acronym: TERIKIDS

lead_sponsor: Genzyme, a Sanofi Company

summary:
Primary Objective:

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

Secondary Objective:

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

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

location_facility:
Investigational Site Number :826003
Investigational Site Number :124001
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Investigational Site Number :156005
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Investigational Site Number :056001
Investigational Site Number :156010
Investigational Site Number :643002
Investigational Site Number :156008
Investigational Site Number :643001
Investigational Site Number :788002
Investigational Site Number :643005
Investigational Site Number :376003
Investigational Site Number :643003
Investigational Site Number :504004
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Investigational Site Number :376001
Investigational Site Number :643004
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Investigational Site Number :528001
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Investigational Site Number :156001
Investigational Site Number :840002
Investigational Site Number :792002
Investigational Site Number :156006
Investigational Site Number :620001
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Investigational Site Number :792003
Investigational Site Number :840012
Investigational Site Number :826001
Investigational Site Number :156004
Investigational Site Number :504005
Investigational Site Number :156003
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Investigational Site Number :804001
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Investigational Site Number :804002
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Investigational Site Number :422001
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Investigational Site Number :688002
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Investigational Site Number :056002
Investigational Site Number :250003
Investigational Site Number :788004

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

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

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


study_start_date_type: Actual

acronym: PREDICTRA

intervention_type: Other

lead_sponsor: AbbVie

summary: The primary objective of the study was to investigate the association between residual disease activity at Baseline as detected by Magnetic Resonance Imaging (MRI) and the occurrence of flares in participants with rheumatoid arthritis (RA) randomized to an adalimumab dose tapering regimen controlled by adalimumab withdrawal.

ReferenceType: derived

ReferenceCitation: Emery P, Burmester GR, Naredo E, Sinigaglia L, Lagunes I, Koenigsbauer F, Conaghan PG. Adalimumab dose tapering in patients with rheumatoid arthritis who are in long-standing clinical remission: results of the phase IV PREDICTRA study. Ann Rheum Dis. 2020 Aug;79(8):1023-1030. doi: 10.1136/annrheumdis-2020-217246. Epub 2020 May 13.

ReferenceCitation: Emery P, Burmester GR, Naredo E, Zhou Y, Hojnik M, Conaghan PG. Design of a phase IV randomised, double-blind, placebo-controlled trial assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) patients (PREDICTRA). BMJ Open. 2018 Feb 28;8(2):e019007. doi: 10.1136/bmjopen-2017-019007.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central;eprints.whiterose.ac.uk

unpaywall_oa_status: gold

publisher_dissemination: British Medical Journal

location_facility: Hosp General Univ de Valencia /ID# 134488

location_facility: CHU de Grenoble - Albet Michal /ID# 135953

location_facility: Hosp Clinico Virgen Arrixaca /ID# 137020

location_facility: The Arthritis Program Res Grp /ID# 129056

location_facility: A.O.U.I. di Verona Policlinico /ID# 132973

location_facility: Institut de Rhum. de Montreal /ID# 129055

location_facility: Mid Essex Hospitals NHS Trust /ID# 151636

location_facility: Debreceni Egyetem Klinikai Koz /ID# 134715

location_facility: Hosp Sant J. Despi-Moises Brog /ID# 135368

location_facility: Hospital Universitario La Paz /ID# 135369

location_facility: Fondazione IRCCS Policlinico /ID# 133886

location_facility: North Georgia Rheumatology Grp /ID# 155225

location_facility: Groupe de Recherche en Maladies Osseuses /ID# 129057

location_facility: Hospital Universitario Basurto /ID# 135529

location_facility: Westlake Medical Research (WMR) Clinical Trials /ID# 155386

location_facility: Optimus Clinical Research Pty. /ID# 133881

location_facility: Charité Universitätsmedizin Campus Mitte /ID# 129142

location_facility: Hospital General Universitario Gregorio Maranon /ID# 133889

location_facility: West Tennessee Research Inst /ID# 148391

location_facility: The Arthritis & Diabetes Clinic, Inc. /ID# 149017

location_facility: St Vincent's University Hosp /ID# 129210

location_facility: Azienda Istituto Gaetano Pini /ID# 132964

location_facility: Guy's and St Thomas' NHS Found /ID# 132965

location_facility: North Mississippi Med Clinics /ID# 149443

location_facility: Low Country Rheumatology, PA /ID# 154198

location_facility: A.O. Univ Consorziale Policlin /ID# 133932

location_facility: Royal Prince Alfred Hospital /ID# 154649

location_facility: Hospital Parc de Salut del Mar /ID# 148670

location_facility: Orszagos Reumatologiai es Fizi /ID# 134710

location_facility: University General Hospital "Attikon" /ID# 134709

status: Completed

title: A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected Via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) Subjects (PREDICTRA)

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Actual

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

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
Germany
Ireland
Italy
Hungary
United Kingdom
Australia
Sweden
Netherlands
Austria
United States
Spain
Greece
Canada
France

study_type: Interventional

ipd_sharing: Yes

lead_sponsor_type: industriel

status_simplified: Completed


time_perspective: Prospective

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

summary: To follow-up on the safety of subjects who were previously treated in a double-blind trial of brexpiprazole.

title: A 2-Month, Observational, Rollover Trial to Evaluate the Safety of Subjects With Agitation Associated With Dementia of the Alzheimer's Type Who Were Previously Treated With Brexpiprazole (OPC 34712) or Placebo in a Phase 3, Double-blind Trial

location_country:
Germany
Slovenia
United Kingdom
United States
Spain
Croatia
Ukraine
Bulgaria
Canada
Serbia
Russian Federation
France

study_type: Observational


type: Other Identifier

type: Registry Identifier

title: A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Multiple Rising Doses of MLN9708 for the Treatment of Subjects With ISN / RPS Class III or IV Lupus Nephritis

summary: The purpose of this study is to characterize the safety and tolerability of ixazomib when administered as multiple oral doses at escalating dose levels in participants with lupus nephritis.

status: Terminated

ipd_sharing_description: Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

lead_sponsor: Takeda

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

intervention_type: Drug

status_simplified: Unknown


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

acronym: CONCEPT-SCLC

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

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

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

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

oa_colors: green hybrid

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

repository_institution: University of Milano-Bicocca - BOA - Bicocca Open Archive

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

lead_sponsor: Bayer

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


title: A Phase 1/2, First in Human, Dose Escalation Study of MGD006, a CD123 x CD3 DART® Bi-Specific Antibody Based Molecule, in Patients With Relapsed or Refractory AML or Intermediate-2/High Risk Myelodysplastic Syndrome (MDS)

acronym: VOYAGE

summary:
Open-label, multi-dose, single-arm, multi-center, Phase 1/2 study conducted in three segments: the Single Patient Dose Escalation Segment (complete), followed by the Multi-Patient Dose Escalation Segment (complete) and the Maximum Tolerated Dose and Schedule (MTDS) Expansion Cohort Segment (closed). Having characterized safety and determined the maximum tolerated dose and schedule, the primary objective of this study now is to assess the anti-neoplastic activity of flotetuzumab in patients with PIF/ER AML, as determined by the proportion of patients who achieve CR or CRh. Starting with Cycle 2, patients who are benefiting from flotetuzumab may receive up to a maximum of 8 cycles of treatment.

