title: A Phase 3, Randomized, Efficacy and Safety Study of Enzalutamide Plus Leuprolide, Enzalutamide Monotherapy, and Placebo Plus Leuprolide in Men With High-Risk Nonmetastatic Prostate Cancer Progressing After Definitive Therapy

summary:
The purpose of this study is to assess enzalutamide plus leuprolide in patients with high-risk nonmetastatic prostate cancer progressing after radical prostatectomy or radiotherapy or both.

The randomized / blinded portion of the study is now completed following primary endpoint analyses. The study remains ongoing in open label format.

ReferenceCitation: Freedland SJ, De Giorgi U, Gleave M, Rosbrook B, Shen Q, Sugg J, Haas GP, Shore ND. A phase 3 randomised study of enzalutamide plus leuprolide and enzalutamide monotherapy in high-risk non-metastatic hormone-sensitive prostate cancer with rising PSA after local therapy: EMBARK study design. BMJ Open. 2021 Aug 12;11(8):e046588. doi: 10.1136/bmjopen-2020-046588.

publisher_dissemination: British Medical Journal

lead_sponsor: Pfizer

collaborators: Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

location_country:
Finland
Italy
Poland
Slovakia
United Kingdom
Denmark
Australia
Brazil
Netherlands
Austria
Sweden
United States
Korea, Republic of
Spain
Taiwan
Canada
France

location_facility: U.O. Oncologia Medica, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Premier Medical Group of the Hudson Valley PC

location_facility: Department of Urology,Paracelsus Medical University Salzburg

location_facility: UO Radiologia,IRCCS Istituto Scientifico Romagnolo Per lO Studio e la Cura dei Tumori (IRST)

location_facility: CLINIONCO - Clinica de Oncologia de Porto Alegre Ltda.

location_facility: Servizio di Radiologia, Ospedale Santa Maria Delle Croci

location_facility: Hospital Barmherzige Schwestern Linz, Department of Urology

location_facility: UO di Radiologia, Azienda Socio Sanitaria Territoriale di Cremona

location_facility: Memorial Sloan Kettering Cancer Center Nassau

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

location_facility: Lakeland Regional Health Hollis Cancer Center

location_facility: Farmacia Interna, Ospedale degli Infermi

location_facility: Associated Medical Professionals of New York, PLLC

location_facility: Complejo Hospitalario Universitario de Orense

location_facility: Servizio di Farmacia, Ospedale Santa Maria delle Croci

location_facility: Centro Oncologico MD Anderson International Espana

location_facility: Laboratorio Farmaci Antiblastici, IRCCS Istituto

location_facility: The University of Kansas Cancer Center, Investigational Drug Services

location_facility: UO di Oncologia,Ospedale Civile degli Infermi

location_facility: Hospital Clinic i Provincial de Barcelona, Dr. Antonio Alcaraz Asensio

location_facility: UO di Radiologia, Ospedale Civile degli Infermi

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale/Oncologia Medica A

location_facility: Sidney Kimmel Center for Prostate and Urologic Cancers

location_facility: Farmacia, Azienda Socio Sanitaria Territoriale di Cremona

location_facility: Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner

location_facility: Centre Hospitalier de l'Universite de Montreal

location_facility: London Health Sciences Centre - Victoria Hospital

location_facility: Kujawsko-Pomorskie Centrum Urologicznw Sp z o.o

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos

location_facility: University Hospitals Bristol NHS Foundation Trust

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: University of California, Irvine Medical Center

location_facility: U.O. Medicina Nucleare, Ospedale Santa Chiara

location_facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o. o.

location_facility: Department of Internal Medicine I, Medical university Vienna

location_facility: S.C.D.U. Radiodiagnostica, A.O.U. San Luigi Gonzaga

location_facility: CHU de Quebec - L'Hotel-Dieu de Quebec - CRCEO

location_facility: Oncosite - Centro de Pesquisa Clinica em Oncologia Ltda

location_facility: Hospital das Clinicas da Faculdade de Ciencias Medicas da UNICAMP

location_facility: Maastricht University Medical Center, Department of Urology

location_facility: Duke Investigational Chemotherapy Services

location_facility: GU Research Network/Wichita Urology Group

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: Hospital General Universitario Gregorio Maranon. Servicio de Oncologia.

location_facility: ICO Girona; Hospital Universitari de Girona Dr. Josep Trueta. Servicio de Oncologia

location_facility: University of California Davis Medical Center

location_facility: Memorial Sloan Kettering Cancer Center Westchester

location_facility: Memorial Sloan Kettering Cancer Center Basking Ridge

location_facility: University Medical Centrum Groningen, Department Urologie

location_facility: Johns Hopkins Kimmel Cancer Center/ Sibley Infusion

location_facility: UO di Oncologia, Ospedale Civile Umberto I

location_facility: VU Medical Centrum, Department of Urology

location_facility: University of California, Davis, School of Medicine

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: The Sidney Kimmel Cancer Center at Johns Hopkins Hospital- Oncology Investigational Drug Services

location_facility: Department of Nuclear Medicine and Endocrinology, University Hospital Salzburg, Austria

location_facility: University of Alabama at Birmingham, IDS Pharmacy

location_facility: Urology Associates/ Urologic Medical Research

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Comprehensive Urology - Royal Oak (Stephenson) office

location_facility: Vychodoslovensky onkologicky ustav, a.s.

location_facility: Urological Associates of Southern Arizona, PC

location_facility: University Health Network - Princess Margaret Cancer Centre

location_facility: UO di Oncologia Medica, Ospedale Santa Maria delle Croci

location_facility: Manitoba Prostate Centre CancerCare Manitoba

location_facility: Clinique Pasteur - Lanroze Service Pharmacie

location_facility: Pusan National University Yangsan Hospital

location_facility: Severance Hospital. Yonsei University Health System

location_facility: Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization

location_facility: GU Research Network, LLC / Urology Cancer Center

location_facility: Vanderbilt Unversity Medical Center, Dept. of Urologic Surgery

location_facility: The University of Kansas Cancer Center and Medical Pavilion

location_facility: U.O. di Oncologia Medica, Ospedale Santa Chiara

location_facility: Struttura Complessa di Oncologia, Azienda Socio Sanitaria Territoriale di Cremona

location_facility: Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii

location_facility: Seoul National University Bundang Hospital

location_facility: Chonnam National University Hwasun Hospital

location_facility: CITO - Centro Integrado de Terapia Onco-Hematologica - Hospital de Clinicas de Passo Fundo

location_facility: TriState Urologic Services PSC Inc., dba The Urology Group

location_facility: Rigshospitalet - Copenhagen University Hospital

location_facility: Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC

location_facility: Azienda Ospedaliera S, Camillo Forlanini, UOC per il governo clinico in Oncologia Medica,pad,Flajani

location_facility: Fakultna nemocnica s poliklinikou F.D.Roosevelta

location_facility: Alaska Urological Institute dba Alaska Clinical Research Center

location_facility: Fakultna nemocnica s poliklinikou Zilina

location_facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o., Oddzial Urologiczny

location_facility: Eastern Connecticut Hematology Oncology Associates

location_facility: Memorial Sloan Kettering Cancer Center Rockville Centre

location_facility: Department of Radiology, University Hospital Salzburg, Austria

location_facility: The Male/Female Health and Research Centre, Royal Court Medical Centre

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Vanderbilt Unversity Medical Center, The Urology Clinic

location_facility: Althaia, Xarxa Assistencial Universitària de Manresa

location_facility: Winship Cancer Institute, Emory University

location_facility: Memorial Sloan Kettering Cancer Center Commack

location_facility: Thomas Jefferson University Hospital, Bodine Buiding

location_facility: Thomas Jefferson University, Medical Oncology

location_facility: Sutter Medical Group, Vascular & Varicose Vein Center

location_facility: Uo di Radiologia, Ospedale Civile Umberto I

location_facility: S.C.D.U. Oncologia Medica, A.O.U. San Luigi Gonzaga


title: Identification and Description of Severe Asthma Patients in a Cross-sectional Study-the IDEAL Study

summary: This will be a non-drug interventional cross-sectional study, where the screening visit and study visit can occur on the same day. Investigational product will not be administered. Approximately 790 subjects with severe asthma will be screened to achieve a total of at least 750 evaluable study subjects. The study will not include a run-in or follow-up period. This study will provide a more reliable description of the severe asthma patient landscape with respect to the potential eligibility for treatment with mepolizumab, omalizumab, and reslizumab. This study aims to estimate the potential overlap of patients eligible for treatment with mepolizumab and those eligible for treatment with omalizumab and/or reslizumab. Additionally, the current study will also ascertain and describe reslizumab eligibility with respect to both mepolizumab and omalizumab, in the severe asthma patient population.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Mullerova H, Cockle SM, Gunsoy NB, Nelsen LM, Albers FC. Clinical characteristics and burden of illness among adolescent and adult patients with severe asthma by asthma control: the IDEAL study. J Asthma. 2021 Apr;58(4):459-470. doi: 10.1080/02770903.2019.1708095. Epub 2020 Jan 9.

