acronym: OPTIC

lead_sponsor: Takeda

summary: The purpose of this study is to characterize the efficacy of ponatinib administered in 3 starting doses (45 mg, 30 mg, and 15 mg daily) in participants with CP-CML who are resistant to prior tyrosine-kinase inhibitor (TKI) therapy or have T315I mutation, as measured by <=1 % Breakpoint Cluster Region-Abelson Transcript Level using International Scale (BCR-ABL1IS) at 12 months.

ReferenceCitation: Cortes J, Apperley J, Lomaia E, Moiraghi B, Undurraga Sutton M, Pavlovsky C, Chuah C, Sacha T, Lipton JH, Schiffer CA, McCloskey J, Hochhaus A, Rousselot P, Rosti G, de Lavallade H, Turkina A, Rojas C, Arthur CK, Maness L, Talpaz M, Mauro M, Hall T, Lu V, Srivastava S, Deininger M. Ponatinib dose-ranging study in chronic-phase chronic myeloid leukemia: a randomized, open-label phase 2 clinical trial. Blood. 2021 Nov 25;138(21):2042-2050. doi: 10.1182/blood.2021012082.

evidence: open (via free article)

publisher_dissemination: American Society of Hematology

location_facility: Royal Liverpool University Hospital NHS Trust

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Hospital General de Agudo Jose Maria Ramos Mejia

location_facility: Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

location_facility: Centre Hospitalier Universitaire de Nancy Hopital de Brabois

location_facility: Emory University Winship Cancer Institute

location_facility: Instituto Portugues de Oncologia de Lisboa Francisco Gentil

location_facility: Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele

location_facility: Hospital Universitario de Gran Canaria Doctor Nergrin

location_facility: Centre Hospitalier Universitaire de Nantes Hotel Dieu

location_facility: GBUZ Moscow Clinical Scientific Center DZM

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

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: Memorial Sloan-Kettering Cancer Center - New York

location_facility: Hospital Regional Universitario Carlos Haya

location_facility: AOUI - Ospedale Policlinico "Giambattista Rossi" di Borgo Roma

location_facility: Almazov Federal North-West Medical Research Centre of Department of Health of Russian Federation

location_facility: University of Utah Huntsman Cancer Institute

location_facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord

location_facility: Azienda Ospedaliera San Gerardo di Monza

location_facility: Centre Hospitalier Regional Universitaire de Lille

location_facility: Ustav Hematologie a Krevni Transfuze Praha

location_facility: Centro de Investigaciones Clinicas Vina del Mar

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

location_facility: Azienda Sanitaria Locale di Pescara Ospedale Civile Dello Spirito Santo

location_facility: Centre de Lutte Contre le Cancer - Institut Bergonie

location_facility: Cleveland Clinic Taussig Cancer Institute Main Campus

location_facility: Center Hospitalier Universitaire d'Angers

location_facility: FGU Russian Scientific Research Institute of Hematology and Transfusiology

location_facility: Institut Universitaire du Cancer de Toulouse Oncopole

location_facility: NewYork-Presbyterian Weill Cornell Medical Center

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Centre Hospitalier Universitaire de Nice Hopital l'Archet

title: A Randomized, Open-label, Phase 2 Trial of Ponatinib in Patients With Resistant Chronic Phase Chronic Myeloid Leukemia to Characterize the Efficacy and Safety of a Range of Doses

type: Registry Identifier

type: Other Grant/Funding Number

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

location_country:
Germany
Poland
Argentina
Australia
Chile
Czechia
Canada
France
Portugal
Hong Kong
Denmark
Switzerland
United States
Italy
United Kingdom
Singapore
Korea, Republic of
Spain
Taiwan
Russian Federation
Sweden


study_start_date_type: Actual

acronym: ANNOUNCE

intervention_type: Drug

lead_sponsor: Eli Lilly and Company

summary: The main purpose of this study is to evaluate the efficacy of the combination of doxorubicin plus the study drug known as olaratumab versus doxorubicin plus placebo in participants with advanced or metastatic soft tissue sarcoma.

ReferenceType: derived

ReferenceCitation: Jones RL, Wagner AJ, Kawai A, Tamura K, Shahir A, Van Tine BA, Martin-Broto J, Peterson PM, Wright J, Tap WD. Prospective Evaluation of Doxorubicin Cardiotoxicity in Patients with Advanced Soft-tissue Sarcoma Treated in the ANNOUNCE Phase III Randomized Trial. Clin Cancer Res. 2021 Jul 15;27(14):3861-3866. doi: 10.1158/1078-0432.CCR-20-4592. Epub 2021 Feb 25.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

license: cc-by

license_normalized: cc-by

repository_institution: University of Illinois at Chicago - INDIGO

version: submittedVersion

unpaywall_oa_status: bronze

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Tap WD, Wagner AJ, Schoffski P, Martin-Broto J, Krarup-Hansen A, Ganjoo KN, Yen CC, Abdul Razak AR, Spira A, Kawai A, Le Cesne A, Van Tine BA, Naito Y, Park SH, Fedenko A, Papai Z, Soldatenkova V, Shahir A, Mo G, Wright J, Jones RL; ANNOUNCE Investigators. Effect of Doxorubicin Plus Olaratumab vs Doxorubicin Plus Placebo on Survival in Patients With Advanced Soft Tissue Sarcomas: The ANNOUNCE Randomized Clinical Trial. JAMA. 2020 Apr 7;323(13):1266-1276. doi: 10.1001/jama.2020.1707.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central
www.repositoriosalud.es

repositories_concat: LIRIAS (KU Leuven);PubMed Central;www.repositoriosalud.es

publisher_dissemination: American Medical Association

ReferenceCitation: Tobias A, O'brien MP, Agulnik M. Olaratumab for advanced soft tissue sarcoma. Expert Rev Clin Pharmacol. 2017 Jul;10(7):699-705. doi: 10.1080/17512433.2017.1324295. Epub 2017 May 5.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Informa

location_facility: University of Texas MD Anderson Cancer Center

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

location_facility: Pennsylvania Oncology Hematology Associates

location_facility: Moffitt Cancer Center & Research Institute

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

location_facility: University of Wisconsin-Madison Hospital and Health Clinic

location_facility: Fairfax Northern Virginia Hematology Oncology, PC

location_facility: University of Florida School of Medicine

status: Active, not recruiting

title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Doxorubicin Plus Olaratumab Versus Doxorubicin Plus Placebo in Patients With Advanced or Metastatic Soft Tissue Sarcoma

primary_purpose: Treatment

type: Other Identifier

type: EudraCT Number

source: euctr

enrollment_type: Actual

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

design_allocation: Randomized

study_completion_date_type: Anticipated

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Japan
Canada
France
Hungary
Denmark
Switzerland
United States
Belgium
Italy
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel

study_type: Interventional

ipd_sharing: Yes

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNF(Alpha) Refractory Subjects With Active Radiographic Axial Spondyloarthritis

summary: The purpose of this study is to assess the efficacy of ustekinumab, in adult anti-TNF(alpha) refractory participants with active radiographic axial spondyloarthritis (AxSpA), as measured by the reduction in signs and symptoms of radiographic AxSpA.

status: Terminated

study_completion_date_type: Actual

ReferenceCitation: Deodhar A, Gensler LS, Sieper J, Clark M, Calderon C, Wang Y, Zhou Y, Leu JH, Campbell K, Sweet K, Harrison DD, Hsia EC, van der Heijde D. Three Multicenter, Randomized, Double-Blind, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Ustekinumab in Axial Spondyloarthritis. Arthritis Rheumatol. 2019 Feb;71(2):258-270. doi: 10.1002/art.40728. Epub 2018 Dec 29.

oa_host_type: repository

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

repository_institution: California Digital Library - eScholarship

unpaywall_oa_status: green

publisher_dissemination: Wiley

lead_sponsor: Janssen Research & Development, LLC

location_country:
Germany
Poland
Argentina
Brazil
Czechia
Canada
France
Portugal
Hungary
United States
Ukraine
Belgium
United Kingdom
Mexico
Korea, Republic of
Spain
Taiwan
Bulgaria
Russian Federation

status_simplified: Unknown


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function

summary: The purpose of this study is to evaluate the efficacy and safety of VX-661 in combination with ivacaftor (IVA, VX-770) and IVA monotherapy in participants with Cystic Fibrosis (CF) who are heterozygous for F508del-CFTR allele and a second allele with a CFTR mutation predicted to have residual function.

status: Completed

ReferenceCitation: Southern KW, Murphy J, Sinha IP, Nevitt SJ. Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del). Cochrane Database Syst Rev. 2020 Dec 17;12(12):CD010966. doi: 10.1002/14651858.CD010966.pub3.

repositories_concat: PubMed Central

ReferenceCitation: Rowe SM, Daines C, Ringshausen FC, Kerem E, Wilson J, Tullis E, Nair N, Simard C, Han L, Ingenito EP, McKee C, Lekstrom-Himes J, Davies JC. Tezacaftor-Ivacaftor in Residual-Function Heterozygotes with Cystic Fibrosis. N Engl J Med. 2017 Nov 23;377(21):2024-2035. doi: 10.1056/NEJMoa1709847. Epub 2017 Nov 3.

repository_institution: The University of Arizona - UA Campus Repository

repository_institution: Imperial College London - Spiral

repository_institution: Queen's University Belfast - Research Portal

repository_institution: PubMed Central - Europe PMC

publisher_dissemination: Massachusetts Medical Society

lead_sponsor: Vertex Pharmaceuticals Incorporated

location_country:
Germany
Italy
Israel
United Kingdom
Australia
Netherlands
Switzerland
Belgium
United States
Canada
France

status_simplified: Completed


acronym: PEMPHIX

lead_sponsor: Hoffmann-La Roche

summary:
This is a Phase III, randomized, double-blind, double-dummy, active-comparator, parallel-arm, multicenter study to evaluate the efficacy and safety of rituximab compared with MMF in participants with moderate-to-severely active PV requiring 60-120 milligrams per day (mg/day) oral prednisone or equivalent. Participants must have a confirmed diagnosis of PV within the previous 24 months (by skin or mucosal biopsy and immunohistochemistry) and evidence of active disease at screening.

Approximately 135 participants will be enrolled at up to 60 centers worldwide. Participants will be randomized in a 1:1 ratio to receive either rituximab plus MMF placebo or rituximab placebo plus MMF. Randomization will be stratified by duration of illness.

The study will consist of three periods: a screening period of up to 28 days, a 52-week double-blind treatment period, and a 48-week safety follow up period that begins at the time of study treatment completion or discontinuation.

