ReferenceCitation: Furie R, Rovin BH, Houssiau F, Malvar A, Teng YKO, Contreras G, Amoura Z, Yu X, Mok CC, Santiago MB, Saxena A, Green Y, Ji B, Kleoudis C, Burriss SW, Barnett C, Roth DA. Two-Year, Randomized, Controlled Trial of Belimumab in Lupus Nephritis. N Engl J Med. 2020 Sep 17;383(12):1117-1128. doi: 10.1056/NEJMoa2001180.

name: From the Division of Rheumatology, Northwell Health, Donald and Barbara Zucker School of Medicine at Hofstra–Northwell, Great Neck, NY (R.F.); the Division of Nephrology, Ohio State University, Columbus (B.H.R.); Pôle de Pathologies Rhumatismales Inflammatoires et Systémiques, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, and Service de Rhumatologie, Cliniques Universitaires Saint-Luc — both in Brussels (F.H.); Organización Médica de Investigación, Buenos Aires (A.M....

family: Furie

full_name: Richard Furie

given: Richard

family: Rovin

full_name: Brad H. Rovin

given: Brad H.

family: Houssiau

full_name: Frédéric Houssiau

given: Frédéric

family: Malvar

full_name: Ana Malvar

given: Ana

family: Teng

full_name: Y.K. Onno Teng

given: Y.K. Onno

family: Contreras

full_name: Gabriel Contreras

given: Gabriel

family: Amoura

full_name: Zahir Amoura

given: Zahir

family: Yu

full_name: Xueqing Yu

given: Xueqing

family: Mok

full_name: Chi-Chiu Mok

given: Chi-Chiu

family: Santiago

full_name: Mittermayer B. Santiago

given: Mittermayer B.

family: Saxena

full_name: Amit Saxena

given: Amit

family: Green

full_name: Yulia Green

given: Yulia

family: Ji

full_name: Beulah Ji

given: Beulah

family: Kleoudis

full_name: Christi Kleoudis

given: Christi

family: Burriss

full_name: Susan W. Burriss

given: Susan W.

family: Barnett

full_name: Carly Barnett

given: Carly

family: Roth

full_name: David A. Roth

given: David A.

journal_name: New England Journal of Medicine

evidence: open (via free article)

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

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

lead_sponsor: Human Genome Sciences Inc., a GSK Company

location_country:
Belgium
Russian Federation
Taiwan
France
Thailand
Argentina
Canada
Korea, Republic of
Colombia
Hong Kong
Netherlands
Philippines
Hungary
China
United States
Germany
United Kingdom
Brazil
Mexico
Czechia
Spain

acronym: BLISS-LN

ipd_sharing: Yes

title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Belimumab Plus Standard of Care Versus Placebo Plus Standard of Care in Adult Subjects With Active Lupus Nephritis

summary: The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab in adult patients with active lupus nephritis.


type: EudraCT Number

type: Other Identifier

title: A Randomised, Double Blind, Placebo-controlled, Multiple Dose, Phase 2b, 24 Week Trial Followed by an Open Label Extension of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Anti-TNFa Biologics

summary: This trial is conducted in Europe, North America and South America. The aim of this trial is to investigate the clinical efficacy of NNC0109-0012, a human monoclonal antibody, compared to placebo when administered as weekly s.c. (subcutaneous, under the skin) injections to patients with active rheumatoid arthritis (RA) who are inadequate responders to anti-TNFa biologics and are on a stable background of methotrexate (MTX) therapy.

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Novo Nordisk A/S

location_country:
Italy
Brazil
Mexico
Germany
France
Czechia
Poland
Hungary
Belgium
Argentina
Spain
United States
United Kingdom

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


title: A Phase 2, Open-Label Study of Daclatasvir (BMS-790052) and TMC435 in Combination With or Without Ribavirin (RBV) For Treatment-Naive Subjects or Null Responders to Prior Peginterferon Alfa (PegIFN)/RBV Therapy With Genotype 1 Chronic Hepatitis C

summary: The purpose of this study is to assess the safety and efficacy of daclatasvir and simeprevir with and without ribavirin for genotype 1 chronic hepatitis C virus infection in patients who are treatment-naive or null responders to previous pegylated interferon/ribavirin therapy.

status: Completed

ReferenceType: derived

ReferenceCitation: Zeuzem S, Hézode C, Bronowicki JP, Loustaud-Ratti V, Gea F, Buti M, Olveira A, Banyai T, Al-Assi MT, Petersen J, Thabut D, Gadano A, Pruitt R, Makara M, Bourlière M, Pol S, Beumont-Mauviel M, Ouwerkerk-Mahadevan S, Picchio G, Bifano M, McPhee F, Boparai N, Cheung K, Hughes EA, Noviello S; LEAGUE-1 Study Team. Daclatasvir plus simeprevir with or without ribavirin for the treatment of chronic hepatitis C virus genotype 1 infection. J Hepatol. 2016 Feb;64(2):292-300. doi: 10.1016/j.jhep.2015.09.024. Epub 2015 Oct 8.

family: Zeuzem

full_name: Stefan Zeuzem

given: Stefan

sequence: first

family: Hézode

full_name: Christophe Hézode

given: Christophe

sequence: additional

family: Bronowicki

full_name: Jean-Pierre Bronowicki

given: Jean-Pierre

family: Loustaud-Ratti

full_name: Veronique Loustaud-Ratti

given: Veronique

family: Gea

full_name: Francisco Gea

given: Francisco

family: Buti

full_name: Maria Buti

given: Maria

family: Olveira

full_name: Antonio Olveira

given: Antonio

family: Banyai

full_name: Tivadar Banyai

given: Tivadar

family: Al-Assi

full_name: M. Tarek Al-Assi

given: M. Tarek

family: Petersen

full_name: Joerg Petersen

given: Joerg

family: Thabut

full_name: Dominique Thabut

given: Dominique

family: Gadano

full_name: Adrian Gadano

given: Adrian

family: Pruitt

full_name: Ronald Pruitt

given: Ronald

family: Makara

full_name: Mihály Makara

given: Mihály

family: Bourlière

full_name: Marc Bourlière

given: Marc

family: Pol

full_name: Stanislas Pol

given: Stanislas

family: Beumont-Mauviel

full_name: Maria Beumont-Mauviel

family: Ouwerkerk-Mahadevan

full_name: Sivi Ouwerkerk-Mahadevan

given: Sivi

family: Picchio

full_name: Gaston Picchio

given: Gaston

family: Bifano

full_name: Marc Bifano

family: McPhee

full_name: Fiona McPhee

given: Fiona

family: Boparai

full_name: Navdeep Boparai

given: Navdeep

family: Cheung

full_name: Kin Cheung

given: Kin

location_country:
United States
France
Hungary
Argentina
Spain
Germany

location_facility:
Kaiser Permanente Med Ctr
Nashville Medical Research Institute
Johns Hopkins University
Texas Clinical Research Institute, Llc
Indiana University
Metropolitan Research
Local Institution
San Francisco General Hospital


title: A Double-blind, Randomized, Placebo-controlled, Parallel, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-00547659 In Subjects With Moderate To Severe Ulcerative Colitis (Turandot)

acronym: TURANDOT

summary: To determine the dose or doses of PF-00547659 that will be the most effective to improve or halt the disease symptoms in patients with moderate to severe ulcerative colitis.

study_start_date_type: Actual

ReferenceCitation: Zhou H, Xi L, Ziemek D, O'Neil S, Lee J, Stewart Z, Zhan Y, Zhao S, Zhang Y, Page K, Huang A, Maciejewski M, Zhang B, Gorelick KJ, Fitz L, Pradhan V, Cataldi F, Vincent M, Von Schack D, Hung K, Hassan-Zahraee M. Molecular Profiling of Ulcerative Colitis Subjects from the TURANDOT Trial Reveals Novel Pharmacodynamic/Efficacy Biomarkers. J Crohns Colitis. 2019 May 27;13(6):702-713. doi: 10.1093/ecco-jcc/jjy217.

family: Zhou

full_name: Huanyu Zhou

given: Huanyu

family: Xi

full_name: Li Xi

given: Li

family: Ziemek

full_name: Daniel Ziemek

given: Daniel

family: O’Neil

full_name: Shawn O’Neil

given: Shawn

family: Lee

full_name: Julie Lee

given: Julie

family: Stewart

full_name: Zachary Stewart

given: Zachary

family: Zhan

full_name: Yutian Zhan

given: Yutian

family: Zhao

full_name: Shanrong Zhao

given: Shanrong

family: Zhang

full_name: Ying Zhang

given: Ying

family: Page

full_name: Karen Page

given: Karen

family: Huang

full_name: Austin Huang

given: Austin

family: Maciejewski

full_name: Mateusz Maciejewski

given: Mateusz

full_name: Baohong Zhang

given: Baohong

family: Gorelick

full_name: Kenneth J Gorelick

given: Kenneth J

family: Fitz

full_name: Lori Fitz

given: Lori

family: Pradhan

full_name: Vivek Pradhan

given: Vivek

family: Cataldi

full_name: Fabio Cataldi

given: Fabio

family: Vincent

full_name: Michael Vincent

given: Michael

family: Von Schack

full_name: David Von Schack

given: David

family: Hung

full_name: Kenneth Hung

given: Kenneth

family: Hassan-Zahraee

full_name: Mina Hassan-Zahraee

given: Mina

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Crohn's and Colitis

ReferenceCitation: Vermeire S, Sandborn WJ, Danese S, Hébuterne X, Salzberg BA, Klopocka M, Tarabar D, Vanasek T, Greguš M, Hellstern PA, Kim JS, Sparrow MP, Gorelick KJ, Hinz M, Ahmad A, Pradhan V, Hassan-Zahraee M, Clare R, Cataldi F, Reinisch W. Anti-MAdCAM antibody (PF-00547659) for ulcerative colitis (TURANDOT): a phase 2, randomised, double-blind, placebo-controlled trial. Lancet. 2017 Jul 8;390(10090):135-144. doi: 10.1016/S0140-6736(17)30930-3. Epub 2017 May 17. Erratum in: Lancet. 2019 Dec 22;392(10165):2696.