Patients will receive daily increasing doses of flotetuzumab for the first week of Cycle 1 (Lead-In Dosing) followed by 3 weeks of continuous intravenous infusion at a specifiedthe assigned dose. Subsequent cycles are each 4 weeks of continuous infusion at the assigned dose. Dosing may continue for up to 8 cycles. Follow up visits may continue for 6 months after treatment is discontinued.

design_allocation: Non-Randomized

ReferenceCitation: Uy GL, Aldoss I, Foster MC, Sayre PH, Wieduwilt MJ, Advani AS, Godwin JE, Arellano ML, Sweet KL, Emadi A, Ravandi F, Erba HP, Byrne M, Michaelis L, Topp MS, Vey N, Ciceri F, Carrabba MG, Paolini S, Huls GA, Jongen-Lavrencic M, Wermke M, Chevallier P, Gyan E, Recher C, Stiff PJ, Pettit KM, Lowenberg B, Church SE, Anderson E, Vadakekolathu J, Santaguida M, Rettig MP, Muth J, Curtis T, Fehr E, Guo K, Zhao J, Bakkacha O, Jacobs K, Tran K, Kaminker P, Kostova M, Bonvini E, Walter RB, Davidson-Moncada JK, Rutella S, DiPersio JF. Flotetuzumab as salvage immunotherapy for refractory acute myeloid leukemia. Blood. 2021 Feb 11;137(6):751-762. doi: 10.1182/blood.2020007732.

oa_colors: green other

evidence: open (via free article)

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

repository_institution: Erasmus University Rotterdam - EUR Research Repository

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

repository_institution: Nottingham Trent Repository - Nottingham Trent University's Institutional Repository

version: acceptedVersion

unpaywall_oa_status: bronze

publisher_dissemination: American Society of Hematology

lead_sponsor: MacroGenics

location_country:
Germany
Italy
France
United Kingdom
Netherlands
United States
Spain
Israel

location_facility: Unità Operativa di Ematologia Ospedale Santa Maria delle Croci

location_facility: UCSF - Helen Diller Family Comprehensive Cancer Center

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: III. Med. Klinik-Klinikum rechts der Isar-Technische Universität München

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: University of North Carolina Lineberger Comprehensive Cancer Center

location_facility: Medizinische Klinik und II, Universitätsklinikum Würzburg

location_facility: Loyola University Chicago - Cardinal Bernadin Cancer Center

location_facility: Washington University School of Medicine

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

location_facility: Georgetown University - Lombardi Cancer Center

location_facility: Universitat Autonomaa de Barcelona (UAB) - Hospital de la Santa Creu i de Sant Pau

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

location_facility: Institut Universitaire du Cancer de Toulouse-Oncopole


title: A Double-Blind, Randomised, Placebo-Controlled, Multi-Centre Field Study to Assess the Efficacy and Safety of HDM-SPIRE in Subjects With a History of House Dust Mite-Induced Rhinoconjunctivitis

summary: The purpose of this study is to compare the treatment effect of three treatment regimens of HDM-SPIRE vs placebo and to evaluates the treatment effect of HDM-SPIRE on symptoms, rescue medication usage, Quality of Life and Sleep Quality

lead_sponsor: Circassia Limited

sponsor_collaborators:
Circassia Limited
Quintiles, Inc.

location_country:
Germany
Italy
Netherlands
United States
Spain
South Africa
Canada
France


acronym: LUME-Colon 1

lead_sponsor: Boehringer Ingelheim

summary: The objective of this Phase III study is to evaluate the efficacy of nintedanib in patients with metastatic colorectal cancer (mCRC) after failure of previous treatment with standard chemotherapy and biological agents.

ReferenceCitation: Van Cutsem E, Yoshino T, Lenz HJ, Lonardi S, Falcone A, Limon ML, Saunders M, Sobrero A, Park YS, Ferreiro R, Hong YS, Tomasek J, Taniguchi H, Ciardiello F, Stoehr J, Oum'Hamed Z, Vlassak S, Studeny M, Argiles G. Nintedanib for the treatment of patients with refractory metastatic colorectal cancer (LUME-Colon 1): a phase III, international, randomized, placebo-controlled study. Ann Oncol. 2018 Sep 1;29(9):1955-1963. doi: 10.1093/annonc/mdy241.

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

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

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

repository_normalized: dnet

ReferenceCitation: Van Cutsem E, Yoshino T, Hocke J, Oum'Hamed Z, Studeny M, Tabernero J. Rationale and Design for the LUME-Colon 1 Study: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Nintedanib Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Patients With Advanced Colorectal Cancer Refractory to Standard Treatment. Clin Colorectal Cancer. 2016 Mar;15(1):91-94.e1. doi: 10.1016/j.clcc.2015.09.005. Epub 2015 Oct 9.

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location_facility: 1199.52.3202 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3402 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3205 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3305 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.6105 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8108 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3905 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.0121 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8803 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.0114 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8109 Boehringer Ingelheim Investigational Site

title: A Double-blind, Randomised, Placebo Controlled Phase III Study of Nintedanib Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Patients With Metastatic Colorectal Cancer Refractory to Standard Therapies.

