologia Medica

location_facility: Klinikum rechts der Isar der TU München; Klinik und Poliklinik für Frauenheilkunde

location_facility: University Hospital of Patras Medical Oncology

location_facility: Bashkirian Republican Clinical Oncology Dispensary

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Alexandras General Hospital of Athens; Oncology Department

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: Klinik Fulda, Medizinisches Versorgungszentrum Osthessen GmbH

location_facility: Clinical Centre Nis, Clinic for Oncology

location_facility: British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre

location_facility: Azienda usl 5 Di Pisa-Ospedale Di Pontedera;U.O. Oncologia

location_facility: Institute for Oncology and Radiology of Serbia; Medical Oncology

location_facility: Klinikum rechts der Isar der TU München; III. Medizinischen Klinik (Hämatologie/Onkologie)

location_facility: Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico

title: Phase I Study of the Combination of Trastuzumab Emtansine (T-DM1) and Capecitabine in HER2-Positive Metastatic Breast Cancer and HER2-Positive Locally Advanced/Metastatic Gastric Cancer Patients, Followed by a Randomized, Open-Label Phase II Study of Trastuzumab Emtansine and Capecitabine Versus Trastuzumab Emtansine Alone in HER2-Positive Metastatic Breast Cancer

summary: This multicenter study will assess the maximum tolerated dose (MTD) of capecitabine in combination with Kadcyla (trastuzumab emtansine) in participants with HER2-positive mBC or HER2-positive LA/mGC using a Phase 1 design, followed by a randomized, open-label Phase 2 part to explore the efficacy and safety of the combination of Kadcyla and capecitabine compared with Kadcyla alone in participants with mBC. The anticipated time on study treatment is until disease progression, intolerable toxicity, withdrawal of consent, or study end.


type: EudraCT Number

title: A Randomized, Double Blind, Placebo-controlled, Multicenter Phase II Study to Evaluate Efficacy and Safety of Roniciclib in Subjects With Extensive-stage Disease Small Cell Lung Cancer (SCLC) Who Are Receiving Cisplatin + Etoposide or Carboplatin + Etoposide as First-line Therapy

acronym: CONCEPT-SCLC

summary:
This is a study to investigate the potential clinical benefit of roniciclib when given in combination with chemotherapy Carboplatin / Etoposide or Cisplatin / Etoposide as first line treatment in patients with extensive disease small cell lung cancer. Approximately 140 patients will be randomized (1:1) to receive treatment with either roniciclib or placebo in combination with chemotherapy.

Roniciclib is an oral (i.e. taken by mouth) protein kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. The growth of the tumor may be decreased by preventing these specific proteins from functioning. By specifically targeting these proteins, roniciclib in combination with chemotherapy may stop cancer growth.

The primary endpoint (the most meaningful result to be tracked) of this study is based on the progression free survival, i.e. the time the disease is not worsening. The aim is to show that the therapy with roniciclib in combination with chemotherapy prolongs the time the disease is not worsening in this patient population compared to patients receiving placebo in combination with chemotherapy.

study_start_date_type: Actual

ReferenceCitation: Reck M, Horn L, Novello S, Barlesi F, Albert I, Juhász E, Kowalski D, Robinet G, Cadranel J, Bidoli P, Chung J, Fritsch A, Drews U, Wagner A, Govindan R. Phase II Study of Roniciclib in Combination with Cisplatin/Etoposide or Carboplatin/Etoposide as First-Line Therapy in Patients with Extensive-Disease Small Cell Lung Cancer. J Thorac Oncol. 2019 Apr;14(4):701-711. doi: 10.1016/j.jtho.2019.01.010. Epub 2019 Jan 21. Erratum in: J Thorac Oncol. 2019 Aug;14(8):1484.

family: Reck

full_name: Martin Reck

given: Martin

family: Horn

full_name: Leora Horn

given: Leora

family: Novello

full_name: Silvia Novello

given: Silvia

family: Barlesi

full_name: Fabrice Barlesi

given: Fabrice

family: Albert

full_name: István Albert

given: István

family: Juhász

full_name: Erzsébet Juhász

given: Erzsébet

family: Kowalski

full_name: Dariusz Kowalski

given: Dariusz

family: Robinet

full_name: Gilles Robinet

given: Gilles

family: Cadranel

full_name: Jacques Cadranel

given: Jacques

family: Bidoli

full_name: Paolo Bidoli

given: Paolo

family: Chung

full_name: John Chung

given: John

family: Fritsch

full_name: Arno Fritsch

given: Arno

family: Drews

full_name: Uta Drews

given: Uta

family: Wagner

full_name: Andrea Wagner

given: Andrea

family: Govindan

full_name: Ramaswamy Govindan

given: Ramaswamy

journal_name: Journal of Thoracic Oncology

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

repository_institution: Università degli Studi di Milano - Institutional Research Information System

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Bayer

location_country:
Italy
United States
France
Japan
Poland
Hungary
Belgium
Germany
Korea, Republic of

intervention_type: Drug


ReferenceCitation: Shi R, Lu T, Ku G, Ding H, Saito T, Gibiansky L, Agarwal P, Li X, Jin JY, Girish S, Miles D, Li C, Lu D. Asian race and origin have no clinically meaningful effects on polatuzumab vedotin pharmacokinetics in patients with relapsed/refractory B-cell non-Hodgkin lymphoma. Cancer Chemother Pharmacol. 2020 Sep;86(3):347-359. doi: 10.1007/s00280-020-04119-8. Epub 2020 Aug 8.

family: Shi

full_name: Rong Shi

given: Rong

family: Lu

full_name: Tong Lu

given: Tong

family: Ku

full_name: Grace Ku

given: Grace

family: Ding

full_name: Hao Ding

given: Hao

family: Saito

full_name: Tomohisa Saito

given: Tomohisa

family: Gibiansky

full_name: Leonid Gibiansky

given: Leonid

family: Agarwal

full_name: Priya Agarwal

given: Priya

family: Li

full_name: Xiaobin Li

given: Xiaobin

family: Jin

full_name: Jin Yan Jin

given: Jin Yan

family: Girish

full_name: Sandhya Girish

given: Sandhya

family: Miles

full_name: Dale Miles

given: Dale

full_name: Chunze Li

given: Chunze

full_name: Dan Lu

given: Dan

journal_name: Cancer Chemotherapy and Pharmacology

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

ReferenceCitation: Lu T, Gibiansky L, Li X, Li C, Shi R, Agarwal P, Hirata J, Miles D, Chanu P, Girish S, Jin JY, Lu D. Exposure-safety and exposure-efficacy analyses of polatuzumab vedotin in patients with relapsed or refractory diffuse large B-cell lymphoma. Leuk Lymphoma. 2020 Dec;61(12):2905-2914. doi: 10.1080/10428194.2020.1795154. Epub 2020 Jul 24.

name: Genentech, Inc, South San Francisco, CA, USA

family: Hirata

name: Genentech, Inc./F. Hoffmann-La Roche Ltd, Lyon, France

ReferenceCitation: Morschhauser F, Flinn IW, Advani R, Sehn LH, Diefenbach C, Kolibaba K, Press OW, Salles G, Tilly H, Chen AI, Assouline S, Cheson BD, Dreyling M, Hagenbeek A, Zinzani PL, Jones S, Cheng J, Lu D, Penuel E, Hirata J, Wenger M, Chu YW, Sharman J. Polatuzumab vedotin or pinatuzumab vedotin plus rituximab in patients with relapsed or refractory non-Hodgkin lymphoma: final results from a phase 2 randomised study (ROMULUS). Lancet Haematol. 2019 May;6(5):e254-e265. doi: 10.1016/S2352-3026(19)30026-2. Epub 2019 Mar 29.

