title: Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial (BENEFIT)

acronym: BENEFIT

summary: The purpose of this study is to learn if Belatacept can provide protection from organ rejection following kidney transplantation while avoiding some of the toxic effects of standard immunosuppressive medications such as kidney damage. Effects on kidney function and patient survival as well as drug safety will also be studied.

ReferenceCitation: Vincenti F, Rostaing L, Grinyo J, Rice K, Steinberg S, Gaite L, Moal MC, Mondragon-Ramirez GA, Kothari J, Polinsky MS, Meier-Kriesche HU, Munier S, Larsen CP. Belatacept and Long-Term Outcomes in Kidney Transplantation. N Engl J Med. 2016 Jan 28;374(4):333-43. doi: 10.1056/NEJMoa1506027. Erratum in: N Engl J Med. 2016 Feb 18;374(7):698.

family: Vincenti

full_name: Flavio Vincenti

given: Flavio

family: Rostaing

full_name: Lionel Rostaing

given: Lionel

family: Grinyo

full_name: Joseph Grinyo

given: Joseph

family: Rice

full_name: Kim Rice

given: Kim

family: Steinberg

full_name: Steven Steinberg

given: Steven

family: Gaite

full_name: Luis Gaite

given: Luis

family: Moal

full_name: Marie-Christine Moal

given: Marie-Christine

family: Mondragon-Ramirez

full_name: Guillermo A. Mondragon-Ramirez

given: Guillermo A.

family: Kothari

full_name: Jatin Kothari

given: Jatin

family: Polinsky

full_name: Martin S. Polinsky

given: Martin S.

family: Meier-Kriesche

full_name: Herwig-Ulf Meier-Kriesche

given: Herwig-Ulf

family: Munier

full_name: Stephane Munier

given: Stephane

family: Larsen

full_name: Christian P. Larsen

given: Christian P.

journal_name: New England Journal of Medicine

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

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

ReferenceCitation: Dobbels F, Wong S, Min Y, Sam J, Kalsekar A. Beneficial effect of belatacept on health-related quality of life and perceived side effects: results from the BENEFIT and BENEFIT-EXT trials. Transplantation. 2014 Nov 15;98(9):960-8. doi: 10.1097/TP.0000000000000159.

family: Dobbels

full_name: Fabienne Dobbels

given: Fabienne

family: Wong

full_name: Schiffon Wong

given: Schiffon

family: Min

full_name: You Min

given: You

family: Sam

full_name: Joo Sam

given: Joo

family: Kalsekar

full_name: Anupama Kalsekar

given: Anupama

journal_name: Transplantation

title: Beneficial Effect of Belatacept on Health-Related Quality of Life and Perceived Side Effects

ReferenceCitation: Vincenti F, Larsen CP, Alberu J, Bresnahan B, Garcia VD, Kothari J, Lang P, Urrea EM, Massari P, Mondragon-Ramirez G, Reyes-Acevedo R, Rice K, Rostaing L, Steinberg S, Xing J, Agarwal M, Harler MB, Charpentier B. Three-year outcomes from BENEFIT, a randomized, active-controlled, parallel-group study in adult kidney transplant recipients. Am J Transplant. 2012 Jan;12(1):210-7. doi: 10.1111/j.1600-6143.2011.03785.x. Epub 2011 Oct 12.

title: Three-Year Outcomes from BENEFIT, a Randomized, Active-Controlled, Parallel-Group Study in Adult Kidney Transplant Recipients

location_country:
Australia
Belgium
Czech Republic
India
France
Poland
Argentina
Canada
South Africa
Sweden
Switzerland
Hungary
Germany
United States
Italy
Austria
Brazil
Mexico
Israel
Spain
Turkey

location_facility: Western New England Renal & Transplant Associates, Pc

location_facility: Columbia University College Of Physicians & Surgeons

location_facility: Sacred Heart Medical Ctr Providence Medical Research Ctr

location_facility: Loma Linda University Medical Center-Transplantation Institu

location_facility: Div Of Multi-Organ Trans, Hepato-Biliary-Pancreatic Surgery

location_facility: University Of California San Francisco Medical Center

location_facility: University Of Colorado Health Sciences Center

location_facility: Yale University School Of Medicine-Yale New Haven Hospital

location_facility: University Of North Carolina At Chapel Hill

location_facility: Washington University School Of Medicine

location_facility: Henry Ford Hospital, Transplant Institute

location_facility: University Of Iowa Hospitals And Clinics


title: A 24-Week Randomized, Double-Blind, Parallel-Group, Multi-Centre, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Tesaglitazar Therapy When Administered as Monotherapy to Drug-Naïve Patients With Type 2 Diabetes

summary:
This is a 24-week randomized, double-blind, parallel-group, multi-center, placebo-controlled study of tesaglitazar (0.5 and 1 mg) in patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period. The study comprises a 6-week single-blind placebo run-in period, followed by 24-week treatment period and a 3-week follow-up period.

The study design of GALLANT 2 is identical to GALLANT 22; the blinded study data from GALLANT 2 will be transferred to the GALLANT 22 database and will be analyzed together with the data from GALLANT 22 clinical study.

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: AstraZeneca

location_country:
Sweden
Former Serbia and Montenegro
Philippines
France
Poland
Greece
Lithuania
Slovakia
Norway
Hungary
Australia
Latvia
Estonia
Czech Republic

intervention_type: Behavioral

lead_sponsor_type: industriel

status_simplified: Unknown


type: EudraCT Number

type: Other Identifier

title: A PHASE 4 SAFETY AND EFFICACY STUDY OF BOSUTINIB (BOSULIF (REGISTERED)) IN PATIENTS WITH PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOID LEUKEMIA PREVIOUSLY TREATED WITH ONE OR MORE TYROSINE KINASE INHIBITORS

summary: The purpose of this study is to fulfill the post-authorization commitment made by Pfizer to the European Medicines Agency in providing additional safety and efficacy data in approximately 150 Philadelphia Chromosome Positive Chronic Myeloid Leukemia patients with high unmet medical need, including 75 Chronic Phase, Accelerated Phase or Blast Phase patients in the fourth or later line treatment setting (i.e., after treatment with at least 3 other Tyrosine Kinase Inhibitors).

study_start_date_type: Actual

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Hochhaus A, Gambacorti-Passerini C, Abboud C, Gjertsen BT, Brümmendorf TH, Smith BD, Ernst T, Giraldo-Castellano P, Olsson-Strömberg U, Saussele S, Bardy-Bouxin N, Viqueira A, Leip E, Russell-Smith TA, Leone J, Rosti G, Watts J, Giles FJ; BYOND Study Investigators. Bosutinib for pretreated patients with chronic phase chronic myeloid leukemia: primary results of the phase 4 BYOND study. Leukemia. 2020 Aug;34(8):2125-2137. doi: 10.1038/s41375-020-0915-9. Epub 2020 Jun 22.

family: Hochhaus

full_name: Andreas Hochhaus

given: Andreas

sequence: first

family: Gambacorti-Passerini

full_name: Carlo Gambacorti-Passerini

given: Carlo

sequence: additional

family: Abboud

full_name: Camille Abboud

given: Camille

family: Gjertsen

full_name: Bjørn Tore Gjertsen

given: Bjørn Tore

family: Brümmendorf

full_name: Tim H. Brümmendorf

given: Tim H.

family: Smith

full_name: B. Douglas Smith

given: B. Douglas

family: Ernst

full_name: Thomas Ernst

given: Thomas

family: Giraldo-Castellano

full_name: Pilar Giraldo-Castellano

given: Pilar

family: Olsson-Strömberg

full_name: Ulla Olsson-Strömberg

given: Ulla

family: Saussele

full_name: Susanne Saussele

given: Susanne

family: Bardy-Bouxin

full_name: Nathalie Bardy-Bouxin

given: Nathalie

family: Viqueira

full_name: Andrea Viqueira

given: Andrea

family: Leip

full_name: Eric Leip

given: Eric

family: Russell-Smith

full_name: T. Alexander Russell-Smith

given: T. Alexander

family: Leone

full_name: Jocelyn Leone

given: Jocelyn

family: Rosti

full_name: Gianantonio Rosti

given: Gianantonio

family: Watts

full_name: Justin Watts

given: Justin

family: Giles

full_name: Francis J. Giles

given: Francis J.

family: Abruzzese

full_name: E. Abruzzese

given: E.

family: Akard

full_name: L. P. Akard

given: L. P.

family: Bosi

full_name: A. Bosi

given: A.

family: Cervantes

full_name: F. Cervantes

given: F.

family: Charbonnier

full_name: A. Charbonnier

name: on behalf of the BYOND Study Investigators

repository_institution: Uppsala University - Uppsala University Publications

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

location_country:
Italy
Austria
Sweden
Germany
France
Norway
Spain
United States

location_facility: RWTH Uniklinik Aachen Klinik fur Onkologie, Hamatologie und Stammzelltransplantation

location_facility: Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)

location_facility: Azienda Socio Sanitaria Territoriale - ASST Monza

location_facility: AOU Policlinico Consorziale di Bari - UO Ematologia con Trapianto

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: A.O. Ospedale Niguarda Ca Granda - SC Ematologia

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Washington University School of Medicine

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: AOU Policlinico Vittorio Emanuele-P.O.G. Rodolico

location_facility: AOU San Luigi Gonzaga SCDU Medicina Interna II ad indirizzo Ematologico

location_facility: Centre Regional De Lutte Contre Le Cancer

location_facility: Indiana Blood and Marrow Transplantation-Clinic

location_facility: Centre Hospitalier de Versailles (CHV)-Hopital Andre Mignot Service d'Hematologie Clinique- Oncology

location_facility: Weill Cornell Medical College - New York-Presbyterian Hospital

location_facility: III. Medizinische Klinik Universitaetsmedizin Mannheim

location_facility: Ordensklinikum Linz Gmbh Barmherzige Schwestern


title: An Open-label, Non-randomised, Multicentre, Comparative, Phase I Study to Determine the Pharmacokinetics, Safety and Tolerability of AZD9291 Following a Single Oral Dose to Patients With Advanced Solid Tumours and Normal Hepatic Function or Mild or Moderate Hepatic Impairment

summary: This is a 2-part study in patients with advanced solid tumours. Part A will investigate the pharmacokinetics (PK) of AZD9291 in patients with mild or moderate hepatic impairment compared to patients with normal hepatic function; Part B will allow any patient with mild or moderate hepatic impairment or normal hepatic function, who completes Part A, continued access to AZD9291 after the PK phase and will provide additional safety data.

status: Completed

design_allocation: Non-Randomized

primary_purpose: Other

ReferenceCitation: Grande E, Harvey RD, You B, Batlle JF, Galbraith H, Sarantopoulos J, Ramalingam SS, Mann H, So K, Johnson M, Vishwanathan K. Pharmacokinetic Study of Osimertinib in Cancer Patients with Mild or Moderate Hepatic Impairment. J Pharmacol Exp Ther. 2019 May;369(2):291-299. doi: 10.1124/jpet.118.255919. Epub 2019 Mar 14.

family: Grande

full_name: Enrique Grande

given: Enrique

family: Harvey

full_name: R. Donald Harvey

given: R. Donald

family: You

full_name: Benoit You

given: Benoit

family: Batlle

full_name: Jaime Feliu Batlle

given: Jaime Feliu

family: Galbraith

full_name: Hal Galbraith

given: Hal

family: Sarantopoulos

full_name: John Sarantopoulos

given: John

family: Ramalingam

full_name: Suresh S. Ramalingam

given: Suresh S.

family: Mann

full_name: Helen Mann

given: Helen

family: So

full_name: Karen So

given: Karen

family: Johnson

full_name: Martin Johnson

given: Martin

family: Vishwanathan

full_name: Karthick Vishwanathan

given: Karthick

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Pharmacology and Experimental Therapeutics

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: American Society for Pharmacology & Experimental Therapeutics (ASPET)

location_country:
France
Belgium
Spain
United States
United Kingdom
Korea, Republic of

intervention_type: Procedure

status_simplified: Completed


title: A Randomized, Double-blind, Placebo-controlled, Phase III, Multi-centre Study of Eltrombopag or Placebo in Combination With Azacitidine in Subjects With IPSS Intermediate-1, Intermediate 2 and High-risk Myelodysplastic Syndromes (MDS) SUPPORT: A StUdy of eltromboPag in myelodysPlastic SyndrOmes Receiving azaciTidine

summary: Eltrombopag olamine (SB-497115-GR) is an orally bioavailable, small molecule thrombopoietin receptor agonist that may be beneficial in medical disorders associated with thrombocytopenia. Eltrombopag has been shown to increase platelet counts in patients with thrombocytopenia from various etiologies (Idiopathic thrombocytopenic purpura [ITP], liver disease, aplastic anemia and chemotherapy induced thrombocytopenia). Approximately 350 subjects will be randomized in a 1:1 ratio (175 into the eltrombopag arm and 175 into the placebo arm). Approximately 55 subjects will be enrolled into the azacitidine. Subjects with intermediate-1, intermediate-2 or high risk MDS by IPSS, and baseline platelet count of <75 Giga (10^9) per liter (Gi/L) will only be enrolled. This is a randomized, double-blind, parallel group, placebo-controlled study designed to explore the platelet supportive care effects of eltrombopag versus placebo in combination with the standard of care hypomethylating agent, azacitidine. The primary objective of this study is to determine the effect of eltrombopag versus placebo on the proportion of subjects who are platelet transfusion free during the first 4 cycles of azacitidine therapy. Key secondary endpoints include overall survival, disease response, and disease progression.

