title: A Phase 3 Study of BBI-608 in Combination With 5-Fluorouracil, Leucovorin, Irinotecan (FOLFIRI) in Adult Patients With Previously Treated Metastatic Colorectal Cancer (CRC).

summary: This is an international multi-center, prospective, open-label, randomized, adaptive design phase 3 trial of the cancer stem cell pathway inhibitor napabucasin plus standard bi-weekly FOLFIRI versus standard bi-weekly FOLFIRI in patients with previously treated metastatic colorectal cancer (CRC).

location_country:
Hong Kong
Spain
Italy
Australia
Netherlands
Canada
Korea, Republic of
United States
France
China
Israel
Belgium
Japan
Germany
Singapore
Czechia

location_facility: Indiana University Health Goshen Center for Cancer Care

location_facility: Consorci Hospital General Universitari Valencia (CHGUV)

location_facility: Pamela Youde Nethersole Eastern Hospital

location_facility: Hospital Universitario Puerta de Hierro-Majadahonda

location_facility: North Shore Hematology Oncology Associates

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Florida Cancer Specialists & Research Institute Fort Myers

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

location_facility: Hôpital Européen Georges Pompidou - Digestive Oncology

location_facility: The cancer insitute hospital of JFCR (Japanese Foundation For Cancer Research)

location_facility: St Mary's Hospital & Regional Med Center

location_facility: Cancer Research Network of Nebraska / Oncology Associates PC

location_facility: Texas Oncology - Wichita Falls Texoma Cancer Center

location_facility: Suburban Hematology-Oncology Associates, PC - Lawrenceville

location_facility: Hospital Universitario Virgen de la Macarena

location_facility: Kobe City Medical Center General Hospital

location_facility: ST. Marianna University School of Medicine

location_facility: The Barzilai Medical Center - Oncology Institute

location_facility: Sunshine Coast Hospital and Health Service

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

location_facility: Hospital Universitario Fundacion Alcorcon (HUFA)

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: AOU Ospedali Riuniti Umberto I - GM.Lanc

location_facility: Medical Hospital, Tokyo Medical and Dental University

location_facility: Hôpital Morvan - CHRU de Brest - cancérologie et d'hématolog

location_facility: Los Angeles Hematology Oncology Medical Group

location_facility: Ospedale Guglielmo da Saliceto, AUSL Piacenza

location_facility: US Oncology - Virginia Cancer Specialists, PC

location_facility: Elizabeth Tweesteden Ziekenhuis locatie Tilburg

location_facility: The Chaim Sheba Medical Centre - Division of Oncology

location_facility: Memorial Cancer Institute at Memorial Hospital

location_facility: Medical Oncology Hematology Consultants, PA

location_facility: Hôpital Privé des Côtes d'Armor - Service oncologie

location_facility: Severance Hospital, Yonsei University Health System

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

location_facility: Peninsula & South Eastern Haematology and Oncology Group

location_facility: AZ Sint-Jan Brugge - Oostende - Campus Sint-Jan

location_facility: Università degli studi della Campania "L.Vanvitelli"

location_facility: University of Toronto - Sunnybrook Health Sciences Centre

location_facility: Policlinico S.Orsola Malpighi, AOU di Bologna

location_facility: Complexo Hospital Universitario A Coruña

location_facility: Tel Aviv Sourasky Medical Center - Oncology

location_facility: CHU de Liège - Domaine Universitaire du Sart Tilman

location_facility: Schwerpunkpraxis für Hämatologie und Onkologie

location_facility: Charite - Campus Benjamin Franklin (Cbf)

location_facility: National Hospital Organization Osaka National Hospital

location_facility: Baptist Health Medical Group Oncology, LLC

location_facility: Osaka Medical Center for Cancer and Cardiovascular Diseases

location_facility: Ziv Medical Center (The Rebecca Sieff Hospital)

location_facility: University of California-San Diego/Moores UCSD Cancer Center

location_facility: Hospital Universitario Central de Asturias

location_facility: Missouri Baptist Medical Center ACCRU Network Site

location_facility: Emory University/Winship Cancer Institute

location_facility: MVZ Onkologischer Schwerpunkt am Oskar-Helene-Heim

location_facility: Grand Hôpital de Charleroi - Site Notre-Dame

location_facility: Hospital Universitario Virgen de la Arrixaca


title: A Phase 1/2, Multicenter, Open-label Study of FT-2102 as a Single Agent and in Combination With Azacitidine or Cytarabine in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome With an IDH1 Mutation

summary: This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 (olutasidenib) as a single agent or in combination with azacitidine or cytarabine. The Phase 1 stage of the study is split into 2 distinct parts: a dose escalation part, which will utilize an open-label design of FT-2102 (olutasidenib) (single agent) and FT-2102 (olutasidenib) + azacitidine (combination agent) administered via one or more intermittent dosing schedules followed by a dose expansion part. The dose expansion part will enroll patients in up to 5 expansion cohorts, exploring single-agent FT-2102 (olutasidenib) activity as well as combination activity with azacitidine or cytarabine. Following the completion of the relevant Phase 1 cohorts, Phase 2 will begin enrollment. Patients will be enrolled across 8 different cohorts, examining the effect of FT-2102 (olutasidenib) (as a single agent) and FT-2102 (olutasidenib) + azacitidine (combination) on various AML/MDS disease states.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Watts JM, Baer MR, Yang J, Prebet T, Lee S, Schiller GJ, Dinner SN, Pigneux A, Montesinos P, Wang ES, Seiter KP, Wei AH, De Botton S, Arnan M, Donnellan W, Schwarer AP, Récher C, Jonas BA, Ferrell PB Jr, Marzac C, Kelly P, Sweeney J, Forsyth S, Guichard SM, Brevard J, Henrick P, Mohamed H, Cortes JE. Olutasidenib alone or with azacitidine in IDH1-mutated acute myeloid leukaemia and myelodysplastic syndrome: phase 1 results of a phase 1/2 trial. Lancet Haematol. 2022 Nov 9. pii: S2352-3026(22)00292-7. doi: 10.1016/S2352-3026(22)00292-7. [Epub ahead of print]

lead_sponsor: Forma Therapeutics, Inc.

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

location_facility: Box Hill Hospital, Monash University and Eastern Health Clinical School

location_facility: Hospital Clínico Universitario de Salamanca

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: Centre Hospitalier Universitaire de Nancy - Hopital Brabois

location_facility: Centre Hospitalier Universitaire (CHU) Bordeaux - Hospitaux du Haut Leveque

location_facility: Staedtisches Klinikum Braunschweig gGmbH

location_facility: Cornell University Weill Medical College

location_facility: Dipartimento di Oncologia Medica - IRST IRCC

location_facility: Institut Català d'Oncologia-Hospital Duran i Reynals

location_facility: Universitaetsklinikum Giessen und Marburg GmbH - Klinik fuer Innere Medizin

location_facility: Hospital Rimini Hematology, Department of Oncology and Hematoloy

location_facility: University of Texas Southwestern Medical Center

location_facility: Sarah Cannon Research Institute - Tennessee Oncology

location_facility: Service d'Hématologie Clinique, Hôpital Avicenne-APHP-Université Paris

location_facility: Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital Nord

location_facility: Ospedale Mazzoni - UOC Ematologia Ascoli Piceno

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole

location_facility: Landeszentrum fuer Zell- und Gentherapie

location_facility: Universitätsklinikum Münster Medizinische Klinik A, Hämatologie, Hämostaseologi

location_facility: Northwestern University Feinberg School of Medicine

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Hopitaux Universitaires Est Parisien Hopital Saint-Antoine

location_facility: Seoul National University Bundang Hospital

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


ipd_sharing: Yes

status: Terminated

intervention_type: Biological

title: A Phase III, Multicentre, Randomised, Double Blind, Parallel Group, Placebo Controlled Study To Assess The Efficacy And Safety Of One Or More Intradetrusor Treatments Of 600 Or 800 Units Of Dysport® For The Treatment Of Urinary Incontinence In Subjects With Neurogenic Detrusor Overactivity Due To Spinal Cord Injury Or Multiple Sclerosis

study_completion_date_type: Actual

lead_sponsor: Ipsen

type: EudraCT Number

source: euctr

design_allocation: Randomized

ipd_sharing_description:
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

location_country:
Brazil
Spain
Colombia
Russian Federation
Australia
Mexico
Argentina
Lithuania
United Kingdom
Ukraine
France
Chile
Israel
Peru
Belgium
Germany

location_facility: National Hospital for Neurology and Neurosurgery - UCL

location_facility: Vilnius University Hospital Santariskiu Klinikos

location_facility: Hospital Universitario "Dr. José Eleuterio González"

location_facility: Universitätsklinikum Bonn Klinik und Poliklinik für Urologie

location_facility: Hospital Privado - Centro Médico de Córdoba

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

location_facility: Hospital de Clinicas, Federal University of Paraná

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital

location_facility: Solano & Terront Servicios Medicos LTDA- Unidad Integral de Endocrinologia

location_facility: Santa Casa de Misericórdia de Porto Alegre - Hospital Santa Clara

location_facility: Scientific research institute of urology and interventional radiology n. a. N. A. Lopatkin

location_facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

location_facility: Ministry of healthcare of the Russian Federation

location_facility: Universidade Estadual de Campinas - Cidade Universitária Zeferino Vaz

location_facility: Penza Regional Clinical Hospital n.a. N.N.Burdenko

location_facility: Unidad de Investigación de la Clínica Internacional Sede San Borja

location_facility: St. Petersburg Research Institute of Phthisiopulmonology

location_facility: Royal National Orthopaedic Hospital Trust

location_facility: Asociacion IPS Medicos Internistas de Caldas

location_facility: Centro de Investigaciones Clinicas - CIC

location_facility: The Mid Yorkshire Hospitals NHS Trust - Pinderfields Hospital

location_facility: Kliniken Maria Hilf GmbH - Krankenhaus St. Franziskus

location_facility: Groupe Hospitalo-Universitaire Pierre Caremau

location_facility: Municipal Healthcare Institution "Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval", Urology Department

location_facility: Pavlov First Saint Petersburg State Medical University

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

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Complexo Hospitalario Universitario A Coruña

summary: The purpose of this study is to provide confirmatory evidence of the safety and efficacy of two Dysport® doses (600 units [U] and 800 U), compared to placebo in reducing urinary incontinence (UI) in adult subjects treated for neurogenic detrusor overactivity (NDO) due to spinal cord injury (SCI) or multiple sclerosis (MS).

status_simplified: Unknown


title: A Phase 3, Double-blind, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Placebo for the Treatment of Anemia Due to the IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes in Subjects With Ring Sideroblasts Who Require Red Blood Cell Transfusions.

acronym: MEDALIST

summary:
The study will be conducted in compliance with the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.