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: hybrid

publisher_dissemination: Informa

ReferenceCitation: Nelsen LM, Cockle SM, Gunsoy NB, Jones P, Albers FC, Bradford ES, Mullerova H. Impact of exacerbations on St George's Respiratory Questionnaire score in patients with severe asthma: post hoc analyses of two clinical trials and an observational study. J Asthma. 2020 Sep;57(9):1006-1016. doi: 10.1080/02770903.2019.1630640. Epub 2019 Jun 28.

evidence: open (via free pdf)

license_normalized: no license

unpaywall_oa_status: bronze

ReferenceCitation: Albers FC, Mullerova H, Gunsoy NB, Shin JY, Nelsen LM, Bradford ES, Cockle SM, Suruki RY. Biologic treatment eligibility for real-world patients with severe asthma: The IDEAL study. J Asthma. 2018 Feb;55(2):152-160. doi: 10.1080/02770903.2017.1322611. Epub 2017 Jun 16.

lead_sponsor: GlaxoSmithKline

location_country:
Germany
United Kingdom
Australia
United States
Canada
France

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


study_start_date_type: Actual

lead_sponsor: Hoffmann-La Roche

summary: This open-label, multicenter, randomized Phase III study is designed to compare the efficacy and safety of a combined regimen of obinutuzumab and venetoclax versus obinutuzumab + chlorambucil in participants with chronic lymphocytic leukemia (CLL) and coexisting medical conditions. The time on study treatment was approximately one year and the follow-up period will be up to 9 years.

ReferenceCitation: Badawi M, Chen X, Marroum P, Suleiman AA, Mensing S, Koenigsdorfer A, Schiele JT, Palenski T, Samineni D, Hoffman D, Menon R, Salem AH. Bioavailability Evaluation of Venetoclax Lower-Strength Tablets and Oral Powder Formulations to Establish Interchangeability with the 100 mg Tablet. Clin Drug Investig. 2022 Aug;42(8):657-668. doi: 10.1007/s40261-022-01172-4. Epub 2022 Jul 13.

oa_colors: green hybrid

oa_host_type: publisher;repository

license: cc-by-nc

license_normalized: cc-by-nc

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

repositories_concat: PubMed Central

publisher_dissemination: Springer-Nature

ReferenceCitation: Samineni D, Gibiansky L, Wang B, Vadhavkar S, Rajwanshi R, Tandon M, Sinha A, Al-Sawaf O, Fischer K, Hallek M, Salem AH, Li C, Miles D. Pharmacokinetics and Exposure-Response Analysis of Venetoclax + Obinutuzumab in Chronic Lymphocytic Leukemia: Phase 1b Study and Phase 3 CLL14 Trial. Adv Ther. 2022 Aug;39(8):3635-3653. doi: 10.1007/s12325-022-02170-w. Epub 2022 Jun 16.

ReferenceCitation: Al-Sawaf O, Zhang C, Lu T, Liao MZ, Panchal A, Robrecht S, Ching T, Tandon M, Fink AM, Tausch E, Schneider C, Ritgen M, Bottcher S, Kreuzer KA, Chyla B, Miles D, Wendtner CM, Eichhorst B, Stilgenbauer S, Jiang Y, Hallek M, Fischer K. Minimal Residual Disease Dynamics after Venetoclax-Obinutuzumab Treatment: Extended Off-Treatment Follow-up From the Randomized CLL14 Study. J Clin Oncol. 2021 Dec 20;39(36):4049-4060. doi: 10.1200/JCO.21.01181. Epub 2021 Oct 28.

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Al-Sawaf O, Zhang C, Tandon M, Sinha A, Fink AM, Robrecht S, Samoylova O, Liberati AM, Pinilla-Ibarz J, Opat S, Sivcheva L, Le Du K, Fogliatto LM, Niemann CU, Weinkove R, Robinson S, Kipps TJ, Tausch E, Schary W, Ritgen M, Wendtner CM, Kreuzer KA, Eichhorst B, Stilgenbauer S, Hallek M, Fischer K. Venetoclax plus obinutuzumab versus chlorambucil plus obinutuzumab for previously untreated chronic lymphocytic leukaemia (CLL14): follow-up results from a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2020 Sep;21(9):1188-1200. doi: 10.1016/S1470-2045(20)30443-5.

oa_host_type: closed

publisher_dissemination: Elsevier

ReferenceCitation: Fischer K, Al-Sawaf O, Bahlo J, Fink AM, Tandon M, Dixon M, Robrecht S, Warburton S, Humphrey K, Samoylova O, Liberati AM, Pinilla-Ibarz J, Opat S, Sivcheva L, Le Du K, Fogliatto LM, Niemann CU, Weinkove R, Robinson S, Kipps TJ, Boettcher S, Tausch E, Humerickhouse R, Eichhorst B, Wendtner CM, Langerak AW, Kreuzer KA, Ritgen M, Goede V, Stilgenbauer S, Mobasher M, Hallek M. Venetoclax and Obinutuzumab in Patients with CLL and Coexisting Conditions. N Engl J Med. 2019 Jun 6;380(23):2225-2236. doi: 10.1056/NEJMoa1815281. Epub 2019 Jun 4.

evidence: open (via free article)

publisher_dissemination: Massachusetts Medical Society

sponsor_collaborators:
Hoffmann-La Roche
AbbVie
German CLL Study Group

location_facility: SBEI of HPE ?Bashkir State Medical University? of MoH RF

location_facility: Uniwersytecki Szpital Kliniczny w Bia?ymstoku, Klinika Hematologii z Pododdzia?em Chorob Naczyn

location_facility: Fundeni Clinical Inst. ; Hematology Dept

location_facility: Ospedali Riuniti Papardo-Piemonte; Struttura Complessa Di Ematologia

location_facility: Universitätsklinikum Köln; Innere Medizin I; Onkologie, Hämatologie

location_facility: Klinikum der Universität München, Campus Großhadern; Medizinische Klinik und Poliklinik III

location_facility: Universitätsspital Zürich Medizin Hämatologie; Klinik für Hämatologie

location_facility: Tom Baker Cancer Centre; Dept of Medicine

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Hopital Hotel Dieu Et Hme;Hopital De Jour

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

location_facility: Stiftung Kathol. Krankenhaus Marienhospital Herne Klinik Mitte

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

location_facility: Inselspital Bern; Hämatologie und Hämatologisches Zentrallabor

location_facility: MHAT Hristo Botev; First Internal Department

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology

location_facility: UMHAT " Sveti Georgi" Plovdiv - Clinic of Oncology and Hematology

location_facility: Hospital Clinico Universitario de Salamanca;Servicio de Hematologia

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

location_facility: Uniklinikum "Carl Gustav Carus"; Med. Klinik 1; Hämatologie, Zelltherapie und Medizinische Onkologie

location_facility: Hopital Pontchaillou; Hematologie Clinique

location_facility: Queen Elizabeth II Health Sciences Centre; Oncology

location_facility: Spitalul Clinic Judetean de Urgenta Targu-Mures; compartiment Hematologie

location_facility: Instituto de Ensino e Pesquisa Sao Lucas - IEP

location_facility: AOU Città della Salute e della Scienza di Torino - Presidio Le Molinette

location_facility: Wojewodzki Szpital Specjalistyczny im. J. Korczaka; Oddzia? Chorób Wewnetrznych/Hematologiczny

