title: A Phase 2 Study of SAR245409 in Patients With Relapsed or Refractory Mantle Cell Lymphoma, Follicular Lymphoma, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Diffuse Large B Cell Lymphoma

summary:
Primary Objective:

- To evaluate the efficacy of SAR245409 as determined by the objective response rate (ORR) in patients with 1 of following relapsed or refractory lymphoma or leukemia subtypes: mantle cell lymphoma (MCL), follicular lymphoma (FL), chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), or diffuse large B cell lymphoma (DLBCL)

Secondary Objectives:

To assess duration of response, progression free survival (PFS), and proportion of patients with PFS at 6 months (24 weeks) in patients with either MCL, FL, CLL/SLL or DLBCL treated with SAR245409
To evaluate the safety and tolerability of SAR245409 in patients with MCL, FL, CLL/SLL or DLBCL
To further characterize the plasma pharmacokinetics (PK) of SAR245409 in patients with MCL, FL, CLL/SLL or DLBCL

ReferenceCitation: Brown JR, Hamadani M, Hayslip J, Janssens A, Wagner-Johnston N, Ottmann O, Arnason J, Tilly H, Millenson M, Offner F, Gabrail NY, Ganguly S, Ailawadhi S, Kasar S, Kater AP, Doorduijn JK, Gao L, Lager JJ, Wu B, Egile C, Kersten MJ. Voxtalisib (XL765) in patients with relapsed or refractory non-Hodgkin lymphoma or chronic lymphocytic leukaemia: an open-label, phase 2 trial. Lancet Haematol. 2018 Apr;5(4):e170-e180. doi: 10.1016/S2352-3026(18)30030-9. Epub 2018 Mar 14. Erratum In: Lancet Haematol. 2018 Jun;5(6):e240.

repository_institution: Cardiff University - ORCA Online Research @Cardiff

repositories_concat: PubMed Central;orca.cardiff.ac.uk

location_country:
Germany
Australia
Netherlands
Belgium
United States
France

location_facility:
Investigational Site Number 840013
Investigational Site Number 056002
Investigational Site Number 250002
Investigational Site Number 840012
Investigational Site Number 250004
Investigational Site Number 840002
Investigational Site Number 276003
Investigational Site Number 840001
Investigational Site Number 840014
Investigational Site Number 840104
Investigational Site Number 276002
Investigational Site Number 036005
Investigational Site Number 036002
Investigational Site Number 840007
Investigational Site Number 250001
Investigational Site Number 250005
Investigational Site Number 036003
Investigational Site Number 528002
Investigational Site Number 528003
Investigational Site Number 840006
Investigational Site Number 528001
Investigational Site Number 840015
Investigational Site Number 276001
Investigational Site Number 840010
Investigational Site Number 036001
Investigational Site Number 840011
Investigational Site Number 250003
Investigational Site Number 840004
Investigational Site Number 056001
Investigational Site Number 056003


study_start_date_type: Actual

intervention_type: Drug

lead_sponsor: Janssen Research & Development, LLC

summary: The purpose of this study is to assess the safety and efficacy of oral abiraterone acetate plus oral prednisone and oral abiraterone acetate plus oral prednisone plus oral exemestane, each compared with oral exemestane alone, in postmenopausal women with estrogen receptor-positive (ER+) metastatic (spreading) breast cancer that has relapsed after treatment with letrozole or anastrozole.

ReferenceType: derived

ReferenceCitation: O'Shaughnessy J, Campone M, Brain E, Neven P, Hayes D, Bondarenko I, Griffin TW, Martin J, De Porre P, Kheoh T, Yu MK, Peng W, Johnston S. Abiraterone acetate, exemestane or the combination in postmenopausal patients with estrogen receptor-positive metastatic breast cancer. Ann Oncol. 2016 Jan;27(1):106-13. doi: 10.1093/annonc/mdv487. Epub 2015 Oct 26.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

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

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

evidence: oa repository (via pmcid lookup)

license_normalized: no license

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories:
LIRIAS (KU Leuven)
PubMed Central
pdfs.semanticscholar.org

repositories_concat: LIRIAS (KU Leuven);PubMed Central;pdfs.semanticscholar.org

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

status: Completed

title: Randomized, Open-Label Study of Abiraterone Acetate (JNJ-212082) Plus Prednisone With or Without Exemestane in Postmenopausal Women With ER+ Metastatic Breast Cancer Progressing After Letrozole or Anastrozole Therapy

primary_purpose: Treatment

type: Other Identifier

type: EudraCT Number

source: euctr

enrollment_type: Actual

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
Ireland
Poland
United Kingdom
Netherlands
Belgium
United States
Korea, Republic of
Spain
Luxembourg
Ukraine
Russian Federation
France

study_type: Interventional

lead_sponsor_type: industriel

status_simplified: Completed


title: A Randomized, Open-label Phase II Multicenter Study Evaluating the Efficacy of Oral Everolimus Alone or in Combination With Pasireotide LAR i.m. in Advanced Progressive Pancreatic Neuroendocrine Tumors (PNET) - The COOPERATE-2 Study

summary:
This study will estimate the treatment effect of everolimus in combination with pasireotide LAR relative to everolimus alone on progression-free survival (PFS) in patients with advanced progressive PNET.

A planned primary analysis was completed with data cut of 02-Apr-2014. The study did not meet its primary objective, which was based on progression-free survival (PFS) as per local radiology assessment and was prematurely terminated with the last patient last visit on 19-Feb-2015. However, it is important to note that the data did not reveal any new safety concerns. It was decided to stop the study and this decision was shared with the study sites on 31-Jul-2014.

status: Terminated

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
New Zealand
Argentina
Australia
Brazil
Japan
Thailand
Turkey
Canada
France
Hungary
Denmark
United States
Belgium
Italy
United Kingdom
Netherlands
Spain
Sweden

location_facility: University of Texas/MD Anderson Cancer Center UT MD Anderson Cancer Ctr

location_facility: Oregon Health & Science University Knight Cancer Institute

status_simplified: Unknown


title: A Multicenter, Randomized, Double-Blind, Active Controlled, Comparative, Fixed-Dose, Dose Response Study of the Efficacy and Safety of BMS-820836 in Patients With Treatment Resistant Major Depression (TRD).

summary: The purpose of the study is to evaluate the efficacy of study drug (BMS-820836) as compared with continued Duloxetine/Escitalopram in the treatment of patients with treatment resistant depression (TRD).

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
India
United Kingdom
Argentina
Australia
Austria
United States
Spain
South Africa
Canada
Puerto Rico
France

location_facility: Neuropsychiatric Research Center Of Orange County

location_facility: Birmingham Psychiatry Pharmaceutical Studies, Inc.

location_facility: Dean Foundation For Health Research & Education

location_facility: Arkansas Psychiatric Clinic Clinical Research Trials, P.A.


title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of the Safety and Efficacy of Fixed Dose OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Pyxis Trial

acronym: Pyxis

summary: To compare the effect of OPC-34712 (brexpiprazole) to the effect of placebo (an inactive substance) as add on treatment to an assigned FDA approved antidepressant treatment (ADT) in patients with Major Depressive Disorder who demonstrate an incomplete response to a prospective trial of the same assigned FDA approved ADT

ReferenceCitation: Newcomer JW, Eriksson H, Zhang P, Meehan SR, Weiss C. Changes in Metabolic Parameters and Body Weight in Patients With Major Depressive Disorder Treated With Adjunctive Brexpiprazole: Pooled Analysis of Phase 3 Clinical Studies. J Clin Psychiatry. 2019 Oct 1;80(6):18m12680. doi: 10.4088/JCP.18m12680.

oa_host_type: publisher

evidence: open (via free pdf)

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Physicians Postgraduate Press, Inc

ReferenceCitation: Hobart M, Zhang P, Weiss C, Meehan SR, Eriksson H. Adjunctive Brexpiprazole and Functioning in Major Depressive Disorder: A Pooled Analysis of Six Randomized Studies Using the Sheehan Disability Scale. Int J Neuropsychopharmacol. 2019 Mar 1;22(3):173-179. doi: 10.1093/ijnp/pyy095.

oa_colors: green gold

evidence: oa journal (via doaj)

repositories_concat: PubMed Central;pdfs.semanticscholar.org

unpaywall_oa_status: gold

publisher_dissemination: Oxford University Press

ReferenceCitation: McIntyre RS, Weiller E, Zhang P, Weiss C. Brexpiprazole as adjunctive treatment of major depressive disorder with anxious distress: Results from a post-hoc analysis of two randomised controlled trials. J Affect Disord. 2016 Sep 1;201:116-23. doi: 10.1016/j.jad.2016.05.013. Epub 2016 May 12.

oa_host_type: closed

ReferenceCitation: Thase ME, Youakim JM, Skuban A, Hobart M, Augustine C, Zhang P, McQuade RD, Carson WH, Nyilas M, Sanchez R, Eriksson H. Efficacy and safety of adjunctive brexpiprazole 2 mg in major depressive disorder: a phase 3, randomized, placebo-controlled study in patients with inadequate response to antidepressants. J Clin Psychiatry. 2015 Sep;76(9):1224-31. doi: 10.4088/JCP.14m09688.

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
Poland
Slovakia
United States
Canada
France


title: Archer 1009:a Randomized, Double Blind Phase 3 Efficacy And Safety Study Of Pf-00299804 (Dacomitinib) Versus Erlotinib For The Treatment Of Advanced Non-small Cell Lung Cancer Following Progression After, Or Intolerance To, At Least One Prior Chemotherapy

acronym: ARCHER 1009

summary: This is a multinational, multicenter, randomized,double-blinded, Phase 3 study comparing the efficacy and safety of treatment with PF-00299804 to treatment with erlotinib in patients with advanced non-small cell lung cancer, previously treated with at least one prior regimen. Analyses of primary objective (Progression Free Survival) will be done in two co-primary populations as defined in the protocol.

ReferenceCitation: Ramalingam SS, O'Byrne K, Boyer M, Mok T, Janne PA, Zhang H, Liang J, Taylor I, Sbar EI, Paz-Ares L. Dacomitinib versus erlotinib in patients with EGFR-mutated advanced nonsmall-cell lung cancer (NSCLC): pooled subset analyses from two randomized trials. Ann Oncol. 2016 Mar;27(3):423-9. doi: 10.1093/annonc/mdv593. Epub 2016 Jan 13. Erratum In: Ann Oncol. 2016 Jul;27(7):1363.