This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study to determine the efficacy and safety of luspatercept (ACE-536) versus placebo in participants with anemia due to the Revised International Prognostic Scoring System (IPSS-R) very low, low, or intermediate MDS with ring sideroblasts who require red blood cell (RBC) transfusions.

status: Completed

ReferenceType: background

ReferenceCitation: Porter J. Beyond transfusion therapy: new therapies in thalassemia including drugs, alternate donor transplant, and gene therapy. Hematology Am Soc Hematol Educ Program. 2018 Nov 30;2018(1):361-370. doi: 10.1182/asheducation-2018.1.361. Review.

ReferenceCitation: Piga A, Perrotta S, Gamberini MR, Voskaridou E, Melpignano A, Filosa A, Caruso V, Pietrangelo A, Longo F, Tartaglione I, Borgna-Pignatti C, Zhang X, Laadem A, Sherman ML, Attie KM. Luspatercept improves hemoglobin levels and blood transfusion requirements in a study of patients with β-thalassemia. Blood. 2019 Mar 21;133(12):1279-1289. doi: 10.1182/blood-2018-10-879247. Epub 2019 Jan 7.

ReferenceType: result

ReferenceCitation: Fenaux P, Platzbecker U, Mufti GJ, Garcia-Manero G, Buckstein R, Santini V, Díez-Campelo M, Finelli C, Cazzola M, Ilhan O, Sekeres MA, Falantes JF, Arrizabalaga B, Salvi F, Giai V, Vyas P, Bowen D, Selleslag D, DeZern AE, Jurcic JG, Germing U, Götze KS, Quesnel B, Beyne-Rauzy O, Cluzeau T, Voso MT, Mazure D, Vellenga E, Greenberg PL, Hellström-Lindberg E, Zeidan AM, Adès L, Verma A, Savona MR, Laadem A, Benzohra A, Zhang J, Rampersad A, Dunshee DR, Linde PG, Sherman ML, Komrokji RS, List AF. Luspatercept in Patients with Lower-Risk Myelodysplastic Syndromes. N Engl J Med. 2020 Jan 9;382(2):140-151. doi: 10.1056/NEJMoa1908892.

ReferenceCitation: Komrokji RS. Luspatercept in Myelodysplastic Syndromes: Who and When? Hematol Oncol Clin North Am. 2020 Apr;34(2):393-400. doi: 10.1016/j.hoc.2019.10.004. Epub 2020 Jan 21. Review.

ReferenceCitation: Fenaux P, Kiladjian JJ, Platzbecker U. Luspatercept for the treatment of anemia in myelodysplastic syndromes and primary myelofibrosis. Blood. 2019 Feb 21;133(8):790-794. doi: 10.1182/blood-2018-11-876888. Epub 2019 Jan 2. Review.

lead_sponsor: Celgene

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

location_facility: Azienda Ospedaliera Santi Antonio Biagio E Cesare Arrigo

location_facility: Azienda Ospedaliera Bianchi Melacrino Morelli

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: Montefiore Medical Center Albert Einstein Cancer Center

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: Istanbul University Cerrahpasa Medical Faculty Hospital

location_facility: Ege Universitesi Tip Fakultesi Hastanesi

location_facility: H Lee Moffitt Cancer Center and Research Institute

location_facility: Universitatsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Cliniques Universitaires UCL de Mont-Godine

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Cleveland Clinic Taussig Cancer Institute

location_facility: Hospital Universitario Central de Asturias

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

location_facility: Azienda Ospedaliero Universitaria Di Bologna Policlinico Sorsola Malpighi

location_facility: Cukurova University Medical Faculty Balcali Hospital

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: CHRU de Lille-Hopital Claude Huriez Service des Maladies du Sang

location_facility: Ankara University Medical Faculty Cebeci Hospital

location_facility: Instituto Catalan de Oncologia-Hospital Duran i Reynals

intervention_type: Other

status_simplified: Completed


title: A Phase 3, Randomized, Controlled, Multi-Center, Open-Label Study to Compare Tivozanib Hydrochloride to Sorafenib in Subjects With Refractory Advanced Renal Cell Carcinoma

summary:
This is a Phase 3, open-label, randomized, controlled, multi-national, multi-center, parallel-arm study comparing tivozanib to sorafenib in subjects with refractory advanced renal cell carcinoma (RCC).

Subjects will be randomized (1:1) to treatment with tivozanib or sorafenib.

Subjects will be stratified by International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk category (favorable; intermediate; poor) and prior therapy (two prior vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR TKI); a prior checkpoint inhibitor [programmed cell death -1 protein (PD-1) or PD-1 ligand (PD1-L) inhibitor] plus a prior VEGFR TKI; a prior VEGFR TKI plus any other systemic agent).

All subjects will be evaluated for progression free survival, overall survival, objective response rate, and the duration of response as well as safety and tolerability.

Pharmacokinetic (PK) analysis are also included in study.

ReferenceCitation: Szarek M, Needle MN, Rini BI, Pal SK, McDermott DF, Atkins MB, Hutson TE, Escudier BJ. Q-TWiST Analysis of Tivozanib Versus Sorafenib in Patients With Advanced Renal Cell Carcinoma in the TIVO-3 Study. Clin Genitourin Cancer. 2021 Oct;19(5):468.e1-468.e5. doi: 10.1016/j.clgc.2021.03.018. Epub 2021 Apr 3.

ReferenceCitation: Rini BI, Pal SK, Escudier BJ, Atkins MB, Hutson TE, Porta C, Verzoni E, Needle MN, McDermott DF. Tivozanib versus sorafenib in patients with advanced renal cell carcinoma (TIVO-3): a phase 3, multicentre, randomised, controlled, open-label study. Lancet Oncol. 2020 Jan;21(1):95-104. doi: 10.1016/S1470-2045(19)30735-1. Epub 2019 Dec 3.

ipd_sharing: Undecided

lead_sponsor: AVEO Pharmaceuticals, Inc.

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

location_facility: Istituto Clinico Humanitas Rozzano, IRCCS

location_facility: Baylor College of Medicine - Baylor Clinic

location_facility: University of Miami Sylvester Comprehensive Cancer Center

location_facility: MAGODENT Sp. z o.o. Szpital Onkologiczno-Kardiologiczny

location_facility: IRCCS AOU San Martino-IST Istituto Nazionale per la Ricerca

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

location_facility: Columbia University Medical Center - Herbert Irving Pavilion

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpo

location_facility: Southampton University Hospitals Nhs Trust

location_facility: City of Hope Comprehensive Breast Cancer Center

location_facility: Wake Forest University Baptist Medical Center (WFUBMC)

location_facility: Texas Oncology-Central Austin Cancer Center

location_facility: Texas Oncology SW Fort Worth Cancer Center

location_facility: Hackensack University Medical Center - John Theurer Cancer

location_facility: Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház

location_facility: Lancashire Teaching Hospitals NHS Foundation Trust

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

location_facility: Uniklinik Köln Klinik und Poliklinik für Urologie

location_facility: AO Spedali Civili di Brescia, PO Spedali Civili

location_facility: St James's University Hospital / Leeds Teaching Hospitals

location_facility: COPERNICUS Podmiot Leczn. Sp z o.o.,Wojew. Centrum Onkologii

location_facility: University of Pittsburgh Medical Center (UPMC)

location_facility: Egyesített Szent István és Szent László Kórház-Rendelőintéze

location_facility: Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego

location_facility: ASST-Istituti Ospitalieri di Cremona, AO di Cremona

location_facility: Usl 7 Siena - Ospedale Alta Valdelsa ASL TOSCANA SUD-EST

location_facility: CHRU de Tours - Hopital Bretonneau TOURS

location_facility: Texas Oncology - South Austin Cancer Center

location_facility: Texas Oncology - El Paso Cancer Treatment Center

location_facility: Kliniken Nordoberpfalz AG, Klinikum Weiden

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

location_facility: Nottingham University Hospitals NHS Trust - City Hospital

location_facility: Azienda Ospedaliera San Camillo Forlanini

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

location_facility: Investigative Clinical Research of Indiana

location_facility: AZ Sint-Jan Brugge - Oostende - Campus Sint-Jan

location_facility: University Of UA Cancer Center(UACC)/DH-SJHMC

location_facility: Arizona Oncology - Phoenix - Deer Valley Women's Center Loca

location_facility: Regina Elena, Istituto Nazionale dei Tumori, IFO, IRCCS

location_facility: Szpital Specjalist w Brzozowie Podkarpacki Ośrodek Onkologiczny

location_facility: SZB Study Center University Hospital Bonn

location_facility: Institut de Cancérologie de l'Ouest Site Paul Papin

location_facility: Nebraska Cancer Specialists (NCS) - Midwest Cancer Center

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Grand Hôpital de Charleroi - Site Notre-Dame

location_facility: Comprehensive Cancer Centers of Nevada (CCCN)

location_facility: Texas Oncology-El Paso Cancer Treatment Center


title: Phase 2 Randomized, Double-Blinded, Controlled Study of Tucatinib vs Placebo in Combination With Capecitabine and Trastuzumab in Patients With Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma

lead_sponsor: Seagen Inc.

ReferenceCitation: Mueller V, Wardley A, Paplomata E, Hamilton E, Zelnak A, Fehrenbacher L, Jakobsen E, Curtit E, Boyle F, Harder Brix E, Brenner A, Crouzet L, Ferrario C, Muñoz-Mateu M, Arkenau HT, Iqbal N, Aithal S, Block M, Cold S, Cancel M, Hahn O, Poosarla T, Stringer-Reasor E, Colleoni M, Cameron D, Curigliano G, Siadak M, DeBusk K, Ramos J, Feng W, Gelmon K. Preservation of quality of life in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer treated with tucatinib or placebo when added to trastuzumab and capecitabine (HER2CLIMB trial). Eur J Cancer. 2021 Aug;153:223-233. doi: 10.1016/j.ejca.2021.05.025. Epub 2021 Jun 29.

ReferenceCitation: Lin NU, Borges V, Anders C, Murthy RK, Paplomata E, Hamilton E, Hurvitz S, Loi S, Okines A, Abramson V, Bedard PL, Oliveira M, Mueller V, Zelnak A, DiGiovanna MP, Bachelot T, Chien AJ, O'Regan R, Wardley A, Conlin A, Cameron D, Carey L, Curigliano G, Gelmon K, Loibl S, Mayor J, McGoldrick S, An X, Winer EP. Intracranial Efficacy and Survival With Tucatinib Plus Trastuzumab and Capecitabine for Previously Treated HER2-Positive Breast Cancer With Brain Metastases in the HER2CLIMB Trial. J Clin Oncol. 2020 Aug 10;38(23):2610-2619. doi: 10.1200/JCO.20.00775. Epub 2020 May 29.