location_country:
Italy
United States
Netherlands
France
Germany
Canada

location_facility: Georgetown University Medical Center Lombardi Cancer Center

location_facility: A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2

location_facility: Klinikum d.Universität München Campus Großhadern

location_facility: Comprehensive Cancer Centers of Nevada - Eastern Avenue

location_facility: Northwest Cancer Specialists - Vancouver

location_facility: Oncology & Hematolgy Associates of SW Va Inc. - Roanoke

location_facility: Texas Oncology, P.A. - Tyler; Tyler Cancer Center

location_facility: Colorado Blood Cancer Institute (CBCI) at Presbyterian/ St. Luke's Medical Center

location_facility: Texas Oncology-Baylor Sammons Cancer Center

location_facility: Florida Cancer Specialists - Fort Myers (Colonial Center Dr)

location_facility: Regional Cancer Care Associates LLC - Morristown

location_facility: Sarah Cannon Cancer Center - Tennessee Oncology, Pllc

location_facility: Universitätsmedizin Johannes Gutenberg Universität; Klinik u. Poliklinik f. Neurologie

location_facility: Yakima Valley Memorial Hospital/North Star Lodge

location_facility: Hematology Oncology Associates; Carol G. Simon Ctr

location_facility: Univ of Michigan Med School; Hematology Oncology

location_facility: Willamette Valley Cancer Ctr - 520 Country Club

location_facility: Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V

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

location_facility: Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset)

title: A Randomized, Open-Label, Multicenter, Phase II Trial Evaluating the Safety and Activity of Pinatuzumab Vedotin (DCDT2980S) in Combination With Rituximab or Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab and a Non-Randomized Phase Ib/II Evaluation of Polatuzumab Vedotin in Combination With Obinutuzumab in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma

summary: This multicenter, open-label study will evaluate the safety and efficacy of pinatuzumab vedotin (DCDT2980S) or polatuzumab vedotin (DCDS4501A) in combination with rituximab (RTX), as well as of polatuzumab vedotin in combination with obinutuzumab in participants with relapsed or refractory (r/r) follicular lymphoma (FL) and r/r diffuse large B-cell lymphoma (DLBCL).


title: MEA115575: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of Mepolizumab Adjunctive Therapy to Reduce Steroid Use in Subjects With Severe Refractory Asthma

summary: This is a randomised, double-blind, placebo-controlled, parallel-group, multicenter study of mepolizumab in comparison with placebo in reducing Oral Corticosteroid (OCS) use in subjects with severe refractory asthma. The study consists of four phases, OCS Optimisation Phase (Week -8 to Week 0), and the double-blind treatment period divided into an Induction Phase (Week 0 to Week 4), OCS Reduction Phase (Week 5 upto Week 20) followed by Maintenance Phase (Week 20 to Week 24). During the Optimisation Phase the investigator will adjust the OCS (prednisone/prednisolone) dose according to the Optimisation titration schedule based on a review of Asthma Control Questionnaire (ACQ)-5 score and exacerbation. In the Induction Phase subjects will be randomized 1:1 (approximately 60 per arm) to receive either mepolizumab (100 mg) administered subcutaneously (SC) or placebo every 4 weeks in addition to their existing maintenance asthma therapy with the lowest dose of OCS from Optimisation Phase. The Induction Phase will allow sufficient time for those subjects randomised to the mepolizumab arm to achieve a decrease in the eosinophilic inflammation prior to the reduction in OCS. During the Reduction Phase, subjects will continue receiving 100 mg mepolizumab/placebo every 4 weeks and the OCS dose reduction will be done every 4 weeks using the reduction titration schedule based on a review of eDiary parameters recorded by the subject, the subjects' exacerbation history, and a review of the signs and symptoms of adrenal insufficiency. In the Maintenance Phase subjects will be maintained without any further OCS dose adjustment. Subjects who complete the 24 week double-blind period and meet the eligibility criteria, will be offered the opportunity to participate in an open label extension (OLE) study otherwise they will return for a Follow-up Visit 12 weeks after their last dose of double blind study treatment. At each clinic visit, adverse events, safety labs, spirometery parameters and exacerbations will be assessed. The pharmacokinetic samples will be collected in the beginning of the treatment, prior to last dose, at the end of study (exit visit) and the follow up.

status: Completed

ReferenceCitation: Khurana S, Brusselle GG, Bel EH, FitzGerald JM, Masoli M, Korn S, Kato M, Albers FC, Bradford ES, Gilson MJ, Price RG, Humbert M. Long-term Safety and Clinical Benefit of Mepolizumab in Patients With the Most Severe Eosinophilic Asthma: The COSMEX Study. Clin Ther. 2019 Oct;41(10):2041-2056.e5. doi: 10.1016/j.clinthera.2019.07.007. Epub 2019 Aug 22.

family: Khurana

full_name: Sandhya Khurana

family: Brusselle

full_name: Guy G. Brusselle

given: Guy G.

family: Bel

full_name: Elisabeth H. Bel

given: Elisabeth H.

family: FitzGerald

full_name: J. Mark FitzGerald

given: J. Mark

family: Masoli

full_name: Matthew Masoli

given: Matthew

family: Korn

full_name: Stephanie Korn

given: Stephanie

family: Kato

full_name: Motokazu Kato

given: Motokazu

family: Albers

full_name: Frank C. Albers

given: Frank C.

family: Bradford

full_name: Eric S. Bradford

given: Eric S.

family: Gilson

full_name: Martyn J. Gilson

given: Martyn J.

family: Price

full_name: Robert G. Price

given: Robert G.

family: Humbert

full_name: Marc Humbert

given: Marc

journal_name: Clinical Therapeutics

repository_institution: Ghent University - Ghent University Academic Bibliography

ReferenceCitation: Yancey SW, Bradford ES, Keene ON. Disease burden and efficacy of mepolizumab in patients with severe asthma and blood eosinophil counts of ≥150-300 cells/μL. Respir Med. 2019 May;151:139-141. doi: 10.1016/j.rmed.2019.04.008. Epub 2019 Apr 8.

family: Yancey

full_name: Steven W. Yancey

given: Steven W.

family: Keene

full_name: Oliver N. Keene

given: Oliver N.

journal_name: Respiratory Medicine

oa_host_type: publisher

title: Disease burden and efficacy of mepolizumab in patients with severe asthma and blood eosinophil counts of ≥150–300 cells/μL

ReferenceCitation: Ortega HG, Meyer E, Brusselle G, Asano K, Prazma CM, Albers FC, Mallett SA, Yancey SW, Gleich GJ. Update on immunogenicity in severe asthma: Experience with mepolizumab. J Allergy Clin Immunol Pract. 2019 Sep - Oct;7(7):2469-2475.e1. doi: 10.1016/j.jaip.2019.03.042. Epub 2019 Apr 5.

journal_name: The Journal of Allergy and Clinical Immunology: In Practice

ReferenceCitation: Keene ON. Strategies for composite estimands in confirmatory clinical trials: Examples from trials in nasal polyps and steroid reduction. Pharm Stat. 2019 Jan;18(1):78-84. doi: 10.1002/pst.1909. Epub 2018 Oct 29.

name: GlaxoSmithKline Research and Development; Middlesex UK

ReferenceCitation: Magnan A, Bourdin A, Prazma CM, Albers FC, Price RG, Yancey SW, Ortega H. Treatment response with mepolizumab in severe eosinophilic asthma patients with previous omalizumab treatment. Allergy. 2016 Sep;71(9):1335-44. doi: 10.1111/all.12914. Epub 2016 May 24.

name: INSERM UMR 1087 CNRS UMR 6291 L'Institut du Thorax CHU de Nantes Université de Nantes Nantes France

name: Département de Pneumologie et Addictologie INSERM U1046 CNRS UMR 9214 Hôpital Arnaud de Villeneuve CHU Montpellier, and PhyMedExp, University of Montpellier Montpellier France

name: Respiratory Therapeutic Area GSK Research Triangle ParkNCUSA

name: Clinical Statistics GSK Uxbridge Middlesex UK

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

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

ReferenceCitation: Bel EH, Wenzel SE, Thompson PJ, Prazma CM, Keene ON, Yancey SW, Ortega HG, Pavord ID; SIRIUS Investigators. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med. 2014 Sep 25;371(13):1189-97. doi: 10.1056/NEJMoa1403291. Epub 2014 Sep 8.

title: Oral Glucocorticoid-Sparing Effect of Mepolizumab in Eosinophilic Asthma

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

location_country:
United States
United Kingdom
Mexico
Netherlands
Germany
France
Poland
Australia
Canada
Czech Republic


title: A Randomized, Double-blind, Placebo-controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat (0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg TID) in Patients With Symptomatic Pulmonary Hypertension Associated With Idiopathic Interstitial Pneumonias (IIP).

acronym: RISE-IIP

summary: To evaluate the efficacy and safety of 26-weeks of treatment with riociguat vs. placebo in patients with symptomatic PH (pulmonary hypertension) associated with IIP (idiopathic interstitial pneumonias).