ReferenceCitation: Dickinson M, Cherif H, Fenaux P, Mittelman M, Verma A, Portella MSO, Burgess P, Ramos PM, Choi J, Platzbecker U; SUPPORT study investigators. Azacitidine with or without eltrombopag for first-line treatment of intermediate- or high-risk MDS with thrombocytopenia. Blood. 2018 Dec 20;132(25):2629-2638. doi: 10.1182/blood-2018-06-855221. Epub 2018 Oct 10.

name: Clinical Haematology, Peter MacCallum Cancer Centre, Melbourne, Australia;

name: Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia;

family: Dickinson

full_name: Michael Dickinson

given: Michael

name: Department of Medical Sciences, Uppsala University, Uppsala, Sweden;

family: Cherif

full_name: Honar Cherif

given: Honar

name: Hopital Avicenne, Assistance Publique–Hopitaux de Paris/University Paris XIII, Bobigny, France;

family: Fenaux

full_name: Pierre Fenaux

given: Pierre

name: Tel Aviv Sourasky Medical Center, Tel Aviv University, Tel Aviv, Israel;

family: Mittelman

full_name: Moshe Mittelman

given: Moshe

name: Division of Medical Oncology, Department of Medicine, Albert Einstein College of Medicine, New York, NY;

family: Verma

full_name: Amit Verma

given: Amit

name: Novartis Pharmaceuticals Corporation, East Hanover, NJ;

family: Portella

full_name: Maria Socorro O. Portella

given: Maria Socorro O.

name: Novartis Pharma AG, Basel, Switzerland; and

family: Burgess

full_name: Paul Burgess

given: Paul

family: Ramos

full_name: Pedro Marques Ramos

given: Pedro Marques

family: Choi

full_name: Jeea Choi

given: Jeea

name: Medical Clinic and Policlinic 1, University Hospital Leipzig, University of Leipzig, Leipzig, Germany

family: Platzbecker

full_name: Uwe Platzbecker

given: Uwe

journal_name: Blood

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free article)

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)

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

lead_sponsor: Novartis Pharmaceuticals

location_country:
Peru
Greece
Australia
Belgium
Russian Federation
Denmark
Taiwan
France
Poland
Thailand
Norway
Argentina
Canada
Korea, Republic of
Sweden
Hong Kong
Switzerland
Hungary
Ireland
Puerto Rico
Germany
United States
Italy
Austria
Brazil
Mexico
Czechia
Israel
Spain
Turkey

intervention_type: Drug


title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in Hospitalized Adults With Respiratory Syncytial Virus (RSV) Infection

summary:
The primary objective of this study is to evaluate the effects of presatovir on respiratory syncytial virus (RSV) viral load in RSV-positive adults who have been hospitalized with acute respiratory infectious symptoms.

Participants will receive 1 dose of presatovir on Day 1 and followed for 27 days postdose. Nasal swabs will be collected at each study visit (excluding Day 28) and assayed for change in viral load as the primary endpoint.

lead_sponsor: Gilead Sciences

location_country:
Italy
Netherlands
France
Poland
Israel
Belgium
Australia
New Zealand
United States
United Kingdom
Korea, Republic of

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: Universite Liebre de Bruxelles - Hopital Erasme

location_facility: Hopital Saint Louis - Service de Pneumologie

location_facility: Southampton University Hospitals NHS Trust


ReferenceCitation: Schmid P, Sablin MP, Bergh J, Im SA, Lu YS, Martínez N, Neven P, Lee KS, Morales S, Pérez-Fidalgo JA, Adamson D, Gonçalves A, Prat A, Jerusalem G, Schlieker L, Espadero RM, Bogenrieder T, Huang DC, Crown J, Cortés J. A phase Ib/II study of xentuzumab, an IGF-neutralising antibody, combined with exemestane and everolimus in hormone receptor-positive, HER2-negative locally advanced/metastatic breast cancer. Breast Cancer Res. 2021 Jan 15;23(1):8. doi: 10.1186/s13058-020-01382-8.

family: Schmid

full_name: Peter Schmid

given: Peter

family: Sablin

full_name: Marie-Paule Sablin

given: Marie-Paule

family: Bergh

full_name: Jonas Bergh

given: Jonas

family: Im

full_name: Seock-Ah Im

given: Seock-Ah

family: Lu

full_name: Yen-Shen Lu

given: Yen-Shen

family: Martínez

full_name: Noelia Martínez

given: Noelia

family: Neven

full_name: Patrick Neven

given: Patrick

family: Lee

full_name: Keun Seok Lee

given: Keun Seok

family: Morales

full_name: Serafín Morales

given: Serafín

family: Pérez-Fidalgo

full_name: J. Alejandro Pérez-Fidalgo

given: J. Alejandro

family: Adamson

full_name: Douglas Adamson

given: Douglas

family: Gonçalves

full_name: Anthony Gonçalves

given: Anthony

family: Prat

full_name: Aleix Prat

given: Aleix

family: Jerusalem

full_name: Guy Jerusalem

given: Guy

family: Schlieker

full_name: Laura Schlieker

given: Laura

family: Espadero

full_name: Rosa-Maria Espadero

given: Rosa-Maria

family: Bogenrieder

full_name: Thomas Bogenrieder

given: Thomas

family: Huang

full_name: Dennis Chin-Lun Huang

given: Dennis Chin-Lun

family: Crown

full_name: John Crown

family: Cortés

full_name: Javier Cortés

given: Javier

currency_apc_doaj: GBP

journal_name: Breast Cancer Research

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

publisher: Springer Science and Business Media LLC

ipd_sharing_description:
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

location_country:
Austria
Sweden
Netherlands
France
Ireland
Belgium
Spain
United Kingdom
Korea, Republic of
Taiwan

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Charleroi - HOSP Grand Hôpital de Charleroi

location_facility: CHU UCL Namur - Site De Sainte-Elisabeth

title: A Phase Ib/II Randomized Study of BI 836845 in Combination With Exemestane and Everolimus Versus Exemestane and Everolimus Alone in Women With Locally Advanced or Metastatic Breast Cancer

summary: Phase Ib / II study to determine the Maximum Tolerated Dose and Recommended Phase II Dose, and to evaluate the safety and antitumour activity, of BI 836845 and everolimus in combination with exemestane in women with HR+/HER2- advanced breast cancer


title: A Randomized, Double-Blind Study of Ruxolitinib or Placebo in Combination With Regorafenib in Subjects With Relapsed or Refractory Metastatic Colorectal Cancer

summary: The purpose of this study was to determine if ruxolitinib, in combination with regorafenib, is safe and effective in the treatment of metastatic colorectal cancer.

lead_sponsor: Incyte Corporation

location_country:
United States
Korea, Democratic People's Republic of
France
Israel
Australia
Spain
Germany
United Kingdom


intervention_type: Biological

lead_sponsor: SOTIO a.s.

location_country:
Belgium
Denmark
Croatia
France
Lithuania
Poland
Slovakia
Sweden
Netherlands
Bulgaria
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Serbia
Czechia
Belarus
Spain
Latvia

acronym: VIABLE

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Azienda Ospedialiera Universitaria Senese

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

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: Specialized Hospital for Active treatment in Oncology

location_facility: N.N. Alexandrov National Research Center

location_facility: California Cancer Associates for Research and Excellence

location_facility: Specialized Hospital for Active Treatment of Oncology Diseases

location_facility: Comprehensive Cancer Research Centers of Nevada

location_facility: Clinique d'Oncologie Medicale Institut Jules Bordet

location_facility: University Hospital Center Sisters of Charity

location_facility: Lithuanian University of Health Science Oncology Institute

location_facility: Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointeszet

location_facility: Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego

location_facility: Cliniques Universitaires Saint Luc- Urologie

location_facility: St. Luke's Cancer Centre Royal Surrey County Hospital NHS Foundation Trust

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

location_facility: UT Health, Internal Medicine, Division of Oncology

location_facility: Urology Department St. Elizabeth Ziekenhuis

location_facility: Multifunctional Hospital for Active Treatment Serdika

location_facility: Winship Cancer Institute of Emory University

location_facility: Premier Urology Associates, LLC / AdvanceMed Research

location_facility: Instituto de Investigaciones Sanitarias (IIS), Fundacíon Jimenez Díaz (FJD)

location_facility: Oncology Institute of Hope and Innovation

location_facility: New Jersey Hematology Oncology Associates

location_facility: Universitatsklinikum fur Urologie und Andrologie

location_facility: Centro Integral Oncológico Clara Campal (CIOCC)

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Desert Hematology Oncology Medical Group

location_facility: Praxigemeinschaft fur Onkologie und Urologie

location_facility: Paula Stradina Kliniska Universitates slimnica

location_facility: Institute of Oncology and Radiology of Serbia

location_facility: University of Kansas Cancer Center & Medical Pavilion

location_facility: West Virginia University Mary Babb Randolph Cancer Center

location_facility: Hospital Universitario Puerta de Hierro de Majadahonda

location_facility: Hospital Universitario Príncipe de Asturias

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Eastern CT Hematology and Oncololgy Associates

location_facility: Hospital General Universitario Gregorio Maranón

location_facility: Northern Centre for Cancer Care, Freeman Hospital

location_facility: Klinika onkologie a radioterapie, Fakultni nemocnice

location_facility: Fakultna nemocnica s poliklinikou Zilina

location_facility: Cancer Care Associates St. Luke's University and Health Network

location_facility: Urologicka ambulancia Uroexam, spol. s r.o.

location_facility: Univ. of Miami, Sylvester Comprehensive Cancer Center

location_facility: University of South Alabama Mitchell Cancer Institute

location_facility: Urologic Consultants of Southeastern Pennsylvania

ipd_sharing: No

source: euctr

title: A Randomized, Double Blind, Multicenter, Parallel-group, Phase III Study to Evaluate Efficacy and Safety of DCVAC/PCa Versus Placebo in Men With Metastatic Castration Resistant Prostate Cancer Eligible for 1st Line Chemotherapy

summary: The VIABLE study sought to confirm the hypothesis that the combination of docetaxel with DCVAC/PCa followed by a maintenance therapy with DCVAC/PCa would improve overall survival in patients with metastatic castration-resistant prostate cancer.