ReferenceCitation: Murthy RK, Loi S, Okines A, Paplomata E, Hamilton E, Hurvitz SA, Lin NU, Borges V, Abramson V, Anders C, Bedard PL, Oliveira M, Jakobsen E, Bachelot T, Shachar SS, Müller V, Braga S, Duhoux FP, Greil R, Cameron D, Carey LA, Curigliano G, Gelmon K, Hortobagyi G, Krop I, Loibl S, Pegram M, Slamon D, Palanca-Wessels MC, Walker L, Feng W, Winer EP. Tucatinib, Trastuzumab, and Capecitabine for HER2-Positive Metastatic Breast Cancer. N Engl J Med. 2020 Feb 13;382(7):597-609. doi: 10.1056/NEJMoa1914609. Epub 2019 Dec 11. Erratum in: N Engl J Med. 2020 Feb 6;382(6):586.

ReferenceCitation: Murthy R, Borges VF, Conlin A, Chaves J, Chamberlain M, Gray T, Vo A, Hamilton E. Tucatinib with capecitabine and trastuzumab in advanced HER2-positive metastatic breast cancer with and without brain metastases: a non-randomised, open-label, phase 1b study. Lancet Oncol. 2018 Jul;19(7):880-888. doi: 10.1016/S1470-2045(18)30256-0. Epub 2018 May 24.

location_country:
Denmark
Portugal
Spain
Italy
Austria
Australia
United Kingdom
Canada
Switzerland
United States
France
Israel
Belgium
Germany
Czechia

location_facility: Cancer Treatment Centers of America / Eastern Regional Medical Center

location_facility: Presido Ospedaliero- Senatore Antonio Perrino

location_facility: Central Coast Medical Oncology Corporation TRIO

location_facility: Leo W. Jenkins Cancer Services / Brody School of Medicine East Carolina University

location_facility: University of California at San Francisco

location_facility: Hopital du Saint-Sacrement, CHU de Quebec-Universite Laval

location_facility: HOPE- Onkologisches Zentrum Rotkreuzklinikum

location_facility: British Columbia Cancer Agency - Vancouver Centre

location_facility: Fakultni Nemocnice Olomouc (Fnol) - Onkologicka Klinika

location_facility: Paris Regional Medical Center / US Oncology

location_facility: James Cancer Hospital / Ohio State University

location_facility: Kaiser Permanente Medical Center Northern California

location_facility: Illinois Cancer Specialists / Advocate Lutheran General Hospital

location_facility: The Center for Cancer and Blood Disorders: Fortworth

location_facility: University of Pennsylvania / Perelman Center for Advanced Medicine

location_facility: University of Colorado Hospital / University of Colorado

location_facility: Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes

location_facility: Texas Oncology - Deke Slayton Cancer Center

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Institute Curie - Centre de Lutte Contre Le Cancer CLCC de Paris

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: MD Anderson Cancer Center / University of Texas

location_facility: Hospital Cuf Descobertas R. Mario Botas Parque das Nacoes

location_facility: University Health Network, Princess Margaret Hospital

location_facility: Florida Cancer Specialists - South Region

location_facility: UCLA Medical Center / David Geffen School of Medicine

location_facility: Cancer Treatment Centers of America - Phoenix

location_facility: Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie

location_facility: Winship Cancer Institute / Emory University School of Medicine

location_facility: Seattle Cancer Care Alliance / University of Washington

location_facility: Hospital Clinico Univ De Santiago De Compostela

location_facility: UNC Lineberger Comprehensive Cancer Center / University of North Carolina

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

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Joe Arrington Cancer Research and Treatment Center

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: Dartmouth-Hitchcock Medical Center/ Norris Cotton Cancer Center

location_facility: Medical University of South Carolina/Hollings Cancer Center

location_facility: Florida Cancer Specialists - East West Palm Beach, FL (SCRI)

location_facility: Kliniken Essen-Mitte - Evang. Huyssens-Stiftung

location_facility: InVO- Institut fUr Versorgungsforschung in der onkologie GbR

location_facility: Kaiser Permanente San Marcos Medical Offices

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Colchester Hospital University NHS Foundation Trust

location_facility: University of South Alabama - Mitchell Cancer Institute

location_facility: Centro Hospitalar do Porto - Hospital Santo Antonio

location_facility: Nottingham University Hospitals NHS Trust

location_facility: New York University (NYU) Cancer Institute

location_facility: LKH Salzburg, Universitatsklinikum der PMU

location_facility: Torrance Memorial Physician Network - TRIO

location_facility: Florida Cancer Specialists - North Region

location_facility: Universitaetsklinikum Hamburg-Eppendorf (UKE) - Onkologisches Zentrum - Interdisziplinaere Klinik und Poliklinik fuer Stammzelltransplantation

location_facility: Texas Oncology - San Antonio Medical Center Northeast

location_facility: Complejo Asistencial Universitario de Leon

location_facility: Carbone Cancer Center / University of Wisconsin

location_facility: University of Alberta / Cross Cancer Institute

location_facility: Hospital Clinico Universitario Lozano Blesa de Zaragoza

location_facility: Lombardi Cancer Center / Georgetown University Medical Center

location_facility: Institute of Oncology of Southern Switzerland

summary:
This study is being done to see if tucatinib works better than placebo to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery. All patients in the study will get capecitabine and trastuzumab, two drugs that are often used to treat this cancer.

There are two parts to this study. The first part of the study is already complete. Patients were randomly assigned to get either tucatinib or placebo (a pill with no medicine). Since this part was "blinded," neither patients nor their doctors knew whether a patient got tucatinib or placebo.

The second part of the study is called the Unblinded Phase. In this part of the study, participants and their doctors know which drugs are being given. Participants who used to get or are currently getting placebo may be able to start taking tucatinib instead.

Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills two times every day. They will swallow capecitabine pills two times a day during the first two weeks of each cycle. Patients will get trastuzumab injections from the study site staff on the first day of every cycle.


title: A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Abacavir/Lamivudine (ABC/3TC) Plus a Third Antiretroviral Agent to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppressed HIV 1 Infected Adult Subjects

summary: The primary objective of this study is to evaluate the efficacy of switching to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) relative to continuing on a baseline regimen consisting of abacavir/lamivudine (ABC/3TC) plus a 3rd antiretroviral agent in HIV-1 infected participants.

ReferenceCitation: A Gori, G Rizzardini, C Miralles, J Olalla, JM Molina, F Raffi, P Kumar, A Antinori, M Ramgopal, HJ Stellbrink, M Das, H Chu, R Ram, W Garner, SK Chuck, D Piontkowsky, R Haubrich. Switching from An Abacavir (ABC)/Lamivudine (3TC)-Based Regimen to a Single-Tablet Regimen of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) is Efficacious and Safe: Week 24 Primary Analysis of a Randomized Controlled Study in Virologically-Suppressed Adults [Presentation]. XVIII Congrès National de la SFLS, 19-20 October 2017, Nice Acropolis, France

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

lead_sponsor: Gilead Sciences

location_country:
Spain
Italy
United Kingdom
United States
France
Germany

location_facility: Midway Immunology & Research Center, LLC

location_facility: Comprensorio Ospedaliero Amedeo di Savoia

location_facility: AIDS Arms, Inc./Trinity Health & Wellness Center

location_facility: Dipartimento di Malattie Infettive e Tropicali

location_facility: Hospital General Universitario de Valencia (Abril)

location_facility: Istituto Nazionale Malattie Infettive Lazzaro Spallanzani I.R.C.C.S.

location_facility: Unit Infectious Diseases - University of Catania - ARNAS Garibaldi

location_facility: Hospital Clínico Universitario de Valencia (Galindo)

location_facility: Steinhart Medical Associates dba The Kinder Medical Group

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: The Positive Health Clinic, Allegheny Health Network

location_facility: Unità Operativa Complessa di Malattie Infettive

location_facility: Azienda Ospedaliero Universitaria Policlinico di Modena


title: A Phase 1, Open-Label, Non-Randomized, Safety, Tolerability and Pharmacokinetic Study of TAS3681 in Patients With Metastatic Castration Resistant Prostate Cancer

summary: The purpose of this trial is to investigate the safety and tolerability of TAS3681, to find the maximum tolerated dose (MTD)/recommended dose of TAS3681 (Escalation Phase) and to further evaluate safety and preliminary efficacy of TAS3681 at the MTD/recommended dose (Expansion Phase).

enrollment_type: Anticipated

lead_sponsor: Taiho Oncology, Inc.

location_country:
United Kingdom
Spain
United States
France
Belgium

location_facility: Institut Catala d Oncologia - L Hospitalet de Llobregat

location_facility: University of Glasgow - Institute of Cancer Sciences;

location_facility: Royal Marsden Hospital (RMH) NHS Foundation Trust (DDU)

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: Florida Cancer Specialists & Research Institute

location_facility: Cambridge University Hospitals NHS Foundation

location_facility: Associated Medical Professionals of NY, PLLC

location_facility: University of Wisconsin-Carbone Cancer Center

location_facility: UMMC-Cancer Center and Research Institute

location_facility: Univeristy of California Davis Comprehensive Cancer Center

location_facility: Institut régional du Cancer de Montpellier - ICM Val d'Aurelle

location_facility: GU Research Network / Urology Cancer Center

location_facility: The Christie NHS Foundation Trust- The Christie Clinic


type: Other Identifier

title: Efficacy and Safety of Rivaroxaban Prophylaxis Compared With Placebo in Ambulatory Cancer Patients Initiating Systemic Cancer Therapy and at High Risk for Venous Thromboembolism

summary: The purpose of this study is to demonstrate that rivaroxaban is superior to placebo for reducing the risk of the primary composite outcome as defined by objectively confirmed symptomatic lower extremity proximal deep vein thrombosis (DVT), asymptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, symptomatic non-fatal pulmonary embolism (PE), incidental PE, and venous thromboembolism (VTE)-related death in ambulatory adult participants with various cancer types receiving systemic cancer therapy who are at high risk of developing a VTE.

primary_purpose: Prevention

ReferenceCitation: Khorana AA, Barnard J, Wun T, Vijapurkar U, Damaraju CV, Moore KT, Wildgoose P, McCrae KR. Biomarker signatures in cancer patients with and without venous thromboembolism events: a substudy of CASSINI. Blood Adv. 2022 Feb 22;6(4):1212-1221. doi: 10.1182/bloodadvances.2021005710.

