title: A Phase 2 Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus

acronym: SLEek

summary: The main objective of this study is to evaluate the safety and efficacy of elsubrutinib, upadacitinib, and ABBV-599 vs placebo for the treatment of signs and symptoms of Systemic Lupus Erythematosus (SLE) in participants with moderately to severely active SLE and to define doses for further development.

ReferenceCitation: Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3:CD007478. doi: 10.1002/14651858.CD007478.pub2.

name: Dermatologist, Masters of Public Health Program; Harvard School of Public Health; Boston Massachusetts USA

family: Hannon

full_name: Cora W Hannon

given: Cora W

name: Department of Dermatology; Royal Victoria Hospital; Belfast UK

family: McCourt

full_name: Collette McCourt

given: Collette

name: Department of Dermatology, Clinical Unit for Research Trials and Outcomes in Skin (CURTIS); Massachusetts General Hospital; Boston Massachusetts USA

family: Lima

full_name: Hermenio C Lima

given: Hermenio C

name: Emory University Hospital; Emory Healthcare; Atlanta Georgia USA

family: Chen

full_name: Suephy Chen

given: Suephy

name: Office of Research and Innovation; Royal College of Surgeons in Ireland Coláiste Ríoga na Máinleá in Éirinn; Dublin Ireland

family: Bennett

full_name: Cathy Bennett

given: Cathy

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

location_country:
Australia
Taiwan
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Colombia
Netherlands
Bulgaria
Hungary
Puerto Rico
China
United States
Germany
United Kingdom
Italy
Mexico
New Zealand
Spain

location_facility: Clinica Universitaria Bolivari /ID# 211897

location_facility: Ohio State University - Wexner Medical Center /ID# 211636

location_facility: Vrije Universiteit Medisch Centrum /ID# 214424

location_facility: Diex Recherche Sherbrooke Inc. /ID# 217734

location_facility: Taipei Medical University Hospital /ID# 221600

location_facility: CHU Bordeaux - Hopital Pellegrin /ID# 211832

location_facility: Rheumatology, Arthritis & Immunology Clinic /ID# 214765

location_facility: NYU Langone Ambulatory Care Brooklyn Heights /ID# 211548

location_facility: University of Colorado Hospital /ID# 211314

location_facility: Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant Anna /ID# 211861

location_facility: AZ Arthritis and Rheumotology Research, PLLC /ID# 214267

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz /ID# 216971

location_facility: WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 212482

location_facility: Centro de Enfermedades del Hígado y Aparato Digestivo /ID# 211634

location_facility: The Queen Elizabeth Hospital /ID# 211901

location_facility: Deerbrook Medical Associates /ID# 212251

location_facility: Hospital Universitario de Galdakao /ID# 212803

location_facility: Hamilton Health Sciences - McMaster University Medical Centre /ID# 212662

location_facility: Universitaetsklinikum Duesseldorf /ID# 212408

location_facility: University of Iowa Hospitals and Clinics /ID# 215246

location_facility: Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. /ID# 212146

location_facility: Centro de Investigacion en Reumatologia CIREEM /ID# 211895

location_facility: The Lundquist Institute at Harbor-UCLA Medical Center /ID# 213402

location_facility: National Taiwan University Hospital /ID# 211752

location_facility: Arizona Arthritis & Rheumatology Research, PLLC /ID# 214522

location_facility: Rheumatology and Pulmonary Clinic /ID# 211398

location_facility: Instituto de Investigaciones Clinicas Tucuman /ID# 211942

location_facility: Trinity Universal Research Associates - Carrollton /ID# 211527

location_facility: CHU Strasbourg - Hopital Civil /ID# 211981

location_facility: Rheumatology Research Unit Sunshine Coast /ID# 211902

location_facility: The Center for Rheumatology and Bone Research /ID# 211610

location_facility: Guy's and St Thomas' NHS Foundation Trust /ID# 211931

location_facility: Hospital Universitario Virgen de Valme /ID# 212721

location_facility: Chonnam National University Hospital /ID# 211695

location_facility: Centro de Estudios de Investigación Básica y Clínica, S.C. /ID# 212532

location_facility: CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 211875

location_facility: Hospital Universitario y Politecnico La Fe /ID# 211720

location_facility: Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 212195

location_facility: Beth Israel Deaconess Medical Center /ID# 212321

location_facility: Consultorio Medico Dra. Rivera /ID# 221885

location_facility: National Hospital Organization Asahikawa Medical Center /ID# 213846

location_facility: Linkou Chang Gung Memorial Ho /ID# 211751

location_facility: St. Josephs Health Care Centre /ID# 212331

location_facility: Hospital Universitario 12 de Octubre /ID# 211757

location_facility: Seoul National University Hospital /ID# 211740

location_facility: Aprillus Asistencia e Investigacion /ID# 211630

location_facility: West Texas Clinical Research /ID# 211529

location_facility: Kumamoto Shinto General Hospital /ID# 215347

location_facility: Centro Medico Privado de Reumatologia /ID# 212714

location_facility: EIRAKU Internal Medicine Clinic /ID# 215419

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 211829

location_facility: Valerius Medical Group & Research Center /ID# 211599

location_facility: Arthritis and Rheumatism Associates /ID# 211411

location_facility: People's Hospital of Xinjiang /ID# 211821

location_facility: Cambridge University Hospitals NHS Foundation Trust /ID# 213189

location_facility: Huashan Hospital of Fudan University /ID# 213976

location_facility: Universitair Medisch Centrum Utrecht /ID# 214415

location_facility: Royal Brisbane and Women's Hospital /ID# 212667

location_facility: Arthritis & Osteo Medical Ctr /ID# 228235

location_facility: Peking Union Medical College Hospital /ID# 211614

location_facility: Ctr Int de Reum del Caribe SAS /ID# 211894

location_facility: Centrum Medyczne Pratia Warszawa /ID# 218176

location_facility: Leids Universitair Medisch Centrum /ID# 214413

location_facility: Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 212770

location_facility: Ctr Arthritis & Rheumatic Dise /ID# 212326

location_facility: Hospital Universitario A Coruna - CHUAC /ID# 211719

location_facility: Centro Integral en Reumatologia S.A de C.V /ID# 211876

location_facility: Orszagos Reumatologiai es Fizioterapias Intezet /ID# 211827

location_facility: Medstar Health Research Institute /ID# 213335

location_facility: Xiangya Hospital Central South University /ID# 212919

location_facility: Fukushima Medical University Hospital /ID# 213913

location_facility: China Medical University Hospital /ID# 212179

location_facility: Morales Vargas Centro de Investigacion S.C. /ID# 212946

location_facility: Medical Care & Research SA de CV /ID# 212682

location_facility: Virginia Mason Medical Center /ID# 211457

location_facility: Hospital Interzonal General de Agudos General Jose de San Martin /ID# 211679

location_facility: ASST Gaetano Pini/Presidio Ospedaliero Pini /ID# 215063

location_facility: AZ Arthritis and Rheumotology Research, PLLC /ID# 211329

location_facility: RM Pharma Specialists S.A de C.V /ID# 211879

location_facility: KonKuk University Medical Center /ID# 213410

location_facility: Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich /ID# 221685

location_facility: Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 212483

location_facility: Inland Rheum Clin Trials Inc. /ID# 213617

location_facility: Manchester University NHS Foundation Trust /ID# 211838

location_facility: Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 211988

location_facility: Premier Rheumatology of Oklahoma /ID# 213850

location_facility: West Broward Rheumatology Associates /ID# 211881

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 212674

location_facility: Guangdong Provincial People's Hospital /ID# 211811

location_facility: Arthritis & Rheumatic Disease Specialties /ID# 214052

location_facility: East Bay Rheumatology Medical /ID# 211638

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 212042

location_facility: Centro de Alta Especialidad en Reumatología e Investigación del Potosí, SC /ID# 212737

location_facility: Hospital Universitario Basurto /ID# 212722

location_facility: Hospital of the University of Occupational and Environmental Health, Japan /ID# 217548

location_facility: IRIS Research and Development, LLC /ID# 213053

location_facility: Taipei Veterans General Hosp /ID# 212216

location_facility: St Vincent's Hospital Melbourne /ID# 212311

location_facility: GCM Medical Group PSC - Hato Rey /ID# 211251

location_facility: Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 213694

location_facility: Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 211858

location_facility: Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 212145

location_facility: Taichung Veterans General Hospital /ID# 211957

location_facility: NYU Langone Orthopedic Center /ID# 213620

location_facility: Accurate Clinical Management /ID# 213571


title: Interventional, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Delayed-Start Study to Evaluate the Efficacy and Safety of Eptinezumab in Patients With Episodic Cluster Headache

acronym: ALLEVIATE

summary: The purpose of this study is to evaluate the efficacy of eptinezumab in participants with episodic Cluster Headache (eCH)

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: H. Lundbeck A/S

location_country:
Italy
Sweden
Spain
Germany
Finland
France
Czechia
Greece
Georgia
Russian Federation
Portugal
Estonia
Denmark
United States
United Kingdom

location_facility: First Moscow State Medical University named after I.M. Sechenov

location_facility: Michigan Headache and Neurological Institute

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Hospitalsenhed Midt og Regionshospitalet Viborg

location_facility: Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS

location_facility: City Hospital No. 33 of the Leninsky District of the city of Nizhny Novgorod

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: New England Institute for Neurology and Headache

location_facility: Centre Hospitalier Universitaire de Saint-Étienne

location_facility: Archangel Saint Michael Multiprofile Clinical Hospital

location_facility: Centro Hospitalar Universitario Lisboa Norte - Hospital De Santa Maria

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: Perm State Medical University n.a. Academician E.A. Wagner

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: General Hospital of Patras Agios Andreas

location_facility: Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele Pisana

location_facility: Azienda Ospedaliero - Universitaria Careggi

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Multicentre, Prospective, Randomized, Open-label, Assessor Blinded Study to Evaluate Granulox® Used as Adjunct Therapy to Defined Standard of Care vs. Defined Standard of Care for the Treatment of Predominantly Chronic Venous Leg Ulcers (VLUs)

summary:
The investigation is designed as an open label, randomized, prospective, assessor blinded, multi centre investigation.

254 evaluable subjects will be randomized to either standard of care group or standard of care with Granulox added as an adjunct therapy in predominantly venous leg ulcer subjects. Standard of care wound management will be completed, including wound cleansing, debridement if necessary and application of a suitable dressing and compression system until complete wound closure.