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


title: A Phase 3 Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AMG0001 in Subjects With Critical Limb Ischemia

acronym: AGILITY

summary: Study to Evaluate the Efficacy and Safety of AMG0001 in Subjects with Critical Limb Ischemia.

lead_sponsor: AnGes USA, Inc.

location_country:
Finland
Italy
Poland
Hungary
Denmark
Sweden
Netherlands
Belgium
United States
Canada
France

location_facility: CHU Amiens - Groupe Hospitalier Hopital Sud

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz Altalanos- Mellkas es Ersebeszeti Osztaly

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: University of Oklahoma - Physicians Surgical Specialists

location_facility: Bekes Megyei Pandy Kalman Korhaz Ersebeszet

location_facility: Sarasota Memorial Hospital Clinical Research Center

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

location_facility: SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

location_facility: Central Arkansas Veteran's Healthcare System

location_facility: Szpital Uniwersytecki nr 1 im. Dr A. Jurasza w Bydgoszczy

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

location_facility: Northwestern Medicine Central DuPage Hospital

location_facility: New York Presbyterian Hospital - Columbia University Medical Center

location_facility: Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika

location_facility: Universita Cattolica Policlinico Gemelli

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinika Központ

location_facility: Karlkirurgiska Kliniken, Karolinska Universitetssjukhuset

location_facility: San Francisco Veterans Affairs Medical Center

location_facility: The Methodist Hospital Research Institute

location_facility: University of California, San Diego (UCSD)

location_facility: CHU de Grenoble - Hôpital Albert Michallon

intervention_type: Biological


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

acronym: RISE-IIP

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

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

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

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


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

acronym: STAR-VT

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

ipd_sharing: No

lead_sponsor: Abbott Medical Devices

location_country:
Italy
United Kingdom
Australia
United States
France

location_facility: Staten Island University Hospital - North

location_facility: Texas Cardiac Arrhythmia Research Foundation

location_facility: Washington University School of Medicine - Barnes Jewish Hospital

location_facility: New York University Langone Medical Center

location_facility: University of California at San Francisco

location_facility: Hospital of the University of Pennsylvania

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

intervention_type: Device


title: A Single Arm, Open-label, Phase 2 Study to Assess the Efficacy and Safety of Lucitanib Given Orally as a Single Agent to Patients With Advanced/Metastatic Lung Cancer and FGF, VEGF, or PDGF Related Genetic Alterations

summary: The purpose of this study is to determine whether lucitanib is safe and effective in the treatment of patients with advanced/metastatic lung cancer and fibroblast growth factor (FGF), vascular endothelial growth factor receptor (VEGF), or platelet derived growth factor (PDGF) related genetic alterations.

ReferenceCitation: Liao M, Zhou J, Wride K, Lepley D, Cameron T, Sale M, Xiao J. Population Pharmacokinetic Modeling of Lucitanib in Patients with Advanced Cancer. Eur J Drug Metab Pharmacokinet. 2022 Sep;47(5):711-723. doi: 10.1007/s13318-022-00773-w. Epub 2022 Jul 18.

repositories_concat: PubMed Central

publisher_dissemination: Springer-Nature

lead_sponsor: Clovis Oncology, Inc.

location_country:
Germany
Italy
United States
Spain
France

location_facility: Fondazione IRCCS Istituto Nazionale Tumori


acronym: MONARCH 2

lead_sponsor: Eli Lilly and Company

summary:
The main purpose of this study is to compare progression-free survival for women with hormone receptor positive (HR+), human epidermal growth factor receptor (HER2) negative advanced breast cancer receiving either abemaciclib + fulvestrant or fulvestrant alone. Participants will be randomized to abemaciclib or placebo in a 2:1 ratio. The study will last about 9 months for each participant.

For the endocrine naïve cohort, all participants will received abemaciclib + fulvestrant.

ReferenceCitation: Neven P, Rugo HS, Tolaney SM, Iwata H, Toi M, Goetz MP, Kaufman PA, Lu Y, Haddad N, Hurt KC, Sledge GW Jr. Abemaciclib plus fulvestrant in hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in premenopausal women: subgroup analysis from the MONARCH 2 trial. Breast Cancer Res. 2021 Aug 23;23(1):87. doi: 10.1186/s13058-021-01463-2.

license: cc-by

license_normalized: cc-by

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repository_institution: California Digital Library - eScholarship

repository_institution: Research Square - Research Square

repository_normalized: Research Square

version: submittedVersion

repositories:
LIRIAS (KU Leuven)
PubMed Central
Research Square
escholarship.org

repositories_concat: LIRIAS (KU Leuven);PubMed Central;Research Square;escholarship.org

ReferenceCitation: Inoue K, Masuda N, Iwata H, Takahashi M, Ito Y, Miyoshi Y, Nakayama T, Mukai H, van der Walt JS, Mori J, Sakaguchi S, Kawaguchi T, Tanizawa Y, Llombart-Cussac A, Sledge GW Jr, Toi M. Japanese subpopulation analysis of MONARCH 2: phase 3 study of abemaciclib plus fulvestrant for treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer that progressed on endocrine therapy. Breast Cancer. 2021 Sep;28(5):1038-1050. doi: 10.1007/s12282-021-01239-8. Epub 2021 Apr 1.

repository_institution: Kyoto University - Kyoto University Research Information Repository

ReferenceCitation: Goetz MP, Okera M, Wildiers H, Campone M, Grischke EM, Manso L, Andre VAM, Chouaki N, San Antonio B, Toi M, Sledge GW Jr. Safety and efficacy of abemaciclib plus endocrine therapy in older patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: an age-specific subgroup analysis of MONARCH 2 and 3 trials. Breast Cancer Res Treat. 2021 Apr;186(2):417-428. doi: 10.1007/s10549-020-06029-y. Epub 2021 Jan 3.

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

ReferenceCitation: Sledge GW Jr, Toi M, Neven P, Sohn J, Inoue K, Pivot X, Burdaeva O, Okera M, Masuda N, Kaufman PA, Koh H, Grischke EM, Conte P, Lu Y, Barriga S, Hurt K, Frenzel M, Johnston S, Llombart-Cussac A. The Effect of Abemaciclib Plus Fulvestrant on Overall Survival in Hormone Receptor-Positive, ERBB2-Negative Breast Cancer That Progressed on Endocrine Therapy-MONARCH 2: A Randomized Clinical Trial. JAMA Oncol. 2020 Jan 1;6(1):116-124. doi: 10.1001/jamaoncol.2019.4782.

evidence: open (via free pdf)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

ReferenceCitation: Sledge GW Jr, Toi M, Neven P, Sohn J, Inoue K, Pivot X, Burdaeva O, Okera M, Masuda N, Kaufman PA, Koh H, Grischke EM, Frenzel M, Lin Y, Barriga S, Smith IC, Bourayou N, Llombart-Cussac A. MONARCH 2: Abemaciclib in Combination With Fulvestrant in Women With HR+/HER2- Advanced Breast Cancer Who Had Progressed While Receiving Endocrine Therapy. J Clin Oncol. 2017 Sep 1;35(25):2875-2884. doi: 10.1200/JCO.2017.73.7585. Epub 2017 Jun 3.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

location_facility: Novant Health, Oncology Research Institute

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

location_facility: Oncology and Hematology Associates of Southwest Virginia Inc

location_facility: Southern California Permanente Medical Group

location_facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

location_facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center

location_facility: Columbia University College of Phys & Surgeons

location_facility: Mount Sinai School of Medicine Dermatology Clinical Trials

title: MONARCH 2: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Fulvestrant With or Without Abemaciclib, a CDK4/6 Inhibitor, for Women With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

location_country:
Finland
Germany
Poland
Australia
Japan
Canada
France
Denmark
Switzerland
United States
Romania
Belgium
Puerto Rico
Italy
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation


title: A Double Blind, Placebo Controlled Two-part Study to Investigate the Dose-ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome

summary: To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome.