ReferenceCitation: Rutjes AW, Porreca E, Candeloro M, Valeriani E, Di Nisio M. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Cochrane Database Syst Rev. 2020 Dec 18;12:CD008500. doi: 10.1002/14651858.CD008500.pub5.

ReferenceCitation: Vadhan-Raj S, McNamara MG, Venerito M, Riess H, O'Reilly EM, Overman MJ, Zhou X, Vijapurkar U, Kaul S, Wildgoose P, Khorana AA. Rivaroxaban thromboprophylaxis in ambulatory patients with pancreatic cancer: Results from a pre-specified subgroup analysis of the randomized CASSINI study. Cancer Med. 2020 Sep;9(17):6196-6204. doi: 10.1002/cam4.3269. Epub 2020 Jul 14.

ReferenceCitation: Khorana AA, Soff GA, Kakkar AK, Vadhan-Raj S, Riess H, Wun T, Streiff MB, Garcia DA, Liebman HA, Belani CP, O'Reilly EM, Patel JN, Yimer HA, Wildgoose P, Burton P, Vijapurkar U, Kaul S, Eikelboom J, McBane R, Bauer KA, Kuderer NM, Lyman GH; CASSINI Investigators. Rivaroxaban for Thromboprophylaxis in High-Risk Ambulatory Patients with Cancer. N Engl J Med. 2019 Feb 21;380(8):720-728. doi: 10.1056/NEJMoa1814630.

ReferenceCitation: Khorana AA, Vadhan-Raj S, Kuderer NM, Wun T, Liebman H, Soff G, Belani C, O'Reilly EM, McBane R, Eikelboom J, Damaraju CV, Beyers K, Dietrich F, Kakkar AK, Riess H, Peixoto RD, Lyman GH. Rivaroxaban for Preventing Venous Thromboembolism in High-Risk Ambulatory Patients with Cancer: Rationale and Design of the CASSINI Trial. Rationale and Design of the CASSINI Trial. Thromb Haemost. 2017 Nov 1;117(11):2135-2145. doi: 10.1160/TH17-03-0171. Epub 2017 Sep 21.

lead_sponsor: Janssen Research & Development, LLC

location_country:
Brazil
United Kingdom
Russian Federation
Canada
United States
France
Belgium
Germany
Bulgaria
Czechia


title: A Phase III Double-blind, Randomized, Parallel Group, Multicenter Placebo-controlled Trial to Study the Efficacy and Safety of Caplacizumab in Patients With Acquired Thrombotic Thrombocytopenic Purpura

acronym: HERCULES

summary: The study was a Phase III, double-blind, placebo-controlled, randomized study to evaluate the efficacy of caplacizumab in more rapidly restoring normal platelet counts as measure of prevention of further microvascular thrombosis

ReferenceCitation: Peyvandi F, Cataland S, Scully M, Coppo P, Knoebl P, Kremer Hovinga JA, Metjian A, de la Rubia J, Pavenski K, Minkue Mi Edou J, De Winter H, Callewaert F. Caplacizumab prevents refractoriness and mortality in acquired thrombotic thrombocytopenic purpura: integrated analysis. Blood Adv. 2021 Apr 27;5(8):2137-2141. doi: 10.1182/bloodadvances.2020001834.

ReferenceCitation: Knoebl P, Cataland S, Peyvandi F, Coppo P, Scully M, Kremer Hovinga JA, Metjian A, de la Rubia J, Pavenski K, Minkue Mi Edou J, De Winter H, Callewaert F. Efficacy and safety of open-label caplacizumab in patients with exacerbations of acquired thrombotic thrombocytopenic purpura in the HERCULES study. J Thromb Haemost. 2020 Feb;18(2):479-484. doi: 10.1111/jth.14679. Epub 2019 Dec 9.

ReferenceCitation: Scully M, Cataland SR, Peyvandi F, Coppo P, Knöbl P, Kremer Hovinga JA, Metjian A, de la Rubia J, Pavenski K, Callewaert F, Biswas D, De Winter H, Zeldin RK; HERCULES Investigators. Caplacizumab Treatment for Acquired Thrombotic Thrombocytopenic Purpura. N Engl J Med. 2019 Jan 24;380(4):335-346. doi: 10.1056/NEJMoa1806311. Epub 2019 Jan 9.

lead_sponsor: Ablynx

location_country:
Spain
Italy
Austria
Australia
Netherlands
Canada
United Kingdom
Switzerland
Hungary
United States
France
Israel
Turkey
Belgium
Germany
Czechia

location_facility:
Investigator Site
Investigator Site 2
Investigator Site 3
Investigator site 2
Investigator Site 4
Invesigator Site
Investigator site 3
Investigator SIte
Investigator Site 1
Investigator site 1
Investigator site
Investigator site 5
Investigator Site 5


title: Randomized, Double-blind, Phase 3 Study Evaluating TAS-102 Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Patients With Metastatic Gastric Cancer Refractory to Standard Treatments

summary: The purpose of this trial is to compare the effects of TAS-102 and best supportive care (BSC) with Placebo (an inactive drug) and best supportive care on metastatic gastric cancer.

ReferenceCitation: Tabernero J, Alsina M, Shitara K, Doi T, Dvorkin M, Mansoor W, Arkenau HT, Prokharau A, Ghidini M, Faustino C, Gorbunova V, Zhavrid E, Nishikawa K, Ando T, Yalçın Ş, Van Cutsem E, Sabater J, Skanji D, Leger C, Amellal N, Ilson DH. Health-related quality of life associated with trifluridine/tipiracil in heavily pretreated metastatic gastric cancer: results from TAGS. Gastric Cancer. 2020 Jul;23(4):689-698. doi: 10.1007/s10120-020-01053-9. Epub 2020 Mar 4.

ReferenceCitation: Ilson DH, Tabernero J, Prokharau A, Arkenau HT, Ghidini M, Fujitani K, Van Cutsem E, Thuss-Patience P, Beretta GD, Mansoor W, Zhavrid E, Alsina M, George B, Catenacci D, McGuigan S, Makris L, Doi T, Shitara K. Efficacy and Safety of Trifluridine/Tipiracil Treatment in Patients With Metastatic Gastric Cancer Who Had Undergone Gastrectomy: Subgroup Analyses of a Randomized Clinical Trial. JAMA Oncol. 2020 Jan 1;6(1):e193531. doi: 10.1001/jamaoncol.2019.3531. Epub 2020 Jan 9.

ReferenceCitation: Shitara K, Doi T, Dvorkin M, Mansoor W, Arkenau HT, Prokharau A, Alsina M, Ghidini M, Faustino C, Gorbunova V, Zhavrid E, Nishikawa K, Hosokawa A, Yalçın Ş, Fujitani K, Beretta GD, Cutsem EV, Winkler RE, Makris L, Ilson DH, Tabernero J. Trifluridine/tipiracil versus placebo in patients with heavily pretreated metastatic gastric cancer (TAGS): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2018 Nov;19(11):1437-1448. doi: 10.1016/S1470-2045(18)30739-3. Epub 2018 Oct 21. Erratum in: Lancet Oncol. 2018 Dec;19(12):e668.

ReferenceCitation: Bando H, Doi T, Muro K, Yasui H, Nishina T, Yamaguchi K, Takahashi S, Nomura S, Kuno H, Shitara K, Sato A, Ohtsu A. A multicenter phase II study of TAS-102 monotherapy in patients with pre-treated advanced gastric cancer (EPOC1201). Eur J Cancer. 2016 Jul;62:46-53. doi: 10.1016/j.ejca.2016.04.009. Epub 2016 May 19.

location_country:
Poland
Portugal
Belarus
Romania
Ireland
Italy
Russian Federation
Spain
Canada
United Kingdom
United States
France
Israel
Turkey
Belgium
Japan
Germany
Czechia

location_facility: IRCCS Centro di Riferimento Oncologico - Aviano

location_facility: Centro Hospitalar de Tras-os-Montes e Alto Douro, EPE

location_facility: University of Pittsburgh Medical Cancer Center

location_facility: Fondazione Poliambulanza Istituto Ospedaliero

location_facility: Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology

location_facility: University of Southern California - Keck School of Medicine

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

location_facility: Ankara University Medical Faculty Cebeci Hospital

location_facility: Szpital MSWiA i Warminsko - Mazurskim Centrum Onkologii w Olsztynie

location_facility: Bezmialem Vakif Üniversitesi Tip Fakültesi Hastanesi

location_facility: Republican center for oncology and medical radiology n.a. Alexandrov

location_facility: N.N. Blokhin Russian Cancer Research Center

location_facility: Górnoslaskie Centrum Medyczne im. prof. Leszka Gieca

location_facility: Dartmouth-Hitchcock Medical Center (DHMC)

location_facility: North-Western State Medical University n.a. I.I. Mechnikov

location_facility: Budget Institution of Healthcare Omsk Region -Clinical Oncology Dispensary

location_facility: Baskent University Adana Practice and Research Centre Kisla

location_facility: N.N.Petrov Research Institute of Oncology

location_facility: Marmara University Pendik Training and Research Hospital

location_facility: Staedtisches Krankenhaus Muenchen Neuperlach

location_facility: Alta Bates Summit Comprehensive Cancer Center

location_facility: The Adelaide and Meath Hospital, Dublin, Incorporating The National Children's Hospital

location_facility: AP-HP - HU La Pitié-Salpêtrière - Charles-Foix

location_facility: Spitalul Judetean de Urgenta "Sfantul Ioan cel Nou" Suceava

location_facility: IRCCS - Istituto Scientifico Romagnolo Per lo Studio e la Cura Dei Tumori (I.R.S.T.)

location_facility: Gomel Regional Clinical Oncology Dispensary

location_facility: A.O. della Valtellina e della Valchiavenna Ospedale di Sondrio

location_facility: Azienda Ospedaliero - Universitaria Careggi

location_facility: A.O.U. Seconda Universita'degli Studi di Napoli

location_facility: Dokuz Eylul University Oncology Institute

location_facility: Diskapi Yildirim Beyazit Training and Research Hospital

location_facility: Guy's and St Thomas' NHS Foundation Trust

location_facility: Azienda Ospedaliero Universitaria Pisana (AOUP)

location_facility: Unidade Local de Saúde de Matosinhos E.P.E.- H. Pedro Hispano

location_facility: Trakya University Medical Faculty Hospital

location_facility: Belfast Health and Social Care Trust - Belfast City Hospital

location_facility: Hospital Universitario Central de Asturias

location_facility: Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research


title: A Long Term, Randomised, Double Blind, Placebo-controlled Study to Determine the Effect of Albiglutide, When Added to Standard Blood Glucose Lowering Therapies, on Major Cardiovascular Events in Patients With Type 2 Diabetes Mellitus

summary: Albiglutide is an analogue of glucagon-like peptide-1 (GLP-1), used to treat type 2 diabetes This study will test whether albiglutide affects the occurrence of major cardiovascular events such as heart attacks or strokes and other important medical outcomes in persons with type 2 diabetes, when used alone or added to other diabetes treatments.