ReferenceCitation: Nathan SD, Behr J, Collard HR, Cottin V, Hoeper MM, Martinez FJ, Corte TJ, Keogh AM, Leuchte H, Mogulkoc N, Ulrich S, Wuyts WA, Yao Z, Boateng F, Wells AU. Riociguat for idiopathic interstitial pneumonia-associated pulmonary hypertension (RISE-IIP): a randomised, placebo-controlled phase 2b study. Lancet Respir Med. 2019 Sep;7(9):780-790. doi: 10.1016/S2213-2600(19)30250-4. Epub 2019 Aug 12.

family: Nathan

full_name: Steven D Nathan

given: Steven D

family: Behr

full_name: Jürgen Behr

given: Jürgen

family: Collard

full_name: Harold R Collard

given: Harold R

family: Cottin

full_name: Vincent Cottin

given: Vincent

family: Hoeper

full_name: Marius M Hoeper

given: Marius M

family: Martinez

full_name: Fernando J Martinez

given: Fernando J

family: Corte

full_name: Tamera J Corte

given: Tamera J

family: Keogh

full_name: Anne M Keogh

given: Anne M

family: Leuchte

full_name: Hanno Leuchte

given: Hanno

family: Mogulkoc

full_name: Nesrin Mogulkoc

given: Nesrin

family: Ulrich

full_name: Silvia Ulrich

given: Silvia

family: Wuyts

full_name: Wim A Wuyts

given: Wim A

family: Yao

full_name: Zhen Yao

given: Zhen

family: Boateng

full_name: Francis Boateng

given: Francis

family: Wells

full_name: Athol U Wells

given: Athol U

journal_name: The Lancet Respiratory Medicine

location_country:
Greece
Belgium
Australia
Russian Federation
Denmark
France
Japan
Argentina
Canada
Colombia
Saudi Arabia
Switzerland
Portugal
United States
Germany
United Kingdom
Italy
Israel
New Zealand
Spain
Turkey

location_facility:
Via Christi Clinic
University of California, Los Angeles
Columbia University Medical Center


title: Substrate Targeted Ablation Using the FlexAbility™ Ablation Catheter System for the Reduction of Ventricular Tachycardia (STAR-VT) - G130132

acronym: STAR-VT

summary: To demonstrate that scar-based ventricular tachycardia (VT) ablation using the FlexAbility™ ablation catheter system results in a superior clinical outcome compared to routine drug therapy in subjects with documented Monomorphic Ventricular Tachycardia [MMVT] (both ischemic and non-ischemic) while maintaining an acceptable safety profile.

ipd_sharing: No

lead_sponsor: Abbott Medical Devices

location_country:
Italy
France
Australia
United States
United Kingdom

location_facility: Staten Island University Hospital - North

location_facility: Hospital of the University of Pennsylvania

location_facility: University of California at San Diego (UCSD) Medical Center

location_facility: Texas Cardiac Arrhythmia Research Foundation

location_facility: Washington University School of Medicine - Barnes Jewish Hospital

location_facility: New York University Langone Medical Center

location_facility: University of California at San Francisco

intervention_type: Device


type: Other Identifier

title: Phase I/IIa, 2-Part, Multi-Center, Single-Arm, Open-Label Study to Determine the Safety, Tolerability and Pharmacokinetics of Oral Dabrafenib in Children and Adolescent Subjects With Advanced BRAF V600-Mutation Positive Solid Tumors

summary: This was a 2-part, Phase I/IIa, multi-center, open label, study in pediatric and adolescent patients with advanced BRAF V600 mutation-positive solid tumors. Part 1 was a dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). Part 2 was an expansion study to further evaluate the safety, tolerability, and clinical activity of dabrafenib in 4 tumor-specific pediatric populations. Patients participated in only either part 1 or part 2 of the study.

design_allocation: Non-Randomized

ReferenceCitation: Hargrave DR, Bouffet E, Tabori U, Broniscer A, Cohen KJ, Hansford JR, Geoerger B, Hingorani P, Dunkel IJ, Russo MW, Tseng L, Dasgupta K, Gasal E, Whitlock JA, Kieran MW. Efficacy and Safety of Dabrafenib in Pediatric Patients with BRAF V600 Mutation-Positive Relapsed or Refractory Low-Grade Glioma: Results from a Phase I/IIa Study. Clin Cancer Res. 2019 Dec 15;25(24):7303-7311. doi: 10.1158/1078-0432.CCR-19-2177.

family: Hargrave

full_name: Darren R. Hargrave

given: Darren R.

family: Bouffet

full_name: Eric Bouffet

given: Eric

family: Tabori

full_name: Uri Tabori

given: Uri

family: Broniscer

full_name: Alberto Broniscer

given: Alberto

family: Cohen

full_name: Kenneth J. Cohen

given: Kenneth J.

family: Hansford

full_name: Jordan R. Hansford

given: Jordan R.

family: Geoerger

full_name: Birgit Geoerger

given: Birgit

family: Hingorani

full_name: Pooja Hingorani

given: Pooja

family: Dunkel

full_name: Ira J. Dunkel

given: Ira J.

family: Russo

full_name: Mark W. Russo

given: Mark W.

family: Tseng

full_name: Lillian Tseng

given: Lillian

family: Dasgupta

full_name: Kohinoor Dasgupta

given: Kohinoor

family: Gasal

full_name: Eduard Gasal

given: Eduard

family: Whitlock

full_name: James A. Whitlock

given: James A.

family: Kieran

full_name: Mark W. Kieran

journal_name: Clinical Cancer Research

oa_host_type: repository

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

version: submittedVersion

publisher: American Association for Cancer Research (AACR)

title: Efficacy and Safety of Dabrafenib in Pediatric Patients with BRAF V600 Mutation–Positive Relapsed or Refractory Low-Grade Glioma: Results from a Phase I/IIa Study

ReferenceCitation: Kieran MW, Geoerger B, Dunkel IJ, Broniscer A, Hargrave D, Hingorani P, Aerts I, Bertozzi AI, Cohen KJ, Hummel TR, Shen V, Bouffet E, Pratilas CA, Pearson ADJ, Tseng L, Nebot N, Green S, Russo MW, Whitlock JA. A Phase I and Pharmacokinetic Study of Oral Dabrafenib in Children and Adolescent Patients with Recurrent or Refractory BRAF V600 Mutation-Positive Solid Tumors. Clin Cancer Res. 2019 Dec 15;25(24):7294-7302. doi: 10.1158/1078-0432.CCR-17-3572. Epub 2019 Sep 10.

full_name: Darren Hargrave

given: Darren

title: A Phase I and Pharmacokinetic Study of Oral Dabrafenib in Children and Adolescent Patients with Recurrent or Refractory BRAF V600 Mutation–Positive Solid Tumors

ReferenceCitation: Wang J, Yao Z, Jonsson P, Allen AN, Qin ACR, Uddin S, Dunkel IJ, Petriccione M, Manova K, Haque S, Rosenblum MK, Pisapia DJ, Rosen N, Taylor BS, Pratilas CA. A Secondary Mutation in BRAF Confers Resistance to RAF Inhibition in a BRAF(V600E)-Mutant Brain Tumor. Cancer Discov. 2018 Sep;8(9):1130-1141. doi: 10.1158/2159-8290.CD-17-1263. Epub 2018 Jun 7.

title: A Secondary Mutation in BRAF Confers Resistance to RAF Inhibition in a BRAFV600E-Mutant Brain Tumor

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:
Italy
United States
Germany
France
Israel
Australia
Spain
Denmark
Canada
United Kingdom


title: Osteonecrosis of the Jaw (ONJ) Case Registry

study_type: Observational

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Schiodt M, Vadhan-Raj S, Chambers MS, Nicolatou-Galitis O, Politis C, Coropciuc R, Fedele S, Jandial D, Zhang J, Ma H, Saunders DP. A multicenter case registry study on medication-related osteonecrosis of the jaw in patients with advanced cancer. Support Care Cancer. 2018 Jun;26(6):1905-1915. doi: 10.1007/s00520-017-4003-2. Epub 2017 Dec 23.

ipd_sharing: Yes

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

lead_sponsor: Amgen

location_country:
Italy
United States
Germany
Finland
France
Greece
Belgium
Spain
Denmark
Canada
United Kingdom

status_simplified: Completed


type: Registry Identifier

title: A Phase 3, Randomized, Controlled, Open-label, Multicenter, Safety and Efficacy Study of Dexamethasone Plus MLN9708 or Physicians Choice of Treatment Administered to Patients With Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis

summary: The purpose of this study is to provide continued access of ixazomib and/or other study medications and to continue collecting relevant safety data to monitor participant's safety, determine whether dexamethasone plus IXAZOMIB improves hematologic response, 2-year vital organ (that is, heart or kidney) deterioration and mortality rate versus a physician's choice of a chemotherapy regimen in participants diagnosed with relapsed or refractory systemic light chain (AL) amyloidosis.