ReferenceCitation: Werth VP, Joly P, Mimouni D, Maverakis E, Caux F, Lehane P, Gearhart L, Kapre A, Pordeli P, Chen DM; PEMPHIX Study Group. Rituximab versus Mycophenolate Mofetil in Patients with Pemphigus Vulgaris. N Engl J Med. 2021 Jun 17;384(24):2295-2305. doi: 10.1056/NEJMoa2028564. Epub 2021 May 19.

oa_host_type: publisher

sponsor_collaborators:
Hoffmann-La Roche
Genentech, Inc.

location_facility: Kompetenzzentrum Fragile Haut Klinik fur Dermatologie und Venerologie

location_facility: Les Hospices Civils de Lyon Dermatologie inflammatoire et médecine interne

location_facility: Karadeniz Teknik Üniversitesi Tıp Fakültesi Farabi Hastanesi

location_facility: Department of Dermatology Avicenne Hospital & University

location_facility: Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez

location_facility: University of Arizona Medical Research Office

location_facility: Territorial Medical Association "Dermatovenerologia"

location_facility: Università di Parma Clinica Dermatologica

location_facility: Gülhane Military Medical Academy in Ankara

location_facility: ASST DEGLI SPEDALI CIVILI DI BRESCIA; Clinica Dermatologica

location_facility: Rambam Medical Centre; Dept. of Dermatology

location_facility: Haydarpasa Numune Training and Research Hospital

location_facility: U.O. Dermatologia Dipartimento Malattie Infettive Fondazione IRCCS Policlinico San Matteo

location_facility: Los Angeles Biomedical Research Institute

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR, Hautklinik und Poliklinik

location_facility: Rabin Medical Centre; Dept. of Dermatology

location_facility: Gaziantep University Medical Faculty Sahinbey Hospital

location_facility: Massachusetts General Hospital Dermatology

location_facility: Klinik und Poliklinik für Dermatologie und Venerologie Universitätsklinikum Köln

location_facility: Ambulatorio di Malattie Rare e Immunopatologia Cutanea

location_facility: S.C. Dermatologia 2 - Ambulatorio Malattie Rare

location_facility: Faculdade de Medicina de Botucatu - Hospital das Clínicas

location_facility: Centro Clinico per le genodermatosi Dipartimento di Dermatologia dell'Immacolata - IRCCS

location_facility: Celal Bayar University Medical Faculty Hafsa Sultan Hospital

location_facility: Wake Forest Baptist Hospital Center for Dermatology Research

location_facility: Santa Casa de São Paulo Hospital Central X

title: A Randomized, Double-Blind, Double-Dummy, Active-Comparator, Multicenter Study to Evaluate the Efficacy and Safety of Rituximab Versus MMF in Patients With Pemphigus Vulgaris

location_country:
Germany
Italy
Israel
Argentina
Australia
Brazil
United States
Spain
Turkey
Canada
Ukraine
France


title: Retrospective Data Collection: Post Study Treatment Anticancer Therapy From All Randomized Patients Involved in IMELDA MO22223

summary: This study aims to understand better the effective results from the IMELDA MO22223 P-trial (NCT00929240) and see if the anti-cancer therapies given during its follow-up time after study treatments were terminated possibly had an effect on efficacy results.

study_type: Observational

time_perspective: Retrospective

location_country: Italy India Brazil Spain Turkey France

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

location_facility: Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology

location_facility: Crio - Centro Regional Integrado de Oncologia

location_facility: Chg de Chartres Hopital Louis Pasteur; Pneumologie

location_facility: Clinique Sainte Marguerite; Oncologie Medicale

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

location_facility: Hospital Virgen de los Lirios; Servicio de Oncologia

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Hospital de Cruces; Servicio de Oncologia

location_facility: Centre Bourgogne, Service de Radiotherapie

location_facility: Complejo Hospitalario la Mancha Centro;Servicio Oncologia

location_facility: Gazi Uni Medical Faculty Hospital; Oncology Dept

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

location_facility: Akdeniz University Medical Faculty; Medical Oncology Department

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Hospital Universitario la Fe; Servicio de Oncologia

location_facility: Ospedale Antonio Perrino; Oncologia Medica

location_facility: Tata Memorial Hospital; Dept of Medical Oncology

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

location_facility: Faculdade de Medicina do ABC - FMABC; Oncologia e Hematologia

location_facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

location_facility: Uni Degli Studi Di Genova ; Clinica Di Medicina Interna Ad Indirizzo Oncologico

location_facility: Università Federico II; Dip. Di Endocrinologia ed Oncologia Molecolare e Clinica

intervention_type: Other


acronym: FRIDA

lead_sponsor: Dompé Farmaceutici S.p.A

summary:
The Objectives of this study:

The primary objective of the study was to evaluate progression-free survival (PFS) (defined as the number of days between the date of randomization and the date of clinical disease progression (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1, as assessed by Independent Radiology Review, or death for any cause, whichever occured first) in patients with metastatic triple-negative breast cancer (TNBC) treated with the combination of paclitaxel and orally administered reparixin compared to paclitaxel alone.

The secondary objectives were:

To determine overall survival (OS).
To evaluate objective response rates (ORR).
To determine median PFS (mPFS).
To assess the safety of the combination of paclitaxel and orally administered reparixin (referred to as combination treatment).

ReferenceCitation: Schott AF, Goldstein LJ, Cristofanilli M, Ruffini PA, McCanna S, Reuben JM, Perez RP, Kato G, Wicha M. Phase Ib Pilot Study to Evaluate Reparixin in Combination with Weekly Paclitaxel in Patients with HER-2-Negative Metastatic Breast Cancer. Clin Cancer Res. 2017 Sep 15;23(18):5358-5365. doi: 10.1158/1078-0432.CCR-16-2748. Epub 2017 May 24.

evidence: oa repository (via page says license)

repositories_concat: PubMed Central;aacr.figshare.com

sponsor_collaborators:
Dompé Farmaceutici S.p.A
PRA Health Sciences

location_facility: Northside Hospital, Inc.-Georgia Cancer Specialists

location_facility: Fakultní nemocnice v Motole, Onkologická klinika 2. LF UK a FN Motol

location_facility: Mid Illinois Hematology & Oncology Associates, Ltd.

location_facility: Mrukmed. Lekarz Beata Madej Mruk i Partner. Spólka Partnerska Oddzial nr 1 w Rzeszowie

location_facility: Azienda Opspedaliero Universitaria Santa Maria della Misericordia

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord

location_facility: Azienda Ospedaliero - Universitaria, Policlinico Vittorio Emanuele

location_facility: Azienda Ospedaliera, Ospedale San Carlo Borromeo

location_facility: CBCC Global Research a Comprehensive Blood and Cancer Center

location_facility: Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu

location_facility: Bialostockie Centrum Onkologii im. Marii Sklodowskiej - Curie

location_facility: Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli

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

location_facility: Centre hospitalier de Saint-Brieuc, Yves Le Foll

location_facility: Centro Oncológico Regional de Galicia, Servicio de Oncologia Medica

location_facility: Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-San Chinarro

location_facility: Hematology and Oncology Associates of Northeast PA

location_facility: Complejo Hospitalario Universitario La Coruña

location_facility: Centre Hospitalier Universitaire (CHU) De Limoges - Hopital Dupuytren

title: A Randomized, Double-blind, Placebo-controlled Phase 2 Study of Paclitaxel in Combination With Reparixin Compared to Paclitaxel Alone as Front-line Therapy for Metastatic Triple- Negative Breast Cancer (FRIDA)

location_country:
Italy
Poland
Belgium
United States
Spain
Czechia
France

ipd_sharing: No


title: A Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Amatuximab in Combination With Pemetrexed and Cisplatin in Subjects With Unresectable Malignant Pleural Mesothelioma

acronym: ARTEMIS

summary:
This study was originally designed as a multicenter, double-blind, randomized, parallel-group study, using a placebo control or amatuximab 5 milligrams per kilogram (mg/kg), administered weekly, designed to evaluate the safety and efficacy of amatuximab in combination with pemetrexed and cisplatin in participants with unresectable Malignant Pleural Mesothelioma (MPM) who have not received prior systemic therapy.

Per a business decision made by the Sponsor, participants who were randomized to amatuximab and were still on active treatment at the time of the protocol amendment may have consented to continue to receive weekly treatment with amatuximab until disease progression or intolerable toxicity at the discretion of the principal investigator. Participants randomized to placebo or who were in follow-up at the time of the amendment have been discontinued from the study.

lead_sponsor: Morphotek

location_country:
Germany
Italy
United Kingdom
Australia
United States
France


lead_sponsor: Novartis Pharmaceuticals

summary: This is a phase IIIb multicenter, open-label; single arm study to evaluate the efficacy and safety of pasireotide LAR 40 mg and 60 mg in patients with inadequately controlled acromegaly with maximal approved doses of first generation somatostatin analogues. The study will enroll inadequately controlled patients by high doses (maximal approved) of first-generation somatostatin analogues given for at least 3 months. Patients will receive pasireotide LAR 40 mg or 60 mg during the 36 week core study phase. Patients who have completed all visits of core phase and have completed all the assessments at the core phase completion visit can move into the 32-week extension phase. Patients can continue with study treatment until pasireotide LAR is commercially available and reimbursed in their respective country or until the end of the extension phase whichever occurs first.

ReferenceCitation: Gadelha M, Bex M, Colao A, Pedroza Garcia EM, Poiana C, Jimenez-Sanchez M, Yener S, Mukherjee R, Bartalotta A, Maamari R, Raverot G. Evaluation of the Efficacy and Safety of Switching to Pasireotide in Patients With Acromegaly Inadequately Controlled With First-Generation Somatostatin Analogs. Front Endocrinol (Lausanne). 2020 Feb 3;10:931. doi: 10.3389/fendo.2019.00931. eCollection 2019.

oa_colors: green gold

evidence: oa journal (via doaj)

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

unpaywall_oa_status: gold

publisher_dissemination: Frontiers

title: A Phase IIIb Multicenter, Open-label, Single Arm Study to Evaluate the Efficacy and Safety of Pasireotide in Patients With Acromegaly Inadequately Controlled With First Generation Somatostatin Analogues

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

location_country:
Italy
Colombia
Portugal
Hungary
Argentina
Romania
United Kingdom
Brazil
Mexico
Belgium
China
Malaysia
Turkey
Bulgaria
France


acronym: VITAL

lead_sponsor: Prothena Biosciences Ltd.

summary: This is a multi-center, international, randomized, double-blind, placebo-controlled, two-arm efficacy and safety study in subjects newly diagnosed with AL amyloidosis. Subjects will remain on-study until study completion, which will occur when all primary endpoint events (all-cause mortality or cardiac hospitalizations) have been reached.