location_country:
Australia
Belgium
Russian Federation
France
Poland
Slovakia
Canada
Korea, Republic of
South Africa
Netherlands
Bulgaria
Hungary
Germany
United States
Italy
Austria
Serbia
Czechia
Israel
New Zealand
Spain

location_facility: Weill Cornell Medical College of Cornell University

location_facility: Centrum Medyczne - Szpital Swietej Rodziny Sp. z o.o.

location_facility: New York Presbyterian Hospital - Weill Cornell Medical College

location_facility: Premier Medical Group of the Hudson Valley, PC

location_facility: Vanderbilt University Medical Center: Drug Shipment

location_facility: Clinical Hospital Center Zemun, Gastroenterology and Hepatology Department

location_facility: Office of Drs. Ranjit Andrew Singh and Jamie D. Papp

location_facility: UNC Hospitals Endoscopy Center At Meadowmont

location_facility: Premier Medical Group Research Department - Drug

location_facility: SBEI of HPE North-West State Medical University n.a. I.I. Mechnikov of the MH of the RF St.P SBIH "

location_facility: Barnes-Jewish Hospital Radiology (X-Ray Only)

location_facility: The Oregon Clinic, PC - Gastroenterology West

location_facility: Vanderbilt University Medical Center: IBD Clinic

location_facility: Universita Cattolica Sacro Cuore Policlinico "A. Gemelli"

location_facility: Hamilton Health Sciences Corporation, McMaster University Medical Centre

location_facility: Vanderbilt University Medical Center: Endoscopy Lab

location_facility: Dept. of Gastroenterology & Hepatology, Meir Medical Center

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Vanderbilt University Medical Center: GI Clinical Research

location_facility: Baylor College Of Medicine - Baylor Medical Center

location_facility: London Health Sciences Centre - University Hospital

location_facility: Gastroenterology Associates of Western Michigan

location_facility: MBAL Sveti Ivan Rilski, Klinika po Gastroenterologia

location_facility: GastroDiagnostics - Community Clinical Trials Drug

location_facility: Gastroenterology Center of Connecticut, PC

location_facility: Barnes-Jewish Hospital Investigational Drug Service (IP Shipping Address)

location_facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Azienda Ospedaliera Universitaria, Policlinico Tor Vergata

location_facility: Vanderbilt University Medical Center: Outpatient Radiology

location_facility: IBD Center - Divisione Gastroenterologia - Istituto Clinico Humanitas IRCCS

location_facility: Policlinico Universitario Campus Bio-Medico

location_facility: Azienda Ospedaliera -Università di Padova

location_facility: Klinika Chorob Wewnetrznych i Gastroenterologii z Pododdzialem

location_facility: Universita' degli Studi "Magna Graecia" di Catanzaro, UO di Fisiopatologia Digestiva

location_facility: University of Nevada School of Medicine (UNSOM)

location_facility: Centre Hospitalier Universitaire (CHU) de Caen - Hopital Cote de Nacre

location_facility: Pavillion Rachel Tourigny, Hopital Maisonneuve-Rosemont

location_facility: Hôpital Nord Service de Gastro-entérologie

location_facility: Steinberg Diagnostic Medical Imaging Centers

location_facility: Rocky Mountain Gastroenterology Associates

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

location_facility: University of North Carolina at Chapel Hill

location_facility: Washington University School of Medicine

location_facility: Yonsei University College of Medicine, Severance Hospital

location_facility: Clinical Centre of Nis, Clinic for Gastroenterology and Hepatology

location_facility: Clinical and Translational Research Institute

location_facility: AKH Wien, Universitaetsklinik fuer Innere Medizin III

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

location_facility: Wojskowy Szpital Kliniczny z Poliklinika SPOZ

location_facility: Clinical Hospital Centre Bezanijska Kosa, Clinic for Internal medicine

location_facility: Gastroenterology and Liver Diseases Unit - Hadassah Ein Kerem University Hospital

location_facility: Covance Central Laboratory Services, Inc

location_facility: Centrum Medyczne HCP Lecznictwo Ambulatoryjne Pracownia Endoskopowa

location_facility: University of Miami Hospital and Clinic - Local Lab

location_facility: Clinical Hospital Centre Zvezdara Clinic for Gastroenterology and Hepatology

location_facility: Weill Cornell Medical College - New York Presbyterian Hospital

location_facility: University Medical Center Groningen (UMCG)

location_facility: Ustredna vojenska nemocnice SNP Ruzomberok

location_facility: Academic Medical Center - University of Amsterdam

location_facility: Gastroenterology Division, Rabin Medical Center, Beilinson Campus

location_facility: University of Kentucky Chandler Medical Center

location_facility: Houston Hospital for Specialized Surgery

location_facility: Department of Pharmacy Investigational Drug Services

location_facility: Centrum endoskopii Zabiegowej, Poradnia Chorob Jelitowych,


title: Randomized, Double-blind, Placebo-controlled Phase 3 Study of Ibrutinib, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Combination With Bendamustine and Rituximab (BR) in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

summary: The purpose of this study is to examine the safety and efficacy of Ibrutinib administered in combination with bendamustine and rituximab in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

ReferenceCitation: Fraser GAM, Chanan-Khan A, Demirkan F, Santucci Silva R, Grosicki S, Janssens A, Mayer J, Bartlett NL, Dilhuydy MS, Loscertales J, Avigdor A, Rule S, Samoilova O, Pavlovsky MA, Goy A, Mato A, Hallek M, Salman M, Tamegnon M, Sun S, Connor A, Nottage K, Schuier N, Balasubramanian S, Howes A, Cramer P. Final 5-year findings from the phase 3 HELIOS study of ibrutinib plus bendamustine and rituximab in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma. Leuk Lymphoma. 2020 Dec;61(13):3188-3197. doi: 10.1080/10428194.2020.1795159. Epub 2020 Aug 6.

name: Juravinski Cancer Centre, McMaster University, Hamilton, Canada

family: Fraser

full_name: Graeme A.M. Fraser

given: Graeme A.M.

name: Division of Hematology, Mayo Clinic Cancer Center, Jacksonville, FL, USA

family: Chanan-Khan

full_name: Asher Chanan-Khan

given: Asher

name: Division of Hematology, Dokuz Eylul University, Izmir, Turkey

family: Demirkan

full_name: Fatih Demirkan

given: Fatih

name: IEP São Lucas/Hemomed Oncologia e Hematologia, São Paulo, Brazil

family: Santucci Silva

full_name: Rodrigo Santucci Silva

given: Rodrigo

name: Department of Hematology and Cancer Prevention, School of Public Health, Silesian Medical University, Katowice, Poland

family: Grosicki

full_name: Sebastian Grosicki

given: Sebastian

name: Universitaire Ziekenhuizen Leuven, Leuven, Belgium

family: Janssens

full_name: Ann Janssens

given: Ann

name: Department of Internal Medicine, Hematology and Oncology, University Hospital Brno, Jihlavska, Brno, Czech Republic

family: Mayer

full_name: Jiri Mayer

given: Jiri

name: Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, USA

family: Bartlett

full_name: Nancy L. Bartlett

given: Nancy L.

family: Dilhuydy

full_name: Marie-Sarah Dilhuydy

given: Marie-Sarah

name: Hematology Department, Hospital Universitario La Princesa, IIS-IP, Madrid, Spain

family: Loscertales

full_name: Javier Loscertales

given: Javier

name: Division of Hematology and Bone Marrow Transplantation, Chaim Sheba Medical Center, Tel-Hashomer and Sackler School of Medicine, University of Tel-Aviv, Tel-Aviv, Israel

family: Avigdor

full_name: Abraham Avigdor

given: Abraham

name: Department of Haematology, University of Plymouth Medical School, Plymouth, UK

family: Rule

full_name: Simon Rule

given: Simon

name: Nizhny Novogorod Regional Clinical Hospital, Nizhny Novogorod, Russia

family: Samoilova

full_name: Olga Samoilova

given: Olga

name: Department of Hematology, Fundaleu, Buenos Aires, Argentina

family: Pavlovsky

full_name: Miguel A. Pavlovsky

given: Miguel A.