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

repository_institution: Queensland University of Technology - QUT ePrints

ReferenceCitation: Ramalingam SS, Janne PA, Mok T, O'Byrne K, Boyer MJ, Von Pawel J, Pluzanski A, Shtivelband M, Docampo LI, Bennouna J, Zhang H, Liang JQ, Doherty JP, Taylor I, Mather CB, Goldberg Z, O'Connell J, Paz-Ares L. Dacomitinib versus erlotinib in patients with advanced-stage, previously treated non-small-cell lung cancer (ARCHER 1009): a randomised, double-blind, phase 3 trial. Lancet Oncol. 2014 Nov;15(12):1369-78. doi: 10.1016/S1470-2045(14)70452-8. Epub 2014 Oct 15.

lead_sponsor: Pfizer

location_country:
Finland
Germany
Ireland
Poland
Japan
France
Slovakia
Hungary
Denmark
Switzerland
United States
India
Belgium
China
United Kingdom
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Russian Federation
Sweden

location_facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

location_facility: Hospital Universitario Virgen del Rocio. Hospital General Planta Baja. Servicio de Oncologia.

location_facility: Aichi cancer center central hospital /Thoracic Oncology

location_facility: Helsingin yliopistollinen sairaala, Meilahden kolmiosairaala, keuhkosairauksien poliklinikka

location_facility: Washington University School of Medicine-IDS Pharmacy

location_facility: Hematology Oncology Associates of the Treasure Coast

location_facility: St.-Petersburg State Medical University I.P.Pavlov of Roszdrav

location_facility: Mercy Physicians of Oklahoma-Communities, Inc. - Mercy Clinic Oncology/Hematology - McAuley

location_facility: Hospital Provincial de Castellon (Farmacia)

location_facility: Samaritan Hematology & Oncology Consultants

location_facility: Hospital General Universitario de Elche - Edificio UIAE

location_facility: National Hospital Organization Kinki-chuo Chest Medical Center

location_facility: Northwest Georgia Oncology Centers, P.C.

location_facility: Karmanos Cancer Institute at Farmington Hills

location_facility: Federal State Healthcare Clinical Hospital #101 of the Federal Biomedical Agency

location_facility: Suburban Hematology-Oncology Associates, P.C.

location_facility: Central Hematology Oncology Medical Group, Inc.

location_facility: Hospital Universitario 12 de Octubre-Radiology

location_facility: Hematology and Oncology Consultants, P.A.

location_facility: Samara Regional Clinical Oncology Dispensary

location_facility: Administrative Address: UCLA Hematology Oncology-Clinical Research Unit (CRU)

location_facility: Union Hospital, Tongji Medical College of Huazhong University of Science & Technology/Cancer Center

location_facility: University of South Alabama Mitchell Cancer Institute

location_facility: Zala Megyei Korhaz, Pulmonologiai Osztaly

location_facility: Samsung Medical Center, Clinical Trial Center

location_facility: Central Hematology Oncology Medical Group Inc.

location_facility: Good Samaritan Hospital Samaritan Ambulatory Infusion Services

location_facility: Veszprem Megyei Onkormanyzat Tudogyogyintezete

location_facility: Desert Oncology Associates dba Ironwood Cancer and Research Centers

location_facility: Specializovana nemocnica sv. Svorada Zobor, n.o.

location_facility: CHU Ambroise Parre- Service Biologie Clinique

location_facility: Josa Andras Oktatokorhaz Egeszsegugyi Szolgaltato Nonprofit Kft.

location_facility: Sozialmedizinisches Zentrum Baumgartner Hoehe - Otto Wagner Spital und Pflegezentrum

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: Winship Cancer Institute of Emory University

location_facility: Russian Scientific Center of Radiology and Surgical Technologies

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: New Cross Hospital - Royal Wolverhampton Hospital NHS Trust

location_facility: Osaka City General Hospital Department of Clinical Oncology

location_facility: Drug Shipment Address: Ronald Reagan UCLA Medical Center, Drug Information Center

location_facility: Institut de Cancerologie de lOuest - Rene Gauducheau

location_facility: Hospital Universitario Madrid Sanchinarro

location_facility: Mercy Hospital Oklahoma City - Oncology Infusion

location_facility: HOSPITAL DE LA SANTA CREU I SANT PAU - Pharmacy

location_facility: Asan Medical Center, Department of Oncology

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

location_facility: City Hospital #2 Krasnodar Multi-Field Diagnostic and Treatment Association

location_facility: Ironwood physicians P C dba Ironwood Cancer & Research Centers

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet

location_facility: University of South Alabama Medical Center

location_facility: National Hospital Organization Asahikawa Medical Center

location_facility: Satakunnan keskussairaala/Keuhkosairauksien osasto A4

location_facility: Istituto Oncologico della Svizzera Italiana

location_facility: Westwood Bowyer Clinic, Peter Morton Medical Building

location_facility: Hospital de la Santa Creu i Sant Pau - AGDAC

location_facility: Ingalls Memorial Hospital - In-Patient Pharmacy

location_facility: Semmelweis Egyetem Pulmonologiai Klinika

location_facility: North Mississippi Hematology and Oncology Associates, Ltd.,

location_facility: Cancer Care Associates Medical Group Inc.

location_facility: Univerzitna Nemocnica Bratislava, Klinika pneumologie a ftizeologie I- Oddelenie klinickej onkologie

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

location_facility: Oncology and Hematology Specialists, P.A.

location_facility: Pandy Kalman Megyei Korhaz, Aktiv Tudogyogyaszat

location_facility: Mercy clinic oklahoma communities, Inc. - Mercy clinic oncology/Hematology - Norman

location_facility: Tumour Hospital of Guangxi Zhuang Autonomous Region

location_facility: Central Coast Medical Oncology Corporation

location_facility: Christie Hospital NHS Trust, Department of Medical Oncology

location_facility: City of Hope South Pasadena Cancer Center

location_facility: Grand Hopital de Charleroi Oncologie-Hematologie

location_facility: Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers

location_facility: National Hospital Organization Kyushu Cancer Center/Department of Thoracic Oncology

location_facility: West China Hospital of Sichuan University

location_facility: National Hospital Organization, Yamaguchi-Ube Medical Center

location_facility: Hospital de la Santa Creu i Sant Pau - Hospital de Día

location_facility: Oncology Specialists of North Georgia, LLC

location_facility: Kyushu University Hospital Respiratory Medicine

location_facility: UCLA Santa Monica Medical Center & Orthopedic Hospital

location_facility: Hospital de la Santa Creu i Sant Pau - Diagnostic per la Imatge i Med. Nuclear

location_facility: Hospital de la Santa Creu i Sant Pau - Anatomia Patológica

location_facility: Hospital Provincial de Castellon - Servicio de Oncologia

location_facility: Krankenhaus Bethanien, Medizinische Klinik III

location_facility: Investigational Drug Services, Florida Hospital

location_facility: Dartmouth-Hitchcock Medical Center /Mary Hitchcock Memorial Hospital


title: A Randomized, Double-blind, Placebo- and Active-controlled Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Safety, Tolerability and Long Term Efficacy up to 1 Year in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFα Agents (CAIN457F2309) and A Four Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Rheumatoid Arthritis (CAIN457F2309E1)

acronym: NURTURE 1

summary: The core and extension studies assessed the safety and efficacy of secukinumab when added to a background therapy in patients with active rheumatoid arthritis who are intolerant to or have had an inadequate response to anti-TNF-α agents. Patients received either secukinumab, placebo or abatacept (active comparator). The core study was completed. However, the extension study was prematurely terminated after the primary endpoint analysis of the core study at week 24 had demonstrated numerically higher efficacy for the active comparator abatacept compared to secukinumab.

ReferenceCitation: Huang Y, Fan Y, Liu Y, Xie W, Zhang Z. Efficacy and safety of secukinumab in active rheumatoid arthritis with an inadequate response to tumor necrosis factor inhibitors: a meta-analysis of phase III randomized controlled trials. Clin Rheumatol. 2019 Oct;38(10):2765-2776. doi: 10.1007/s10067-019-04595-1. Epub 2019 May 14.

publisher_dissemination: Springer-Nature

ReferenceCitation: Blanco FJ, Moricke R, Dokoupilova E, Codding C, Neal J, Andersson M, Rohrer S, Richards H. Secukinumab in Active Rheumatoid Arthritis: A Phase III Randomized, Double-Blind, Active Comparator- and Placebo-Controlled Study. Arthritis Rheumatol. 2017 Jun;69(6):1144-1153. doi: 10.1002/art.40070. Epub 2017 May 3.

evidence: open (via free article)

publisher_dissemination: Wiley

location_country:
France
Germany
Italy
Colombia
Slovakia
Hungary
Romania
Brazil
Mexico
United States
Spain
Bulgaria
Canada
Russian Federation
Czech Republic

intervention_type: Biological


acronym: GEMSAV

lead_sponsor: Bayer

summary:
Subjects referred for a routine CTA (computed tomography angiography) or MRA (magnetic resonance angiography) will be invited to participate in the study and subjects will be involved in the study for between 2 and 12 days. Two to three visits to the study doctor will be required.

This study will compare the diagnostic results of Gadobutrol enhanced MRA images with MRA images taken without contrast agent using images from a CTA as the standard of reference, which may have been performed up to 60 days prior to enrolment. If a CTA has not been performed in this prior time period, a CTA is required for the study.

MRA and CTA images will be collected for an independent review (blinded read).

title: Multicenter, Open-label Study to Evaluate the Safety and Efficacy (by Blinded Reading) of Contrast-Enhanced Magnetic Resonance Angiography (MRA) After a Single Intravenous Injection of 0.1 mmol/kg Gadobutrol in Subjects With Known or Suspected Vascular Disease of the Supra-aortic Vessels

primary_purpose: Diagnostic

location_country:
Germany
Italy
Poland
Argentina
Australia
Sweden
Switzerland
Austria
United States
China
Korea, Republic of
Turkey
Czechia
France


title: Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of ADX48621 in the Treatment of Levodopa Induced Dyskinesia in Patients With Parkinson's Disease

summary:
The primary objective of the study is to evaluate the safety and tolerability of ADX48621 in Parkinson's disease patients following four weeks of dosing.

The secondary objectives of the study include the evaluation of the efficacy of ADX48621 compared with placebo in reducing levodopa induced dyskinesia in patients with Parkinson's; the evaluation of the effect of ADX48621 on symptoms of Parkinson's disease and patient ability to function, and the evaluation of the effect of coadministration of ADX48621 on L-dopa efficacy.

ReferenceCitation: McFarthing K, Prakash N, Simuni T. CLINICAL TRIAL HIGHLIGHTS - DYSKINESIA. J Parkinsons Dis. 2019;9(3):449-465. doi: 10.3233/JPD-199002. No abstract available.

evidence: open (via page says Open Access)

license: unspecified-oa

license_normalized: unspecified-oa

repositories_concat: PubMed Central

publisher_dissemination: IOS Press

lead_sponsor: Addex Pharma S.A.

location_country:
United States
Germany
Austria
France


title: A Phase 2, Multi-Center, Double-Blind, Placebo Controlled, Randomized Study of Ombrabulin in Patients With Platinum-Sensitive Recurrent Ovarian Cancer Treated With Carboplatin/Paclitaxel

acronym: OPSALIN

summary:
Primary Objective:

- To demonstrate an improvement in Progression-Free Survival (PFS) for Ombrabulin versus placebo in patients with platinum-sensitive recurrent ovarian cancer (OC) treated with paclitaxel and carboplatin.

Secondary Objectives:

To compare the overall survival (OS) between the 2 treatment arms
To compare the objective response rate (RR) between the 2 treatment arms

lead_sponsor: Sanofi

location_country:
Germany
Italy
Poland
Belgium
United States
Spain
Ukraine
Czech Republic
Russian Federation
France

location_facility:
Investigational Site Number 056002
Investigational Site Number 804005
Investigational Site Number 250002
Investigational Site Number 724002
Investigational Site Number 250004
Investigational Site Number 840009
Investigational Site Number 203001
Investigational Site Number 840002
Investigational Site Number 203004
Investigational Site Number 840001
Investigational Site Number 616004
Investigational Site Number 250006
Investigational Site Number 840202
Investigational Site Number 616001
Investigational Site Number 380003
Investigational Site Number 250001
Investigational Site Number 840007
Investigational Site Number 380001
Investigational Site Number 380004
Investigational Site Number 724001
Investigational Site Number 056005
Investigational Site Number 804003
Investigational Site Number 616005
Investigational Site Number 643001
Investigational Site Number 203002
Investigational Site Number 276001
Investigational Site Number 643002
Investigational Site Number 643004
Investigational Site Number 203003
Investigational Site Number 804002
Investigational Site Number 804004
Investigational Site Number 643003
Investigational Site Number 616002
Investigational Site Number 724003
Investigational Site Number 250003
Investigational Site Number 056001
Investigational Site Number 056003
Investigational Site Number 616003


title: A Randomized Open-label Study to Evaluate the Sustained Virologic Response of Danoprevir/Ritonavir and Copegus in Combination With RO5024048 and/or Pegasys in Chronic Hepatitis C Genotype 1 Patients Who Failed Previous Standard Therapy

summary: This randomized, open-label, multi-center study will evaluate the sustained virological response, pharmacokinetics and safety of various combinations of danoprevir/ritonavir with Copegus plus RO5024048 and/or Pegasys in patients with chronic hepatitis C infection. Patients will be divided into 2 separate cohorts. Cohort A, previous partial responders, will be randomized to Groups 1-3 and cohort B, previous null responders, will be randomized to Groups 4-6. Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Groups 1 and 4 will receive RO5024048 1000 mg twice a day and Copegus 1000 mg or 1200 mg twice a day for 24 weeks; Group 2 will receive Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks; Groups 3, 5 and 6 will receive RO5024048 1000 mg twice a day, Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. In addition, patients in Group 6 will receive another 24 weeks of Pegasys plus Copegus treatment.