location_facility: Hospital Universitario Puerta de Hierro - Maiadahonda

location_facility: University of Calgary-Southern Alberta Cancer Research Institute

location_facility: University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital

location_facility: John Hopkins University School of Medicine

location_facility: The University of Queensland-Princess Alexandra Hospital (PAH)

location_facility: University of Pittsburg - Hillman Cancer Center

location_facility: University of North Carolina Chapel Hill Comprehensive Cancer Center

location_facility: The Royal Free London NHS Foundation Trust-The Royal Free Hospital

location_facility: Columbia University - College of Physicians & Surgeons

location_facility: Amyloidosis Clinic Cnr Darcy Road and Bridge St. Westmead

location_facility: Policlinico S.Orsola Malpighi, Unita' Operativa di Ematologia

location_facility: Winship Cancer Institute of Emory University

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Froedtert & Medical College of Wisconsin, Cancer Center-Froedtert Hospital

location_facility: Princess Margaret Cancer Research Centre

location_facility: Sylvester Cancer Center, University of Miami

location_facility: Universitatsklinik fur Innere Medizin 1 Kinische Abteilung fur Onkologie Aligemeines Krankenhaus - Universitatskliniken

location_facility: NNUH NHS Foundation Trust - Norfolk and Norwich University Hospital

location_facility: Hospital of the University of Pennsylvania

location_facility: University of Texas; MD Anderson Cancer Center

location_facility: University Hospitals Bristol NHS Foundation Trust - Bristol Haematology and Oncology Centre

location_facility: Radiant Research Northwestern University

title: A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, 2-Arm, Efficacy and Safety Study of NEOD001 Plus Standard of Care Versus Placebo Plus Standard of Care in Subjects With Light Chain (AL) Amyloidosis

location_country:
Germany
Italy
Poland
Israel
United Kingdom
Denmark
Australia
Netherlands
Austria
Belgium
United States
Spain
Greece
Canada
France


title: A Randomised, Double-blind Study to Evaluate the Efficacy and Safety of Avastin Plus Roferon Compared With Placebo Plus Roferon on Overall Survival and Tumor Assessment in Nephrectomised Patients With Metastatic Clear Cell Renal Cell Carcinoma

summary: This 2-arm study will evaluate the efficacy and safety of Avastin versus placebo in combination with Roferon as first-line treatment in participants with metastatic renal cell cancer (clear cell type) who have had nephrectomy. The anticipated time of study treatment is 1-2 years, and the target sample size is greater than (>)500 individuals.

location_country:
Finland
Germany
Italy
Poland
Hungary
Israel
Norway
Australia
Singapore
Netherlands
Switzerland
Belgium
United Kingdom
Spain
Taiwan
Czech Republic
Russian Federation
France


title: Multicentre, Controlled, Randomised, Investigator-Blinded, Comparative Study of Oral Mesalazine 4g Once Daily Versus Mesalazine 4g in Two Divided Doses in Patients With Active Ulcerative Colitis.

summary:
The purpose of this study was to demonstrate that mesalazine 4g orally per day once daily (QD) is non-inferior to the reference regimen, mesalazine 4g per day in two divided doses (BID) (2g x 2 per day), in patients with active ulcerative colitis (UC) treated for 8 weeks, in terms of remission evaluated with the Ulcerative Colitis Disease Activity Index (UC-DAI) score and defined as less than or equal to 1. Both groups (4g QD and 2gx2) received an enema containing 1g of mesalazine at bedtime during the initial 4 weeks.

Participants in remission at week 8 received an additional 4 weeks of maintenance therapy with 2g oral mesalazine once a day. Participants who did not achieve remission at Week 8 completed the study at week 8.

ReferenceCitation: Flourie B, Hagege H, Tucat G, Maetz D, Hebuterne X, Kuyvenhoven JP, Tan TG, Pierik MJ, Masclee AA, Dewit O, Probert CS, Aoucheta D; MOTUS study investigators. Randomised clinical trial: once- vs. twice-daily prolonged-release mesalazine for active ulcerative colitis. Aliment Pharmacol Ther. 2013 Apr;37(8):767-75. doi: 10.1111/apt.12266. Epub 2013 Mar 4.

lead_sponsor: Ferring Pharmaceuticals

location_country:
United Kingdom
Netherlands
Belgium
France

location_facility: Investigational site - 91 rue Caulaincourt

location_facility: Clinique Saint Martin - 18 rue Rocquemonts

location_facility: Investigational site - 186 avenue de la Rose

location_facility: Clinique Saint Jean Languedoc - 20 route de Revel

location_facility: Investigational site - 127 boulevard St Germain

location_facility: Investigational site - 23 bis, place Sébastol

location_facility: IJsselmeer Ziekenhuis Loc. Lelystad, Poli MDL

location_facility: Centre Hospitalier Universitaire Albert MICHALON


lead_sponsor: Boehringer Ingelheim

summary: This study evaluates the effects of 12-week treatment with two doses of tiotropium bromide (2.5 mcg q.d. and 5 mcg q.d.) compared to placebo administered via the Respimat device on lung function in patients with Cystic Fibrosis. The selection of the optimal dose will be based on bronchodilator efficacy, safety evaluations and pharmacokinetic evaluations

ReferenceCitation: Ratjen F, Koker P, Geller DE, Langellier-Cocteaux B, Le Maulf F, Kattenbeck S, Moroni-Zentgraf P, Elborn JS; Tiotropium Cystic Fibrosis Study Group. Tiotropium Respimat in cystic fibrosis: Phase 3 and Pooled phase 2/3 randomized trials. J Cyst Fibros. 2015 Sep;14(5):608-14. doi: 10.1016/j.jcf.2015.03.004. Epub 2015 Mar 26.

oa_colors: green hybrid

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

repositories_institution: Queen's University Belfast - Research Portal

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ReferenceCitation: Bradley JM, Koker P, Deng Q, Moroni-Zentgraf P, Ratjen F, Geller DE, Elborn JS; Tiotropium Cystic Fibrosis Study Group. Testing two different doses of tiotropium Respimat(R) in cystic fibrosis: phase 2 randomized trial results. PLoS One. 2014 Sep 4;9(9):e106195. doi: 10.1371/journal.pone.0106195. eCollection 2014.

evidence: oa repository (semantic scholar lookup)

publisher_dissemination: Public Library of Science

location_facility: 205.339.011 Boehringer Ingelheim Investigational Site

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location_facility: 205.339.231 Boehringer Ingelheim Investigational Site

title: A Randomized, Double-blind, Placebo-controlled Parallel Group Study to Investigate the Safety and Efficacy of Two Doses of Tiotropium Bromide (2.5 mcg and 5 mcg) Administered Once Daily Via the Respimat Device for 12 Weeks in Patients With Cystic Fibrosis.

location_country:
Germany
Italy
Portugal
New Zealand
United Kingdom
Australia
Netherlands
Belgium
United States
Russian Federation
France


title: Treatment of Sleep-Disordered Breathing With Predominant Central Sleep Apnea by Adaptive Servo Ventilation in Patients With Heart Failure

acronym: Serve-HF

summary: The purpose of this trial is to evaluate the long-term effects and cost-effectiveness of adaptive servo-ventilation (ASV) on the mortality and morbidity of patients with stable heart failure due to left ventricular systolic dysfunction, already receiving optimal medical therapy, who have sleep disordered breathing (SDB) that is predominantly central sleep apnea. Assumptions: the intervention reduces the hazard rate by 20%. The event rate in the control group is 35% in the first year. It is assumed that the hazard rate is constant over time.

ReferenceType: result

ReferenceCitation: Cowie MR, Wegscheider K, Teschler H. Adaptive Servo-Ventilation for Central Sleep Apnea in Heart Failure. N Engl J Med. 2016 Feb 18;374(7):690-1. doi: 10.1056/NEJMc1515007. No abstract available.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

ReferenceCitation: Eulenburg C, Wegscheider K, Woehrle H, Angermann C, d'Ortho MP, Erdmann E, Levy P, Simonds AK, Somers VK, Zannad F, Teschler H, Cowie MR. Mechanisms underlying increased mortality risk in patients with heart failure and reduced ejection fraction randomly assigned to adaptive servoventilation in the SERVE-HF study: results of a secondary multistate modelling analysis. Lancet Respir Med. 2016 Nov;4(11):873-881. doi: 10.1016/S2213-2600(16)30244-2. Epub 2016 Aug 31.

ReferenceCitation: Woehrle H, Cowie MR, Eulenburg C, Suling A, Angermann C, d'Ortho MP, Erdmann E, Levy P, Simonds AK, Somers VK, Zannad F, Teschler H, Wegscheider K. Adaptive servo ventilation for central sleep apnoea in heart failure: SERVE-HF on-treatment analysis. Eur Respir J. 2017 Aug 31;50(2):1601692. doi: 10.1183/13993003.01692-2016. Print 2017 Aug.

license: unspecified-oa

license_normalized: unspecified-oa

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

repositories_concat: PubMed Central;pure.rug.nl

publisher_dissemination: European Respiratory Society

ReferenceCitation: Shafazand S, Badr MS. Adaptive Servo-Ventilation and Central Apnea Associated with Systolic Heart Failure. J Clin Sleep Med. 2016 Jan;12(1):147-50. doi: 10.5664/jcsm.5420. No abstract available.

publisher_dissemination: American Academy of Sleep Medicine (AASM)

ReferenceCitation: Cowie MR, Woehrle H, Wegscheider K, Angermann C, d'Ortho MP, Erdmann E, Levy P, Simonds AK, Somers VK, Zannad F, Teschler H. Adaptive Servo-Ventilation for Central Sleep Apnea in Systolic Heart Failure. N Engl J Med. 2015 Sep 17;373(12):1095-105. doi: 10.1056/NEJMoa1506459. Epub 2015 Sep 1.

repositories_institution:
Imperial College London - Spiral
PubMed Central - Europe PMC

collaborators: CRI-The Clinical Research Institute GmbH

location_country:
Finland
Germany
Norway
United Kingdom
Denmark
Australia
Sweden
Netherlands
Switzerland
Czechia
France

location_facility: Oslo University Hospital, Rikshospitalet

location_facility: Kardiologische Praxis Dr. Rudolf/ Dr. Bernhardt

location_facility: Hospices Civils de Lyon, Hopital de la Croix-Rousse

location_facility: Centre Hospitalier d'Antibes Juan-les-Pins

location_facility: Augusta-Kranken-Anstalt gGmbH Thoraxzentrum Ruhrgebiet

location_facility: Schwerpunktpraxis Kardiologie Drs. Ophoff/Fritzsch

location_facility: Gemeinschaftspraxis Dres. Wauer / Windstetter

location_facility: Kardiologie Gemeinschaftspraxis Dres Tenholt&Metzger&Dexling

location_facility: Klinikum der Johannes Gutenberg-Universität Mainz

location_facility: Fachärzte für Innere Medizin Dres Ritter, Richter, Mehrer, Kahl

location_facility: Gemeinschaftspraxis Kardiologie Dr. Becker

location_facility: Universitätsklinikum Schleswig-Holstein Campus Lübeck-Schlaflabor

location_facility: CH de Forbach, Hospitalor, Hopital Marie Madeleine-Pneumology

location_facility: Ambulantes Zentrum für Lungenkrankheiten&Schlafmedizin

location_facility: Universitätsklinikum Gießen/Marburg Standort Marburg-Kardiologie

location_facility: Tampere University Hospital, Pirkanmaa sairaanhoitopiiri

location_facility: Kardiologische Praxis Dr. Siegfried Frickel

location_facility: Gemeinschaftspraxis Dres. Brandt / Jakobs

location_facility: Charité Campus Mitte CCM- Schlafmedizinisches Zentrum

location_facility: Universitätsklinikum Schleswig-Holstein Campus Lübeck-Kardiologie

location_facility: Westdeutsches Herzzentrum, Universitätsklinikum Essen

location_facility: Universitätsklinikum Gießen / Marburg, Standort Marburg-Schlafmedizin

location_facility: Kardiologische Praxis Dr. Burkhard-Meier


title: Optimal Antitachycardia Therapy in ICD Patients Without Pacing Indications

acronym: OPTION

summary: This study evaluates the impact of a new pacing mode avoiding unnecessary ventricular stimulation in combination with advanced dual chamber detection with slow VT management on the clinical outcome for hospitalization and mortality and inadequate therapy in medically stable, ICD-indicated patients with impaired left ventricular function (LVEF ≤ 40%) who do not have pacing indications and no indication for Cardiac Resynchronization Therapy (CRT). It compares a new pacing mode avoiding ventricular stimulation when not needed combined with dual chamber detection with a pure ventricular back up pacing and single chamber detection criteria with pure ventricular back up pacing. Therapies are compared in a prospective, randomized, single-blinded, parallel trial with a 24-month randomized treatment period. Randomization follows a 1:1 ratio. ICD therapy is enabled for all patients throughout the study. All patients receive optimal drug therapy for arrhythmia and heart failure treatment.