The study will be divided into two phases. Firstly, a two week run-in period to ensure compliance to compression therapy followed by a 20 weeks treatment period starting with randomization and allocation of treatment.

ipd_sharing: No

lead_sponsor: Molnlycke Health Care AB

location_country:
Croatia
Czechia
France
Poland
Hungary
Germany
United Kingdom

location_facility: Debreceni Egyetem, Klinikai Kozpont, Borgyogyaszati Klinika

location_facility: Hull University Teaching Hospitals NHS Trust

location_facility: MDC Clinic Egészégugyi és Diagnosztikai Központ

location_facility: Szpital Uniwersytecki nr 1 im. dr. A. Jurasza w Bydgoszczy Poradnia Leczenia Ran Przewleklych

location_facility: Markhot Ferenc oktatókórház és rendelöintézet

location_facility: Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus - Klinik fuer Dermatologie

location_facility: Department od Dermatology, Venerology and Allergology, University of Essen

intervention_type: Device


ReferenceType: derived

ReferenceCitation: Bachelot T, Ciruelos E, Schneeweiss A, Puglisi F, Peretz-Yablonski T, Bondarenko I, Paluch-Shimon S, Wardley A, Merot JL, du Toit Y, Easton V, Lindegger N, Miles D; PERUSE investigators. Preliminary safety and efficacy of first-line pertuzumab combined with trastuzumab and taxane therapy for HER2-positive locally recurrent or metastatic breast cancer (PERUSE). Ann Oncol. 2019 May 1;30(5):766-773. doi: 10.1093/annonc/mdz061.

family: Bachelot

full_name: T. Bachelot

given: T.

sequence: first

family: Ciruelos

full_name: E. Ciruelos

given: E.

sequence: additional

family: Schneeweiss

full_name: A. Schneeweiss

given: A.

family: Puglisi

full_name: F. Puglisi

given: F.

family: Peretz-Yablonski

full_name: T. Peretz-Yablonski

family: Bondarenko

full_name: I. Bondarenko

given: I.

family: Paluch-Shimon

full_name: S. Paluch-Shimon

given: S.

family: Wardley

full_name: A. Wardley

family: Merot

full_name: J.-L. Merot

family: du Toit

full_name: Y. du Toit

given: Y.

family: Easton

full_name: V. Easton

given: V.

family: Lindegger

full_name: N. Lindegger

given: N.

family: Miles

full_name: D. Miles

given: D.

family: Bouzid

full_name: Kamel Bouzid

given: Kamel

family: Campone

full_name: Mario Campone

given: Mario

family: Coudert

full_name: Bruno Coudert

given: Bruno

family: Nowecki

full_name: Zbigniew Nowecki

given: Zbigniew

family: Errihani

full_name: Hassan Errihani

given: Hassan

family: Dalenc

full_name: Florence Dalenc

given: Florence

family: Ferreira

full_name: Ana Ferreira

given: Ana

family: Mano

full_name: Max Mano

given: Max

family: Ricci

full_name: Francesco Ricci

given: Francesco

family: Kalofonos

full_name: Haralabos Kalofonos

given: Haralabos

family: Andreetta

full_name: Claudia Andreetta

given: Claudia

family: Montemurro

full_name: Filippo Montemurro

given: Filippo

location_country:
Peru
Finland
Greece
Australia
Belgium
Ukraine
Ecuador
Morocco
Pakistan
Uruguay
France
Poland
Lithuania
Argentina
Canada
Slovenia
Turkey
Sweden
United Arab Emirates
Saudi Arabia
Hong Kong
Netherlands
Hungary
Algeria
China
Portugal
Germany
United Kingdom
Italy
Austria
Brazil
Serbia
Lebanon
Mexico
Venezuela
Israel
Egypt
Spain
Estonia

location_facility: Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

location_facility: Catharina ZKHS; Inwendige Geneeskunde Afd.

location_facility: Polyclinique De Courlancy; Centre Radiotherapie Oncologie

location_facility: Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.

location_facility: Sourasky / Ichilov Hospital; Dept. of Oncology

location_facility: Uni Oncology Inst. ; Chemo - Radiation Dept

location_facility: Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU; Chair of Oncology and Medical Radiology

location_facility: Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia

location_facility: Derriford Hospital; Plymouth Oncology Centre

location_facility: Akdeniz University Medical Faculty; Medical Oncology Department

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1

location_facility: Gynaekologicum Bremen; Prof. Dr. Willibald Schröder

location_facility: Hospital Beatriz Angelo; Departamento de Oncologia

location_facility: Orszagos Onkologial Intezet; Onkologiai Osztaly X

location_facility: Turku Uni Central Hospital; Oncology Clinics

location_facility: Az. Osp. Ospedale Civile; U.O. Di Oncologia Medica Ed Ematologia

location_facility: Royal United Hospital; Oncology Department

location_facility: Hospital Quiron Barcelona; Servicio de Oncologia

location_facility: Centro Médico Docente La Trinidad; Servicio de Gastroenterología

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

location_facility: Centro Oncologico MD Anderson Internacional; Servicio de Oncologia

location_facility: Southwest Hospital , Third Military Medical University

location_facility: Hadassah Ein Karem Hospital; Oncology Dept

location_facility: Chaim Sheba Medical Center; Oncology Dept

location_facility: Ospedale Degli Infermi Di Biella; Reparto Oncologia Medica

location_facility: University Hospital of Patras Medical Oncology

location_facility: Hospital Severo Ochoa; Servicio de Oncologia

location_facility: Ordensklinikum Linz Barmherzige Schwestern; Abt. fur Innere Medizin 1

location_facility: Royal Prince Alfred Hospital; Medical Oncology

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Hospital General de Elda; Servicio de Oncologia

location_facility: The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital)

location_facility: Hospital San Pedro De Alcantara; Servicio de Oncologia

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly

location_facility: Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Clinique Onco Des Dentellieres; Chimiotherapie Radiotherapie

location_facility: Martini Ziekenhuis; Dept of Internal Medicine

location_facility: Kreiskrankenhaus Torgau; Abt.Gynäkologie und Geburtshilfe

location_facility: Hospital de Gran Canaria Dr. Negrin; Servicio de Oncologia

location_facility: Fundacion Jimenez Diaz; Servicio de Oncologia

location_facility: Kyiv City Clinical Oncological Center; Chemotherapy Department

location_facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

location_facility: Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Ente Ospedaliero Ospedali Galliera; S.C. Oncologia Medica

location_facility: Hameed Latif Hospital; Department of Oncology

location_facility: Hospital Central De Las FF.AA.; Servicio De Oncologia

location_facility: Hopital Saint Louis; Service Onco Thoracique

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg

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

location_facility: Zaporozhye Regional Oncology Hospital; Dept of Oncology

location_facility: SRH Wald-Klinikum Gera; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie

location_facility: Hospital Universitari Sant Joan de Reus; Servicio de Oncologia

location_facility: Grupo Oncológico Cooperativo Uruguayo; Hospital de Clínicas - Dpto. de Oncología

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: Szent Margit Hospital; Dept. of Oncology

location_facility: Institut Paoli Calmettes; Oncologie Medicale

location_facility: Centre Azureen De Cancerologie; Cons externes

location_facility: Skånes University Hospital, Skånes Department of Onclology

location_facility: University Hospital of Larissa; Oncology

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Hospital Universitario Virgen Macarena; Servicio de Oncologia

location_facility: Hippokratio Hospital; 2Nd Internal Medicine

location_facility: Klinikum Esslingen; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Queen Elizabeth Hospital; Clinical Oncology

location_facility: Hospital de Jerez de la Frontera; Servicio de Oncologia

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii

location_facility: Irccs Policlinico S. Matteo - Uni Pavia; Clinica Medica I Div. Med. Int. Onc. Medica E Gastroent.

location_facility: Hospital Provincial de Castellon; Servicio de Oncologia

location_facility: Ospedale Mater Salutis; Dept of Oncology

location_facility: King Abdul Aziz Medical City, King Fahd National Guard; Oncology

location_facility: Leeds Teaching Hosp NHS Trust;St James's Institute of Onc

location_facility: Shaare Zedek Medical Center; Oncology Dept

location_facility: Chp Saint Gregoire; Cancerologie Radiotherapie

location_facility: Christie Hospital; Breast Cancer Research Office

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

location_facility: Queen Elizabeth II Health Sciences Centre; Oncology

location_facility: Hospital de Cabueñes; Servicio de Oncologia

location_facility: Hospital Pereira Rossell; Oncology Department

location_facility: Clinique Sainte Marguerite; Oncologie Medicale

location_facility: Västmanlands sjukhus Västerås, Onkologkliniken

location_facility: Hopital Prive Drome Ardeche; Hopital De Jour

location_facility: King Faisal Specialist Hospital & Research Centre; Oncology

location_facility: North Estonia Medical Centre Foundation; Oncology Center

location_facility: Austin and Repatriation Medical Centre; Cancer Services

location_facility: Bcca - Vancouver Island Cancer Centre; Oncology

location_facility: Cent.Onkologii-Instytut im. M. S-Curie, Klinika Now. Piersi i Chirurgii Rekon

location_facility: Asst Papa Giovanni XXIII; Oncologia Medica

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: Hospital Nacional LNS dela Policia Nacional del Perú. Unidad Onco; Deapartamento de Oncología

location_facility: American University of Beirut - Medical Center

location_facility: Lkh-Univ. Klinikum Graz; Klinik Für Gynäkologie

location_facility: Azienda Ospedaliera San Giuseppe Moscati

location_facility: Instituto Nacional de Cancerologia; Oncology

location_facility: Hospital do Espirito Santo; Servico de Oncologia Medica

location_facility: Brustzentrum Rhein-Ruhr Servicegesellschaft mbH

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Shifa International Hospital; Department of Oncology

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

location_facility: William Osler Health System Brampton Civic Hospital

location_facility: Irccs Ospedale San Raffaele;Oncologia Medica

location_facility: Freeman Hospital; Northern Centre For Cancer Care

location_facility: Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding

location_facility: Hospital de Barbastro; Servicio de Oncologia

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej

location_facility: Tampere University Hospital; Dept of Oncology

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Centre Hospitalier Fleyriat; Oncologie/Hematologie

location_facility: Hospital da Luz; Departamento de Oncologia Medica

location_facility: Tartu University Hospital; Clinic of Hematology and Oncology

location_facility: Universitätsklinikum Essen; Zentrum Für Frauenheilkunde

location_facility: Klinikum rechts der Isar der TU München; Klinik und Poliklinik für Frauenheilkunde

location_facility: Hospital de Sao Joao; Servico de Oncologia

location_facility: Hospital Universitario Virgen de las Nieves; Servicio de Oncologia

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: Eastbourne District Hospital; Department of Pharmacy

location_facility: Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Świętokrzyskie Centrum Onkologii; Dział Chemioterapii

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

location_facility: Hospital General Universitario de Guadalajara; Servicio de Oncologia

