ReferenceCitation: Hokusai-VTE Investigators, Büller HR, Décousus H, Grosso MA, Mercuri M, Middeldorp S, Prins MH, Raskob GE, Schellong SM, Schwocho L, Segers A, Shi M, Verhamme P, Wells P. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med. 2013 Oct 10;369(15):1406-15. doi: 10.1056/NEJMoa1306638. Epub 2013 Aug 31. Erratum in: N Engl J Med. 2014 Jan 23;370(4):390.

oa_host_type: repository

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

title: Edoxaban versus Warfarin for the Treatment of Symptomatic Venous Thromboembolism

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
Guatemala
Malaysia
Romania
Russian Federation
Denmark
Taiwan
Ukraine
India
Croatia
France
Panama
Thailand
Norway
Argentina
El Salvador
Canada
Slovenia
Korea, Republic of
Kenya
Chile
Netherlands
Bulgaria
Singapore
Hungary
Portugal
United States
Germany
Brazil
Serbia
Lebanon
Czechia
Israel
Spain
Turkey

location_facility: Izmir Dr. Behcet Uz Cocuk Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi

location_facility: Izmir Tepecik Training and Research Hospital

location_facility: University of Szeged, Department of Pediatrics

location_facility: CI of Healthcare Regional Children CH Gastroenterology Center Kharkiv NMU

location_facility: Hospital El Carmen Dr. Luis Valentin Ferrada

location_facility: University Hospital Centre Zagreb, University of Zagreb School of Medicine

location_facility: University of Oklahoma Health Sciences Center

location_facility: Centro de Hematologia e Hemoterapia - Hemocentro de Campinas - UNICAMP

location_facility: Russian Scientific Center of Radiology and Nuclear Medicine of Ministry of Health of Russian Federation, Department of Pediatric Oncology

location_facility: Children's Hospital & Clinics of Minnesota

location_facility: Ankara Çocuk Sağlığı Ve Hastalıkları Hematoloji Onkoloji Eğitim Araştırma Hastanesi

location_facility: HMCG - Hospital e Maternidade Dr. Christovão da Gama

location_facility: Mother and Child Health Care Institute of Serbia "Dr. Vukan Cupic"

location_facility: Hospital de Câncer de Barretos - Fundação Pio XII

location_facility: Chiang Mai University Hospital, Faculty of Medicine, Chiang Mai University

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

location_facility: Central Hospital of Southern Pest - National Institute of Hematology and Infectious Diseases

location_facility: Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria

location_facility: Instituto de Cardiologia do Rio Grande do Sul

location_facility: Unidad Nacional de Oncología Pediátrica (UNOP)

location_facility: CHU Clermont Ferrand - Hôpital d'Estaing

location_facility: Washington University School of Medicine

location_facility: Seoul National University Bundang Hospital

location_facility: Clinical Hospital Centre Cavale Blanche BREST

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

location_facility: Medical Center for Specialized Ambulatory Medical Assistance for Children's Diseases

location_facility: UNIFESP - Universidade Federal de São Paulo

location_facility: M. S. Ramaiah Medical College and Hospital

location_facility: Saint George University Hospital Medical Center

location_facility: Centro Multidisciplinar de Estudos Clínicos - CEMEC

location_facility: Unidad de Cirugía Cardiovascular de Guatemala (UNICAR)

location_facility: Hospital Clinico Pontificia Universidad Catolica de Chile

location_facility: GRAACC - Grupo de Apoio ao Adolescente e à Criança com Câncer

location_facility: Semmelweis University 2nd Department of Pediatrics

location_facility: University of Miami Miller School of Medicine

location_facility: Cukurova University Faculty of Medicine Balcali Hospital Pediatry Department

location_facility: Istanbul University Istanbul Medical Faculty

location_facility: Mersin University Health Research and Practice Hospital

location_facility: Shree Krishna Hospital & Medical Research Centre, H M Patel Centre for Medical Care and Education

location_facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque

location_facility: American University of Beirut Medical Center

location_facility: Hospital Nacional de Niños Benjamín Bloom

location_facility: Spectrum Health Helen DeVos Children's Hospital Grand Rapids

location_facility: Indiana Hemophilia and Thrombosis Center

location_facility: FSBI of Science "Kirov Scientific and Research Institute of Hematology and Blood Transfusion, FMBA"

location_facility: IMIP - Instituto de Medicina Integral Professor Fernando Figueira

location_facility: Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santa Marta

type: Registry Identifier

title: A Phase 3, Open-label, Randomized, Multi-center, Controlled Trial to Evaluate the Pharmacokinetics and Pharmacodynamics of Edoxaban and to Compare the Efficacy and Safety of Edoxaban With Standard of Care Anticoagulant Therapy in Pediatric Subjects From Birth to Less Than 18 Years of Age With Confirmed Venous Thromboembolism (VTE)

summary: This is an event driven Phase 3, prospective, randomized, open-label, blinded endpoint evaluation (PROBE) parallel group study in subjects with confirmed VTE. This study is designed to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of edoxaban and to compare the efficacy and safety of edoxaban against standard of care in pediatric subjects with confirmed VTE.


type: Other Identifier

title: A Phase 3, International, Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Efficacy, Immunogenicity, and Safety of the 9vHPV Vaccine, a Multivalent L1 Virus-like Particle Vaccine, in the Prevention of Oral Persistent Infection With HPV Types 16, 18, 31, 33, 45, 52, or 58 in Adult Males, 20 to 45 Years of Age

summary: The purpose of this study is to evaluate the efficacy, immunogenicity and safety of the 9-valent human papillomavirus (9vHPV) vaccine in men 20 to 45 years of age. The primary hypothesis tested in this study is that administration of a 3-dose regimen of 9vHPV vaccine will reduce the incidence of HPV 16/18/31/33/45/52/58-related oral persistent infection (6 months or longer) compared with placebo.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Anticipated

ipd_sharing: Yes

lead_sponsor: Merck Sharp & Dohme Corp.

location_country:
Italy
Brazil
Peru
Mexico
Germany
France
Czechia
Japan
Israel
Thailand
Belgium
Spain
United States
Korea, Republic of
Taiwan
Colombia

location_facility: Preferred Primary Care Physicians ( Site 0032)

location_facility: Centro de Atención e Investigación Médica SAS - CAIMED CHIA ( Site 0156)

location_facility: Clinical Research of South Florida ( Site 0036)

location_facility: Armed Forces Research Institute of Medical Sciences ( Site 1051)

location_facility: Fundacion Centro de Investigacion Clinica CIC ( Site 0153)

location_facility: Acevedo Clinical Research Associates ( Site 0001)

location_facility: Solaris Clinical Research, LLC ( Site 0003)

location_facility: Medical Corporation Houeikai Sekino Clinical Pharmacology Clinic ( Site 1102)

location_facility: Universita di Roma "La Sapienza" ( Site 0553)

location_facility: Cotton-O'Neil Clinical Research Center ( Site 0044)

location_facility: Hallym University Kangnam Sacred Heart Hospital ( Site 0951)

location_facility: Medical Corporation Iseikai My City Clinic ( Site 1108)

location_facility: Arke Estudios Clinicos S.A. de C.V. ( Site 0203)

location_facility: National Taiwan University Hospital ( Site 1000)

location_facility: Istittuto Nazionale dei Tumori Regina Elena IRCCS - IFO ( Site 0551)

location_facility: Health Research of Hampton Roads, Inc. ( Site 0015)

location_facility: Universitair Ziekenhuis Gasthuisberg ( Site 0353)

location_facility: Instituto de Investigacion Nutricional - Anexo Huascar ( Site 0251)

location_facility: Medical Corporation Mori to Umi Tokyo Tokyo Kamata Hospital ( Site 1112)

location_facility: Vaccine Trial Center Faculty of Tropical Medicine ( Site 1052)

location_facility: Certified Research Associates ( Site 0041)

location_facility: Kentucky Pediatric/Adult Research Inc ( Site 0011)

location_facility: Alta California Medical Group ( Site 0031)

location_facility: Valley Clinical Trials Inc. ( Site 0002)

location_facility: Inland Empire Clinical Trials, LLC ( Site 0025)

location_facility: Healthcare Research Network LLC ( Site 0035)

location_facility: Research Institute for Health Sciences ( Site 1053)