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Sanchorawala V, Palladini G, Kukreti V, Zonder JA, Cohen AD, Seldin DC, Dispenzieri A, Jaccard A, Schönland SO, Berg D, Yang H, Gupta N, Hui AM, Comenzo RL, Merlini G. A phase 1/2 study of the oral proteasome inhibitor ixazomib in relapsed or refractory AL amyloidosis. Blood. 2017 Aug 3;130(5):597-605. doi: 10.1182/blood-2017-03-771220. Epub 2017 May 26. Erratum in: Blood. 2020 Mar 26;135(13):1071.

name: Amyloidosis Center, Boston University School of Medicine, Boston, MA;

family: Sanchorawala

full_name: Vaishali Sanchorawala

given: Vaishali

name: Amyloidosis Research and Treatment Center, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy;

name: Department of Molecular Medicine, University of Pavia, Pavia, Italy;

family: Palladini

full_name: Giovanni Palladini

given: Giovanni

name: Princess Margaret Hospital, Toronto, ON, Canada;

family: Kukreti

full_name: Vishal Kukreti

given: Vishal

name: Barbara Ann Karmanos Cancer Institute, Detroit, MI;

family: Zonder

full_name: Jeffrey A. Zonder

given: Jeffrey A.

name: Fox Chase Cancer Center, Philadelphia, PA;

full_name: Adam D. Cohen

given: Adam D.

family: Seldin

full_name: David C. Seldin

given: David C.

family: Dispenzieri

full_name: Angela Dispenzieri

given: Angela

name: Centre Hospitalier Universitaire, Limoges, France;

family: Jaccard

full_name: Arnaud Jaccard

given: Arnaud

name: Medical Department V, Amyloidosis Center, University Hospital of Heidelberg, Heidelberg, Germany;

family: Schönland

full_name: Stefan O. Schönland

given: Stefan O.

name: Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA;

family: Berg

full_name: Deborah Berg

given: Deborah

family: Yang

full_name: Huyuan Yang

given: Huyuan

family: Gupta

full_name: Neeraj Gupta

given: Neeraj

family: Hui

full_name: Ai-Min Hui

given: Ai-Min

family: Comenzo

full_name: Raymond L. Comenzo

given: Raymond L.

family: Merlini

full_name: Giampaolo Merlini

given: Giampaolo

journal_name: Blood

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

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

lead_sponsor: Millennium Pharmaceuticals, Inc.

location_country:
Italy
Brazil
United States
Netherlands
Germany
France
Czechia
Greece
Israel
Australia
Spain
Denmark
Canada
United Kingdom
Korea, Republic of

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

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

location_facility: Severance Hospital at Yonsei University Health System - PPDS

location_facility: Froedtert and The Medical College of Wisconsin

location_facility: Arhus Universitetshospital Arhus Sygehus

location_facility: Irmandade Da Santa Casa de Misericordia de Sao Paulo

location_facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

location_facility: Institute of Hematology "Seragnoli" University of Bologna

location_facility: Hadasit Medical Research Services and Development Ltd

location_facility: Centre Hospitalier et Universitaire de Limoges

location_facility: Royal Free and University College Medical School

location_facility: Fondazione IRCCS Policlinico San Matteo di Pavia

location_facility: University of Texas Southwestern Medical Center

location_facility: Hospital Universitario Clementino Fraga Filho (UFRJ)

status_simplified: Ongoing


title: A Multi-centre, Phase II, Double-blind, Randomised, Placebo-controlled, Parallel Group, Dose-ranging Study in Patients With Faecal Incontinence; to Evaluate the Efficacy, Safety and Tolerability of Locally Applied NRL001 Over an 8 Week Treatment Period

summary: The purpose of this study is to evaluate the safety, tolerability and efficacy of NRL001 in the treatment of faecal incontinence, compared against placebo

lead_sponsor: Norgine

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

location_facility: Unita Operativa Complessa Patologia Chirurgica A Indirizzo Gastroenterologico

location_facility: Chu Lyon Groupement Hospitalier Edouard Herriot

location_facility: University of Szeged, Albert Szent-Gyorgyi Clinical Center, Faculty of Medicine

location_facility: Fakultni Nemocnice Na Bulovce, Gynekologicko-Porodnicka Klinika

location_facility: Osrodek Badawczo - Leczniczy Zbigniew Zegota

location_facility: Unita Operativa Complessa Gastroenteroloogia A

location_facility: Chu Nantes - Hotel Dieu - Institut Des Maladies De L'Appareil Digestif (IMAD)

location_facility: Polyclinic for Outpatients, Szakrendelo Intezet

location_facility: Hospital Clinico Universtiaria Lozana Blesa

location_facility: Centrum Medyczne, Wyzszej Szkoly Informatycznej

location_facility: Seconda Unita Operativa Di Chirurgia Generale

location_facility: Lecznica Prosen SMO Private Medical Health Care Centre

location_facility: University of Debrecen, Medical and Health Science Center


title: A Randomized, Controlled, Open-Label, Multicenter Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, Versus Temsirolimus in Subjects With Relapsed or Refractory Mantle Cell Lymphoma Who Have Received at Least One Prior Therapy

summary: The purpose of this study is to evaluate the efficacy and safety of ibrutinib versus temsirolimus in patients with relapsed or refractory mantle cell lymphoma who received at least 1 prior chemotherapy regimen.

ReferenceCitation: Brown JR, Moslehi J, O'Brien S, Ghia P, Hillmen P, Cymbalista F, Shanafelt TD, Fraser G, Rule S, Kipps TJ, Coutre S, Dilhuydy MS, Cramer P, Tedeschi A, Jaeger U, Dreyling M, Byrd JC, Howes A, Todd M, Vermeulen J, James DF, Clow F, Styles L, Valentino R, Wildgust M, Mahler M, Burger JA. Characterization of atrial fibrillation adverse events reported in ibrutinib randomized controlled registration trials. Haematologica. 2017 Oct;102(10):1796-1805. doi: 10.3324/haematol.2017.171041. Epub 2017 Jul 27.

family: Brown

full_name: Jennifer R. Brown

given: Jennifer R.

family: Moslehi

full_name: Javid Moslehi

given: Javid

family: O’Brien

full_name: Susan O’Brien

given: Susan

family: Ghia

full_name: Paolo Ghia

given: Paolo

family: Hillmen

full_name: Peter Hillmen

given: Peter

family: Cymbalista

full_name: Florence Cymbalista

given: Florence

family: Shanafelt

full_name: Tait D. Shanafelt

given: Tait D.

family: Fraser

full_name: Graeme Fraser

given: Graeme

family: Rule

full_name: Simon Rule

given: Simon

family: Kipps

full_name: Thomas J. Kipps

given: Thomas J.

family: Coutre

full_name: Steven Coutre

given: Steven

family: Dilhuydy

full_name: Marie-Sarah Dilhuydy

given: Marie-Sarah

family: Cramer

full_name: Paula Cramer

given: Paula

family: Tedeschi

full_name: Alessandra Tedeschi

given: Alessandra

family: Jaeger

full_name: Ulrich Jaeger

given: Ulrich

family: Dreyling

full_name: Martin Dreyling

given: Martin

family: Byrd

full_name: John C. Byrd

given: John C.

family: Howes

full_name: Angela Howes

family: Todd

full_name: Michael Todd

given: Michael

family: Vermeulen

full_name: Jessica Vermeulen

given: Jessica

family: James

full_name: Danelle F. James

given: Danelle F.

family: Clow

full_name: Fong Clow

given: Fong

family: Styles

repository_institution: University of California - eScholarship University of California

repository_normalized: California Digital Library - eScholarship

publisher: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Dreyling M, Jurczak W, Jerkeman M, Silva RS, Rusconi C, Trneny M, Offner F, Caballero D, Joao C, Witzens-Harig M, Hess G, Bence-Bruckler I, Cho SG, Bothos J, Goldberg JD, Enny C, Traina S, Balasubramanian S, Bandyopadhyay N, Sun S, Vermeulen J, Rizo A, Rule S. Ibrutinib versus temsirolimus in patients with relapsed or refractory mantle-cell lymphoma: an international, randomised, open-label, phase 3 study. Lancet. 2016 Feb 20;387(10020):770-8. doi: 10.1016/S0140-6736(15)00667-4. Epub 2015 Dec 7. Erratum in: Lancet. 2016 Feb 20;387(10020):750.