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Italy
Poland
United Kingdom
Australia
Brazil
Austria
Mexico
United States
Spain
Canada
Puerto Rico
France


type: Registry Identifier

title: Effect of Roflumilast on Exacerbation Rate in Patients With COPD Treated With Fixed Combinations of LABA and ICS. A 52-week, Randomised Double-blind Trial With Roflumilast 500 µg Versus Placebo. The REACT Trial

acronym: REACT

summary:
The objective of the REACT trial is to investigate the effect of roflumilast 500 μg tablets once daily versus placebo on exacerbation rate and pulmonary function in COPD patients who are concomitantly treated with a fixed combination of long-acting β2-agonists (LABA) and inhaled glucocorticosteroids (ICS). In addition, data on safety and tolerability of roflumilast will be obtained. An additional objective is to further characterize the population pharmacokinetic profile of roflumilast and roflumilast N oxide and to further characterize their pharmacokinetics/pharmacodynamics (PK/PD) relationship in terms of efficacy and relevant safety aspects.

Patients to be included are required to have severe COPD associated with chronic bronchitis and a history of frequent exacerbations and must be concomitantly treated with a fixed combination of LABA and ICS. Two parallel treatment arms (roflumilast 500 μg once daily and placebo) are included.

ReferenceCitation: Facius A, Marostica E, Gardiner P, Watz H, Lahu G. Pharmacokinetic and Pharmacodynamic Modelling to Characterize the Tolerability of Alternative Up-Titration Regimens of Roflumilast in Patients with Chronic Obstructive Pulmonary Disease. Clin Pharmacokinet. 2018 Aug;57(8):1029-1038. doi: 10.1007/s40262-018-0671-4.

evidence: open (via page says license)

ReferenceCitation: Martinez FJ, Rabe KF, Calverley PMA, Fabbri LM, Sethi S, Pizzichini E, McIvor A, Anzueto A, Alagappan VKT, Siddiqui S, Reisner C, Zetterstrand S, Roman J, Purkayastha D, Bagul N, Rennard SI. Determinants of Response to Roflumilast in Severe Chronic Obstructive Pulmonary Disease. Pooled Analysis of Two Randomized Trials. Am J Respir Crit Care Med. 2018 Nov 15;198(10):1268-1278. doi: 10.1164/rccm.201712-2493OC.

publisher_dissemination: American Thoracic Society

ReferenceCitation: Rabe KF, Calverley PMA, Martinez FJ, Fabbri LM. Effect of roflumilast in patients with severe COPD and a history of hospitalisation. Eur Respir J. 2017 Jul 5;50(1):1700158. doi: 10.1183/13993003.00158-2017. Print 2017 Jul. No abstract available.

publisher_dissemination: European Respiratory Society

ReferenceCitation: Martinez FJ, Calverley PM, Goehring UM, Brose M, Fabbri LM, Rabe KF. Effect of roflumilast on exacerbations in patients with severe chronic obstructive pulmonary disease uncontrolled by combination therapy (REACT): a multicentre randomised controlled trial. Lancet. 2015 Mar 7;385(9971):857-66. doi: 10.1016/S0140-6736(14)62410-7. Epub 2015 Feb 13.

ReferenceCitation: Calverley PM, Martinez FJ, Fabbri LM, Goehring UM, Rabe KF. Does roflumilast decrease exacerbations in severe COPD patients not controlled by inhaled combination therapy? The REACT study protocol. Int J Chron Obstruct Pulmon Dis. 2012;7:375-82. doi: 10.2147/COPD.S31100. Epub 2012 Jun 20.

lead_sponsor: AstraZeneca

location_country:
Germany
Poland
Australia
Brazil
Turkey
Canada
France
Slovakia
Hungary
Denmark
Belgium
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Greece
South Africa
Russian Federation
Israel

location_facility:
Nycomed Investigational site
Nycomed Investigational Site


title: Phase II, Randomized Double-blind Study of Efficacy and Safety of Two Dose Levels of LDE225 in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma

acronym: BOLT

summary: This study assessed the efficacy and safety of oral treatment with two dose levels of LDE225 in patients with locally advanced or metastatic BCC.

ReferenceCitation: Gutzmer R, Robert C, Loquai C, Schadendorf D, Squittieri N, Arntz R, Martelli S, Dummer R. Assessment of various efficacy outcomes using ERIVANCE-like criteria in patients with locally advanced basal cell carcinoma receiving sonidegib: results from a preplanned sensitivity analysis. BMC Cancer. 2021 Nov 19;21(1):1244. doi: 10.1186/s12885-021-08968-1.

license: cc-by

license_normalized: cc-by

ReferenceCitation: Lewis K, Dummer R, Farberg AS, Guminski A, Squittieri N, Migden M. Effects of Sonidegib Following Dose Reduction and Treatment Interruption in Patients with Advanced Basal Cell Carcinoma During 42-Month BOLT Trial. Dermatol Ther (Heidelb). 2021 Dec;11(6):2225-2234. doi: 10.1007/s13555-021-00619-4. Epub 2021 Oct 20.

ReferenceCitation: Lear JT, Migden MR, Lewis KD, Chang ALS, Guminski A, Gutzmer R, Dirix L, Combemale P, Stratigos A, Plummer R, Castro H, Yi T, Mone M, Zhou J, Trefzer U, Kaatz M, Loquai C, Kudchadkar R, Sellami D, Dummer R. Long-term efficacy and safety of sonidegib in patients with locally advanced and metastatic basal cell carcinoma: 30-month analysis of the randomized phase 2 BOLT study. J Eur Acad Dermatol Venereol. 2018 Mar;32(3):372-381. doi: 10.1111/jdv.14542. Epub 2017 Nov 6.

ReferenceCitation: Migden MR, Guminski A, Gutzmer R, Dirix L, Lewis KD, Combemale P, Herd RM, Kudchadkar R, Trefzer U, Gogov S, Pallaud C, Yi T, Mone M, Kaatz M, Loquai C, Stratigos AJ, Schulze HJ, Plummer R, Chang AL, Cornelis F, Lear JT, Sellami D, Dummer R. Treatment with two different doses of sonidegib in patients with locally advanced or metastatic basal cell carcinoma (BOLT): a multicentre, randomised, double-blind phase 2 trial. Lancet Oncol. 2015 Jun;16(6):716-28. doi: 10.1016/S1470-2045(15)70100-2. Epub 2015 May 14.

ipd_sharing: Yes

location_country:
Germany
Italy
Hungary
United Kingdom
Australia
Switzerland
Belgium
United States
Spain
Greece
Canada
France

location_facility: University of Colorado School of Medicine UC

location_facility: H Lee Moffitt Cancer Center and Research Institute Cutaneous Onc Dept

location_facility: Baylor Health Care System/Sammons Cancer Center Baylor Texas Oncology

location_facility: Texoma Cancer Center Texoma Cancer Center

location_facility: Stanford University Medical Center Stanford Univ 2

location_facility: Penn State University / Milton S. Hershey Medical Center Hershey Medical

location_facility: Texas Oncology Cancer Care & Research Center

location_facility: Washington University School Of Medicine-Siteman Cancer Ctr Siteman

location_facility: University of Pittsburgh Medical Center UPMC

location_facility: University of Texas MD Anderson Cancer Center MD Anderson

location_facility: University of California at Los Angeles UCLA 3

location_facility: Washington Hospital Center Wash Hospital

location_facility: Comprehensive Cancer Centers of Nevada CCC of Nevada- Southwest (2)

location_facility: Hackensack University Medical Center Hackensack (SC)

location_facility: University of Utah / Huntsman Cancer Institute Huntsman/Univ UT

location_facility: NorthwesternUniv.Med.School/Robert H. Lurie Comp.Cancer Ctr Study coordinator


title: A 6-month, Phase II, Double-masked, Multicenter, Randomized, Placebo Controlled, Parallel Group Study to Assess the Safety and Efficacy of Topical Administration of Two Concentrations of FOV2304 (High Dose or Low Dose) for the Treatment of Center-involving Clinically Significant Macular Edema Associated With Diabetic Retinopathy

summary: The purpose of the study is to determine whether concentrations of FOV2304 (high dose or low dose) administered in the eye are more effective than placebo in treating patients with diabetic macular edema, following 12 weeks of treatment.

lead_sponsor: Fovea Pharmaceuticals SA

location_country:
Germany
Italy
Poland
Israel
Australia
Belgium
United States
Spain
Czech Republic
France

location_facility:
Center 1502
Center 1609
Center 1202
Center 1303
Center 1604
Center 1401
Center 1204
Center 1705
Center 1109
Center 1402
Center 1501
Center 1404
Center 1503
Center 1112
Center 1116
Center 1201
Center 1505
Center 1610
Center 1703
Center1801
Center 1208
Center 1909
Center 1203
Center 1907
Center 1607
Center 1111
Center 1405
Center 1301
Center 1206
Center 1103
Center 1114
Center 1701
Center 1101
Center 1107
Center 1606
Center 1105
Center 1507
Center 1110
Center 1906
Center 2001
Center 2004
Center 1901
Center 1704
Center 1903
Center 1104
Center 2003
Center 1205
Center 1115
Center 1108
Center 1904
Center 1504
Center 1902
Center 1702
Center 1506
Center 1802
Center 1302
Center 1608
Center 1209
Center 1908
Center 1106
Center 1905
Center 1706
Center 2002
Center 1601
Center 1403


title: A Randomized, Double-blind, Placebo-controlled Trial of the Efficacy and Safety of DEB025/Alisporivir in Combination With Peg-IFNα2a and Ribavirin in Hepatitis C Genotype 1 Treatment-naïve Patients

summary: This study will assess the safety and efficacy of alisporivir (ALV; DEB025) triple therapy [i.e., when added to peginterferon alfa-2a (PEG) and ribavirin (RBV)] to optimize treatment in treatment-naïve participants with hepatitis C virus (HCV) genotype 1 (GT1)

lead_sponsor: Debiopharm International SA

location_country:
Germany
Poland
Argentina
Australia
Thailand
Vietnam
Canada
France
Hungary
Hong Kong
United States
Romania
Belgium
Puerto Rico
Italy
United Kingdom
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation


title: A Clinical Outcomes Study to Compare the Effect of Fluticasone Furoate/Vilanterol Inhalation Powder 100/25mcg With Placebo on Survival in Subjects With Moderate Chronic Obstructive Pulmonary Disease (COPD) and a History of or at Increased Risk for Cardiovascular Disease

summary: The purpose of this study is to determine if fluticasone furoate/vilanterol improves survival in patients with chronic obstructive pulmonary disease with a history of or increased risk of heart disease.