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroc?awiu; Klinika Hematologii

location_facility: Wojewódzki Szpital Specjalistyczny im.Miko?ajaKopernika;KlinikaHematologiiUniwersytetuMedycznego

location_facility: Klinik Esslingen; Klinik für Allgemeine Innere Medizin, Onkologie/Haematologie

location_facility: Az. Osp. S. Maria; Dept. Di Oncologia Medica

location_facility: Hospital Universitario de la Princesa; Servicio de Hematologia

location_facility: München Klinik Schwabing; Klinik für Hämatologie, Onkologie, Immunologie

location_facility: Arcispedale S. Anna; Sezione Di Ematologia

location_facility: Gesundheitszentrum St. Marien GmbH; Med. II, Hämatologie/Onkologie

location_facility: Regional Clinical Hospital N.A. Semashko; Hematology

location_facility: University Hospital Merkur Clinic for Internal Medicine/ Hematology

location_facility: Klinikum rechts der Isar der Technischen Universität München

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

location_facility: Royal Adelaide Hospital; Haematology Clinical Trials

location_facility: University Multiprofile Hospital For Active Treatment "Sveti Ivan Rilski" EAD; clinical hematology

location_facility: Institut d'Hématologie de Basse Normandie

location_facility: Tartu Uni Hospital; Hematology - Oncology Clinic

location_facility: Institutul Regional de Oncologie Iasi; Clinica de Hematologie

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Hämatologie & Hämostaseologie

location_facility: Uni Göttingen, Georg-August-Universität; Klinik für Hämatologie und Medizinische Onkologie

location_facility: Universitätsklinikum Essen; Klinik für Hämatologie

location_facility: Chu Estaing; Hematologie Clinique Adultes

location_facility: Uniklinik RWTH Aachen; Klinik IV; Klinik Hämatologie, Onkologie, Hämostaseologie und Stamm.

location_facility: Kliniken Maria Hilf GmbH; Innere Medizin I; Hämatologie und internistische Onkologie

location_facility: Hospital Arnau de Vilanova (Valencia) Servicio de Hematologia

location_facility: Hospital del Mar; Servicio de Hematologia

location_facility: Praxisklinik für Hämatologie und Onkologie Koblenz

location_facility: Universtitätsklinikum Ulm; Klinik für Innere Medizin III

location_facility: Western General Hospital; Department of Haematology

location_facility: University Hospital Sv.Georgi Clnic of Hematology; Hematology

location_facility: Gemeinschaftspraxis Dr. med. Holger Klaproth

location_facility: Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie

location_facility: University Hospital Center Zagreb; Haematology Department

location_facility: Hanusch-Krankenhaus; Iii. Medizinische Abt.

location_facility: Hospital Univ. 12 de Octubre; Servicio de Hematologia

location_facility: Moscow State Budgetary Healthcare Institution

location_facility: Republican Clinical Oncologic Dispensary of Republic Of Tatarstan

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

location_facility: Canterbury Health Laboratories; Haematology

location_facility: Krankenhaus Barmherzige Bruder Regensburg

location_facility: Ashford Cancer Centre Research; Internal Medicine/Medical Oncology

location_facility: Hôpital Saint Eloi; Service d?Hématologie et Oncologie Clinique - Recherche Clinique

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

location_facility: Hospital Universitario de Canarias;servicio de Hematologia

location_facility: North Estonia medical Centre; Hematology

status: Active, not recruiting

title: A Prospective, Open-Label, Multicenter Randomized Phase III Trial to Compare The Efficacy and Safety of A Combined Regimen of Obinutuzumab and Venetoclax Versus Obinutuzumab and Chlorambucil in Previously Untreated Patients With CLL and Coexisting Medical Conditions

primary_purpose: Treatment

type: EudraCT Number

source: euctr

design_allocation: Randomized

study_completion_date_type: Anticipated

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Croatia
Canada
France
Denmark
Switzerland
United States
Romania
Estonia
Italy
United Kingdom
Austria
Mexico
Spain
Bulgaria
Russian Federation

collaborators:
AbbVie
German CLL Study Group

status_simplified: Ongoing


acronym: POLO

lead_sponsor: AstraZeneca

summary: A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance Olaparib Monotherapy in Patients with gBRCA Mutated Metastatic Pancreatic Cancer whose Disease Has Not Progressed on First Line Platinum Based Chemotherapy

ReferenceType: background

ReferenceCitation: Golan T, Hammel P, Reni M, Van Cutsem E, Macarulla T, Hall MJ, Park JO, Hochhauser D, Arnold D, Oh DY, Reinacher-Schick A, Tortora G, Algul H, O'Reilly EM, McGuinness D, Cui KY, Schlienger K, Locker GY, Kindler HL. Maintenance Olaparib for Germline BRCA-Mutated Metastatic Pancreatic Cancer. N Engl J Med. 2019 Jul 25;381(4):317-327. doi: 10.1056/NEJMoa1903387. Epub 2019 Jun 2.

ReferenceCitation: Amin S, Joo S, Nolte S, Yoo HK, Patel N, Byrnes HF, Costa-Cabral S, Johnson CD. Health-related quality of life scores of metastatic pancreatic cancer patients responsive to first line chemotherapy compared to newly derived EORTC QLQ-C30 reference values. BMC Cancer. 2022 May 20;22(1):563. doi: 10.1186/s12885-022-09661-7.

oa_colors: green gold

evidence: oa journal (via doaj)

unpaywall_oa_status: gold

ReferenceCitation: Li N, Zheng H, Huang Y, Zheng B, Cai H, Liu M. Cost-Effectiveness Analysis of Olaparib Maintenance Treatment for Germline BRCA-Mutated Metastatic Pancreatic Cancer. Front Pharmacol. 2021 Apr 20;12:632818. doi: 10.3389/fphar.2021.632818. eCollection 2021.

publisher_dissemination: Frontiers

ReferenceCitation: Zhan M, Zheng H, Yang Y, He Z, Xu T, Li Q. Cost-Effectiveness Analysis of Maintenance Olaparib in Patients with Metastatic Pancreatic Cancer and a Germline BRCA1/2 Mutation Based on the POLO Trial. Cancer Manag Res. 2020 Dec 16;12:12919-12926. doi: 10.2147/CMAR.S283169. eCollection 2020.

ReferenceCitation: Golan T, Kindler HL, Park JO, Reni M, Macarulla T, Hammel P, Van Cutsem E, Arnold D, Hochhauser D, McGuinness D, Locker GY, Goranova T, Schatz P, Liu YZ, Hall MJ. Geographic and Ethnic Heterogeneity of Germline BRCA1 or BRCA2 Mutation Prevalence Among Patients With Metastatic Pancreatic Cancer Screened for Entry Into the POLO Trial. J Clin Oncol. 2020 May 1;38(13):1442-1454. doi: 10.1200/JCO.19.01890. Epub 2020 Feb 19.

ReferenceCitation: Hammel P, Kindler HL, Reni M, Van Cutsem E, Macarulla T, Hall MJ, Park JO, Hochhauser D, Arnold D, Oh DY, Reinacher-Schick A, Tortora G, Algul H, O'Reilly EM, McGuinness D, Cui KY, Joo S, Yoo HK, Patel N, Golan T; POLO Investigators. Health-related quality of life in patients with a germline BRCA mutation and metastatic pancreatic cancer receiving maintenance olaparib. Ann Oncol. 2019 Dec 1;30(12):1959-1968. doi: 10.1093/annonc/mdz406.