ReferenceCitation: Zheng B, Duffy D, Tricoci P, Kastrissios H, Pfister M, Wright SD, Gille A, Tortorici MA. Pharmacometric analyses to characterize the effect of CSL112 on apolipoprotein A-I and cholesterol efflux capacity in acute myocardial infarction patients. Br J Clin Pharmacol. 2021 Jun;87(6):2558-2571. doi: 10.1111/bcp.14666. Epub 2020 Dec 23.

family: Zheng

full_name: Bo Zheng

given: Bo

family: Duffy

full_name: Danielle Duffy

given: Danielle

family: Tricoci

full_name: Pierluigi Tricoci

given: Pierluigi

name: Certara Strategic Consulting  Princeton NJ USA

family: Kastrissios

full_name: Helen Kastrissios

given: Helen

family: Pfister

full_name: Marc Pfister

given: Marc

family: Wright

full_name: Samuel D. Wright

given: Samuel D.

family: Gille

full_name: Andreas Gille

given: Andreas

family: Tortorici

full_name: Michael A. Tortorici

given: Michael A.

journal_name: British Journal of Clinical Pharmacology

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Pharmacometric analyses to characterize the effect of CSL112 on apolipoprotein A‐I and cholesterol efflux capacity in acute myocardial infarction patients

ReferenceCitation: Michael Gibson C, Korjian S, Tricoci P, Daaboul Y, Yee M, Jain P, Alexander JH, Steg PG, Lincoff AM, Kastelein JJ, Mehran R, D'Andrea DM, Deckelbaum LI, Merkely B, Zarebinski M, Ophuis TO, Harrington RA. Safety and Tolerability of CSL112, a Reconstituted, Infusible, Plasma-Derived Apolipoprotein A-I, After Acute Myocardial Infarction: The AEGIS-I Trial (ApoA-I Event Reducing in Ischemic Syndromes I). Circulation. 2016 Dec 13;134(24):1918-1930. Epub 2016 Nov 15.

ReferenceCitation: Gibson CM, Korjian S, Tricoci P, Daaboul Y, Alexander JH, Steg PG, Lincoff AM, Kastelein JJ, Mehran R, D'Andrea D, Merkely B, Zarebinski M, Ophius TO, Harrington RA. Rationale and design of Apo-I Event Reduction in Ischemic Syndromes I (AEGIS-I): A phase 2b, randomized, placebo-controlled, dose-ranging trial to investigate the safety and tolerability of CSL112, a reconstituted, infusible, human apoA-I, after acute myocardial infarction. Am Heart J. 2016 Oct;180:22-8. doi: 10.1016/j.ahj.2016.06.017. Epub 2016 Jul 5.

family: Gibson

full_name: C. Michael Gibson

given: C. Michael

family: Korjian

full_name: Serge Korjian

given: Serge

family: Daaboul

full_name: Yazan Daaboul

given: Yazan

family: Alexander

full_name: John H. Alexander

given: John H.

family: Steg

full_name: Philippe G. Steg

given: Philippe G.

family: Lincoff

full_name: A. Michael Lincoff

given: A. Michael

family: Kastelein

full_name: John J.P. Kastelein

given: John J.P.

family: Mehran

full_name: Roxana Mehran

given: Roxana

family: D'Andrea

full_name: Denise D'Andrea

given: Denise

family: Merkely

full_name: Bela Merkely

given: Bela

family: Zarebinski

location_country:
Italy
Austria
United States
Netherlands
Germany
France
Bulgaria
Czechia
Israel
Poland
Hungary
Australia
Spain
Denmark
Canada
United Kingdom

location_facility:
Study Site 14008
Study Site 16174
Study Site 12006
Study Site 21004
Study Site 14015
Study Site - 13012
Study Site 21003
Study Site - 25002
Study Site 18007
Study Site 12003
Study Site 16025
Study Site 12010
Study Site 14003
Study Site - 23001
Study Site 17007
Study Site 16112
Study Site 16063
Study Site 10006
Study Site - 23005
Study Site - 23009
Study Site - 23011
Study Site 19005
Study Site - 22015
Study Site 21009
Study Site - 22012
Study Site - 25004
Study Site - 23002
Study Site 14004
Study Site 16033
Study Site 19009
Study Site - 23012
Study Site 16016
Study Site 16100
Study Site 19002
Study Site 20011
Study Site - 23004
Study Site 16018
Study Site 16101
Study Site 22009
Study Site 15003
Study Site - 13007
Study Site 16078
Study Site 16179
Study Site 15004
Study Site 21015
Study Site 20008
Study Site 19007
Study Site 16135
Study Site 17014
Study Site - 22014
Study Site 10012
Study Site 16168
Study Site 17010
Study Site - 24010
Study Site 14017
Study Site 17003
Study Site 16061
Study Site 16202
Study Site 16039
Study Site 24005
Study Site 14006
Study Site 16130
Study Site 10005
Study Site - 25003
Study Site 18003
Study Site 16234
Study Site 19003
Study Site 15001
Study Site - 22013
Study Site 20001
Study Site 16028
Study Site 18006
Study Site 21006
Study Site 11004
Study Site 19008
Study Site 14005
Study Site 16024
Study Site 12018
Study Site 17005
Study Site 16099
Study Site 20002
Study Site 21013
Study Site 12007
Study Site 17009
Study Site 16026
Study Site - 13003
Study Site 16088
Study Site 16170
Study Site 14001
Study Site 21016
Study Site - 22008
Study Site 21011
Study Site 11002
Study Site - 22016
Study Site 12001
Study Site 19004
Study Site 16003
Study Site 20012
Study Site 12012
Study Site - 13014
Study Site 17002
Study Site 14011
Study Site 18005
Study Site 14010
Study Site 19006
Study Site 16015
Study Site 18008
Study Site 12005
Study Site - 22007
Study Site 16208
Study Site 14016
Study Site 16060
Study Site 17012
Study Site 21001
Study Site 16031
Study Site 18002
Study Site 14009
Study Site 16213
Study Site 15005
Study Site 20007
Study Site - 23013
Study Site 16211
Study Site - 24009
Study Site 12021
Study Site 14012
Study Site - 22005
Study Site 16047
Study Site 20009
Study Site 12016
Study Site - 25005
Study Site 16241
Study Site - 22006
Study Site 19010
Study Site 16056
Study Site 15002
Study Site 10007
Study Site 14007
Study Site 18001
Study Site - 13019
Study Site 12017
Study Site - 23007
Study Site 16038
Study Site 21010
Study Site - 23010
Study Site 10002
Study Site - 16168
Study Site 12008
Study Site 12011
Study Site 21008
Study Site - 22010
Study Site 16022
Study Site 12013
Study Site 18009
Study Site 12004
Study Site - 13010
Study Site 12002
Study Site 16079
Study Site 16062
Study Site 16144
Study Site 21014
Study Site 17011
Study Site 16004
Study Site 16014
Study Site 12014
Study Site 20003
Study Site 11001
Study Site 14002
Study Site - 23003
Study Site 16201
Study Site 20006
Study Site - 25008
Study Site - 13008
Study Site 14014
Study Site - 24006
Study Site - 13017
Study Site - 24003
Study Site - 25001
Study Site 17001
Study Site 12019
Study Site 16017
Study Site - 24004
Study Site - 13002
Study Site 12009
Study Site 17006
Study Site 16148
Study Site 16147
Study Site 16166
Study Site - 23006
Study Site 16102

title: A Phase 2b, Multi-center, Randomized, Placebo-controlled, Dose-ranging Study to Investigate the Safety and Tolerability of Multiple Dose Administration of CSL112 in Subjects With Acute Myocardial Infarction.

summary: This is a multicenter randomized, double-blind, placebo-controlled, parallel-group, dose-ranging phase 2b study to investigate the hepatic and renal safety and tolerability of multiple dose administration of two dose levels of CSL112 compared with placebo in subjects with acute myocardial infarction (AMI).


ReferenceCitation: Chalmers JD, Cipolla D, Thompson B, Davis AM, O'Donnell A, Tino G, Gonda I, Haworth C, Froehlich J. Changes in respiratory symptoms during 48-week treatment with ARD-3150 (inhaled liposomal ciprofloxacin) in bronchiectasis: results from the ORBIT-3 and -4 studies. Eur Respir J. 2020 Oct 22;56(4). pii: 2000110. doi: 10.1183/13993003.00110-2020. Print 2020 Oct.

family: Chalmers

full_name: James D. Chalmers

given: James D.

family: Cipolla

full_name: David Cipolla

given: David

family: Thompson

full_name: Bruce Thompson

given: Bruce

family: Davis

full_name: Angela M. Davis

given: Angela M.

family: O'Donnell

full_name: Anne O'Donnell

given: Anne

family: Tino

full_name: Gregory Tino

given: Gregory

family: Gonda

full_name: Igor Gonda

given: Igor

family: Haworth

full_name: Charles Haworth

given: Charles

family: Froehlich

full_name: Juergen Froehlich

given: Juergen

journal_name: European Respiratory Journal

oa_host_type: repository

repository_institution: University of Dundee - Discovery Research Portal

version: submittedVersion

publisher: European Respiratory Society (ERS)

publisher_dissemination: European Respiratory Society

publisher_group: European Respiratory Society

publisher_normalized: European Respiratory Society

ReferenceCitation: Haworth CS, Bilton D, Chalmers JD, Davis AM, Froehlich J, Gonda I, Thompson B, Wanner A, O'Donnell AE. Inhaled liposomal ciprofloxacin in patients with non-cystic fibrosis bronchiectasis and chronic lung infection with Pseudomonas aeruginosa (ORBIT-3 and ORBIT-4): two phase 3, randomised controlled trials. Lancet Respir Med. 2019 Mar;7(3):213-226. doi: 10.1016/S2213-2600(18)30427-2. Epub 2019 Jan 15. Erratum in: Lancet Respir Med. 2019 Jan 25;:.

full_name: Charles S Haworth

given: Charles S

family: Bilton

full_name: Diana Bilton

given: Diana

full_name: James D Chalmers

given: James D

full_name: Angela M Davis

given: Angela M

family: Wanner

full_name: Adam Wanner

given: Adam

full_name: Anne E O'Donnell

given: Anne E

journal_name: The Lancet Respiratory Medicine

location_country:
Italy
United States
Peru
Former Serbia and Montenegro
France
Poland
Israel
Georgia
Romania
Hungary
Australia
New Zealand
Spain
Canada
United Kingdom
Korea, Republic of

acronym: Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (Orbit 4)

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections With Pseudomonas Aeruginosa in Patients With Non-Cystic Fibrosis Bronchiectasis, Including 28 Day Open-Label Extension

summary: This study (ARD-3150-1202, ORBIT-4) will evaluate the safety and efficacy of inhaled Pulmaquin (ciprofloxacin dispersion for inhalation) compared to inhaled placebo in subjects who have a confirmed diagnosis of non-cystic fibrosis (non-CF) bronchiectasis with a history of pulmonary exacerbations and chronic P. aeruginosa infections.


title: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase 3 Efficacy and Safety Study of Benralizumab (MEDI-563) to Reduce Oral Corticosteroid Use in Patients With Uncontrolled Asthma on High Dose Inhaled Corticosteroid Plus Long-acting β2 Agonist and Chronic Oral Corticosteroid Therapy (ZONDA)

summary: The purpose of this trial is to confirm if benralizumab can reduce the use of maintenance OCS in systemic corticosteroid dependent patients with severe refractory asthma with elevated eosinophils.

ReferenceType: background

ReferenceCitation: Nair P, Wenzel S, Rabe KF, Bourdin A, Lugogo NL, Kuna P, Barker P, Sproule S, Ponnarambil S, Goldman M; ZONDA Trial Investigators. Oral Glucocorticoid-Sparing Effect of Benralizumab in Severe Asthma. N Engl J Med. 2017 Jun 22;376(25):2448-2458. doi: 10.1056/NEJMoa1703501. Epub 2017 May 22.