name: John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ, USA

family: Goy

full_name: Andre Goy

given: Andre

name: Memorial Sloan-Kettering Cancer Center, NY, USA

family: Mato

full_name: Anthony Mato

given: Anthony

name: Department I of Internal Medicine and German CLL Study Group, University of Cologne, Faculty of Medicine and University Hospital of Cologne, Cologne, Germany

family: Hallek

full_name: Michael Hallek

name: Janssen Research & Development, Raritan, NJ, USA

family: Salman

full_name: Mariya Salman

given: Mariya

family: Tamegnon

full_name: Monelle Tamegnon

given: Monelle

family: Sun

full_name: Steven Sun

given: Steven

name: Janssen Research & Development, Spring House, PA, USA

family: Connor

full_name: Anne Connor

given: Anne

family: Nottage

full_name: Kerri Nottage

given: Kerri

family: Schuier

name: Janssen Research & Development, High Wycombe, UK

ReferenceCitation: Lavezzi SM, de Jong J, Neyens M, Cramer P, Demirkan F, Fraser G, Bartlett N, Dilhuydy MS, Loscertales J, Avigdor A, Rule S, Samoilova O, Goy A, Ganguly S, Salman M, Howes A, Mahler M, De Nicolao G, Poggesi I. Systemic Exposure of Rituximab Increased by Ibrutinib: Pharmacokinetic Results and Modeling Based on the HELIOS Trial. Pharm Res. 2019 May 1;36(7):93. doi: 10.1007/s11095-019-2605-8.

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.

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

repository_institution: University of California - eScholarship University of California

repository_normalized: California Digital Library - eScholarship

publisher: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Chanan-Khan A, Cramer P, Demirkan F, Fraser G, Silva RS, Grosicki S, Pristupa A, Janssens A, Mayer J, Bartlett NL, Dilhuydy MS, Pylypenko H, Loscertales J, Avigdor A, Rule S, Villa D, Samoilova O, Panagiotidis P, Goy A, Mato A, Pavlovsky MA, Karlsson C, Mahler M, Salman M, Sun S, Phelps C, Balasubramanian S, Howes A, Hallek M; HELIOS investigators. Ibrutinib combined with bendamustine and rituximab compared with placebo, bendamustine, and rituximab for previously treated chronic lymphocytic leukaemia or small lymphocytic lymphoma (HELIOS): a randomised, double-blind, phase 3 study. Lancet Oncol. 2016 Feb;17(2):200-211. doi: 10.1016/S1470-2045(15)00465-9. Epub 2015 Dec 5.

location_country:
Greece
Belgium
Russian Federation
Ukraine
France
Poland
Argentina
Canada
Korea, Republic of
Colombia
Sweden
Portugal
United States
Germany
United Kingdom
Brazil
Mexico
Czechia
Israel
Spain
Turkey


ReferenceCitation: Curran D, Matthews S, Rowley SD, Young JH, Bastidas A, Anagnostopoulos A, Barista I, Chandrasekar PH, Dickinson M, El Idrissi M, Heras I, Milliken ST, Monserrat Coll J, Navarro Matilla MB, Oostvogels L, Piątkowska-Jakubas B, Quiel D, Sabry W, Schwartz S, Selleslag DLD, Sullivan KM, Theunissen K, Yegin ZA, Yeh SP, Zaja F, Szer J; ZOE-HSCT Study group collaborators. Recombinant Zoster Vaccine Significantly Reduces the Impact on Quality of Life Caused by Herpes Zoster in Adult Autologous Hematopoietic Stem Cell Transplant Recipients: A Randomized Placebo-Controlled Trial (ZOE-HSCT). Biol Blood Marrow Transplant. 2019 Dec;25(12):2474-2481. doi: 10.1016/j.bbmt.2019.07.036. Epub 2019 Aug 5.

family: Curran

full_name: Desmond Curran

given: Desmond

family: Matthews

full_name: Sean Matthews

given: Sean

family: Rowley

full_name: Scott D. Rowley

given: Scott D.

family: Young

full_name: Jo-Anne H. Young

given: Jo-Anne H.

family: Bastidas

full_name: Adriana Bastidas

given: Adriana

family: Anagnostopoulos

full_name: Achilles Anagnostopoulos

given: Achilles

family: Barista

full_name: Ibrahim Barista

given: Ibrahim

family: Chandrasekar

full_name: Pranatharthi Haran Chandrasekar

given: Pranatharthi Haran

family: Dickinson

full_name: Michael Dickinson

given: Michael

family: El Idrissi

full_name: Mohamed El Idrissi

given: Mohamed

family: Heras

full_name: Inmaculada Heras

given: Inmaculada

family: Milliken

full_name: Samuel T. Milliken

given: Samuel T.

family: Monserrat Coll

full_name: Jorge Monserrat Coll

given: Jorge

family: Navarro Matilla

full_name: María Belén Navarro Matilla

given: María Belén

family: Oostvogels

full_name: Lidia Oostvogels

given: Lidia

family: Piątkowska-Jakubas

full_name: Beata Piątkowska-Jakubas

given: Beata

family: Quiel

full_name: Dimas Quiel

given: Dimas

family: Sabry

full_name: Waleed Sabry

given: Waleed

family: Schwartz

full_name: Stefan Schwartz

given: Stefan

family: Selleslag

full_name: Dominik L.D. Selleslag

given: Dominik L.D.

family: Sullivan

full_name: Keith M. Sullivan

given: Keith M.

family: Theunissen

full_name: Koen Theunissen

given: Koen

family: Yegin

full_name: Zeynep Arzu Yegin

given: Zeynep Arzu

family: Yeh

full_name: Su-Peng Yeh

given: Su-Peng

family: Zaja

full_name: Francesco Zaja

given: Francesco

journal_name: Biology of Blood and Marrow Transplantation

repository_institution: University of Trieste https://www.units.it/ - ArTS Archivio della ricerca di Trieste

ReferenceCitation: Bastidas A, de la Serna J, El Idrissi M, Oostvogels L, Quittet P, López-Jiménez J, Vural F, Pohlreich D, Zuckerman T, Issa NC, Gaidano G, Lee JJ, Abhyankar S, Solano C, Perez de Oteyza J, Satlin MJ, Schwartz S, Campins M, Rocci A, Vallejo Llamas C, Lee DG, Tan SM, Johnston AM, Grigg A, Boeckh MJ, Campora L, Lopez-Fauqued M, Heineman TC, Stadtmauer EA, Sullivan KM; ZOE-HSCT Study Group Collaborators. Effect of Recombinant Zoster Vaccine on Incidence of Herpes Zoster After Autologous Stem Cell Transplantation: A Randomized Clinical Trial. JAMA. 2019 Jul 9;322(2):123-133. doi: 10.1001/jama.2019.9053. Erratum in: JAMA. 2019 Aug 27;322(8):785.

name: Hospital Universitario 12 de Octubre, Madrid, Spain

name: University Hospital of Montpellier, Montpellier, France

name: Ege University Medical School, Izmir, Turkey

name: Charles University Hospital, Prague, Czech Republic

name: Rambam Health Care Campus, Haifa, Israel

name: Brigham and Women’s Hospital/Dana-Farber Cancer Institute, Boston, Massachusetts

name: Department of Translational Medicine, University of Eastern Piedmont, Novara, Italy

name: Chonnam National University Hwasun Hospital, Jellanamdo, Republic of Korea

name: University of Kansas Cancer Center, Westwood

name: Hospital Clínico Universitario, School of Medicine, University of Valencia, Valencia, Spain

name: Centro Integral Oncológico Clara Campal (CIOCC), Universidad CEU San Pablo, Madrid, Spain

name: Weill Medical College of Cornell University, New York, New York

name: Department of Hematology and Oncology, Charité University Medical Center, Berlin, Germany

name: Preventive Medicine and Epidemiology Department, University Hospital Vall d’Hebron, Barcelona, Spain

name: Haematology Department, Manchester University NHS Foundation Trust, Manchester Royal Infirmary, Manchester, England

name: Faculty of Biology, Medicine and Health, School of Medical Science, Division of Cancer Sciences, University of Manchester, Manchester, England

name: Hospital de Donostia, San Sebastián, Spain

name: Department of Internal Medicine, Seoul St Mary’s Hospital, College of Medicine, Catholic University of Korea, Seoul, South Korea

name: Royal Hobart Hospital, Hobart, Australia

name: Department of Clinical Haematology, Austin Health, Heidelberg, Australia

name: Fred Hutchinson Cancer Research Center, Seattle, Washington

name: Halozyme Therapeutics, San Diego, California

name: University of Pennsylvania, Philadelphia

name: Duke University Medical Center, Durham, North Carolina

name: for the ZOE-HSCT Study Group Collaborators

location_country:
Finland
Malaysia
Greece
Romania
Belgium
Australia
Russian Federation
Taiwan
France
Japan
Panama
Poland
Canada
Korea, Republic of
Turkey
South Africa
Hong Kong
Netherlands
Bulgaria
United States
Germany
United Kingdom
Italy
Czechia
Israel
New Zealand
Spain
Estonia

title: Observer-blind Study to Evaluate Efficacy, Safety, and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A

summary: The purpose of this study is to evaluate the efficacy of GSK Biologicals' vaccine GSK1437173A in the prevention of Herpes zoster (HZ) in autologous haematopoietic cell transplant recipients 18 years of age and older. To this end, the study will evaluate vaccine efficacy (VE) of the GSK1437173A vaccine, administered on a 2-dose schedule, compared to placebo in reducing the risk of developing HZ in this population.


type: Registry Identifier

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate Cardiovascular Outcomes of TAK-875, 50 mg in Addition to Standard of Care in Subjects With Type 2 Diabetes and With Cardiovascular Disease or Multiple Risk Factors for Cardiovascular Events

summary: The purpose of this study is to demonstrate no excess risk of cardiovascular (CV) composite events exists following long term treatment with TAK-875 compared with placebo.