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie

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

location_facility: Mc Haaglanden, Locatie Antoniushove; Interne Geneeskunde

location_facility: First Affiliated Hospital of Medical College of Xi'an Jiaotong University

location_facility: Hospital of Lithuanian University of Health. Sciences Kaunas Clinics

location_facility: Hopital Cochin; Unite Fonctionnelle D Oncologie

location_facility: Ege University Medical Faculty; Medical Oncology Department

location_facility: Hospital de Navarra; Servicio de Oncologia

location_facility: Centro Medico Nacional Siglo Xxi - Imss; Hospital de Oncologia

location_facility: Huddersfield Royal Infirmary - Pharmacy department

location_facility: Clinique De L Europe; Radiotherapie Chimiotherapie

location_facility: Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology

location_facility: Twee Steden Ziekenhuis - Locatie Tilburg; Interne Geneesekunde

location_facility: Hospital Sirio Libanes; Centro de Oncologia

location_facility: Shaukat Khanum Memorial Cancer Hospital; Department of Oncology

location_facility: Fundacion Hospital de Alcorcon; Servicio de Oncologia

location_facility: Hospital de Basurto; Servicio de Oncologia

location_facility: Hospital de Rio Hortega; Servicio de Oncologia

location_facility: State Oncology Regional Treatment-Diagnostic Center; Chemotherapy Department

location_facility: Ospedale Maggiore Della Carita; Oncologia Medica

location_facility: Centre Hospitalier de l'Université de Montréal (CHUM)

location_facility: Hospital General de México; Unidad de Oncologia

location_facility: Complejo Hospitalario San Millan - San Pedro; Servicio de Oncologia

location_facility: Helsinki University Central Hospital; Oncology Clinics

location_facility: LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie

location_facility: Royal Melbourne Hospital; Hematology and Medical Oncology

location_facility: Kings College Hospital NHS Foundation Trust

location_facility: Azienda USL di Ravenna; Unità Operativa di Oncologia Medica

location_facility: Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia

location_facility: Cross Cancer Institute ; Dept of Medical Oncology

location_facility: Ruppiner Kliniken, Klinik fuer Gynaekologie und Geburtshilfe

location_facility: Papageorgiou General Hospital; Medical Oncology

location_facility: Complejo Asistencial Universitario De Burgos; Servicio de Oncologia

location_facility: Consultorio de Medicina Especializada; Dentro de Condominio San Francisco

location_facility: Hospital de Sagunto; Servicio de Oncologia

location_facility: Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Institut National D'oncologie Sidi Mohammed Ben Abdellah; Anatomopathologie

location_facility: Universitätsklinikum des Saarlandes; Klinik f. Frauenheilkunden und Geburtshilfe

location_facility: Hospital Clinico Universitario de Valladolid; Servicio de Oncologia

location_facility: Centre Rene Huguenin; ONCOLOGIE GENETIQUE

location_facility: A.Ö. Lhk; Ii. Medizinische Abt. Mit Schwerpunkt Gaströnter. & Onkologie

location_facility: IPO de Coimbra; Servico de Oncologia Medica

location_facility: Hospital General Universitario J.M Morales Meseguer; Servicio de Oncologia

location_facility: Centro Clinico Champalimaud; Oncologia Medica

location_facility: Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia

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

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

location_facility: Hospital Virgen de los Lirios; Servicio de Oncologia

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii; Poradnia Chemioterapii

location_facility: University General Hospital of Heraklion

location_facility: Debreceni Egyetem Klinikai Kozpont ; Department of Oncology

location_facility: Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie

location_facility: Fondazione Del Piemonte; Medical Oncology

location_facility: Complejo Asistencial Universitario de Leon; Servicio de Oncologia

location_facility: Instituto Nacional de Ciencias Médicas Y de La Nutricion Zubirán

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

location_facility: Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine

location_facility: Complejo Hospitalario de Orense; Servicio de Oncologia

location_facility: Hospital Clinico Universitario de Salamanca; Servicio de Oncologia

location_facility: Polyclinique de Blois; Chimiotherapie Ambulatoire

location_facility: Fovarosi Szent Laszlo Korhaz-Rendelointezet; Onkologiai Osztaly X

title: A Multicenter, Open-Label, Single-Arm Study of Pertuzumab in Combination With Trastuzumab and a Taxane in First Line Treatment of Patients With HER2-Positive Advanced (Metastatic or Locally Recurrent) Breast Cancer

summary: This multicenter, open-label, single-arm, Phase IIIb study will evaluate the safety and tolerability of pertuzumab in combination with trastuzumab (Herceptin) and a taxane (docetaxel, paclitaxel or nab-paclitaxel) in first-line treatment in participants with metastatic or locally recurrent HER2-positive breast cancer. Participants will receive pertuzumab intravenously (IV) and trastuzumab (Herceptin) IV plus a taxane in cycles of 3 weeks each until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurs first.


ReferenceCitation: Gridelli C, de Castro Carpeno J, Dingemans AC, Griesinger F, Grossi F, Langer C, Ohe Y, Syrigos K, Thatcher N, Das-Gupta A, Truman M, Donica M, Smoljanovic V, Bennouna J. Safety and Efficacy of Bevacizumab Plus Standard-of-Care Treatment Beyond Disease Progression in Patients With Advanced Non-Small Cell Lung Cancer: The AvaALL Randomized Clinical Trial. JAMA Oncol. 2018 Dec 1;4(12):e183486. doi: 10.1001/jamaoncol.2018.3486. Epub 2018 Dec 13. Erratum in: JAMA Oncol. 2018 Dec 1;4(12):1792.

name: Division of Medical Oncology, S.G. Moscati Hospital, Avellino, Italy

family: Gridelli

full_name: Cesare Gridelli

given: Cesare

name: Division of Medical Oncology, Hospital Universitario La Paz, IdiPAZ, Madrid, Spain

family: de Castro Carpeno

full_name: Javier de Castro Carpeno

given: Javier

name: Department of Pulmonology, Maastricht University Medical Center, Maastricht, the Netherlands

family: Dingemans

full_name: Anne-Marie C. Dingemans

given: Anne-Marie C.

name: Department of Hematology and Oncology, University Department of Internal Medicine–Oncology, Pius-Hospital, University of Oldenburg, Oldenburg, Germany

family: Griesinger

full_name: Frank Griesinger

given: Frank

name: Lung Cancer Unit, Ospedale Policlinico San Martino, Genova, Italy

family: Grossi

full_name: Francesco Grossi

name: Thoracic Oncology Unit, Abramson Cancer Center, University of Pennsylvania, Philadelphia

family: Langer

full_name: Corey Langer

given: Corey

name: Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan

family: Ohe

full_name: Yuichiro Ohe

given: Yuichiro

name: Department of Medicine, National and Kapodistrian University, Athens, Greece

family: Syrigos

full_name: Konstantinos Syrigos

given: Konstantinos

name: Christie Hospital NHS Trust, Manchester, United Kingdom

family: Thatcher

full_name: Nick Thatcher

given: Nick

name: F. Hoffmann-La Roche Ltd, Basel, Switzerland

family: Das-Gupta

full_name: Ashis Das-Gupta

given: Ashis

name: Roche Products Pty Ltd, Sydney, New South Wales, Australia

name: Now with OzBiostat Pty Ltd, Manly, New South Wales, Australia

family: Truman

full_name: Matt Truman

given: Matt

family: Donica

full_name: Margarita Donica

given: Margarita

family: Smoljanovic

full_name: Vlatka Smoljanovic

given: Vlatka

name: Institut de Cancérologie de l’Ouest, Nantes, France

family: Bennouna

full_name: Jaafar Bennouna

given: Jaafar

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: JAMA Oncology

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

title: Safety and Efficacy of Bevacizumab Plus Standard-of-Care Treatment Beyond Disease Progression in Patients With Advanced Non–Small Cell Lung Cancer

ReferenceCitation: Takeda M, Yamanaka T, Seto T, Hayashi H, Azuma K, Okada M, Sugawara S, Daga H, Hirashima T, Yonesaka K, Urata Y, Murakami H, Saito H, Kubo A, Sawa T, Miyahara E, Nogami N, Nakagawa K, Nakanishi Y, Okamoto I. Bevacizumab beyond disease progression after first-line treatment with bevacizumab plus chemotherapy in advanced nonsquamous non-small cell lung cancer (West Japan Oncology Group 5910L): An open-label, randomized, phase 2 trial. Cancer. 2016 Apr 1;122(7):1050-9. doi: 10.1002/cncr.29893. Epub 2016 Feb 1.

name: Department of Medical Oncology, Faculty of Medicine; Kinki University; Osaka Japan

family: Takeda

full_name: Masayuki Takeda

given: Masayuki

name: Department of Biostatistics; Yokohama City University; Yokohama Japan

family: Yamanaka

full_name: Takeharu Yamanaka

given: Takeharu

name: Department of Thoracic Oncology; National Kyushu Cancer Center; Fukuoka Japan

family: Seto

full_name: Takashi Seto

given: Takashi

name: Department of Medical Oncology; Kishiwada City Hospital; Osaka Japan

family: Hayashi

full_name: Hidetoshi Hayashi

given: Hidetoshi

name: Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine; Kurume University School of Medicine; Kurume Japan

name: Department of Surgical Oncology; Hiroshima University; Hiroshima Japan

name: Department of Pulmonary Medicine; Sendai Kousei Hospital; Sendai Japan

name: Department of Clinical Oncology; Osaka City General Hospital; Osaka Japan

name: Department of Thoracic Malignancy; Osaka Prefectural Medical Center for Respiratory and Allergic Diseases; Osaka Japan

name: Department of Medical Oncology; Izumi Municipal Hospital; Izumi Japan

name: Department of Thoracic Oncology; Hyogo Cancer Center; Akashi Japan

name: Division of Thoracic Oncology; Shizuoka Cancer Center; Shizuoka Japan

name: Department of Thoracic Oncology; Kanagawa Cancer Center; Yokohama Japan

name: Division of Respiratory Medicine and Allergology; Aichi Medical University School of Medicine; Nagakute Japan

name: Division of Respiratory Medicine; Gifu Municipal Hospital; Gifu Japan

name: Department of Surgery; Saiseikai Hiroshima Hospital; Hiroshima Japan

name: Department of Thoracic Oncology; NHO Shikoku Cancer Center; Matsuyama Japan

name: Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University; Fukuoka Japan

ReferenceCitation: Gridelli C, Bennouna J, de Castro J, Dingemans AM, Griesinger F, Grossi F, Rossi A, Thatcher N, Wong EK, Langer C. Randomized phase IIIb trial evaluating the continuation of bevacizumab beyond disease progression in patients with advanced non-squamous non-small-cell lung cancer after first-line treatment with bevacizumab plus platinum-based chemotherapy: treatment rationale and protocol dynamics of the AvaALL (MO22097) trial. Clin Lung Cancer. 2011 Nov;12(6):407-11. doi: 10.1016/j.cllc.2011.05.002. Epub 2011 Jun 25.