ReferenceType: background

ReferenceCitation: Devinsky O, Cross JH, Laux L, Marsh E, Miller I, Nabbout R, Scheffer IE, Thiele EA, Wright S; Cannabidiol in Dravet Syndrome Study Group. Trial of Cannabidiol for Drug-Resistant Seizures in the Dravet Syndrome. N Engl J Med. 2017 May 25;376(21):2011-2020. doi: 10.1056/NEJMoa1611618.

ReferenceCitation: Madan Cohen J, Checketts D, Dunayevich E, Gunning B, Hyslop A, Madhavan D, Villanueva V, Zolnowska M, Zuberi SM. Time to onset of cannabidiol treatment effects in Dravet syndrome: Analysis from two randomized controlled trials. Epilepsia. 2021 Sep;62(9):2218-2227. doi: 10.1111/epi.16974. Epub 2021 Jul 15.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: Wiley

lead_sponsor: Jazz Pharmaceuticals

location_country:
United States
United Kingdom
Poland
France


lead_sponsor: PTC Therapeutics

summary:
The primary objective of this study is to obtain long term safety data of ataluren in male participants with nonsense mutation dystrophinopathy (who participated and completed a previous Phase 3 study of ataluren [PTC124-GD-020-DMD {NCT01826487}]) to augment the overall safety database. Screening and baseline procedures are structured to avoid a gap in treatment between the double-blind study (PTC124-GD-020-DMD) and this extension study.

This study may be further extended by amendment until either ataluren becomes commercially available or the clinical development of ataluren in duchenne muscular dystrophy (DMD) is discontinued.

ReferenceCitation: Thangarajh M, Elfring GL, Trifillis P, McIntosh J, Peltz SW; Ataluren Phase 2b Study Group. The relationship between deficit in digit span and genotype in nonsense mutation Duchenne muscular dystrophy. Neurology. 2018 Sep 25;91(13):e1215-e1219. doi: 10.1212/WNL.0000000000006245. Epub 2018 Aug 22.

publisher_dissemination: Wolters Kluwer Health

location_facility: Children's Hospital Colorado - Center for Cancer and Blood Disorders

location_facility: Columbia University College of Physicians & Surgeons

location_facility: Washington University School of Medicine, Division of Endocrinology, Metabolism and Lipid Research

location_facility: University College London Institute of Child Health

location_facility: The Newcastle upon Tyne Hospitals, NHS Foundation Trust

location_facility: Universidade Federal do Rio de Janeiro - Instituto de Puericultura e Pediatria Martagao Gesteira

location_facility: Seattle Children's Hospital - Childhood Cancer and Blood Disorders

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano

location_facility: Child Neurology Center of Northwest Florida

location_facility: U.O. Complessa di Neuropsichiatria Infantile

location_facility: Hospital Universitari i Politecnic la Fe

location_facility: Universitat Munchen - von Haunersche Kinder Clinic

title: A Phase 3 Extension Study of Ataluren (PTC124) in Patients With Nonsense Mutation Dystrophinopathy

location_country:
Germany
Poland
Australia
Brazil
Turkey
Chile
Czechia
Canada
France
Switzerland
United States
Belgium
Italy
United Kingdom
Sweden
Korea, Republic of
Spain
Bulgaria
Israel


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

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

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

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

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

evidence: oa journal (via observed oa rate)

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

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

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

oa_host_type: publisher

publisher_dissemination: Massachusetts Medical Society

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

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

Access can be requested for all interventional clinical studies:

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

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

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

lead_sponsor: Institut de Recherches Internationales Servier

location_country:
United States
France

location_facility: Northwestern University Medical Hospital

status_simplified: Ongoing


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

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

ReferenceCitation: Jeyaratnam J, Simon A, Calvo I, Constantin T, Shcherbina A, Hofer M, Gattorno M, Martini A, Bader-Meunier B, Vastert B, Levy J, Dekker E, de Benedetti F, Frenkel J. Long-term efficacy and safety of canakinumab in patients with mevalonate kinase deficiency: results from the randomised Phase 3 CLUSTER trial. Rheumatology (Oxford). 2022 May 5;61(5):2088-2094. doi: 10.1093/rheumatology/keab696.

publisher_dissemination: Oxford University Press

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

repository_institution: University of Liège - ORBi - Open Repository and Bibliography of the University of Liège

repository_institution: Université de Lausanne - SERVAL

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

lead_sponsor: Novartis Pharmaceuticals

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


acronym: LixiLan-O

lead_sponsor: Sanofi

summary:
Primary Objective:

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

Secondary Objective:

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

ReferenceType: result

ReferenceCitation: Rosenstock J, Aronson R, Grunberger G, Hanefeld M, Piatti P, Serusclat P, Cheng X, Zhou T, Niemoeller E, Souhami E, Davies M; LixiLan-O Trial Investigators. Benefits of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide, Versus Insulin Glargine and Lixisenatide Monocomponents in Type 2 Diabetes Inadequately Controlled on Oral Agents: The LixiLan-O Randomized Trial. Diabetes Care. 2016 Nov;39(11):2026-2035. doi: 10.2337/dc16-0917. Epub 2016 Aug 15. Erratum In: Diabetes Care. 2017 Jun;40(6):809.

repository_institution: University of Illinois at Chicago - INDIGO

repository_institution: University of Leicester - Leicester Research Archive

publisher_dissemination: American Diabetes Association

ReferenceCitation: Shao H, Kianmehr H, Guo J, Li P, Fonseca V, Shi L. Efficacy of iGlarLixi on 5-year risk of diabetes-related complications: A simulation study. J Diabetes Complications. 2022 Mar;36(3):108132. doi: 10.1016/j.jdiacomp.2022.108132. Epub 2022 Jan 25.