ReferenceType: background

ReferenceCitation: Kolb C, Tzeis S, Sturmer M, Babuty D, Schwab JO, Mantovani G, Janko S, Aime E, Ocklenburg R, Sick P. Rationale and design of the OPTION study: optimal antitachycardia therapy in ICD patients without pacing indications. Pacing Clin Electrophysiol. 2010 Sep;33(9):1141-8. doi: 10.1111/j.1540-8159.2010.02790.x.

ReferenceCitation: Kolb C, Sturmer M, Sick P, Reif S, Davy JM, Molon G, Schwab JO, Mantovani G, Dan D, Lennerz C, Borri-Brunetto A, Babuty D. Reduced risk for inappropriate implantable cardioverter-defibrillator shocks with dual-chamber therapy compared with single-chamber therapy: results of the randomized OPTION study. JACC Heart Fail. 2014 Dec;2(6):611-9. doi: 10.1016/j.jchf.2014.05.015. Epub 2014 Oct 1.

lead_sponsor: LivaNova

location_country:
Germany
Italy
Portugal
United Kingdom
Netherlands
Belgium
United States
Canada
France

location_facility: Universitatsklinikum Schleswig-Holstein Campus Lübeck

location_facility: Heart Center Virga Jesse Ziekenhuis - Hasselt

intervention_type: Device


title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Nonsteroidal Aromatase Inhibitors (Anastrozole or Letrozole) Plus LY2835219, a CDK4/6 Inhibitor, or Placebo in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative Locoregionally Recurrent or Metastatic Breast Cancer With No Prior Systemic Therapy in This Disease Setting

acronym: MONARCH 3

summary: The main purpose of this study is to evaluate how effective nonsteroidal aromatase inhibitors (NSAI) plus abemaciclib are in postmenopausal women with breast cancer. Participants will be randomized to abemaciclib or placebo in a 2:1 ratio.

ReferenceCitation: Goetz MP, Toi M, Campone M, Sohn J, Paluch-Shimon S, Huober J, Park IH, Tredan O, Chen SC, Manso L, Freedman OC, Garnica Jaliffe G, Forrester T, Frenzel M, Barriga S, Smith IC, Bourayou N, Di Leo A. MONARCH 3: Abemaciclib As Initial Therapy for Advanced Breast Cancer. J Clin Oncol. 2017 Nov 10;35(32):3638-3646. doi: 10.1200/JCO.2017.75.6155. Epub 2017 Oct 2.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Johnston S, Martin M, Di Leo A, Im SA, Awada A, Forrester T, Frenzel M, Hardebeck MC, Cox J, Barriga S, Toi M, Iwata H, Goetz MP. MONARCH 3 final PFS: a randomized study of abemaciclib as initial therapy for advanced breast cancer. NPJ Breast Cancer. 2019 Jan 17;5:5. doi: 10.1038/s41523-018-0097-z. eCollection 2019.

publisher_dissemination: Springer-Nature

ReferenceCitation: Takahashi M, Tokunaga E, Mori J, Tanizawa Y, van der Walt JS, Kawaguchi T, Goetz MP, Toi M. Japanese subgroup analysis of the phase 3 MONARCH 3 study of abemaciclib as initial therapy for patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer. Breast Cancer. 2022 Jan;29(1):174-184. doi: 10.1007/s12282-021-01295-0. Epub 2021 Oct 18.

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

location_country:
Germany
New Zealand
Australia
Japan
Turkey
Canada
France
Slovakia
United States
Belgium
Puerto Rico
Italy
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel

location_facility: California Cancer Associates Research and Excellence (cCARE)

location_facility: TRIO - Translational Research in Oncology-US, Inc.

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

location_facility: Walter Reed National Military Medical Center IRB

location_facility: Central Coast Medical Oncology Corporation

location_facility: St Mary's Hospital Regional Cancer Center

location_facility: North Valley Hematology/Oncology Medical Group

location_facility: Kaiser Permanente / Central Interstate Medical Office

location_facility: Scott & White Memorial Hosptial & Clinic


acronym: OSAKA

lead_sponsor: Astellas Pharma Inc

summary: To compare how well the new formulation of Tacrolimus® used once daily, in combination with other drugs helps prevent the rejection of a new kidney after transplantation compared to the twice daily dose of Tacrolimus

ReferenceCitation: Albano L, Banas B, Klempnauer JL, Glyda M, Viklicky O, Kamar N; Optimising immunoSuppression After Kidney transplantation with ADVAGRAF Study Group. OSAKA trial: a randomized, controlled trial comparing tacrolimus QD and BD in kidney transplantation. Transplantation. 2013 Nov 27;96(10):897-903. doi: 10.1097/TP.0b013e3182a203bd. Erratum In: Transplantation. 2014 Mar 27;97(6):38.

ReferenceCitation: Kramer BK, Albano L, Banas B, Charpentier B, Backman L, Tedesco-Silva H Jr, Lehner F, Mondragon-Ramirez GA, Glyda M, Cassuto-Viguier E, Viklicky O, Mourad G, Rigotti P, Schleibner S, Kamar N. Efficacy of Prolonged- and Immediate-release Tacrolimus in Kidney Transplantation: A Pooled Analysis of Two Large, Randomized, Controlled Trials. Transplant Proc. 2017 Nov;49(9):2040-2049. doi: 10.1016/j.transproceed.2017.07.011.

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

repository_normalized: HAL

repository_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

title: A Multicenter, Four Arm, Randomized, Open Label Clinical Study Investigating Optimized Dosing in a Prograf®-/Advagraf®-Based Immunosuppressive Regimen in Kidney Transplant Subjects (OSAKA Study)

primary_purpose: Prevention

ipd_sharing_description: Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.

location_country:
Germany
Ireland
Poland
Argentina
Czechia
France
Portugal
Slovakia
Hungary
Switzerland
Romania
Belgium
Italy
Norway
United Kingdom
Netherlands
Austria
Spain
Greece
South Africa
Russian Federation
Sweden


title: FORTIS-M: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Oral Talactoferrin in Addition to Best Supportive Care in Patients With Non-small Cell Lung Cancer Who Have Failed Two or More Prior Treatment Regimens

acronym: FORTIS-M

summary: The purpose of this study is to determine whether talactoferrin can improve overall survival in patients with non-small cell lung cancer (NSCLC) who have been previously treated with two or more regimens.

lead_sponsor: Agennix

location_country:
Germany
Poland
Australia
Turkey
Canada
France
Czech Republic
Hungary
United States
Latvia
India
Romania
Malaysia
Philippines
Italy
United Kingdom
Singapore
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Russian Federation

location_facility: Oncology Dispensary #2 of Krasnodar Region

location_facility: General Hospital of Chania 'Ag. Georgios'

location_facility: CCH #2 n.a. N. A. Semashko of LLC "Russian Railways"

location_facility: General Hospital of Thessaloniki "G. Papanikolaou"

location_facility: Orszagos Koranyi TBC es Pulmonologiai Intezet

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

location_facility: John Hopkins Singapore International Medical Centre

location_facility: Arkhangelsk Regional Clinical Oncology Dispensary

location_facility: Deenanath Mangeshkar Hospital and Research Center

location_facility: Institut Onkologie a Rehabilitace Na Plesi

location_facility: Kaushalya Medical Foundation Trust Hospital

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Klinikum rechts der Isar der TU Muenchen

location_facility: Azienda Ospedaliera Istituti Ospitalieri di Cremona

location_facility: P.D. Hinduja Nat. Hospital & Med. Research Centre

location_facility: Cancer Care & Hematology Specialists of Chicagoland

location_facility: SEIHPE "Saint Petersburg SMU RosZdrav n.a. I.I.Pavlov"

location_facility: P. Stradina Clinical University Hospital

location_facility: NCI, CCR, The Waren Grant Magnuson Clinical Center

location_facility: Staedt. Krankenhaus Martha-Maria Halle-Doelau gGmbH

location_facility: CRO Centro di Riferimento Oncologico di Aviano

location_facility: Specjalistyczny Szpital im. Prof. A. Sokolowskiego

location_facility: Gerald Bronfman Centre for Clinical Research in Oncology

location_facility: University Hospital of North Staffordshire

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I

location_facility: Chang-Gung Memorial Hospital, Linkou Branch

location_facility: Praxis fuer interdisziplinaere Onkologie

location_facility: Mahaveer Cancer Hospital and Research Centre

location_facility: Nilai Cancer Institute (NCI Cancer Hospital)

location_facility: Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca

location_facility: Szabolcs-Szatmar Bereg Megyei Josa Andras Oktato Korhaz

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

location_facility: Washington University School of Medicine

location_facility: Chonnam National University Hwasun Hospital

location_facility: Seoul National University Bundang Hospital

location_facility: Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

location_facility: Indo-American Cancer Institute and Research Center

location_facility: Spitalul Judetean de Urgenta "Dr. Constantin Opris"

location_facility: Cancer Care Specialists of Central Illinois

location_facility: Miskolc Megyei Jogu Varos Onkormanyzat Miskolci Egeszsegugyi

location_facility: Istituto per la Ricerca e la Cura del Cancro

location_facility: Riga Eastern Clinical University Hospital

location_facility: University Hospital of South Manchester NHS Foundation Trust Wythenshawe Hospital

location_facility: Gemeinschaftspraxis fuer Haematologie Onkologie

location_facility: The Catholic University of Korea St. Vincent's Hospital

location_facility: Akademickie Centrum Kliniczne - Szpital AM w Gdansku

location_facility: University Hospital of Coventry and Warwickshire

location_facility: Dr. Anna Levcenko GP and Internist Practice

location_facility: NZOZ Olsztynski Osr. Onkologiczny "Kopernik" Sp.z o.o

location_facility: Spitalul Judetean de Urgenta "Sf. Ioan cel Nou" Suceava


summary: This study will evaluate the efficacy and safety of adding bevacizumab to crossover fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer who have experienced disease progression under first line treatment with standard chemotherapy plus bevacizumab. Participants will receive chemotherapy alone, or in combination with bevacizumab. The anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. Participants are allowed to continue on bevacizumab, even after stopping chemotherapy.