location_facility: J Lewis Research Inc/Jordan River Family Medicine ( Site 0023)

location_facility: Medical Corporation Seiwakai Hayakawa Clinic ( Site 1113)

location_facility: Universitatsklinikum Hamburg-Eppendorf ( Site 0451)

location_facility: P-One Clinic, Keikokai Medical Corp. ( Site 1101)

location_facility: The Catholic University of Korea Eunpyeong St Mary s Hospital ( Site 0954)

location_facility: Diablo Clinical Research, Inc ( Site 0042)

location_facility: Infektiologikum Frankfurt-Sachsenhausen ( Site 0456)

location_facility: Azienda Ospedaliera Policlinico di Bari ( Site 0550)

location_facility: Maccabi Health Services Medical Center ( Site 0604)

location_facility: Encompass Clinical Research ( Site 0028)

location_facility: Centro de Pesquisa Clinica II - ICHC - FMUSP ( Site 0102)

location_facility: Medical Corporation Heishinkai OPHAC Hospital ( Site 1105)

location_facility: Texas Center For Drug Development ( Site 0013)

location_facility: Medical Corporation Shinanokai Shinanozaka Clinic ( Site 1106)

location_facility: CHU Nantes - Hopital Hotel Dieu ( Site 0510)

location_facility: Charlottesville Medical Research Center, LLC ( Site 0007)

location_facility: Hospital Santo Antonio - Obras Sociais Irma Dulce ( Site 0101)

location_facility: Rochester Clinical Research, Inc. ( Site 0008)

location_facility: Institut Catala d Oncologia Hospital Germans Trias i Pujol ( Site 0755)

location_facility: Hadassah Medical Center. Ein Kerem ( Site 0600)

location_facility: National Cheng Kung University Hospital ( Site 1002)

location_facility: Investigaciones Medicas en Salud - INMENSA ( Site 0255)

location_facility: Korea University Guro Hospital ( Site 0950)

location_facility: J Lewis Research Inc/Foothill Family Clinic South ( Site 0006)

location_facility: Icaro Investigaciones en Medicina S.A. de C.V. ( Site 0200)

location_facility: Faculty of Medicine Siriraj Hospital ( Site 1050)

location_facility: Coastal Carolina Research Center ( Site 0043)

location_facility: Souseikai Nishikumamoto Hospital ( Site 1104)

location_facility: Doujin Memorial Medical Foundation, Meiwa Hospital ( Site 1111)

location_facility: University of Texas Medical Branch at Galveston ( Site 0038)

location_facility: ARKE Estudios Clinicos S.A de C.V ( Site 0211)

location_facility: Asociacion Civil Selva Amazonica ( Site 0252)

location_facility: AOU Policlinico Vittorio Emanuele ( Site 0552)

location_facility: Korea University Ansan Hospital ( Site 0952)

location_facility: Policlinico Universidad Nacional Mayor de San Marcos ( Site 0257)

location_facility: Alliance for Multispecialty Reseach, LLC ( Site 0021)

location_facility: Chang Gung Medical Foundation.Linkou Branch ( Site 1001)

location_facility: Clinical Research Partners, LLC. ( Site 0004)

location_facility: Crossroads Clinical Research LLC ( Site 0027)

location_facility: CHU Dijon Bourgogne - Hopital F. Mitterrand ( Site 0223)

location_facility: C.H.R.U. de Rennes. Hopital de Pontchaillou ( Site 0507)

location_facility: Instituto Nacional de Salud Publica ( Site 0202)

location_facility: Heartland Research Associates, LLC ( Site 0034)

location_facility: Centrum ambulantni gynekologie a primarni pece ( Site 0401)

location_facility: Chang Gung Medical Foundation. Kaohsiung Branch ( Site 1003)

location_facility: Azienda Ospedaliera - Universita di Padova ( Site 0555)

location_facility: Rapid Medical Research, Inc. ( Site 0037)

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Ongoing


type: EudraCT Number

title: A Phase 1b, Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-368 Plus Tilsotolimod and Other Therapy Combinations in Subjects With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

summary: The main objective of this study is to assess safety, tolerability, and pharmacokinetics (PK) of ABBV-368 plus tilsotolimod; ABBV-368 plus tilsotolimod and nab-paclitaxel; and ABBV-368 plus tilsotolimod, nab-paclitaxel, and ABBV-181 in participants with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).

status: Recruiting

design_allocation: Non-Randomized

primary_purpose: Treatment

ipd_sharing: No

lead_sponsor: AbbVie

location_country:
United States
Netherlands
France
Israel
Spain
Germany

location_facility: Barbara Ann Karmanos Cancer In /ID# 214050

location_facility: Gastroenterology Institute, Division of Medicine /ID# 215862

location_facility: Hospital Universitario HM Sanchinarro /ID# 214110

location_facility: AP-HM - Hopital de la Timone /ID# 215657

location_facility: The University of Chicago Medical Center /ID# 217196

location_facility: Hospital Clinico Universitario de Valencia /ID# 221401

location_facility: Hospital Clinic de Barcelona /ID# 214264

location_facility: Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 221402

location_facility: The Chaim Sheba Medical Center /ID# 215229

location_facility: Roswell Park Comprehensive Cancer Center /ID# 215882

location_facility: Vanderbilt Ingram Cancer Center /ID# 214040

location_facility: Universitaetsklinikum Leipzig /ID# 214200

location_facility: Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 214197

location_facility: Universitaetsklinikum Erlangen /ID# 214196

location_facility: Hospital Universitario de Fuenlabrada /ID# 214263

location_facility: Centre Antoine Lacassagne - Nice /ID# 215706

location_facility: Hospital Universitario 12 de Octubre /ID# 214198

location_facility: Hospital Universitario Virgen de la Victoria /ID# 214109

intervention_type: Drug


title: A Phase 1, Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Combinations of ABBV-927 With ABBV-368, Budigalimab (ABBV-181) and/or Chemotherapy in Subjects With Locally Advanced or Metastatic Solid Tumors

summary: A study evaluating the safety, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of ABBV-927 with ABBV-368, Budigalimab (ABBV-181) and/or chemotherapy in participants with selected solid tumors. This study consists of 2 main parts, a dose-escalation phase and a dose-expansion phase. The dose-expansion phase can begin once the recommended phase 2 dose/maximum tolerated dose (RP2D/MTD) is determined in the dose-escalation phase.

location_country:
France
Israel
Australia
Spain
United States
Taiwan

location_facility: Carolina BioOncology Institute /ID# 210664

location_facility: AP-HP - Hopital Bichat - Claude-Bernard /ID# 212869

location_facility: Hospital Universitario Virgen de la Victoria /ID# 221671

location_facility: Virginia Cancer Specialists - Fairfax /ID# 210671

location_facility: Hospital Universitario Vall d'Hebron /ID# 212804

location_facility: National Taiwan University Hospital /ID# 210993

location_facility: Mary Crowley Cancer Research /ID# 210716

location_facility: Tennessee Oncology-Nashville Centennial /ID# 221400

location_facility: Institut de Cancérologie de l'Ouest René Gauducheau /ID# 212880

location_facility: China Medical University Hosp /ID# 221090

location_facility: St Jude Hospital dba St Joseph /ID# 211130

location_facility: Washington University-School of Medicine /ID# 221399

location_facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 212806

location_facility: Hospital Universitario HM Sanchinarro /ID# 212805


ReferenceType: derived

ReferenceCitation: Guttman-Yassky E, Teixeira HD, Simpson EL, Papp KA, Pangan AL, Blauvelt A, Thaçi D, Chu CY, Hong HC, Katoh N, Paller AS, Calimlim B, Gu Y, Hu X, Liu M, Yang Y, Liu J, Tenorio AR, Chu AD, Irvine AD. Once-daily upadacitinib versus placebo in adolescents and adults with moderate-to-severe atopic dermatitis (Measure Up 1 and Measure Up 2): results from two replicate double-blind, randomised controlled phase 3 trials. Lancet. 2021 Jun 5;397(10290):2151-2168. doi: 10.1016/S0140-6736(21)00588-2. Epub 2021 May 21. Erratum in: Lancet. 2021 Jun 5;397(10290):2150.