ReferenceCitation: Hernandez AF, Green JB, Janmohamed S, D'Agostino RB Sr, Granger CB, Jones NP, Leiter LA, Rosenberg AE, Sigmon KN, Somerville MC, Thorpe KM, McMurray JJV, Del Prato S; Harmony Outcomes committees and investigators. Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial. Lancet. 2018 Oct 27;392(10157):1519-1529. doi: 10.1016/S0140-6736(18)32261-X. Epub 2018 Oct 2.

ReferenceCitation: O'Brien EC, Raman SR, Ellis A, Hammill BG, Berdan LG, Rorick T, Janmohamed S, Lampron Z, Hernandez AF, Curtis LH. The use of electronic health records for recruitment in clinical trials: a mixed methods analysis of the Harmony Outcomes Electronic Health Record Ancillary Study. Trials. 2021 Jul 19;22(1):465. doi: 10.1186/s13063-021-05397-0.

ReferenceCitation: Green JB, Hernandez AF, D'Agostino RB, Granger CB, Janmohamed S, Jones NP, Leiter LA, Noronha D, Russell R, Sigmon K, Del Prato S, McMurray JJV. Harmony Outcomes: A randomized, double-blind, placebo-controlled trial of the effect of albiglutide on major cardiovascular events in patients with type 2 diabetes mellitus-Rationale, design, and baseline characteristics. Am Heart J. 2018 Sep;203:30-38. doi: 10.1016/j.ahj.2018.03.030. Epub 2018 Jun 12.

ReferenceCitation: Wittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population. Am J Manag Care. 2018 Apr;24(8 Suppl):S146-S155.

lead_sponsor: GlaxoSmithKline

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Peru
Belgium
Philippines
South Africa
Czechia
Poland
Hong Kong
Russian Federation
Argentina
Mexico
Norway
Sweden
Canada
Hungary
Germany
Bulgaria
Denmark
Taiwan
Greece
Thailand
Korea, Republic of
France
Netherlands


title: A Randomized, Multicenter, Double-blind, Placebo-controlled, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib in Combination With Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine, in the First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma

summary: This is a phase 3 study to evaluate the efficacy of ibrutinib in combination with nab-paclitaxel and gemcitabine for the first line treatment of patients with metastatic pancreatic adenocarcinoma.

lead_sponsor: Pharmacyclics LLC.

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

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Chonnam National University Hwasun Hospital

location_facility: Groupe Hospitalier Saint André - Hôpital Saint André

location_facility: Oncology Specialties, PC; Clearview Cancer Institute

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: ICO l´Hospitalet - Hospital Duran i Reynals

location_facility: Gemeinschaftspraxis Haematologie und Onkologie

location_facility: Berkshire Hematology Oncology Services at Berkshire Medical Center Cancer and Infusion Center

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Penn State University Milton S. Hershey Medical Center

location_facility: Azienda Ospedaliero Universitaria San Martino

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: Eastern Connecticut Hematology/Oncology Assoc.

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

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: Azienda Ospedaliera Ospedale Niguarda Ca' Granda

location_facility: Investigative Clinical Research of Indiana

location_facility: Nebraska Medicine - Peggy D. Cowdery Patient Care Center

location_facility: Ingalls Memorial Hospital Cancer Research Center

location_facility: Seoul National University Bundang Hospital

location_facility: MultiCare Health System Institute for Research and Innovation

location_facility: Joliet Oncology-Hematology Associates, LTD


title: Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Ramucirumab and Best Supportive Care (BSC) Versus Placebo and BSC as Second-Line Treatment in Patients With Hepatocellular Carcinoma and Elevated Baseline Alpha-Fetoprotein (AFP) Following First-Line Therapy With Sorafenib

lead_sponsor: Eli Lilly and Company

ReferenceCitation: Shao G, Bai Y, Yuan X, Chen X, Gu S, Gu K, Hu C, Liang H, Guo Y, Wang J, Yen CJ, Lee VH, Wang C, Widau RC, Zhang W, Liu J, Zhang Q, Qin S. Ramucirumab as second-line treatment in Chinese patients with advanced hepatocellular carcinoma and elevated alpha-fetoprotein after sorafenib (REACH-2 China): A randomised, multicentre, double-blind study. EClinicalMedicine. 2022 Oct 6;54:101679. doi: 10.1016/j.eclinm.2022.101679. eCollection 2022 Dec.

ReferenceCitation: Llovet JM, Singal AG, Villanueva A, Finn RS, Kudo M, Galle PR, Ikeda M, Callies S, McGrath LM, Wang C, Abada P, Widau RC, Gonzalez-Gugel E, Zhu AX. Prognostic and Predictive Factors in Patients with Advanced HCC and Elevated Alpha-Fetoprotein Treated with Ramucirumab in Two Randomized Phase III Trials. Clin Cancer Res. 2022 Jun 1;28(11):2297-2305. doi: 10.1158/1078-0432.CCR-21-4000.

ReferenceCitation: Mitani S, Chen Y, Inoue K, Mori J, Gao L, Long A, Wakabayashi S. Clinical Impact of a Shortened Infusion Duration of Ramucirumab in Japanese Patients -A Model-Based Approach. Gan To Kagaku Ryoho. 2021 Nov;48(11):1381-1387.

ReferenceCitation: Trojan J, Mollon P, Daniele B, Marteau F, Martín L, Li Y, Xu Q, Piscaglia F, Zaucha R, Sarker D, Lim HY, Venerito M. Comparative Efficacy of Cabozantinib and Ramucirumab After Sorafenib for Patients with Hepatocellular Carcinoma and Alpha-fetoprotein ≥ 400 ng/mL: A Matching-Adjusted Indirect Comparison. Adv Ther. 2021 May;38(5):2472-2490. doi: 10.1007/s12325-021-01700-2. Epub 2021 Apr 6.

ReferenceCitation: Zhu AX, Finn RS, Kang YK, Yen CJ, Galle PR, Llovet JM, Assenat E, Brandi G, Motomura K, Ohno I, Daniele B, Vogel A, Yamashita T, Hsu CH, Gerken G, Bilbruck J, Hsu Y, Liang K, Widau RC, Wang C, Abada P, Kudo M. Serum alpha-fetoprotein and clinical outcomes in patients with advanced hepatocellular carcinoma treated with ramucirumab. Br J Cancer. 2021 Apr;124(8):1388-1397. doi: 10.1038/s41416-021-01260-w. Epub 2021 Feb 3.

ReferenceCitation: Reig M, Galle PR, Kudo M, Finn R, Llovet JM, Metti AL, Schelman WR, Liang K, Wang C, Widau RC, Abada P, Zhu AX. Pattern of progression in advanced hepatocellular carcinoma treated with ramucirumab. Liver Int. 2021 Mar;41(3):598-607. doi: 10.1111/liv.14731. Epub 2020 Dec 5.

ReferenceCitation: Zhu AX, Nipp RD, Finn RS, Galle PR, Llovet JM, Blanc JF, Okusaka T, Chau I, Cella D, Girvan A, Gable J, Bowman L, Wang C, Hsu Y, Abada PB, Kudo M. Ramucirumab in the second-line for patients with hepatocellular carcinoma and elevated alpha-fetoprotein: patient-reported outcomes across two randomised clinical trials. ESMO Open. 2020 Aug;5(4). pii: e000797. doi: 10.1136/esmoopen-2020-000797.

ReferenceCitation: Kudo M, Okusaka T, Motomura K, Ohno I, Morimoto M, Seo S, Wada Y, Sato S, Yamashita T, Furukawa M, Aramaki T, Nadano S, Ohkawa K, Fujii H, Kudo T, Furuse J, Takai H, Homma G, Yoshikawa R, Zhu AX. Ramucirumab after prior sorafenib in patients with advanced hepatocellular carcinoma and elevated alpha-fetoprotein: Japanese subgroup analysis of the REACH-2 trial. J Gastroenterol. 2020 Jun;55(6):627-639. doi: 10.1007/s00535-020-01668-w. Epub 2020 Feb 27.

ReferenceCitation: Zhu AX, Kang YK, Yen CJ, Finn RS, Galle PR, Llovet JM, Assenat E, Brandi G, Pracht M, Lim HY, Rau KM, Motomura K, Ohno I, Merle P, Daniele B, Shin DB, Gerken G, Borg C, Hiriart JB, Okusaka T, Morimoto M, Hsu Y, Abada PB, Kudo M; REACH-2 study investigators. Ramucirumab after sorafenib in patients with advanced hepatocellular carcinoma and increased α-fetoprotein concentrations (REACH-2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 Feb;20(2):282-296. doi: 10.1016/S1470-2045(18)30937-9. Epub 2019 Jan 18.

ipd_sharing_description:
Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

location_country:
Poland
Taiwan
Brazil
Hong Kong
Spain
Italy
Austria
Australia
United Kingdom
Canada
Switzerland
Korea, Republic of
United States
France
China
Israel
Belgium
Japan
Germany
Czechia

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 Oklahoma Health Sciences Center

location_facility: Hospital Universitari de Girona Dr. Josep Trueta

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: Cenantron - Centro Avançado de Tratamento Oncológico

location_facility: Pacific Hematology and Oncology Associates

summary: The purpose of this study is to evaluate the safety and efficacy of ramucirumab in participants with hepatocellular carcinoma (HCC) and elevated baseline alpha-fetoprotein. Participants will be randomized to ramucirumab or placebo in a 2:1 ratio (Main Global Cohort and China Maximized Extended Enrollment [ME2] Cohort). Participants may also receive ramucirumab if eligible to be enrolled in Open-Label Expansion (OLE) Cohort.


title: A Phase III, Open-Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Bevacizumab Versus Sunitinib in Patients With Untreated Advanced Renal Cell Carcinoma

lead_sponsor: Hoffmann-La Roche

ReferenceCitation: Motzer RJ, Powles T, Atkins MB, Escudier B, McDermott DF, Alekseev BY, Lee JL, Suarez C, Stroyakovskiy D, De Giorgi U, Donskov F, Mellado B, Banchereau R, Hamidi H, Khan O, Craine V, Huseni M, Flinn N, Dubey S, Rini BI. Final Overall Survival and Molecular Analysis in IMmotion151, a Phase 3 Trial Comparing Atezolizumab Plus Bevacizumab vs Sunitinib in Patients With Previously Untreated Metastatic Renal Cell Carcinoma. JAMA Oncol. 2022 Feb 1;8(2):275-280. doi: 10.1001/jamaoncol.2021.5981.