ReferenceCitation: Shavadia JS, Sharma A, Gu X, Neaton J, DeLeve L, Holmes D, Home P, Eckel RH, Watkins PB, Granger CB. Determination of fasiglifam-induced liver toxicity: Insights from the data monitoring committee of the fasiglifam clinical trials program. Clin Trials. 2019 Jun;16(3):253-262. doi: 10.1177/1740774519836766. Epub 2019 Mar 18.

name: Duke Clinical Research Institute, Durham, NC, USA

name: Division of Cardiology, Department of Medicine, University of Saskatchewan, Saskatoon, SK, Canada

family: Shavadia

full_name: Jay S Shavadia

given: Jay S

family: Sharma

full_name: Abhinav Sharma

given: Abhinav

family: Gu

full_name: Xiangqiong Gu

given: Xiangqiong

name: School of Public Health, University of Minnesota, Minneapolis, MN, USA

family: Neaton

full_name: James Neaton

given: James

name: Keck School of Medicine, University of Southern California, Los Angeles, CA, USA

family: DeLeve

full_name: Laurie DeLeve

given: Laurie

family: Holmes

full_name: David Holmes

given: David

name: Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK

family: Home

full_name: Phillip Home

given: Phillip

name: Division of Endocrinology, Metabolism & Diabetes, University of Colorado, Boulder, CO, USA

family: Eckel

full_name: Robert H Eckel

given: Robert H

name: Institute for Drug Safety Sciences, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA

family: Watkins

full_name: Paul B Watkins

given: Paul B

family: Granger

full_name: Christopher B Granger

given: Christopher B

journal_name: Clinical Trials

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

ReferenceCitation: Menon V, Lincoff AM, Nicholls SJ, Jasper S, Wolski K, McGuire DK, Mehta CR, Rosenstock J, Lopez C, Marcinak J, Cao C, Nissen SE; GRAND 306 Investigators. Fasiglifam-Induced Liver Injury in Patients With Type 2 Diabetes: Results of a Randomized Controlled Cardiovascular Outcomes Safety Trial. Diabetes Care. 2018 Dec;41(12):2603-2609. doi: 10.2337/dc18-0755.

family: Menon

full_name: Venu Menon

given: Venu

family: Lincoff

full_name: A. Michael Lincoff

given: A. Michael

family: Nicholls

full_name: Stephen J. Nicholls

given: Stephen J.

family: Jasper

full_name: Susan Jasper

given: Susan

family: Wolski

full_name: Kathy Wolski

given: Kathy

family: McGuire

full_name: Darren K. McGuire

given: Darren K.

family: Mehta

full_name: Cyrus R. Mehta

given: Cyrus R.

family: Rosenstock

full_name: Julio Rosenstock

given: Julio

family: Lopez

full_name: Claudia Lopez

given: Claudia

location_country:
Peru
Malaysia
Romania
Australia
Russian Federation
Czech Republic
Taiwan
Ukraine
Croatia
France
Lithuania
Poland
Slovakia
Thailand
Argentina
Canada
Korea, Republic of
South Africa
Hong Kong
Philippines
Bulgaria
Hungary
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Israel
New Zealand
Estonia
Latvia


ReferenceCitation: Oza AM, Dubois F, Hegg R, Hernández CA, Finocchiaro G, Ghiringhelli F, Zamagni C, Nick S, Irahara N, Perretti T, Colombo N. A Long-Term Extension Study of Bevacizumab in Patients With Solid Tumors. Oncologist. 2021 Sep 9. doi: 10.1002/onco.13971. [Epub ahead of print]

name: Princess Margaret Cancer Centre, University Health Network and Mt Sinai Health System  Toronto Ontario Canada

family: Oza

full_name: Amit M. Oza

given: Amit M.

name: Centre Hospitalier Régional Universitaire de Lille  Lille France

family: Dubois

full_name: François Dubois

given: François

name: Centro de Referência da Saúde da Mulher  São Paulo Brazil

family: Hegg

full_name: Roberto Hegg

given: Roberto

name: Hospital Regional Presidente Juárez, Institute for Social Security and Services for State Workers  Oaxaca Mexico

family: Hernández

full_name: Carlos Alberto Hernández

given: Carlos Alberto

name: Department of Neurology, Istituto di Ricovero e Cura a Carattere Scientifico Ospedale San Raffaele  Milano Italy

family: Finocchiaro

full_name: Gaetano Finocchiaro

given: Gaetano

name: Department of Medical Oncology, Center Georges François Leclerc, Research Platform in Biological Oncology, Genetic and Immunology Medical Institute, University of Burgundy‐Franche Comté, UMR INSERM 1231  Dijon France

family: Ghiringhelli

full_name: François Ghiringhelli

name: Istituto di Ricovero e Cura a Carattere Scientifico S Azienda Ospedaliero‐universitaria di Bologna  via Albertoni 15 Bologna Italy

family: Zamagni

full_name: Claudio Zamagni

given: Claudio

name: F. Hoffmann‐La Roche Ltd  Basel Switzerland

family: Nick

full_name: Sonja Nick

given: Sonja

family: Irahara

full_name: Natsumi Irahara

given: Natsumi

family: Perretti

full_name: Thomas Perretti

given: Thomas

name: Università Milano‐Bicocca, and Programma Ginecologia, Istituto Europeo Oncologia, Istituto di Ricovero e Cura a Carattere Scientifico  Milano Italy

family: Colombo

full_name: Nicoletta Colombo

given: Nicoletta

journal_name: The Oncologist

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: A Long‐Term Extension Study of Bevacizumab in Patients With Solid Tumors

design_allocation: Non-Randomized

lead_sponsor: Hoffmann-La Roche

location_country:
Romania
Russian Federation
Estonia
France
Slovakia
Canada
Korea, Republic of
South Africa
Sweden
Netherlands
Bulgaria
Hungary
Germany
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Spain
Turkey

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Blokhin Cancer Research Center; Combined Treatment

location_facility: Hopital Roger Salengro; Service de Neurologie

location_facility: Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica

location_facility: North Estonia Medical Centre Foundation; Oncology Center

location_facility: Centro Catanese Di Oncologia; Oncologia Medica

location_facility: P.A. Gertsen Cancer Research Inst. ; Chemotherapy Dept

location_facility: Centre Georges François Leclerc; Service Pharmacie, Bp 77980

location_facility: Klinikum Joh.Wolfg.Goethe-UNI Senckenbergisches Institut für Neuroonkologie

location_facility: Fundación Rodolfo Padilla Padilla, A.C.; Oncology

location_facility: Hospital de Basurto; Servicio de Oncologia

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: Addenbrooke'S Hospital; Dept of Neurosurgery

location_facility: North Wales Cancer Treatment Centre, Glan Clwyd Hospital

location_facility: Russian Research Center of Roentgenoradiology; Dept of Chemotherapy

location_facility: A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii

location_facility: Instituto Nacional de Cancerologia; Oncology

location_facility: Hospital de Cruces; Servicio de Oncologia

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

location_facility: Fondazione IRCCS Istituto Neurologico C. Besta; Neuro-oncologia Sperimentale e Terapia Genica

location_facility: Universitetssjukhuset Örebro, Onkologiska kliniken

location_facility: A.O. Universitaria Federico II Di Napoli; Oncologia Ed Endocrinologia Clinica

location_facility: Complejo Asistencial Universitario De Burgos; Servicio de Oncologia

location_facility: National Cancer Center; Medical Oncology

location_facility: Medical Radiological Scientific Center; Department of Radiotherapy of Gynaecological Disease

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Orszagos Onkologiai Intezet; Nogyogyaszati Osztaly

location_facility: Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology

location_facility: Ospedale Nuovo Della Versilia; Divisione Di Oncologia Medica

location_facility: Bashkirian Republican Clinical Oncology Dispensary

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología

location_facility: Wits Donald Gordon Clinical Trial Centre; Medical Oncology

location_facility: Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia

location_facility: Altai Region Oncology Dispensory; Oncology

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1

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

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

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

location_facility: Ospedale Antonio Perrino; Oncologia Medica

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Ospedale Misericordia E Dolce; Oncologia Medica

location_facility: Hospital Araujo Jorge; Departamento de Ginecologia E Mama

location_facility: Azienda Ospedaliera Le Molintte di Torino; Dipartimento Di Neurologia - Oncologia

location_facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept

source: euctr

title: A Single Arm, Open Label Multicentre Extension Study of Bevacizumab in Patients With Solid Tumours on Study Treatment With Bevacizumab, at the End of A F. Hoffmann-La Roche and/or Genentech Sponsored Study

summary: This single-arm, open-label, multicenter extension study will provide continued bevacizumab therapy to participants with solid tumors who were previously enrolled in a Roche/Genentech sponsored study and who derived benefit from the bevacizumab therapy. Participants will receive the same dose and regimen of bevacizumab as used in the previous parent trial and continue this treatment until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.