family: Guttman-Yassky

full_name: Emma Guttman-Yassky

given: Emma

sequence: first

family: Teixeira

full_name: Henrique D Teixeira

given: Henrique D

sequence: additional

family: Simpson

full_name: Eric L Simpson

given: Eric L

family: Papp

full_name: Kim A Papp

given: Kim A

family: Pangan

full_name: Aileen L Pangan

given: Aileen L

family: Blauvelt

full_name: Andrew Blauvelt

given: Andrew

family: Thaçi

full_name: Diamant Thaçi

given: Diamant

family: Chu

full_name: Chia-Yu Chu

given: Chia-Yu

family: Hong

full_name: H Chih-ho Hong

given: H Chih-ho

family: Katoh

full_name: Norito Katoh

given: Norito

family: Paller

full_name: Amy S Paller

given: Amy S

family: Calimlim

full_name: Brian Calimlim

given: Brian

family: Gu

full_name: Yihua Gu

given: Yihua

family: Hu

full_name: Xiaofei Hu

given: Xiaofei

family: Liu

full_name: Meng Liu

given: Meng

family: Yang

full_name: Yang Yang

given: Yang

full_name: John Liu

given: John

family: Tenorio

full_name: Allan R Tenorio

given: Allan R

full_name: Alvina D Chu

given: Alvina D

family: Irvine

full_name: Alan D Irvine

given: Alan D

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: The Lancet

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

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:
Greece
Australia
Belgium
Denmark
Taiwan
Croatia
France
Canada
Korea, Republic of
Netherlands
Bulgaria
Singapore
Hungary
Ireland
Portugal
Germany
United States
United Kingdom
Italy
Austria
Czechia
New Zealand
Spain

location_facility: Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 207982

location_facility: Treasure Valley Medical Research /ID# 210298

location_facility: Vseobecna fakultni nemocnice v Praze /ID# 205201

location_facility: South Infirmary Victoria University Hospital /ID# 204265

location_facility: Murdoch Children's Research Institute /ID# 205667

location_facility: Vital Prospects Clinical Research Institute, PC /ID# 205824

location_facility: Acibadem City Clinic UMHAT Tokuda /ID# 205292

location_facility: Hospital Clinic de Barcelona /ID# 210564

location_facility: Dr. S.K. Siddha Medicine Professional Corporation /ID# 207138

location_facility: Austin Institute for Clinical Research /ID# 206640

location_facility: Semmleweis Ignac Egeszsegugyi /ID# 218072

location_facility: Hospital Vital Alvarez Buylla /ID# 205770

location_facility: Universal Axon Clinical Research /ID# 213703

location_facility: CHP, EPE- Hospital Geral de Sa /ID# 205187

location_facility: 401 GSNA - 401 Army General Hospital /ID# 205352

location_facility: Hospital Universitario Reina Sofia /ID# 204712

location_facility: Hospital Parc de Salut del Mar /ID# 204709

location_facility: Hospital General Universitario Gregorio Maranon /ID# 204380

location_facility: PMG Research of Wilmington LLC /ID# 205968

location_facility: Total Skin and Beauty Derm Ctr /ID# 205129

location_facility: The Guenther Dermatology Research Centre /ID# 206772

location_facility: Allergy Research Canada Inc. /ID# 213547

location_facility: Palmtree Clinical Research Inc. /Id# 206184

location_facility: Taipei Medical University Shuang Ho Hospital /ID# 204804

location_facility: General Hospital Andreas Syggros /ID# 204527

location_facility: Dermatologische Gemeinschaftspraxis Mahlow /ID# 205765

location_facility: Hospital Infantil Universitario Nino Jesus /ID# 210437

location_facility: Military Medical Academy Multiprofile Hospital /ID# 205291

location_facility: Ideal Clinical Research Inc. /ID# 209880

location_facility: Keck School of Medicine of USC /ID# 206971

location_facility: SoonChunHyang University Buchon Hospital /ID# 206391

location_facility: Timber Lane Allergy & Asthma Research, LLC /ID# 206897

location_facility: Medical Dermatology Specialist /ID# 205516

location_facility: Sanatorium profesora Arenbergera /ID# 205098

location_facility: Arizona Research Center, Inc. /ID# 205795

location_facility: Haut- und Laserzentrum Hunsrück /ID# 205768

location_facility: Hautarztpraxis Dr. med. Matthias Hoffmann /ID# 205766

location_facility: Allergy, Asthma & Immunology Associates, PC /ID# 218169

location_facility: Marietta Dermatology Clinical Research /ID# 210317

location_facility: University of New Mexico School of Medicine /ID# 206756

location_facility: ASST Spedali civili di Brescia /ID# 205927

location_facility: Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 205085

location_facility: The Catholic University of Korea Incheon St.Mary's Hospital /ID# 206529

location_facility: Advanced Research for Health Improvement /ID# 218003

location_facility: University Hospitals Case Medical Center /ID# 206639

location_facility: Innovative Clinical Research - Lafayette /ID# 208400

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 204993

location_facility: Naftalan - Specijalna bolnica za medicinsku rehabilitaciju /ID# 203448

location_facility: Duplicate_Summit Medical Group /ID# 213863

location_facility: The Royal Melbourne Hospital /ID# 205919

location_facility: Rady Children's Hospital San Diego /ID# 208244

location_facility: Medical center Sveti Panteleimon /ID# 210414

location_facility: Centro Hospitalar de Leiria, EPE /ID# 209906

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 205611

location_facility: CCA Braga - Hospital de Braga /ID# 205854

location_facility: Dr. Lyne Giroux Medicine Professional Corporation /ID# 206771

location_facility: Awasty Research Network, LLC /ID# 206748

location_facility: Clinical Research Trials of Florida, Inc. /ID# 206840

location_facility: Hospital Universitario Infanta Leonor /ID# 204710

location_facility: Derm Clin Res Ctr San Antonio /ID# 205469

location_facility: Universitair Medisch Centrum Groningen /ID# 205162

location_facility: UBC Department of Dermatology and Skin Science The Skin Care Centre /ID# 207837

location_facility: University of Michigan Health Systems /ID# 206895

location_facility: University of California Irvine /ID# 205136

location_facility: Centro Hospitalar Universitario de Sao Joao, EPE /ID# 205679

location_facility: KK Women's & Children Hospital /ID# 206693

location_facility: Child Hosp of Orange County,CA /ID# 205735

location_facility: Clinexpert Obuda Egeszsegcentruma /ID# 211246

location_facility: The Education & Research Foundation, Inc. /ID# 206900

location_facility: Centre Hospitalier Universitaire du Sart Tilman CHU de Liege /ID# 204938

location_facility: DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 205429

location_facility: University Hospital Waterford /ID# 204266

location_facility: Velocity Clinical Research Hallandale Beach /ID# 207544

location_facility: Hospital General Universitario de Valencia /ID# 210565

location_facility: University Hospital Plymouth NHS Foundation Trust /ID# 204649

location_facility: Northshore University Health System Dermatology Clinical Trials Unit /ID# 205135

location_facility: 251 Airforce General Hospital /ID# 205841

location_facility: Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 205839

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 205987

location_facility: Continental Clinical Solutions /ID# 210327

location_facility: Midflorida Clinical Research, Inc. /ID# 213700

location_facility: National Taiwan University Hospital /ID# 204803

location_facility: Chung Shan Medical University /ID# 205092

location_facility: Epiphany Dermatology - Fort Worth /ID# 210073

location_facility: Linkou Chang Gung Memorial Ho /ID# 204783

location_facility: Poliklinika Vlatka Cavka d.o.o. /ID# 211126

location_facility: Azienda Ospedaliero-Universitaria di Modena /ID# 205169

location_facility: Seoul National University Hospital /ID# 206396

location_facility: Advanced Research for Health Improvement /ID# 217987

location_facility: Dermatology Treatment and Research Center, PA /ID# 205473

location_facility: CHRU de Brest - Hopital Morvan /ID# 206555

location_facility: Universitaetsklinikum St. Poelten /ID# 206909

location_facility: University Hospital Southampton NHS Foundation Trust /ID# 205711