ReferenceCitation: Menzies-Gow A, Corren J, Bel EH, Maspero J, Heaney LG, Gurnell M, Wessman P, Martin UJ, Siddiqui S, Garcia Gil E. Corticosteroid tapering with benralizumab treatment for eosinophilic asthma: PONENTE Trial. ERJ Open Res. 2019 Sep 25;5(3). pii: 00009-2019. doi: 10.1183/23120541.00009-2019. eCollection 2019 Jul.

apc_source: doaj

family: Menzies-Gow

full_name: Andrew Menzies-Gow

given: Andrew

family: Corren

full_name: Jonathan Corren

given: Jonathan

family: Bel

full_name: Elisabeth H. Bel

given: Elisabeth H.

family: Maspero

full_name: Jorge Maspero

given: Jorge

family: Heaney

full_name: Liam G. Heaney

given: Liam G.

family: Gurnell

full_name: Mark Gurnell

given: Mark

family: Wessman

full_name: Peter Wessman

given: Peter

family: Martin

full_name: Ubaldo J. Martin

given: Ubaldo J.

family: Siddiqui

full_name: Shahid Siddiqui

given: Shahid

family: Garcia Gil

full_name: Esther Garcia Gil

given: Esther

currency_apc_doaj: EUR

journal_name: ERJ Open Research

license: cc-by-nc

license_normalized: cc-by-nc

license: implied-oa

license_normalized: implied-oa

repository_institution: Queen's University Belfast - Research Portal

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

repository_institution: University of Cambridge - Apollo

ReferenceCitation: Chupp G, Lugogo NL, Kline JN, Ferguson GT, Hirsch I, Goldman M, Zangrilli JG, Trudo F. Rapid onset of effect of benralizumab on morning peak expiratory flow in severe, uncontrolled asthma. Ann Allergy Asthma Immunol. 2019 May;122(5):478-485. doi: 10.1016/j.anai.2019.02.016. Epub 2019 Feb 23.

family: Chupp

full_name: Geoffrey Chupp

given: Geoffrey

family: Lugogo

full_name: Njira L. Lugogo

given: Njira L.

family: Kline

full_name: Joel N. Kline

location_country:
United States
Chile
Germany
France
Bulgaria
Poland
Argentina
Spain
Turkey
Canada
Korea, Republic of
Ukraine


title: A Phase 3, Randomized, Placebo-controlled, Multicenter, Double-blind Study to Evaluate the Safety and Efficacy of Telotristat Etiprate (LX1606) in Patients With Carcinoid Syndrome

acronym: TELECAST

summary: The purpose of the study is to evaluate the effect of telotristat etiprate versus placebo on the incidence of treatment-emergent adverse events and on 5-hydroxyindoleacetic acid (5-HIAA) levels.

ReferenceCitation: Dillon JS, Kulke MH, Hörsch D, Anthony LB, Warner RRP, Bergsland E, Welin S, O'Dorisio TM, Kunz PL, McKee C, Lapuerta P, Banks P, Pavel M. Time to Sustained Improvement in Bowel Movement Frequency with Telotristat Ethyl: Analyses of Phase III Studies in Carcinoid Syndrome. J Gastrointest Cancer. 2021 Mar;52(1):212-221. doi: 10.1007/s12029-020-00375-2.

family: Dillon

full_name: Joseph S. Dillon

given: Joseph S.

family: Kulke

full_name: Matthew H. Kulke

given: Matthew H.

family: Hörsch

full_name: Dieter Hörsch

given: Dieter

family: Anthony

full_name: Lowell B. Anthony

given: Lowell B.

family: Warner

full_name: Richard R. P. Warner

given: Richard R. P.

family: Bergsland

full_name: Emily Bergsland

given: Emily

family: Welin

full_name: Staffan Welin

given: Staffan

family: O’Dorisio

full_name: Thomas M. O’Dorisio

given: Thomas M.

family: Kunz

full_name: Pamela L. Kunz

given: Pamela L.

family: McKee

full_name: Chad McKee

given: Chad

family: Lapuerta

full_name: Pablo Lapuerta

given: Pablo

family: Banks

full_name: Phillip Banks

given: Phillip

family: Pavel

full_name: Marianne Pavel

given: Marianne

journal_name: Journal of Gastrointestinal Cancer

repositories_institution: Uppsala University - Uppsala University Publications

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Pavel M, Gross DJ, Benavent M, Perros P, Srirajaskanthan R, Warner RRP, Kulke MH, Anthony LB, Kunz PL, Hörsch D, Weickert MO, Lapuerta P, Jiang W, Kassler-Taub K, Wason S, Fleming R, Fleming D, Garcia-Carbonero R. Telotristat ethyl in carcinoid syndrome: safety and efficacy in the TELECAST phase 3 trial. Endocr Relat Cancer. 2018 Mar;25(3):309-322. doi: 10.1530/ERC-17-0455. Epub 2018 Jan 12.

family: Gross

full_name: David J Gross

given: David J

family: Benavent

full_name: Marta Benavent

repository_institution: Universitätsbibliothek der Freien Universität Berlin - Refubium

repository_institution: Newcastle Univesity - Newcastle University ePrints

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

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

location_facility:
Lexicon Investigative Site
Lexicon Investigational Site


title: A 48 Weeks Study of Three Different Dose Regimens of BI 655066 Administered Subcutaneously in Patients With Moderate to Severe Chronic Plaque Psoriasis (Randomised, Dose-ranging, Active-comparator-controlled (Ustekinumab), Double-blind Within Dose Groups of BI 655066)

summary: The overall purpose of this trial is to assess clinical efficacy and safety of different subcutaneous doses of BI 655066 in adult patients with chronic plaque psoriasis in order to select doses for further clinical trials.

ReferenceCitation: Suleiman AA, Khatri A, Oberoi RK, Othman AA. Exposure-Response Relationships for the Efficacy and Safety of Risankizumab in Japanese Subjects with Psoriasis. Clin Pharmacokinet. 2020 May;59(5):575-589. doi: 10.1007/s40262-019-00829-2.

family: Suleiman

full_name: Ahmed A. Suleiman

given: Ahmed A.

family: Khatri

full_name: Amit Khatri

given: Amit

family: Oberoi

full_name: Rajneet K. Oberoi

given: Rajneet K.

family: Othman

full_name: Ahmed A. Othman

journal_name: Clinical Pharmacokinetics

title: Exposure–Response Relationships for the Efficacy and Safety of Risankizumab in Japanese Subjects with Psoriasis

ReferenceCitation: Suleiman AA, Minocha M, Khatri A, Pang Y, Othman AA. Population Pharmacokinetics of Risankizumab in Healthy Volunteers and Subjects with Moderate to Severe Plaque Psoriasis: Integrated Analyses of Phase I-III Clinical Trials. Clin Pharmacokinet. 2019 Oct;58(10):1309-1321. doi: 10.1007/s40262-019-00759-z.

family: Minocha

full_name: Mukul Minocha

given: Mukul

family: Pang

full_name: Yinuo Pang

given: Yinuo

evidence: open (via page says license)

title: Population Pharmacokinetics of Risankizumab in Healthy Volunteers and Subjects with Moderate to Severe Plaque Psoriasis: Integrated Analyses of Phase I–III Clinical Trials

ReferenceCitation: Papp KA, Blauvelt A, Bukhalo M, Gooderham M, Krueger JG, Lacour JP, Menter A, Philipp S, Sofen H, Tyring S, Berner BR, Visvanathan S, Pamulapati C, Bennett N, Flack M, Scholl P, Padula SJ. Risankizumab versus Ustekinumab for Moderate-to-Severe Plaque Psoriasis. N Engl J Med. 2017 Apr 20;376(16):1551-1560. doi: 10.1056/NEJMoa1607017.

family: Papp

full_name: Kim A. Papp

given: Kim A.

family: Blauvelt

full_name: Andrew Blauvelt

given: Andrew

family: Bukhalo

full_name: Michael Bukhalo

given: Michael

family: Gooderham

full_name: Melinda Gooderham

given: Melinda

family: Krueger

location_country:
United States
Sweden
Finland
France
Norway
Germany
Canada

location_facility: 1311.2.10005 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.10003 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.49005 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.47001 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.35802 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.10004 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.49002 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.35801 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.49004 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.33005 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.47002 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.33006 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.20004 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.10001 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.20003 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.20005 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.10013 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.10011 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.10009 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.33003 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.10010 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.10012 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.49003 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.49001 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.46001 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.10006 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.33001 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.33004 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.10007 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.10002 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.33002 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.20002 Boehringer Ingelheim Investigational Site


ReferenceCitation: Carbone DP, Reck M, Paz-Ares L, Creelan B, Horn L, Steins M, Felip E, van den Heuvel MM, Ciuleanu TE, Badin F, Ready N, Hiltermann TJN, Nair S, Juergens R, Peters S, Minenza E, Wrangle JM, Rodriguez-Abreu D, Borghaei H, Blumenschein GR Jr, Villaruz LC, Havel L, Krejci J, Corral Jaime J, Chang H, Geese WJ, Bhagavatheeswaran P, Chen AC, Socinski MA; CheckMate 026 Investigators. First-Line Nivolumab in Stage IV or Recurrent Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Jun 22;376(25):2415-2426. doi: 10.1056/NEJMoa1613493.

family: Carbone

full_name: David P. Carbone

given: David P.

family: Reck

full_name: Martin Reck

given: Martin

family: Paz-Ares

full_name: Luis Paz-Ares

given: Luis

family: Creelan

full_name: Benjamin Creelan

given: Benjamin

family: Horn

full_name: Leora Horn

given: Leora

family: Steins

full_name: Martin Steins

family: Felip

full_name: Enriqueta Felip

given: Enriqueta

family: van den Heuvel

full_name: Michel M. van den Heuvel

given: Michel M.

family: Ciuleanu

full_name: Tudor-Eliade Ciuleanu

given: Tudor-Eliade

family: Badin

full_name: Firas Badin

given: Firas

family: Ready

full_name: Neal Ready

given: Neal

family: Hiltermann

full_name: T. Jeroen N. Hiltermann

given: T. Jeroen N.

family: Nair

full_name: Suresh Nair

given: Suresh

family: Juergens

full_name: Rosalyn Juergens

given: Rosalyn

family: Peters

full_name: Solange Peters

given: Solange

family: Minenza

full_name: Elisa Minenza

given: Elisa

family: Wrangle

full_name: John M. Wrangle

given: John M.

family: Rodriguez-Abreu

full_name: Delvys Rodriguez-Abreu

given: Delvys

family: Borghaei

full_name: Hossein Borghaei

given: Hossein

family: Blumenschein

full_name: George R. Blumenschein

given: George R.

suffix: Jr.

family: Villaruz

full_name: Liza C. Villaruz

given: Liza C.

family: Havel

full_name: Libor Havel

given: Libor

family: Krejci

full_name: Jana Krejci

given: Jana

family: Corral Jaime

full_name: Jesus Corral Jaime

given: Jesus

family: Chang

full_name: Han Chang

repository_institution: Queensland University of Technology - QUT ePrints

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

title: First-Line Nivolumab in Stage IV or Recurrent Non–Small-Cell Lung Cancer

location_country:
Finland
Greece
Romania
Australia
Belgium
Taiwan
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Sweden
Switzerland
Netherlands
Hungary
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Spain
Turkey

acronym: CheckMate 026: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 026

location_facility: University Of Texas Southwestern Medical Center

location_facility: Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

location_facility: Emory University - Winship Cancer Institute

location_facility: CISSS du Bas-Saint-Laurent Hopital Regional de Rimouski

location_facility: Centre Hospitalier De L'Universite De Montreal

location_facility: University Of North Carolina At Chapel Hill

location_facility: Yakima Valley Memorial Hospital/North Star Lodge

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: New York University Clinical Cancer Center

location_facility: Arizona Oncol Assoc Dba (Hem Onc Physicians&Extenders) Hope

location_facility: Ohio State University Comprehensive Cancer Center

title: An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer

summary: The purpose of this study is to show that Nivolumab will improve progression free survival in subjects with strongly Stage IV or Recurrent PD-L1+ non-small cell lung cancer when compared to chemotherapy


type: Registry Identifier

title: A Randomized, Double-blind, Placebo-controlled, Phase 2 Clinical Trial of Alisertib (MLN8237) in Combination With Paclitaxel Versus Placebo in Combination With Paclitaxel as Second Line Therapy for Small Cell Lung Cancer (SCLC).

summary: This is a two-arm, randomized, double-blind, placebo-controlled, multicenter, phase 2 study designed to is to determine if the combination treatment can improve progression free survival (defined as the time from the date of randomization to the date of first documentation of disease progression or death, whichever occurs first) when compared with placebo + paclitaxel.