status_simplified: Completed


title: A Multicenter, Double-blind, Randomized Withdrawal Extension Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate Long-term Efficacy, Safety, and Tolerability up to 4 Years in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Completing Preceding Psoriasis Phase III Studies With Secukinumab

summary: This was an extension study of secukinumab prefilled syringes in subjects with moderate to severe chronic plaque-type psoriasis completing preceding psoriasis phase III studies with secukinumab. Subjects on secukinumab at the end of treatment period in phase III studies (e.g., ongoing CAIN457A2302 and CAIN457A2303 and potentially other secukinumab phase III studies) were eligible to join this extension study. This extension study was planned to collect an additional 2 years of long-term efficacy, safety, and tolerability data of secukinumab in either continuous or interrupted therapy (randomized withdrawal period) in subjects showing at least partial response to secukinumab and completing treatment period on secukinumab in previous phase III studies. In this extension study, the prefilled syringe (PFS) liquid formulation of secukinumab were used.

ipd_sharing: Undecided

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Guatemala
Finland
Romania
Belgium
Australia
Taiwan
Iceland
France
Japan
Lithuania
Poland
Argentina
Canada
Korea, Republic of
Colombia
Sweden
Singapore
Hungary
United States
Germany
United Kingdom
Italy
Israel
Spain
Estonia
Latvia


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia

summary: This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effect of idelalisib in combination with rituximab on the onset, magnitude, and duration of tumor control in participants previously treated for chronic lymphocytic leukemia (CLL). Eligible patients will be randomized with a 1:1 ratio into 1 of the 2 treatment arms to receive either idelalisib plus rituximab or placebo plus rituximab. Participants who are tolerating primary study therapy but experience definitive CLL progression are eligible to receive active idelalisib therapy in the extension study, GS-US-312-0117.

ReferenceCitation: Barrientos JC, Hillmen P, Salles G, Sharman J, Stilgenbauer S, Gurtovaya O, Xing G, Ruzicka B, Bhargava P, Ghia P, Pagel JM. No increased bleeding events in patients with relapsed chronic lymphocytic leukemia and indolent non-Hodgkin lymphoma treated with idelalisib. Leuk Lymphoma. 2021 Apr;62(4):837-845. doi: 10.1080/10428194.2020.1845339. Epub 2020 Dec 10.

name: Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA

family: Barrientos

full_name: Jacqueline C. Barrientos

given: Jacqueline C.

name: St. James’s University Hospital, Leeds, UK

family: Hillmen

full_name: Peter Hillmen

given: Peter

name: Hospices Civils de Lyon, University Claude Bernard, Pierre Benite, France

family: Salles

full_name: Gilles Salles

given: Gilles

name: Willamette Valley Cancer Institute and Research Center/US Oncology Research, Springfield, OR, USA

family: Sharman

full_name: Jeff Sharman

given: Jeff

name: Department of Medicine III, University of Ulm, Ulm, Germany

family: Stilgenbauer

full_name: Stephan Stilgenbauer

given: Stephan

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

family: Gurtovaya

full_name: Oksana Gurtovaya

given: Oksana

family: Xing

full_name: Guan Xing

given: Guan

family: Ruzicka

full_name: Bianca Ruzicka

given: Bianca

family: Bhargava

full_name: Pankaj Bhargava

given: Pankaj

name: Università Vita-Salute San Raffaele and IRCCS Instituto Scientifico San Raffaele, Milano, Italy

family: Ghia

full_name: Paolo Ghia

given: Paolo

name: Swedish Cancer Institute, Seattle, WA, USA

family: Pagel

full_name: John M. Pagel

given: John M.

journal_name: Leukemia & Lymphoma

oa_colors: green hybrid

oa_host_type: publisher;repository

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

host_type: repository

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ReferenceCitation: Gordon MJ, Huang J, Chan RJ, Bhargava P, Danilov AV. Medical comorbidities in patients with chronic lymphocytic leukaemia treated with idelalisib: analysis of two large randomised clinical trials. Br J Haematol. 2021 Feb;192(4):720-728. doi: 10.1111/bjh.16879. Epub 2020 Jun 29.

name: Oregon Health and Science University Portland OR USA

family: Gordon

full_name: Max J. Gordon

given: Max J.

family: Huang

full_name: Julie Huang

given: Julie

family: Chan

full_name: Rebecca J. Chan

given: Rebecca J.

name: City of Hope National Medical Center Duarte CA USA

family: Danilov

full_name: Alexey V. Danilov

given: Alexey V.

journal_name: British Journal of Haematology

ReferenceCitation: Furman RR, Sharman JP, Coutre SE, Cheson BD, Pagel JM, Hillmen P, Barrientos JC, Zelenetz AD, Kipps TJ, Flinn I, Ghia P, Eradat H, Ervin T, Lamanna N, Coiffier B, Pettitt AR, Ma S, Stilgenbauer S, Cramer P, Aiello M, Johnson DM, Miller LL, Li D, Jahn TM, Dansey RD, Hallek M, O'Brien SM. Idelalisib and rituximab in relapsed chronic lymphocytic leukemia. N Engl J Med. 2014 Mar 13;370(11):997-1007. doi: 10.1056/NEJMoa1315226. Epub 2014 Jan 22.

title: Idelalisib and Rituximab in Relapsed Chronic Lymphocytic Leukemia

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.

location_country:
Italy
United States
France
Germany
United Kingdom

location_facility: Georgetown University Medical Center Lombardi Cancer Center

location_facility: University of California, San Diego- Moores Cancer Center

location_facility: Hematology Oncology Associates of Northern New Jersey

location_facility: Rocky Mountain Blood and Marrow Transplant Program

location_facility: Winship Cancer Institute at Emory University

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino

location_facility: Ventura County Hematology Oncology Specialists

location_facility: Centre Hospitalier Régional Universitaire de Lille (CHRU)

location_facility: Yakima Valley Memorial Hospital / North Star Lodge

location_facility: Oncology and Hematology Associates of Southwest Virginia, Inc

location_facility: Hämatologische/Onkologische Gemeinschaftspraxis Dr. Peter Schmidt / Dr. Holger Klaproth

location_facility: Collaborative Medical Research Corporation

location_facility: Ospedale Oncologico Regionale A. Businco


title: A Phase 1/2, Open-Label, Safety, Pharmacokinetic and Preliminary Efficacy Study of Oral Rociletinib in Patients With Previously Treated Mutant EGFR Non-Small Cell Lung Cancer (NSCLC)

summary: Rociletinib is a novel, potent, small molecule irreversible tyrosine kinase inhibitor (TKI) that selectively targets mutant forms of the epidermal growth factor receptor (EGFR) while sparing wild-type (WT) EGFR. The purpose of the study is to evaluate the pharmacokinetic (PK) and safety profile of oral rociletinib; to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of oral rociletinib; to assess the safety and efficacy of rociletinib in previously treated NSCLC patients known to have the T790M EGFR mutation.

ReferenceCitation: Krug AK, Enderle D, Karlovich C, Priewasser T, Bentink S, Spiel A, Brinkmann K, Emenegger J, Grimm DG, Castellanos-Rizaldos E, Goldman JW, Sequist LV, Soria JC, Camidge DR, Gadgeel SM, Wakelee HA, Raponi M, Noerholm M, Skog J. Improved EGFR mutation detection using combined exosomal RNA and circulating tumor DNA in NSCLC patient plasma. Ann Oncol. 2018 Mar 1;29(3):700-706. doi: 10.1093/annonc/mdx765.

family: Krug

full_name: A.K. Krug

family: Enderle

full_name: D. Enderle

given: D.

family: Karlovich

full_name: C. Karlovich

given: C.

family: Priewasser

full_name: T. Priewasser

given: T.

family: Bentink

full_name: S. Bentink

given: S.

family: Spiel

full_name: A. Spiel

given: A.

family: Brinkmann

full_name: K. Brinkmann

given: K.

family: Emenegger

full_name: J. Emenegger

given: J.

family: Grimm

full_name: D.G. Grimm

family: Castellanos-Rizaldos

full_name: E. Castellanos-Rizaldos

given: E.

family: Goldman

full_name: J.W. Goldman

family: Sequist

full_name: L.V. Sequist

family: Soria

full_name: J.-C. Soria

family: Camidge

full_name: D.R. Camidge

family: Gadgeel

full_name: S.M. Gadgeel

family: Wakelee

full_name: H.A. Wakelee

family: Raponi

full_name: M. Raponi

given: M.