ReferenceCitation: Kubicka S, Greil R, Andre T, Bennouna J, Sastre J, Van Cutsem E, von Moos R, Osterlund P, Reyes-Rivera I, Muller T, Makrutzki M, Arnold D; ML18147 study investigators including AIO, GERCOR, FFCD, UNICANCER GI, TTD, BGDO, GEMCAD, and AGMT groups. Bevacizumab plus chemotherapy continued beyond first progression in patients with metastatic colorectal cancer previously treated with bevacizumab plus chemotherapy: ML18147 study KRAS subgroup findings. Ann Oncol. 2013 Sep;24(9):2342-9. doi: 10.1093/annonc/mdt231. Epub 2013 Jul 12.

ReferenceCitation: Bennouna J, Sastre J, Arnold D, Osterlund P, Greil R, Van Cutsem E, von Moos R, Vieitez JM, Bouche O, Borg C, Steffens CC, Alonso-Orduna V, Schlichting C, Reyes-Rivera I, Bendahmane B, Andre T, Kubicka S; ML18147 Study Investigators. Continuation of bevacizumab after first progression in metastatic colorectal cancer (ML18147): a randomised phase 3 trial. Lancet Oncol. 2013 Jan;14(1):29-37. doi: 10.1016/S1470-2045(12)70477-1. Epub 2012 Nov 16.

title: A Randomized, Open-label Phase III Intergroup Study: Effect of Adding Bevacizumab to Cross Over Fluoropyrimidine Based Chemotherapy (CTx) in Patients With Metastatic Colorectal Cancer and Disease Progression Under First-line Standard CTx/Bevacizumab Combination

location_country:
Finland
France
Germany
Portugal
Norway
Denmark
Sweden
Netherlands
Austria
Belgium
Switzerland
Saudi Arabia
Spain
Estonia
Czech Republic


title: A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects With Unstable Angina/Non-ST-Elevation Myocardial Infarction Who Are Medically Managed

acronym: TRILOGY ACS

summary: This study will evaluate the relative efficacy and safety of prasugrel and clopidogrel in a medically managed Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) acute coronary syndrome (ACS) population (that is, patients who are not managed with acute coronary revascularization).

ReferenceCitation: Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.

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

repository_institution: The University of Sydney - The Sydney eScholarship Repository

repositories_concat: PubMed Central;ses.library.usyd.edu.au

ReferenceCitation: Marquis-Gravel G, Neely ML, Valgimigli M, Costa F, Van Klaveren D, Altner R, Bhatt DL, Armstrong PW, Fox KAA, White HD, Ohman EM, Roe MT. Long-Term Bleeding Risk Prediction with Dual Antiplatelet Therapy After Acute Coronary Syndromes Treated Without Revascularization. Circ Cardiovasc Qual Outcomes. 2020 Sep;13(9):e006582. doi: 10.1161/CIRCOUTCOMES.120.006582. Epub 2020 Aug 31.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Kaul P, Alexander KP, Ohman EM, Savu A, Roe MT, Goodman SG, Fox KA, White HD, Prabhakaran D, Hochman JS, Clemmensen P, Armstrong PW. Sex And Prognostic Significance of Self-Reported Frailty in Non-ST-Segment Elevation Acute Coronary Syndromes: Insights From the TRILOGY ACS Trial. Can J Cardiol. 2019 Apr;35(4):430-437. doi: 10.1016/j.cjca.2018.12.035. Epub 2018 Dec 31.

ReferenceCitation: Fanaroff AC, Cyr D, Neely ML, Bakal J, White HD, Fox KAA, Armstrong PW, Lopes RD, Ohman EM, Roe MT. Days Alive and Out of Hospital: Exploring a Patient-Centered, Pragmatic Outcome in a Clinical Trial of Patients With Acute Coronary Syndromes. Circ Cardiovasc Qual Outcomes. 2018 Dec;11(12):e004755. doi: 10.1161/CIRCOUTCOMES.118.004755.

ReferenceCitation: Inohara T, Pieper K, Wojdyla DM, Patel MR, Jones WS, Tricoci P, Mahaffey KW, James SK, Alexander JH, Lopes RD, Wallentin L, Ohman EM, Roe MT, Vemulapalli S. Incidence, timing, and type of first and recurrent ischemic events in patients with and without peripheral artery disease after an acute coronary syndrome. Am Heart J. 2018 Jul;201:25-32. doi: 10.1016/j.ahj.2018.03.013. Epub 2018 Mar 28.

ReferenceCitation: Chan MY, Neely ML, Roe MT, Goodman SG, Erlinge D, Cornel JH, Winters KJ, Jakubowski JA, Zhou C, Fox KAA, Armstrong PW, White HD, Prabhakaran D, Ohman EM, Huber K; TRILOGY ACS Investigators. Temporal Biomarker Profiling Reveals Longitudinal Changes in Risk of Death or Myocardial Infarction in Non-ST-Segment Elevation Acute Coronary Syndrome. Clin Chem. 2017 Jul;63(7):1214-1226. doi: 10.1373/clinchem.2016.265272. Epub 2017 May 17.

publisher_dissemination: Oxford University Press

ReferenceCitation: Goldstein SA, Newby LK, Cyr DD, Neely M, Luscher TF, Brown EB, White HD, Ohman EM, Roe MT, Hamm CW. Relationship Between Peak Troponin Values and Long-Term Ischemic Events Among Medically Managed Patients With Acute Coronary Syndromes. J Am Heart Assoc. 2017 Apr 11;6(4):e005334. doi: 10.1161/JAHA.116.005334.

repository_institution: University of Zurich - Zurich Open Repository and Archive

ReferenceCitation: Alfredsson J, Neely B, Neely ML, Bhatt DL, Goodman SG, Tricoci P, Mahaffey KW, Cornel JH, White HD, Fox KA, Prabhakaran D, Winters KJ, Armstrong PW, Ohman EM, Roe MT; TRILOGY ACS Investigators. Predicting the risk of bleeding during dual antiplatelet therapy after acute coronary syndromes. Heart. 2017 Aug;103(15):1168-1176. doi: 10.1136/heartjnl-2016-310090. Epub 2017 Apr 5.

ReferenceCitation: Cornel JH, Ohman EM, Neely B, Jakubowski JA, Bhatt DL, White HD, Ardissino D, Fox KA, Prabhakaran D, Armstrong PW, Erlinge D, Tantry US, Gurbel PA, Roe MT. Relationship of Platelet Reactivity With Bleeding Outcomes During Long-Term Treatment With Dual Antiplatelet Therapy for Medically Managed Patients With Non-ST-Segment Elevation Acute Coronary Syndromes. J Am Heart Assoc. 2016 Nov 4;5(11):e003977. doi: 10.1161/JAHA.116.003977.

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

repository_institution: University of Edinburgh - Edinburgh Research Explorer

repository_institution: London School of Hygiene and Tropical Medicine - LSHTM Research Online

ReferenceCitation: Chin CT, Boden WE, Roe MT, Neely B, Neely ML, Leiva-Pons JL, Corbalan R, Gottlieb S, Dalby AJ, Armstrong PW, Prabhakaran D, Fox KA, White HD, Ohman EM, Winters KJ, Schiele F. Effect of prior clopidogrel use on outcomes in medically managed acute coronary syndrome patients. Heart. 2016 Aug 1;102(15):1221-9. doi: 10.1136/heartjnl-2015-308840. Epub 2016 Mar 30.

ReferenceCitation: Lopes RD, Leonardi S, Neely B, Neely ML, Ohman EM, Ardissino D, Hamm CW, Goodman SG, Bhatt DL, White HD, Prabhakaran D, Martinez F, Nicolau JC, Winters KJ, Fox KA, Armstrong PW, Roe MT. Spontaneous MI After Non-ST-Segment Elevation Acute Coronary Syndrome Managed Without Revascularization: The TRILOGY ACS Trial. J Am Coll Cardiol. 2016 Mar 22;67(11):1289-97. doi: 10.1016/j.jacc.2016.01.034.

ReferenceCitation: Doll JA, Neely ML, Roe MT, Armstrong PW, White HD, Prabhakaran D, Winters KJ, Duvvuru S, Sundseth SS, Jakubowski JA, Gurbel PA, Bhatt DL, Ohman EM, Fox KAA; TRILOGY ACS Investigators. Impact of CYP2C19 Metabolizer Status on Patients With ACS Treated With Prasugrel Versus Clopidogrel. J Am Coll Cardiol. 2016 Mar 1;67(8):936-947. doi: 10.1016/j.jacc.2015.12.036.

ReferenceCitation: Chin CT, Neely B, Magnus Ohman E, Armstrong PW, Corbalan R, White HD, Prabhakaran D, Winters KJ, Fox KA, Roe MT; TRILOGY ACS Investigators. Time-Varying Effects of Prasugrel Versus Clopidogrel on the Long-Term Risks of Stroke After Acute Coronary Syndromes: Results From the TRILOGY ACS Trial. Stroke. 2016 Apr;47(4):1135-9. doi: 10.1161/STROKEAHA.115.012454. Epub 2016 Feb 16.

ReferenceCitation: Roe MT, Cyr DD, Eckart D, Schulte PJ, Morse MA, Blackwell KL, Ready NE, Zafar SY, Beaven AW, Strickler JH, Onken JE, Winters KJ, Houterloot L, Zamoryakhin D, Wiviott SD, White HD, Prabhakaran D, Fox KA, Armstrong PW, Ohman EM; TRILOGY ACS Investigators. Ascertainment, classification, and impact of neoplasm detection during prolonged treatment with dual antiplatelet therapy with prasugrel vs. clopidogrel following acute coronary syndrome. Eur Heart J. 2016 Jan 21;37(4):412-22. doi: 10.1093/eurheartj/ehv611. Epub 2015 Dec 5.

ReferenceCitation: Clemmensen P, Roe MT, Hochman JS, Cyr DD, Neely ML, McGuire DK, Cornel JH, Huber K, Zamoryakhin D, White HD, Armstrong PW, Fox KA, Prabhakaran D, Ohman EM; TRILOGY ACS Investigators. Long-term outcomes for women versus men with unstable angina/non-ST-segment elevation myocardial infarction managed medically without revascularization: insights from the TaRgeted platelet Inhibition to cLarify the Optimal strateGy to medicallY manage Acute Coronary Syndromes trial. Am Heart J. 2015 Oct;170(4):695-705.e5. doi: 10.1016/j.ahj.2015.06.011. Epub 2015 Jun 20.