title: Randomized Phase IIIb Trial Evaluating the Continuation of Bevacizumab Beyond Disease Progression in Patients with Advanced Non-Squamous Non–Small-Cell Lung Cancer after First-Line Treatment with Bevacizumab Plus Platinum-Based Chemotherapy: Treatment Rationale and Protocol Dynamics of the AvaALL (MO22097) Trial

location_country:
Italy
Austria
Brazil
United Arab Emirates
Lebanon
Mexico
Germany
Netherlands
France
Japan
Greece
Slovakia
Oman
Argentina
Belgium
Spain
Denmark
United States

location_facility: National Hospital Organization Kyushu Cancer Center, Thoracic Oncology

location_facility: University of Tennessee Medical Center Cancer Institute

location_facility: Lkh Natters; Abt. Für Atemwegs- & Lungenkrankheiten

location_facility: Ch Lyon Sud; Chir Onc Gyne Sct Jules Courmont

location_facility: A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii

location_facility: Johannes-Wesling-Klinikum Minden; Onkologische Ambulanz / Tagesklinik

location_facility: Eastern Ct Hema/Onco Assoc; Dept of Oncology

location_facility: Tufts Medical Center; Neely Cancer Center

location_facility: IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica A

location_facility: Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin I

location_facility: Az. Osp. Di Busto P.O. Di Saronno; U.O. Di Oncologia Medica

location_facility: Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie

location_facility: Hôpital Saint Joseph; Oncologie Medicale

location_facility: Yokohama Municipal Citizen'S Hospital; Respiratory

location_facility: The Cancer Institute Hospital of JFCR, Respiratory Medicine

location_facility: Centro Médico Abc the American British Cowdray Medical Center, I.A.P. - Centro de Cáncer

location_facility: National Cancer Center Hospital; Thoracic Medical Oncology

location_facility: Universitaetsklinikum des Saarlandes; Innere Medizin V

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

location_facility: Centro Oncologico MD Anderson International Espana

location_facility: Centro de Pesquisa Clínica- Instituto do Câncer do Ceará- ICC

location_facility: General Hospital of Thessaloniki Papanikolaou; Uni Pneumonology Dept.

location_facility: Ziekenhuis St Jansdal; Dept of Lung Diseases

location_facility: St. Vincentius Kliniken Karlsruhe; Abteilung Hämatologie / Onkologie

location_facility: Miyagi Cancer Center; Respiratory Medicine

location_facility: Inst. of Tb & Respiratory Diseases; Dep. of Oncology

location_facility: National Cancer Center Hospital East; Thoracic Oncology

location_facility: UNI OF WISCONSIN SCHOOL OF MEDICINE; GI Oncology Research Group, Paul P Carbone Cancer Center

location_facility: Tawam Hospital; Medical Oncology Department

location_facility: Osaka International Cancer Institute; Thoracic Oncology

location_facility: Cancer & Hematology Center of West Michigan

location_facility: University of Pennsylvania; Radiation Oncology

location_facility: Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1

location_facility: Hospital Universitario Dr. Peset; Servicio de Oncologia

location_facility: IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A

location_facility: Centro de Estudos e Pesquisas Oncologicas - CESPO

location_facility: Oncology Hematology Associates of Southwest Indiana

location_facility: Hematology & Oncology Assoc; North Eastern Pennsylvania

location_facility: Nordsjællands Hospital, Hillerød, Onkologisk Afdeling

location_facility: Pius-Hospital; Klinik fuer Haematologie und Onkologie

location_facility: Cancer Care & Hematology; Specialists of Chicagoland

location_facility: Oncology-Evanston Nthwest Healthcare Kellogg Cancer Care Ctr

location_facility: East Valley Hematology ; Oncology Medical Group

location_facility: Signal Point Clinical; Research Center, LLC

location_facility: American University of Beirut - Medical Center

location_facility: Metropolitan Hospital; 2Nd Oncology Clinic

location_facility: Henry Ford Hospital; Hematology Oncology

location_facility: Hospital de Cruces; Servicio de Oncologia

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

location_facility: Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire

location_facility: Citta Ospedaliera; Divisione Oncologia Medica

location_facility: Catharina Ziekenhuis; Dept of Lung Diseases

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: College of Medicine & Sciences, Sultan Qaboos University Hospital

location_facility: Ludwig-Maximilians Uni Klinik Innenstadt; Medizinische Klinik

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie

location_facility: Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica

location_facility: Okayama University Hospital; Respiratory and Allergy Medicine

location_facility: Klinikum Esslingen; Klinik für Kardiologie, Angiologie und Pneumologie

location_facility: SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie

location_facility: National Hospital Organization Shikoku Cancer Center; Thoracic Oncology

location_facility: California Cancer Associates for Research & Excellence, Inc.

location_facility: Fnsp Fdr Banska Bystrica; Dep of Pneumology&Ftizeology

location_facility: Krankenhaus Der Stadt Wien Lainz; V. Medizinische Abt.

location_facility: Aichi Cancer Center Hospital; Respiratory Medicine

location_facility: Hospital General Univ. de Alicante; Servicio de Oncologia

location_facility: Anne Arundel Health System Research Instit-Annapolis Oncology Ctr

location_facility: Centre Hospitalier Intercommunal; Service de Pneumologie

location_facility: Stony Brook Univ Cancer Ctr; Medical Oncology Clinic

location_facility: Shizuoka Cancer Center; Thoracic Oncology

location_facility: Carolina Oncology Specialists, PA - Hickory

location_facility: Heartland CCOP/Missouri Baptist Medical Center

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: OSAKA CITY GENERAL HOSPITAL;Medical Oncology

location_facility: Sociedade beneficente de senhoras Hospital Sirio Libanes

location_facility: SMZ - Baumgartner Hohe, Pavilion Leopold; 1.Interne Lungenabteilung, Onkologische Tagesklinik

location_facility: Joliet Oncology Hematology Associates, Ltd.

location_facility: Chi De La Haute Saone De Vesoul; Pneumologie

location_facility: Kanagawa Cardiovascular and Respiratory Center; Respiratory Medicine

location_facility: Hopital Nord; Service d'Oncologie Multidisciplinaire et Innovation Thérapeutique

location_facility: Antonius Ziekenhuis; Dept of Lung Diseases

location_facility: Hospital Central Sur de Alta Especialidad Petróleos Mexicanos

location_facility: Zentralklinik Bad Berka GmbH; Pneumologie

title: An Open-label, Randomized, Phase IIIb Trial Evaluating the Efficacy and Safety of Standard of Care +/- Continuous Bevacizumab Treatment Beyond Progression of Disease (PD) in Patients With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC) After First Line Treatment With Bevacizumab Plus a Platinum Doublet-containing Chemotherapy

summary: This open-label, randomized, multicenter study will evaluate the efficacy and safety of bevacizumab (Avastin) in combination with standard of care (SOC) treatment in participants with advanced non-squamous NSCLC. Participants will be enrolled at documentation of progression of disease (PD) after 4-6 cycles of first-line treatment with bevacizumab plus a platinum doublet-containing therapy and a minimum of two cycles of bevacizumab maintenance treatment prior to PD. Participants will be randomly assigned to one of two treatment arms to receive either bevacizumab plus SOC treatment or SOC treatment alone.


type: EudraCT Number

type: Other Identifier

type: Registry Identifier

title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MK-4482 for the Prevention of COVID-19 (Laboratory-confirmed SARS-CoV-2 Infection With Symptoms) in Adults Residing With a Person With COVID-19

acronym: MOVe-AHEAD

summary: The primary objectives of this phase 3, multicenter, randomized, double-blind, placebo-controlled study are to determine the efficacy, and safety/tolerability, of molnupiravir (MK-4482) in adults who reside with a person infected with COVID-19. It is hypothesized that molnupiravir is superior to placebo in preventing laboratory-confirmed COVID-19 infection through Day 14 in participants (regardless of baseline viral test result) who do not have confirmed or suspected COVID-19 at time of screening and randomization.

primary_purpose: Prevention

ipd_sharing: Yes

lead_sponsor: Merck Sharp & Dohme Corp.

location_country:
Brazil
South Africa
Guatemala
Mexico
Philippines
France
Japan
Romania
Hungary
Argentina
Russian Federation
Spain
Turkey
United States
Colombia
Ukraine

location_facility: Limited liability company "Scientific research center Eco-safety" ( Site 1809)

location_facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0312)

location_facility: Allina Health Infectious Diseases Research Clinic ( Site 2507)

location_facility: Hospital Universitario Infanta Leonor ( Site 2002)

location_facility: MNCE -Odesa regional clinical hospital of Odesa regional council ( Site 2226)

location_facility: Chicago Clinical Research Institute Inc ( Site 2454)

location_facility: Hospital Nossa Senhora das Gracas ( Site 0310)

location_facility: Faculdade de Medicina da Universidade Federal de Mato Grosso do Sul - UFMS ( Site 0305)

location_facility: Unidad de Diagnostico Cardiologico ( Site 0701)

location_facility: Municipal Enterprise Poltava Regional Clinical Infectious Hospital ( Site 2227)

location_facility: Limpopo Clinical Research Initiative ( Site 1901)

location_facility: Cherokee Nation WW Hastings Indian Hospital/Cherokee Nation Health Services ( Site 2459)

location_facility: Centro de Referencia Professor Helio Fraga - FIOCRUZ/RJ ( Site 0314)

location_facility: LLC -Clinic of modern medicine of Doctor Bogorodskaya ( Site 1828)

location_facility: Centrul Medical Unirea SRL IASI ( Site 1701)

location_facility: Crossroads Clinical Research LLC ( Site 2451)

location_facility: National Research Institute ( Site 2452)

location_facility: Instituto Medico de la Fundacion Estudios Clinicos ( Site 0106)

location_facility: Oncosite-Centro de Pesquisa Clinica em Oncologia ( Site 0300)

location_facility: Ankara Universitesi Ibni Sina Hastanesi ( Site 2101)

location_facility: Maison de Sante Universitaire La Providence ( Site 0506)

location_facility: Clinical Site Partners, LLC d/b/a CSP Miami ( Site 2508)

location_facility: Medipol Universite Hastanesi ( Site 2108)

location_facility: Valley Clinical Trials Inc. ( Site 2406)

location_facility: Michigan Center of Medical Research ( Site 2445)

location_facility: Fundacion Centro de Investigacion Clinica CIC ( Site 0402)

location_facility: Future Innovative Treatments, LLC ( Site 2471)

location_facility: Medical Research Institute LLC. ( Site 1814)

location_facility: C.S. Vallcarca-Sant Gervasi ( Site 2000)

location_facility: Clinical Site Partners, LLC d/b/a CSP Miami ( Site 2425)

location_facility: Centrul Medical Unirea SRL Bucuresti ( Site 1706)

location_facility: Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 2107)

location_facility: Hospital Universitari Germans Trias i Pujol ( Site 2010)

location_facility: Fundacion Centro de Investigaciones Clinicas CARDIOMET ( Site 0409)

location_facility: SPb SBHI City outpatient clinic 112 ( Site 1829)

location_facility: Limited Liability Company Medical center Healthy Happy ( Site 2225)

location_facility: Hôpital Pitié - Salpêtrière ( Site 0501)

location_facility: Republican Clinical Infectious Hospital n.a. A.F. Agafonov ( Site 1802)

location_facility: Obudai Egeszsegugyi Centrum - Zalaegerszeg ( Site 0819)

location_facility: Mercury Street Medical Group PLLC ( Site 2476)

location_facility: Right To Care Research - Esizayo ( Site 1907)

location_facility: Amici Clinical Research LLC ( Site 2426)

location_facility: PCNE Kharkiv City polyclinic 9 of the Kharkiv City Council ( Site 2201)