ReferenceCitation: Atkins MB, Rini BI, Motzer RJ, Powles T, McDermott DF, Suarez C, Bracarda S, Stadler WM, Donskov F, Gurney H, Oudard S, Uemura M, Lam ET, Grüllich C, Quach C, Carroll S, Ding B, Zhu QC, Piault-Louis E, Schiff C, Escudier B. Patient-Reported Outcomes from the Phase III Randomized IMmotion151 Trial: Atezolizumab + Bevacizumab versus Sunitinib in Treatment-Naïve Metastatic Renal Cell Carcinoma. Clin Cancer Res. 2020 Jun 1;26(11):2506-2514. doi: 10.1158/1078-0432.CCR-19-2838. Epub 2020 Mar 3.

ReferenceCitation: Rini BI, Powles T, Atkins MB, Escudier B, McDermott DF, Suarez C, Bracarda S, Stadler WM, Donskov F, Lee JL, Hawkins R, Ravaud A, Alekseev B, Staehler M, Uemura M, De Giorgi U, Mellado B, Porta C, Melichar B, Gurney H, Bedke J, Choueiri TK, Parnis F, Khaznadar T, Thobhani A, Li S, Piault-Louis E, Frantz G, Huseni M, Schiff C, Green MC, Motzer RJ; IMmotion151 Study Group. Atezolizumab plus bevacizumab versus sunitinib in patients with previously untreated metastatic renal cell carcinoma (IMmotion151): a multicentre, open-label, phase 3, randomised controlled trial. Lancet. 2019 Jun 15;393(10189):2404-2415. doi: 10.1016/S0140-6736(19)30723-8. Epub 2019 May 9.

location_country:
Spain
Italy
United Kingdom
United States
Japan
Czechia
Poland
Russian Federation
Australia
Turkey
Mexico
Singapore
Bosnia and Herzegovina
Brazil
Canada
Germany
Denmark
Taiwan
Thailand
Korea, Republic of
France

location_facility: Herlev Hospital; Afdeling for Kræftbehandling

location_facility: Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia

location_facility: Maharaj Nakorn Chiangmai Hospital; Department of Surgery/ Urology unit

location_facility: Sarah Cannon Cancer Center and Research Institute

location_facility: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

location_facility: Songklanagarind Hospital; Department of Oncology

location_facility: Calvary Mater Newcastle; Medical Oncology

location_facility: Klinikum d.Universität München Campus Großhadern

location_facility: Comprehensive Cancer Centers of Nevada - Eastern Avenue

location_facility: Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika

location_facility: Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department

location_facility: Nationales Centrum für Tumorerkrankungen Heidelberg (NCT); Thoraxklinik Heidelberg

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: The Cancer Institute Hospital, JFCR; Urology

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Irccs Ospedale San Raffaele;Oncologia Medica

location_facility: Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica

location_facility: The Ottawa Hospital Cancer Centre; Oncology

location_facility: Institut Paoli Calmettes; Oncologie Medicale

location_facility: Universitätsklinikum Tübingen; Klinik für Urologie

location_facility: Royal Marsden Hospital; Dept of Medical Oncology

location_facility: Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia

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

location_facility: Centre D'Oncologie de Gentilly; Oncology

location_facility: Rocky Mountain Cancer Center; Medical Oncology

location_facility: New York Oncology Hematology,P.C.-Albany

location_facility: Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale

location_facility: Osaka International Cancer Institute; Urology

location_facility: Odense Universitetshospital, Onkologisk Afdeling R

location_facility: Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc

location_facility: Hamilton Health Sciences - Juravinski Cancer Centre

location_facility: Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung

location_facility: Cleveland Clinic Foundation; Taussig Cancer Center

location_facility: National Cancer Centre; Medical Oncology

location_facility: A.O. Universitaria Policlinico Di Modena; Oncologia

location_facility: Niigata University Medical & Dental Hospital

location_facility: Southampton General Hospital; Medical Oncology

location_facility: National Taiwan Uni Hospital; Dept of Oncology

location_facility: Chang Gung Medical Foundation-Linkou, Urinary Oncology

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Queen Elizabeth II Health Sciences Centre; Oncology

location_facility: ALTAI REGIONAL ONCOLOGICAL CENTER; "Nadezhda" Clinic

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Centre Francois Baclesse; Urologie Gynecologie

location_facility: P.A. Herzen Oncological Inst. ; Oncology

location_facility: Az. Osp. Cardarelli; Divisione Di Oncologia

location_facility: Taichung Veterans General Hospital; Division of Urology

location_facility: University of California at Irvine Medical Center; Department of Oncology

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Lynn Cancer Institute/Boca Raton Regional Hospital

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

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

location_facility: University Clinical Centre of the Republic of Srpska

location_facility: Barts Health NHS Trust - St Bartholomew's Hospital

location_facility: Tokyo Medical and Dental University Hospital

location_facility: GBUZ Nizhegorodskay Region: Clinical Diagnostic Center

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: Churchill Hospital; Oxford Cancer and Haematology Centre

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

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Fondazione IRCCS Policlinico San Matteo, Oncologia

location_facility: Institut Gustave Roussy; Departement Oncologie Medicale

location_facility: Szpital Kliniczny; Przemienienia Panskiego;Uniwersytetu Medyczny im.; Karola Marcinkowskiego w Pozna

location_facility: Florida Cancer Specialists - Port Charlotte

location_facility: Addenbrookes Nhs Trust; Oncology Clinical Trials Unit

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

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

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: Texas Oncology-Baylor Sammons Cancer Center

location_facility: Oncology and Hematology Associates of SW Virginia-Raonoke

location_facility: University of Colorado; Anschutz Cancer Pavilion

location_facility: Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Hospital Clínic i Provincial; Servicio de Oncología

summary: This multi-center, randomized, open-label study will evaluate the efficacy and safety of atezolizumab plus bevacizumab versus sunitinib in participants with inoperable, locally advanced, or metastatic RCC who have not received prior systemic active or experimental therapy, either in the adjuvant or metastatic setting.


title: A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Persistent Asthma

summary:
Primary Objective:

To evaluate the efficacy of dupilumab (SAR231893 / REGN668) in participants with persistent asthma.

Secondary Objectives:

To evaluate the safety and tolerability of dupilumab.
To evaluate the effect of dupilumab on improving participant-reported outcomes including health-related quality of life.
To evaluate dupilumab systemic exposure and incidence of anti-drug antibodies.

ReferenceCitation: Castro M, Corren J, Pavord ID, Maspero J, Wenzel S, Rabe KF, Busse WW, Ford L, Sher L, FitzGerald JM, Katelaris C, Tohda Y, Zhang B, Staudinger H, Pirozzi G, Amin N, Ruddy M, Akinlade B, Khan A, Chao J, Martincova R, Graham NMH, Hamilton JD, Swanson BN, Stahl N, Yancopoulos GD, Teper A. Dupilumab Efficacy and Safety in Moderate-to-Severe Uncontrolled Asthma. N Engl J Med. 2018 Jun 28;378(26):2486-2496. doi: 10.1056/NEJMoa1804092. Epub 2018 May 21.

ReferenceCitation: Bourdin A, Virchow JC, Papi A, Lugogo NL, Bardin P, Antila M, Halpin DMG, Daizadeh N, Djandji M, Ortiz B, Jacob-Nara JA, Gall R, Deniz Y, Rowe PJ. Dupilumab efficacy in subgroups of type 2 asthma with high-dose inhaled corticosteroids at baseline. Respir Med. 2022 Oct;202:106938. doi: 10.1016/j.rmed.2022.106938. Epub 2022 Aug 11.

ReferenceCitation: Papi A, Corren J, Castro M, Domingo C, Rogers L, Chapman KR, Jackson DJ, Daizadeh N, Pandit-Abid N, Gall R, Jacob-Nara JA, Rowe PJ, Deniz Y, Ortiz B. Dupilumab reduced impact of severe exacerbations on lung function in patients with moderate-to-severe type 2 asthma. Allergy. 2022 Jul 28. doi: 10.1111/all.15456. [Epub ahead of print]

ReferenceCitation: Wechsler ME, Klion AD, Paggiaro P, Nair P, Staumont-Salle D, Radwan A, Johnson RR, Kapoor U, Khokhar FA, Daizadeh N, Chen Z, Laws E, Ortiz B, Jacob-Nara JA, Mannent LP, Rowe PJ, Deniz Y. Effect of Dupilumab on Blood Eosinophil Counts in Patients With Asthma, Chronic Rhinosinusitis With Nasal Polyps, Atopic Dermatitis, or Eosinophilic Esophagitis. J Allergy Clin Immunol Pract. 2022 Oct;10(10):2695-2709. doi: 10.1016/j.jaip.2022.05.019. Epub 2022 May 28.

ReferenceCitation: Rabe KF, Pavord ID, Castro M, Wechsler ME, Daizadeh N, Kapoor U, Ortiz B, Radwan A, Johnson RR, Rowe PJ, Deniz Y, Jacob-Nara JA. Dupilumab efficacy and safety in patients with asthma and blood eosinophils ≥500 cells·µL(-1). Eur Respir J. 2022 Jun 23;59(6). pii: 2102577. doi: 10.1183/13993003.02577-2021. Print 2022 Jun.

ReferenceCitation: Rhee CK, Park JW, Park HW, Cho YS. Effect of Dupilumab in Korean Patients With Uncontrolled Moderate-to-Severe Asthma: A LIBERTY ASTHMA QUEST Sub-analysis. Allergy Asthma Immunol Res. 2022 Mar;14(2):182-195. doi: 10.4168/aair.2022.14.2.182.

ReferenceCitation: Geng B, Bachert C, Busse WW, Gevaert P, Lee SE, Niederman MS, Chen Z, Lu X, Khokhar FA, Kapoor U, Pandit-Abid N, Jacob-Nara JA, Rowe PJ, Deniz Y, Ortiz B. Respiratory Infections and Anti-Infective Medication Use From Phase 3 Dupilumab Respiratory Studies. J Allergy Clin Immunol Pract. 2022 Mar;10(3):732-741. doi: 10.1016/j.jaip.2021.12.006. Epub 2021 Dec 22.