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 206658

location_facility: Chung-Ang University Hostipal /ID# 206397

location_facility: Clinical Investigation Specialists, Inc. /ID# 206898

location_facility: Clinical Investigation Specialist, Inc - Kenosha /ID# 215933

location_facility: The Dermatology Clinic of Arkansas /ID# 218749

location_facility: Georgia Pollens Clinical Research Centers, Inc /ID# 218567

location_facility: Clinical Research of West Florida, Inc /ID# 206146

location_facility: IRCCS Istituti Fisioterapici Ospitalieri-Istituto Dermatologico San Gallicano /ID# 205986

location_facility: Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o. z. /ID# 205097

location_facility: Southern California Derma. Inc /ID# 205734

location_facility: Korea University Ansan Hospital /ID# 206342

location_facility: National University Hospital /ID# 205224

location_facility: Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 208281

location_facility: Azienda Ospedaliero Universitaria di Cagliari- Presidio Ospedaliero /ID# 205168

location_facility: Ordensklinikum Linz GmbH Elisabethinen /ID# 206573

location_facility: Presidio Ospedaliero San Salvatore /ID# 205167

location_facility: Miami Dade Medical Research Institute /ID# 209413

location_facility: Papageorgiou General Hospital Thessaloniki /ID# 204526

location_facility: New England Research Associates, LLC /ID# 206896

location_facility: SimcoDerm Medical and Surgical Dermatology Center /ID# 206333

location_facility: Agile Clinical Research Trials /ID# 218080

location_facility: Skin Laser and Surgery Specialists of NY and NJ /ID# 206754

location_facility: Bellingham Asthma Allergy and Immunology Clinic /ID# 210357

location_facility: Beacon Clinical Research, LLC /ID# 206894

location_facility: Hallym University Kangnam Sacred Heart Hospital /ID# 206343

location_facility: Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 205767

location_facility: Niakosari Medicine Professional Corporation /ID# 206004

location_facility: Dr. Dusan Sajic Medicine Professional Corporation /ID# 206890

location_facility: Sjællands Universitetshospital /ID# 205960

location_facility: Clinical Research Solutions, LLC /ID# 218416

title: A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis

summary: The objective of this study is to assess the efficacy and safety of upadacitinib for the treatment of adolescent and adult participants with moderate to severe AD who are candidates for systemic therapy.


title: Brigatinib in Patients With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non-Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib

summary: The primary purpose of this study is to determine the efficacy of brigatinib by confirmed objective response rate (ORR) by response evaluation criteria in solid tumors (Response Evaluation Criteria in Solid Tumors [RECIST]), in participants with ALK+ locally advanced or metastatic NSCLC whose disease has progressed on therapy with alectinib or ceritinib.

enrollment_type: Actual

ReferenceCitation: Kim ES, Barlesi F, Mok T, Ahn MJ, Shen J, Zhang P, Ou SI. ALTA-2: Phase II study of brigatinib in patients with ALK-positive, advanced non-small-cell lung cancer who progressed on alectinib or ceritinib. Future Oncol. 2021 May;17(14):1709-1719. doi: 10.2217/fon-2020-1119. Epub 2021 Feb 11.

name: Levine Cancer Institute, Atrium Health, Charlotte, NC 28210, USA

family: Kim

full_name: Edward S Kim

given: Edward S

name: Multidisciplinary Oncology & Therapeutic Innovations Department, Aix-Marseille University, CNRS, INSERM, CRCM, Marseille, 13007, France

name: Gustave Roussy Cancer Campus, Villejuif, 94805, France

family: Barlesi

full_name: Fabrice Barlesi

given: Fabrice

name: State Key Laboratory of Translational Oncology, The Chinese University of Hong Kong, Hong Kong, 999077, China

family: Mok

full_name: Tony Mok

given: Tony

name: Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, 135-710, South Korea

family: Ahn

full_name: Myung-Ju Ahn

given: Myung-Ju

name: Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA 02139, USA

family: Shen

full_name: Junwu Shen

given: Junwu

family: Zhang

full_name: Pingkuan Zhang

given: Pingkuan

name: Chao Family Comprehensive Cancer Center, University of California Irvine School of Medicine, Orange, CA 92868, USA

family: Ou

full_name: Sai-Hong Ignatius Ou

given: Sai-Hong Ignatius

journal_name: Future Oncology

oa_host_type: publisher

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

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: Ariad Pharmaceuticals

location_country:
Italy
Austria
United States
Sweden
Hong Kong
Netherlands
Spain
Germany
France
Japan
Australia
China
Canada
Korea, Republic of
Taiwan

location_facility: USOR - Rocky Mountain Cancer Centers - Pueblo

location_facility: The First Affiliated Hospital of Zhejiang University School of Medicine

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Hopital Larrey, CHU de Toulouse, Service de Pneumologie

location_facility: The Cancer Institute Hospital of Japanese Foundation for Cancer Research

location_facility: University of California Irvine Health Chao Family Comprehensive Cancer Center

location_facility: Centre de Lutte Contre le Cancer Centre Leon Berard

location_facility: Peninsula & South Eastern Haematology and Oncology Group

location_facility: USOR - Virginia Cancer Specialists - Fairfax Office

location_facility: Azienda Ospedaliero - Universitaria San Luigi Gonzaga

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

location_facility: Washington University School of Medicine

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Kansai Medical University Hirakata Hospital

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Centro di Riferimento Oncologico di Aviano

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Keimyung University Dongsan Medical Center

location_facility: Assistance Publique-Hopitaux de Marseille Hopital Nord

location_facility: Centre Hospitalier Intercommunal de Creteil

location_facility: Jilin Provincial Cancer Hospital (Changchun Cancer Hospital)

location_facility: The Oncology Institute of Hope and Innovation


title: A Phase 2, Multicenter, Open-Label, 2-Cohort Study of Trastuzumab Deruxtecan (DS-8201a), an Anti-HER2 Antibody Drug Conjugate (ADC), for HER2-Over-Expressing or -Mutated, Unresectable and/or Metastatic Non Small Cell Lung Cancer (NSCLC) (DESTINY-Lung01)

summary: The primary objective of this trial is to evaluate the efficacy of trastuzumab deruxtecan in HER2-overexpressing and/or HER2-mutated advanced NSCLC participants.

ReferenceCitation: Li BT, Smit EF, Goto Y, Nakagawa K, Udagawa H, Mazières J, Nagasaka M, Bazhenova L, Saltos AN, Felip E, Pacheco JM, Pérol M, Paz-Ares L, Saxena K, Shiga R, Cheng Y, Acharyya S, Vitazka P, Shahidi J, Planchard D, Jänne PA; DESTINY-Lung01 Trial Investigators. Trastuzumab Deruxtecan in HER2-Mutant Non-Small-Cell Lung Cancer. N Engl J Med. 2021 Sep 18. doi: 10.1056/NEJMoa2112431. [Epub ahead of print]

name: From Memorial Sloan Kettering Cancer Center and Weill Cornell Medicine, New York (B.T.L.); the Netherlands Cancer Institute, Amsterdam (E.F.S); the National Cancer Center Hospital, Tokyo (Y.G.), Kindai University Hospital, Osaka (K.N.), and the National Cancer Center East, Kashiwa (H.U.) — all in Japan; Centre Hospitalier Universitaire, Toulouse (J.M.), Centre Léon Bérard, Lyon (M.P.), and the Department of Medical Oncology, Thoracic Group, Gustave Roussy, Villejuif (D.P.) — all in France; Karmanos...

family: Li

full_name: Bob T. Li

given: Bob T.

family: Smit

full_name: Egbert F. Smit

given: Egbert F.

family: Goto

full_name: Yasushi Goto

given: Yasushi

family: Nakagawa

full_name: Kazuhiko Nakagawa

given: Kazuhiko

family: Udagawa

full_name: Hibiki Udagawa

given: Hibiki

family: Mazières

full_name: Julien Mazières

given: Julien

family: Nagasaka

full_name: Misako Nagasaka

given: Misako

family: Bazhenova

full_name: Lyudmila Bazhenova

given: Lyudmila

family: Saltos

full_name: Andreas N. Saltos

given: Andreas N.

family: Felip

full_name: Enriqueta Felip

given: Enriqueta

family: Pacheco

full_name: Jose M. Pacheco

given: Jose M.