family: Noerholm

full_name: M. Noerholm

family: Skog

full_name: J. Skog

journal_name: Annals of Oncology

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

ReferenceCitation: Sequist LV, Soria JC, Goldman JW, Wakelee HA, Gadgeel SM, Varga A, Papadimitrakopoulou V, Solomon BJ, Oxnard GR, Dziadziuszko R, Aisner DL, Doebele RC, Galasso C, Garon EB, Heist RS, Logan J, Neal JW, Mendenhall MA, Nichols S, Piotrowska Z, Wozniak AJ, Raponi M, Karlovich CA, Jaw-Tsai S, Isaacson J, Despain D, Matheny SL, Rolfe L, Allen AR, Camidge DR. Rociletinib in EGFR-mutated non-small-cell lung cancer. N Engl J Med. 2015 Apr 30;372(18):1700-9. doi: 10.1056/NEJMoa1413654.

title: Rociletinib in EGFR-Mutated Non–Small-Cell Lung Cancer

location_facility: University of Colorado Anschutz Medical Campus

location_facility: University of California Davis Medical Center

location_facility: Sylvester Comprehensive Cancer Center/UMHC

location_facility: East Valley Hematology and Oncology Medical Group, Inc.

location_facility: Providence CancerCenter Oncology and Hematology Care Clinic-Eastside Portland

location_facility: University of Chicago Medical Center, The Duchossois Center for Advanced Medicine

location_facility: Ohio State University, Comprehensive Cancer Center

location_facility: Centre Hospitalier Régional Universitaire de Lille

location_facility: University of Southern California, Norris Comprehensive Cancer Center

location_facility: Centre Hospitalier Intercommunal Créteil

location_facility: University of Texas Southwestern Medical Center

location_facility: University of Pittsburgh Cancer Institute (UPMC), Div. of Medical Oncology

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: The Oncology Institute of Hope and Innovations


title: A Long-Term Follow-Up Study of Subjects Who Participated in a Clinical Trial in Which Peginterferon Lambda-1a (BMS-914143) Was Administered for the Treatment of Chronic Hepatitis C

summary: The primary purpose of this study is to determine whether the hepatitis C virus continues to remain unable to be detected in subjects who were previously treated with BMS-914143 and achieved sustained virologic response

study_type: Observational

time_perspective: Prospective

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Austria
Mexico
Netherlands
Germany
Spain
Finland
France
Korea, Republic of
Greece
Poland
Romania
Argentina
Australia
Belgium
New Zealand
Puerto Rico
United States
Canada

location_facility: University Of Texas Health Science Center At Houston

location_facility: St. Luke'S Episcopal Hospital - Baylor College Of Medicine

location_facility: Toronto Digestive Disease Associates, Inc.


title: A Randomized, Double-blind, 12-week, Parallel Group, Placebo-controlled Study of Efficacy and Safety of RO4917523 in Patients With Fragile X Syndrome.

summary: This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will investigate the efficacy and safety of RO4917523 in adolescent and adult patients with fragile X syndrome. Patients will be randomized to receive oral doses of 0.5 mg or 1.5 mg of RO4917523, or matching placebo once daily. The anticipated time on study treatment is 12 weeks.

location_country:
United States
Chile
Peru
Sweden
Mexico
France
Argentina
Spain
Canada
United Kingdom


title: A Randomised, Placebo-controlled, Double-blind, Multicenter Phase II Trial of Intravenous GC33 at 1600 mg Q2W in Previously Treated Patients With Unresectable Advanced or Metastatic Hepatocellular Carcinoma (HCC)

summary: This randomized, placebo-controlled, multicenter study will evaluate the efficacy and safety of GC33 (RO5137382) in previously treated patients with unresectable advanced or metastatic hepatocellular carcinoma. Participants will be stratified according to the level of GPC-3 expression in tumors and randomized to receive either GC33 (1600 mg intravenously) or placebo on Days 1 and 8 of Cycle 1 and every 2 weeks thereafter. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

ReferenceCitation: Pradier MF, Reis B, Jukofsky L, Milletti F, Ohtomo T, Perez-Cruz F, Puig O. Case-control Indian buffet process identifies biomarkers of response to Codrituzumab. BMC Cancer. 2019 Mar 28;19(1):278. doi: 10.1186/s12885-019-5472-0.

family: Pradier

full_name: Melanie F. Pradier

given: Melanie F.

family: Reis

full_name: Bernhard Reis

given: Bernhard

family: Jukofsky

full_name: Lori Jukofsky

given: Lori

family: Milletti

full_name: Francesca Milletti

given: Francesca

family: Ohtomo

full_name: Toshihiko Ohtomo

given: Toshihiko

family: Perez-Cruz

full_name: Fernando Perez-Cruz

given: Fernando

family: Puig

full_name: Oscar Puig

given: Oscar

currency_apc_doaj: GBP

journal_name: BMC Cancer

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: ETH Zurich - Repository for Publications and Research Data

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Abou-Alfa GK, Puig O, Daniele B, Kudo M, Merle P, Park JW, Ross P, Peron JM, Ebert O, Chan S, Poon TP, Colombo M, Okusaka T, Ryoo BY, Minguez B, Tanaka T, Ohtomo T, Ukrainskyj S, Boisserie F, Rutman O, Chen YC, Xu C, Shochat E, Jukofsky L, Reis B, Chen G, Di Laurenzio L, Lee R, Yen CJ. Randomized phase II placebo controlled study of codrituzumab in previously treated patients with advanced hepatocellular carcinoma. J Hepatol. 2016 Aug;65(2):289-95. doi: 10.1016/j.jhep.2016.04.004. Epub 2016 Apr 13.

family: Abou-Alfa

full_name: Ghassan K. Abou-Alfa

given: Ghassan K.

family: Daniele

full_name: Bruno Daniele

given: Bruno

family: Kudo

full_name: Masatoshi Kudo

given: Masatoshi

family: Merle

full_name: Philippe Merle

given: Philippe

family: Park

full_name: Joong-Won Park

given: Joong-Won

family: Ross

full_name: Paul Ross

given: Paul

family: Peron

location_country:
Italy
United States
Hong Kong
France
Japan
Singapore
Belgium
New Zealand
Spain
Germany
United Kingdom
Korea, Republic of
Taiwan

location_facility: Hôpital d'Adultes; Service hépato-gastro-entérologie

location_facility: Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I

location_facility: Klinikum rechts der Isar der TU München; Klinikapotheke

location_facility: Prince of Wales Hosp; Dept. Of Clinical Onc

location_facility: Hôpital Saint Antoine; Service Hépathologie

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Chang Gung Memorial Foundation - Kaohsiung

location_facility: Hopital de L'Archet; Pole de Reference Hepatite C

location_facility: Charité Uni.-medizin Berlin, Campus Virchow-Klinikum; Med. Klinik m.S. Hepatologie Gastroenterologie

location_facility: Hospital Universitario Miguel Servet; Servicio Hematologia

location_facility: Hopital Purpan;Gastro Enterologie Hepatologie

location_facility: Uni Heidelberg Med. Klinik; Innere Medizin IV

location_facility: Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia

location_facility: Auckland Hospital; New Zealand Liver Transplant Unit

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

location_facility: National Cancer Institute; Ctr for Cancer Research

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Policlinico Universitario Agostino Gemelli

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

location_facility: National Taiwan Uni Hospital; Dept of Oncology

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

location_facility: The Clatterbridge Cancer Ctr NHS Foundation Trust

location_facility: National Cancer Centre; Medical Oncology

location_facility: Azienda Ospedaliera G. Rummo; Unità Operativa di Oncologia Medica 1

location_facility: Washington Univ School of Med; Barnes-Jewish Hospital; Siteman Cancer Center


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SUN13837 Injection in Adult Subjects With Acute Spinal Cord Injury

summary: The purpose of this research study is to gather scientific information about the effectiveness of the study drug, SUN13837 Injection, when compared with the placebo (inactive substance) in participants with acute spinal cord injury.