ReferenceCitation: Owonikoko TK, Niu H, Nackaerts K, Csoszi T, Ostoros G, Mark Z, Baik C, Joy AA, Chouaid C, Jaime JC, Kolek V, Majem M, Roubec J, Santos ES, Chiang AC, Speranza G, Belani CP, Chiappori A, Patel MR, Czebe K, Byers L, Bahamon B, Li C, Sheldon-Waniga E, Kong EF, Williams M, Badola S, Shin H, Bedford L, Ecsedy JA, Bryant M, Jones S, Simmons J, Leonard EJ, Ullmann CD, Spigel DR; C14018 study investigators. Randomized Phase II Study of Paclitaxel plus Alisertib versus Paclitaxel plus Placebo as Second-Line Therapy for SCLC: Primary and Correlative Biomarker Analyses. J Thorac Oncol. 2020 Feb;15(2):274-287. doi: 10.1016/j.jtho.2019.10.013. Epub 2019 Oct 23.

family: Owonikoko

full_name: Taofeek K. Owonikoko

given: Taofeek K.

family: Niu

full_name: Huifeng Niu

given: Huifeng

family: Nackaerts

full_name: Kristiaan Nackaerts

given: Kristiaan

family: Csoszi

full_name: Tibor Csoszi

given: Tibor

family: Ostoros

full_name: Gyula Ostoros

given: Gyula

family: Mark

full_name: Zsuzsanna Mark

given: Zsuzsanna

family: Baik

full_name: Christina Baik

given: Christina

family: Joy

full_name: Anil Abraham Joy

given: Anil Abraham

family: Chouaid

full_name: Christos Chouaid

given: Christos

family: Jaime

given: Jesus Corral

family: Kolek

full_name: Vitezslav Kolek

given: Vitezslav

family: Majem

full_name: Margarita Majem

given: Margarita

family: Roubec

full_name: Jaromir Roubec

given: Jaromir

family: Santos

full_name: Edgardo S. Santos

given: Edgardo S.

family: Chiang

full_name: Anne C. Chiang

given: Anne C.

family: Speranza

full_name: Giovanna Speranza

given: Giovanna

family: Belani

full_name: Chandra P. Belani

given: Chandra P.

family: Chiappori

full_name: Alberto Chiappori

given: Alberto

family: Patel

full_name: Manish R. Patel

given: Manish R.

family: Czebe

full_name: Krisztina Czebe

given: Krisztina

family: Byers

full_name: Lauren Byers

given: Lauren

family: Bahamon

full_name: Brittany Bahamon

given: Brittany

family: Li

location_country:
Italy
United States
Germany
France
Czechia
Poland
Hungary
Belgium
Spain
Canada


lead_sponsor: Bausch Health Americas, Inc.

location_country:
Italy
United States
Switzerland
Mexico
United Kingdom
France
Bulgaria
Greece
Poland
Slovakia
Hungary
Belgium
Russian Federation
Spain
Estonia
Canada
Czech Republic

ipd_sharing: Yes

title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy, Safety and Effect on Radiographic Progression of Brodalumab in Subjects With Psoriatic Arthritis: AMVISION-1

summary: The primary objective of this study is to evaluate the efficacy of brodalumab, compared to placebo, in subjects with psoriatic arthritis.


ipd_sharing_description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

lead_sponsor: Astellas Pharma Europe B.V.

location_country:
North Macedonia
Finland
Romania
Russian Federation
Ukraine
Spain
Croatia
France
Poland
Slovakia
Montenegro
Slovenia
Netherlands
Bulgaria
Hungary
Ireland
Portugal
Germany
United Kingdom
Austria
Serbia
Czechia
Israel
Georgia
Belarus
Latvia

acronym: Dolomites

location_facility:
Site RS38103
Site SK42113
Site RS38117
Site RU70054
Site BY37505
Site RS38102
Site BG35916
Site FR33007
Site IL97215
Site ES34026
Site HU36046
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Site ME38202
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Site CZ42021
Site PT35112
Site PT35132
Site DE49065
Site UA38008
Site HU36027
Site UA38016
Site FR33062
Site FR33004
Site UA38017
Site PL48001
Site RU70024
Site RS38101
Site GB44100
Site RU70011
Site AT43009
Site BY37502
Site BG35907
Site RU70014
Site HU36029
Site GB44080
Site FI35810
Site GB44101
Site GE99504
Site FR33010
Site UA38007
Site PT35119
Site HR38510
Site PT35122
Site ES34039
Site HU36028
Site RU70060
Site RU70057
Site RO40003
Site PT35118
Site BY37506
Site RU70001
Site RU70047
Site FR33009
Site GB44099
Site CZ42018
Site GB44006
Site DE49075
Site PL48013
Site HR38509
Site HR38502
Site SI38619
Site DE49057
Site UA38011
Site RS38105
Site HR38505
Site ME38201
Site ES34054
Site RU70006
Site UA38009
Site RO40004
Site PL48059
Site PT35133
Site BY37503
Site HU36008
Site MK38901
Site RU70004
Site RO40012
Site UA38021
Site SI38603
Site HR38504
Site GB44082
Site GE99502
Site RS38104
Site RU70003
Site ES34041
Site DE49054
Site RO40021
Site ES34017
Site GB44001
Site PT35120
Site SK42109
Site IE35301
Site PT35131
Site FR33012
Site MK38903
Site PL48004
Site DE49073
Site PL48007
Site PL48066
Site SK42116
Site SI38615
Site BY37501
Site ES34049
Site LV37104
Site ES34030
Site BY37507
Site ES34010
Site GB44102
Site GB44086
Site SK42102
Site RU70002
Site GE99503
Site CZ42008
Site ES34037
Site GB44098
Site UA38001
Site NL31005
Site UA38006
Site GB44097
Site SI38609
Site GB44081
Site GB44064
Site BG35927
Site PL48009
Site UA38018

title: A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate the Efficacy and Safety of Roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis

summary: The primary objective of this study was to evaluate the efficacy of roxadustat compared to darbepoetin alfa in the treatment of anemia in nondialysis-dependent chronic kidney disease (NDD CKD) participants.


title: A Phase 2, Dose-Finding, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study, Evaluating the Safety and Efficacy of Pridopidine 45, 67.5, 90, and 112.5 mg Twice-Daily vs Placebo for Symptomatic Treatment in Patients With Huntington's Disease

summary: This is a multicenter, multinational, randomized, parallel-group, double-blind, placebo-controlled, dose range finding study to compare the efficacy and safety of different doses of pridopidine versus placebo in the treatment of motor impairment in Huntington's Disease (HD).

ReferenceCitation: McGarry A, Leinonen M, Kieburtz K, Geva M, Olanow CW, Hayden M. Effects of Pridopidine on Functional Capacity in Early-Stage Participants from the PRIDE-HD Study. J Huntingtons Dis. 2020;9(4):371-380. doi: 10.3233/JHD-200440.

ReferenceCitation: Rodrigues FB, Quinn L, Wild EJ. Huntington's Disease Clinical Trials Corner: January 2019. J Huntingtons Dis. 2019;8(1):115-125. doi: 10.3233/JHD-190001. Review.

name: UCL Huntington’s Disease Centre, UCL Queen Square Institute of Neurology, University College London, UK

name: Laboratory of Clinical Pharmacology and Therapeutics, Faculty of Medicine, University of Lisbon, PT

name: Clinical Pharmacology Unit, Instituto de Medicina Molecular, Lisbon, PT

family: Rodrigues

full_name: Filipe B. Rodrigues

given: Filipe B.

name: Department of Biobehavioral Sciences, Teachers College, Columbia University, USA

family: Quinn

full_name: Lori Quinn

given: Lori

family: Wild

full_name: Edward J. Wild

given: Edward J.

journal_name: Journal of Huntington's Disease

oa_colors: green other

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

publisher: IOS Press

publisher_dissemination: IOS Press

publisher_group: IOS Press

publisher_normalized: IOS Press

title: Huntington’s Disease Clinical Trials Corner: January 2019

ReferenceCitation: Reilmann R, McGarry A, Grachev ID, Savola JM, Borowsky B, Eyal E, Gross N, Langbehn D, Schubert R, Wickenberg AT, Papapetropoulos S, Hayden M, Squitieri F, Kieburtz K, Landwehrmeyer GB; European Huntington's Disease Network; Huntington Study Group investigators. Safety and efficacy of pridopidine in patients with Huntington's disease (PRIDE-HD): a phase 2, randomised, placebo-controlled, multicentre, dose-ranging study. Lancet Neurol. 2019 Feb;18(2):165-176. doi: 10.1016/S1474-4422(18)30391-0. Epub 2018 Dec 15.

family: Reilmann

full_name: Ralf Reilmann

given: Ralf

family: McGarry

full_name: Andrew McGarry

given: Andrew

family: Grachev

full_name: Igor D Grachev

given: Igor D

family: Savola

full_name: Juha-Matti Savola

given: Juha-Matti

family: Borowsky

full_name: Beth Borowsky

given: Beth

family: Eyal

full_name: Eli Eyal

given: Eli

family: Gross

full_name: Nicholas Gross

given: Nicholas

family: Langbehn

full_name: Douglas Langbehn

given: Douglas

family: Schubert

full_name: Robin Schubert

given: Robin

family: Wickenberg

full_name: Anna Teige Wickenberg

given: Anna Teige

family: Papapetropoulos

full_name: Spyros Papapetropoulos

given: Spyros

family: Hayden

full_name: Michael Hayden

given: Michael

family: Squitieri

full_name: Ferdinando Squitieri

given: Ferdinando

family: Kieburtz

full_name: Karl Kieburtz

location_country:
Italy
Austria
United States
Netherlands
Germany
France
Poland
Australia
Russian Federation
Denmark
Canada
United Kingdom

location_facility:
Investigational Site 35124
Investigational Site 53151
Investigational Site 12208
Investigational Site 78056
Investigational Site 34058
Investigational Site 12199
Investigational Site 78058
Investigational Site 33027
Investigational Site 39027
Investigational Site 11036
Investigational Site 34057
Investigational Site 34059
Investigational Site 33021
Investigational Site 53149
Investigational Site 12206
Investigational Site 35122
Investigational Site 34056
Investigational Site 53148
Investigational Site 35123
Investigational Site 12204
Investigational Site 50215
Investigational Site 32410
Investigational Site 30084
Investigational Site 12205
Investigational Site 12197
Investigational Site 34061
Investigational Site 12201
Investigational Site 12207
Investigational Site 35165
Investigational Site 30081
Investigational Site 30082
Investigational Site 35121
Investigational Site 50214
Investigational Site 34054
Investigational Site 34055
Investigational Site 12210
Investigational Site 32409
Investigational Site 12202
Investigational Site 50213
Investigational Site 12209
Investigational Site 32407
Investigational Site 30083
Investigational Site 12198
Investigational Site 34060
Investigational Site 11035
Investigational Site 78057
Investigational Site 30080
Investigational Site 39028
Investigational Site 38059
Investigational Site 12211
Investigational Site 53150
Investigational Site 12200
Investigational Site 11037
Investigational Site 32408
Investigational Site 78055
Investigational Site 12196
Investigational Site 12203
Investigational Site 35125


title: An Open-Label, Multicenter, Phase 1b Study of JNJ-54767414 (HuMax CD38) (Anti-CD38 Monoclonal Antibody) in Combination With Backbone Regimens for the Treatment of Subjects With Multiple Myeloma

summary: The purpose of this study is to evaluate the safety, tolerability, and dose regimen of daratumumab when administered in combination with various treatment regimens for the treatment of multiple myeloma.