family: Pérol

full_name: Maurice Pérol

given: Maurice

family: Paz-Ares

full_name: Luis Paz-Ares

given: Luis

family: Saxena

full_name: Kapil Saxena

given: Kapil

family: Shiga

full_name: Ryota Shiga

given: Ryota

family: Cheng

full_name: Yingkai Cheng

given: Yingkai

family: Acharyya

full_name: Suddhasatta Acharyya

given: Suddhasatta

family: Vitazka

full_name: Patrik Vitazka

given: Patrik

family: Shahidi

full_name: Javad Shahidi

given: Javad

family: Planchard

full_name: David Planchard

given: David

family: Jänne

full_name: Pasi A. Jänne

given: Pasi A.

bso_classification: Chemistry

journal_name: New England Journal of Medicine

publisher: Massachusetts Medical Society

title: Trastuzumab Deruxtecan in HER2-Mutant Non–Small-Cell Lung Cancer

location_country:
Netherlands
France
Japan
Spain
United States

location_facility: University of California San Diego (UCSD)

location_facility: Washington University School of Medicine at St. Louis


title: A 12-Week Double-blind, Randomised, Placebo-controlled, Parallel Group Phase III Study, Followed by a 4-Week Randomised Withdrawal Period to Evaluate the Efficacy and Safety of Oral Ibodutant 10 mg Once Daily in Female Patients With Irritable Bowel Syndrome With Diarrhea

summary: Irritable Bowel Syndrome with diarrhoea (IBS-D) is a functional gastrointestinal disorder characterised by chronic or recurrent abdominal pain or discomfort and diarrhoea. This trial aims at the evaluation of the efficacy and safety of oral ibodutant 10 mg once daily as compared to placebo in women with IBS-D over a 12-week treatment period.

status: Completed

study_completion_date_type: Actual

lead_sponsor: Menarini Group

location_country:
Italy
United States
United Kingdom
France
Bulgaria
Poland
Romania
Russian Federation
Spain
Germany
Czech Republic

status_simplified: Completed


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Effects of Ranolazine on Major Adverse Cardiovascular Events in Subjects With a History of Chronic Angina Who Undergo Percutaneous Coronary Intervention With Incomplete Revascularization

acronym: RIVER-PCI

summary: This study will evaluate the efficacy of ranolazine as compared with placebo when used as part of standard medical therapy in chronic angina subjects with incomplete revascularization post-percutaneous coronary intervention (PCI; formerly known as angioplasty with stent) on the composite of ischemia-driven revascularization or ischemia-driven hospitalization without revascularization.

ReferenceType: background

ReferenceCitation: Weisz G, Farzaneh-Far R, Ben-Yehuda O, Debruyne B, Montalescot G, Lerman A, Mahmud E, Alexander KP, Ohman EM, White HD, Olmsted A, Walker GA, Stone GW. Use of ranolazine in patients with incomplete revascularization after percutaneous coronary intervention: design and rationale of the Ranolazine for Incomplete Vessel Revascularization Post-Percutaneous Coronary Intervention (RIVER-PCI) trial. Am Heart J. 2013 Dec;166(6):953-959.e3. doi: 10.1016/j.ahj.2013.08.004. Epub 2013 Oct 16.

ReferenceType: result

ReferenceCitation: Weisz G, Généreux P, Iñiguez A, Zurakowski A, Shechter M, Alexander KP, Dressler O, Osmukhina A, James S, Ohman EM, Ben-Yehuda O, Farzaneh-Far R, Stone GW; RIVER-PCI investigators. Ranolazine in patients with incomplete revascularisation after percutaneous coronary intervention (RIVER-PCI): a multicentre, randomised, double-blind, placebo-controlled trial. Lancet. 2016 Jan 9;387(10014):136-45. doi: 10.1016/S0140-6736(15)00459-6. Epub 2015 Oct 22.

family: Weisz

full_name: Giora Weisz

given: Giora

family: Généreux

full_name: Philippe Généreux

given: Philippe

family: Iñiguez

full_name: Andres Iñiguez

given: Andres

family: Zurakowski

full_name: Aleksander Zurakowski

given: Aleksander

family: Shechter

full_name: Michael Shechter

given: Michael

family: Alexander

full_name: Karen P Alexander

given: Karen P

family: Dressler

full_name: Ovidiu Dressler

given: Ovidiu

family: Osmukhina

full_name: Anna Osmukhina

given: Anna

family: James

full_name: Stefan James

given: Stefan

family: Ohman

full_name: E Magnus Ohman

given: E Magnus

family: Ben-Yehuda

full_name: Ori Ben-Yehuda

given: Ori

family: Farzaneh-Far

full_name: Ramin Farzaneh-Far

given: Ramin

family: Stone

full_name: Gregg W Stone

given: Gregg W

ReferenceCitation: Alexander KP, Weisz G, Prather K, James S, Mark DB, Anstrom KJ, Davidson-Ray L, Witkowski A, Mulkay AJ, Osmukhina A, Farzaneh-Far R, Ben-Yehuda O, Stone GW, Ohman EM. Effects of Ranolazine on Angina and Quality of Life After Percutaneous Coronary Intervention With Incomplete Revascularization: Results From the Ranolazine for Incomplete Vessel Revascularization (RIVER-PCI) Trial. Circulation. 2016 Jan 5;133(1):39-47. doi: 10.1161/CIRCULATIONAHA.115.019768. Epub 2015 Nov 10.

name: From Duke Clinical Research Institute and Duke University, Durham, NC (K.P.A., K.P., D.B.M., K.J.A., L.D.-R., E.M.O.); Shaare Zedek Medical Center, Jerusalem, Israel (G.W.); Cardiovascular Research Foundation, New York (G.W., O.B.-Y.); Department of Medical Sciences, Cardiology, Uppsala University, Sweden (S.J.); Department of Interventional Cardiology & Angiology, Institute of Cardiology, Warsaw, Poland (A.W.); Holy Name Medical Center, Hackensack, NJ (A.J.M.); Gilead Sciences Inc, Foster City,...

full_name: Karen P. Alexander

given: Karen P.

family: Prather

full_name: Kristi Prather

given: Kristi

family: Mark

full_name: Daniel B. Mark

given: Daniel B.

family: Anstrom

full_name: Kevin J. Anstrom

given: Kevin J.

family: Davidson-Ray

full_name: Linda Davidson-Ray

given: Linda

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Fanaroff AC, Prather K, Brucker A, Wojdyla D, Davidson-Ray L, Mark DB, Williams RB, Barefoot J, Weisz G, Ben-Yehuda O, Stone GW, Ohman EM, Alexander KP. Relationship Between Optimism and Outcomes in Patients With Chronic Angina Pectoris. Am J Cardiol. 2019 May 1;123(9):1399-1405. doi: 10.1016/j.amjcard.2019.01.036. Epub 2019 Feb 7.

location_country:
Italy
Austria
United States
Sweden
United Kingdom
Netherlands
Germany
France
Poland
Israel
Belgium
Russian Federation
Spain
Canada
Czech Republic

location_facility: Centennial Heart Cardiovascular Consultants, LLC

location_facility: Research Institute for Complex Issues of Cardiovascular Diseases

location_facility: Hospital Universitario Marques de Valdecilla

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

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec

location_facility: Ashford and Saint Peter's Hospital NHS Trust

location_facility: A.R.N.A.S. Civico G. Di Cristina Benfratelli

location_facility: Hospital Clinico Universitario de Valencia

location_facility: 4th Wojskowy Szpital Kliniczny z Poliklinika, Klinika Kardiologii

location_facility: Complejo Hospitalario Universitario de Vigo, Meixoeiro Hospital

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: Federal Center of Heart, Blood and Endocrinology n.a. V.A.Almazov

location_facility: City Clinical Hospital # 23 n.a."Medsantrud"

location_facility: University of Florida Health Sciences Center-Jacksonville

location_facility: Spectrum Clinical Research Institute, Inc

location_facility: Cardiovascular Institute of Northwest Florida

location_facility: Cardiology Associates of North Mississippi

location_facility: SPZOZ, Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie

location_facility: San Antonio Endovascular and Heart Institute

location_facility: City Clinical Hospital #15 named after O.M. Filatov

location_facility: SPZOZ, SPSK nr 7 Slaskiego Uniwersytetu Medycznego w Katowicach, Górnoslaskie Centrum Medyczne

location_facility: Pepin Heart Hospital and Dr. Kiran C. Patel Research Institute

location_facility: Veterans Affairs Medical Center, Duke University Medical Center

location_facility: Centre Hospitalier de l'Universite de Montreal (CHUM)