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

repository_institution: PubMed Central - Europe PMC

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repository_institution: Consorci de Serveis Universitaris de Catalunya - RECERCAT

repositories:
LIRIAS (KU Leuven)
PubMed Central
UCL Discovery
recercat.cat

repositories_concat: LIRIAS (KU Leuven);PubMed Central;UCL Discovery;recercat.cat

ReferenceCitation: Lowery MA, Kelsen DP, Capanu M, Smith SC, Lee JW, Stadler ZK, Moore MJ, Kindler HL, Golan T, Segal A, Maynard H, Hollywood E, Moynahan M, Salo-Mullen EE, Do RKG, Chen AP, Yu KH, Tang LH, O'Reilly EM. Phase II trial of veliparib in patients with previously treated BRCA-mutated pancreas ductal adenocarcinoma. Eur J Cancer. 2018 Jan;89:19-26. doi: 10.1016/j.ejca.2017.11.004. Epub 2017 Dec 8.

evidence: open (via crossref license, author manuscript)

sponsor_collaborators:
AstraZeneca
Myriad Genetic Laboratories, Inc.
Merck Sharp & Dohme LLC

title: A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance Olaparib Monotherapy in Patients With gBRCA Mutated Metastatic Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum Based Chemotherapy

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

location_country:
Germany
Italy
Israel
United Kingdom
Australia
Netherlands
Belgium
United States
Korea, Republic of
Spain
Canada
France


title: A Phase III Clinical Trial of BBI608 Plus Weekly Paclitaxel vs. Placebo Plus Weekly Paclitaxel in Adult Patients With Advanced, Previously Treated Gastric and Gastro-Esophageal Junction Adenocarcinoma

acronym: BRIGHTER

summary: The purpose of this study is to find out whether it is better to receive a new drug, BBI608, in addition to paclitaxel chemotherapy or better to receive paclitaxel chemotherapy alone as second line treatment for gastric and gastroesophageal junction cancer after prior first line platinum and fluoropyrimidine based chemotherapy.

lead_sponsor: Sumitomo Pharma America, Inc.

location_country:
Germany
Poland
Australia
Brazil
Japan
Czechia
Canada
France
Lithuania
Hungary
United States
Romania
Belgium
China
Estonia
Italy
United Kingdom
Korea, Republic of
Spain
Bulgaria
Russian Federation
Israel

location_facility: Uni. Multiprofile Hospital for Active treatment Sveta Marina

location_facility: Northern Indiana Cancer Research Consortium

location_facility: CHU de Liège - Domaine Universitaire du Sart Tilman

location_facility: GBUZ of Stavropol Territory Pyatigorsk Oncology Dispensary

location_facility: Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház- Rendelőinté

location_facility: Weill Medical College of Cornell University

location_facility: Hospital de Base de São José do Rio Preto

location_facility: Centre Hospitalier De Mont De Marsan - Hopital Layné

location_facility: The First Hospital of China Medical University

location_facility: AOU S.Martino, IRCCS, IST-Istituto Nazionale Ricerca Sul Can

location_facility: East Tallinn Central Hospital Oncology Center

location_facility: Kobe City Medical Center General Hospital

location_facility: Swedish Cancer Institute/ Swedish Health Services

location_facility: Charite - Campus Benjamin Franklin (Cbf)

location_facility: Russian Oncological Research Center n.a. N.N. Blokhin RAMS

location_facility: Fujian Medical University Union Hospital

location_facility: Ospedale Guglielmo da Saliceto, AUSL Piacenza

location_facility: UPCO - Unidade de Pesquisa Clinica em Oncologia LTDA

location_facility: Hospital of Lithuanian University of Health Sciences

location_facility: Vilniaus Universiteto ligonines Santariskiu Klinikos

location_facility: IRCCS Ospedale Oncologico "Giovanni Paolo II"

location_facility: The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital

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

location_facility: Ospedale Molinette, AO Città della Salute e della Scienza di

location_facility: The First Affiliated Hospital of Zhengzhou University

location_facility: Klinikum der Johann Wolfgang Goethe-Universität

location_facility: Spitalul Clinic Judetean de Urgenta Sibiu

location_facility: Southern Medical University, Nanfang Hospital

location_facility: Indiana University Health University Hospital

location_facility: NZOZ Centrum Medyczne HCP Lecznictwo Stacjonarne

location_facility: Ballarat Oncology and Haematology Services

location_facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onko

location_facility: Military Medical Academy n.a. S.M. Kirov

location_facility: Hospital of Lithuanian University of Health sciences

location_facility: Osaka Medical Center for Cancer and Cardiovascular Diseases

location_facility: New Hampshire Oncology Hematology - Concord

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Policlinico S.Orsola Malpighi, AOU di Bologna

location_facility: Unità di Biostatistica e Sperimentazioni Cliniche IRST

location_facility: The University of Oklahoma Health Sciences Center (OUHSC)

location_facility: First Pavlov State Medical University of Saint-Petersburg

location_facility: Tartu University Hospital Clinic of Hematology and Oncology

location_facility: Multiprofile hospital for active treatment

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

location_facility: Kliniken Essen-Mitte Evang. Huyssens-Stiftung

location_facility: SPb State Budget Institution Oncology Dispansery

location_facility: The First Bethune Hospital of Jilin University

location_facility: Instituto do Câncer do Ceará - Instituto do Câncer do Cear

location_facility: Indiana University Health Goshen Center For Cancer Care

location_facility: Azienda Ospedaliera Fatebenefratelli e Oftalmico

location_facility: Spitalul Clinic Municipal de Urgenta Timisoara

location_facility: Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital

location_facility: Seoul National University Bundang Hospital

location_facility: Saint Michael's Hospital Li Ka Shing Knowledge Institute

location_facility: Harbin Medical University Cancer Hospital

location_facility: Wojewodzki Szpital Specjalistyczny im. M.Kopernika

location_facility: Ospedale Umberto I, AOU Ospedali Riuniti Umberto I - GM.Lanc

location_facility: District Dispensery with Stationary - Sofia District

location_facility: Egyesített Szent István és Szent László Kórház-Rendelőintéze

location_facility: The 307th Hospital of Chinese People's Liberation Army

location_facility: The 81 Hospital of the Chinese People's Liberation Army

location_facility: Szpital Specjalistyczny im. L. Rydygiera w Krakowie

location_facility: The E. Wolfson Medical Center [Oncology]

location_facility: Sp. Jud. de Urg. "Dr. Constantin Opris" Baia Mare

location_facility: Sir Run Run Shaw Hospital School of Medicine, Zhejiang University

location_facility: New Hampshire Oncology Hematology - Laconia

location_facility: GBUZ Saint Petersburg clinical scientific and practical cent

location_facility: Xin Jiang Tumor Hospital, Xin Jiang Medical University

location_facility: Sunshine Coast Hospital and Health Service

location_facility: Magodent sp. z o.o. Szpital Onkologiczny

location_facility: McGill University Health Centre - Montreal General Hospital

location_facility: Radiotherapy Center CJ radioterapie si chimioterapie adulti

location_facility: Azienda Ospedaliera "Istituti Ospitalieri" di Cremona

location_facility: State University of New York Upstate Medical University

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Peninsula & South Eastern Haematology and Oncology Group

location_facility: Northwestern State Medical University n.a. Mechnikov

location_facility: UMHAT ""Dr. Georgi Stranski"" Dept. Medical Oncology

location_facility: Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina

location_facility: Institut Català d'Oncologia-Hospital Germans Trias i Pujol

location_facility: General Hospital of Ningxia Medical University

location_facility: The Beatson West Of Scotland Cancer Centre

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: Saku Central Hospital Advanced Care Center

location_facility: Specialised Hospital for Active Treatment in Oncology


title: Prospective Observational Study of Febrile Neutropenia (FN) and Pegfilgrastim Primary Prophylaxis in Breast Cancer and Non-Hodgkin's Lymphoma Patients Receiving High (>20%) FN-risk Chemotherapy

summary: To estimate the incidence of febrile neutropenia in patients with breast cancer and non-Hodgkin's lymphoma receiving high (> 20%) FN-risk chemotherapy and pegfilgrastim primary prophylaxis.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Mahtani RL, Belani R, Crawford J, Dale D, DeCosta L, Gawade PL, Huynh C, Lawrence T, Lewis S, MacLaughlin WW, Narang M, Rifkin R. A prospective cohort study to evaluate the incidence of febrile neutropenia in patients receiving pegfilgrastim on-body injector versus other options for prophylaxis of febrile neutropenia: breast cancer subgroup analysis. Support Care Cancer. 2022 Jul;30(7):6135-6144. doi: 10.1007/s00520-022-07025-2. Epub 2022 Apr 14.