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi ( Site 2110)

location_facility: Maison de santé du Pays Neufchatelois ( Site 0507)

location_facility: University of Missouri Hospital ( Site 2486)

location_facility: Caja de Compensacion Familiar CAFAM ( Site 0403)

location_facility: Medical Clinical Investigational Center of Medical Center Health Clinic ( Site 2210)

location_facility: The Institute for Liver Health DBA Arizona Clinical Trials ( Site 2448)

location_facility: Emerson Clinical Research Institute ( Site 2457)

location_facility: FSBI Central Hospital with Policlinics ( Site 1807)

location_facility: Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 0702)

location_facility: CHU de la Reunion - Groupe Hospitalier Sud ( Site 0508)

location_facility: Advanced Research For Health Improvement LLC ( Site 2436)

location_facility: Ege Universitesi Tip Fakultesi Hastanesi ( Site 2105)

location_facility: MNPE Consultative-Diagnostic Centre of Desnyanskyi District of Kyiv ( Site 2205)

location_facility: The Institute for Liver Health DBA Arizona Clinical Trials ( Site 2484)

location_facility: Velocity Clinical Research-Providence ( Site 2432)

location_facility: Centro Cientifico Asistencial Jose Luis Accini ( Site 0412)

location_facility: NPME -Central Clinical Hospital of Ivano-Frankivsk City Council ( Site 2204)

location_facility: Kyiv railway clinical hospital 2 of Branch Health center ( Site 2207)

location_facility: Fundaçao de Medicina Tropical Doutor Heitor Vieira Dourado ( Site 0303)

location_facility: Smolensk State Medical University ( Site 1803)

location_facility: Michigan Center of Medical Research ( Site 2525)

location_facility: Obudai Egeszsegugyi Centrum - OEC ( Site 0821)

location_facility: Gazi Universitesi Tip Fakultesi Hastanesi ( Site 2106)

location_facility: Mautalen Salud e Investigacion ( Site 0103)

location_facility: Oaxaca Site Management Organization S.C. ( Site 1304)

location_facility: DRC Gyogyszervizsgalo Kozpont Kft. ( Site 0801)

location_facility: Jadestone Clinical Research, LLC ( Site 2530)

location_facility: Asian Hospital and Medical Center ( Site 1503)

location_facility: Preferred Clinical Research ( Site 2470)

location_facility: Private Clinic - Dr. Hugo Pezzarossi ( Site 0704)

location_facility: Hospital Universitario La Paz ( Site 2024)

location_facility: Centro de Investigacion y Avances Medicos Especializados -CIAME ( Site 1301)

location_facility: Clinical Research Trials of Florida ( Site 2402)

location_facility: Centro de Investigaciones Pediatricas ( Site 0703)

location_facility: Centro de Referência e Treinamento DST/AIDS ( Site 0301)

location_facility: LLC -Medical Center . Capital-Polis ( Site 1825)

location_facility: Regional Phthisiopulmonological Center ( Site 2203)

location_facility: Tribe Clinical Research, LLC ( Site 2409)

location_facility: Instituto de Investigaciones Clínicas Mar del Plata ( Site 0105)

location_facility: St.Petersburg Outpatient Clinic No. 109 ( Site 1818)

location_facility: University of Nebraska Medical Center ( Site 2430)

location_facility: Accel Research Sites-DeLand Clinical Research Unit ( Site 2535)

location_facility: Voronezh Regional Clinical Hospital #1 ( Site 1823)

location_facility: SC Policlinica CCBR SRL. Bucuresti ( Site 1704)

location_facility: Centrul Medical Unirea SRL Constanta ( Site 1703)

location_facility: Instituto Neumologico del Oriente S.A. ( Site 0408)

location_facility: Institute of Human Virology ( Site 2504)

location_facility: Quirino Memorial Medical Center ( Site 1501)

location_facility: Sanatorio de la Trinidad Mitre ( Site 0108)

location_facility: Center Hospital of the National Center for Global Health and Medicine ( Site 1101)

location_facility: Hacettepe Universitesi Tip Fakultesi ( Site 2102)

location_facility: Municipal Noncommercial Enterprise Lviv 4th City Clinical Hospital ( Site 2200)

location_facility: Centro de Investigacion Medica Aguascalientes ( Site 1305)

location_facility: Excel Clinical Research, LLC ( Site 2404)

location_facility: Velocity Clinical Research, Hallandale Beach ( Site 2485)

location_facility: The Lindner Center for Research and Education at The Christ Hospital ( Site 2517)

location_facility: Indago Research and Health Center Inc ( Site 2412)


location_country:
United States
United Kingdom
Chile
France

location_facility: Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu ( Site 1517)

location_facility: Hôpital Saint-Louis-Infectious Diseases and tropical diseases ( Site 1511)

location_facility: Biomedica Research Group-Infectology ( Site 0201)

location_facility: Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 0202)

location_facility: Tourcoing Hospital-Service Universitaire des Maladies Infectieuses et du Voyageur ( Site 1519)

location_facility: North Texas Infectious Diseases Consultants, P.A-Research ( Site 0004)

location_facility: The Crofoot Research Center ( Site 0008)

location_facility: Brighton and Sussex University Hospitals NHS Trust ( Site 2104)

location_facility: KC CARE Health Center-Clinical Trials ( Site 0012)

source: euctr

title: A Phase 3 Open-label Rollover Clinical Study of Doravirine/Islatravir (DOR/ISL) Once-daily for the Treatment of HIV-1 Infection in Participants Who Previously Received DOR/ISL in a Phase 2 or Phase 3 DOR/ISL Clinical Study

summary: The safety and tolerability of MK-8591A, a novel 2-drug fixed dose combination (FDC) of doravirine (DOR) and islatravir (ISL) will be evaluated in adult and pediatric participants with Human Immunodeficiency Virus -1 (HIV-1) who were treated with DOR and ISL in earlier clinical studies.


title: A Phase 2, Open-Label Study of Ixazomib+Daratumumab+Dexamethasone (IDd) in Relapsed and/or Refractory Multiple Myeloma (RRMM)

summary: The purpose of this study is to evaluate the percentage of participants with a response of very good partial response (VGPR) or better to IDd treatment.

status: Active, not recruiting

enrollment_type: Actual

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

lead_sponsor: Millennium Pharmaceuticals, Inc.

location_country:
Netherlands
France
Czechia
Greece
Poland
United States

location_facility: Szpitale Pomorskie Spolka z ograniczona odpowiedzialnoscia

location_facility: SCRI - Florida Cancer Specialists - Panhandle

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

location_facility: University General Hospital of Patras Panagia I Voithia

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

location_facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza

location_facility: SCRI - Tennessee Oncology - Nashville - Centennial

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Onkologicka klinika Vseobecna fakultni nemocnice v Praze a 1


title: A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of the Safety, Tolerability and Pharmacokinetics of ABBV-368 as a Single Agent and Combination in Subjects With Locally Advanced or Metastatic Solid Tumors

summary: The primary purpose of this Phase 1, open-label study is to evaluate the safety, pharmacokinetics, and preliminary efficacy of ABBV-368 as a monotherapy and in combination with ABBV-181 in participants with locally advanced or metastatic solid tumors. The study will consist of 3 parts: ABBV-368 dose escalation, ABBV-368 tumor-specific dose expansion (triple negative breast cancer [TNBC] cohort and head and neck cancer cohort) and 18F-AraG Imaging Substudy.

design_allocation: Non-Randomized

lead_sponsor: AbbVie

location_country:
France
Japan
Puerto Rico
Spain
United States
Taiwan

location_facility: Moore UC San Diego Cancer Center /ID# 201334

location_facility: Hospital Clinico Universitario de Valencia /ID# 211499

location_facility: Hospital General Universitario Gregorio Maranon /ID# 205999

location_facility: National Cancer Center Hospital /ID# 214531

location_facility: National Cheng Kung University Hospital /ID# 164002

location_facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 211500

location_facility: National Cancer Center Hospital East /ID# 214530

location_facility: Carolina BioOncology Institute /ID# 160786

location_facility: CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 208879

location_facility: AP-HM - Hopital de la Timone /ID# 165036

location_facility: Hospital Universitario Puerta de Hierro, Majadahonda /ID# 206973

location_facility: Virginia Cancer Specialists - Fairfax /ID# 160787

location_facility: Taipei Medical University Hospital /ID# 164001

location_facility: CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 205996

location_facility: University of Texas Southwestern Medical Center /ID# 201934

location_facility: Pan American Center for Oncology Trials, LLC /ID# 213809

location_facility: South Texas Accelerated Research Therapeutics /ID# 160788

location_facility: University of California, Davis Comprehensive Cancer Center /ID# 201342

location_facility: National Taiwan University Hospital /ID# 164000


title: A Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Adults With Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection

acronym: ENDURANCE-5 6

summary: A Phase 3b, open-label, multicenter study to evaluate the efficacy and safety of glecaprevir/pibrentasvir for an 8- or 12-week treatment duration in participants with chronic hepatitis C virus (HCV) genotype (GT) 5 or 6 infection, with or without compensated cirrhosis respectively.

status: Completed

study_completion_date_type: Actual

ReferenceType: background

ReferenceCitation: Asselah T, Lee SS, Yao BB, Nguyen T, Wong F, Mahomed A, Lim SG, Abergel A, Sasadeusz J, Gane E, Zadeikis N, Schnell G, Zhang Z, Porcalla A, Mensa FJ, Nguyen K. Efficacy and safety of glecaprevir/pibrentasvir in patients with chronic hepatitis C virus genotype 5 or 6 infection (ENDURANCE-5,6): an open-label, multicentre, phase 3b trial. Lancet Gastroenterol Hepatol. 2019 Jan;4(1):45-51. doi: 10.1016/S2468-1253(18)30341-8. Epub 2018 Nov 2.

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

location_country:
United States
South Africa
Vietnam
France
Singapore
Belgium
Australia
New Zealand
Canada

location_facility: National University Hospital /ID# 156855

location_facility: Auckland Clinical Studies Ltd /ID# 157033

location_facility: National Hospital of Tropical Diseases /ID# 162282

location_facility: Zuckerberg San Francisco Gener /ID# 157040

location_facility: Royal Brisbane and Women's Hospital /ID# 157025

location_facility: Cedars-Sinai Medical Center - West Hollywood /ID# 157045

status_simplified: Completed


title: A Phase 2, Multicenter Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-144) for Treatment of Patients With Metastatic Melanoma

summary: Prospective, interventional multicenter study evaluating adoptive cell therapy (ACT) via infusion of LN-144 (autologous TIL) followed by interleukin 2 (IL-2) after a nonmyeloablative lymphodepletion (NMA LD) preconditioning regimen.