ReferenceCitation: Horne BD, Hegewald MJ, Crim C, Rea S, Bair TL, Blagev DP. The Summit Score Stratifies Mortality and Morbidity in Chronic Obstructive Pulmonary Disease. Int J Chron Obstruct Pulmon Dis. 2020 Jul 20;15:1741-1750. doi: 10.2147/COPD.S254437. eCollection 2020.

publisher_dissemination: Informa

ReferenceCitation: Wise RA, Anderson JA, Amarenco P, Cowans NJ, Crim C, Denvir MA, Gomez CR, Jones MP, Morris A, Niewoehner D, Yates JC. Adjudication of cardiovascular events in patients with chronic obstructive pulmonary disease: SUMMIT trial. Clin Trials. 2020 Aug;17(4):430-436. doi: 10.1177/1740774520920897. Epub 2020 May 22.

repository_institution: University of Edinburgh - Edinburgh Research Explorer

version: acceptedVersion

repositories_concat: PubMed Central;pure.ed.ac.uk

publisher_dissemination: SAGE Publications

ReferenceCitation: Celli BR, Anderson JA, Brook R, Calverley P, Cowans NJ, Crim C, Dixon I, Kim V, Martinez FJ, Morris A, Newby DE, Yates J, Vestbo J. Serum biomarkers and outcomes in patients with moderate COPD: a substudy of the randomised SUMMIT trial. BMJ Open Respir Res. 2019 May 4;6(1):e000431. doi: 10.1136/bmjresp-2019-000431. eCollection 2019.

publisher_dissemination: British Medical Journal

ReferenceCitation: Fawzy A, Anderson JA, Cowans NJ, Crim C, Wise R, Yates JC, Hansel NN. Association of platelet count with all-cause mortality and risk of cardiovascular and respiratory morbidity in stable COPD. Respir Res. 2019 May 8;20(1):86. doi: 10.1186/s12931-019-1059-1.

ReferenceCitation: Vestbo J, Dransfield M, Anderson JA, Brook RD, Calverley PMA, Celli BR, Cowans NJ, Crim C, Martinez F, Newby DE, Yates J, Lange P. Impact of pre-enrolment medication use on clinical outcomes in SUMMIT. ERJ Open Res. 2019 Feb 25;5(1):00203-2018. doi: 10.1183/23120541.00203-2018. eCollection 2019 Feb.

ReferenceCitation: Adamson PD, Anderson JA, Brook RD, Calverley PMA, Celli BR, Cowans NJ, Crim C, Dixon IJ, Martinez FJ, Newby DE, Vestbo J, Yates JC, Mills NL. Cardiac Troponin I and Cardiovascular Risk in Patients With Chronic Obstructive Pulmonary Disease. J Am Coll Cardiol. 2018 Sep 4;72(10):1126-1137. doi: 10.1016/j.jacc.2018.06.051. Erratum In: J Am Coll Cardiol. 2018 Oct 30;72(18):2282.

ReferenceCitation: Kunisaki KM, Dransfield MT, Anderson JA, Brook RD, Calverley PMA, Celli BR, Crim C, Hartley BF, Martinez FJ, Newby DE, Pragman AA, Vestbo J, Yates JC, Niewoehner DE; SUMMIT Investigators. Exacerbations of Chronic Obstructive Pulmonary Disease and Cardiac Events. A Post Hoc Cohort Analysis from the SUMMIT Randomized Clinical Trial. Am J Respir Crit Care Med. 2018 Jul 1;198(1):51-57. doi: 10.1164/rccm.201711-2239OC.

repository_institution: The University of Manchester - Research Explorer

repositories:
PubMed Central
Pure (Denmark)
pure.ed.ac.uk

ReferenceCitation: Celli B, Anderson JA, Brook R, Calverley P, Crim C, Holmes AP, Martinez FJ, Newby DE, Yates J, Vestbo J; SUMMIT Investigators. Long-Acting beta-Agonist/Inhaled Corticosteroid in Patients with Chronic Obstructive Pulmonary Disease with Cardiovascular Disease or Risk: A Factorial Analysis of the SUMMIT Clinical Trial. Am J Respir Crit Care Med. 2018 Jun 15;197(12):1641-1644. doi: 10.1164/rccm.201710-2052LE. No abstract available.

ReferenceCitation: Dransfield MT, McAllister DA, Anderson JA, Brook RD, Calverley PMA, Celli BR, Crim C, Gallot N, Martinez FJ, Scanlon PD, Yates J, Vestbo J, Newby DE; SUMMIT Investigators. beta-Blocker Therapy and Clinical Outcomes in Patients with Moderate Chronic Obstructive Pulmonary Disease and Heightened Cardiovascular Risk. An Observational Substudy of SUMMIT. Ann Am Thorac Soc. 2018 May;15(5):608-614. doi: 10.1513/AnnalsATS.201708-626OC.

repository_institution: The University of Glasgow - Enlighten: Publications

ReferenceCitation: Bhatt SP, Anderson JA, Brook RD, Calverley PMA, Celli BR, Cowans NJ, Crim C, Martinez FJ, Newby DE, Vestbo J, Yates JC, Dransfield MT. Cigarette smoking and response to inhaled corticosteroids in COPD. Eur Respir J. 2018 Jan 18;51(1):1701393. doi: 10.1183/13993003.01393-2017. Print 2018 Jan. No abstract available.

ReferenceCitation: Crim C, Calverley PMA, Anderson JA, Holmes AP, Kilbride S, Martinez FJ, Brook RD, Newby DE, Yates JC, Celli BR, Vestbo J; SUMMIT investigators. Pneumonia risk with inhaled fluticasone furoate and vilanterol in COPD patients with moderate airflow limitation: The SUMMIT trial. Respir Med. 2017 Oct;131:27-34. doi: 10.1016/j.rmed.2017.07.060. Epub 2017 Aug 1.

ReferenceCitation: Calverley PMA, Anderson JA, Brook RD, Crim C, Gallot N, Kilbride S, Martinez FJ, Yates J, Newby DE, Vestbo J, Wise R, Celli BR; SUMMIT (Study to Understand Mortality and Morbidity) Investigators. Fluticasone Furoate, Vilanterol, and Lung Function Decline in Patients with Moderate Chronic Obstructive Pulmonary Disease and Heightened Cardiovascular Risk. Am J Respir Crit Care Med. 2018 Jan 1;197(1):47-55. doi: 10.1164/rccm.201610-2086OC.

ReferenceCitation: Brook RD, Anderson JA, Calverley PM, Celli BR, Crim C, Denvir MA, Magder S, Martinez FJ, Rajagopalan S, Vestbo J, Yates J, Newby DE; SUMMIT Investigators. Cardiovascular outcomes with an inhaled beta2-agonist/corticosteroid in patients with COPD at high cardiovascular risk. Heart. 2017 Oct;103(19):1536-1542. doi: 10.1136/heartjnl-2016-310897. Epub 2017 Apr 17.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

ReferenceCitation: Martinez FJ, Vestbo J, Anderson JA, Brook RD, Celli BR, Cowans NJ, Crim C, Dransfield M, Kilbride S, Yates J, Newby DE, Niewoehner D, Calverley PM; SUMMIT Investigators. Effect of Fluticasone Furoate and Vilanterol on Exacerbations of Chronic Obstructive Pulmonary Disease in Patients with Moderate Airflow Obstruction. Am J Respir Crit Care Med. 2017 Apr 1;195(7):881-888. doi: 10.1164/rccm.201607-1421OC.

ReferenceCitation: Vestbo J, Anderson JA, Brook RD, Calverley PM, Celli BR, Crim C, Martinez F, Yates J, Newby DE; SUMMIT Investigators. Fluticasone furoate and vilanterol and survival in chronic obstructive pulmonary disease with heightened cardiovascular risk (SUMMIT): a double-blind randomised controlled trial. Lancet. 2016 Apr 30;387(10030):1817-26. doi: 10.1016/S0140-6736(16)30069-1. Epub 2016 Apr 28.

ReferenceCitation: Vestbo J, Anderson J, Brook RD, Calverley PM, Celli BR, Crim C, Haumann B, Martinez FJ, Yates J, Newby DE. The Study to Understand Mortality and Morbidity in COPD (SUMMIT) study protocol. Eur Respir J. 2013 May;41(5):1017-22. doi: 10.1183/09031936.00087312. Epub 2012 Sep 27.

location_country: Macedonia, The Former Yugoslav Republic of


title: An Open Label Two-stage Study of Orally Administered BKM120 in Patients With Metastatic Non-small Cell Lung Cancer With Activated PI3K Pathway

summary: The purpose of this two-stage phase II study is to assess the efficacy of BKM120, as measured by determining the progression free survival (PFS), in patients with pretreated metastatic Non-small Cell Lung Cancer (NSCLC) that exhibits PI3K pathway activation. BKM120 will be investigated in two groups of NSCLC patients according to the histology of the cancer: squamous and non-squamous.

design_allocation: Non-Randomized

ReferenceType: result

ReferenceCitation: Vansteenkiste JF, Canon JL, De Braud F, Grossi F, De Pas T, Gray JE, Su WC, Felip E, Yoshioka H, Gridelli C, Dy GK, Thongprasert S, Reck M, Aimone P, Vidam GA, Roussou P, Wang YA, Di Tomaso E, Soria JC. Safety and Efficacy of Buparlisib (BKM120) in Patients with PI3K Pathway-Activated Non-Small Cell Lung Cancer: Results from the Phase II BASALT-1 Study. J Thorac Oncol. 2015 Sep;10(9):1319-1327. doi: 10.1097/JTO.0000000000000607.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

location_country:
Germany
Italy
Hungary
Argentina
Hong Kong
Japan
Brazil
Netherlands
Singapore
Belgium
United Kingdom
United States
Spain
Thailand
Turkey
Taiwan
Canada
France

location_facility: Medical University of South Carolina MUSC

location_facility: University of Chicago Medical Center Unvi Chi

location_facility: Hematology Oncology Associates of Northern New Jersey PA DeptofHem-OncofNorthern NJ (2)

location_facility: Arizona Oncology Associates Tucson (Rudasill & La Cholla)

location_facility: Massachusetts General Hospital Mass General

location_facility: Virginia Oncology Associates VOA - Lake Wright (2)

location_facility: University of Oklahoma Health Sciences Center Dept. of Oklahoma Univ. HSC

location_facility: Memorial Sloan Kettering Cancer Center Sloan Kettering

location_facility: H. Lee Moffitt Cancer Center & Research Institute H Lee Moffitt

location_facility: MetroHealth Medical Center Dept.ofMetroHealthMedCtr.(2)

location_facility: Overlook Hospital - Carol G Simon Cancer Center Carol G Simon

location_facility: Rocky Mountain Cancer Centers Dept. of Rocky Mountain Cancer

location_facility: Fallon Clinic at Worcester Medical Center Fallon Clinic Worcester Med

location_facility: University of California at San Diego, Moores Cancer Ctr SC

location_facility: Northwest Cancer Specialists Compass Oncology -BKM

location_facility: University of Pittsburgh Medical Center SC-2

location_facility: U of TX Southwestern Medical Center - SimmonsCompCancerCtr Clinical Research Office

location_facility: University of Kansas Cancer Center Univ of KS

location_facility: Washington University School of Medicine Washington University (16)

location_facility: Karmanos Cancer Institute Wayne St Karmanos

location_facility: Cedars Sinai Medical Center Dept.of Cedars-Sinai Med. Ctr.

location_facility: Mayo Clinic - Arizona Mayo Scottsdale AZ

location_facility: Emory University School of Medicine/Winship Cancer Institute Emory 2

location_facility: Highlands Oncology Group Dept of Highlands Oncology Grp


title: A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-936557 in Subjects With Active Ulcerative Colitis (UC)

summary: The purpose of this study is to determine whether BMS-936557 is effective in the treatment of moderate to severely active ulcerative colitis in patients who have had insufficient response and/or intolerance to other medical therapy for ulcerative colitis

ReferenceCitation: Sandborn WJ, Colombel JF, Ghosh S, Sands BE, Dryden G, Hebuterne X, Leong RW, Bressler B, Ullman T, Lakatos PL, Reinisch W, Xu LA, Luo A. Eldelumab [Anti-IP-10] Induction Therapy for Ulcerative Colitis: A Randomised, Placebo-Controlled, Phase 2b Study. J Crohns Colitis. 2016 Apr;10(4):418-28. doi: 10.1093/ecco-jcc/jjv224. Epub 2015 Dec 30.

oa_host_type: repository

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

repository_institution: University of California - eScholarship University of California

repositories_concat: PubMed Central;escholarship.org

unpaywall_oa_status: green

location_country:
Germany
Italy
Poland
Hungary
Australia
Brazil
Netherlands
Austria
Belgium
Mexico
United States
South Africa
Canada
France

location_facility: Gastroenterology Research Of New Orleans

location_facility: Metropolitan Gastroenterology Group, Pc, Chevy Chase Cr

location_facility: Charlotte Gastroenterology & Hepatology, Pllc

location_facility: Gastroenterology Research Of San Antonio

location_facility: University Of North Carolina At Chapel Hill

location_facility: Gastroenterology Research Of Tyler (Gerty)

location_facility: Long Island Clinical Research Assoc., Llp


title: An Adaptive, Comparative, Randomized, Parallel-group, Multi Center, Phase Ib Study of Subcutaneous (SC) Rituximab Versus Intravenous (IV) Rituximab Both in Combination With Chemotherapy (Fludarabine and Cyclophosphamide), in Patients With Previously Untreated CLL

summary: This randomized, parallel-group, multi-center study will compare the pharmacokinetics and safety of subcutaneous administration of MabThera (rituximab) versus intravenous MabThera in combination with chemotherapy in previously untreated patients with chronic lymphocytic leukemia (CLL). The study consists of 2 parts. In part 1, patients who have previously received 4 cycles of intravenous MabThera will receive in Cycle 5 intravenous MabThera and in Cycle 6 subcutaneous MabThera. In part 2, patients will be randomized to receive either 6 cycles of intravenous MabThera, or 1 cycle of intravenous MabThera and 5 cycles of subcutaneous MabThera. Additionally, all patients will receive chemotherapy (fludarabine and cyclophosphamide) on Days 1-3 or Days 1-5 of every cycle. The anticipated time on study drug is 24 weeks.