ReferenceCitation: Mahaffey KW, Hager R, Wojdyla D, White HD, Armstrong PW, Alexander JH, Tricoci P, Lopes RD, Ohman EM, Roe MT, Harrington RA, Wallentin L. Meta-analysis of intracranial hemorrhage in acute coronary syndromes: incidence, predictors, and clinical outcomes. J Am Heart Assoc. 2015 Jun 18;4(6):e001512. doi: 10.1161/JAHA.114.001512.

repositories_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

ReferenceCitation: Roy A, Roe MT, Neely ML, Cyr DD, Zamoryakhin D, Fox KA, White HD, Armstrong PW, Ohman EM, Prabhakaran D. Impact of Human Development Index on the profile and outcomes of patients with acute coronary syndrome. Heart. 2015 Feb;101(4):279-86. doi: 10.1136/heartjnl-2014-306389. Epub 2014 Dec 23.

ReferenceCitation: Bakal JA, Roe MT, Ohman EM, Goodman SG, Fox KA, Zheng Y, Westerhout CM, Hochman JS, Lokhnygina Y, Brown EB, Armstrong PW. Applying novel methods to assess clinical outcomes: insights from the TRILOGY ACS trial. Eur Heart J. 2015 Feb 7;36(6):385-92a. doi: 10.1093/eurheartj/ehu262. Epub 2014 Jul 10.

ReferenceCitation: Cornel JH, Ohman EM, Neely B, Clemmensen P, Sritara P, Zamoryakhin D, Armstrong PW, Prabhakaran D, White HD, Fox KA, Gurbel PA, Roe MT; TRILOGY ACS Investigators. Impact of smoking status on platelet function and clinical outcomes with prasugrel vs. clopidogrel in patients with acute coronary syndromes managed without revascularization: Insights from the TRILOGY ACS trial. Am Heart J. 2014 Jul;168(1):76-87.e1. doi: 10.1016/j.ahj.2014.04.011. Epub 2014 Apr 24. Erratum In: Am Heart J. 2014 Oct;168(4):605.

ReferenceCitation: Wiviott SD, White HD, Ohman EM, Fox KA, Armstrong PW, Prabhakaran D, Hafley G, Lokhnygina Y, Boden WE, Hamm C, Clemmensen P, Nicolau JC, Menozzi A, Ruzyllo W, Widimsky P, Oto A, Leiva-Pons J, Pavlides G, Winters KJ, Roe MT, Bhatt DL. Prasugrel versus clopidogrel for patients with unstable angina or non-ST-segment elevation myocardial infarction with or without angiography: a secondary, prespecified analysis of the TRILOGY ACS trial. Lancet. 2013 Aug 17;382(9892):605-13. doi: 10.1016/S0140-6736(13)61451-8. Erratum In: Lancet. 2013 Aug 31;382(9894):768.

ReferenceCitation: Gurbel PA, Erlinge D, Ohman EM, Neely B, Neely M, Goodman SG, Huber K, Chan MY, Cornel JH, Brown E, Zhou C, Jakubowski JA, White HD, Fox KA, Prabhakaran D, Armstrong PW, Tantry US, Roe MT; TRILOGY ACS Platelet Function Substudy Investigators. Platelet function during extended prasugrel and clopidogrel therapy for patients with ACS treated without revascularization: the TRILOGY ACS platelet function substudy. JAMA. 2012 Nov 7;308(17):1785-94. doi: 10.1001/jama.2012.17312.

ReferenceCitation: Roe MT, Armstrong PW, Fox KA, White HD, Prabhakaran D, Goodman SG, Cornel JH, Bhatt DL, Clemmensen P, Martinez F, Ardissino D, Nicolau JC, Boden WE, Gurbel PA, Ruzyllo W, Dalby AJ, McGuire DK, Leiva-Pons JL, Parkhomenko A, Gottlieb S, Topacio GO, Hamm C, Pavlides G, Goudev AR, Oto A, Tseng CD, Merkely B, Gasparovic V, Corbalan R, Cinteza M, McLendon RC, Winters KJ, Brown EB, Lokhnygina Y, Aylward PE, Huber K, Hochman JS, Ohman EM; TRILOGY ACS Investigators. Prasugrel versus clopidogrel for acute coronary syndromes without revascularization. N Engl J Med. 2012 Oct 4;367(14):1297-309. doi: 10.1056/NEJMoa1205512. Epub 2012 Aug 25.

ReferenceCitation: Jeong YH, Tantry US, Gurbel PA. Importance of potent P2Y(12) receptor blockade in acute myocardial infarction: focus on prasugrel. Expert Opin Pharmacother. 2012 Aug;13(12):1771-96. doi: 10.1517/14656566.2012.704909. Epub 2012 Jul 12.

ReferenceCitation: Chin CT, Roe MT, Fox KA, Prabhakaran D, Marshall DA, Petitjean H, Lokhnygina Y, Brown E, Armstrong PW, White HD, Ohman EM; TRILOGY ACS Steering Committee. Study design and rationale of a comparison of prasugrel and clopidogrel in medically managed patients with unstable angina/non-ST-segment elevation myocardial infarction: the TaRgeted platelet Inhibition to cLarify the Optimal strateGy to medicallY manage Acute Coronary Syndromes (TRILOGY ACS) trial. Am Heart J. 2010 Jul;160(1):16-22.e1. doi: 10.1016/j.ahj.2010.04.022.

sponsor_collaborators:
Eli Lilly and Company
Daiichi Sankyo Co., Ltd.
Duke Clinical Research Institute

location_country:
Finland
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Brazil
Costa Rica
Malta
Thailand
Turkey
Croatia
Chile
Canada
Serbia
France
Czech Republic
Lithuania
Colombia
Portugal
Slovakia
Hungary
Denmark
Switzerland
United States
Ukraine
India
Romania
Tunisia
Belgium
China
Malaysia
Peru
Puerto Rico
Egypt
Philippines
Italy
United Kingdom
Singapore
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Panama
South Africa
Taiwan
Bulgaria
Russian Federation
Israel

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


title: Open-label, Randomized, Controlled, Multicenter Phase II Trial Investigating 2 Sym004 Doses Versus Investigator's Choice (Best Supportive Care, Capecitabine, 5-FU) in Subjects With Metastatic Colorectal Cancer and Acquired Resistance to Anti-EGFR Monoclonal Antibodies

summary: This is a Phase 2, open-label, randomized, 3-arm trial investigating the efficacy of two Sym004 doses (Arm A and Arm B) compared with a control group (Arm C) in subjects with metastatic colorectal cancer (mCRC) and acquired resistance to anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (mAbs).

ReferenceCitation: Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.

ReferenceCitation: Fayers PM, Aaronson NK, Bjordal K, Groenvold M, Curran D, Bottomley A, on behalf of the EORTC Quality of Life Group. The EORTC QLQ-C30 Scoring Manual (3rd Edition). Published by: European Organisation for Research and Treatment of Cancer, Brussels 2001.

ipd_sharing: Undecided

lead_sponsor: Symphogen A/S

location_country:
Germany
Italy
Poland
Hungary
Austria
Belgium
United States
Spain
Russian Federation
France

location_facility: Seconda Università degli Studi di Napoli

location_facility: SMZ Süd - Kaiser Franz Josef Spital Wien

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Azienda Ospedaliera Ospedale Niguarda Ca' Granda

location_facility: Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: ICO l´Hospitalet - Hospital Duran i Reynals

location_facility: Azienda Ospedaliero Universitaria San Martino

location_facility: Policlinico Universitario Agostino Gemelli

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

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

location_facility: Washington University School of Medicine

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti

location_facility: Hematology - Oncology Associates of Treasure Coast

location_facility: St. Petersburg SHI "City Clinical Oncology Dispensary"

location_facility: Groupe Hospitalier Saint André - Hôpital Saint André

location_facility: Hospital Universitario Central de Asturias

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: BHI of Omsk region "Clinical Oncology Dispensary"


title: Double-Blind, Randomized, Placebo-Controlled, Multi-Centre Study to Investigate the Efficacy and Safety of GLPG0634 in Subjects With Active Crohn's Disease With Evidence of Mucosal Ulceration

summary:
180 patients suffering from active Crohn's disease with evidence of mucosal ulceration will be evaluated for improvement of disease activity (efficacy) when taking GLPG0634 or matching placebo once daily for 20 weeks in addition to their stable background treatment.
During the course of the study, patients will also be examined for any side effects that may occur (safety and tolerability), and the amount of GLPG0634 present in the blood (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood and stool (Pharmacodynamics) will be determined. Also, the effects GLPG0634 administration on subjects' quality of life will be evaluated.

ReferenceCitation: Vermeire S, Schreiber S, Petryka R, Kuehbacher T, Hebuterne X, Roblin X, Klopocka M, Goldis A, Wisniewska-Jarosinska M, Baranovsky A, Sike R, Stoyanova K, Tasset C, Van der Aa A, Harrison P. Clinical remission in patients with moderate-to-severe Crohn's disease treated with filgotinib (the FITZROY study): results from a phase 2, double-blind, randomised, placebo-controlled trial. Lancet. 2017 Jan 21;389(10066):266-275. doi: 10.1016/S0140-6736(16)32537-5. Epub 2016 Dec 15.

lead_sponsor: Galapagos NV

location_country:
Germany
Poland
Hungary
United Kingdom
Romania
Belgium
Czech Republic
Russian Federation
France

location_facility: University of Debrecen, Medical and Health Science Center

location_facility: Lille Regional University Hospital Center

location_facility: Maternal, Pediatric and Adolescent Healtcare Centre, Gastroenterology Diagnostic Facility for Adults

location_facility: Clinical Hospital of Ministry of Internal Affairs and Administration

location_facility: A.N. Ryzhikh State Research Center for Coloproctology

location_facility: Vladimirsky Regional Clinical Research Institute

location_facility: Saint Etienne University Hospital Center

location_facility: Outpatient Clinic of Internal Medicine and Gastroenterology

location_facility: Interdisciplinary Crohn Colitis Center Rhein Main

location_facility: Semashko Nizhny Novgorod Regional Clinical Hospital

location_facility: Internal Medicine Group Practice Oldenburg

location_facility: Institute of Clinical and Experimental Medicine

location_facility: Mechnikov North-Western State Medical University


acronym: BIRCH

summary: This multicenter, single-arm study will evaluate the efficacy and safety of Atezolizumab in participants with PD-L1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Participants will receive Atezolizumab 1200 milligrams (mg) intravenously every 3 weeks as long as participants are experiencing clinical benefit as assessed by the investigator, that is , in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.