ReferenceCitation: Sarnaik AA, Hamid O, Khushalani NI, Lewis KD, Medina T, Kluger HM, Thomas SS, Domingo-Musibay E, Pavlick AC, Whitman ED, Martin-Algarra S, Corrie P, Curti BD, Oláh J, Lutzky J, Weber JS, Larkin JMG, Shi W, Takamura T, Jagasia M, Qin H, Wu X, Chartier C, Graf Finckenstein F, Fardis M, Kirkwood JM, Chesney JA. Lifileucel, a Tumor-Infiltrating Lymphocyte Therapy, in Metastatic Melanoma. J Clin Oncol. 2021 Aug 20;39(24):2656-2666. doi: 10.1200/JCO.21.00612. Epub 2021 May 12. Erratum in: J Clin Oncol. 2021 Sep 10;39(26):2972.

family: Sarnaik

full_name: Amod A. Sarnaik

given: Amod A.

name: The Angeles Clinic and Research Institute, A Cedars Sinai Affiliate, Los Angeles, CA

family: Hamid

full_name: Omid Hamid

given: Omid

family: Khushalani

full_name: Nikhil I. Khushalani

given: Nikhil I.

name: University of Colorado Cancer Center—Anschutz Medical Campus, Aurora, CO

family: Lewis

full_name: Karl D. Lewis

given: Karl D.

family: Medina

full_name: Theresa Medina

given: Theresa

name: Yale University School of Medicine, Smilow Cancer Center, New Haven Hospital, New Haven, CT

family: Kluger

full_name: Harriet M. Kluger

given: Harriet M.

name: University of Florida Health Cancer Center at Orlando Health, Orlando, FL

family: Thomas

full_name: Sajeve S. Thomas

given: Sajeve S.

name: Masonic Cancer Center, University of Minnesota, Minneapolis, MN

family: Domingo-Musibay

full_name: Evidio Domingo-Musibay

given: Evidio

name: Laura and Isaac Perlmutter Cancer Center, NYU Langone Medical Center, New York, NY

family: Pavlick

full_name: Anna C. Pavlick

given: Anna C.

name: Atlantic Health System Cancer Care, Morristown, NJ

family: Whitman

full_name: Eric D. Whitman

given: Eric D.

name: Clínica Universidad de Navarra, Pamplona, Spain

family: Martin-Algarra

full_name: Salvador Martin-Algarra

given: Salvador

name: Cambridge University Hospitals NHS Foundation Trust—Addenbrooke's Hospital, Cambridge, United Kingdom

family: Corrie

full_name: Pippa Corrie

given: Pippa

name: Earle A. Chiles Research Institute at Robert W. Franz Cancer Center, Providence Cancer Institute, Portland, OR

family: Curti

full_name: Brendan D. Curti

given: Brendan D.

name: University of Szeged—Albert Szent-Györgyi Health Center, Szeged, Hungary

family: Oláh

full_name: Judit Oláh

given: Judit

name: Mount Sinai Comprehensive Cancer Center, Miami, FL

family: Lutzky

full_name: Jose Lutzky

given: Jose

family: Weber

full_name: Jeffrey S. Weber

given: Jeffrey S.

name: Royal Marsden NHS Foundation Trust, London, United Kingdom

family: Larkin

full_name: James M. G. Larkin

given: James M. G.

name: Iovance Biotherapeutics Inc, San Carlos, CA

family: Shi

full_name: Wen Shi

given: Wen

family: Takamura

full_name: Toshimi Takamura

given: Toshimi

family: Jagasia

full_name: Madan Jagasia

given: Madan

family: Qin

full_name: Harry Qin

given: Harry

family: Wu

full_name: Xiao Wu

given: Xiao

family: Chartier

full_name: Cecile Chartier

given: Cecile

family: Graf Finckenstein

name: Hillman Cancer Center, University of Pittsburgh Medical Center, Pittsburgh, PA

name: James Graham Brown Cancer Center, University of Louisville, Louisville, KY

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

publisher: American Society of Clinical Oncology (ASCO)

location_country:
Italy
United States
Switzerland
France
Hungary
Spain
Germany
United Kingdom

location_facility: Szegedi Tudomanyegyetem Szent-Györgyi Albert Klinikai Központ

location_facility: Hospital Universitario Quirónsalud Madrid

location_facility: Centre Hospitalier Universitaire Vaudois Lausanne - Centre Pluridisciplinaire d'Oncologie

location_facility: Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia

location_facility: University of California San Diego Moores Cancer Center

location_facility: Universitätsklinikum Schleswig-Holstein - Campus Lübeck

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

location_facility: University of Minnesota, Masonic Cancer Center

location_facility: Providence Cancer Center Oncology and Hematology Care Clinic

location_facility: Klinikum Rechts der Isar der Technischen Universität München

location_facility: Centro di Riferimento Oncologico di Aviano

location_facility: University of Pittsburgh Medical Center - Hillman Cancer Center

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale

location_facility: New York University Langone Medical Center

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: University of South Florida H. Lee Moffitt Cancer Center and Research Institute

location_facility: HM Centro Integral Oncológico Clara Campal

location_facility: Consorci Hospital General Universitari de València

location_facility: Universitaetsklinikum Tuebingen (UKT) - Suedwestdeutschen Tumorzentrum - Zentrum für Neuroonkologie

location_facility: University of California Los Angeles - David Geffen School of Medicine - Westwood Rheumatology


ReferenceCitation: Arun BK, Han HS, Kaufman B, Wildiers H, Friedlander M, Ayoub JP, Puhalla SL, Bell-McGuinn KM, Bach BA, Kundu MG, Ratajczak CK, Maag D, Diéras V. Efficacy and safety of first-line veliparib and carboplatin-paclitaxel in patients with HER2- advanced germline BRCA+ breast cancer: Subgroup analysis of a randomised clinical trial. Eur J Cancer. 2021 Sep;154:35-45. doi: 10.1016/j.ejca.2021.05.037. Epub 2021 Jul 6.

family: Arun

full_name: Banu K. Arun

given: Banu K.

family: Han

full_name: Hyo S. Han

given: Hyo S.

family: Kaufman

full_name: Bella Kaufman

given: Bella

family: Wildiers

full_name: Hans Wildiers

given: Hans

family: Friedlander

full_name: Michael Friedlander

given: Michael

family: Ayoub

full_name: Jean-Pierre Ayoub

given: Jean-Pierre

family: Puhalla

full_name: Shannon L. Puhalla

given: Shannon L.

family: Bell-McGuinn

full_name: Katherine M. Bell-McGuinn

given: Katherine M.

family: Bach

full_name: Bruce A. Bach

given: Bruce A.

family: Kundu

full_name: Madan G. Kundu

given: Madan G.

family: Ratajczak

full_name: Christine K. Ratajczak

given: Christine K.

family: Maag

full_name: David Maag

given: David

family: Diéras

full_name: Véronique Diéras

given: Véronique

journal_name: European Journal of Cancer

oa_host_type: publisher

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Efficacy and safety of first-line veliparib and carboplatin–paclitaxel in patients with HER2− advanced germline BRCA+ breast cancer: Subgroup analysis of a randomised clinical trial

ReferenceCitation: Diéras V, Han HS, Kaufman B, Wildiers H, Friedlander M, Ayoub JP, Puhalla SL, Bondarenko I, Campone M, Jakobsen EH, Jalving M, Oprean C, Palácová M, Park YH, Shparyk Y, Yañez E, Khandelwal N, Kundu MG, Dudley M, Ratajczak CK, Maag D, Arun BK. Veliparib with carboplatin and paclitaxel in BRCA-mutated advanced breast cancer (BROCADE3): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2020 Oct;21(10):1269-1282. doi: 10.1016/S1470-2045(20)30447-2. Epub 2020 Aug 27.

full_name: Hyo S Han

given: Hyo S

full_name: Shannon L Puhalla

given: Shannon L

family: Bondarenko

full_name: Igor Bondarenko

given: Igor

location_country:
Finland
Romania
Australia
Belgium
Russian Federation
Denmark
Taiwan
Ukraine
Spain
France
Poland
Lithuania
Norway
Argentina
Canada
Korea, Republic of
Turkey
Colombia
South Africa
Chile
Sweden
Netherlands
Singapore
Hungary
Puerto Rico
Portugal
Germany
United States
United Kingdom
Italy
Austria
Mexico
Czechia
Israel
Belarus
Estonia
Latvia

location_facility: Duplicate_Sunnybrook Health Sciences Ctr /ID# 124882

location_facility: State Institution Republican Scientific Practical Center of Oncology and Medical /ID# 125223

location_facility: Univ of Mississippi Med Ctr,US /ID# 131352

location_facility: Centro Hospitalar Universitario de Sao Joao, EPE /ID# 126508

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 125575

location_facility: Southern Medical Day Care Centre /ID# 124844

location_facility: Spitalul Clinic Judetean de Urgenta Cluj -Napoca /ID# 124945

location_facility: The Cancer Ctr at DeKalb Med C /ID# 125024

location_facility: University of Free State, Universitas Annex (National Hospital Grounds) /ID# 128499

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE /ID# 126510

location_facility: Altay Regional Oncological Dispesary /ID# 127160

location_facility: S.C. Centrul de Oncologie Sf. Nectarie S.R.L. /ID# 124948

location_facility: Instituto Nacional del Cancer /ID# 129343

location_facility: Centrum Onkologii Lukaszczyka /ID# 124938

location_facility: Duplicate_Karolinska Univ Sjukhuset /ID# 124964

location_facility: UMass Memorial Medical Center /ID# 129067

location_facility: Unidade Local de Saúde de Matosinhos, EPE /ID# 126511

location_facility: Duplicate_Akdeniz University Medical Fac /ID# 125339

location_facility: University of Vermont Medical Center /ID# 125350

location_facility: Hospital Universitario HM Sanchinarro /ID# 124960

location_facility: Hospital Clinico Universitario de Valencia /ID# 124959

location_facility: University Hospitals Bristol /ID# 128343

location_facility: Wojewodzki Szpital Zespolony /ID# 126998

location_facility: Townsville University Hospital /ID# 126731

location_facility: Centro di Riferimento Oncologico /ID# 126738

location_facility: Nottingham University Hospitals NHS Trust /ID# 125340

location_facility: Gastroenterology Institute, Division of Medicine /ID# 124919

location_facility: Oregon Health and Science University /ID# 134229

location_facility: Hull University Teaching Hospitals NHS Trust /ID# 133030

location_facility: Seoul National University Hospital /ID# 125600

location_facility: University Hospitals Birmingham NHS Foundation Trust /ID# 125342

location_facility: Vitebsk Regional Clinical Oncology Dispensary /ID# 125219

location_facility: Ad-Vance Medical Research, LLC /ID# 126043

location_facility: Duplicate_Jewish General Hospital /ID# 124880

location_facility: Siberian State Medical University /ID# 127161

location_facility: Wojewodzki Szpital Specjalistyczny /ID# 127258

location_facility: Donetsk Regional Antitumor Ctr /ID# 124970

location_facility: Hospital General Universitario Gregorio Maranon /ID# 124962

location_facility: Universitair Ziekenhuis Antwerpen /ID# 124977

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz /ID# 124911

location_facility: East Tallinn Central Hospital /ID# 126475

location_facility: Bezmi Alem Univ Med Fac Hosp /ID# 127901

location_facility: Institut de Cancérologie de l'Ouest René Gauducheau /ID# 137726

location_facility: Universitair Ziekenhuis Leuven /ID# 124980

location_facility: Duplicate_lnstitutul Oncologic Prof Dr Alexandru Trestioreanu /ID# 124943