ReferenceCitation: Assouline S, Buccheri V, Delmer A, Gaidano G, Trneny M, Berthillon N, Brewster M, Catalani O, Li S, McIntyre C, Sayyed P, Badoux X. Pharmacokinetics, safety, and efficacy of subcutaneous versus intravenous rituximab plus chemotherapy as treatment for chronic lymphocytic leukaemia (SAWYER): a phase 1b, open-label, randomised controlled non-inferiority trial. Lancet Haematol. 2016 Mar;3(3):e128-38. doi: 10.1016/S2352-3026(16)00004-1.

ReferenceCitation: Assouline S, Buccheri V, Delmer A, Gaidano G, McIntyre C, Brewster M, Catalani O, Hourcade-Potelleret F, Sayyed P, Badoux X. Pharmacokinetics and safety of subcutaneous rituximab plus fludarabine and cyclophosphamide for patients with chronic lymphocytic leukaemia. Br J Clin Pharmacol. 2015 Nov;80(5):1001-9. doi: 10.1111/bcp.12662. Epub 2015 Jul 29.

oa_colors: green other

ReferenceCitation: Mao CP, Brovarney MR, Dabbagh K, Birnbock HF, Richter WF, Del Nagro CJ. Subcutaneous versus intravenous administration of rituximab: pharmacokinetics, CD20 target coverage and B-cell depletion in cynomolgus monkeys. PLoS One. 2013 Nov 12;8(11):e80533. doi: 10.1371/journal.pone.0080533. eCollection 2013.

publisher_dissemination: Public Library of Science

ReferenceCitation: Shpilberg O, Jackisch C. Subcutaneous administration of rituximab (MabThera) and trastuzumab (Herceptin) using hyaluronidase. Br J Cancer. 2013 Sep 17;109(6):1556-61. doi: 10.1038/bjc.2013.371. Epub 2013 Sep 3.

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

publisher_dissemination: Springer

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Turkey
Croatia
Chile
Czechia
Canada
France
Portugal
Slovakia
Italy
Mexico
Spain
Greece
Russian Federation

location_facility: Wellington Hospital; Wellington Blood and Cancer Centre

location_facility: Istituto S. Raffaele Monte Tabor; Divisione Ematologia E Utmo

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Hematologia

location_facility: N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis

location_facility: Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik

location_facility: Centre de sante et de services sociaux Rimouski Neigette

location_facility: Univ. Piemonte Est Amedeo Avogadro; Div.Ematologia- Dip.Clinica Med.Sperim.& Ircad

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Hematologia

location_facility: Haematology Research Center; Haematology

location_facility: Hopital Robert Debre; Hematologie Clinique

location_facility: Policlinico G. B. Rossi; Divisione Di Ematologia

location_facility: Clinical Hospital Merkur; Dept of Haematology

location_facility: Onkologischer Schwerpunkt am Oskar-Helene-Heim; Dres. Herrenberger, Keitel-Wittig u. Kirsch

location_facility: University Hospital and Medical School; IV.Dept. of Internal Medicine and Hematology

location_facility: BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie

location_facility: St George Hospital; Department of Haematology

location_facility: Institut J Paolii Calmettes; Onco Hematologie 1

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

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

location_facility: University Hospital; Clinic of Hematology & Transfusiology

location_facility: Hospital de Santa Maria; Servico de Hematologia e Transplantacao de Medula

location_facility: ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Struttura Complessa di Ematologia

location_facility: Hospital Clinico Universitario de Salamanca;Servicio de Hematologia

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

location_facility: Queen Elizabeth II Health Sciences Centre; Oncology

location_facility: Papageorgiou General Hospital of Thessaloniki; Hematology Clinic

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii

location_facility: National Oncology Inst. ; Dept. of Haematology

location_facility: Hacettepe Uni Medical Faculty; Hematology

location_facility: Hospital Universitario de la Princesa; Servicio de Hematologia

location_facility: Klinikum Frankfurt; Medizinische Klinik I

location_facility: Ospedale Infermi Di Rimini; Unità Operativa di Oncologia e Oncoematologia

location_facility: Royal Brisbane and Women'S Hospital; Haematology

location_facility: A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia; Clinica Ematologica

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

location_facility: St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta

location_facility: Hospital da Cidade de Passo Fundo; Centro de Pesquisa em Oncologia

location_facility: Hospital Universitario Dr. Jose E. Gonzalez; Haematology

location_facility: Onkologische Schwerpunktpraxis Dres. Bernd Gaede, Hans-Ulrich Ehlers, Ulrike Rodewig u.w.

location_facility: Az. Osp. S. Maria Delle Croci; U.O. Di Ematologia

location_facility: Hopitaux De Brabois; Hematologie Medecine Interne

location_facility: Katedra i Klinika Hematoonkologii i Transplantacji Szpiku; Uniwersytetu Medycznego w Lublinie

location_facility: Klinik der Uni zu Köln; Klinik für Innere Medizin

location_facility: Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK

location_facility: Hospital General De Culiacan; Servicio De Hematologia

location_facility: Centro Internacional de Estudios Clínicos (CIEC)

location_facility: City Clinical Hospital After Botkin; Hematology

location_facility: Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine

location_facility: Hospital Sirio Libanes; Centro de Oncologia

location_facility: Gemeinschaftspraxis Dr. Siehl & Dr. Soeling

location_facility: Centro Estatal De Cancerologia De Chihuahua; Servicio De Hematologia Banco De Sangre

location_facility: University Hospital Center Zagreb; Haematology Department

location_facility: Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: Gemeinschaftspraxis Fr. Dr. med. Balser & Hr. Dr. med. Weidenbach

location_facility: HOSPITAL PRIVADO - CENTRO MEDICO DE CÓRDOBA; Dpto Oncología

location_facility: Gemeinschaftspraxis Dr. med. Holger Klaproth / Dr. med. Anca Astrid Cura

location_facility: Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Hematología

location_facility: Canterbury Health Laboratories; Haematology

location_facility: Istanbul University Cerrahpasa Medical Faculty; Hematology Department

location_facility: Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Lymphoma Dept.

location_facility: IPO do Porto; Servico de Onco-Hematologia

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


title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Tolerability of TMC435 Versus Placebo as Part of a Treatment Regimen Including Peginterferon α-2a (Pegasys®) and Ribavirin (Copegus®) or Peginterferon α-2b (PegIntron®) and Ribavirin (Rebetol®) in Treatment-naïve, Genotype 1, Hepatitis C-infected Subjects

summary: The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in participants who are infected with genotype 1 hepatitis C virus who have never received treatment before. Participants will also receive peginterferon alfa-2a or peginterferon alfa-2b and ribavirin as part of their treatment.

ReferenceCitation: Lenz O, Verbinnen T, Fevery B, Tambuyzer L, Vijgen L, Peeters M, Buelens A, Ceulemans H, Beumont M, Picchio G, De Meyer S. Virology analyses of HCV isolates from genotype 1-infected patients treated with simeprevir plus peginterferon/ribavirin in Phase IIb/III studies. J Hepatol. 2015 May;62(5):1008-14. doi: 10.1016/j.jhep.2014.11.032. Epub 2014 Nov 28.

ReferenceCitation: Manns M, Marcellin P, Poordad F, de Araujo ES, Buti M, Horsmans Y, Janczewska E, Villamil F, Scott J, Peeters M, Lenz O, Ouwerkerk-Mahadevan S, De La Rosa G, Kalmeijer R, Sinha R, Beumont-Mauviel M. Simeprevir with pegylated interferon alfa 2a or 2b plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection (QUEST-2): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2014 Aug 2;384(9941):414-26. doi: 10.1016/S0140-6736(14)60538-9. Epub 2014 Jun 4. Erratum In: Lancet. 2016 Apr 30;387(10030):1816.

lead_sponsor: Janssen R&D Ireland

location_country:
Germany
Poland
Portugal
Slovakia
Argentina
Brazil
Netherlands
Austria
Belgium
United States
Spain
Turkey
Bulgaria
Puerto Rico
France


title: An Open-Label, Multicenter, Phase I Trial of the Safety and Pharmacokinetics Of Escalating Doses of DCDS4501A in Patients With Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma and Chronic Lymphocytic Leukemia and DCDS4501A in Combination With Rituximab in Patients With Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma

summary: This is a Phase I, multicenter, open-label, dose-escalation study of polatuzumab vedotin administered as a single agent by intravenous (IV) infusion to participants with relapsed or refractory hematologic malignancies. In Phase Ib, participants will receive polatuzumab vedotin in combination with rituximab.

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

ReferenceCitation: Palanca-Wessels MC, Czuczman M, Salles G, Assouline S, Sehn LH, Flinn I, Patel MR, Sangha R, Hagenbeek A, Advani R, Tilly H, Casasnovas O, Press OW, Yalamanchili S, Kahn R, Dere RC, Lu D, Jones S, Jones C, Chu YW, Morschhauser F. Safety and activity of the anti-CD79B antibody-drug conjugate polatuzumab vedotin in relapsed or refractory B-cell non-Hodgkin lymphoma and chronic lymphocytic leukaemia: a phase 1 study. Lancet Oncol. 2015 Jun;16(6):704-15. doi: 10.1016/S1470-2045(15)70128-2. Epub 2015 Apr 27.

lead_sponsor: Genentech, Inc.

location_country:
United States
Canada
Netherlands
France

location_facility: Centre Hospitalier Regional Universitaire de Lille

location_facility: Cross Cancer Institute ; Dept of Medical Oncology

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


lead_sponsor: Amgen

summary:
To determine if AMG 386 plus pegylated liposomal doxorubicin (PLD) is superior to placebo plus PLD as measured by progression-free survival (PFS)

The hypothesis for this study is that AMG 386 plus PLD will prolong PFS compared to placebo plus PLD in women with recurrent partially platinum sensitive or resistant epithelial ovarian, primary peritoneal or fallopian tube cancer.