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Leleu X, Beksac M, Chou T, Dimopoulos M, Yoon SS, Prince HM, Pour L, Shelekhova T, Chari A, Khurana M, Zhang J, Obreja M, Qi M, Oriol A, Siegel D. Efficacy and safety of weekly carfilzomib (70 mg/m(2)), dexamethasone, and daratumumab (KdD70) is comparable to twice-weekly KdD56 while being a more convenient dosing option: a cross-study comparison of the CANDOR and EQUULEUS studies. Leuk Lymphoma. 2021 Feb;62(2):358-367. doi: 10.1080/10428194.2020.1832672. Epub 2020 Oct 28.

name: Service d'Hématologie et Thérapie cellulaire, CHU and Inserm, Poitiers, France

family: Leleu

full_name: Xavier Leleu

given: Xavier

name: Department of Hematology, Ankara University, Ankara, Turkey

family: Beksac

full_name: Meral Beksac

given: Meral

name: Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan

family: Chou

full_name: Takaaki Chou

given: Takaaki

name: Hematology and Medical Oncology, Department of Clinical Therapeutics, National and Kapodistrian University of Athens School of Medicine, Athens, Greece

family: Dimopoulos

full_name: Meletios Dimopoulos

given: Meletios

name: Department of Internal Medicine, Seoul National University, Seoul, South Korea

family: Yoon

full_name: Sung-Soo Yoon

given: Sung-Soo

name: Epworth Healthcare and Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia

family: Prince

full_name: H. Miles Prince

given: H. Miles

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

family: Pour

full_name: Ludek Pour

given: Ludek

name: Clinic of Professional Pathology, Saratov, Russian Federation

family: Shelekhova

full_name: Tatiana Shelekhova

given: Tatiana

name: Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA

family: Chari

full_name: Ajai Chari

given: Ajai

name: Clinical Development, Oncology, Amgen Inc., Thousand Oaks, CA, USA

family: Khurana

full_name: Monica Khurana

given: Monica

name: Global Biostatistical Science, Amgen Inc., Thousand Oaks, CA, USA

family: Zhang

full_name: Jianqi Zhang

given: Jianqi

family: Obreja

full_name: Mihaela Obreja

given: Mihaela

name: Hematology and Oncology, Janssen Research and Development, LLC, Spring House, PA, USA

family: Qi

full_name: Ming Qi

given: Ming

name: Institut Català d'Oncologia and Josep Carreras Research Leukaemia Institute, Hospital Germans Trias i Pujol, Barcelona, Spain

family: Oriol

full_name: Albert Oriol

given: Albert

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

family: Siegel

full_name: David Siegel

given: David

journal_name: Leukemia & Lymphoma

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

title: Efficacy and safety of weekly carfilzomib (70 mg/m2), dexamethasone, and daratumumab (KdD70) is comparable to twice-weekly KdD56 while being a more convenient dosing option: a cross-study comparison of the CANDOR and EQUULEUS studies

ReferenceCitation: Xu XS, Moreau P, Usmani SZ, Lonial S, Jakubowiak A, Oriol A, Krishnan A, Bladé J, Luo M, Sun YN, Zhou H, Nnane I, Deraedt W, Qi M, Ukropec J, Clemens PL. Split First Dose Administration of Intravenous Daratumumab for the Treatment of Multiple Myeloma (MM): Clinical and Population Pharmacokinetic Analyses. Adv Ther. 2020 Apr;37(4):1464-1478. doi: 10.1007/s12325-020-01247-8. Epub 2020 Feb 20.

family: Xu

full_name: Xu Steven Xu

given: Xu Steven

family: Moreau

full_name: Philippe Moreau

given: Philippe

family: Usmani

full_name: Saad Z. Usmani

given: Saad Z.

family: Lonial

full_name: Sagar Lonial

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

ReferenceCitation: Chari A, Martinez-Lopez J, Mateos MV, Bladé J, Benboubker L, Oriol A, Arnulf B, Rodriguez-Otero P, Pineiro L, Jakubowiak A, de Boer C, Wang J, Clemens PL, Ukropec J, Schecter J, Lonial S, Moreau P. Daratumumab plus carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma. Blood. 2019 Aug 1;134(5):421-431. doi: 10.1182/blood.2019000722. Epub 2019 May 21.

name: Tisch Cancer Institute, Mount Sinai School of Medicine, New York, NY;

name: Hospital 12 de Octubre, H12O-CNIO, Haematological Malignancies Clinical Research Unit, Universidad Complutense, Centro de Investigación Biomédica en Red de Cáncer, Madrid, Spain;

name: University Hospital of Salamanca/Instituto de Investigación Biomédica de Salamanca, Salamanca, Spain;

name: Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona, Barcelona, Spain;

name: Hôpital Bretonneau, Centre Hospitalier Régional Universitaire, Tours, France;

name: Institut Català d’Oncologia and Institut Josep Carreras, Hospital Germans Trias i Pujol, Barcelona, Spain;

name: Clinica Universidad de Navarra, Instituto de Investigación Sanitaria de Navarra, Navarra, Spain;

name: Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas, TX;

name: University of Chicago Medical Center, Chicago, IL;

name: Janssen Research & Development, LLC, Leiden, The Netherlands;

name: Janssen Research & Development, LLC, Raritan, NJ;

name: Janssen Research & Development, LLC, Spring House, PA;

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

name: University Hospital Hôtel-Dieu, Nantes, France

ReferenceCitation: Chari A, Suvannasankha A, Fay JW, Arnulf B, Kaufman JL, Ifthikharuddin JJ, Weiss BM, Krishnan A, Lentzsch S, Comenzo R, Wang J, Nottage K, Chiu C, Khokhar NZ, Ahmadi T, Lonial S. Daratumumab plus pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma. Blood. 2017 Aug 24;130(8):974-981. doi: 10.1182/blood-2017-05-785246. Epub 2017 Jun 21.

name: Indiana University School of Medicine and Simon Cancer Center, Richard L. Roudebush VA Medical Center, Indianapolis, IN;

name: Baylor Institute for Immunology Research, Dallas, TX;

name: Unité d’Immuno-hématologie, Assistance Publique–Hôpitaux de Paris, Centre d’Investigations Cliniques 1427, Hôpital Saint Louis Lariboisière, Paris, France;

name: Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA;

name: James P. Wilmot Cancer Center, University of Rochester Strong Memorial Hospital, Rochester, NY;

name: Abramson Cancer Center and Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA;

name: The Judy and Bernard Briskin Myeloma Center, City of Hope, Duarte, CA;

name: Columbia University Medical Center, New York, NY;

name: Division of Hematology-Oncology, Tufts Medical Center, Boston, MA;

name: Janssen Research & Development, Raritan, NJ; and

name: Janssen Research & Development, Spring House, PA


status: Withdrawn

lead_sponsor: Crucell Holland BV

location_country:
Brazil
South Africa
Sweden
Netherlands
Germany
France
Bulgaria
Belgium
Australia
Spain
United States
Canada

title: Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of CR8020 and CR6261 in Hospitalized Patients With Influenza A Infection

summary: The purpose of this study is to evaluate the rate of decline in quantitative viral load measured in hospitalized patients with Influenza A infection


title: A Multi-center, Randomized, Double-blind Study to Compare the Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea (CDAD)

summary: This clinical study is conducted to assess the efficacy of cadazolid compared to vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).

ReferenceCitation: Gerding DN, Cornely OA, Grill S, Kracker H, Marrast AC, Nord CE, Talbot GH, Buitrago M, Gheorghe Diaconescu I, Murta de Oliveira C, Preotescu L, Pullman J, Louie TJ, Wilcox MH. Cadazolid for the treatment of Clostridium difficile infection: results of two double-blind, placebo-controlled, non-inferiority, randomised phase 3 trials. Lancet Infect Dis. 2019 Mar;19(3):265-274. doi: 10.1016/S1473-3099(18)30614-5. Epub 2019 Jan 29.

family: Gerding

full_name: Dale N Gerding

given: Dale N

family: Cornely

full_name: Oliver A Cornely

given: Oliver A

family: Grill

full_name: Simon Grill

given: Simon

family: Kracker

full_name: Hilke Kracker

given: Hilke

family: Marrast

full_name: Anne Claire Marrast

given: Anne Claire

family: Nord

full_name: Carl Erik Nord

given: Carl Erik

family: Talbot

full_name: George H Talbot

given: George H

family: Buitrago

full_name: Martha Buitrago

given: Martha

family: Gheorghe Diaconescu

full_name: Iulian Gheorghe Diaconescu

given: Iulian

family: Murta de Oliveira

full_name: Claudia Murta de Oliveira

given: Claudia

family: Preotescu

full_name: Liliana Preotescu

given: Liliana

family: Pullman

full_name: John Pullman

given: John

family: Louie

full_name: Thomas J Louie

given: Thomas J

family: Wilcox

full_name: Mark H Wilcox

given: Mark H

journal_name: The Lancet Infectious Diseases

version: acceptedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Kleinman L, Talbot GH, Hunsche E, Schüler R, Nord CE. The CDI-DaySyms: Content Development of a New Patient-Reported Outcome Questionnaire for Symptoms of Clostridium difficile Infection. Value Health. 2018 Apr;21(4):441-448. doi: 10.1016/j.jval.2017.08.3017. Epub 2017 Nov 7. Review.

family: Kleinman

full_name: Leah Kleinman

given: Leah

full_name: George H. Talbot

given: George H.

family: Hunsche

full_name: Elke Hunsche

given: Elke

family: Schüler

full_name: René Schüler

given: René

location_country:
Italy
Brazil
United States
Peru
Netherlands
Germany
France
Poland
Romania
Australia
Spain
Canada


ReferenceCitation: Poordad F, Sievert W, Mollison L, Bennett M, Tse E, Bräu N, Levin J, Sepe T, Lee SS, Angus P, Conway B, Pol S, Boyer N, Bronowicki JP, Jacobson I, Muir AJ, Reddy KR, Tam E, Ortiz-Lasanta G, de Lédinghen V, Sulkowski M, Boparai N, McPhee F, Hughes E, Swenson ES, Yin PD; UNITY-1 Study Group. Fixed-dose combination therapy with daclatasvir, asunaprevir, and beclabuvir for noncirrhotic patients with HCV genotype 1 infection. JAMA. 2015 May 5;313(17):1728-35. doi: 10.1001/jama.2015.3860.

name: Texas Liver Institute, University of Texas Health Science Center, San Antonio

family: Poordad

full_name: Fred Poordad

given: Fred

name: Monash Health and Monash University, Melbourne, Australia

family: Sievert

full_name: William Sievert

given: William

name: Fremantle Hepatitis Services, School of Medicine and Pharmacology, University of Western Australia, Fremantle, Australia

family: Mollison

full_name: Lindsay Mollison

given: Lindsay

name: Medical Associates Research Group, San Diego, California

family: Bennett

full_name: Michael Bennett

given: Michael

name: Royal Adelaide Hospital, Adelaide, Australia

family: Tse

full_name: Edmund Tse

given: Edmund

name: James J. Peters Veterans Affairs Medical Center, Bronx, New York7Icahn School of Medicine at Mount Sinai, New York, New York

family: Bräu

full_name: Norbert Bräu

given: Norbert

family: Levin

full_name: James Levin

given: James

name: University Gastroenterology, Providence, Rhode Island

family: Sepe

full_name: Thomas Sepe

given: Thomas

name: University of Calgary, Calgary, Alberta, Canada

family: Lee

full_name: Samuel S. Lee

given: Samuel S.

family: Angus

full_name: Peter Angus

given: Peter

name: Vancouver Infectious Diseases Centre, Vancouver, British Columbia, Canada

family: Conway

full_name: Brian Conway

given: Brian

name: Université Paris Descartes, AP-HP, Unité d’Hépatologie, Hôpital Cochin, INSERM UMS-20, Institut Pasteur, Paris, France

family: Pol

full_name: Stanislas Pol

given: Stanislas

name: Service d’Hépatologie, Hôpital Beaujon, Clichy, France

family: Boyer

full_name: Nathalie Boyer

given: Nathalie

name: INSERM U954, Centre Hospitalier Universitaire de Nancy, Université de Lorraine, Vandoeuvre les Nancy, France

family: Bronowicki

full_name: Jean-Pierre Bronowicki

given: Jean-Pierre

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

family: Jacobson

full_name: Ira Jacobson

given: Ira

name: Duke University Medical Center, Durham, North Carolina

family: Muir

full_name: Andrew J. Muir

given: Andrew J.

name: University of Pennsylvania, Philadelphia

family: Reddy

full_name: K. Rajender Reddy

given: K. Rajender

name: LAIR Centre, Vancouver, British Columbia, Canada

family: Tam

full_name: Edward Tam

given: Edward

name: Fundacion de Investigacion, San Juan, Puerto Rico

family: Ortiz-Lasanta

full_name: Grisell Ortiz-Lasanta

given: Grisell

family: de Lédinghen

full_name: Victor de Lédinghen

given: Victor

name: Johns Hopkins University School of Medicine, Baltimore, Maryland

family: Sulkowski

full_name: Mark Sulkowski

given: Mark

name: Bristol-Myers Squibb, Princeton, New Jersey

family: Boparai

full_name: Navdeep Boparai

given: Navdeep

name: Bristol-Myers Squibb, Wallingford, Connecticut

family: McPhee

full_name: Fiona McPhee

given: Fiona

family: Hughes

full_name: Eric Hughes

given: Eric

family: Swenson

full_name: E. Scott Swenson

given: E. Scott

title: Fixed-Dose Combination Therapy With Daclatasvir, Asunaprevir, and Beclabuvir for Noncirrhotic Patients With HCV Genotype 1 Infection

location_country:
United States
France
Puerto Rico
Australia
Canada

location_facility: The Gastroenterology Group Of South Jersey

location_facility: Hospital Of The University Of Pennsylvania

location_facility: University Hospitals Case Medical Center

location_facility: University Of Pittsburgh Medical Center, Ctr For Liver Diseases

location_facility: Asheville Gastroenterology Associates, Pa

location_facility: University Of Colorado Denver & Hospital

location_facility: Bon Secours St. Mary'S Hospital Of Richmond, Inc.

location_facility: Washington University School Of Medicine

location_facility: Premier Medical Group Of The Hudson Valley, Pc

title: A Phase 3 Evaluation of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination in Non-cirrhotic Subjects With Genotype 1 Chronic Hepatitis C

summary: To demonstrate the effectiveness of DCV 3DAA fixed dose regimen in treatment naive and treatment experienced non-cirrhotic subjects


title: A Multi-center, Multinational, Randomized, Double-blind, Controlled, Dose Comparison Study to Evaluate Safety and Efficacy of MP4OX Plus Standard Treatment, in Severely Injured Trauma Subjects With Lactic Acidosis Due to Hemorrhagic Shock

summary: MP4OX is being developed as an ischemic rescue therapy to perfuse and oxygenate tissues at risk during hemorrhagic shock. MP4OX is a pegylated hemoglobin-based colloid designed to improve perfusion and target delivery of oxygen to ischemic tissues. This study will evaluate safety and efficacy of MP4OX treatment, in addition to standard therapy, in trauma patients suffering from lactic acidosis due to severe hemorrhagic shock.