repositories_institution: Ghent University - Ghent University Academic Bibliography

location_country:
Belgium
Russian Federation
Taiwan
Ukraine
France
Poland
Canada
Korea, Republic of
Colombia
Chile
Sweden
Netherlands
Hungary
Ireland
Portugal
Germany
United Kingdom
Brazil
Mexico
Czechia
Spain


title: A Phase I, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation

summary: The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-120 in advanced hematologic malignancies that harbor an IDH1 mutation. The first portion of the study is a dose escalation phase where cohorts of patients will receive ascending oral doses of AG-120 to determine maximum tolerated dose (MTD) and/or the recommended Phase II dose. The second portion of the study is a dose expansion phase where four cohorts of patients will receive AG-120 to further evaluate the safety, tolerability, and clinical activity of the recommended Phase II dose. Additionally, the study includes a substudy evaluating the safety and tolerability, clinical activity, pharmacokinetics, and pharmacodynamics of AG-120 in subjects with relapsed or refractory myelodysplastic syndrome with an IDH1 mutation. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

status: Recruiting

enrollment_type: Anticipated

ReferenceCitation: Jiang X, Wada R, Poland B, Kleijn HJ, Fan B, Liu G, Liu H, Kapsalis S, Yang H, Le K. Population pharmacokinetic and exposure-response analyses of ivosidenib in patients with IDH1-mutant advanced hematologic malignancies. Clin Transl Sci. 2021 May;14(3):942-953. doi: 10.1111/cts.12959. Epub 2021 Jan 25.

name: Agios Pharmaceuticals, Inc. Cambridge Massachusetts USA

family: Jiang

full_name: Xuemin Jiang

given: Xuemin

family: Wada

full_name: Russ Wada

given: Russ

family: Poland

full_name: Bill Poland

given: Bill

family: Kleijn

full_name: Huub Jan Kleijn

given: Huub Jan

family: Fan

full_name: Bin Fan

given: Bin

family: Liu

full_name: Guowen Liu

given: Guowen

full_name: Hua Liu

given: Hua

family: Kapsalis

full_name: Stephanie Kapsalis

given: Stephanie

family: Yang

full_name: Hua Yang

family: Le

full_name: Kha Le

given: Kha

journal_name: Clinical and Translational Science

license: cc-by-nc

license_normalized: cc-by-nc

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Population pharmacokinetic and exposure‐response analyses of ivosidenib in patients with IDH1 ‐mutant advanced hematologic malignancies

ReferenceCitation: Choe S, Wang H, DiNardo CD, Stein EM, de Botton S, Roboz GJ, Altman JK, Mims AS, Watts JM, Pollyea DA, Fathi AT, Tallman MS, Kantarjian HM, Stone RM, Quek L, Konteatis Z, Dang L, Nicolay B, Nejad P, Liu G, Zhang V, Liu H, Goldwasser M, Liu W, Marks K, Bowden C, Biller SA, Attar EC, Wu B. Molecular mechanisms mediating relapse following ivosidenib monotherapy in IDH1-mutant relapsed or refractory AML. Blood Adv. 2020 May 12;4(9):1894-1905. doi: 10.1182/bloodadvances.2020001503.

name: Agios Pharmaceuticals, Inc., Cambridge, MA;

family: Choe

full_name: Sung Choe

given: Sung

family: Wang

full_name: Hongfang Wang

given: Hongfang

name: University of Texas MD Anderson Cancer Center, Houston, TX;

family: DiNardo

full_name: Courtney D. DiNardo

given: Courtney D.

name: Memorial Sloan Kettering Cancer Center, New York, NY;

family: Stein

full_name: Eytan M. Stein

given: Eytan M.

name: Department of Hematology, Institut Gustave Roussy, Villejuif, France;

family: de Botton

full_name: Stéphane de Botton

given: Stéphane

name: Weill Cornell Medicine/New York-Presbyterian Hospital, New York, NY;

family: Roboz

full_name: Gail J. Roboz

given: Gail J.

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

family: Altman

full_name: Jessica K. Altman

given: Jessica K.

name: The Ohio State University Wexner Medical Center, Columbus, OH;

family: Mims

full_name: Alice S. Mims

given: Alice S.

name: Sylvester Comprehensive Cancer Center, University of Miami, Miami, FL;

name: Division of Hematology, University of Colorado School of Medicine, Aurora, CO;

name: Massachusetts General Hospital, Harvard Medical School, Boston, MA;

name: Dana-Farber Cancer Institute, Boston, MA; and

name: Medical Research Council Molecular Hematology Unit, Weatherall Institute of Molecular Medicine, University of Oxford, Oxford, United Kingdom

ReferenceCitation: Fan B, Dai D, DiNardo CD, Stein E, de Botton S, Attar EC, Liu H, Liu G, Lemieux I, Agresta SV, Yang H. Clinical pharmacokinetics and pharmacodynamics of ivosidenib in patients with advanced hematologic malignancies with an IDH1 mutation. Cancer Chemother Pharmacol. 2020 May;85(5):959-968. doi: 10.1007/s00280-020-04064-6. Epub 2020 Apr 15.

ReferenceCitation: Roboz GJ, DiNardo CD, Stein EM, de Botton S, Mims AS, Prince GT, Altman JK, Arellano ML, Donnellan W, Erba HP, Mannis GN, Pollyea DA, Stein AS, Uy GL, Watts JM, Fathi AT, Kantarjian HM, Tallman MS, Choe S, Dai D, Fan B, Wang H, Zhang V, Yen KE, Kapsalis SM, Hickman D, Liu H, Agresta SV, Wu B, Attar EC, Stone RM. Ivosidenib induces deep durable remissions in patients with newly diagnosed IDH1-mutant acute myeloid leukemia. Blood. 2020 Feb 13;135(7):463-471. doi: 10.1182/blood.2019002140.

name: Weill Cornell Medicine/NewYork-Presbyterian Hospital, New York, NY;

name: The Johns Hopkins Hospital, Baltimore, MD;

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

name: Winship Cancer Institute of Emory University, Atlanta, GA;

name: Sarah Cannon Research Institute, Nashville, TN;

name: UAB Comprehensive Cancer Center, University of Alabama at Birmingham, Birmingham, AL;

name: UCSF Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA;

name: City of Hope Medical Center, Duarte, CA;

name: Division of Oncology, Washington University School of Medicine, St Louis, MO;

name: Massachusetts General Hospital/Harvard Medical School, Boston, MA;

name: Agios Pharmaceuticals, Inc, Cambridge, MA; and

ReferenceCitation: DiNardo CD, Stein EM, de Botton S, Roboz GJ, Altman JK, Mims AS, Swords R, Collins RH, Mannis GN, Pollyea DA, Donnellan W, Fathi AT, Pigneux A, Erba HP, Prince GT, Stein AS, Uy GL, Foran JM, Traer E, Stuart RK, Arellano ML, Slack JL, Sekeres MA, Willekens C, Choe S, Wang H, Zhang V, Yen KE, Kapsalis SM, Yang H, Dai D, Fan B, Goldwasser M, Liu H, Agresta S, Wu B, Attar EC, Tallman MS, Stone RM, Kantarjian HM. Durable Remissions with Ivosidenib in IDH1-Mutated Relapsed or Refractory AML. N Engl J Med. 2018 Jun 21;378(25):2386-2398. doi: 10.1056/NEJMoa1716984. Epub 2018 Jun 2.

name: From the University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., H.M.K.); Memorial Sloan Kettering Cancer Center (E.M.S., M.S.T.) and Weill Cornell Medical College (G.J.R.), New York; Institut Gustave Roussy, Villejuif (S.B., C.W.), and Centre Hospitalier Universitaire Bordeaux, Bordeaux (A.P.) — both in France; Northwestern University, Chicago (J.K.A.); Ohio State University Wexner Medical Center, Columbus (A.S.M.); Sylvester Comprehensive Cancer Center, University of Miami, Miami (R.S.);...

title: Durable Remissions with Ivosidenib inIDH1-Mutated Relapsed or Refractory AML

ReferenceCitation: Birendra KC, DiNardo CD. Evidence for Clinical Differentiation and Differentiation Syndrome in Patients With Acute Myeloid Leukemia and IDH1 Mutations Treated With the Targeted Mutant IDH1 Inhibitor, AG-120. Clin Lymphoma Myeloma Leuk. 2016 Aug;16(8):460-5. doi: 10.1016/j.clml.2016.04.006. Epub 2016 May 5.