ReferenceType: background

ReferenceCitation: Marth C, Vergote I, Scambia G, Oberaigner W, Clamp A, Berger R, Kurzeder C, Colombo N, Vuylsteke P, Lorusso D, Hall M, Renard V, Pignata S, Kristeleit R, Altintas S, Rustin G, Wenham RM, Mirza MR, Fong PC, Oza A, Monk BJ, Ma H, Vogl FD, Bach BA. ENGOT-ov-6/TRINOVA-2: Randomised, double-blind, phase 3 study of pegylated liposomal doxorubicin plus trebananib or placebo in women with recurrent partially platinum-sensitive or resistant ovarian cancer. Eur J Cancer. 2017 Jan;70:111-121. doi: 10.1016/j.ejca.2016.09.004. Epub 2016 Dec 1.

title: A Phase 3, Randomized, Double-Blind Trial of Pegylated Liposomal Doxorubicin (PLD) Plus AMG 386 or Placebo in Women With Recurrent Partially Platinum Sensitive or Resistant Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

location_country:
Germany
Italy
Poland
New Zealand
Slovakia
Hungary
Hong Kong
Denmark
Australia
Singapore
Switzerland
Austria
Belgium
United Kingdom
United States
Taiwan
Canada
France


lead_sponsor: Sandoz

summary: The purpose of this study is to determine the PK/PD, efficacy and safety of GP2013 in patients with severe rheumatoid arthritis.

ReferenceCitation: Smolen JS, Cohen SB, Tony HP, Scheinberg M, Kivitz A, Balanescu A, Gomez-Reino J, Cen L, Zhu P, Shisha T. A randomised, double-blind trial to demonstrate bioequivalence of GP2013 and reference rituximab combined with methotrexate in patients with active rheumatoid arthritis. Ann Rheum Dis. 2017 Sep;76(9):1598-1602. doi: 10.1136/annrheumdis-2017-211281. Epub 2017 Jun 21.

repositories_institution: University of Oxford - Oxford Academic Notes & Queries

sponsor_collaborators:
Sandoz
Novartis Pharmaceuticals

location_facility: Megyei Csolnoky Ferenc Kórház Nonprofit Zrt.

location_facility: Arthritis & Osteoporosis Center of South Texas

title: A Randomized, Double-blind, Controlled Study to Evaluate PK, PD, Safety and Efficacy of GP2013 and Rituximab in Patients With Rheumatoid Arthritis Refractory or Intolerant to Standard DMARDs and up to Three Anti-TNF Therapies.

location_country:
Germany
Italy
India
Hungary
Argentina
Romania
Brazil
Austria
Belgium
United States
Spain
Turkey
Estonia
France


title: A 16-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Reslizumab (0.3 or 3.0 mg/kg) as Treatment for Patients (12-75 Years of Age) With Eosinophilic Asthma

summary: The primary objective of this study is to determine whether reslizumab, at a dosage of 0.3 or 3.0 mg/kg administered once every 4 weeks for a total of 4 doses, is more effective than placebo in improving lung function in patients with eosinophilic asthma as assessed by the overall change from baseline in forced expiratory volume in 1 second (FEV1).

ReferenceCitation: Bjermer L, Lemiere C, Maspero J, Weiss S, Zangrilli J, Germinaro M. Reslizumab for Inadequately Controlled Asthma With Elevated Blood Eosinophil Levels: A Randomized Phase 3 Study. Chest. 2016 Oct;150(4):789-798. doi: 10.1016/j.chest.2016.03.032. Epub 2016 Apr 4.

lead_sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

location_country:
Poland
Colombia
Hungary
Argentina
Israel
Brazil
Netherlands
Mexico
Belgium
Sweden
United States
Canada
France

location_facility:
Teva Investigational Site 9
Teva Investigational Site 103
Teva Investigational Site 344
Teva Investigational Site 147
Teva Investigational Site 263
Teva Investigational Site 12
Teva Investigational Site 8
Teva Investigational Site 140
Teva Investigational Site 182
Teva Investigational Site 21
Teva Investigational Site 203
Teva Investigational Site 422
Teva Investigational Site 143
Teva Investigational Site 45
Teva Investigational Site 602
Teva Investigational Site 10
Teva Investigational Site 16
Teva Investigational Site 420
Teva Investigational Site 183
Teva Investigational Site 407
Teva Investigational Site 24
Teva Investigational Site 504
Teva Investigational Site 15
Teva Investigational Site 123
Teva Investigational Site 260
Teva Investigational Site 340
Teva Investigational Site 400
Teva Investigational Site 2
Teva Investigational Site 144
Teva Investigational Site 342
Teva Investigational Site 500
Teva Investigational Site 502
Teva Investigational Site 1
Teva Investigational Site 121
Teva Investigational Site 184
Teva Investigational Site 406
Teva Investigational Site 26
Teva Investigational Site 127
Teva Investigational Site 421
Teva Investigational Site 264
Teva Investigational Site 105
Teva Investigational Site 120
Teva Investigational Site 601
Teva Investigational Site 7
Teva Investigational Site 403
Teva Investigational Site 124
Teva Investigational Site 5
Teva Investigational Site 18
Teva Investigational Site 142
Teva Investigational Site 145
Teva Investigational Site 404
Teva Investigational Site 128
Teva Investigational Site 513
Teva Investigational Site 512
Teva Investigational Site 104
Teva Investigational Site 402
Teva Investigational Site 200
Teva Investigational Site 205
Teva Investigational Site 181
Teva Investigational Site 202
Teva Investigational Site 505
Teva Investigational Site 14
Teva Investigational Site 460
Teva Investigational Site 3
Teva Investigational Site 600
Teva Investigational Site 185
Teva Investigational Site 27
Teva Investigational Site 20
Teva Investigational Site 204
Teva Investigational Site 401
Teva Investigational Site 122
Teva Investigational Site 11
Teva Investigational Site 19
Teva Investigational Site 180
Teva Investigational Site 17
Teva Investigational Site 343
Teva Investigational Site 141
Teva Investigational Site 43
Teva Investigational Site 126
Teva Investigational Site 125
Teva Investigational Site 507
Teva Investigational Site 6
Teva Investigational Site 146
Teva Investigational Site 101
Teva Investigational Site 4
Teva Investigational Site 73
Teva Investigational Site 150
Teva Investigational Site 341
Teva Investigational Site 261


title: A Randomized, Controlled Phase III Study Investigating IMA901 Multipeptide Cancer Vaccine in Patients Receiving Sunitinib as First-line Therapy for Advanced/Metastatic Renal Cell Carcinoma

summary:
The primary objective of the phase III study is to investigate whether IMA901 can prolong overall survival in patients with metastatic and/or locally advanced renal cell carcinoma (RCC) when added to standard first-line therapy with sunitinib.

Secondary objectives include a subgroup analysis of overall survival in patients defined by a certain biomarker signature, the investigation of progression-free survival, best tumor response, safety, and immunological parameters.

ReferenceCitation: Rini BI, Stenzl A, Zdrojowy R, Kogan M, Shkolnik M, Oudard S, Weikert S, Bracarda S, Crabb SJ, Bedke J, Ludwig J, Maurer D, Mendrzyk R, Wagner C, Mahr A, Fritsche J, Weinschenk T, Walter S, Kirner A, Singh-Jasuja H, Reinhardt C, Eisen T. IMA901, a multipeptide cancer vaccine, plus sunitinib versus sunitinib alone, as first-line therapy for advanced or metastatic renal cell carcinoma (IMPRINT): a multicentre, open-label, randomised, controlled, phase 3 trial. Lancet Oncol. 2016 Nov;17(11):1599-1611. doi: 10.1016/S1470-2045(16)30408-9. Epub 2016 Oct 3.

repository_institution: University of Southampton - ePrints Soton

repositories_institution: University of Southampton - ePrints Soton

lead_sponsor: Immatics Biotechnologies GmbH

location_country:
Germany
Italy
Poland
Hungary
Norway
Romania
United Kingdom
Netherlands
United States
Russian Federation
France

location_facility: Orenburg Regional Clinical Oncological Dispensary

location_facility: Medical Oncology, Hospital Santa Maria Nuova of Reggio Emilia

location_facility: CRUK Research Unit, Somers Cancer Research Building, Southampton General Hospital

location_facility: Centre Rene Gauducheau, Service d'oncologie medicale

location_facility: Klinikum rechts der Isar, Urologischen Klinik und Poliklinik, Technische Universität München

location_facility: Centre Francois Baclesse, Comite Urologie-Gynecologie

location_facility: Federal State Institution "Russian Scientific Center of Radiology and Surgery Technologies" of Ministry of Healthcare of Russian Federation"

location_facility: Cleveland Clinic Taussig Cancer Institute

location_facility: Uzsoki Utcai Hospital, Oncoradiology Center

location_facility: Paterson Institute for Cancer Research, Christie Hospital NHS Foundation Trust, Medical Oncology

location_facility: Saint Petersburg State Institution of Healthcare "City Clinical Oncological Dispensary"

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Urologii

location_facility: Péterfy Utcai Hospital, Urology department

location_facility: University Medical Center St. Radboud Centraal, Department of Urology

location_facility: Klinik für Urologie, Universitätsklinikum Tübingen

location_facility: Georgetown University Medical Center, Lombardi Comprehensive Cancer Center

location_facility: South West Wales Cancer Institute, Singleton Hospital, School of Medicine

location_facility: Medizinische Klinik III für Hämatologie und Onkologie, Universitätsklinikum Bonn

location_facility: Hospital Européen Georges Pompidou, Service d'oncologie medicale

location_facility: Dipartimento di Oncologia, IRCCS Fondazione

location_facility: Cedars-Siani Medical Center, Samuel Oschin Comprehensive Cancer Institute

location_facility: Universitätsmedizin Berlin, Charité Campus Benjamin Franklin, Urologische Klinik und Hochschulambulanz

location_facility: UPMC Cancer Pavilion, University of Pittsburgh Cancer Institute, Division of Hematology / Oncology

location_facility: Weinberg Cancer Institute at Franklin Hospital

location_facility: Federal State Institution "Russian Scientific Center of Radiology and Nuclear Medicine of Healthcare of Russian Federation"

location_facility: Dzieciątka Jezus Clinical Hospital of Medical University, General Urology and Oncology Clinic

location_facility: CHU Estaing, Service d'hematologie clinique adulte et de therapie cellulaire

location_facility: Prof. Franciszek Łukaszczyk Oncology Center

location_facility: North Central Cancer Treatment Group, Illinois Cancer Care

location_facility: Medical Oncology Unit, Policlinico Sant'Orsola Malpighi

location_facility: Urologische Klinik Dr. Castringius, München-Planegg

location_facility: Klinik für Hämatologie und internistische Onkologie, Augusta-Krankenanstalt gGmbH

location_facility: Nationales Centrum für Tumorerkrankungen (NCT), Medizinische Onkologie

location_facility: University of Arkansas for Medical Sciences

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej "Magodent"

location_facility: University Hospital, UOS - Radiumhospital

location_facility: Leeds Institute of Molecular Medicine, Section of Oncology and Clinical Research, St. James's University Hospital

location_facility: Klinik und Poliklinik für Urologie, Abteilung für Operative Medizin, Universitätsklinikum Leipzig

location_facility: State Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncological Hospital"

location_facility: Chemotherapy Department Center of Oncology of the Lublin Region

location_facility: Oxford Cancer and Haematology Centre, University of Oxford, The Churchill Hospital, Oxford Radcliffe Hospital NHS Trust, Dept.of Medical Oncology

location_facility: Saint-Petersburg Clinical Scientific and Practical Centre of Special Methods of Medical Aid (Oncology)

location_facility: Department of Oncology and Haematology, Division of Medical Oncology, University of Modena and Reggio Emilia

location_facility: Moscow Hertsen Scientific Research Oncological Institute

location_facility: Emergency Clinical County Hospital Oradea

location_facility: "Prof. Dr. Ioan Chiricuta" Oncology Institute

location_facility: Centro di riferimento Oncologico di Aviano

location_facility: Postgraduate Medical School, University of Surrey

location_facility: Federal State Institution "Scientific Research Institute of Oncology named after N.N. Petrov of Ministry of Healthcare of Russian Federation"

location_facility: Pándy Kálmán County Hospital, Oncology and Radiotherapy Center