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
France
Czechia
Poland
Spain
United States
United Kingdom
Canada


status: Active, not recruiting

lead_sponsor: Genentech, Inc.

location_country:
Italy
Netherlands
France
Czechia
Greece
Romania
Spain
United States
United Kingdom

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

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Hospital General Universitario de Elche; Servicio de Oncologia

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: Queen Elizabeth Hospital; Centre for Clinical Haematology

location_facility: Azienda Ospedaliera Istituti Ospitalieri

location_facility: Urology Cancer Center & GU Research Network

location_facility: Sint Franciscus Gasthuis; Inwendige Geneeskunde

location_facility: Metropolitan Hospital; 2Nd Oncology Clinic

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: Fakultni nemocnice Hradec Kralove; I. interni klinika,Oddeleni invazivni kardiologie

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

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

location_facility: Irccs Ospedale San Raffaele;Oncologia Medica

location_facility: HonorHealth Research Institute - Bisgrove

location_facility: University Hospital of Larissa; Oncology

location_facility: Prof. Dr. Th. Burghele Clin Urology Hosp

location_facility: St. James University Hospital; Pharmacy Department

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

location_facility: University Hospital of Patras Medical Oncology

location_facility: Sarah Cannon Cancer Center - Tennessee Oncology, Pllc

location_facility: Florida Cancer Specialists - Fort Myers (New Hampshire Ct)

location_facility: Johns Hopkins Univ; Bunting Blaustein Cancer Center

location_facility: New York Cancer and Blood Specialists - Setauket Medical Oncology

location_facility: Institut Gustave Roussy; Departement Oncologie Medicale

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica

location_facility: Alexandras Hospital; Dept. of Clin. Therapeutics, Athens Uni School of Medicine

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

location_facility: Hopital d'Instruction des Armees de Begin

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: Vu Medisch Centrum; Afdeling Longziekten

location_facility: GH Paris Saint Joseph; Hopital De Jour Oncologie

location_facility: Centre Léon Bérard - Centre régional de lutte contre le cancer Rhône-Alpes

location_facility: Ospedale S. Donato; Divisione Di Reumatologia

location_facility: Fakultni Thomayerova Nemocnice; Revmatologicke Oddeleni

study_completion_date_type: Anticipated

title: A Phase Ib/II Study of Ipatasertib (GDC-0068) or Apitolisib (GDC-0980) With Abiraterone Acetate Versus Abiraterone Acetate in Patients With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy

summary: This multicenter, international, Phase Ib/II trial consists of three stages: a Phase Ib, open-label stage in which the recommended Phase II dose was determined for ipataseritib administrated in combination with abiraterone and of apitolisib administrated in combination with abiraterone (this phase is no longer active), a Phase II, 3-arm, double-blind, randomized comparison of ipatasertib with abiraterone and prednisone/prednisolone versus placebo with abiraterone and prednisone/prednisolone and a safety single-arm, open-label cohort of ipatasertib 400 mg daily alone or in combination with prednisone/prednisolone or prednisone/prednisolone plus abiraterone.

status_simplified: Ongoing


title: A Phase IIa, Randomised, Double-blind, Placebo-controlled, Parallel-arm, Multicenter Study to Evaluate the Efficacy and Safety of Tralokinumab (CAT-354), a Recombinant Human Monoclonal Antibody Directed Against Interleukin-13 (IL-13), as add-on Therapy, on Clinical Response in Patients With Active, Moderate-to-severe, Ulcerative Colitis

summary: The study is designed to evaluate the clinical efficacy and safety of tralokinumab as compared to placebo. Investigational product will be administered as subcutaneous injection. All patients will continue background therapy for ulcerative colitis as per local standards of care in addition to investigational product.

ReferenceType: result

ReferenceCitation: Danese S, Rudziński J, Brandt W, Dupas JL, Peyrin-Biroulet L, Bouhnik Y, Kleczkowski D, Uebel P, Lukas M, Knutsson M, Erlandsson F, Hansen MB, Keshav S. Tralokinumab for moderate-to-severe UC: a randomised, double-blind, placebo-controlled, phase IIa study. Gut. 2015 Feb;64(2):243-9. doi: 10.1136/gutjnl-2014-308004. Epub 2014 Oct 10.

family: Danese

full_name: Silvio Danese

given: Silvio

family: Rudziński

full_name: Janusz Rudziński

given: Janusz

family: Brandt

full_name: Wolfgang Brandt

given: Wolfgang

family: Dupas

full_name: Jean-Louis Dupas

given: Jean-Louis

family: Peyrin-Biroulet

full_name: Laurent Peyrin-Biroulet

given: Laurent

family: Bouhnik

full_name: Yoram Bouhnik

given: Yoram

family: Kleczkowski

full_name: Dariusz Kleczkowski

given: Dariusz

family: Uebel

full_name: Peter Uebel

given: Peter

family: Lukas

full_name: Milan Lukas

given: Milan

family: Knutsson

full_name: Mikael Knutsson

given: Mikael

family: Erlandsson

full_name: Fredrik Erlandsson

given: Fredrik

family: Hansen

full_name: Mark Berner Hansen

given: Mark Berner

family: Keshav

full_name: Satish Keshav

given: Satish

journal_name: Gut

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: AstraZeneca

location_country:
Italy
United Kingdom
France
Poland
Germany
Czech Republic


title: A Phase 2, Randomized Study of Bortezomib/Dexamethasone With or Without Elotuzumab in Subjects With Relapsed/Refractory Multiple Myeloma

summary: The purpose of the study is to determine whether the addition of Elotuzumab to Bortezomib/ Dexamethasone will prolong the time before myeloma worsens [progression free survival (PFS)].

ReferenceCitation: Jakubowiak A, Offidani M, Pégourie B, De La Rubia J, Garderet L, Laribi K, Bosi A, Marasca R, Laubach J, Mohrbacher A, Carella AM, Singhal AK, Tsao LC, Lynch M, Bleickardt E, Jou YM, Robbins M, Palumbo A. Randomized phase 2 study: elotuzumab plus bortezomib/dexamethasone vs bortezomib/dexamethasone for relapsed/refractory MM. Blood. 2016 Jun 9;127(23):2833-40. doi: 10.1182/blood-2016-01-694604. Epub 2016 Apr 18.

name: Myeloma Program, Section of Hematology/Oncology, University of Chicago Medical Center, Chicago, IL;

family: Jakubowiak

full_name: Andrzej Jakubowiak

given: Andrzej

name: Clinica di Ematologia, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Ancona, Italy;

family: Offidani

full_name: Massimo Offidani

given: Massimo

name: Centre Hospitalier Universitaire de Grenoble–Hôpital Albert Michallon, Grenoble, France;

family: Pégourie

full_name: Brigitte Pégourie

given: Brigitte

name: Hospital Universitario Doctor Peset and Universidad Católica “San Vicente Mártir,” Valencia, Spain;

family: De La Rubia

full_name: Javier De La Rubia

given: Javier

name: Service d'hématologie, Hôpital Saint Antoine, Paris, France;

family: Garderet

full_name: Laurent Garderet

name: Department of Hematology, Centre Hospitalier, Le Mans, France;

family: Laribi

full_name: Kamel Laribi

given: Kamel

name: Department of Hematology, Azienda Ospedaliero Universitaria Careggi, Florence, Italy;

family: Bosi

full_name: Alberto Bosi

given: Alberto

name: Department of Hematology, Azienda Ospedaliera Universitaria–Policlinico di Modena, Modena, Italy;

family: Marasca

full_name: Roberto Marasca

given: Roberto

name: Department of Hematology/Oncology, Dana-Farber Cancer Institute, Boston, MA;

family: Laubach

full_name: Jacob Laubach

given: Jacob

name: Division of Hematology, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA;

family: Mohrbacher

full_name: Ann Mohrbacher

given: Ann

name: Hematology Unit, Istituto di Ricovero e Cura a Carattere Scientifico San Martino–Istituto Scientifico Tumori, Genoa, Italy;

family: Carella

full_name: Angelo Michele Carella

given: Angelo Michele

name: Statistics, AbbVie Biotherapeutics Inc, Redwood City, CA;

family: Singhal

full_name: Anil K. Singhal

given: Anil K.

family: Tsao

full_name: L. Claire Tsao

given: L. Claire

name: Oncology Clinical Development, Bristol-Myers Squibb, Wallingford, CT;

family: Lynch

full_name: Mark Lynch

given: Mark

family: Bleickardt

full_name: Eric Bleickardt

given: Eric

name: Global Biometric Sciences, Bristol-Myers Squibb, Hopewell, NJ;

family: Jou

full_name: Ying-Ming Jou

given: Ying-Ming

name: Exploratory Clinical and Translational Research–Oncology, Bristol-Myers Squibb, Princeton, NJ; and

family: Robbins

full_name: Michael Robbins

given: Michael

name: Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy

family: Palumbo

full_name: Antonio Palumbo

given: Antonio

journal_name: Blood

location_facility: University Of Kentucky Markey Cancer Center

location_facility: Investigative Clinical Research Of Indiana, Llc

location_facility: Kaiser Permanente-Moanalua Medical Center

location_facility: Southern Nevada Cancer Research Foundation

location_facility: Pikeville Medical Center Leonard Lawson Cancer Center

location_facility: Washington University School Of Medicine


title: A Phase 2 Open-label Study of MEDI-551 and Bendamustine vs Rituximab and Bendamustine in Adults With Relapsed or Refractory CLL

summary: The overall purpose of the study was to determine if MEDI-551, when used in combination with salvage chemotherapy (bendamustine) in participants with relapsed or refractory CLL who are not eligible for Autologous Stem Cell Transplant (ASCT), had superior efficacy compared to rituximab in the same population.

lead_sponsor: MedImmune LLC

location_country:
Italy
United States
Germany
France
Poland
Israel
Belgium
Canada


title: Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Fixed-dose Combinations Compared With Individual Components and Placebo When Administered to Patients With Stable Chronic Obstructive Pulmonary Disease.

summary: The objective is to provide data supporting the use of LAS40464 as an efficacious and safe maintenance bronchodilator treatment of patients with Chronic Obstructive Pulmonary Disease (COPD).