location_facility: Linkoping University Hospital /ID# 126795

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 125266

location_facility: Zaporizhzhia Med. Academy MOH /ID# 129800

location_facility: Hospital Clinico Vina del Mar /ID# 148502

location_facility: Hematology and Oncology Assoc /ID# 130058

location_facility: Centro Oncologico Riojano Integral /ID# 127938

location_facility: Rutgers Cancer Institute of New Jersey /ID# 125017

location_facility: University of Texas Southwestern Medical Center /ID# 124989

location_facility: Duplicate_archangel Clinical Oncology /ID# 126031

location_facility: Duplicate_Saratov State Medical University n.s. Chernyshevskiy /ID# 139395

location_facility: California Cancer Associates for Research & Excellence (cCARE) /ID# 136078

location_facility: Communal non-profit enterprise Regional Center of Oncology /ID# 124972

location_facility: Instituto Nacional de Cancerología INCAN /ID# 128676

location_facility: Instituto de Oncoloia de Rosario /ID# 127157

location_facility: Instituto Medico de Alta Tecnologia Oncomédica S.A /ID# 129211

location_facility: Duplicate_AZ St-Jan Brugge-Oostende AV /ID# 124975

location_facility: National University Hospital /ID# 125315

location_facility: Hospital Universitario Virgen de la Victoria /ID# 124961

location_facility: Administradora del Country_S.A-Clinica Del Country /ID# 125255

location_facility: Belgorod Oncology Dispensary /ID# 129315

location_facility: Korea University Anam Hospital /ID# 128968

location_facility: Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 125299

location_facility: Riga East Clinical University Hospital /ID# 125265

location_facility: Centro de Estudios Clínicos Especializados /ID# 128680

location_facility: Banner MD Anderson Cancer Ctr /ID# 125011

location_facility: Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 125256

location_facility: Sverdlovsk Regional Oncology Dispensary /ID# 130950

location_facility: Regional Oncology Dispensary /ID# 125936

location_facility: Pauls Stradins Clinical University Hospital /ID# 125264

location_facility: Assaf Harofeh Medical Center /ID# 124915

location_facility: Medical Oncology Ctr Rosebank /ID# 125322

location_facility: Netcare Oncology Intervent Ctr /ID# 125320

location_facility: Florida Cancer Specialists - East /ID# 125007

location_facility: Institut Curie - site CLCC René Huguenin /ID# 124904

location_facility: Cancer Research Collaboration /ID# 128860

location_facility: Duplicate_CHUQ-Hospital St. Sacrement /ID# 124881

location_facility: Univ of Colorado Cancer Center /ID# 124983

location_facility: Duplicate_Zala Megyei Korhaz /ID# 131341

location_facility: Penn State University and Milton S. Hershey Medical Center /ID# 124997

location_facility: Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 125298

location_facility: Medizinische Universitaet Graz /ID# 126450

location_facility: Spectrum Health Medical Group /ID# 148471

location_facility: Bobruysk Interdistrict Onco. /ID# 137729

location_facility: Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 127180

location_facility: University of Texas MD Anderson Cancer Center /ID# 125353

location_facility: Medizinische Universitaet Wien /ID# 126184

location_facility: Centro Oncologico de Chihuahua /ID# 128679

location_facility: Norrlands University hospital /ID# 124967

location_facility: Cancercare Outeniqua Oncology Centre /ID# 125319

location_facility: Northwest Medical Specialties - Tacoma /ID# 125344

location_facility: Duplicate_Helsinki Univ Central Hospital /ID# 124897

location_facility: Duplicate_The Prince of Wales Hospital /ID# 124845

location_facility: NorthShore University HealthSystem /ID# 124996

location_facility: Poltava Regional Clinical Oncology Centre of Poltava Regional Council /ID# 124969

location_facility: Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 124939

location_facility: Vseobecna fakultni nemocnice v Praze /ID# 124887

location_facility: Duplicate_Soroka University Medical Center /ID# 124917

location_facility: Universitair Medisch Centrum Groningen /ID# 129069

location_facility: Maastricht Universitair Medisch Centrum /ID# 129068

location_facility: Lehigh Valley Hosp/Muhlenberg /ID# 130277

location_facility: The Royal Melbourne Hospital /ID# 124846

location_facility: Tel Aviv Sourasky Medical Center /ID# 130276

location_facility: Nebraska Hematology Oncology /ID# 132711

location_facility: Haukeland University Hospital /ID# 150177

location_facility: Lehigh Valley Health Network /ID# 130059

location_facility: Universitaetsklinikum Tuebingen /ID# 129968

location_facility: Istanbul University Istanbul Medical Faculty /ID# 145144

location_facility: University of Illinois - Chicago /ID# 127576

location_facility: University of Arkansas for Medical Sciences /ID# 124992

location_facility: Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 125259

location_facility: Centro Medico Imbanaco de Cali /ID# 126656

location_facility: ME Kryviy Rih Oncology Dispensary /ID# 129806

location_facility: Texas Health Physicians Group /ID# 137740

location_facility: Ordensklinikum Linz GmbH Elisabethinen /ID# 126185

location_facility: Hospital Santa Creu i Sant Pau /ID# 124963

location_facility: IEO -Istituto Europeo di Oncologia /ID# 125260

location_facility: Hacettepe University Faculty of Medicine /ID# 125336

location_facility: Hospital Clinico Vina del Mar /ID# 130100

location_facility: Spectrum Health Medical Group /ID# 133568

location_facility: Grande Ospedale Metropolitano Bianchi Melacrino Morelli /ID# 125263

location_facility: IRCCS Ospedale Sacro Cuore Don Calabria /ID# 125262

location_facility: Municipal Non-Profit Enterprise City Clinical Hospital No.4 of Dnipro City Counc /ID# 124968

location_facility: COIBA Centro de Oncologia e Investigacion de Buenos Aires /ID# 124839

location_facility: CHU UCL Namur - Sainte Elisabeth /ID# 124979

location_facility: Moore UC San Diego Cancer Center /ID# 124991

location_facility: Volgograd Regional Clinical Oncology Dispensary /ID# 124952

location_facility: Sahlgrenska University Hospital /ID# 124965

location_facility: Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 126449

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopern /ID# 126999

location_facility: Duplicate_Tampere University Hospital /ID# 124898

location_facility: Winship Cancer Institute of Emory University /ID# 133192

location_facility: Duplicate_Mogilev Reg Clin Oncology Dis /ID# 137728

location_facility: Washington University-School of Medicine /ID# 127575

location_facility: National Taiwan University Hospital /ID# 125324

location_facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 125337

location_facility: Universitaetsklinik Heidelberg /ID# 126664

location_facility: Duplicate_Flinders Centre for Innovation /ID# 127535

location_facility: Lviv Oncological Regional Therapeutical and Diagnostic Centre /ID# 124974

title: A Phase 3 Randomized, Placebo-Controlled Trial of Carboplatin and Paclitaxel With or Without the PARP Inhibitor Veliparib (ABT-888) in HER2 Negative Metastatic or Locally Advanced Unresectable BRCA-Associated Breast Cancer

summary: The study seeks to evaluate the efficacy and tolerability of veliparib/placebo in combination with carboplatin and paclitaxel in HER2-negative metastatic or locally advanced, unresectable, BRCA-associated breast cancer.


ReferenceCitation: Hyman DM, Piha-Paul SA, Won H, Rodon J, Saura C, Shapiro GI, Juric D, Quinn DI, Moreno V, Doger B, Mayer IA, Boni V, Calvo E, Loi S, Lockhart AC, Erinjeri JP, Scaltriti M, Ulaner GA, Patel J, Tang J, Beer H, Selcuklu SD, Hanrahan AJ, Bouvier N, Melcer M, Murali R, Schram AM, Smyth LM, Jhaveri K, Li BT, Drilon A, Harding JJ, Iyer G, Taylor BS, Berger MF, Cutler RE Jr, Xu F, Butturini A, Eli LD, Mann G, Farrell C, Lalani AS, Bryce RP, Arteaga CL, Meric-Bernstam F, Baselga J, Solit DB. HER kinase inhibition in patients with HER2- and HER3-mutant cancers. Nature. 2018 Feb 8;554(7691):189-194. doi: 10.1038/nature25475. Epub 2018 Jan 31. Erratum in: Nature. 2019 Feb;566(7745):E11-E12.

ReferenceCitation: Smyth LM, Piha-Paul SA, Won HH, Schram AM, Saura C, Loi S, Lu J, Shapiro GI, Juric D, Mayer IA, Arteaga CL, de la Fuente MI, Brufksy AM, Spanggaard I, Mau-Sørensen M, Arnedos M, Moreno V, Boni V, Sohn J, Schwartzberg LS, Gonzàlez-Farré X, Cervantes A, Bidard FC, Gorelick AN, Lanman RB, Nagy RJ, Ulaner GA, Chandarlapaty S, Jhaveri K, Gavrila EI, Zimel C, Selcuklu SD, Melcer M, Samoila A, Cai Y, Scaltriti M, Mann G, Xu F, Eli LD, Dujka M, Lalani AS, Bryce R, Baselga J, Taylor BS, Solit DB, Meric-Bernstam F, Hyman DM. Efficacy and Determinants of Response to HER Kinase Inhibition in HER2-Mutant Metastatic Breast Cancer. Cancer Discov. 2020 Feb;10(2):198-213. doi: 10.1158/2159-8290.CD-19-0966. Epub 2019 Dec 5.

ReferenceCitation: Oaknin A, Friedman CF, Roman LD, D'Souza A, Brana I, Bidard FC, Goldman J, Alvarez EA, Boni V, ElNaggar AC, Passalacqua R, Do KTM, Santin AD, Keyvanjah K, Xu F, Eli LD, Lalani AS, Bryce RP, Hyman DM, Meric-Bernstam F, Solit DB, Monk BJ. Neratinib in patients with HER2-mutant, metastatic cervical cancer: Findings from the phase 2 SUMMIT basket trial. Gynecol Oncol. 2020 Oct;159(1):150-156. doi: 10.1016/j.ygyno.2020.07.025. Epub 2020 Jul 25.

family: Oaknin

full_name: Ana Oaknin

given: Ana

family: Friedman

full_name: Claire F. Friedman

given: Claire F.

family: Roman

full_name: Lynda D. Roman

given: Lynda D.

family: D'Souza

full_name: Anishka D'Souza

given: Anishka

family: Brana

full_name: Irene Brana

given: Irene

family: Bidard

full_name: François-Clement Bidard

given: François-Clement

family: Goldman

full_name: Jonathan Goldman

given: Jonathan

family: Alvarez

full_name: Edwin A. Alvarez

given: Edwin A.

family: Boni

full_name: Valentina Boni

given: Valentina

family: ElNaggar

full_name: Adam C. ElNaggar

given: Adam C.

family: Passalacqua

full_name: Rodolfo Passalacqua

given: Rodolfo

family: Do

full_name: Khanh T.M. Do

given: Khanh T.M.

family: Santin

full_name: Alessandro D. Santin

given: Alessandro D.

family: Keyvanjah

full_name: Kiana Keyvanjah

given: Kiana

family: Xu

full_name: Feng Xu

given: Feng

family: Eli

full_name: Lisa D. Eli

given: Lisa D.