ReferenceCitation: Tohda Y, Matsumoto H, Miyata M, Taguchi Y, Ueyama M, Joulain F, Arakawa I. Cost-effectiveness analysis of dupilumab among patients with oral corticosteroid-dependent uncontrolled severe asthma in Japan. J Asthma. 2022 Nov;59(11):2162-2173. doi: 10.1080/02770903.2021.1996596. Epub 2021 Dec 8.

ReferenceCitation: Busse WW, Paggiaro P, Muñoz X, Casale TB, Castro M, Canonica GW, Douglass JA, Tohda Y, Daizadeh N, Ortiz B, Pandit-Abid N. Impact of baseline patient characteristics on dupilumab efficacy in type 2 asthma. Eur Respir J. 2021 Oct 7;58(4). pii: 2004605. doi: 10.1183/13993003.04605-2020. Print 2021 Oct.

ReferenceCitation: Corren J, Katelaris CH, Castro M, Maspero JF, Ford LB, Halpin DMG, Rice MS, Radwan A, Deniz Y, Rowe PJ, Teper A, Djandji M. Effect of exacerbation history on clinical response to dupilumab in moderate-to-severe uncontrolled asthma. Eur Respir J. 2021 Oct 28;58(4). pii: 2004498. doi: 10.1183/13993003.04498-2020. Print 2021 Oct.

ReferenceCitation: Busse WW, Wenzel SE, Casale TB, FitzGerald JM, Rice MS, Daizadeh N, Deniz Y, Patel N, Harel S, Rowe PJ, Graham NMH, O'Riordan T, Pavord ID. Baseline FeNO as a prognostic biomarker for subsequent severe asthma exacerbations in patients with uncontrolled, moderate-to-severe asthma receiving placebo in the LIBERTY ASTHMA QUEST study: a post-hoc analysis. Lancet Respir Med. 2021 Oct;9(10):1165-1173. doi: 10.1016/S2213-2600(21)00124-7. Epub 2021 Jun 25.

ReferenceCitation: Hamilton JD, Harel S, Swanson BN, Brian W, Chen Z, Rice MS, Amin N, Ardeleanu M, Radin A, Shumel B, Ruddy M, Patel N, Pirozzi G, Mannent L, Graham NMH. Dupilumab suppresses type 2 inflammatory biomarkers across multiple atopic, allergic diseases. Clin Exp Allergy. 2021 Jul;51(7):915-931. doi: 10.1111/cea.13954. Epub 2021 Jun 26.

ReferenceCitation: Maspero JF, FitzGerald JM, Pavord ID, Rice MS, Maroni J, Rowe PJ, Pirozzi G, Amin N, Ruddy M, Graham NMH, Teper A, Hardin M. Dupilumab efficacy in adolescents with uncontrolled, moderate-to-severe asthma: LIBERTY ASTHMA QUEST. Allergy. 2021 Aug;76(8):2621-2624. doi: 10.1111/all.14872. Epub 2021 May 10.

ReferenceCitation: Bansal A, Simpson EL, Paller AS, Siegfried EC, Blauvelt A, de Bruin-Weller M, Corren J, Sher L, Guttman-Yassky E, Chen Z, Daizadeh N, Kamal MA, Shumel B, Mina-Osorio P, Mannent L, Patel N, Graham NMH, Khokhar FA, Ardeleanu M. Conjunctivitis in Dupilumab Clinical Trials for Adolescents with Atopic Dermatitis or Asthma. Am J Clin Dermatol. 2021 Jan;22(1):101-115. doi: 10.1007/s40257-020-00577-1.

ReferenceCitation: Bourdin A, Papi AA, Corren J, Virchow JC, Rice MS, Deniz Y, Djandji M, Rowe P, Pavord ID. Dupilumab is effective in type 2-high asthma patients receiving high-dose inhaled corticosteroids at baseline. Allergy. 2021 Jan;76(1):269-280. doi: 10.1111/all.14611. Epub 2020 Oct 21.

ReferenceCitation: Tohda Y, Nakamura Y, Fujisawa T, Ebisawa M, Arima K, Miyata M, Takahashi Y, Rice MS, Deniz Y, Rowe P, Patel N, Graham NMH, Teper A. Dupilumab efficacy and safety in Japanese patients with uncontrolled, moderate-to-severe asthma in the phase 3 LIBERTY ASTHMA QUEST study. Allergol Int. 2020 Oct;69(4):578-587. doi: 10.1016/j.alit.2020.04.002. Epub 2020 May 20.

ReferenceCitation: Corren J, Castro M, O'Riordan T, Hanania NA, Pavord ID, Quirce S, Chipps BE, Wenzel SE, Thangavelu K, Rice MS, Harel S, Jagerschmidt A, Khan AH, Kamat S, Maroni J, Rowe P, Lu Y, Amin N, Pirozzi G, Ruddy M, Graham NMH, Teper A. Dupilumab Efficacy in Patients with Uncontrolled, Moderate-to-Severe Allergic Asthma. J Allergy Clin Immunol Pract. 2020 Feb;8(2):516-526. doi: 10.1016/j.jaip.2019.08.050. Epub 2019 Sep 12.

ReferenceCitation: Maspero JF, Katelaris CH, Busse WW, Castro M, Corren J, Chipps BE, Peters AT, Pavord ID, Ford LB, Sher L, Rabe KF, Rice MS, Rowe P, Lu Y, Harel S, Jagerschmidt A, Khan AH, Kamat S, Pirozzi G, Amin N, Ruddy M, Graham NMH, Mannent LP, Teper A. Dupilumab Efficacy in Uncontrolled, Moderate-to-Severe Asthma with Self-Reported Chronic Rhinosinusitis. J Allergy Clin Immunol Pract. 2020 Feb;8(2):527-539.e9. doi: 10.1016/j.jaip.2019.07.016. Epub 2019 Jul 24.

ReferenceCitation: Corren J, Castro M, Chanez P, Fabbri L, Joish VN, Amin N, Graham NMH, Mastey V, Abbé A, Taniou C, Mahajan P, Teper A, Pirozzi G, Eckert L. Dupilumab improves symptoms, quality of life, and productivity in uncontrolled persistent asthma. Ann Allergy Asthma Immunol. 2019 Jan;122(1):41-49.e2. doi: 10.1016/j.anai.2018.08.005. Epub 2018 Aug 21.

ReferenceCitation: Busse WW, Maspero JF, Rabe KF, Papi A, Wenzel SE, Ford LB, Pavord ID, Zhang B, Staudinger H, Pirozzi G, Amin N, Akinlade B, Eckert L, Chao J, Graham NMH, Teper A. Liberty Asthma QUEST: Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Dupilumab Efficacy/Safety in Patients with Uncontrolled, Moderate-to-Severe Asthma. Adv Ther. 2018 May;35(5):737-748. doi: 10.1007/s12325-018-0702-4. Epub 2018 May 3.

ReferenceCitation: Weinstein SF, Katial R, Jayawardena S, Pirozzi G, Staudinger H, Eckert L, Joish VN, Amin N, Maroni J, Rowe P, Graham NMH, Teper A. Efficacy and safety of dupilumab in perennial allergic rhinitis and comorbid asthma. J Allergy Clin Immunol. 2018 Jul;142(1):171-177.e1. doi: 10.1016/j.jaci.2017.11.051. Epub 2018 Jan 31.

lead_sponsor: Sanofi

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
South Africa
Japan
Poland
Russian Federation
Australia
Argentina
Turkey
Mexico
Brazil
Canada
Hungary
Germany
Taiwan
Korea, Republic of
France
Chile
Colombia

location_facility:
Investigational Site Number 392162
Investigational Site Number 158004
Investigational Site Number 152012
Investigational Site Number 158007
Investigational Site Number 840116
Investigational Site Number 840094
Investigational Site Number 392136
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Investigational Site Number 724005
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Investigational Site Number 124001
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Investigational Site Number 250004
Investigational Site Number 392134
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Investigational Site Number 124006
Investigational Site Number 792001
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Investigational Site Number 840100
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Investigational Site Number 158009
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Investigational Site Number 840089
Investigational Site Number 804011
Investigational Site Number 036006
Investigational Site Number 032007
Investigational Site Number 792003
Investigational Site Number 792005
Investigational Site Number 840056
Investigational Site Number 250010
Investigational Site Number 840036
Investigational Site Number 840111
Investigational Site Number 840019
Investigational Site Number 710001
Investigational Site Number 250014
Investigational Site Number 840008
Investigational Site Number 380001
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Investigational Site Number 250002
Investigational Site Number 792011
Investigational Site Number 276010
Investigational Site Number 804016
Investigational Site Number 392119
Investigational Site Number 840115
Investigational Site Number 840010
Investigational Site Number 036005
Investigational Site Number 392127
Investigational Site Number 392142
Investigational Site Number 392158
Investigational Site Number 643001
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Investigational Site Number 036002
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Investigational Site Number 616009
Investigational Site Number 152008
Investigational Site Number 643006
Investigational Site Number 032001
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Investigational Site Number 170003
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Investigational Site Number 840028
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Investigational Site Number 076009
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Investigational Site Number 484008
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Investigational Site Number 392110
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Investigational Site Number 276005
Investigational Site Number 840064
Investigational Site Number 643013
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Investigational Site Number 840032
Investigational Site Number 276003
Investigational Site Number 840122
Investigational Site Number 484001
Investigational Site Number 792002
Investigational Site Number 392107
Investigational Site Number 840003
Investigational Site Number 804006
Investigational Site Number 484014
Investigational Site Number 392186
Investigational Site Number 840037
Investigational Site Number 643011
Investigational Site Number 840083
Investigational Site Number 380009
Investigational Site Number 410011
Investigational Site Number 380011
Investigational Site Number 392129
Investigational Site Number 032002
Investigational Site Number 124009
Investigational Site Number 124015
Investigational Site Number 410001
Investigational Site Number 804002
Investigational Site Number 840107
Investigational Site Number 152014
Investigational Site Number 410010
Investigational Site Number 792004
Investigational Site Number 076006
Investigational Site Number 840042
Investigational Site Number 616003
Investigational Site Number 840011
Investigational Site Number 710005
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title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

acronym: UNIFI

summary: The purpose of this study is to evaluate the efficacy and safety of ustekinumab as intravenous (IV: into the vein) infusion in induction study in participants with moderately to severely active Ulcerative Colitis (UC) and as subcutaneous (SC) administration in maintenance study in participants with moderately to severely active Ulcerative Colitis (UC) who have demonstrated a clinical response to Induction treatment with IV ustekinumab.