location_facility: Presidio Ospedaliero Ospedale San Donato, U.O. Oncologia Medica

location_facility: Klinik für Innere Medizin III, Hämatologie - Onkologie - Rheumatologie - Infektionskrankheiten, Universitätsklinikum Ulm

location_facility: Universitätsklinikum Essen, Klinik für Innere Medizin (Tumorforschung)

location_facility: State Budget Institution of Healthcare "Chelyabinsk regional clinical oncological Dispensary"

location_facility: University of Debrecen, Faculty of Medicine, Institute of Oncology

location_facility: Addenbrooke's Hospital & Peterborough District Hospital, Cambridge University Hospitals NHS Foundation Trust, Oncology Center

location_facility: Przemienienia Pańskiego Clinical Hospital no. 1, Oncology Clinic

location_facility: Urology and Urological Oncology Department and Clinic

location_facility: IRCC-Istituto di Ricerca e Cura del Cancro

location_facility: Oncology Department, Zala County Hospital

location_facility: Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation, Medizinische Hochschule Hannover

location_facility: Urology Department, Bajcsy-Zsilinszky Hospital

location_facility: South Texas Oncology & Hematology, P.A., The Start Center For Cancer Care

location_facility: Institution of Russian Academy of Medical Science, "Russian Oncological Scientific Center named after N.N. Blokhin of Russian Academy of Medical Science"

location_facility: Wojewódzki Szpital Zespolony, Oncology Department

location_facility: Republican Clinical Oncology Dispensary of Ministry of Health of Republic Tatarstan

location_facility: Nonstate Institution of Healthcare "Railway clinical Hospital at Station Saratov-2 of "RZGD" PC"

location_facility: Oncology Centre, Markhot Ferenc Training Hospital and Clinic

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie

location_facility: County Oncology Centre, Hetényi Géza Hospital

location_facility: State Budget Institution of Ryazan Region "Regional Clinical Oncological Diespensary"

location_facility: Kaiser Permanente Oncology Hematology Clinic

location_facility: ROSEMERE CANCER CENTRE, Royal Preston Hospital, Lancashire Teaching Hospital

location_facility: State Institution "City Clinical Hospital NO20"

location_facility: State Institution of Healthcare "Leningrad Regional Oncological Dispensary"

location_facility: University of Debrecen, Faculty of Medicine, Urology Clinic

location_facility: Schwarzwald-Baar Klinikum Villingen-Schwenningen, Abteilung Hämatologie und Onkologie

location_facility: State Educational Institution of High Professional Education "Rostov State Medical University of Roszdrav"

location_facility: Saint-Petersburg State Institution of Healthcare "City Universal Hospital N02"

location_facility: Oncology Therapy Clinic, University of Szeged

location_facility: Pomeranian Medical University Hospital, NZOZ Innowacyjna Medycyna

location_facility: Targu-Mures Clinical County Hospital, Oncology and Radiotherapy Department


title: A Multinational, Randomized, Double Blind, Controlled Phase II Trial of Ombrabulin With Taxane and Platinum Combination Administered Every Three Weeks, in First Line Treatment of Patients Metastatic Non-small Cell Lung Cancer

acronym: DISRUPT

summary:
Primary Objective:

To demonstrate progression free survival (PFS) improvement for ombrabulin compared to placebo, in combination with taxane and platinum, as first line treatment for patients with metastatic non-small cell lung cancer (NSCLC).

Secondary Objective:

To determine overall survival (OS), overall response rate (ORR) according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria, safety, and evaluate potential biomarkers, pharmacokinetic (PK) analysis of ombrabulin and its main metabolite, RPR258063, using a population approach.

location_country:
Germany
Italy
Poland
Romania
Australia
United States
Korea, Republic of
Croatia
Chile
Ukraine
Serbia
Russian Federation
France

location_facility:
Investigational Site Number 642001
Investigational Site Number 152005
Investigational Site Number 191002
Investigational Site Number 152002
Investigational Site Number 250002
Investigational Site Number 250004
Investigational Site Number 840009
Investigational Site Number 840002
Investigational Site Number 688001
Investigational Site Number 276003
Investigational Site Number 688003
Investigational Site Number 840001
Investigational Site Number 616004
Investigational Site Number 152004
Investigational Site Number 276002
Investigational Site Number 616001
Investigational Site Number 036002
Investigational Site Number 380003
Investigational Site Number 250001
Investigational Site Number 380001
Investigational Site Number 250005
Investigational Site Number 410002
Investigational Site Number 840003
Investigational Site Number 410003
Investigational Site Number 642003
Investigational Site Number 152003
Investigational Site Number 642004
Investigational Site Number 804003
Investigational Site Number 616005
Investigational Site Number 191001
Investigational Site Number 276001
Investigational Site Number 643002
Investigational Site Number 643004
Investigational Site Number 804001
Investigational Site Number 804002
Investigational Site Number 191003
Investigational Site Number 036001
Investigational Site Number 380002
Investigational Site Number 250003
Investigational Site Number 642002
Investigational Site Number 840005
Investigational Site Number 616003
Investigational Site Number 410001


title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Four 12-week Treatment Cycles (48 Weeks Total) of Epratuzumab in Systemic Lupus Erythematosus Subjects With Moderate to Severe Disease

summary: The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with Systemic Lupus Erythematosus (SLE).

ReferenceCitation: Gottenberg JE, Dorner T, Bootsma H, Devauchelle-Pensec V, Bowman SJ, Mariette X, Bartz H, Oortgiesen M, Shock A, Koetse W, Galateanu C, Bongardt S, Wegener WA, Goldenberg DM, Meno-Tetang G, Kosutic G, Gordon C. Efficacy of Epratuzumab, an Anti-CD22 Monoclonal IgG Antibody, in Systemic Lupus Erythematosus Patients With Associated Sjogren's Syndrome: Post Hoc Analyses From the EMBODY Trials. Arthritis Rheumatol. 2018 May;70(5):763-773. doi: 10.1002/art.40425. Epub 2018 Apr 12.

repository_institution: University of Birmingham - University of Birmingham Research Portal

repository_normalized: Pure (Denmark)

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

repositories:
PubMed Central
Pure (Denmark)
pure.rug.nl

ReferenceCitation: Clowse ME, Wallace DJ, Furie RA, Petri MA, Pike MC, Leszczynski P, Neuwelt CM, Hobbs K, Keiserman M, Duca L, Kalunian KC, Galateanu C, Bongardt S, Stach C, Beaudot C, Kilgallen B, Gordon C; EMBODY Investigator Group. Efficacy and Safety of Epratuzumab in Moderately to Severely Active Systemic Lupus Erythematosus: Results From Two Phase III Randomized, Double-Blind, Placebo-Controlled Trials. Arthritis Rheumatol. 2017 Feb;69(2):362-375. doi: 10.1002/art.39856.

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

repository_institution: University of Debrecen - University of Debrecen Electronic Archive

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

repositories_concat: LIRIAS (KU Leuven);PubMed Central;escholarship.org;ganymedesd.lib.unideb.hu;iris.unife.it;publicatio.bibl.u-szeged.hu

repositories_institution: University of California - eScholarship University of California

lead_sponsor: UCB Pharma

location_country:
Germany
Italy
Poland
India
Hungary
United Kingdom
Romania
Brazil
Mexico
United States
Spain
South Africa
Canada
Ukraine
Russian Federation
France


lead_sponsor: GlaxoSmithKline

summary: The purpose of this study is to determine whether GSK2402968 is effective in the treatment of ambulant boys with Duchenne muscular dystrophy resulting from a mutation thought to be corrected by exon 51 skipping.

ReferenceCitation: Goemans N, Mercuri E, Belousova E, Komaki H, Dubrovsky A, McDonald CM, Kraus JE, Lourbakos A, Lin Z, Campion G, Wang SX, Campbell C; DEMAND III study group. A randomized placebo-controlled phase 3 trial of an antisense oligonucleotide, drisapersen, in Duchenne muscular dystrophy. Neuromuscul Disord. 2018 Jan;28(1):4-15. doi: 10.1016/j.nmd.2017.10.004. Epub 2017 Dec 6.

repository_institution: Leiden University - Leiden Repository

repositories_institution: University of Ferrara - Institutional Research Information System University of Ferrara

title: A Phase III, Randomized, Double Blind, Placebo-controlled Clinical Study to Assess the Efficacy and Safety of GSK2402968 in Subjects With Duchenne Muscular Dystrophy

location_country:
Germany
Poland
Argentina
Japan
Brazil
Turkey
Chile
Czechia
Canada
France
Hungary
Denmark
Belgium
Italy
Norway
Netherlands
Korea, Republic of
Spain
Taiwan
Russian Federation


title: A Two Arm Phase II Study of FOLFIRI in Combination With Standard or Escalating Dose of Cetuximab as First Line Treatment of K-Ras Wild Type Metastatic Colorectal Cancer: Everest 2

summary: The purposes of this study are to determine whether administering escalating doses of cetuximab in patients with no early skin toxicity could delay the progression of disease in a significant proportion of patients and to study the molecular signatures of response.

ipd_sharing: No

lead_sponsor: Universitaire Ziekenhuizen KU Leuven

sponsor_collaborators:
Universitaire Ziekenhuizen KU Leuven
Merck KGaA, Darmstadt, Germany

location_country: Hungary Austria Belgium Spain France

location_facility: Centre Hospitalier de Jolimont-Lobbes, Oncology Médicale

location_facility: Landeskrankenhaus Salzburg, Univ. Klinik für innere Medizin III, Universitätsklinikum der PMU

location_facility: Medical Center of the University of Pecs , National Institute Oncology

location_facility: Hospital Clinico Universitario De Valencia

location_facility: AKH Linz, Innere Medizin 3, Zentrum für Hämatologie und medizinishe Onkologie

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Universitätsklinik für Innere medizin, Klinishe abteilung für hämatologie und Onkologie

location_facility: Krankenanstalt Rudolfstiftung, 1 medizinishe Abteilung

lead_sponsor_type: academique


acronym: OPERA I

summary: This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy and safety of ocrelizumab in comparison with interferon beta-1a (Rebif) in participants with relapsing multiple sclerosis. Participants will be randomized to receive either ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week; or interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks). Planned duration of double-blind treatment is 96 weeks. Participants who complete the 96-week double-blind treatment will have an option to enter a single-group, active-treatment, open-label extension period, providing they fulfill the eligibility criteria.

ReferenceCitation: Arnold DL, Sprenger T, Bar-Or A, Wolinsky JS, Kappos L, Kolind S, Bonati U, Magon S, van Beek J, Koendgen H, Bortolami O, Bernasconi C, Gaetano L, Traboulsee A. Ocrelizumab reduces thalamic volume loss in patients with RMS and PPMS. Mult Scler. 2022 Oct;28(12):1927-1936. doi: 10.1177/13524585221097561. Epub 2022 Jun 7.

ReferenceCitation: Krishnan AP, Song Z, Clayton D, Gaetano L, Jia X, de Crespigny A, Bengtsson T, Carano RAD. Joint MRI T1 Unenhancing and Contrast-enhancing Multiple Sclerosis Lesion Segmentation with Deep Learning in OPERA Trials. Radiology. 2022 Mar;302(3):662-673. doi: 10.1148/radiol.211528. Epub 2021 Dec 14.

publisher_dissemination: Radiological Society of North America (RSNA)

ReferenceCitation: Giovannoni G, Kappos L, de Seze J, Hauser SL, Overell J, Koendgen H, Manfrini M, Wang Q, Wolinsky JS. Risk of requiring a walking aid after 6.5 years of ocrelizumab treatment in patients with relapsing multiple sclerosis: Data from the OPERA I and OPERA II trials. Eur J Neurol. 2022 Apr;29(4):1238-1242. doi: 10.1111/ene.14823. Epub 2021 May 5.