ReferenceCitation: Cole RH, Vandegriff KD. MP4, a vasodilatory PEGylated hemoglobin. Adv Exp Med Biol. 2011;701:85-90. doi: 10.1007/978-1-4419-7756-4_12.

ReferenceCitation: Young MA, Lohman J, Malavalli A, Vandegriff KD, Winslow RM. Hemospan improves outcome in a model of perioperative hemodilution and blood loss in the rat: comparison with hydroxyethyl starch. J Cardiothorac Vasc Anesth. 2009 Jun;23(3):339-47. doi: 10.1053/j.jvca.2008.08.006. Epub 2008 Oct 22.

ReferenceCitation: Vandegriff KD, Winslow RM. Hemospan: design principles for a new class of oxygen therapeutic. Artif Organs. 2009 Feb;33(2):133-8. doi: 10.1111/j.1525-1594.2008.00697.x.

ReferenceCitation: Vandegriff KD, Malavalli A, Mkrtchyan GM, Spann SN, Baker DA, Winslow RM. Sites of modification of hemospan, a poly(ethylene glycol)-modified human hemoglobin for use as an oxygen therapeutic. Bioconjug Chem. 2008 Nov 19;19(11):2163-70. doi: 10.1021/bc8002666.

ReferenceCitation: Svergun DI, Ekström F, Vandegriff KD, Malavalli A, Baker DA, Nilsson C, Winslow RM. Solution structure of poly(ethylene) glycol-conjugated hemoglobin revealed by small-angle X-ray scattering: implications for a new oxygen therapeutic. Biophys J. 2008 Jan 1;94(1):173-81. Epub 2007 Sep 7.

ReferenceCitation: Cole RH, Vandegriff KD, Szeri AJ, Savaş O, Baker DA, Winslow RM. A quantitative framework for the design of acellular hemoglobins as blood substitutes: implications of dynamic flow conditions. Biophys Chem. 2007 Jun;128(1):63-74. Epub 2007 Mar 13.

ReferenceCitation: Young MA, Riddez L, Kjellström BT, Bursell J, Winslow F, Lohman J, Winslow RM. MalPEG-hemoglobin (MP4) improves hemodynamics, acid-base status, and survival after uncontrolled hemorrhage in anesthetized swine. Crit Care Med. 2005 Aug;33(8):1794-804.

ReferenceCitation: Drobin D, Kjellstrom BT, Malm E, Malavalli A, Lohman J, Vandegriff KD, Young MA, Winslow RM. Hemodynamic response and oxygen transport in pigs resuscitated with maleimide-polyethylene glycol-modified hemoglobin (MP4). J Appl Physiol (1985). 2004 May;96(5):1843-53. Epub 2004 Jan 16.

ReferenceCitation: Winslow RM, Lohman J, Malavalli A, Vandegriff KD. Comparison of PEG-modified albumin and hemoglobin in extreme hemodilution in the rat. J Appl Physiol (1985). 2004 Oct;97(4):1527-34. Epub 2004 Jun 18.

ReferenceCitation: Vandegriff KD, Bellelli A, Samaja M, Malavalli A, Brunori M, Winslow RM. Kinetics of NO and O2 binding to a maleimide poly(ethylene glycol)-conjugated human haemoglobin. Biochem J. 2004 Aug 15;382(Pt 1):183-9.

ReferenceCitation: Tsai AG, Vandegriff KD, Intaglietta M, Winslow RM. Targeted O2 delivery by low-P50 hemoglobin: a new basis for O2 therapeutics. Am J Physiol Heart Circ Physiol. 2003 Oct;285(4):H1411-9. Epub 2003 Jun 12.

ReferenceCitation: Vandegriff KD, Malavalli A, Wooldridge J, Lohman J, Winslow RM. MP4, a new nonvasoactive PEG-Hb conjugate. Transfusion. 2003 Apr;43(4):509-16.

ReferenceCitation: McCarthy MR, Vandegriff KD, Winslow RM. The role of facilitated diffusion in oxygen transport by cell-free hemoglobins: implications for the design of hemoglobin-based oxygen carriers. Biophys Chem. 2001 Aug 30;92(1-2):103-17.

ReferenceCitation: Young MA, Riddez L, Kjellström BT, Winslow RM. Effect of maleimide-polyethylene glycol hemoglobin (MP4) on hemodynamics and acid-base status after uncontrolled hemorrhage in anesthetized swine: comparison with crystalloid and blood. J Trauma. 2007 Dec;63(6):1234-44. doi: 10.1097/TA.0b013e31815bd7b0.

ReferenceCitation: Wettstein R, Tsai AG, Erni D, Winslow RM, Intaglietta M. Resuscitation with polyethylene glycol-modified human hemoglobin improves microcirculatory blood flow and tissue oxygenation after hemorrhagic shock in awake hamsters. Crit Care Med. 2003 Jun;31(6):1824-30.

ReferenceCitation: Husain FA, Martin MJ, Mullenix PS, Steele SR, Elliott DC. Serum lactate and base deficit as predictors of mortality and morbidity. Am J Surg. 2003 May;185(5):485-91.

ReferenceCitation: Régnier MA, Raux M, Le Manach Y, Asencio Y, Gaillard J, Devilliers C, Langeron O, Riou B. Prognostic significance of blood lactate and lactate clearance in trauma patients. Anesthesiology. 2012 Dec;117(6):1276-88. doi: 10.1097/ALN.0b013e318273349d.

ReferenceCitation: McNelis J, Marini CP, Jurkiewicz A, Szomstein S, Simms HH, Ritter G, Nathan IM. Prolonged lactate clearance is associated with increased mortality in the surgical intensive care unit. Am J Surg. 2001 Nov;182(5):481-5.

ReferenceCitation: Abramson D, Scalea TM, Hitchcock R, Trooskin SZ, Henry SM, Greenspan J. Lactate clearance and survival following injury. J Trauma. 1993 Oct;35(4):584-8; discussion 588-9.

ReferenceCitation: Tsai AG, Cabrales P, Manjula BN, Acharya SA, Winslow RM, Intaglietta M. Dissociation of local nitric oxide concentration and vasoconstriction in the presence of cell-free hemoglobin oxygen carriers. Blood. 2006 Nov 15;108(10):3603-10. Epub 2006 Jul 20.

lead_sponsor: Sangart

location_country:
Brazil
South Africa
Switzerland
France
Israel
Norway
Belgium
Australia
New Zealand
Germany
United Kingdom

location_facility: Faculdade de Medicina de S. J. Do Rio Preto

location_facility: Vincent Palotti Dr Christiaan Barnard Memorial Hospital

location_facility: Charlotte Maxeke Johannesburg Academic Hospita

location_facility: Hopital Universitário, Centro de Estudos em Emergências em Saúde, USP Ribeirão Preto

location_facility: Klinikum der J.-W.-Goethe-Universität Frankfurt a.M.

location_facility: Hadassah Medical Organization, Hadassah University Hospital, Ein-Karem

location_facility: Universitätsklinikum der Rheinisch-Westfälische Technische Hochschule Aachen

location_facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo - FMUSP

location_facility: Kliniken der Stadt Köln gGmbH Krankenhaus Merheim


ReferenceCitation: Muir AJ, Poordad F, Lalezari J, Everson G, Dore GJ, Herring R, Sheikh A, Kwo P, Hézode C, Pockros PJ, Tran A, Yozviak J, Reau N, Ramji A, Stuart K, Thompson AJ, Vierling J, Freilich B, Cooper J, Ghesquiere W, Yang R, McPhee F, Hughes EA, Swenson ES, Yin PD. Daclatasvir in combination with asunaprevir and beclabuvir for hepatitis C virus genotype 1 infection with compensated cirrhosis. JAMA. 2015 May 5;313(17):1736-44. doi: 10.1001/jama.2015.3868.

name: Duke Clinical Research Institute, Duke University, Durham, North Carolina

name: Texas Liver Institute-University of Texas Health Science Center, San Antonio

family: Poordad

full_name: Fred Poordad

given: Fred

name: Quest Clinical Research, San Francisco, California

family: Lalezari

full_name: Jacob Lalezari

given: Jacob

name: University of Colorado School of Medicine, Denver

family: Everson

full_name: Gregory Everson

given: Gregory

name: Kirby Institute, University of New South Wales, Kensington, New South Wales, Australia6St Vincent’s Hospital, Sydney, New South Wales, Australia

family: Dore

full_name: Gregory J. Dore

given: Gregory J.

name: Quality Medical Research, Nashville, Tennessee

family: Herring

full_name: Robert Herring

given: Robert

name: Gastrointestinal Specialists Of Georgia, Marietta

family: Sheikh

full_name: Aasim Sheikh

given: Aasim

name: Indiana University School of Medicine, Indianapolis

family: Kwo

full_name: Paul Kwo

given: Paul

name: Hôpital Henri Mondor, AP-HP, INSERM U955, Université Paris-Est, Créteil, France

family: Hézode

full_name: Christophe Hézode

given: Christophe

family: Pockros

full_name: Paul J. Pockros

given: Paul J.

name: INSERM U1065, Team 8, Hepatic Complications in Obesity, Nice, France13Centre Hospitalier Universitaire of Nice, Digestive Center, Nice, France

family: Tran

full_name: Albert Tran

given: Albert

name: Lehigh Valley Health Network, Allentown, Pennsylvania

family: Yozviak

full_name: Joseph Yozviak

given: Joseph

name: University of Chicago Medical Center, Chicago, Illinois

family: Reau

full_name: Nancy Reau

given: Nancy

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

family: Ramji

full_name: Alnoor Ramji

given: Alnoor

name: Gallipoli Medical Research Foundation, Greenslopes Private Hospital, Brisbane, Australia

family: Stuart

full_name: Katherine Stuart

given: Katherine

name: St Vincent's Hospital, Melbourne, Victoria, Australia19University of Melbourne, Melbourne, Victoria, Australia

family: Thompson

full_name: Alexander J. Thompson

given: Alexander J.

name: Baylor College of Medicine, Houston, Texas

family: Vierling

full_name: John Vierling

given: John

name: Kansas City Research Institute, Kansas City, Missouri

family: Freilich

full_name: Bradley Freilich

given: Bradley

name: Inova Fairfax Hospital, Falls Church, Virginia

family: Cooper

full_name: James Cooper

given: James

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

family: Ghesquiere

full_name: Wayne Ghesquiere

given: Wayne

family: Yang

full_name: Rong Yang

given: Rong

full_name: Eric A. Hughes

given: Eric A.

family: Yin

full_name: Philip D. Yin

given: Philip D.

title: Daclatasvir in Combination With Asunaprevir and Beclabuvir for Hepatitis C Virus Genotype 1 Infection With Compensated Cirrhosis

title: A Phase 3 Evaluation of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination in Subjects With Genotype 1 Chronic Hepatitis C and Compensated Cirrhosis

summary: To demonstrate the effectiveness of DCV 3DAA fixed dose combination with or without Ribavirin in treatment naive cirrhotic subjects.


title: A Randomized, Global, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Once-daily Oral Avatrombopag for the Treatment of Adults With Thrombocytopenia Associated With Liver Disease Prior to an Elective Procedure

summary: This is a global, multicenter, randomized, double-blind, placebo-controlled, parallel group study using avatrombopag to treat adults with thrombocytopenia associated with liver disease. The study will evaluate avatrombopag in the treatment of thrombocytopenia associated with liver disease prior to an elective procedure to reduce the need for platelet transfusions or any rescue procedure for bleeding due to procedural and post-procedural bleeding complications. Participants will be enrolled into 2 cohorts according to mean baseline platelet count and, within each baseline platelet count cohort will be further stratified by risk of bleeding associated with the elective procedure (low, moderate, or high) and hepatocellular carcinoma (HCC) status (Yes or No).