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

Access can be requested for all interventional clinical studies:

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

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

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

lead_sponsor: Institut de Recherches Internationales Servier


title: A Phase 2, Multicenter, Single-Arm, Study to Evaluate the Efficacy and Safety of Single-Agent Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Subjects With Mantle Cell Lymphoma Who Progress After Bortezomib Therapy

summary: The purpose of this study is to evaluate the efficacy and safety of ibrutinib in patients with mantle cell lymphoma who received at least 1 prior rituximab-containing chemotherapy regimen and who progressed after bortezomib therapy.

lead_sponsor: Janssen Research & Development, LLC

location_country:
France
Poland
Israel
Belgium
Puerto Rico
Russian Federation
Spain
United States
United Kingdom


title: Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry

summary:
The purpose of this registry is to compile characteristics of world-wide outcomes for the use of Boston Scientific's commercially available Vercise DBS system in the treatment of Parkinson's disease.

Additionally, the utilization of Guide XT (GXT) System when used as a planning tool for the programming of patients with the Boston Scientific's Vercise DBS Systems is also evaluated.

lead_sponsor: Boston Scientific Corporation

location_country:
Italy
Austria
United States
Germany
France
Poland
Israel
Hungary
Belgium
Spain
Canada
United Kingdom
Korea, Republic of

location_facility: Wake Forest University School of Medicine

location_facility: Universitaetsklinikum Giessen und Marburg GmbH

location_facility: Texas Institute for Neurological Disorders

location_facility: Azienda Ospedaliero-Universitaria di Ferrara

location_facility: University Berlin, Charite Virchow Standort, Wedding

location_facility: Hadassah Hebrew University Medical Center

location_facility: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Fondazione Istituto Neurologico Casimiro Mondino

location_facility: University of Texas Health Medical Arts and Research Center

location_facility: Queen Elizabeth II Health Sciences Center

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


title: A Randomized, Double-blind, Placebo Controlled Study of Canakinumab in Patients With Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF), With Subsequent Randomized Withdrawal/Dosing Frequency Reduction and Open-label Long-term Treatment Epochs

summary: This study is to determine whether canakinumab is able to induce and maintain a clinically meaningful reduction of disease activity in participants with Hereditary Periodic Fevers (HPF) compared to placebo.

ReferenceCitation: Jeyaratnam J, Simon A, Calvo I, Constantin T, Shcherbina A, Hofer M, Gattorno M, Martini A, Bader-Meunier B, Vastert B, Levy J, Dekker E, de Benedetti F, Frenkel J. Long-term efficacy and safety of canakinumab in patients with mevalonate kinase deficiency: results from the randomised Phase 3 CLUSTER trial. Rheumatology (Oxford). 2021 Sep 23. pii: keab696. doi: 10.1093/rheumatology/keab696. [Epub ahead of print]

name: Department of Pediatrics, University Medical Center Utrecht, Utrecht

family: Jeyaratnam

full_name: Jerold Jeyaratnam

given: Jerold

name: Department of Internal Medicine, Radboud University Medical Center, Radboudumc Expertise Center for Immunodeficiency and Autoinflammation (REIA), Nijmegen, The Netherlands

family: Simon

full_name: Anna Simon

given: Anna

name: Pediatric Rheumatology Unit, Hospital Universitario y Politécnico La Fe, Valencia, Spain

family: Calvo

full_name: Inmaculada Calvo

given: Inmaculada

name: 2nd Department of Pediatrics, Semmelweis University, Budapest, Hungary

family: Constantin

full_name: Tamas Constantin

given: Tamas

name: Department of Immunology, Dmitry Rogachev National Medical Center of Pediatric Hematology, Oncology and Immunology, Moscow, Russia

family: Shcherbina

full_name: Anna Shcherbina

name: Unité Centre Multisite Romande d'Immuno-e Rhumatologie Pediatrique, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland

family: Hofer

full_name: Michael Hofer

given: Michael

name: Center for Autoinflammatory Diseases and Immunodeficiencies, IRCCS, G. Gaslini

family: Gattorno

full_name: Marco Gattorno

given: Marco

family: Martini

full_name: Alberto Martini

given: Alberto

name: Department of Pediatric Immunology, Hematology and Rheumatology, Universite de Paris, Institut des Maladies Genetiques (IMAGINE Institute), Reference Centre for Rheumatic, AutoImmune, and Systemic Diseases in Children (RAISE), Necker Hospital, Assistance Publique-Hopitaux de Paris, Paris, France

family: Bader-Meunier

full_name: Brigitte Bader-Meunier

given: Brigitte

name: Department of Pediatric Immunology, University Medical Center Utrecht, Utrecht, The Netherlands

family: Vastert

full_name: Bas Vastert

given: Bas

family: Levy

full_name: Jeremy Levy

given: Jeremy

family: Dekker

full_name: Elise Dekker

given: Elise

name: Division of Rheumatology, Ospedale Pediatrico Bambino Gesù, Roma, Italy

family: de Benedetti

full_name: Fabrizio de Benedetti

given: Fabrizio

family: Frenkel

full_name: Joost Frenkel

given: Joost

journal_name: Rheumatology

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: De Benedetti F, Gattorno M, Anton J, Ben-Chetrit E, Frenkel J, Hoffman HM, Koné-Paut I, Lachmann HJ, Ozen S, Simon A, Zeft A, Calvo Penades I, Moutschen M, Quartier P, Kasapcopur O, Shcherbina A, Hofer M, Hashkes PJ, Van der Hilst J, Hara R, Bujan-Rivas S, Constantin T, Gul A, Livneh A, Brogan P, Cattalini M, Obici L, Lheritier K, Speziale A, Junge G. Canakinumab for the Treatment of Autoinflammatory Recurrent Fever Syndromes. N Engl J Med. 2018 May 17;378(20):1908-1919. doi: 10.1056/NEJMoa1706314.

name: From the Division of Rheumatology, Ospedale Pediatrico Bambino Gesù, Rome (F.D.B.), Clinica Pediatrica e Reumatologia, Unità Operativa Semplice Dipartimentale di Malattie Autoinfiammatorie e Immunodeficienze, IRCCS, Istituto G. Gaslini, Genoa (M.G.), the Pediatric Clinic, University of Brescia and Spedali Civili, Brescia (M.C.), and the Amyloidosis Research and Treatment Center, Biotechnology Research Laboratories, Fondazione IRCCS Policlinico San Matteo, Pavia (L.O.) — all in Italy; the Division of...

family: De Benedetti

full_name: Fabrizio De Benedetti

family: Anton

full_name: Jordi Anton

given: Jordi

family: Ben-Chetrit

full_name: Eldad Ben-Chetrit

given: Eldad

family: Hoffman

full_name: Hal M. Hoffman

given: Hal M.

family: Koné-Paut

full_name: Isabelle Koné-Paut

repository_institution: hacettepe.edu.tr - Hacettepe University Institutional Repository

repository_institution: University of Liège - Open Repository and Bibliography

repositories_institution: University College London - UCL Discovery

location_country:
Italy
United States
Switzerland
Netherlands
Germany
France
Japan
Israel
Hungary
Belgium
Ireland
Russian Federation
Spain
Turkey
Canada
United Kingdom


ReferenceType: result

ReferenceCitation: Rosenstock J, Aronson R, Grunberger G, Hanefeld M, Piatti P, Serusclat P, Cheng X, Zhou T, Niemoeller E, Souhami E, Davies M; LixiLan-O Trial Investigators. Benefits of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide, Versus Insulin Glargine and Lixisenatide Monocomponents in Type 2 Diabetes Inadequately Controlled on Oral Agents: The LixiLan-O Randomized Trial. Diabetes Care. 2016 Nov;39(11):2026-2035. Epub 2016 Aug 15. Erratum in: Diabetes Care. 2017 Jun;40(6):809.