ReferenceCitation: Hauser SL, Kappos L, Arnold DL, Bar-Or A, Brochet B, Naismith RT, Traboulsee A, Wolinsky JS, Belachew S, Koendgen H, Levesque V, Manfrini M, Model F, Hubeaux S, Mehta L, Montalban X. Five years of ocrelizumab in relapsing multiple sclerosis: OPERA studies open-label extension. Neurology. 2020 Sep 29;95(13):e1854-e1867. doi: 10.1212/WNL.0000000000010376. Epub 2020 Jul 20.

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

repositories_concat: PubMed Central;ddd.uab.cat

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Kappos L, Wolinsky JS, Giovannoni G, Arnold DL, Wang Q, Bernasconi C, Model F, Koendgen H, Manfrini M, Belachew S, Hauser SL. Contribution of Relapse-Independent Progression vs Relapse-Associated Worsening to Overall Confirmed Disability Accumulation in Typical Relapsing Multiple Sclerosis in a Pooled Analysis of 2 Randomized Clinical Trials. JAMA Neurol. 2020 Sep 1;77(9):1132-1140. doi: 10.1001/jamaneurol.2020.1568.

publisher_dissemination: American Medical Association

ReferenceCitation: Hauser SL, Bar-Or A, Comi G, Giovannoni G, Hartung HP, Hemmer B, Lublin F, Montalban X, Rammohan KW, Selmaj K, Traboulsee A, Wolinsky JS, Arnold DL, Klingelschmitt G, Masterman D, Fontoura P, Belachew S, Chin P, Mairon N, Garren H, Kappos L; OPERA I and OPERA II Clinical Investigators. Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis. N Engl J Med. 2017 Jan 19;376(3):221-234. doi: 10.1056/NEJMoa1601277. Epub 2016 Dec 21.

license: public-domain

license_normalized: public-domain

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

repository_institution: Queen Mary University of London - Queen Mary Research Online

repository_institution: Tampere University - Tampere University Institutional Repository

location_facility: Universitaetsklinikum Mainz - PS; Klinik und Poliklinik fuer Neurologie

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez; Universidad Autónoma de Nuevo León

location_facility: Azienda Socio Sanitaria Territoriale della Valle Olona (pres

location_facility: Michigan Institute for Neurological Disorders

location_facility: Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Neurologia

location_facility: MRC for Oncology and Neurology Biotherapy

location_facility: Washington University; Wash Uni. Sch. Of Med

location_facility: Fovarosi Onkormanyzat Jahn Ferenc Del-Pesti

location_facility: VFN Praha Poliklinika Rs Centrum - Budova A

location_facility: Asklepiosklinik Barmbek; Abteilung Neurologie

location_facility: CHU Hopital Gabriel Montpied; Service de Neurologie

location_facility: The Ohio State University Wexner Medical Center

location_facility: Praxis Dr. med. Mathias Niedhammer, Facharzt für Neurologie

location_facility: Clinica Neurologica; Neurocirurgica de Joinville

location_facility: MMA of Ministry of Defense of Russia named after S.M. Kirov

location_facility: Universitätsklinikum Rostock, Zentrum für Nervenheilkunde; Klinik und Poliklinik für Neurologie

location_facility: ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD; Clinic of Neurology and Sleep Medicine

location_facility: Studienzentrum Nordwest, Dr. med. Joachim Springub / Herr Wolfgang Schwarz

location_facility: Neurologiczny NZOZ Centrum Leczenia SM; Osrodek Badan Klinicznych

location_facility: Central Clinical Hospital #2 N.A. Semashko OAO RJHD

location_facility: Diakoniekrankenhaus Henriettenstiftung gGMBH; Klinik für Neurologie und klinische Neurophysiologie

location_facility: Universitätsklinikum Tübingen, Zentrum für Neurologie

location_facility: Emory University; Department of Neurology

location_facility: Azienda Ospedaliera di Padova; Clinica Neurologica

location_facility: MMPIDon.Reg.Cl.&Ter.Med.Com.Neur.Dept.DNMU n.a.M.Gorkiy; Ch. of Nervous Diseases and Med. Genetics

location_facility: Ospedale Regionale Lugano Civico Medizin Neurologie; Neurologia

location_facility: Vilnius University Hospital Santariskiu Clinic

location_facility: Hospital de Braga; Servico de Neurologia

location_facility: Vin.Reg.Psych.Hosp.N.A Yuschenko O.I., Vnmu N.A. Pyrogov; Department of Nervous Diseases

location_facility: Fakultni nemocnice u sv. Anny; Neurologicka klinika

location_facility: Atrium Health Neurosciences Institute ? Charlotte

location_facility: MHATNP Sv.Naum EAD; Clinic in neurology diseases for movement disorders

location_facility: Krajska zdravotni, a. s. ? Nemocnice Teplice, o. z.; Neurologicke oddeleni

location_facility: Walton Centre NHS Foundation Trust, Neuroscience Research Centre; CLINICAL TRIALS UNIT

location_facility: Krajska Nemocnice Pardubice Neurologicka Klinika

location_facility: Neurozentrum Prien Elisabeth Hans-Thümmler Stefan Braune

location_facility: Hopital Universitaire Fattouma Bourguiba

location_facility: St.-Peterburg State institution of health care City multifield hospital #2

location_facility: The MS Center; Advance Neurology and Pain

location_facility: COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddzia? Neurologiczny

location_facility: Regional Multiple Sclerosis Centre b/o CC ECM "Neftyanik"

location_facility: Reg. SI of Health Care Smolensk Regional Clinical Hospital

location_facility: Fundacion Rosarina de Neurorehabilitacion

location_facility: Universitätsklinikum "Carl Gustav Carus"; MS Center Dresden

location_facility: Albert Einstein Medical Center; Depatment of Neurosensory sciences

location_facility: P. Stradins Clinical University Hospital; Neurology

location_facility: St.In.Inst. of Neurol.Psych.and Narcol.of the AMSU; Dept. of Neuroinfection and Multiply Sclerosis

location_facility: Charité Universitaetsmedizin Berlin, Campus Charité Mitte

location_facility: Nemocnice Jihlava; NEU-Neurologicke oddeleni

location_facility: Klaipeda University Hospital Public Institution

location_facility: Uni of Texas Health Science Center At Houston

location_facility: Hospital Universitario Puerta De Hierro Majadahonda; Servicio de Neurología

location_facility: Cliniques Universitaires Saint-Luc; Neurology

location_facility: Hopital Hautepierre - CHU Strasbourg; Service de Neurologie

location_facility: Maritime Medicine Centre of Latvia Hospital of Vecmilgravis Department of Neurology

location_facility: Semmelweis Egyetem AOK; Neurologiai Klinika

location_facility: CHU de Nîmes Hopital Caremeau; Service de Neurologie

location_facility: Multicare Research Institute; Multicare Neuroscience Center of Washington

location_facility: Southern California Permanente Medical Group

location_facility: Specjal. Praktyka Lekarska; Prof. Grzegorz Opala

location_facility: Fakultna nemocnica s poliklinikou Zilina

location_facility: Hospital das Clinicas - UFG;Reumatologia

location_facility: Universitätsspital Basel Medizin Neurologie; Neurologische Poliklinik

location_facility: Chaim Sheba Medical Center; Neurology Department

location_facility: University of California at San Francisco

location_facility: Lviv Regional Clinical Hospital; Department of Neurology

location_facility: Univerzitna nemocnica Bratislava Nemocnica sv. Cyrila a Metoda; Nemocnicna lekaren

location_facility: Northwestern University; Dept. of Neurology

location_facility: Clinica Centenario Peruano Japonesa; Neurology

location_facility: Kyiv City Cl.Hosp.#4 Depart.of Neurology #2NMU; Department of Neurology

location_facility: FSBIH Siberian Regional Medical Centre of FMBA of Russia

location_facility: Royal North Shore Hospital; Department of Neurology

title: A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif®) in Patients With Relapsing Multiple Sclerosis

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Chile
Czechia
Serbia
France
Lithuania
Portugal
Slovakia
Hungary
Switzerland
United States
Latvia
Ukraine
Tunisia
Belgium
Peru
Estonia
Italy
United Kingdom
Netherlands
Austria
Mexico
Spain
South Africa
Bulgaria
Russian Federation
Israel


title: An Open-Label Long-Term Study of the Safety and Tolerability of Repeated Administration of CEP-33457 in Patients With Systemic Lupus Erythematosus

summary: The primary objective of this study is to evaluate the long term safety and tolerability of repeated administration of subcutaneous (SC) CEP-33457 for injection every 4 weeks over 72 weeks (18 doses) in participants with systemic lupus erythematosus (SLE) who have participated in a previous Cephalon sponsored clinical study of CEP-33457, and completed at least Visit 8 (Week 24 of that study).

lead_sponsor: Cephalon, Inc.

location_country:
Germany
Poland
Portugal
Hungary
United Kingdom
Belgium
United States
Spain
Czechia
Ukraine
France

location_facility:
Teva Investigational Site 752
Teva Investigational Site 9
Teva Investigational Site 39
Teva Investigational Site 802
Teva Investigational Site 12
Teva Investigational Site 8
Teva Investigational Site 21
Teva Investigational Site 203
Teva Investigational Site 30
Teva Investigational Site 29
Teva Investigational Site 602
Teva Investigational Site 33
Teva Investigational Site 10
Teva Investigational Site 16
Teva Investigational Site 36
Teva Investigational Site 301
Teva Investigational Site 24
Teva Investigational Site 15
Teva Investigational Site 700
Teva Investigational Site 800
Teva Investigational Site 302
Teva Investigational Site 400
Teva Investigational Site 2
Teva Investigational Site 500
Teva Investigational Site 900
Teva Investigational Site 606
Teva Investigational Site 502
Teva Investigational Site 1
Teva Investigational Site 22
Teva Investigational Site 406
Teva Investigational Site 23
Teva Investigational Site 25
Teva Investigational Site 26
Teva Investigational Site 605
Teva Investigational Site 904
Teva Investigational Site 703
Teva Investigational Site 201
Teva Investigational Site 803
Teva Investigational Site 32
Teva Investigational Site 601
Teva Investigational Site 7
Teva Investigational Site 102
Teva Investigational Site 100
Teva Investigational Site 303
Teva Investigational Site 403
Teva Investigational Site 28
Teva Investigational Site 5
Teva Investigational Site 901
Teva Investigational Site 18
Teva Investigational Site 404
Teva Investigational Site 903
Teva Investigational Site 402
Teva Investigational Site 200
Teva Investigational Site 34
Teva Investigational Site 751
Teva Investigational Site 38
Teva Investigational Site 801
Teva Investigational Site 304
Teva Investigational Site 202
Teva Investigational Site 501
Teva Investigational Site 14
Teva Investigational Site 405
Teva Investigational Site 3
Teva Investigational Site 600
Teva Investigational Site 31
Teva Investigational Site 40
Teva Investigational Site 37
Teva Investigational Site 27
Teva Investigational Site 20
Teva Investigational Site 905
Teva Investigational Site 603
Teva Investigational Site 401
Teva Investigational Site 35
Teva Investigational Site 300
Teva Investigational Site 11
Teva Investigational Site 19
Teva Investigational Site 17
Teva Investigational Site 750
Teva Investigational Site 702
Teva Investigational Site 604
Teva Investigational Site 701
Teva Investigational Site 902
Teva Investigational Site 6
Teva Investigational Site 101
Teva Investigational Site 4


title: An Open-Label, Multi-Center, Expanded Access Program With Eribulin for the Treatment of Advanced Breast Cancer Refractory

summary: This expanded access program is an open-label, multi-center study, which will consist of a PreTreatment Phase and a Treatment Phase. Patients with locally advanced or metastatic breast cancer who fulfill the eligibility criteria will be treated. The program will continue in each country until eribulin is approved, reimbursed and launched in that country, or termination of the program by the Sponsor.

status: Approved for marketing

study_completion_date_type: Anticipated

study_type: Expanded Access

lead_sponsor: Eisai Inc.

location_country: Canada Belgium France