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

repository_institution: University of Dundee - Discovery Research Portal

repository_institution: La Trobe University - OPAL (Open@LaTrobe)

repository_institution: University of Warwick - Warwick Research Archive Portal

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

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

publisher_dissemination: Informa

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

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

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

location_facility:
Investigational Site Number 840065
Investigational Site Number 840126
Investigational Site Number 348012
Investigational Site Number 276005
Investigational Site Number 840028
Investigational Site Number 840012
Investigational Site Number 203014
Investigational Site Number 484004
Investigational Site Number 710007
Investigational Site Number 152008
Investigational Site Number 152006
Investigational Site Number 276003
Investigational Site Number 348010
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title: A Randomized, 30 Week, Active-controlled, Open-label, 3-treatment Arm, Parallel-group Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination to Insulin Glargine Alone and to Lixisenatide Alone on Top of Metformin in Patients With Type 2 Diabetes Mellitus (T2DM)

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


lead_sponsor: Calithera Biosciences, Inc

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

ReferenceCitation: Lim B, Potter DA, Salkeni MA, Silverman P, Haddad TC, Forget F, Awada A, Canon JL, Danso M, Lortholary A, Bourgeois H, Tan-Chiu E, Vincent S, Bahamon B, Galinsky KJ, Patel C, Neuwirth R, Leonard EJ, Diamond JR. Sapanisertib Plus Exemestane or Fulvestrant in Women with Hormone Receptor-Positive/HER2-Negative Advanced or Metastatic Breast Cancer. Clin Cancer Res. 2021 Jun 15;27(12):3329-3338. doi: 10.1158/1078-0432.CCR-20-4131. Epub 2021 Apr 5.

evidence: oa repository (via page says license)

publisher_dissemination: American Association for Cancer Research

location_facility: Santa Barbara Hematology Oncology Medical Group, Inc.

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

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

location_facility: Herbert Irving Comprehensive Cancer Center

location_facility: University of California at San Francisco (PARENT)

location_facility: Eastchester Center for Cancer Care / BRANY

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

location_facility: University of Cincinnati Physicians Company, LLC

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Weill Cornell Medical College New York Presbyterian Hospital

location_facility: GZA Ziekenhuizen - Campus Sint-Augustinus

location_facility: Clinique Victor Hugo - Centre Jean Bernard

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

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

location_country:
United States
Belgium
France


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

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

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

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

lead_sponsor: Gilead Sciences

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

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

location_facility: Emergency County Clinical Hospital Brasov

location_facility: Hospital Universitario Marques de Valdecilla

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

location_facility: University Hospital Southampton NHS Trust

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

location_facility: Washington University School of Medicine

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

location_facility: Willamette Valley Cancer Center and Research Institute

location_facility: Innsbruck University Hospital, Inner Medicine,

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

location_facility: Royal Liverpool & Broadgreen Univ. Hospitals

location_facility: Centre Hospitalier Universitaire Hôpital Avicenne

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

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

location_facility: Hospital Clinico Universitario De Valencia (Chuv)

location_facility: Azienda Ospedaliero Universitaria Policlinico di Modena


lead_sponsor: Sucampo Pharma Americas, LLC

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

ReferenceCitation: Benninga MA, Hussain SZ, Sood MR, Nurko S, Hyman P, Clifford RA, O'Gorman M, Losch-Beridon T, Mareya S, Lichtlen P, Di Lorenzo C. Lubiprostone for Pediatric Functional Constipation: Randomized, Controlled, Double-Blind Study With Long-term Extension. Clin Gastroenterol Hepatol. 2022 Mar;20(3):602-610.e5. doi: 10.1016/j.cgh.2021.04.005. Epub 2021 Apr 7.

sponsor_collaborators:
Sucampo Pharma Americas, LLC
Sucampo AG

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

location_facility: Arizona Children's Center at Maricopa Medical Center

location_facility: Pediatric Gastroenterology Carilion Medical Center

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

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

location_facility: Coastal Pediatrics Associates - Mount Pleasant

location_facility: MultiCare Health System Institute for Research and Innovation

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

location_facility: Arkansas Children's Hospital Research Institute

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

location_facility: University of Oklahoma Health Sciences Center

location_facility: Texas Tech University Health Sciences Center

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

location_facility: Chelsea and Westminster Hospital NHS Foundation Trust

location_facility: Monroe Carell Junior Children's Hospital at Vanderbilt

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

location_facility: Coastal Pediatric Associates - James Island

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

location_facility: Pediatric Research of Charlottesville, LLC

location_facility: University of Alabama Pediatric Gastroenterology

location_facility: Great Ormond Street Hospital for children NHS Foundation Trust

location_facility: INOVA Pediatric Digestive Diseases Center

location_facility: Nemours/Alfred I. duPont Hospital for Children

location_facility: University of Mississippi Medical Center

location_facility: Midwest Children's Health Research Institute

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

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

location_country:
Poland
United Kingdom
Netherlands
Belgium
United States
Canada
France


acronym: CheckMate 140, CHECKpoint pathway and nivoluMAb clinical Trial Evaluation

lead_sponsor: Bristol-Myers Squibb

summary: The purpose of this study is to assess the clinical benefit of Nivolumab, as measured by independent radiologic review committee (IRRC)-assessed objective response rate (ORR) in subjects with FL lymphoma who have failed therapy with both CD20 antibody and an alkylating agent.

ReferenceCitation: Armand P, Janssens A, Gritti G, Radford J, Timmerman J, Pinto A, Mercadal Vilchez S, Johnson P, Cunningham D, Leonard JP, Rodig SJ, Martin-Regueira P, Sumbul A, Samakoglu S, Tang H, Ansell SM. Efficacy and safety results from CheckMate 140, a phase 2 study of nivolumab for relapsed/refractory follicular lymphoma. Blood. 2021 Feb 4;137(5):637-645. doi: 10.1182/blood.2019004753.

repository_institution: University of Southampton - ePrints Soton

repositories_concat: PubMed Central;eprints.soton.ac.uk

location_facility: Beth Israel Deaconess Medical Center (BIDMC)

location_facility: Division Of Hematology & Oncology Ctr. For Health Sciences

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

title: A Single Arm, Open-Label Phase 2 Study of Nivolumab (BMS-936558) in Subjects With Relapsed or Refractory Follicular Lymphoma (FL)

location_country:
Germany
Italy
Norway
Singapore
United Kingdom
Australia
Sweden
Belgium
United States
Spain
Canada
France


acronym: CheckMate 139: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 139

summary: The purpose of this study is to determine whether Nivolumab is effective in the treatment of DLBCL in patients that have failed or are ineligible for ASCT

ReferenceCitation: Ansell SM, Minnema MC, Johnson P, Timmerman JM, Armand P, Shipp MA, Rodig SJ, Ligon AH, Roemer MGM, Reddy N, Cohen JB, Assouline S, Poon M, Sharma M, Kato K, Samakoglu S, Sumbul A, Grigg A. Nivolumab for Relapsed/Refractory Diffuse Large B-Cell Lymphoma in Patients Ineligible for or Having Failed Autologous Transplantation: A Single-Arm, Phase II Study. J Clin Oncol. 2019 Feb 20;37(6):481-489. doi: 10.1200/JCO.18.00766. Epub 2019 Jan 8.