lead_sponsor: Amgen

location_country: Germany Poland Romania Austria Belgium Greece Czechia Bulgaria France


title: Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT

acronym: CLEPSYDRA

summary: This clinical investigation is a prospective, non-randomized, multi-center, pivotal trial.This trial is being performed in order to demonstrate the sensivity of the diagnostic feature "Physiological Diagnostic" (PhD).

primary_purpose: Diagnostic

lead_sponsor: LivaNova

location_country:
Germany
Italy
United Kingdom
Netherlands
Switzerland
United States
Spain
Canada
France

location_facility:
Pr. Anselme
Dr. Sperzel
Dr Fluck - Dr. Beeton
Pr. Kacet
Dr. Pisapia
Dr Abbey
Pr. Brachmann
Dr. NG
Drs. Lewis, Garg
Dr. Klein - Dr. Oswald
Dr. Delnoy
Dr. Vogt
Dr. Butter
Dr Auricchio
Dr. Leonardo Calo
Dr. Jauvert
Dr. Murgatroyd
Dr. Haines
Dr. Gold
Pr. Bauer
Drs. Jagmeet Singh, Kevin, Hiest
Dr Mantovan
Dr. Brugada
Pr. Mewis - Pr. Fröhlig
Dr. Bru
Dr. Bowes
Dr. Beiras
Dr. Wieckhorst
Pr. Da Costa
Pr. Sadoul
Dr. Leyva
Pr. Davy
Pr. Mabo
Dr. Ritter
Dr. Morgan
Drs. Thibualt, Guerra
Dr. Bonnemeier
Pr. Weiss
Dr. Kolb
Drs. John Fisher, Jay Gross
Dr. Delay
Dr. Dupuis
Dr. Peinado
Dr. Champagne, Dr. Philippon
Dr. Schlegl
Dr. Burban
Pr. Eckhardt
Dr. Martinez
Dr. Defaye
Dr. Fleck - Dr. Goetze

intervention_type: Device


title: Prospective Research Assessment in Multiple Myeloma: An Observational Evaluation (PREAMBLE)

summary: The purpose of this study is to assess the clinical effectiveness of all approved multiple myeloma (MM) therapies in the newly-diagnosed (NDMM) and the relapsed/refractory MM (RRMM) settings in real-world clinical practice.

status: Recruiting

enrollment_type: Anticipated

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
Italy
United Kingdom
United States
Canada
France

location_facility: Florida Cancer Specialists & Research Institute

location_facility: Indiana Blood and Marrow Transplantation LLC

location_facility: The Oncology Institute Of Hope And Innovation

location_facility: Pottstown Hospital Tower Health - Oncology

location_facility: Cancer Center of Acadiana at Lafayette General Health

location_facility: Dallas Presbyterian Hospital - Texas Oncology PA

location_facility: East Valley Hematology And Oncology Medical Group


acronym: METIV-HCC

lead_sponsor: Daiichi Sankyo, Inc.

summary: The purpose of this study is to determine if tivantinib (ARQ 197) is effective in treating patients with MET diagnostic-high hepatocellular carcinoma (liver cancer) who have already been treated once with another therapy.

ReferenceCitation: Rimassa L, Assenat E, Peck-Radosavljevic M, Pracht M, Zagonel V, Mathurin P, Rota Caremoli E, Porta C, Daniele B, Bolondi L, Mazzaferro V, Harris W, Damjanov N, Pastorelli D, Reig M, Knox J, Negri F, Trojan J, Lopez Lopez C, Personeni N, Decaens T, Dupuy M, Sieghart W, Abbadessa G, Schwartz B, Lamar M, Goldberg T, Shuster D, Santoro A, Bruix J. Tivantinib for second-line treatment of MET-high, advanced hepatocellular carcinoma (METIV-HCC): a final analysis of a phase 3, randomised, placebo-controlled study. Lancet Oncol. 2018 May;19(5):682-693. doi: 10.1016/S1470-2045(18)30146-3. Epub 2018 Apr 3.

sponsor_collaborators: ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)

title: A Phase 3, Randomized, Double-Blind Study of Tivantinib (ARQ 197) in Subjects With MET Diagnostic-High Inoperable Hepatocellular Carcinoma Treated With One Prior Systemic Therapy

location_country:
Germany
Italy
Portugal
New Zealand
Argentina
Australia
Brazil
Netherlands
Austria
Belgium
Sweden
United States
Spain
Switzerland
Canada
France

ipd_sharing: No


title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Rilotumumab (AMG102) With Epirubicin, Cisplatin, and Capecitabine (ECX) as First-line Therapy in Advanced MET-Positive Gastric or Gastroesophageal Junction Adenocarcinoma

summary: This is a phase 3, multicenter, randomized, double-blind, placebo controlled study of epirubicin, cisplatin & capecitabine (ECX) with rilotumumab or placebo for untreated advanced MET-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma

status: Terminated

ReferenceCitation: Catenacci DVT, Tebbutt NC, Davidenko I, Murad AM, Al-Batran SE, Ilson DH, Tjulandin S, Gotovkin E, Karaszewska B, Bondarenko I, Tejani MA, Udrea AA, Tehfe M, De Vita F, Turkington C, Tang R, Ang A, Zhang Y, Hoang T, Sidhu R, Cunningham D. Rilotumumab plus epirubicin, cisplatin, and capecitabine as first-line therapy in advanced MET-positive gastric or gastro-oesophageal junction cancer (RILOMET-1): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2017 Nov;18(11):1467-1482. doi: 10.1016/S1470-2045(17)30566-1. Epub 2017 Sep 25.

oa_host_type: repository

version: acceptedVersion

unpaywall_oa_status: green

ReferenceCitation: Doshi S, Gisleskog PO, Zhang Y, Zhu M, Oliner KS, Loh E, Perez Ruixo JJ. Rilotumumab exposure-response relationship in patients with advanced or metastatic gastric cancer. Clin Cancer Res. 2015 Jun 1;21(11):2453-61. doi: 10.1158/1078-0432.CCR-14-1661. Epub 2015 Feb 24.

evidence: oa repository (via page says license)

version: submittedVersion

publisher_dissemination: American Association for Cancer Research

location_country:
Germany
Poland
Australia
Brazil
Turkey
Canada
France
Czech Republic
Portugal
Slovakia
Hungary
Denmark
Switzerland
United States
Ukraine
Romania
Belgium
Italy
United Kingdom
Austria
Mexico
Spain
Greece
South Africa
Bulgaria
Russian Federation
Sweden

status_simplified: Unknown


title: An International, Multi-Center Study Evaluating the Correlation of IL28B Genotypes With Patient Demographics and Disease Characteristics in Patients With Chronic Hepatitis C

summary: This multicenter study will evaluate the correlation of interleukin 28B (IL28B) genotypes with disease characteristics and demographics in treatment-naïve and treatment-experienced chronic hepatitis C patients, including patients with HIV co-infection. There will be a single study visit for testing.

design_allocation: Non-Randomized

location_country: Macedonia, The Former Yugoslav Republic of

intervention_type: Other


title: Clinical Trial of the SonRtip Lead and Automatic AV-VV Optimization Algorithm in the PARADYM RF SonR CRT-D

acronym: RESPOND-CRT

summary:
The objective of this study is to assess the safety and effectiveness of the automatic atrioventricular (AV) delay and interventricular (VV) delay optimization algorithm used in the PARADYM RF SONR Cardiac Resynchronization Therapy with Defibrillation (CRT-D) device (Model 9770) in combination with the SonRtip Lead, which includes a SonR sensor in the tip of the atrial pacing lead, and compatible SmartView programming software.