ReferenceCitation: Shemesh CS, Chan P, Legrand FA, Shames DS, Das Thakur M, Shi J, Bailey L, Vadhavkar S, He X, Zhang W, Bruno R. Pan-cancer population pharmacokinetics and exposure-safety and -efficacy analyses of atezolizumab in patients with high tumor mutational burden. Pharmacol Res Perspect. 2020 Dec;8(6):e00685. doi: 10.1002/prp2.685.

location_facility: Centre René Gauducheau - cancer Nantes - Atlantique; Service Oncologie Médicale

location_facility: Kyoto University Hospital, Respiratory Medicine

location_facility: University Clinical Center Sarajevo;Institute of oncology

location_facility: Klinikum Nuernberg Nord; Medizinische Klinik 3, Schwerpunkt Pneumologie, Allergologie, Schlafmedizin

location_facility: Hopital Arnaud De Villeneuve; Maladies Respiratoires

location_facility: Kansai Medical university Hospital; Thoracic Oncology

location_facility: Hematology Oncology Associates of the Treasure Coast

location_facility: Academ Ziekenhuis Groningen; Medical Oncology

location_facility: Barts & London School of Med; Medical Oncology

location_facility: Northwestern University; Robert H. Lurie Comp Can Ctr

location_facility: University Clinical Centre of the Republic of Srpska

location_facility: University of Colorado Health Science Center; Biomedical Research Bldg. Room 511

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Uni of Maryland; Greenebaum Cancer Center

location_facility: CHU Limoges - Dupuytren; Oncologie Thoracique Cutanee

location_facility: Schwarzwald-Baar Klinikum/VS GmbH; Onkologie/Hämatologie/Infektologie

location_facility: Sendai Kousei Hospital; Pulmonary Medicine

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

location_facility: Toranomon Hospital; Respiratory Medicine

location_facility: Kantonsspital St. Gallen; Onkologie/Hämatologie

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

location_facility: Northwest Georgia Oncology Centers PC - Marietta

location_facility: Princess AleXandra Hospital; Department of Medical Oncology

location_facility: Queen Elizabeth Hospital; Clinical Oncology

location_facility: University Of Chicago Medical Center; Section Of Hematology/Oncology

location_facility: National Cancer Center Hospital; Thoracic Medical Oncology

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Ege University School of Medicine; Chest Diseases Department

location_facility: Ohio State University; B406 Starling-Loving Hall

location_facility: Pius-Hospital; Klinik fuer Haematologie und Onkologie

location_facility: Sir Charles Gairdner Hospital; Medical Oncology

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

location_facility: Yokohama Municipal Citizen'S Hospital; Respiratory Medicine

location_facility: Specialized Hospital for Active Treatment of Oncology

location_facility: Queen Mary Hospital; Dept. of Clinical Oncology

location_facility: Ankara Ataturk Chest Diseases Training and Research Hospital

location_facility: Georgetown University Medical Center Lombardi Cancer Center

location_facility: ICO Badalona - Hospital Germans Trias i Pujol

location_facility: Peter Maccallum Cancer Institute; Medical Oncology

location_facility: Kitasato University Hospital; Respiratory Medicine

location_facility: Institut Gustave Roussy; Departement Oncologie Medicale

location_facility: National University Hospital; National University Cancer Institute, Singapore (NCIS)

location_facility: The Ottawa Hospital Cancer Centre; Oncology

location_facility: Washington University School of Medicine

location_facility: University Clinical Center Sarajevo;Clinic for Pulmonary disease

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

location_facility: Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung

location_facility: Huntsman Cancer Institute; University of Utah

location_facility: City of Hope Comprehensive Cancer Center

location_facility: Research institute for Clinical Medicine

location_facility: Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico

location_facility: National Hospital Organization Kyushu Medical Center; Respiratory Internal Medicine

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Emory Uni - Winship Cancer Center; Hematology/Oncology

location_facility: Tennessee Oncology PLLC - Nashville (20th Ave)

location_facility: University of Washington Seattle Cancer Care Alliance

location_facility: Kanagawa Cardiovascular and Respiratory Center; Respiratory Medicine

location_facility: Antoni Van Leeuwenhoek Ziekenhuis; Thoracic Oncology

location_facility: National Cancer Centre; Medical Oncology

location_facility: Hopital Augustin Morvan; Oncologie Thoracique

location_facility: HonorHealth Research Institute - Bisgrove

location_facility: Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department

location_facility: UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie

location_facility: University of Virginia; Office of Sponsored Programs

location_facility: Chemotherapy and Immunotherapy Clinic Medulla

location_facility: Osaka International Cancer Institute; Thoracic Oncology

location_facility: Fox Chase Cancer Center; Hematology/Oncology

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1

title: A Phase II, Multicenter, Single-Arm Study OF Atezolizumab In Patients With PD-L1-Positive Locally Advanced Or Metastatic Non-Small Cell Lung Cancer

location_country:
Germany
Australia
Japan
Bosnia and Herzegovina
Turkey
Canada
France
Slovenia
Hong Kong
Switzerland
United States
Belgium
Italy
United Kingdom
Singapore
Netherlands
Spain
Bulgaria
Georgia


title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Brodalumab in Subjects With Psoriatic Arthritis: AMVISION-2

summary: The primary objective of this study is to evaluate the efficacy of brodalumab, compared to placebo, in subjects with psoriatic arthritis. The key secondary objective is to evaluate the efficacy of brodalumab compared to placebo at week 16. The safety objective of this study is to evaluate the safety profile of brodalumab in subjects with psoriatic arthritis.

lead_sponsor: Bausch Health Americas, Inc.

location_country:
Germany
Poland
Hungary
Mexico
United States
Latvia
Greece
Canada
Russian Federation
France


acronym: CheckMate 143

intervention_type: Biological

lead_sponsor: Bristol-Myers Squibb

summary: The purpose of the study is to compare the efficacy and safety of nivolumab administered alone versus bevacizumab in patients diagnosed with recurrent glioblastoma (a type of brain cancer, also known as GBM), and to evaluate the safety and tolerability of nivolumab administered alone or in combination with ipilimumab in patients with different lines of GBM therapy.

ReferenceCitation: Woroniecka K, Fecci PE. Immuno-synergy? Neoantigen vaccines and checkpoint blockade in glioblastoma. Neuro Oncol. 2020 Sep 29;22(9):1233-1234. doi: 10.1093/neuonc/noaa170. No abstract available.

ReferenceCitation: Reardon DA, Brandes AA, Omuro A, Mulholland P, Lim M, Wick A, Baehring J, Ahluwalia MS, Roth P, Bahr O, Phuphanich S, Sepulveda JM, De Souza P, Sahebjam S, Carleton M, Tatsuoka K, Taitt C, Zwirtes R, Sampson J, Weller M. Effect of Nivolumab vs Bevacizumab in Patients With Recurrent Glioblastoma: The CheckMate 143 Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 Jul 1;6(7):1003-1010. doi: 10.1001/jamaoncol.2020.1024.

repositories_concat: PubMed Central;www.zora.uzh.ch

repositories_institution: University of Zurich - Zurich Open Repository and Archive

ReferenceCitation: Stupp R. Drug development for glioma: are we repeating the same mistakes? Lancet Oncol. 2019 Jan;20(1):10-12. doi: 10.1016/S1470-2045(18)30827-1. Epub 2018 Dec 3. No abstract available.

location_facility: Preston Robert Tisch Brain Tumor Center at Duke University

location_facility: Johns Hopkins University School Of Medicine

location_facility: University Hospitals Cleveland Medical Center

location_facility: The Regents of the University of California, San Francisco

location_facility: University of Washington - Seattle Cancer Care Alliance

location_facility: Centre hospitalier universitaire Vaudois (CHUV)

location_facility: University Of Texas Md Anderson Cancer Ctr

location_facility: Thomas Jefferson University - Clinical Research Institute

location_facility: Klinikum Der J. W. Goethe-Universitaet Frankfurt/Main

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza

title: A Randomized Phase 3 Open Label Study of Nivolumab Versus Bevacizumab and Multiple Phase 1 Safety Cohorts of Nivolumab or Nivolumab in Combination With Ipilimumab Across Different Lines of Glioblastoma

location_country:
Germany
Italy
Poland
United Kingdom
Denmark
Australia
Netherlands
Switzerland
Belgium
United States
Spain
France


title: A Multicenter, Phase 2, Single Arm, Two Cohort Study Evaluating the Efficacy, Safety, and Pharmacokinetics of AMG337 in Subjects With MET Amplified Gastric/Gastroesophageal Junction/Esophageal Adenocarcinoma or Other MET Amplified Solid Tumors

summary: This is a multi-centre Phase 2 study. The study will evaluate the activity and safety of AMG 337 in patients who have MET amplified gastric, gastroesophageal junction or esophageal adenocarcinoma or other MET amplified solid tumors. The study is designed to estimate the objective response rate of AMG 337 by tumor type.

lead_sponsor: Amgen

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Australia
Austria
Belgium
United States
Korea, Republic of
Spain
Greece
Chile
Czechia
Canada
Peru
Russian Federation
France


title: Prevalence of Peripheral Arterial Disease in Subjects With a Moderate CVD Risk, With No Overt Vascular Diseases nOR diAbetes Mellitus

acronym: PANDORA

summary: Non interventional study aimed to establish the prevalence of lower extremity peripheral arterial disease (PAD), defined as an ankle-brachial index (ABI) not above 0.90 in subjects with a moderate risk of cardiovascular disease, with no overt cardiovascular diseases nor diabetes mellitus.

time_perspective: Cross-Sectional

ReferenceCitation: Sanna G, Alesso D, Mediati M, Cimminiello C, Borghi C, Fazzari AL, Mangrella M; PANDORA study investigators. Prevalence of peripheral arterial disease in subjects with moderate cardiovascular risk: Italian results from the PANDORA study Data from PANDORA (Prevalence of peripheral Arterial disease in subjects with moderate CVD risk, with No overt vascular Diseases nor Diabetes mellitus). BMC Cardiovasc Disord. 2011 Oct 7;11:59. doi: 10.1186/1471-2261-11-59.