ReferenceCitation: Poordad F, Terrault NA, Alkhouri N, Tian W, Allen LF, Rabinovitz M. Avatrombopag, an Alternate Treatment Option to Reduce Platelet Transfusions in Patients with Thrombocytopenia and Chronic Liver Disease-Integrated Analyses of 2 Phase 3 Studies. Int J Hepatol. 2020 Jan 25;2020:5421632. doi: 10.1155/2020/5421632. eCollection 2020.

name: Texas Liver Institute and University of Texas Health San Antonio, San Antonio, TX, USA

family: Poordad

full_name: Fred Poordad

given: Fred

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

family: Terrault

full_name: Norah A. Terrault

given: Norah A.

name: Texas Liver Institute, San Antonio, TX, USA

family: Alkhouri

full_name: Naim Alkhouri

given: Naim

name: Dova Pharmaceuticals, Inc., Durham, NC, USA

family: Tian

full_name: Wei Tian

given: Wei

family: Allen

full_name: Lee F. Allen

given: Lee F.

name: University of Pittsburgh, Pittsburgh, PA, USA

family: Rabinovitz

full_name: Mordechai Rabinovitz

given: Mordechai

currency_apc_doaj: USD

journal_name: International Journal of Hepatology

publisher: Hindawi Limited

publisher_dissemination: Hindawi

publisher_group: Hindawi

publisher_normalized: Hindawi

ReferenceCitation: Terrault N, Chen YC, Izumi N, Kayali Z, Mitrut P, Tak WY, Allen LF, Hassanein T. Avatrombopag Before Procedures Reduces Need for Platelet Transfusion in Patients With Chronic Liver Disease and Thrombocytopenia. Gastroenterology. 2018 Sep;155(3):705-718. doi: 10.1053/j.gastro.2018.05.025. Epub 2018 May 17.

full_name: Norah Terrault

given: Norah

family: Chen

full_name: Yi-Cheng Chen

given: Yi-Cheng

family: Izumi

full_name: Namiki Izumi

given: Namiki

family: Kayali

full_name: Zeid Kayali

given: Zeid

family: Mitrut

full_name: Paul Mitrut

family: Tak

full_name: Won Young Tak

given: Won Young

family: Hassanein

full_name: Tarek Hassanein

given: Tarek

journal_name: Gastroenterology

location_country:
Italy
Austria
Brazil
Chile
Spain
Germany
France
Korea, Republic of
Poland
Thailand
Hungary
Argentina
Australia
Belgium
China
United States
United Kingdom
Canada
Taiwan
Portugal


title: A Randomized Multi-Center Open Label Study of BMS-354825 vs. Imatinib Mesylate (Gleevec) 800 mg/d in Subjects With Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Have Disease That is Resistant to Imatinib at a Dose at 400 - 600 mg/d

summary: The primary purpose of this study is to estimate the major cytogenetic response rates of BMS-354825 and imatinib (800 mg/d) in subjects with chronic phase, Philadelphia chromosome positive, chronic myeloid leukemia (PH+ CML) with disease resistant to imatinib at a dose of 400-600 mg/d.

ReferenceCitation: Kantarjian H, Pasquini R, Lévy V, Jootar S, Holowiecki J, Hamerschlak N, Hughes T, Bleickardt E, Dejardin D, Cortes J, Shah NP. Dasatinib or high-dose imatinib for chronic-phase chronic myeloid leukemia resistant to imatinib at a dose of 400 to 600 milligrams daily: two-year follow-up of a randomized phase 2 study (START-R). Cancer. 2009 Sep 15;115(18):4136-47. doi: 10.1002/cncr.24504.

ReferenceCitation: Müller MC, Cortes JE, Kim DW, Druker BJ, Erben P, Pasquini R, Branford S, Hughes TP, Radich JP, Ploughman L, Mukhopadhyay J, Hochhaus A. Dasatinib treatment of chronic-phase chronic myeloid leukemia: analysis of responses according to preexisting BCR-ABL mutations. Blood. 2009 Dec 3;114(24):4944-53. doi: 10.1182/blood-2009-04-214221. Epub 2009 Sep 24.

lead_sponsor: Bristol-Myers Squibb

location_country:
Peru
Finland
Australia
Belgium
Russian Federation
Denmark
Taiwan
France
Poland
Thailand
Norway
Argentina
Canada
Korea, Republic of
South Africa
Sweden
Switzerland
Philippines
Singapore
Hungary
Ireland
Puerto Rico
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Israel
Spain
Estonia


title: Randomized, Double-Blind, Safety and Efficacy Trial With Intravenous Zoledronic Acid for the Treatment of Paget's Disease of Bone Using Risedronate as a Comparator, Including an Extended Observation Period

summary: The primary objective of this core study was to show non-inferiority of zoledronic acid to risedronate, with respect to the proportion of patients who achieved therapeutic response. The extended observation period included participants of the core study who responded to treatment.

location_country:
United States
South Africa
Germany
France
Belgium
Australia
New Zealand
Spain
Canada
United Kingdom

location_facility:
Novartis Investigative site
Novartis Investigative Site


title: A Phase II Study of BMS-354825 in Subjects With Myeloid Blast Phase Chronic Myeloid Leukemia Resistant to or Intolerant of Imatinib Mesylate

summary: The purpose of this study is to see what effect an investigational drug (BMS-354825) has on subjects who are currently in the myeloid blast phase of chronic myeloid leukemia (CML) and who are either resistant to or intolerant of imatinib mesylate. Another purpose of the study is to see what side effects this drug may have on subjects.

ReferenceCitation: Cortes J, Rousselot P, Kim DW, Ritchie E, Hamerschlak N, Coutre S, Hochhaus A, Guilhot F, Saglio G, Apperley J, Ottmann O, Shah N, Erben P, Branford S, Agarwal P, Gollerkeri A, Baccarani M. Dasatinib induces complete hematologic and cytogenetic responses in patients with imatinib-resistant or -intolerant chronic myeloid leukemia in blast crisis. Blood. 2007 Apr 15;109(8):3207-13. Epub 2006 Dec 21.

ReferenceCitation: Porkka K, Koskenvesa P, Lundán T, Rimpiläinen J, Mustjoki S, Smykla R, Wild R, Luo R, Arnan M, Brethon B, Eccersley L, Hjorth-Hansen H, Höglund M, Klamova H, Knutsen H, Parikh S, Raffoux E, Gruber F, Brito-Babapulle F, Dombret H, Duarte RF, Elonen E, Paquette R, Zwaan CM, Lee FY. Dasatinib crosses the blood-brain barrier and is an efficient therapy for central nervous system Philadelphia chromosome-positive leukemia. Blood. 2008 Aug 15;112(4):1005-12. doi: 10.1182/blood-2008-02-140665. Epub 2008 May 13.

location_country:
Italy
Austria
United States
Sweden
Switzerland
Netherlands
Philippines
Germany
Finland
France
Israel
Norway
Singapore
Australia
Belgium
Denmark
Canada
United Kingdom
Korea, Republic of
Taiwan


title: A Phase II Study to Determine the Activity of BMS-354825 in Subjects With Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Have Disease That is Resistant to High Dose Imatinib Mesylate (Gleevec) or Who Are Intolerant of Imatinib

summary: The purpose of this study is assess the effects of the investigational drug dasatinib on participants who are in chronic phase Philadelphia chromosome chronic myeloid leukemia and who are either resistant to or intolerant of imatinib. Other purposes of the study are to identify any side effects the drug may produce and to study the level of dasatanib in the blood and assess the efficacy of dasatanib in the treatment of leukemia.

ReferenceCitation: Hochhaus A, Kantarjian HM, Baccarani M, Lipton JH, Apperley JF, Druker BJ, Facon T, Goldberg SL, Cervantes F, Niederwieser D, Silver RT, Stone RM, Hughes TP, Muller MC, Ezzeddine R, Countouriotis AM, Shah NP. Dasatinib induces notable hematologic and cytogenetic responses in chronic-phase chronic myeloid leukemia after failure of imatinib therapy. Blood. 2007 Mar 15;109(6):2303-9. Epub 2006 Nov 30. Erratum in: Blood. 2007 Sep 1;110(5):1438.

location_country:
Peru
Finland
Australia
Belgium
Denmark
France
Norway
Canada
Korea, Republic of
South Africa
Sweden
Switzerland
Netherlands
Singapore
Ireland
United States
Germany
United Kingdom
Italy
Austria
Israel
Spain

location_facility:
Local Institution
Local Instituion


title: A Phase II Study of BMS-354825 in Subjects With Accelerated Phase Chronic Myeloid Leukemia Resistant to or Intolerant of Imatinib Mesylate

summary: The purpose of this clinical research study is to learn if BMS-354825 will have activity, defined by hematologic response, in subjects who have accelerated phase chronic myeloid leukemia (CML) who are resistant to or intolerant to imatinib mesylate. The safety of this treatment will also be studied.

ReferenceCitation: Guilhot F, Apperley J, Kim DW, Bullorsky EO, Baccarani M, Roboz GJ, Amadori S, de Souza CA, Lipton JH, Hochhaus A, Heim D, Larson RA, Branford S, Muller MC, Agarwal P, Gollerkeri A, Talpaz M. Dasatinib induces significant hematologic and cytogenetic responses in patients with imatinib-resistant or -intolerant chronic myeloid leukemia in accelerated phase. Blood. 2007 May 15;109(10):4143-50. Epub 2007 Jan 30.

ReferenceCitation: Apperley JF, Cortes JE, Kim DW, Roy L, Roboz GJ, Rosti G, Bullorsky EO, Abruzzese E, Hochhaus A, Heim D, de Souza CA, Larson RA, Lipton JH, Khoury HJ, Kim HJ, Sillaber C, Hughes TP, Erben P, Van Tornout J, Stone RM. Dasatinib in the treatment of chronic myeloid leukemia in accelerated phase after imatinib failure: the START a trial. J Clin Oncol. 2009 Jul 20;27(21):3472-9. doi: 10.1200/JCO.2007.14.3339. Epub 2009 Jun 1.

location_country:
Peru
Finland
Belgium
Australia
Denmark
Taiwan
France
Thailand
Norway
Argentina
Canada
Korea, Republic of
Sweden
Switzerland
Netherlands
Philippines
Singapore
Germany
United States
United Kingdom
Italy
Brazil
Israel


title: A Phase II Study of BMS-354825 in Subjects With Lymphoid Blast Phase Chronic Myeloid Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Resistant to or Intolerant of Imatinib Mesylate

summary: The purpose of this clinical research study is to learn if BMS-354825 will have activity as defined by hematologic responses in subjects with lymphoid blast phase chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia with primary or acquired resistance to imatinib mesylate.

ReferenceCitation: Ottmann O, Dombret H, Martinelli G, Simonsson B, Guilhot F, Larson RA, Rege-Cambrin G, Radich J, Hochhaus A, Apanovitch AM, Gollerkeri A, Coutre S. Dasatinib induces rapid hematologic and cytogenetic responses in adult patients with Philadelphia chromosome positive acute lymphoblastic leukemia with resistance or intolerance to imatinib: interim results of a phase 2 study. Blood. 2007 Oct 1;110(7):2309-15. Epub 2007 May 11.

location_country:
Italy
Austria
Brazil
Peru
Sweden
Switzerland
Netherlands
Germany
Finland
France
Korea, Republic of
Israel
Norway
Argentina
Australia
Belgium
Denmark
United States
United Kingdom
Canada