This study will evaluate the effectiveness of the automatic optimization algorithm in increasing the rate of patients responding to the therapy as compared to an echocardiographic optimization method.

This study will also evaluate the safety and effectiveness of the SonRtip atrial pacing lead.

status: Unknown status

ReferenceCitation: Brugada J, Delnoy PP, Brachmann J, Reynolds D, Padeletti L, Noelker G, Kantipudi C, Rubin Lopez JM, Dichtl W, Borri-Brunetto A, Verhees L, Ritter P, Singh JP; RESPOND CRT Investigators. Contractility sensor-guided optimization of cardiac resynchronization therapy: results from the RESPOND-CRT trial. Eur Heart J. 2017 Mar 7;38(10):730-738. doi: 10.1093/eurheartj/ehw526.

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

repositories_concat: PubMed Central;dash.harvard.edu

publisher_dissemination: Oxford University Press

ReferenceCitation: Brugada J, Brachmann J, Delnoy PP, Padeletti L, Reynolds D, Ritter P, Borri-Brunetto A, Singh JP. Automatic optimization of cardiac resynchronization therapy using SonR-rationale and design of the clinical trial of the SonRtip lead and automatic AV-VV optimization algorithm in the paradym RF SonR CRT-D (RESPOND CRT) trial. Am Heart J. 2014 Apr;167(4):429-36. doi: 10.1016/j.ahj.2013.12.007. Epub 2013 Dec 19.

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

repositories_concat: Zenodo

lead_sponsor: MicroPort CRM

sponsor_collaborators:
MicroPort CRM
Sorin CRM

location_country:
Germany
Italy
Slovenia
Portugal
United Kingdom
Australia
Netherlands
Austria
Switzerland
United States
Spain
France

location_facility: KH Hietzing,4. Medizinische Abteilung Mit Kardiologie

location_facility: Ashford and St. Peter's Hospitals NHS Trust

location_facility: Brookwood Medical Center CardioVascular Associates

location_facility: A.O. Città della Salute e della Scienza di Torino Cardiologia 1 - U

location_facility: Herz- und Diabeteszentrum Nordrhein-Westfalen

location_facility: Az. Osp. Univ. S. Maria della Misericordia

location_facility: Centre Hospitalier Universitaire Vaudois Lausanne (CHUV)

location_facility: Centro Hospitalar Lisboa Ocidental -Hospital de Santa Cruz (CHLO)

location_facility: Az. Osp-Univ. Ospedali Riuniti Umberto I-Lancisi-Salesi

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Lkh Innsbruck - Invasoren Kardiologie - Innere Medizin

location_facility: Hospital Universitario Marques de Valdecilla Sur

location_facility: Centre Hospitalier Universitaire de La Timone

location_facility: Azienda Ospedaliero-Universitaria Ospedali Riuniti di Trieste

location_facility: Providence Cardiology d/b/a South Caroline Heart Center

location_facility: Kardiocentrum Frankfurt and der Klinik Rotes Kreuz

location_facility: Hospital General Universitario de Alicante

location_facility: CHU de Bordeaux, Groupe hospitalier Sud, Hôpital Haut-L'évêque

location_facility: Centro Hospitalar do Porto CHP Hospital de Santo Antonio

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Universitätsklinik Münster Innere Medizin C

location_facility: Hospital Professor Doutor Fernando Fonseca

location_facility: A.O. Città della Salute e della Scienza di Torino Cardiologia 2 ospedaliera

location_facility: Azienda Ospedaliera S. Anna e S. Sebastiano

location_facility: Castle Hill Hospital Hull and East Yorkshire Hospitals NHS T

location_facility: The University of Chicago Medicine Hospital


title: A Long-Term Follow-up Study of Subjects Who Participated in a Clinical Trial in Which Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) Was Administered for the Treatment of Chronic Hepatitis C

summary: The primary purpose of this study is to determine whether the hepatitis C virus continues to remain unable to be detected in subjects who were previously treated with Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) and achieved sustained virologic response.

ReferenceCitation: Reddy KR, Pol S, Thuluvath PJ, Kumada H, Toyota J, Chayama K, Levin J, Lawitz EJ, Gadano A, Ghesquiere W, Gerken G, Brunetto MR, Peng CY, Silva M, Strasser SI, Heo J, McPhee F, Liu Z, Yang R, Linaberry M, Noviello S. Long-term follow-up of clinical trial patients treated for chronic HCV infection with daclatasvir-based regimens. Liver Int. 2018 May;38(5):821-833. doi: 10.1111/liv.13596. Epub 2017 Oct 12.

publisher_dissemination: Wiley

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Canada
France
Denmark
United States
Puerto Rico
Italy
United Kingdom
Mexico
Korea, Republic of
Spain
Taiwan
Sweden

location_facility: University Of Pennsylvania School Of Medicine

location_facility: Bon Secours St. Mary's Hospital of Richmond, Inc.

location_facility: Instituto Centralizado De Asistencia E Investigacion Clinica

location_facility: Alabama Liver & Digestive Specialists (Alds)

location_facility: University Of Colorado Denver & Hospital

location_facility: University Of North Carolina At Chapel Hill School Of Med


title: A Phase III Study to Demonstrate the Antiviral Activity and Safety of Dolutegravir in HIV-1 Infected Adult Subjects With Treatment Failure on an Integrase Inhibitor Containing Regimen.

summary: The purpose of this trial is to assess the antiviral activity and safety of a dolutegravir (DTG) containing regimen in HIV-1 infected, antiretroviral therapy (ART)-experienced adults with current or historical failure on an integrase inhibitor (INI) containing regimen. The study will assess DTG 50mg twice daily administered initially with the current failing ART regimen but then with an optimised background ART regimen (OBR) after Day 7. The first analyses will be conducted after the last subject enrolled has completed 24 weeks. Subjects may remain on study after Week 24.

ReferenceCitation: Eron JJ, Clotet B, Durant J, Katlama C, Kumar P, Lazzarin A, Poizot-Martin I, Richmond G, Soriano V, Ait-Khaled M, Fujiwara T, Huang J, Min S, Vavro C, Yeo J; VIKING Study Group. Safety and efficacy of dolutegravir in treatment-experienced subjects with raltegravir-resistant HIV type 1 infection: 24-week results of the VIKING Study. J Infect Dis. 2013 Mar 1;207(5):740-8. doi: 10.1093/infdis/jis750. Epub 2012 Dec 7.

ReferenceCitation: Castagna A, Maggiolo F, Penco G, Wright D, Mills A, Grossberg R, Molina JM, Chas J, Durant J, Moreno S, Doroana M, Ait-Khaled M, Huang J, Min S, Song I, Vavro C, Nichols G, Yeo JM; VIKING-3 Study Group. Dolutegravir in antiretroviral-experienced patients with raltegravir- and/or elvitegravir-resistant HIV-1: 24-week results of the phase III VIKING-3 study. J Infect Dis. 2014 Aug 1;210(3):354-62. doi: 10.1093/infdis/jiu051. Epub 2014 Jan 19.

repository_institution: The Pennsylvania State University - CiteSeer X

repository_normalized: CiteSeerX

evidence: oa repository (semantic scholar lookup)

repositories:
CiteSeerX
PubMed Central
pdfs.semanticscholar.org

lead_sponsor: ViiV Healthcare

collaborators: Shionogi GlaxoSmithKline

sponsor_collaborators:
ViiV Healthcare
Shionogi
GlaxoSmithKline

location_country:
Italy
Portugal
Belgium
United States
Spain
Canada
France


title: A Phase III Double-blind, Extension, Placebo-controlled Parallel Group Safety and Efficacy Trial of BI 10773 (10 and 25mg Once Daily) and Sitagliptin (100mg Once Daily) Given for Minimum 76 Weeks (Incl. 24 Weeks of Preceding Trial) as Monotherapy or With Different Back-ground Therapies in Patients With Type 2 Diabetes Mellitus Previously Completing Trial 1245.19, 1245.20 or 1245.23

summary: This study will investigate the efficacy and long term safety and tolerability of BI 10773 in type 2 diabetic patients.