repository_institution: PubMed Central - Europe PMC

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

repositories_institution: University of Southampton - ePrints Soton

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Columbia University Medical Center (Cumc)

title: A Single-Arm, Open-Label, Phase 2 Study of Nivolumab (BMS-936558) in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) After Failure of Autologous Stem Cell Transplant (ASCT) or After Failure of At Least Two Prior Multi-Agent Chemotherapy Regimens in Subjects Who Are Not Candidates for ASCT

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


title: A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 2 STUDY OF THE EFFICACY, SAFETY AND TOLERABILITY OF RG1662 IN ADULTS AND ADOLESCENTS WITH DOWN SYNDROME (CLEMATIS)

summary: This multi-center, randomized, double-blind, 3-arm, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RG1662 in adults and adolescents with Down syndrome. Subjects will be randomized to receive RG1662 either at low or high dose or placebo orally twice daily for 26 weeks.

ReferenceCitation: Goeldner C, Kishnani PS, Skotko BG, Casero JL, Hipp JF, Derks M, Hernandez MC, Khwaja O, Lennon-Chrimes S, Noeldeke J, Pellicer S, Squassante L, Visootsak J, Wandel C, Fontoura P, d'Ardhuy XL; Clematis Study Group. A randomized, double-blind, placebo-controlled phase II trial to explore the effects of a GABAA-alpha5 NAM (basmisanil) on intellectual disability associated with Down syndrome. J Neurodev Disord. 2022 Feb 5;14(1):10. doi: 10.1186/s11689-022-09418-0.

repository_institution: Universitat Pompeu Fabra - Repositori digital de la UPF

repositories_concat: PubMed Central;repositori.upf.edu

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
New Zealand
United Kingdom
Argentina
Singapore
Mexico
United States
Spain
Canada
France

location_facility: Hospital Infantil Universitario Niño Jesus; Pediatria Social

location_facility: Groupement Hospitalier Est-Hopital Femme Mere enfant/Hospice civils de lyon

location_facility: IMIM, Human Pharmacology and Clinical Neurosciences,

location_facility: CHU de Saint Etienne; Service de Génétique

location_facility: University of Otago; Psychological Medicine Department

location_facility: University of Wisconsin Madison, Waisman Center

location_facility: Ospedale Microcitemico; Clinica Pediatrica

location_facility: Clínica Para la Atención del Neurodesarrollo

location_facility: Massachusette General Hospital; Medical Genetics

location_facility: Institut Jérôme Lejeune; Neuropsychology

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez; Pediatria

location_facility: Blackpool Teaching Hospitals NHS Foundation Trust; Child Development and Family Support Centre

location_facility: Hospital Universitario de la Princesa; Medicina Interna

location_facility: CHU de Montpellier Hopital Arnaud de Villeneuve; de Génétique

location_facility: Fundación Síndrome de Down; Fundación Síndrome de Down

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS); Area Asistencial Integrada de Pediatría

location_facility: Doncaster and Bassetlaw Hospitals NHS Foundation Trust; Doncaster Royal Infirmary

location_facility: KK Women's and Children's Hospital; Department of Neonatology

location_facility: Cornwall Partnership NHS Foundation Trust

location_facility: Mental Health of Learning Disability, Kent & Medway NHS and Social Care Partnership Trust

location_facility: Emory University School of Medicine; Department of Human Genetics & Pediatrics

location_facility: UVaMID Hospital Santa Caterina;; Servicio de Neurología

location_facility: Univ of CA San Diego; Neurosciences Comp.Alzheimer's

location_facility: Policlinico Universitario "Agostino Gemelli";Dip. Tutela Salute Donna Bambino Adolescente

location_facility: University of California DAVIS Medical Center; M.I.N.D. Institute, Section of Developmental Behavior

location_facility: University of Utah School of Medicine; Department of Pediatrics


title: A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination + Ribavirin Administered in Subjects Infected With Chronic HCV Who Have Advanced Liver Disease or Are Post-Liver Transplant

summary:
This study will evaluate ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) in participants with advanced liver disease or posttransplant and chronic genotype 1 or 4 hepatitis C virus (HCV) infection.

Cohort A: decompensated cirrhosis (advanced liver disease), no prior liver transplant;
Cohort B: post-liver transplant, with or without cirrhosis;
Group assignment within cohorts is based on severity of liver impairment at screening (Child-Pugh-Turcotte (CPT) score for participants with cirrhosis; fibrosis; or presence of disease for fibrosing cholestatic hepatitis (FCH) groups)
Randomization is 1:1 within groups to 12 or 24 weeks of LDV/SOF+RBV treatment.

ReferenceCitation: Manns M, Samuel D, Gane EJ, Mutimer D, McCaughan G, Buti M, Prieto M, Calleja JL, Peck-Radosavljevic M, Mullhaupt B, Agarwal K, Angus P, Yoshida EM, Colombo M, Rizzetto M, Dvory-Sobol H, Denning J, Arterburn S, Pang PS, Brainard D, McHutchison JG, Dufour JF, Van Vlierberghe H, van Hoek B, Forns X; SOLAR-2 investigators. Ledipasvir and sofosbuvir plus ribavirin in patients with genotype 1 or 4 hepatitis C virus infection and advanced liver disease: a multicentre, open-label, randomised, phase 2 trial. Lancet Infect Dis. 2016 Jun;16(6):685-697. doi: 10.1016/S1473-3099(16)00052-9. Epub 2016 Feb 18. Erratum In: Lancet Infect Dis. 2016 Jun;16(6):636.

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

location_country:
Germany
Italy
New Zealand
United Kingdom
Australia
Netherlands
Austria
Belgium
Switzerland
Spain
Canada
France

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: London Health Sciences Centre-University Hospital

location_facility: Hospital Mondor \\ Service d'Hépatologie et de Gastroentérologie,

location_facility: Royal Infirmary of Edinburgh \\ Scottish Liver Transplant Unit-Edinburgh

location_facility: Hospital Universitario y Politecnico La Fe de Valencia

location_facility: Universitätsklinikum Essen - klinikum für Gastroenterolgie und Hepatologie

location_facility: McGill University Health Centre \\ Royal Victoria Hospital

location_facility: IRCCS Cà Grande Ospedale Maggiore Policlinico

location_facility: Division of Gastroenterology, University of Alberta, Edmonton

location_facility: University Health Network // Toronto General Hospital

location_facility: University Hospital Johann Wolfgang Goethe University, Department of Internal Medicine I

location_facility: Hospital General Universitari Vall d' Hebron

location_facility: University of British Columbia and Vancouver General Hospital

location_facility: Azienda Ospedaliera San Giovanni, Battista di Torino \\ Professor of Gastroenterology-San Giovanni Battista Hospital-University of Torino

location_facility: Royal Prince Alfred Hospital, University of Sydney

location_facility: Kings College Hospital, Institute of Liver Studies

location_facility: Austin Repatriation Hospital (Melbourne) // Victorian Transplant Centre


lead_sponsor: Alexion Pharmaceuticals, Inc.

summary: The purpose of this study is to determine if eculizumab is safe and effective for the treatment of refractory generalized Myasthenia Gravis.