ReferenceCitation: Davies MJ, Russell-Jones D, Barber TM, Lavalle-González FJ, Galstyan GR, Zhu D, Baxter M, Dessapt-Baradez C, McCrimmon RJ. Glycaemic benefit of iGlarLixi in insulin-naive type 2 diabetes patients with high HbA1c or those with inadequate glycaemic control on two oral antihyperglycaemic drugs in the LixiLan-O randomized trial. Diabetes Obes Metab. 2019 Aug;21(8):1967-1972. doi: 10.1111/dom.13791. Epub 2019 Jun 18.

name: Department of Health Services, Diabetes Research CentreUniversity of Leicester, Leicester General Hospital and University Hospitals of Leicester NHS Trust Leicester UK

family: Davies

full_name: Melanie J. Davies

given: Melanie J.

name: Department of Diabetes and EndocrinologyUniversity of Surrey Guildford UK

family: Russell‐Jones

full_name: David Russell‐Jones

given: David

name: Translational Medicine, Warwick Medical School, University of Warwick Coventry UK

family: Barber

full_name: Thomas M. Barber

given: Thomas M.

name: Department of EndocrinologyHospital Universitario “Dr. José Eleuterio González” Monterrey Mexico

family: Lavalle‐González

full_name: Fernando J. Lavalle‐González

given: Fernando J.

name: Diabetic Foot Department, Endocrinology Research Center Moscow Russia

family: Galstyan

full_name: Gagik R. Galstyan

given: Gagik R.

name: Department of Endocrinology, Affiliated Drum Tower Hospital, Nanjing University Medical School Nanjing China

family: Zhu

full_name: Dalong Zhu

given: Dalong

family: Baxter

full_name: Mike Baxter

given: Mike

family: Dessapt‐Baradez

full_name: Cecile Dessapt‐Baradez

given: Cecile

name: Division of Systems Medicine, School of MedicineUniversity of Dundee Dundee UK

family: McCrimmon

full_name: Rory J. McCrimmon

given: Rory J.

journal_name: Diabetes, Obesity and Metabolism

repository_institution: University of Dundee - Discovery Research Portal

repository_institution: University of Leicester - Leicester Research Archive

repository_institution: University of Warwick - Warwick Research Archive Portal

title: Glycaemic benefit of iGlarLixi in insulin‐naive type 2 diabetes patients with high HbA1c or those with inadequate glycaemic control on two oral antihyperglycaemic drugs in the LixiLan‐O randomized trial

ReferenceCitation: Dailey G, Bajaj HS, Dex T, Groleau M, Stager W, Vinik A. Post hoc efficacy and safety analysis of insulin glargine/lixisenatide fixed- ratio combination in North American patients compared with the rest of world. BMJ Open Diabetes Res Care. 2019 Mar 21;7(1):e000581. doi: 10.1136/bmjdrc-2018-000581. eCollection 2019.

family: Dailey

full_name: George Dailey

given: George

family: Bajaj

full_name: Harpreet S Bajaj

given: Harpreet S

family: Dex

full_name: Terry Dex

given: Terry

family: Groleau

full_name: Melanie Groleau

given: Melanie

ReferenceCitation: Schmider W, Belder R, Lee M, Niemoeller E, Souhami E, Frias JP. Impact of dose capping in insulin glargine/lixisenatide fixed-ratio combination trials in patients with type 2 diabetes. Curr Med Res Opin. 2019 Jun;35(6):1081-1089. doi: 10.1080/03007995.2018.1558852. Epub 2019 Jan 11.

name: National Research Institute, Los Angeles, CA, USA

ReferenceCitation: Rosenstock J, Handelsman Y, Vidal J, Ampudia Blasco FJ, Giorgino F, Liu M, Perfetti R, Meier JJ. Propensity-score-matched comparative analyses of simultaneously administered fixed-ratio insulin glargine 100 U and lixisenatide (iGlarLixi) vs sequential administration of insulin glargine and lixisenatide in uncontrolled type 2 diabetes. Diabetes Obes Metab. 2018 Dec;20(12):2821-2829. doi: 10.1111/dom.13462. Epub 2018 Aug 13.

name: Dallas Diabetes Research Center at Medical City; Dallas Texas

name: Metabolic Institute of America; Tarzana California

name: Hospital Clinic of Barcelona; Barcelona Spain

name: Centro Investigación Biomédica en Red en Diabetes y Enfermeades Metabólicas (CIBERDEM); Madrid Spain

name: Clinic University Hospital of Valencia; Valencia Spain

name: University of Bari Aldo Moro; Bari Italy

name: BDM Consulting, Inc.; Somerset New Jersey

name: St Josef Hospital, Ruhr-University Bochum; Bochum Germany

ReferenceCitation: Trujillo JM, Roberts M, Dex T, Chao J, White J, LaSalle J. Low incidence of gastrointestinal adverse events over time with a fixed-ratio combination of insulin glargine and lixisenatide versus lixisenatide alone. Diabetes Obes Metab. 2018 Nov;20(11):2690-2694. doi: 10.1111/dom.13444. Epub 2018 Aug 21.

name: Department of Clinical Pharmacy, Skaggs School of Pharmacy and Pharmaceutical SciencesUniversity of Colorado Aurora Colorado

name: Department of PharmacyWashington State University Spokane Washington

name: Excelsior Springs Clinic Excelsior Springs Missouri

title: Low incidence of gastrointestinal adverse events over time with a fixed‐ratio combination of insulin glargine and lixisenatide versus lixisenatide alone

ReferenceCitation: Davies MJ, Leiter LA, Guerci B, Grunberger G, Ampudia-Blasco FJ, Yu C, Stager W, Niemoeller E, Souhami E, Rosenstock J. Impact of baseline glycated haemoglobin, diabetes duration and body mass index on clinical outcomes in the LixiLan-O trial testing a titratable fixed-ratio combination of insulin glargine/lixisenatide (iGlarLixi) vs insulin glargine and lixisenatide monocomponents. Diabetes Obes Metab. 2017 Dec;19(12):1798-1804. doi: 10.1111/dom.12980. Epub 2017 Jul 7.

name: Diabetes Research CentreUniversity of Leicester Leicester UK

name: Keenan Research Centre in the Li Ka Shing Knowledge Institute of St Michael's HospitalUniversity of Toronto Toronto Canada

name: Department of Diabetology, Metabolic Diseases and Nutrition, Brabois Adult HospitalUniversity of Lorraine Vandoeuvre‐lès‐Nancy France

name: Grunberger Diabetes Institute Bloomfield Hills Michigan

name: Hospital Clínico Universitario de Valencia Valencia Spain

name: Dallas Diabetes Research Center at Medical City Dallas Texas

title: Impact of baseline glycated haemoglobin, diabetes duration and body mass index on clinical outcomes in the LixiLan‐O trial testing a titratable fixed‐ratio combination of insulin glargine/lixisenatide ( iGlarLixi ) vs insulin glargine and lixisenatide monocomponents

location_country:
Romania
Belgium
Australia
Russian Federation
Denmark
Czech Republic
Ukraine
France
Poland
Lithuania
Canada
South Africa
Chile
Sweden
Hungary
United States
Germany
United Kingdom
Italy
Mexico
Spain
Estonia
Latvia

location_facility:
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title: A Randomized, 30 Week, Active-controlled, Open-label, 3-treatment Arm, Parallel-group Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination to Insulin Glargine Alone and to Lixisenatide Alone on Top of Metformin in Patients With Type 2 Diabetes Mellitus (T2DM)

summary:
Primary Objective:

To compare the insulin glargine/lixisenatide fixed ratio combination to lixisenatide alone and to insulin glargine alone (on top of metformin treatment) in glycated hemoglobin (HbA1c) change from baseline to Week 30.

Secondary Objective:

To compare the overall efficacy and safety of insulin glargine/lixisenatide fixed ratio combination (FRC) to insulin glargine alone and to lixisenatide alone (on top of metformin treatment) over a 30 week treatment period in participants with type 2 diabetes.


location_country:
United States
Belgium
France

location_facility: Oncology and Hematology Assoc. of SW VA, Inc.

location_facility: University of Kansas Medical Center Research Institute, Inc.

location_facility: Eastchester Center for Cancer Care / BRANY

location_facility: University of Cincinnati Physicians Company, LLC

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: Santa Barbara Hematology Oncology Medical Group, Inc.

location_facility: University of California at San Francisco (PARENT)

location_facility: GZA Ziekenhuizen - Campus Sint-Augustinus

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Cancer Care Network of South Texas - SAT&BC

location_facility: Weill Cornell Medical College New York Presbyterian Hospital

location_facility: Herbert Irving Comprehensive Cancer Center

source: euctr

title: A Phase 1b/2 Study of Safety and Efficacy of MLN0128 (Dual TORC1/2 Inhibitor) in Combination With Exemestane or Fulvestrant Therapy in Postmenopausal Women With ER+/HER2- Advanced or Metastatic Breast Cancer That Has Progressed on Treatment With Everolimus in Combination With Exemestane or Fulvestrant

summary: This is a phase 1b/2 study of the safety and efficacy of sapanisertib (MLN0128) in combination with exemestane or fulvestrant therapy in women with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) advanced or metastatic breast cancer who progressed on treatment with everolimus in combination with exemestane or fulvestrant.


title: A Phase 2, Single Arm Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion

summary:
The primary objective of this study is to evaluate overall response rate (ORR) following treatment with idelalisib plus rituximab in participants with previously untreated chronic lymphocytic leukemia (CLL) with 17p deletion.