ReferenceCitation: Singh D, D'Urzo AD, Donohue JF, Kerwin EM, Molins E, Chuecos F, Ribera A, Jarreta D. An Evaluation Of Single And Dual Long-Acting Bronchodilator Therapy As Effective Interventions In Maintenance Therapy-Naïve Patients With COPD. Int J Chron Obstruct Pulmon Dis. 2019 Dec 6;14:2835-2848. doi: 10.2147/COPD.S217710. eCollection 2019. Review.

family: Singh

full_name: Dave Singh

given: Dave

family: D'Urzo

full_name: Anthony D D'Urzo

given: Anthony D

family: Donohue

full_name: James F Donohue

given: James F

family: Kerwin

full_name: Edward M Kerwin

given: Edward M

family: Molins

full_name: Eduard Molins

given: Eduard

family: Chuecos

full_name: Ferran Chuecos

given: Ferran

family: Ribera

full_name: Anna Ribera

given: Anna

family: Jarreta

full_name: Diana Jarreta

given: Diana

currency_apc_doaj: USD

journal_name: International Journal of Chronic Obstructive Pulmonary Disease

ReferenceCitation: Singh D, D'Urzo AD, Chuecos F, Muñoz A, Garcia Gil E. Reduction in clinically important deterioration in chronic obstructive pulmonary disease with aclidinium/formoterol. Respir Res. 2017 May 30;18(1):106. doi: 10.1186/s12931-017-0583-0.

family: D’Urzo

full_name: Anthony D. D’Urzo

given: Anthony D.

family: Muñoz

full_name: Anna Muñoz

family: Garcia Gil

full_name: Esther Garcia Gil

given: Esther

journal_name: Respiratory Research

repositories_institution:
PubMed Central - Europe PMC
University of Toronto - TSpace

ReferenceCitation: Bateman ED, Chapman KR, Singh D, D'Urzo AD, Molins E, Leselbaum A, Gil EG. Aclidinium bromide and formoterol fumarate as a fixed-dose combination in COPD: pooled analysis of symptoms and exacerbations from two six-month, multicentre, randomised studies (ACLIFORM and AUGMENT). Respir Res. 2015 Aug 2;16:92. doi: 10.1186/s12931-015-0250-2.

repository_institution: University of Cape Town - Open University of Cape Town

ReferenceCitation: Singh D, Jones PW, Bateman ED, Korn S, Serra C, Molins E, Caracta C, Gil EG, Leselbaum A. Efficacy and safety of aclidinium bromide/formoterol fumarate fixed-dose combinations compared with individual components and placebo in patients with COPD (ACLIFORM-COPD): a multicentre, randomised study. BMC Pulm Med. 2014 Nov 18;14:178. doi: 10.1186/1471-2466-14-178.

location_country:
Finland
Romania
Belgium
Russian Federation
Denmark
Czech Republic
Ukraine
Croatia
France
Poland
Slovakia
Korea, Republic of
South Africa
Sweden
Netherlands
Bulgaria
Hungary
Germany
United Kingdom
Italy
Austria
Spain

location_facility:
Almirall Investigational Site #11
Almirall Investigational Site #33
Almirall Investigational Site #2
Almirall Investigational Site #26
Almirall Investigational Site #8
Almirall Investigational Site #7
Almirall Investigational Site #36
Almirall Investigational Site #13
Almirall Investigational Site #12
Almirall Investigational Site #15
Almirall Investigational Site #3
Almirall Investigational Site #14
Almirall Investigational Site #16
Almirall Investigational Site #25
Almirall Investigational Site #17
Almirall Investigational Site #19
Almirall Investigational Site #35
Almirall Investigational Site #6
Almirall Investigational Site #4
Almirall Investigational Site #32
Almirall Investigational Site #20
Almirall Investigational Site #21
Almirall Investigational Site #27
Almirall Investigational Site #1
Almirall Investigational Site #34
Almirall Investigational Site #24
Almirall Investigational Site #10
Almirall Investigational Site #5
Almirall Investigational Site #9
Almirall Investigational Site #22
Almirall Investigational Site #28
Almirall Investigational Site #23
Almirall Investigational Site #18


title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study of SAR302503 in Patients With Intermediate-2 or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis With Splenomegaly

acronym: JAKARTA

summary:
Primary Objective:

To evaluate the efficacy of daily oral doses of 400 mg or 500 mg of SAR302503 (Investigational Medicinal Product, IMP) compared to placebo in the reduction of spleen volume as determined by magnetic resonance imaging (MRI) (or computed tomography scan in patients with contraindications for MRI).

Secondary Objectives:

To evaluate the effect on Myelofibrosis (MF)-associated symptoms (key MF symptoms) as measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF) diary.
To evaluate the Overall Survival of patients treated with either 400 mg/day or 500 mg/day of IMP as compared to placebo.
To evaluate the Progression Free Survival of patients treated with either 400 mg/day or 500 mg/day of IMP as compared to placebo.
To evaluate the durability of splenic response.
To evaluate the safety of IMP.

ReferenceCitation: Pardanani A, Harrison C, Cortes JE, Cervantes F, Mesa RA, Milligan D, Masszi T, Mishchenko E, Jourdan E, Vannucchi AM, Drummond MW, Jurgutis M, Kuliczkowski K, Gheorghita E, Passamonti F, Neumann F, Patki A, Gao G, Tefferi A. Safety and Efficacy of Fedratinib in Patients With Primary or Secondary Myelofibrosis: A Randomized Clinical Trial. JAMA Oncol. 2015 Aug;1(5):643-51. doi: 10.1001/jamaoncol.2015.1590.

name: Department of Medicine, Mayo Clinic, Rochester, Minnesota

family: Pardanani

full_name: Animesh Pardanani

given: Animesh

name: Guy’s and St Thomas’ NHS Foundation Trust, St Thomas’ Hospital, London, England

family: Harrison

full_name: Claire Harrison

given: Claire

name: University of Texas MD Anderson Cancer Center, Houston

family: Cortes

full_name: Jorge E. Cortes

given: Jorge E.

name: Hospital Clinic, IDIBAPS University of Barcelona, Barcelona, Spain

family: Cervantes

full_name: Francisco Cervantes

given: Francisco

name: Division of Hematology-Oncology, Mayo Clinic, Scottsdale, Arizona

family: Mesa

full_name: Ruben A. Mesa

given: Ruben A.

name: Centre for Haematology and Stem Cell Transplantation, Heartlands Hospital, Birmingham, England

family: Milligan

full_name: Donald Milligan

given: Donald

name: Department of Haematology and Stem Cell Transplantation, St István and St László Hospital, Budapest, Hungary

family: Masszi

full_name: Tamás Masszi

given: Tamás

name: Hematology-Oncology Unit, Bnai-Zion Medical Center, Haifa, Israel

family: Mishchenko

full_name: Elena Mishchenko

given: Elena

name: Groupe Hospitalo-Universitaire Nimes, Nimes, France

family: Jourdan

full_name: Eric Jourdan

name: Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy

family: Vannucchi

full_name: Alessandro M. Vannucchi

given: Alessandro M.

name: Beatson West of Scotland Cancer Centre, Gartnavel General Hospital, Glasgow, Scotland

family: Drummond

full_name: Mark W. Drummond

given: Mark W.

name: Hematology Department, Klaipeda Seamen’s Hospital, Klaipeda, Lithuania

family: Jurgutis

full_name: Mindaugas Jurgutis

given: Mindaugas

name: Department of Hematology, Blood Neoplasms and Bone Marrow Transplantation, Wroclaw Medical University, Wroclaw, Poland

family: Kuliczkowski

full_name: Kazimierz Kuliczkowski

given: Kazimierz

name: Brasov Country Hospital, Brasov, Romania

family: Gheorghita

full_name: Emanuil Gheorghita

given: Emanuil

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

family: Passamonti

full_name: Francesco Passamonti

given: Francesco

name: Sanofi Oncology, Cambridge, Massachusetts

family: Neumann

full_name: Frank Neumann

given: Frank

family: Patki

full_name: Abhay Patki

given: Abhay

family: Gao

full_name: Guozhi Gao

given: Guozhi

family: Tefferi

full_name: Ayalew Tefferi

given: Ayalew

journal_name: JAMA Oncology

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

location_country:
Romania
Australia
Belgium
Russian Federation
Taiwan
France
Poland
Lithuania
Canada
Korea, Republic of
South Africa
Sweden
Singapore
Hungary
Ireland
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
Spain

location_facility:
Investigational Site Number 826007
Investigational Site Number 376003
Investigational Site Number 250005
Investigational Site Number 642004
Investigational Site Number 410006
Investigational Site Number 616002
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Investigational Site Number 702001
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Investigational Site Number 250004
Investigational Site Number 372001
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Investigational Site Number 440002
Investigational Site Number 840004
Investigational Site Number 036001
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Investigational Site Number 250006
Investigational Site Number 826009
Investigational Site Number 643008
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Investigational Site Number 376002
Investigational Site Number 348001
Investigational Site Number 840006
Investigational Site Number 410002
Investigational Site Number 040001
Investigational Site Number 036005
Investigational Site Number 643005
Investigational Site Number 642001
Investigational Site Number 348002
Investigational Site Number 056003
Investigational Site Number 840012
Investigational Site Number 250007