ReferenceCitation: Cimminiello C, Borghi C, Kownator S, Wautrecht JC, Carvounis CP, Kranendonk SE, Kindler B, Mangrella M; PANDORA Study Investigators. Prevalence of peripheral arterial disease in patients at non-high cardiovascular risk. Rationale and design of the PANDORA study. BMC Cardiovasc Disord. 2010 Aug 5;10:35. doi: 10.1186/1471-2261-10-35.

lead_sponsor: AstraZeneca

location_country: Italy Netherlands Switzerland Belgium Greece France


title: Prospective, Randomized, Double-blind, Multicenter, Multinational Study Comparing Efficacy and Safety of Moxifloxacin 400 mg po od for 14 Days With Ofloxacin 400 mg po Bid Plus Metronidazole 500 mg po Bid for 14 Days in Patients With Uncomplicated Pelvic Inflammatory Disease (PID)

acronym: MAIDEN

summary: Comparison of various antibiotics in treatment of uncomplicated pelvic inflammatory disease

lead_sponsor: Bayer

location_country:
Finland
Germany
Italy
Lithuania
Poland
Hungary
United Kingdom
Denmark
Sweden
Greece
South Africa
Russian Federation
France


title: European Registry of Anti-epileptic Drug Use in Patients With Lennox-Gastaut Syndrome (LGS).

summary: This is a registry study, where sites will enter patients with LGS who require a modification in anti-epileptic therapy (either the addition of another anti-epileptic drug, or the change of one drug to another). This will include patients who are started on rufinamide. Patients will be reviewed according to local practice, but it is envisaged that review will occur at approximately one month, three months and six months, and then every six months. Upon entry to the registry baseline details concerning disease severity, diagnosis, prior therapy, and developmental assessment will be recorded. On each subsequent visit the patient (usually through their caregiver) will be asked about current medication, general seizure profile, any seizures deemed to be of medical significance, tolerability, AEs (including suicidal-related events), and healthcare resource utilisation.

time_perspective: Prospective

ReferenceCitation: Nikanorova M, Brandt C, Auvin S, McMurray R. Real-world data on rufinamide treatment in patients with Lennox-Gastaut syndrome: Results from a European noninterventional registry study. Epilepsy Behav. 2017 Nov;76:63-70. doi: 10.1016/j.yebeh.2017.08.026. Epub 2017 Sep 15.

lead_sponsor: Eisai Limited

location_country:
Germany
Italy
United Kingdom
Denmark
Sweden
Austria
Spain
France


title: EPidemiological Study In Patients With Recently DiagnosEd PSOriasis: Clinical Assessment and Psychosocial Impact of This Disease

acronym: EPIDEPSO

summary: The purpose of this study is to explore the impact of plaque psoriasis on the different dimensions of patient life including psychological disorders, different types of addictions, and their consequences on health-related quality of life and socioeconomic parameters at baseline (cross-sectional part) and during the initial years of the psoriasis disease (longitudinal part).

lead_sponsor: Janssen Pharmaceutica N.V., Belgium

location_country:
Ireland
Israel
Norway
United Kingdom
Netherlands
Austria
Belgium
Spain
Greece
South Africa
Russian Federation
France


title: An International, Multi-Center, Double-Blind, Randomized, Phase III Trial of 90Y-Clivatuzumab Tetraxetan Plus Low-Dose Gemcitabine Versus Placebo Plus Low-Dose Gemcitabine in Patients With Metastatic (Stage IV) Pancreatic Adenocarcinoma Who Received at Least Two Prior Treatments (PANCRIT-1)

summary: The is a double-blind, randomized phase 3 study of 90Y-clivatuzumab tetraxetan with low-dose gemcitabine, versus placebo and low-dose gemcitabine in metastatic pancreatic cancer patients who have progressed on at least 2 prior therapies for metastatic cancer (1 of which was a gemcitabine-containing regimen).

ReferenceCitation: Ocean AJ, Pennington KL, Guarino MJ, Sheikh A, Bekaii-Saab T, Serafini AN, Lee D, Sung MW, Gulec SA, Goldsmith SJ, Manzone T, Holt M, O'Neil BH, Hall N, Montero AJ, Kauh J, Gold DV, Horne H, Wegener WA, Goldenberg DM. Fractionated radioimmunotherapy with (90) Y-clivatuzumab tetraxetan and low-dose gemcitabine is active in advanced pancreatic cancer: A phase 1 trial. Cancer. 2012 Nov 15;118(22):5497-506. doi: 10.1002/cncr.27592. Epub 2012 May 8.

ReferenceCitation: Gulec SA, Cohen SJ, Pennington KL, Zuckier LS, Hauke RJ, Horne H, Wegener WA, Teoh N, Gold DV, Sharkey RM, Goldenberg DM. Treatment of advanced pancreatic carcinoma with 90Y-Clivatuzumab Tetraxetan: a phase I single-dose escalation trial. Clin Cancer Res. 2011 Jun 15;17(12):4091-100. doi: 10.1158/1078-0432.CCR-10-2579. Epub 2011 Apr 28.

ReferenceCitation: Sharkey RM, Karacay H, Govindan SV, Goldenberg DM. Combination radioimmunotherapy and chemoimmunotherapy involving different or the same targets improves therapy of human pancreatic carcinoma xenograft models. Mol Cancer Ther. 2011 Jun;10(6):1072-81. doi: 10.1158/1535-7163.MCT-11-0115. Epub 2011 Apr 5.

ReferenceCitation: Tokh M, Bathini V, Saif MW. First-line treatment of metastatic pancreatic cancer. JOP. 2012 Mar 10;13(2):159-62.

ReferenceCitation: Gold DV, Newsome G, Liu D, Goldenberg DM. Mapping PAM4 (clivatuzumab), a monoclonal antibody in clinical trials for early detection and therapy of pancreatic ductal adenocarcinoma, to MUC5AC mucin. Mol Cancer. 2013 Nov 20;12(1):143. doi: 10.1186/1476-4598-12-143.

ReferenceCitation: Gold DV, Gaedcke J, Ghadimi BM, Goggins M, Hruban RH, Liu M, Newsome G, Goldenberg DM. PAM4 enzyme immunoassay alone and in combination with CA 19-9 for the detection of pancreatic adenocarcinoma. Cancer. 2013 Feb 1;119(3):522-8. doi: 10.1002/cncr.27762. Epub 2012 Aug 16.

ReferenceCitation: Gold DV, Goggins M, Modrak DE, Newsome G, Liu M, Shi C, Hruban RH, Goldenberg DM. Detection of early-stage pancreatic adenocarcinoma. Cancer Epidemiol Biomarkers Prev. 2010 Nov;19(11):2786-94. doi: 10.1158/1055-9965.EPI-10-0667. Epub 2010 Sep 1.

ReferenceCitation: Gold DV, Goldenberg DM, Karacay H, Rossi EA, Chang CH, Cardillo TM, McBride WJ, Sharkey RM. A novel bispecific, trivalent antibody construct for targeting pancreatic carcinoma. Cancer Res. 2008 Jun 15;68(12):4819-26. doi: 10.1158/0008-5472.CAN-08-0232.

ReferenceCitation: Gold DV, Karanjawala Z, Modrak DE, Goldenberg DM, Hruban RH. PAM4-reactive MUC1 is a biomarker for early pancreatic adenocarcinoma. Clin Cancer Res. 2007 Dec 15;13(24):7380-7. doi: 10.1158/1078-0432.CCR-07-1488.

ReferenceCitation: Gold DV, Modrak DE, Ying Z, Cardillo TM, Sharkey RM, Goldenberg DM. New MUC1 serum immunoassay differentiates pancreatic cancer from pancreatitis. J Clin Oncol. 2006 Jan 10;24(2):252-8. doi: 10.1200/JCO.2005.02.8282. Epub 2005 Dec 12.

ReferenceCitation: Gold DV, Modrak DE, Schutsky K, Cardillo TM. Combined 90Yttrium-DOTA-labeled PAM4 antibody radioimmunotherapy and gemcitabine radiosensitization for the treatment of a human pancreatic cancer xenograft. Int J Cancer. 2004 Apr 20;109(4):618-26. doi: 10.1002/ijc.20004.

ReferenceCitation: Gold DV, Schutsky K, Modrak D, Cardillo TM. Low-dose radioimmunotherapy ((90)Y-PAM4) combined with gemcitabine for the treatment of experimental pancreatic cancer. Clin Cancer Res. 2003 Sep 1;9(10 Pt 2):3929S-37S.

ReferenceCitation: Cardillo TM, Blumenthal R, Ying Z, Gold DV. Combined gemcitabine and radioimmunotherapy for the treatment of pancreatic cancer. Int J Cancer. 2002 Jan 20;97(3):386-92. doi: 10.1002/ijc.1613.

ReferenceCitation: Cardillo TM, Ying Z, Gold DV. Therapeutic advantage of (90)yttrium- versus (131)iodine-labeled PAM4 antibody in experimental pancreatic cancer. Clin Cancer Res. 2001 Oct;7(10):3186-92.

ReferenceCitation: Gold DV, Cardillo T, Goldenberg DM, Sharkey RM. Localization of pancreatic cancer with radiolabeled monoclonal antibody PAM4. Crit Rev Oncol Hematol. 2001 Jul-Aug;39(1-2):147-54. doi: 10.1016/s1040-8428(01)00114-7.

ReferenceCitation: Gold DV, Cardillo T, Vardi Y, Blumenthal R. Radioimmunotherapy of experimental pancreatic cancer with 131I-labeled monoclonal antibody PAM4. Int J Cancer. 1997 May 16;71(4):660-7. doi: 10.1002/(sici)1097-0215(19970516)71:43.0.co;2-e.

ReferenceCitation: Mariani G, Molea N, Bacciardi D, Boggi U, Fornaciari G, Campani D, Salvadori PA, Giulianotti PC, Mosca F, Gold DV, et al. Initial tumor targeting, biodistribution, and pharmacokinetic evaluation of the monoclonal antibody PAM4 in patients with pancreatic cancer. Cancer Res. 1995 Dec 1;55(23 Suppl):5911s-5915s.

ReferenceCitation: Alisauskus R, Wong GY, Gold DV. Initial studies of monoclonal antibody PAM4 targeting to xenografted orthotopic pancreatic cancer. Cancer Res. 1995 Dec 1;55(23 Suppl):5743s-5748s.

ReferenceCitation: Gold DV, Lew K, Maliniak R, Hernandez M, Cardillo T. Characterization of monoclonal antibody PAM4 reactive with a pancreatic cancer mucin. Int J Cancer. 1994 Apr 15;57(2):204-10. doi: 10.1002/ijc.2910570213.

lead_sponsor: Gilead Sciences

location_country:
Poland
Israel
Austria
Belgium
United States
Spain
Canada
France

location_facility: Masonic Cancer Center, University of Minnesota

location_facility: New York Presbyterian Hospital/Weill Cornell Medical Center

location_facility: Centrum Onkologii Instytut im. M. Sklodowskiej-Curie - Warszawa

location_facility: Mountain States Tumor Institute at St. Luke's Regional Medical Center

location_facility: Oncology Hematology West P.C. dba Nebraska Cancer Specialists

location_facility: University of North Carolina Hospitals, Lineberger Comprehensive Cancer Center

location_facility: The Ohio State University - Comprehensive Cancer Center

location_facility: The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center

location_facility: Indiana University Health Goshen Center for Cancer Care

location_facility: University of Pennsylvania Abramson Cancer Center

location_facility: University of Pittsburgh Medical Center/Hillman Cancer Center

location_facility: University of Mississippi Medical Center

location_facility: University of Tennessee Medical Center, Cancer Institute

location_facility: Michael and Dianne Bienes Comprehensive Cancer Center - Holy Cross Hospital

location_facility: Indiana University Melvin and Bren Simon Cancer Center

location_facility: Centre Léon Bérard Cancerologie Medicale

location_facility: Centre Hospitalier Université de Sherbrooke