family: Lalani

full_name: Alshad S. Lalani

given: Alshad S.

family: Bryce

full_name: Richard P. Bryce

given: Richard P.

family: Hyman

full_name: David M. Hyman

given: David M.

family: Meric-Bernstam

full_name: Funda Meric-Bernstam

given: Funda

family: Solit

full_name: David B. Solit

given: David B.

family: Monk

full_name: Bradley J. Monk

given: Bradley J.

journal_name: Gynecologic Oncology

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

repository_institution: California Digital Library - eScholarship

ReferenceCitation: Ulaner GA, Saura C, Piha-Paul SA, Mayer I, Quinn D, Jhaveri K, Stone B, Shahin S, Mann G, Dujka M, Bryce R, Meric-Bernstam F, Solit DB, Hyman DM. Impact of FDG PET Imaging for Expanding Patient Eligibility and Measuring Treatment Response in a Genome-Driven Basket Trial of the Pan-HER Kinase Inhibitor, Neratinib. Clin Cancer Res. 2019 Dec 15;25(24):7381-7387. doi: 10.1158/1078-0432.CCR-19-1658. Epub 2019 Sep 23.

publisher: American Association for Cancer Research (AACR)

ReferenceCitation: Hanker AB, Brewer MR, Sheehan JH, Koch JP, Sliwoski GR, Nagy R, Lanman R, Berger MF, Hyman DM, Solit DB, He J, Miller V, Cutler RE Jr, Lalani AS, Cross D, Lovly CM, Meiler J, Arteaga CL. An Acquired HER2(T798I) Gatekeeper Mutation Induces Resistance to Neratinib in a Patient with HER2 Mutant-Driven Breast Cancer. Cancer Discov. 2017 Jun;7(6):575-585. doi: 10.1158/2159-8290.CD-16-1431. Epub 2017 Mar 8. Erratum in: Cancer Discov. 2019 Feb;9(2):303.

title: An Acquired HER2T798I Gatekeeper Mutation Induces Resistance to Neratinib in a Patient with HER2 Mutant–Driven Breast Cancer

ipd_sharing_description:
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In accordance with legal and regulatory requirements, Puma publishes study protocol information and clinical study results on clinical trial registries, including ClinicalTrials.gov and EU Clinical Trials Register. Puma also publishes information about clinical studies in peer-reviewed scientific journals and shares data in scientific meetings.

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location_country:
Italy
United States
Serbia
Finland
France
Israel
Ireland
Belgium
Australia
Spain
Denmark
Canada
United Kingdom
Korea, Republic of

location_facility: Winship Cancer Institute, Emory University

location_facility: Hospital Universitario Madrid Sanchinarro (START Madrid)

location_facility: Abington Memorial Hospital, Asplundh Cancer Pavilion

location_facility: Metro Minnesota Community Oncology Research Consortium

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center

location_facility: UPMC Magee-Woman's Hospital, Women's Cancer Center

location_facility: Instituto Nazionale dei Tumori Fond Pascale IRCCS

location_facility: Gundersen Center for Cancer and Blood Disorders

location_facility: University of Wisconsin Carbone Cancer Center

location_facility: Christiana Care Health Services, Christiana Hospital

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Roswell Park Comprehensive Cancer Center

location_facility: Institute for Oncology and Radiology of Serbia

location_facility: Yonsei University Health System, Serverance Hospital

location_facility: AOU Citta della Salute e della Scienza di Torino

location_facility: Davidoff Cancer Center, Rabin Medical Center

location_facility: Hospital Clinico Universitario San Carlos

location_facility: Istituto Europeo di Oncologia (IEO) I.R.C.C.S.

location_facility: Fondazione Policlinico Universitario Gemelli I.R.C.C.S.

location_facility: Azienda Socio Sanitaria Territoriale di Cremona

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Hospital Clinico Universitario de Valencia

title: An Open-Label, Phase 2 Basket Study of Neratinib in Patients With Solid Tumors With Somatic Activating HER Mutations

summary: This is an open-label, multicenter, multinational, Phase 2 basket study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in participants with HER (EGFR, HER2) mutation-positive solid tumors.


ReferenceCitation: Roberts AW, Ma S, Kipps TJ, Coutre SE, Davids MS, Eichhorst B, Hallek M, Byrd JC, Humphrey K, Zhou L, Chyla B, Nielsen J, Potluri J, Kim SY, Verdugo M, Stilgenbauer S, Wierda WG, Seymour JF. Efficacy of venetoclax in relapsed chronic lymphocytic leukemia is influenced by disease and response variables. Blood. 2019 Jul 11;134(2):111-122. doi: 10.1182/blood.2018882555. Epub 2019 Apr 25.

name: Royal Melbourne Hospital, Melbourne, VIC, Australia;

name: Peter MacCallum Cancer Center, Melbourne, VIC, Australia;

name: The Walter and Eliza Hall Institute of Medical Research, Parkville, VIC, Australia;

name: Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Parkville, VIC, Australia;

family: Roberts

full_name: Andrew W. Roberts

given: Andrew W.

name: Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL;

family: Ma

full_name: Shuo Ma

given: Shuo

name: Moores Cancer Center, University of California School of Medicine, San Diego, CA;

family: Kipps

full_name: Thomas J. Kipps

given: Thomas J.

name: Stanford Cancer Center, Stanford University School of Medicine, Stanford CA;

family: Coutre

full_name: Steven E. Coutre

given: Steven E.

name: Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA;

family: Davids

full_name: Matthew S. Davids

given: Matthew S.

family: Eichhorst

full_name: Barbara Eichhorst

given: Barbara

name: University Hospital Cologne and Center for Integrated Oncology Cologne-Bonn, University of Cologne, Cologne, Germany;

family: Hallek

full_name: Michael Hallek

given: Michael

name: Division of Hematology, Ohio State University College of Medicine, Columbus, OH;

family: Byrd

full_name: John C. Byrd

given: John C.

name: F. Hoffman-La Roche Ltd., Basel, Switzerland;

family: Humphrey

full_name: Kathryn Humphrey

given: Kathryn

family: Zhou

full_name: Lang Zhou

given: Lang

family: Chyla

full_name: Brenda Chyla

given: Brenda

family: Nielsen

full_name: Jacqueline Nielsen

given: Jacqueline

family: Potluri

full_name: Jalaja Potluri

given: Jalaja

family: Kim

full_name: Su Young Kim

given: Su Young

family: Verdugo

full_name: Maria Verdugo

given: Maria

name: Internal Medicine III, Ulm University, Ulm, Germany; and

family: Stilgenbauer

full_name: Stephan Stilgenbauer

given: Stephan

name: MD Anderson Cancer Center, University of Texas, Houston, TX

family: Wierda

full_name: William G. Wierda

given: William G.

family: Seymour

full_name: John F. Seymour

given: John F.

journal_name: Blood

evidence: open (via free article)

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

ReferenceCitation: Stilgenbauer S, Eichhorst B, Schetelig J, Hillmen P, Seymour JF, Coutre S, Jurczak W, Mulligan SP, Schuh A, Assouline S, Wendtner CM, Roberts AW, Davids MS, Bloehdorn J, Munir T, Böttcher S, Zhou L, Salem AH, Desai M, Chyla B, Arzt J, Kim SY, Verdugo M, Gordon G, Hallek M, Wierda WG. Venetoclax for Patients With Chronic Lymphocytic Leukemia With 17p Deletion: Results From the Full Population of a Phase II Pivotal Trial. J Clin Oncol. 2018 Jul 1;36(19):1973-1980. doi: 10.1200/JCO.2017.76.6840. Epub 2018 May 1. Erratum in: J Clin Oncol. 2019 Sep 1;37(25):2299.

name: Stephan Stilgenbauer and Johannes Bloehdorn, Ulm University, Ulm; Stephan Stilgenbauer, Klinik für Innere Medizin I, Universitätsklinikum des Saarlandes, Homburg; Barbara Eichhorst and Michael Hallek, Universitätsklinikum Köln, Köln; Johannes Schetelig, University Hospital, Technische Universität Dresden, Dresden; Clemens-Martin Wendtner, Klinikum Schwabing, Munich; Sebastian Böttcher, University Hospital of Schleswig-Holstein, Kiel, Germany; Peter Hillmen and Talha Munir, St James’s University Hospital,...

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Stilgenbauer S, Eichhorst B, Schetelig J, Coutre S, Seymour JF, Munir T, Puvvada SD, Wendtner CM, Roberts AW, Jurczak W, Mulligan SP, Böttcher S, Mobasher M, Zhu M, Desai M, Chyla B, Verdugo M, Enschede SH, Cerri E, Humerickhouse R, Gordon G, Hallek M, Wierda WG. Venetoclax in relapsed or refractory chronic lymphocytic leukaemia with 17p deletion: a multicentre, open-label, phase 2 study. Lancet Oncol. 2016 Jun;17(6):768-778. doi: 10.1016/S1470-2045(16)30019-5. Epub 2016 May 10.

location_country:
United States
Germany
France
Poland
Australia
Canada
United Kingdom

location_facility: Northwestern University Feinberg School of Medicine /ID# 92499

location_facility: Universitaetsklinikum Freiburg /ID# 113276

location_facility: Georgetown University Hospital /ID# 96954

location_facility: Rutgers Cancer Institute of NJ /ID# 92513

location_facility: Samodzielny Publiczny Szpital /ID# 98848

location_facility: Universitaetsklinikum Dresden /ID# 113256

location_facility: The Royal Bournemouth Hospital /ID# 118975

location_facility: University of Texas MD Anderson Cancer Center /ID# 92521

location_facility: Stanford University School of Med /ID# 105117

location_facility: University of Arizona Cancer Center - North Campus /ID# 96748

location_facility: Universitaetsmedizin Goettinge /ID# 113258

location_facility: Christie NHS Foundation Trust /ID# 98864

location_facility: Universitaetsklinikum Schleswig-Holstein /ID# 113235

location_facility: Columbia Univ Medical Center /ID# 103835

location_facility: St. James University Hospital /ID# 98863

location_facility: SP ZOZ Szpital Uniwersytecki w Krakowie /ID# 98849

location_facility: St Bartholomew's Hospital, Bar /ID# 98862

location_facility: Moore UC San Diego Cancer Center /ID# 91793

location_facility: Universitaetsklinik Heidelberg /ID# 98845

location_facility: Royal Liverpool and Broadgreen /ID# 98860

title: A Phase 2 Open-Label Study of the Efficacy of ABT-199 (GDC-0199) in Subjects With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia Harboring the 17p Deletion

summary: This is a Phase 2, open label, multicenter, study evaluating the efficacy and safety of ABT-199 (Venetoclax) in relapsed or refractory subjects with CLL harboring 17p13 (TP53 locus) deletion. One hundred seven (107) subjects were enrolled in the main cohort, with evaluation of efficacy as the primary objective, and approximately 50 subjects will be enrolled in the safety expansion cohort to evaluate safety and updated tumor lysis syndrome prophylaxis and management measures. Enrollment into the main cohort is closed. Enrollment into the safety expansion cohort is closed.