ReferenceCitation: Danese S, Sands BE, Abreu MT, O'Brien CD, Bravatà I, Nazar M, Miao Y, Wang Y, Rowbotham D, Leong RWL, Arasaradnam RP, Afif W, Marano C. Early Symptomatic Improvement After Ustekinumab Therapy in Patients With Ulcerative Colitis: 16-Week Data From the UNIFI Trial. Clin Gastroenterol Hepatol. 2022 Mar 8. pii: S1542-3565(22)00207-5. doi: 10.1016/j.cgh.2022.02.050. [Epub ahead of print]

ReferenceCitation: Panaccione R, Danese S, Sandborn WJ, O'Brien CD, Zhou Y, Zhang H, Adedokun OJ, Tikhonov I, Targan S, Abreu MT, Hisamatsu T, Scherl EJ, Leong RW, Rowbotham DS, Arasaradnam RP, Sands BE, Marano C. Ustekinumab is effective and safe for ulcerative colitis through 2 years of maintenance therapy. Aliment Pharmacol Ther. 2020 Dec;52(11-12):1658-1675. doi: 10.1111/apt.16119. Epub 2020 Oct 21. Erratum in: Aliment Pharmacol Ther. 2021 May;53(9):1057-1060. Aliment Pharmacol Ther. 2021 Nov;54(9):1221-1222.

ReferenceCitation: Sandborn WJ, Feagan BG, Danese S, O'Brien CD, Ott E, Marano C, Baker T, Zhou Y, Volger S, Tikhonov I, Gasink C, Sands BE, Ghosh S. Safety of Ustekinumab in Inflammatory Bowel Disease: Pooled Safety Analysis of Results from Phase 2/3 Studies. Inflamm Bowel Dis. 2021 Jun 15;27(7):994-1007. doi: 10.1093/ibd/izaa236. Erratum in: Inflamm Bowel Dis. 2021 Jun 15;27(7):1175.

ReferenceCitation: Li K, Marano C, Zhang H, Yang F, Sandborn WJ, Sands BE, Feagan BG, Rubin DT, Peyrin-Biroulet L, Friedman JR, De Hertogh G. Relationship Between Combined Histologic and Endoscopic Endpoints and Efficacy of Ustekinumab Treatment in Patients With Ulcerative Colitis. Gastroenterology. 2020 Dec;159(6):2052-2064. doi: 10.1053/j.gastro.2020.08.037. Epub 2020 Aug 25.

ReferenceCitation: Sands BE, Sandborn WJ, Panaccione R, O'Brien CD, Zhang H, Johanns J, Adedokun OJ, Li K, Peyrin-Biroulet L, Van Assche G, Danese S, Targan S, Abreu MT, Hisamatsu T, Szapary P, Marano C; UNIFI Study Group. Ustekinumab as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2019 Sep 26;381(13):1201-1214. doi: 10.1056/NEJMoa1900750.

location_country:
Serbia
United Kingdom
Ukraine
United States
Romania
Belgium
Japan
Czechia
Poland
Austria
Australia
Russian Federation
Israel
Slovakia
Canada
Hungary
Germany
Bulgaria
Denmark
New Zealand
Korea, Republic of
France
Netherlands


title: A Phase III Open-Label, Multicenter Trial of Avelumab (MSB0010718C) Versus Docetaxel in Subjects With Non-Small Cell Lung Cancer That Has Progressed After a Platinum-Containing Doublet

lead_sponsor: EMD Serono Research & Development Institute, Inc.

ReferenceCitation: Coon CD, Schlichting M, Zhang X. Interpreting Within-Patient Changes on the EORTC QLQ-C30 and EORTC QLQ-LC13. Patient. 2022 Nov;15(6):691-702. doi: 10.1007/s40271-022-00584-w. Epub 2022 Jun 30.

ReferenceCitation: Hrinczenko B, Iannotti N, Goel S, Spigel D, Safran H, Taylor MH, Bennouna J, Wong DJ, Kelly K, Verschraegen C, Bajars M, Manitz J, Ruisi M, Gulley JL. Long-term avelumab in advanced non-small-cell lung cancer: summaries and post hoc analyses from JAVELIN Solid Tumor. Future Oncol. 2022 Apr;18(11):1333-1342. doi: 10.2217/fon-2021-0930. Epub 2022 Feb 11.

ReferenceCitation: Park K, Özgüroğlu M, Vansteenkiste J, Spigel D, Yang JC, Bajars M, Ruisi M, Manitz J, Barlesi F. Impact of subsequent immune checkpoint inhibitor treatment on overall survival with avelumab vs docetaxel in platinum-treated advanced NSCLC: Post hoc analyses from the phase 3 JAVELIN Lung 200 trial. Lung Cancer. 2021 Apr;154:92-98. doi: 10.1016/j.lungcan.2021.01.026. Epub 2021 Feb 6.

ReferenceCitation: Barlesi F, Vansteenkiste J, Spigel D, Ishii H, Garassino M, de Marinis F, Özgüroğlu M, Szczesna A, Polychronis A, Uslu R, Krzakowski M, Lee JS, Calabrò L, Arén Frontera O, Ellers-Lenz B, Bajars M, Ruisi M, Park K. Avelumab versus docetaxel in patients with platinum-treated advanced non-small-cell lung cancer (JAVELIN Lung 200): an open-label, randomised, phase 3 study. Lancet Oncol. 2018 Nov;19(11):1468-1479. doi: 10.1016/S1470-2045(18)30673-9. Epub 2018 Sep 24. Erratum in: Lancet Oncol. 2018 Nov;19(11):e581.

ipd_sharing_description: Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html

location_country:
Croatia
Spain
Italy
United Kingdom
United States
Peru
Romania
Belgium
Japan
South Africa
Czechia
Poland
Russian Federation
Australia
Argentina
Israel
Turkey
Mexico
Slovakia
Brazil
Switzerland
Hungary
Bulgaria
Denmark
Taiwan
Korea, Republic of
France
Chile
Colombia

location_facility: The Center for Cancer and Blood Disorders

location_facility: Clinica Colsanitas S.A. sede Clinica Universitaria Colombia

location_facility: Chonnam National University Hwasun Hospital

location_facility: Konya Necmettin Erbakan University Meram Faculty of Medicine

location_facility: Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: CITO - Centro Integrado de Terapia Onco-Hematológica - Hospital da Cidade de Passo Fundo

location_facility: Hematology Oncology Associates of Rockland

location_facility: Osaka Prefectural Medical Center for Respiratory and Allergic Diseases

location_facility: Univerzitna nemocnica Bratislava, Nemocnica Ruzinov

location_facility: Kobe City Hospital Organization Kobe City Medical Center General Hospital

location_facility: Oncosinos - Clínica de Oncologia - Hospital Regina

location_facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque

location_facility: FSBHI Clinical research institute of phthisiopulmonology

location_facility: Centro de Investigacion Clinica Chapultepec S.A. de C.V.

location_facility: SHI "Republican Clinical Oncological Dispensary of HM RT"

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

location_facility: University Clinic for Pulmonary Diseases

location_facility: CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Clinical Hospital Centar "Sestre Milosrdnice"

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

location_facility: Spitalul Clinic Municipal "Dr. Gavril Curteanu" Oradea

location_facility: ICO l´Hospitalet - Hospital Duran i Reynals

location_facility: ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 5 SUM

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: University of Texas Health Science Center at Tyler

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

location_facility: Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna

location_facility: Nemocnica s poliklinikou Sv. Jakuba, n.o. Bardejov

location_facility: A.O.U. Senese Policlinico Santa Maria alle Scotte

location_facility: Istituto Nazionale Tumori Regina Elena IRCCS

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: Seconda Università degli Studi di Napoli

location_facility: Ustredna vojenska nemocnica SNP Ruzomberok- Fakultna nemocnica

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Azienda Ospedaliera Ospedale Treviglio-Caravaggio di Treviglio

location_facility: Instituto de Terapias Oncologicas Providencia

location_facility: Miskolci Semmelweis Korhaz es Egyetemi Oktatokorhaz

location_facility: Centro Oncologico Riojano Integral (Cori)

location_facility: Liga Norte-Rio-Grandense Contra o Câncer

location_facility: CIEC - Centro Internacional de Estudios Clínicos

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

location_facility: Complex Oncological Center - Plovdiv, EOOD

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

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

location_facility: FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"

location_facility: Clínica Universitaria Privada Reina Fabiola

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

location_facility: Phylasis Clinicas Research S de RL de CV

location_facility: Hospital Nacional Guillermo Almenara Irigoyen

location_facility: Hospital Nacional Almanzor Aguinaga Asenjo

location_facility: Hospital General Universitario de Alicante

location_facility: Cenantron - Centro Avançado de Tratamento Oncológico S/C Ltda

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

location_facility: Instituto Clinico Oncologico del Sur (ICOS)

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Bezmi Alem Foundation University Medical Faculty Hospital

location_facility: Marmara University Pendik Research and Training Center

location_facility: Penn State Univ. Milton S. Hershey Medical Center

location_facility: CEPON - Centro de Pesquisas Oncológicas de Santa Catarina

location_facility: Hospital Nacional Adolfo Guevara Velasco

location_facility: ICO Badalona - Hospital Germans Trias i Pujol

location_facility: Seoul National University Bundang Hospital

location_facility: University of Pretoria Oncology Department

location_facility: Centro de Oncologia e Investigacion Buenos Aires

location_facility: Health Pharma Professional Research S.A. de C.V.

location_facility: Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza

location_facility: Azienda Ospedaliera Istituti Ospitalieri di Cremona

location_facility: Centro de Investigaciones Clinicas Viña del Mar

location_facility: Instituto Nacional de Cancerologia E.S.E.

location_facility: Oaxaca Site Management Organization S.C.

location_facility: IPS IMAT- Instituto Medico de Alta Tecnologia - Oncomedica S.A.

location_facility: Osaka Medical Center for Cancer and Cardiovascular Diseases

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: Hospital Universitario Materno-Infantil de Canarias

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: IOS - Instituto de Oncologia de Sorocaba "Dr. Gilson Delgado"

location_facility: Institute of Biomedical Research and Innovation Hospital

location_facility: Instituto Nacional de Enfermedades Neoplásicas

location_facility: Royal Devon and Exeter Hospital (Wonford)

location_facility: SHBI Moscow Clinical Scientific Center of Department of Healthcare of Moscow

location_facility: Fundacion Cardioinfantil Instituto de Cardiologia

summary: The main purpose of this study was to demonstrate superiority with regard to overall survival of avelumab versus docetaxel in participants with programmed death ligand 1 (PD-L1) positive, non-small cell lung cancer (NSCLC) after failure of a platinum-based doublet.