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: Volgograd Regional Clinical Cardiological Center

location_facility: Cardiology Associates of Fairfield County, PC

location_facility: Samodzielny Publiczny Szpital Kliniczny nr. 1 im. Przemienienia Panskiego

location_facility: Krankenhaus Der Barmherzigen Brüder Trier

location_facility: Wojewódzki Szpital Zespolony im. Ludwika Rydygiera w Toruniu

location_facility: Oklahoma City Veterans' Affairs Medical Center

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Northwest Indiana Cardiovascular Physicians

location_facility: Hospital Clínico Universitario Virgen de la Victoria

location_facility: Hospital General Universitario de Alicante

location_facility: National Research Center For Preventive Medicine

location_facility: Scientific and Research Institution Of Cardiology

location_facility: North Texas Healthcare System, Dept. of Veteran's Affairs

location_facility: Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie

location_facility: University of Vermont Medical Center, Fletcher Allen Health Care

location_facility: Cardiology Associates of Southeast Ohio, Inc.

location_facility: Sentara Cardiovascular Research Institute

location_facility: Scarborough Cardiology Research Associates

location_facility: Centre Hospitalier Universitaire Sart Tilman Liège

location_facility: Buffalo Cardiology and Pulmonary Associates, PC

location_facility: Azienda Ospedaliera S. Sebastiano di Caserta

location_facility: Fondazione Centro S. Raffaele del Monte Tabor, Ospedale San Raffaele

location_facility: Azienda Ospedaliera "Maggiore della Carita" di Novara

location_facility: Veterans Affairs San Diego Healthcare System


title: A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease

summary: This is a study to evaluate the safety and efficacy of IPX066 in advanced Parkinson's disease.

ReferenceCitation: Morgan JC, Dhall R, Rubens R, Khanna S, Gupta S. Dosing Patterns during Conversion to IPX066, Extended-Release Carbidopa-Levodopa (ER CD-LD), in Parkinson's Disease with Motor Fluctuations. Parkinsons Dis. 2018 Oct 22;2018:9763057. doi: 10.1155/2018/9763057. eCollection 2018.

name: Movement Disorders Program, Parkinson’s Foundation Center of Excellence, Department of Neurology, Medical College of Georgia, Augusta University, 1429 Harper Street, HF-1154, Augusta, GA 30912, USA

family: Morgan

full_name: John C. Morgan

given: John C.

name: University of Arkansas for Medical Science, 4301 W. Markham Street, Little Rock, AR 72205, USA

family: Dhall

full_name: Rohit Dhall

given: Rohit

name: Impax Laboratories, LLC, 31047 Genstar Road, Hayward, CA 94544, USA

family: Rubens

full_name: Robert Rubens

given: Robert

family: Khanna

full_name: Sarita Khanna

given: Sarita

family: Gupta

full_name: Suneel Gupta

given: Suneel

currency_apc_doaj: USD

journal_name: Parkinson's Disease

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

host_type: repository

repository_institution: Hindawi - Hindawi

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_institution:
Hindawi - Hindawi
PubMed Central - Europe PMC

publisher: Hindawi Limited

publisher_dissemination: Hindawi

publisher_group: Hindawi

publisher_normalized: Hindawi

title: Dosing Patterns during Conversion to IPX066, Extended-Release Carbidopa-Levodopa (ER CD-LD), in Parkinson’s Disease with Motor Fluctuations

ReferenceCitation: Hauser RA, Hsu A, Kell S, Espay AJ, Sethi K, Stacy M, Ondo W, O'Connell M, Gupta S; IPX066 ADVANCE-PD investigators. Extended-release carbidopa-levodopa (IPX066) compared with immediate-release carbidopa-levodopa in patients with Parkinson's disease and motor fluctuations: a phase 3 randomised, double-blind trial. Lancet Neurol. 2013 Apr;12(4):346-56. doi: 10.1016/S1474-4422(13)70025-5. Epub 2013 Feb 26.

family: Hauser

full_name: Robert A Hauser

given: Robert A

family: Hsu

full_name: Ann Hsu

given: Ann

family: Kell

full_name: Sherron Kell

given: Sherron

family: Espay

full_name: Alberto J Espay

given: Alberto J

family: Sethi

full_name: Kapil Sethi

given: Kapil

family: Stacy

full_name: Mark Stacy

given: Mark

family: Ondo

full_name: William Ondo

given: William

family: O'Connell

full_name: Martin O'Connell

given: Martin

location_country:
United States
France
Poland
Romania
Spain
Germany
Canada
Ukraine

location_facility:
Investigator 62
Investigator 65
Investigator 43
Investigator 18
Investigator 32
Investigator 71
Investigator 24
Investigator 45
Investigator 12
Investigator 3
Investigator 41
Investigator 55
Investigator 17
Investigator 46
Investigator 58
Investigator 66
Investigator 9
Investigator 48
Investigator 19
Investigator 38
Investigator 30
Investigator 6
Investigator 57
Investigator 35
Investigator 36
Investigator 52
Investigator 14
Investigator 49
Investigator 33
Investigator 47
Investigator 54
Investigator 51
Investigator 69
Investigator 28
Investigator 1
Investigator 5
Investigator 56
Investigator 25
Investigator 29
Investigator 23
Investigator 61
Investigator 59
Investigator 53
Investigator 39
Investigator 4
Investigator 13
Investigator 26
Investigator 42
Investigator 22
Investigator 8
Investigator 34
Investigator 16
Investigator 70
Investigator 40
Investigator 68
Investigator 15
Investigator 72
Investigator 50
Investigator 64
Investigator 11
Investigator 2
Investigator 21
Investigator 37
Investigator 7
Investigator 10
Investigator 60
Investigator 31
Investigator 63
Investigator 44
Investigator 27
Investigator 67
Investigator 20


type: U.S. NIH Grant/Contract

title: A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients With 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer With Recurrence Score (RS) of 25 or Less. RxPONDER: A Clinical Trial Rx for Positive Node, Endocrine Responsive Breast Cancer

summary: This randomized phase III clinical trial studies how well tamoxifen citrate, anastrozole, letrozole, or exemestane with or without chemotherapy work in treating patients with breast cancer that has spread from where it began in the breast to surrounding normal tissue (invasive). Estrogen can cause the growth of breast cancer cells. Hormone therapy, using tamoxifen citrate, may fight breast cancer by blocking the use of estrogen by the tumor cells. Aromatase inhibitors, such as anastrozole, letrozole, and exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving tamoxifen citrate, anastrozole, letrozole, or exemestane is more effective with combination chemotherapy in treating patients with breast cancer.

lead_sponsor: National Cancer Institute (NCI)

location_country:
Saudi Arabia
Mexico
France
Korea, Republic of
Ireland
Puerto Rico
Spain
United States
Canada
Colombia

location_facility: Saint James Community Hospital and Cancer Treatment Center

location_facility: Toledo Community Hospital Oncology Program CCOP

location_facility: Owensboro Health Mitchell Memorial Cancer Center

location_facility: Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

location_facility: Institut de Cancerologie de l'Ouest-Rene Gauducheau

location_facility: Saint Patrick Hospital - Community Hospital

location_facility: Minnesota Oncology Hematology PA-Maplewood

location_facility: Comprehensive Cancer Centers of Nevada-Southeast Henderson

location_facility: Comprehensive Cancer Centers of Nevada - Henderson

location_facility: MidHudson Regional Hospital of Westchester Medical Center

location_facility: Saint Vincent Hospital Cancer Center at Sturgeon Bay

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: Kaiser Permanente Medical Center - Santa Clara

location_facility: Indiana University/Melvin and Bren Simon Cancer Center

location_facility: University of Cincinnati Cancer Center-West Chester

location_facility: Hematology Oncology Associates of Illinois - Skokie

location_facility: Southern Illinois University School of Medicine

location_facility: USC / Norris Comprehensive Cancer Center

location_facility: Coborn Cancer Center at Saint Cloud Hospital

location_facility: Medical Oncology and Hematology Associates-Des Moines

location_facility: Kaiser Permanente Moanalua Medical Center

location_facility: Palo Alto Medical Foundation Health Care

location_facility: The University of Kansas Cancer Center-South

location_facility: Academic Hematology Oncology Specialists

location_facility: UPMC Washington Hospital Radiation Oncology

location_facility: University Hospitals Parma Medical Center

location_facility: Providence Regional Cancer System-Shelton

location_facility: Wichita NCI Community Oncology Research Program

location_facility: Forrest General Hospital / Cancer Center

location_facility: OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center

location_facility: Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

location_facility: Trillium Health Partners - Credit Valley Hospital

location_facility: Memorial Regional Cancer Center Day Road

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Wayne State University/Karmanos Cancer Institute