An increased rate of deaths and serious adverse events (SAEs) among participants with front-line CLL and early-line indolent non-Hodgkin lymphoma (iNHL) treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated those studies in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). All front-line studies of idelalisib, including this study, were also terminated.

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

lead_sponsor: Gilead Sciences

location_country:
Italy
Austria
Spain
France
Czechia
Poland
Romania
Hungary
Australia
Belgium
Portugal
Denmark
United States
United Kingdom

location_facility: Centre Hospitalier Universitaire Hôpital Avicenne

location_facility: Azienda Ospedaliero Universitaria Policlinico di Modena

location_facility: Centro Hospitalar De Lisboa Norte, E.P.E. - Hospital Santa Maria

location_facility: SCDU Medicina II ed Ematologia, A.O.U. San Luigi Gonzaga

location_facility: Hospital of the University of Pennsylvania, Abramson Cancer Center

location_facility: Washington University School of Medicine

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Centrum Onkologii-Instytut Marii Sklodowskiej -Curie klinika Nowotworow Ukladu Chlonnego

location_facility: Hospital Clinico Universitario De Valencia (Chuv)

location_facility: Medizinische Universität Wien, Univ. Klinik f. Innere Med. I, Abteilung für Hämatologie und Hämostaseologie

location_facility: University of Debrecen HSC Institute of internal Medicine, Department of Hematology

location_facility: Willamette Valley Cancer Center and Research Institute

location_facility: Emergency County Clinical Hospital Brasov

location_facility: Royal Liverpool & Broadgreen Univ. Hospitals

location_facility: University Hospital Southampton NHS Trust

location_facility: Institute of Hematology "L. e A. Seràgnoli"

location_facility: Innsbruck University Hospital, Inner Medicine,


ReferenceCitation: Benninga MA, Hussain SZ, Sood MR, Nurko S, Hyman P, Clifford RA, O'Gorman M, Losch-Beridon T, Mareya S, Lichtlen P, Di Lorenzo C. Lubiprostone for Pediatric Functional Constipation: Randomized, Controlled, Double-Blind Study With Long-term Extension. Clin Gastroenterol Hepatol. 2021 Apr 7. pii: S1542-3565(21)00393-1. doi: 10.1016/j.cgh.2021.04.005. [Epub ahead of print]

family: Benninga

full_name: Marc A. Benninga

given: Marc A.

family: Hussain

full_name: Sunny Z. Hussain

given: Sunny Z.

family: Sood

full_name: Manu R. Sood

given: Manu R.

family: Nurko

full_name: Samuel Nurko

given: Samuel

family: Hyman

full_name: Paul Hyman

given: Paul

family: Clifford

full_name: Robert A. Clifford

given: Robert A.

family: O’Gorman

full_name: Molly O’Gorman

given: Molly

family: Losch-Beridon

full_name: Taryn Losch-Beridon

given: Taryn

family: Mareya

full_name: Shadreck Mareya

given: Shadreck

family: Lichtlen

full_name: Peter Lichtlen

given: Peter

family: Di Lorenzo

full_name: Carlo Di Lorenzo

given: Carlo

journal_name: Clinical Gastroenterology and Hepatology

ipd_sharing_description: Basic results are provided here, with statistical results and discussion reserved for publications.

lead_sponsor: Sucampo Pharma Americas, LLC

location_country:
United States
Netherlands
France
Poland
Belgium
Canada
United Kingdom

location_facility: Nemours/Alfred I. duPont Hospital for Children

location_facility: Arizona Children's Center at Maricopa Medical Center

location_facility: University of Mississippi Medical Center

location_facility: Chelsea and Westminster Hospital NHS Foundation Trust

location_facility: The Children's Hospital of the King's Daughter

location_facility: Arkansas Children's Hospital Research Institute

location_facility: University of South Alabama Women's and Children's Hospital

location_facility: University of Oklahoma Health Sciences Center

location_facility: Children's Center for Digestive Healthcare/GI Care for Kids

location_facility: Midwest Children's Health Research Institute

location_facility: Coastal Pediatrics Associates - Mount Pleasant

location_facility: Great Ormond Street Hospital for children NHS Foundation Trust

location_facility: University of Louisville Research Foundation Inc. Kosair Charities Pediatric Clinical Research Unit

location_facility: Morgan Stanley Children's Hospital of New York Presbyterian

location_facility: Pediatric Gastroenterology Carilion Medical Center

location_facility: Digestive Diseases and Nutrition Center Women and Childrens Hospital of Buffalo

location_facility: Monroe Carell Junior Children's Hospital at Vanderbilt

location_facility: UnityPoint Health Des Moines/ Blank Children's Clinic

location_facility: INOVA Pediatric Digestive Diseases Center

location_facility: Texas Tech University Health Sciences Center

location_facility: Pediatric Research of Charlottesville, LLC

location_facility: St. Christopher's Hospital for Children/Drexel University

location_facility: MultiCare Health System Institute for Research and Innovation

location_facility: Coastal Pediatric Associates - James Island

location_facility: University of Alabama Pediatric Gastroenterology

title: A Multicentre, Randomised, Placebo-controlled, Double-blinded Study of the Efficacy, Safety, and Pharmacokinetics of Lubiprostone in Paediatric Subjects Aged ≥ 6 Years to < 18 Years With Functional Constipation

summary: Study to determine if children (6-17 years old) with functional constipation will respond to being treated with lubiprostone for 12 weeks.


title: A Phase II, Multicenter, Open Label, Single Arm Study of SAR302503 in Subjects Previously Treated With Ruxolitinib and With a Current Diagnosis of Intermediate or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis

summary:
Primary Objective:

- To evaluate the efficacy of once daily dose of SAR302503 in subjects previously treated with ruxolitinib and with a current diagnosis of intermediate-1 with symptoms, Intermediate-2 or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (Post-PV MF), or post-essential thrombocythemia myelofibrosis (Post-ET MF) based on the reduction of spleen volume at the end of 6 treatment cycles;

Secondary Objectives:

To evaluate the effect of SAR302503 on Myelofibrosis (MF) associated symptoms as measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF) diary
To evaluate the durability of splenic response
To evaluate the splenic response to SAR302503 by palpation at the end of Cycle 6
To evaluate the splenic response to SAR302503 at the end of Cycle 3
To evaluate the effect of SAR302503 on the Janus kinase 2 (JAK2) V617F allele burden
To evaluate the safety and tolerability of SAR302503 in this population
To evaluate plasma concentrations of SAR302503 for population PK analysis, if warranted

ReferenceCitation: Harrison CN, Schaap N, Vannucchi AM, Kiladjian JJ, Tiu RV, Zachee P, Jourdan E, Winton E, Silver RT, Schouten HC, Passamonti F, Zweegman S, Talpaz M, Lager J, Shun Z, Mesa RA. Janus kinase-2 inhibitor fedratinib in patients with myelofibrosis previously treated with ruxolitinib (JAKARTA-2): a single-arm, open-label, non-randomised, phase 2, multicentre study. Lancet Haematol. 2017 Jul;4(7):e317-e324. doi: 10.1016/S2352-3026(17)30088-1. Epub 2017 Jun 8.

family: Harrison

full_name: Claire N Harrison

given: Claire N

family: Schaap

full_name: Nicolaas Schaap

given: Nicolaas

family: Vannucchi

full_name: Alessandro M Vannucchi

given: Alessandro M

family: Kiladjian

full_name: Jean-Jacques Kiladjian

given: Jean-Jacques

family: Tiu

full_name: Ramon V Tiu

given: Ramon V

family: Zachee

full_name: Pierre Zachee

given: Pierre

family: Jourdan

full_name: Eric Jourdan

given: Eric

family: Winton

full_name: Elliott Winton

given: Elliott

family: Silver

full_name: Richard T Silver

given: Richard T

family: Schouten

full_name: Harry C Schouten

given: Harry C

family: Passamonti

full_name: Francesco Passamonti

given: Francesco

family: Zweegman

full_name: Sonja Zweegman

given: Sonja

family: Talpaz

full_name: Moshe Talpaz

given: Moshe

family: Lager

full_name: Joanne Lager

given: Joanne

family: Shun

full_name: Zhenming Shun

given: Zhenming

family: Mesa

full_name: Ruben A Mesa

given: Ruben A

journal_name: The Lancet Haematology

lead_sponsor: Sanofi

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

location_facility:
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