ReferenceCitation: Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.

oa_colors: green other

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

repository_institution: University of Illinois at Chicago - INDIGO

repositories_institution: University College London - UCL Discovery

repositories_institution: University of Illinois at Chicago - INDIGO

publisher_dissemination: American Diabetes Association

ReferenceCitation: Inzucchi SE, Davies MJ, Khunti K, Trivedi P, George JT, Zwiener I, Johansen OE, Sattar N. Empagliflozin treatment effects across categories of baseline HbA1c, body weight and blood pressure as an add-on to metformin in patients with type 2 diabetes. Diabetes Obes Metab. 2021 Feb;23(2):425-433. doi: 10.1111/dom.14234. Epub 2020 Nov 20.

repository_institution: The University of Glasgow - Enlighten: Publications

repositories_institution: The University of Glasgow - Enlighten: Publications

ReferenceCitation: Shiba T, Ishii S, Okamura T, Mitsuyoshi R, Pfarr E, Koiwai K. Efficacy and safety of empagliflozin in Japanese patients with type 2 diabetes mellitus: A sub-analysis by body mass index and age of pooled data from three clinical trials. Diabetes Res Clin Pract. 2017 Sep;131:169-178. doi: 10.1016/j.diabres.2017.07.004. Epub 2017 Jul 8.

ReferenceCitation: Roden M, Merker L, Christiansen AV, Roux F, Salsali A, Kim G, Stella P, Woerle HJ, Broedl UC; EMPA-REG EXTEND MONO investigators. Safety, tolerability and effects on cardiometabolic risk factors of empagliflozin monotherapy in drug-naive patients with type 2 diabetes: a double-blind extension of a Phase III randomized controlled trial. Cardiovasc Diabetol. 2015 Dec 23;14:154. doi: 10.1186/s12933-015-0314-0.

repositories_concat: PubMed Central;frl.publisso.de

ReferenceCitation: Haering HU, Merker L, Christiansen AV, Roux F, Salsali A, Kim G, Meinicke T, Woerle HJ, Broedl UC; EMPA-REG EXTEND METSU investigators. Empagliflozin as add-on to metformin plus sulphonylurea in patients with type 2 diabetes. Diabetes Res Clin Pract. 2015 Oct;110(1):82-90. doi: 10.1016/j.diabres.2015.05.044. Epub 2015 May 29.

sponsor_collaborators:
Boehringer Ingelheim
Eli Lilly and Company

location_country:
Germany
Ireland
Japan
Turkey
Canada
France
Slovenia
Slovakia
Switzerland
United States
Ukraine
India
Belgium
China
Philippines
Mexico
Korea, Republic of
Greece
Taiwan

location_facility: 1245.31.81013 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.91015 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10123 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.82004 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.81012 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10145 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.75004 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.32018 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.20029 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10071 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.86045 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10149 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.20030 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10137 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.91105 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.49017 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.35304 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.82008 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.88006 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.90002 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.91007 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.20018 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.63005 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.20057 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.41004 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.33018 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.86058 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10006 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.74004 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.75003 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.20011 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10059 Boehringer Ingelheim Investigational Site

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location_facility: 1245.31.88013 Kaohsiung Medical University Chung-Ho Memorial Hospital

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type: Other Identifier

title: A 6-month, Open Label, Prospective, Multicenter, International, Exploratory Study of a Transition to Flexibly Dosed Paliperidone Palmitate in Patients With Schizophrenia Previously Unsuccessfully Treated With Oral or Long-acting Injectable Antipsychotics

acronym: PALMFlexS

summary: This study explores the tolerability, safety and efficacy (i.e. how well the drug works) of flexibly dosed paliperidone palmitate in the treatment of schizophrenia in patients previously unsuccessfully treated with other oral or long-acting injectable (LAI) (i.e. with a long duration of action) antipsychotics.

ReferenceCitation: Schreiner A, Bergmans P, Cherubin P, Keim S, Rancans E, Bez Y, Parellada E, Carpiniello B, Vidailhet P, Hargarter L. A prospective flexible-dose study of paliperidone palmitate in nonacute but symptomatic patients with schizophrenia previously unsuccessfully treated with oral antipsychotic agents. Clin Ther. 2014 Oct 1;36(10):1372-88.e1. doi: 10.1016/j.clinthera.2014.08.014. Epub 2014 Oct 23. Erratum In: Clin Ther. 2014 Nov 1;36(11):1705.

lead_sponsor: Janssen-Cilag International NV

location_country:
Germany
Turkey
Croatia
France
Lithuania
Portugal
Hungary
Denmark
Switzerland
Latvia
Ukraine
Belgium
Estonia
United Kingdom
Sweden
Netherlands
Austria
Spain
Greece
Israel


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of ARQ197 Plus Erlotinib Versus Placebo Plus Erlotinib in Previously Treated Subjects With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer (NSCLC)

summary: This study is to determine if the combination regimen of tivantinib with erlotinib will improve overall survival relative to erlotinib alone in subjects with locally advanced or metastatic non-squamous, non-small cell lung cancer who have received 1 or 2 prior systemic anti-cancer therapies.

ReferenceCitation: Scagliotti G, von Pawel J, Novello S, Ramlau R, Favaretto A, Barlesi F, Akerley W, Orlov S, Santoro A, Spigel D, Hirsh V, Shepherd FA, Sequist LV, Sandler A, Ross JS, Wang Q, von Roemeling R, Shuster D, Schwartz B. Phase III Multinational, Randomized, Double-Blind, Placebo-Controlled Study of Tivantinib (ARQ 197) Plus Erlotinib Versus Erlotinib Alone in Previously Treated Patients With Locally Advanced or Metastatic Nonsquamous Non-Small-Cell Lung Cancer. J Clin Oncol. 2015 Aug 20;33(24):2667-74. doi: 10.1200/JCO.2014.60.7317. Epub 2015 Jul 13.

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

ReferenceCitation: Scagliotti GV, Novello S, Schiller JH, Hirsh V, Sequist LV, Soria JC, von Pawel J, Schwartz B, Von Roemeling R, Sandler AB. Rationale and design of MARQUEE: a phase III, randomized, double-blind study of tivantinib plus erlotinib versus placebo plus erlotinib in previously treated patients with locally advanced or metastatic, nonsquamous, non-small-cell lung cancer. Clin Lung Cancer. 2012 Sep;13(5):391-5. doi: 10.1016/j.cllc.2012.01.003. Epub 2012 Mar 21.

collaborators: ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)

location_country:
Germany
Poland
Argentina
Australia
Brazil
Chile
Czechia
Canada
France
Hungary
Denmark
United States
Romania
Belgium
Peru
Italy
United Kingdom
Netherlands
Austria
Mexico
Spain
Russian Federation
Sweden


title: Phase III MultiCenter Randomized Controlled Study to Assess Efficacy and Safety of ON 01910.Na 72-Hr Continuous IV Infusion in MDS Patients With Excess Blasts Relapsing After or Refractory to or Intolerant to Azacitidine or Decitabine

acronym: ONTIME

summary: The primary objective of this study is to compare overall survival (OS) in patients receiving ON 01910.Na + best supportive care (BSC) to OS of patients receiving BSC in a population of patients with myelodysplastic syndrome (MDS) with excess blasts (5% to 30% bone marrow blasts) who have failed azacitidine or decitabine treatment. This patient population has no available therapy and a short life expectancy (approximately 4 months). The high level of bone marrow activity of ON 01910.Na documented in Phase 1 and 2 studies has the potential to delay substantially the transition of MDS to Acute Myeloid Leukemia(AML), a very significant and severe complication, which shortens survival of these MDS patients.

ReferenceCitation: Seetharam M, Fan AC, Tran M, Xu L, Renschler JP, Felsher DW, Sridhar K, Wilhelm F, Greenberg PL. Treatment of higher risk myelodysplastic syndrome patients unresponsive to hypomethylating agents with ON 01910.Na. Leuk Res. 2012 Jan;36(1):98-103. doi: 10.1016/j.leukres.2011.08.022. Epub 2011 Sep 14.