ReferenceCitation: Howard JF Jr, Barohn RJ, Cutter GR, Freimer M, Juel VC, Mozaffar T, Mellion ML, Benatar MG, Farrugia ME, Wang JJ, Malhotra SS, Kissel JT; MG Study Group. A randomized, double-blind, placebo-controlled phase II study of eculizumab in patients with refractory generalized myasthenia gravis. Muscle Nerve. 2013 Jul;48(1):76-84. doi: 10.1002/mus.23839. Epub 2013 Apr 30.

ReferenceCitation: Howard JF Jr, Utsugisawa K, Benatar M, Murai H, Barohn RJ, Illa I, Jacob S, Vissing J, Burns TM, Kissel JT, Muppidi S, Nowak RJ, O'Brien F, Wang JJ, Mantegazza R; REGAIN Study Group. Safety and efficacy of eculizumab in anti-acetylcholine receptor antibody-positive refractory generalised myasthenia gravis (REGAIN): a phase 3, randomised, double-blind, placebo-controlled, multicentre study. Lancet Neurol. 2017 Dec;16(12):976-986. doi: 10.1016/S1474-4422(17)30369-1. Epub 2017 Oct 20. Erratum In: Lancet Neurol. 2017 Dec;16(12 ):954.

ReferenceCitation: Monteleone JPR, Gao X, Kleijn HJ, Bellanti F, Pelto R. Eculizumab Pharmacokinetics and Pharmacodynamics in Patients With Generalized Myasthenia Gravis. Front Neurol. 2021 Nov 2;12:696385. doi: 10.3389/fneur.2021.696385. eCollection 2021.

publisher_dissemination: Frontiers

ReferenceCitation: Siddiqi ZA, Nowak RJ, Mozaffar T, O'Brien F, Yountz M, Patti F; REGAIN Study Group. Eculizumab in refractory generalized myasthenia gravis previously treated with rituximab: subgroup analysis of REGAIN and its extension study. Muscle Nerve. 2021 Dec;64(6):662-669. doi: 10.1002/mus.27422. Epub 2021 Oct 14.

ReferenceCitation: Nowak RJ, Muppidi S, Beydoun SR, O'Brien FL, Yountz M, Howard JF Jr. Concomitant Immunosuppressive Therapy Use in Eculizumab-Treated Adults With Generalized Myasthenia Gravis During the REGAIN Open-Label Extension Study. Front Neurol. 2020 Nov 24;11:556104. doi: 10.3389/fneur.2020.556104. eCollection 2020.

ReferenceCitation: Mantegazza R, Wolfe GI, Muppidi S, Wiendl H, Fujita KP, O'Brien FL, Booth HDE, Howard JF Jr; REGAIN Study Group. Post-intervention Status in Patients With Refractory Myasthenia Gravis Treated With Eculizumab During REGAIN and Its Open-Label Extension. Neurology. 2021 Jan 26;96(4):e610-e618. doi: 10.1212/WNL.0000000000011207. Epub 2020 Nov 23.

evidence: open (via page says license)

repository_institution: University of Birmingham - University of Birmingham Research Portal

repository_normalized: Pure (Denmark)

repository_institution: Ghent University - Ghent University Academic Bibliography

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

repository_institution: University of Szeged - SZTE Publicatio Repozitórium - SZTE - Repository of Publications

repositories_concat: LIRIAS (KU Leuven);PubMed Central;Pure (Denmark);archive.ugent.be;ddd.uab.cat;iris.uniroma1.it;publicatio.bibl.u-szeged.hu

ReferenceCitation: Mantegazza R, O'Brien FL, Yountz M, Howard JF Jr; REGAIN study group. Consistent improvement with eculizumab across muscle groups in myasthenia gravis. Ann Clin Transl Neurol. 2020 Aug;7(8):1327-1339. doi: 10.1002/acn3.51121. Epub 2020 Jul 22.

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

repository_institution: University of Florence - Florence Research

repositories_concat: LIRIAS (KU Leuven);PubMed Central;archive.ugent.be;diposit.ub.edu;flore.unifi.it;iris.uniroma1.it

ReferenceCitation: Jacob S, Murai H, Utsugisawa K, Nowak RJ, Wiendl H, Fujita KP, O'Brien F, Howard JF Jr. Response to eculizumab in patients with myasthenia gravis recently treated with chronic IVIg: a subgroup analysis of REGAIN and its open-label extension study. Ther Adv Neurol Disord. 2020 May 6;13:1756286420911784. doi: 10.1177/1756286420911784. eCollection 2020.

ReferenceCitation: Vissing J, Jacob S, Fujita KP, O'Brien F, Howard JF; REGAIN study group. 'Minimal symptom expression' in patients with acetylcholine receptor antibody-positive refractory generalized myasthenia gravis treated with eculizumab. J Neurol. 2020 Jul;267(7):1991-2001. doi: 10.1007/s00415-020-09770-y. Epub 2020 Mar 18.

repositories_concat: LIRIAS (KU Leuven);PubMed Central;archive.ugent.be;flore.unifi.it

ReferenceCitation: Andersen H, Mantegazza R, Wang JJ, O'Brien F, Patra K, Howard JF Jr; REGAIN Study Group. Eculizumab improves fatigue in refractory generalized myasthenia gravis. Qual Life Res. 2019 Aug;28(8):2247-2254. doi: 10.1007/s11136-019-02148-2. Epub 2019 Mar 23. Erratum In: Qual Life Res. 2019 May 21;:

repository_institution: University of Copenhagen - Research at the University of Copenhagen

repository_institution: Newcastle Univesity - Newcastle University ePrints

repositories_concat: LIRIAS (KU Leuven);PubMed Central;Pure (Denmark);archive.ugent.be;eprint.ncl.ac.uk