location_facility: Michiana Hematology Oncology PC-South Bend

location_facility: Kaiser Permanente-Capitol Hill Medical Center

location_facility: East Bay Medical Oncology Hematology Medical Associates-Antioch

location_facility: Lincoln Medical and Mental Health Center

location_facility: Cone Health Cancer Center at Alamance Regional

location_facility: Mid-Illinois Hematology Oncology Associates Limited

location_facility: Natalie Warren Bryant Cancer Center at Saint Francis

location_facility: University of Kansas Cancer Center-Overland Park

location_facility: The Dana-Farber Cancer Institute at Londonderry

location_facility: Walter Reed National Military Medical Center

location_facility: Saint Luke's Cancer Institute - Meridian

location_facility: Saint Vincent Hospital Cancer Center at Oconto Falls

location_facility: Lowcountry Hematology Oncology PA-North Charleston

location_facility: The Research Institute of the McGill University Health Centre (MUHC)

location_facility: Kaiser Permanente Medical Center-Vacaville

location_facility: Hematology Oncology Associates of Illinois-Highland Park

location_facility: Providence Saint Mary Regional Cancer Center

location_facility: McLaren Cancer Institute-Northern Michigan

location_facility: Novant Health Carolina Surgical - Randolph

location_facility: George Washington University Medical Center

location_facility: Saint Alphonsus Medical Center-Baker City

location_facility: Great Lakes Cancer Management Specialists-Van Elslander Cancer Center

location_facility: Palo Alto Medical Foundation-Gynecologic Oncology

location_facility: Alegent Health Bergan Mercy Medical Center

location_facility: Novant Health Cancer Specialists-Matthews

location_facility: Illinois CancerCare-Community Cancer Center

location_facility: Arnot Ogden Medical Center/Falck Cancer Center

location_facility: Michigan Cancer Research Consortium NCORP

location_facility: TidalHealth Nanticoke / Allen Cancer Center

location_facility: Atrium Medical Center-Middletown Regional Hospital

location_facility: CHI Saint Vincent Cancer Center Hot Springs

location_facility: Providence Willamette Falls Medical Center

location_facility: UPMC-Heritage Valley Health System Beaver

location_facility: Legacy Good Samaritan Hospital and Medical Center

location_facility: Centre Hospitlier Intercommunal de Creteil

location_facility: Northeast Georgia Medical Center-Gainesville

location_facility: Vanderbilt Breast Center at One Hundred Oaks

location_facility: University Health Network-Princess Margaret Hospital

location_facility: University of South Alabama Mitchell Cancer Institute

location_facility: Ascension Providence Hospitals - Southfield

location_facility: Michiana Hematology Oncology PC-Crown Point

location_facility: Hematology Oncology Associates of Fredericksburg Inc

location_facility: Saint Joseph Regional Medical Center-Mishawaka

location_facility: Harrison HealthPartners Hematology and Oncology-Poulsbo

location_facility: Carolina Blood and Cancer Care Associates PA-Lancaster

location_facility: The James Graham Brown Cancer Center at University of Louisville

location_facility: Lovelace Medical Center-Saint Joseph Square

location_facility: UC Irvine Health/Chao Family Comprehensive Cancer Center

location_facility: Oncology Hematology Associates of Saginaw Valley PC

location_facility: Cleveland Clinic Cancer Center/Fairview Hospital

location_facility: Kaiser Permanente - Largo Medical Center

location_facility: Kaiser Permanente Los Angeles Medical Center

location_facility: Northeast Alabama Regional Medical Center

location_facility: Franciscan Saint Francis Health-Beech Grove

location_facility: Tacoma/Valley Radiation Oncology Centers-Gig Harbor

location_facility: Mount Sinai Comprehensive Cancer Center at Aventura

location_facility: Genesee Cancer and Blood Disease Treatment Center

location_facility: Smilow Cancer Hospital Care Center-Fairfield

location_facility: Saint Joseph Radiation Oncology Resource Center

location_facility: Siteman Cancer Center at West County Hospital

location_facility: Montefiore Medical Center-Weiler Hospital

location_facility: Virginia Commonwealth University/Massey Cancer Center

location_facility: Prisma Health Greenville Memorial Hospital

location_facility: Sutter Solano Medical Center/Cancer Center

location_facility: Departemental Hospitalier Roche-sur-Yon (Les Oudairies)

location_facility: UMass Memorial Medical Center - University Campus

location_facility: Marshfield Clinic Cancer Center at Sacred Heart

location_facility: Christiana Care Health System-Wilmington Hospital

location_facility: CHU de Quebec-Hopital du Saint-Sacrement (HSS)

location_facility: Memorial Health University Medical Center

location_facility: Hematology and Oncology Associates of North East Pennsylvania

location_facility: Greenville Health System Cancer Institute-Andrews

location_facility: Atrium Health University City/LCI-University

location_facility: Sutter Cancer Centers Radiation Oncology Services-Cameron Park

location_facility: Cancer Research Consortium of West Michigan NCORP

location_facility: Michiana Hematology Oncology PC-Plymouth

location_facility: Groupe Hospitalier Public du Sud de l'Oise Senlis

location_facility: Florida Hospital Memorial Medical Center

location_facility: Northern Indiana Cancer Research Consortium

location_facility: Siteman Cancer Center at Christian Hospital

location_facility: Providence Saint Joseph Medical Center/Disney Family Cancer Center

location_facility: Franciscan Research Center-Northwest Medical Plaza

location_facility: Smilow Cancer Hospital Care Center - Waterford

location_facility: Long Beach Memorial Medical Center-Todd Cancer Institute

location_facility: BCCA-Cancer Centre for the Southern Interior

location_facility: HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway

location_facility: Cancer Care Specialists of Illinois - Decatur

location_facility: Wilcox Memorial Hospital and Kauai Medical Clinic

location_facility: Cancer Center-Metro Medical Center Bayamon

location_facility: University of Miami Miller School of Medicine-Sylvester Cancer Center

location_facility: East Bay Medical Oncology Hematology Associates Inc

location_facility: Vanderbilt University/Ingram Cancer Center

location_facility: Ochsner LSU Health Monroe Medical Center

location_facility: Valley Medical Oncology Consultants-Fremont

location_facility: MultiCare Deaconess Cancer and Blood Specialty Center - North

location_facility: Great Lakes Cancer Management Specialists-Macomb Medical Campus

location_facility: University Medical Center of Southern Nevada

location_facility: UH Seidman Cancer Center at Landerbrook Health Center

location_facility: Delaware Health Center-Grady Cancer Center

location_facility: IHA Hematology Oncology Consultants-Ann Arbor

location_facility: Cancer Center of Kansas-Wichita Medical Arts Tower

location_facility: Regional West Medical Center Cancer Center

location_facility: Radiation Oncology Centers of Nevada Central

location_facility: Alliance for Childhood Diseases/Cure 4 the Kids Foundation

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone

location_facility: Southeast Clinical Oncology Research Consortium NCORP

location_facility: Tacoma/Valley Radiation Oncology Centers-Puyallup

location_facility: University of Florida Health Science Center - Gainesville

location_facility: Presbyterian - Saint Lukes Medical Center - Health One

location_facility: Marion L Shepard Cancer Center at Vidant Beaufort Hospital

location_facility: Hopital Prive Drome Ardeche-Clinique Pasteur

location_facility: Minnesota Oncology Hematology PA-Woodbury

location_facility: Regional Cancer Center at Indian Path Community Hospital

location_facility: Freeport Memorial Hospital/Leonard C Ferguson Cancer Center

location_facility: Geisinger Wyoming Valley/Henry Cancer Center

location_facility: Geisinger Medical Center-Cancer Center Hazleton

location_facility: McFarland Clinic PC-Trinity Cancer Center

location_facility: Tacoma/Valley Radiation Oncology Centers-Saint Joe's

location_facility: ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

location_facility: Saint Mary's Hospital and Regional Medical Center

location_facility: King Faisal Specialist Hospital and Research Centre

location_facility: Palo Alto Medical Foundation-Camino Division

location_facility: Radiation Oncology Centers of Nevada Southeast

location_facility: Providence Regional Cancer System-Aberdeen

location_facility: Ohio State University Comprehensive Cancer Center

location_facility: Southeastern Medical Oncology Center-Goldsboro

location_facility: Saint Louis Cancer and Breast Institute-South City

location_facility: Peninsula Cancer Institute-Cancer Specialists of Tidewater

location_facility: SwedishAmerican Regional Cancer Center/ACT

location_facility: Alta Bates Summit Medical Center - Summit Campus

location_facility: Kansas Institute of Medicine Cancer and Blood Center

location_facility: Great Lakes Cancer Management Specialists-Macomb Professional Building