ReferenceCitation: Athuluri-Divakar SK, Vasquez-Del Carpio R, Dutta K, Baker SJ, Cosenza SC, Basu I, Gupta YK, Reddy MV, Ueno L, Hart JR, Vogt PK, Mulholland D, Guha C, Aggarwal AK, Reddy EP. A Small Molecule RAS-Mimetic Disrupts RAS Association with Effector Proteins to Block Signaling. Cell. 2016 Apr 21;165(3):643-55. doi: 10.1016/j.cell.2016.03.045.

ReferenceType: result

ReferenceCitation: Garcia-Manero G, Fenaux P, Al-Kali A, Baer MR, Sekeres MA, Roboz GJ, Gaidano G, Scott BL, Greenberg P, Platzbecker U, Steensma DP, Kambhampati S, Kreuzer KA, Godley LA, Atallah E, Collins R Jr, Kantarjian H, Jabbour E, Wilhelm FE, Azarnia N, Silverman LR; ONTIME study investigators. Rigosertib versus best supportive care for patients with high-risk myelodysplastic syndromes after failure of hypomethylating drugs (ONTIME): a randomised, controlled, phase 3 trial. Lancet Oncol. 2016 Apr;17(4):496-508. doi: 10.1016/S1470-2045(16)00009-7. Epub 2016 Mar 9.

ReferenceCitation: Navada SC, Silverman LR. The safety and efficacy of rigosertib in the treatment of myelodysplastic syndromes. Expert Rev Anticancer Ther. 2016 Aug;16(8):805-10. doi: 10.1080/14737140.2016.1209413. Epub 2016 Jul 15.

ReferenceCitation: Al-Kali A. Relationship of bone marrow blast (BMBL) response to overall survival (OS) in a multicenter study of rigosertib (Rigo) in patients (pts) with myelodysplastic syndrome (MDS) with excess blasts progressing on or after treatment with a hypomethylating agent (HMA). Journal of Clinical Oncology 2017 35:15_suppl, 7056-7056 ASCO 2017

ReferenceCitation: Garcia-Manero G, Fenaux P. Comprehensive Analysis of Safety: Rigosertib in 557 Patients with Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML). Blood Dec 2016, 128 (22) 2011; ASH 2016.

lead_sponsor: Onconova Therapeutics, Inc.

sponsor_collaborators:
Onconova Therapeutics, Inc.
The Leukemia and Lymphoma Society

location_country:
Germany
Italy
Belgium
United States
Spain
France

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: CHU Perpignan Centre Hospitalier Hôpital Saint-Jean

location_facility: University of Pennsylvania Health System

location_facility: CHU Avignon Centre Hospitalier Henri Dufaut

location_facility: Klinikum der Johann Wolfgang-Goethe-Universität

location_facility: University of Texas Southwestern Medical Center at Dallas

location_facility: Emory University Winship Cancer Institute

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: Klinikum Rechts der Isar der Technischen Universität München

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte

location_facility: CHU Angers Service de Medecine D - Maladies du Sang

location_facility: Azienda Ospedaliera-Universitairia Vittorio Emanuele-Ferrarotto-Santo Bambino

location_facility: Innovative Medical Research of South Florida, Inc.

location_facility: Hospital Clínico Universitario de Salamanca

location_facility: University of California San Diego Moores Cancer Center

location_facility: Azienda Ospedaliero-Universitaria di Bologa Policlinico S. Orsola-Malpighi

location_facility: Hospital Universitario Central de Asturias

location_facility: University of Texas M. D. Anderson Cancer Center

location_facility: Azienda Ospedaliero Universitaria San Giovanni Battista di Torino

location_facility: Hospital Clínico Universitario Virgen de la Victoria

location_facility: Azienda Osperdaliera Universitaria Maggiore della Carità

location_facility: Mount Sinai Comprehensive Cancer Centers

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo

location_facility: University of Oklahoma Health Science Center

location_facility: Azienda Ospedaliera Universitaria Careggi di Firenze


title: An Observational Study of the Treatment of Multiple Myeloma in Routine Clinical Practice

summary: The primary objective of this observational study is to document and describe current treatment regimens and disease progression of patients with Multiple Myeloma (MMY). The aim of this registry is to provide accurate, descriptive information on the way Multiple Myeloma is treated in routine clinical practice. The registry will collect information related to the treatment received for Multiple Myeloma. About 3000 patients will take part in the study in about 28 countries. The registry will only collect information that is already in medical files regarding treatment. Patients will not be required to actively do anything in addition to what would be done without participating in this registry, nor will there be any procedures or interventions that are not already part of the current treatment.

lead_sponsor: Janssen Pharmaceutica N.V., Belgium


lead_sponsor: Millennium Pharmaceuticals, Inc.

summary: This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel (TAK-700) plus prednisone compared with placebo plus prednisone in the treatment of men with progressive, chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC)

ReferenceCitation: Heller G, McCormack R, Kheoh T, Molina A, Smith MR, Dreicer R, Saad F, de Wit R, Aftab DT, Hirmand M, Limon A, Fizazi K, Fleisher M, de Bono JS, Scher HI. Circulating Tumor Cell Number as a Response Measure of Prolonged Survival for Metastatic Castration-Resistant Prostate Cancer: A Comparison With Prostate-Specific Antigen Across Five Randomized Phase III Clinical Trials. J Clin Oncol. 2018 Feb 20;36(6):572-580. doi: 10.1200/JCO.2017.75.2998. Epub 2017 Dec 22.

ReferenceCitation: Suri A, Chapel S, Lu C, Venkatakrishnan K. Physiologically based and population PK modeling in optimizing drug development: A predict-learn-confirm analysis. Clin Pharmacol Ther. 2015 Sep;98(3):336-44. doi: 10.1002/cpt.155. Epub 2015 Jul 14.

ReferenceCitation: Saad F, Fizazi K, Jinga V, Efstathiou E, Fong PC, Hart LL, Jones R, McDermott R, Wirth M, Suzuki K, MacLean DB, Wang L, Akaza H, Nelson J, Scher HI, Dreicer R, Webb IJ, de Wit R; ELM-PC 4 investigators. Orteronel plus prednisone in patients with chemotherapy-naive metastatic castration-resistant prostate cancer (ELM-PC 4): a double-blind, multicentre, phase 3, randomised, placebo-controlled trial. Lancet Oncol. 2015 Mar;16(3):338-48. doi: 10.1016/S1470-2045(15)70027-6. Epub 2015 Feb 18.

title: A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel Plus Prednisone With Placebo Plus Prednisone in Patients With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer

type: Registry Identifier

location_country:
Finland
Germany
Ireland
Poland
New Zealand
Australia
Brazil
Japan
Chile
Canada
France
Czech Republic
Belarus
Lithuania
Colombia
Portugal
Slovakia
Hong Kong
Switzerland
United States
Latvia
Ukraine
Romania
Belgium
Peru
Puerto Rico
Italy
United Kingdom
Singapore
Sweden
Netherlands
Austria
Mexico
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


title: A MultiCentre, Randomized, Double-blind, Placebo-controlled Phase IIb Study to Compare the Efficacy and Safety of Two Dosing Regimens of Intravenous Infusions of AZD9773 (CytoFab™) in Adult Patients With Severe Sepsis and/or Septic Shock

summary: The primary purpose of this study to evaluate the effect of two different doses of AZD9773 (CytoFab™) versus placebo on ventilator free days (VFDs) over the first 28 days after the start of dosing with AZD9773 in patients with severe sepsis and/or septic shock, who are already receiving appropriate standard of care treatment for sepsis.

ReferenceCitation: Yates JW, Das S, Mainwaring G, Kemp J. Population pharmacokinetic/pharmacodynamic modelling of the anti-TNF-alpha polyclonal fragment antibody AZD9773 in patients with severe sepsis. J Pharmacokinet Pharmacodyn. 2012 Dec;39(6):591-9. doi: 10.1007/s10928-012-9270-4. Epub 2012 Sep 23.

location_country:
Finland
France
Australia
Belgium
Spain
Canada
Czech Republic