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Azienda Ospedaliera Sant'Andrea - Università di Roma La Sapienza

location_facility: Southern Illinois University School of Medicine

location_facility: General Hospital of Thessaloniki "G. Papanikolaou"

location_facility: Johns Hopkins University School Of Medicine

location_facility: Wayne State University School of Medicine

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Hospital For Special Surgery/New York Presbyterian Hospital Cornell Campus

location_facility: Azienda Ospedaliera Universitaria "Federico II"

location_facility: University of California San Francisco-Fresno

location_facility: University of Texas Health Science Center at San Antonio

location_facility: University of North Carolina at Chapel Hill

location_facility: UNIFESP - Universidade Federal de São Paulo

location_facility: Umberto I Pol. di Roma-Università di Roma La Sapienza

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Seoul Metropolitan Government Seoul National University

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

location_facility: Instituto de Investigaciones Neurologicas Raul Carrea, FLENI

location_facility: Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin. Közp.

location_facility: Karolinska Universitetssjukhuset - Solna

location_facility: University of California Davis Health System

location_facility: HUCFF-UFRJ - Hospital Universitário Clementino Fraga Filho - Universidade Federal do Rio de Janeiro

location_facility: University of Florida Health Science Center

location_facility: Groupe Hospitalier Pellegrin - Hôpital Pellegrin

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta

title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Eculizumab in Subjects With Refractory Generalized Myasthenia Gravis (gMG)

location_country:
Finland
Germany
Argentina
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
Hungary
Denmark
United States
Belgium
Italy
United Kingdom
Netherlands
Korea, Republic of
Spain
Greece
Sweden


title: A Phase Ib/II Study Evaluating the Safety, Tolerability and Anti-Tumor Activity of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab, Cyclophosphamide, Doxorubicin, and Prednisone in Patients With B-Cell Non-Hodgkin's Lymphoma

summary: This multicenter, open-label, dose-escalation study will evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of polatuzumab vedotin in combination with rituximab or obinutuzumab, cyclophosphamide, doxorubicin, and prednisone (CHP chemotherapy) in participants with non-Hodgkin's lymphoma (NHL). Participants will receive escalating doses of polatuzumab vedotin intravenously (IV) every 3 weeks in combination with standard doses of rituximab plus CHP chemotherapy (R-CHP) or obinutuzumab plus CHP chemotherapy (G-CHP). Participants will be treated for a total of six or eight cycles in accordance with local institutional practice. Two parallel treatment arms will explore doses of polatuzumab vedotin in combination with R-CHP or G-CHP. The maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of polatuzumab vedotin in combination with R-CHP will be identified before it is combined with G-CHP. Once the MTD or RP2D is determined, polatuzumab vedotin will be dosed at MTD or RP2D -1 in combination with G-CHP to start the dose escalation of this combination.

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

ReferenceCitation: Tilly H, Morschhauser F, Bartlett NL, Mehta A, Salles G, Haioun C, Munoz J, Chen AI, Kolibaba K, Lu D, Yan M, Penuel E, Hirata J, Lee C, Sharman JP. Polatuzumab vedotin in combination with immunochemotherapy in patients with previously untreated diffuse large B-cell lymphoma: an open-label, non-randomised, phase 1b-2 study. Lancet Oncol. 2019 Jul;20(7):998-1010. doi: 10.1016/S1470-2045(19)30091-9. Epub 2019 May 14.

evidence: open (via crossref license, author manuscript)

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

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

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

repositories_concat: HAL

lead_sponsor: Genentech, Inc.

location_facility: Hopital Henri Mondor, Unite Hemopathies lymphoides

location_facility: Hopital Claude Huriez - CHU Lille; Service des maladies du sang

location_facility: Willamette Valley Clinical Studies; Cancer Institute


summary: This randomized, multicenter, open-label study will evaluate the safety and efficacy of DNIB0600A (RO5541081) in comparison with PLD in participants with PROC, primary peritoneal cancer or fallopian tube cancer. Participants will be randomized to receive either DNIB0600A 2.4 milligrams per kilogram (mg/kg) intravenously (IV) every 3 weeks or PLD 40 milligrams per meter-squared (mg/m^2) IV every 4 weeks.

ReferenceCitation: Banerjee S, Oza AM, Birrer MJ, Hamilton EP, Hasan J, Leary A, Moore KN, Mackowiak-Matejczyk B, Pikiel J, Ray-Coquard I, Trask P, Lin K, Schuth E, Vaze A, Choi Y, Marsters JC, Maslyar DJ, Lemahieu V, Wang Y, Humke EW, Liu JF. Anti-NaPi2b antibody-drug conjugate lifastuzumab vedotin (DNIB0600A) compared with pegylated liposomal doxorubicin in patients with platinum-resistant ovarian cancer in a randomized, open-label, phase II study. Ann Oncol. 2018 Apr 1;29(4):917-923. doi: 10.1093/annonc/mdy023.

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Oklahoma University Health Sciences Center

location_facility: University of California Irvine Medical Center

location_facility: Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes

location_facility: Wojskowy Instytut Medyczny Centralny Szpital Kliniczny MON

location_facility: HonorHealth Research Institute - Pima Center

location_facility: Hospital Universitario Vall d'Hebron; Servicio de Neumologia

location_facility: Chum Hopital Notre Dame; Centre D'Oncologie

location_facility: HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

title: A Randomized, Open-Label, Multicenter, Phase II Trial Evaluating the Safety and Activity of DNIB0600A Compared to Pegylated Liposomal Doxorubicin Administered Intravenously to Patients With Platinum-Resistant Ovarian Cancer

location_country:
Poland
United Kingdom
Belgium
United States
Spain
Canada
France


title: A Phase IIB, Randomized, Blinded, Dose-ranging, Active-controlled, Parallel-group, Multi-center Study to Evaluate the Dose Response Relationship of GSK1278863 Over the First 4 Weeks of Treatment and Evaluate the Safety and Efficacy of GSK1278863 Over 24 Weeks in Hemodialysis-Dependent Subjects With Anemia Associated With Chronic Kidney Disease Who Switch From Recombinant Human Erythropoietin

summary: This study is intended to evaluate the dose-response relationship of GSK1278863 over the first 4 weeks of treatment and evaluate the safety and efficacy of GSK1278863 over 24 weeks to maintain hemoglobin (Hgb) level in hemodialysis-dependent (HDD) subjects with anemia associated with chronic kidney disease (CKD) who are switched from a stable dose of recombinant human erythropoietin (rhEPO). The data generated will enable selection of the starting dose(s) and optimize dose adjustment regimen(s) for Phase 3 clinical trials.

ReferenceCitation: Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Poland
Hungary
Norway
Denmark
Australia
Japan
Sweden
United Kingdom
United States
Korea, Republic of
Spain
Czechia
Canada
Russian Federation
France