location_facility: Doctors Medical Center- JC Robinson Regional Cancer Center

location_facility: American Fork Hospital / Huntsman Intermountain Cancer Center

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Kansas City NCI Community Oncology Research Program

location_facility: Dell Seton Medical Center at The University of Texas

location_facility: Saint Joseph's Hospital/Children's Hospital-Tampa

location_facility: Trillium Health Partners - Queensway Health Centre

location_facility: Juravinski Cancer Centre at Hamilton Health Sciences

location_facility: Oklahoma Cancer Specialists and Research Institute-Tulsa

location_facility: Mayo Clinic Health System-Franciscan Healthcare

location_facility: Saint Luke's University Hospital-Bethlehem Campus

location_facility: Siteman Cancer Center at Saint Peters Hospital

location_facility: Sidney Kimmel Cancer Center Washington Township

location_facility: Green Bay Oncology at Saint Vincent Hospital

location_facility: Thunder Bay Regional Health Science Centre

location_facility: IU Health Central Indiana Cancer Centers-East

location_facility: Saint Luke's Cancer Institute - Fruitland

location_facility: Virginia Mason Bainbridge Island Medical Center

location_facility: Columbus NCI Community Oncology Research Program

location_facility: Mercyhealth Hospital and Cancer Center - Janesville

location_facility: Kapiolani Medical Center for Women and Children

location_facility: Benefis Healthcare- Sletten Cancer Institute

location_facility: Toledo Radiation Oncology at Northwest Ohio Onocolgy Center

location_facility: Rocky Mountain Regional VA Medical Center

location_facility: Cleveland Clinic Cancer Center Mansfield

location_facility: Carolina Blood and Cancer Care Associates PA

location_facility: University of Washington Medical Center - Montlake

location_facility: Fairview Clinics and Surgery Center Maple Grove

location_facility: Dana Farber Community Cancer Care-Quincy

location_facility: Texas Tech University Health Sciences Center-Lubbock

location_facility: University of Mississippi Medical Center

location_facility: Providence Cancer Institute Clackamas Clinic

location_facility: University of California Davis Comprehensive Cancer Center

location_facility: HaysMed University of Kansas Health System

location_facility: Southeastern Medical Oncology Center-Jacksonville

location_facility: Hinsdale Hematology Oncology Associates Incorporated

location_facility: Pulmonary Medicine Center of Chattanooga-Hixson

location_facility: Medical Oncology and Hematology Associates-Laurel

location_facility: Saint Mary's Oncology/Hematology Associates of Marlette

location_facility: Baptist Health Madisonville/Merle Mahr Cancer Center

location_facility: Suburban Community Hospital and Cancer Center

location_facility: Smilow Cancer Hospital-Orange Care Center

location_facility: Ascension Saint Francis - Reiman Cancer Center

location_facility: University of Chicago Comprehensive Cancer Center

location_facility: Marshfield Clinic - Wisconsin Rapids Center

location_facility: HealthCare Partners Medical Group Oncology/Hematology-Tenaya

location_facility: Western Illinois Cancer Treatment Center

location_facility: California Pacific Medical Center-Pacific Campus

location_facility: Eastern Connecticut Hematology and Oncology Associates

location_facility: Constantinou, Costas L MD (UIA Investigator)

location_facility: Novant Health Cancer Institute - Mooresville

location_facility: Smilow Cancer Hospital Care Center - Guiford

location_facility: Prisma Health Cancer Institute - Eastside

location_facility: Atlantic Health Sciences Corporation-Saint John Regional Hospital

location_facility: Kaiser Permanente Tysons Corner Medical Center

location_facility: Wellmont Medical Associates Oncology and Hematology-Johnson City

location_facility: Louisiana State University Health Science Center

location_facility: Great Lakes Cancer Management Specialists-Rochester Hills

location_facility: Great Plains Health Callahan Cancer Center

location_facility: ThedaCare Regional Medical Center - Appleton

location_facility: Grupo Espanol de Investigacion en Cancer de Mama

location_facility: Faith Regional Health Services Carson Cancer Center

location_facility: Emory University Hospital/Winship Cancer Institute

location_facility: IHA Hematology Oncology Consultants-Canton

location_facility: University of Pittsburgh Cancer Institute (UPCI)

location_facility: Grand River Regional Cancer Centre at Grand River Hospital

location_facility: Toledo Clinic Cancer Centers-Bowling Green

location_facility: Sanford USD Medical Center - Sioux Falls

location_facility: University of Alabama at Birmingham Cancer Center

location_facility: Wellmont Bristol Regional Medical Center

location_facility: Prisma Health Cancer Institute - Laurens

location_facility: Cancer Therapy and Research Center at The UT Health Science Center at San Antonio

location_facility: UC Comprehensive Cancer Center at Silver Cross

location_facility: Alta Bates Summit Medical Center-Herrick Campus

location_facility: Centra Lynchburg Hematology-Oncology Clinic Inc

location_facility: UPMC Uniontown Hospital Radiation Oncology

location_facility: Yale-New Haven Hospital North Haven Medical Center

location_facility: Avera McKennan Hospital and University Health Center

location_facility: Anchorage Associates in Radiation Medicine

location_facility: Lowcountry Hematology Oncology PA-West Ashley

location_facility: Ascension Columbia Saint Mary's Hospital Ozaukee

location_facility: Gaston Hematology and Oncology Associates-Belmont

location_facility: SSM Health Saint Louis University Hospital

location_facility: Christus Saint Vincent Regional Cancer Center

location_facility: University of Tennessee Health Science Center

location_facility: University of Maryland Shore Medical Center at Easton

location_facility: Southeastern Medical Oncology Center-Clinton

location_facility: Virginia Mason Federal Way Medical Center

location_facility: Kaiser Permanente-Gaithersburg Medical Center

location_facility: William E Kahlert Regional Cancer Center/Sinai Hospital

location_facility: Saint Mary's Oncology/Hematology Associates of West Branch

location_facility: Franciscan Saint Anthony Health-Michigan City

location_facility: Kaiser Permanente-Deer Valley Medical Center

location_facility: Washington University School of Medicine

location_facility: Michigan Breast Specialists-Grosse Pointe Woods

location_facility: Sutter Cancer Centers Radiation Oncology Services-Roseville

location_facility: Saint Vincent Hospital Cancer Center Green Bay

location_facility: Oncology Associates at Mercy Medical Center

location_facility: Legacy Emanuel Hospital and Health Center

location_facility: Cleveland Clinic Cancer Center Strongsville

location_facility: Harrison HealthPartners Hematology and Oncology-Bremerton

location_facility: Our Lady of the Lake Physicians Group - Medical Oncology

location_facility: Comprehensive Cancer Centers of Nevada-Summerlin

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: Guthrie Medical Group PC-Robert Packer Hospital

location_facility: Cancer Centers of Southwest Oklahoma Research

location_facility: Columbus Oncology and Hematology Associates Inc

location_facility: Christiana Care Health System-Christiana Hospital

location_facility: Carolinas Medical Center/Levine Cancer Institute

location_facility: Diablo Valley Oncology and Hematology Medical Group-Pleasant Hill

location_facility: IHA Hematology Oncology Consultants-Brighton

location_facility: Comprehensive Cancer Centers of Nevada - Northwest

location_facility: Saint Alphonsus Cancer Care Center-Boise

location_facility: Cheshire Medical Center-Dartmouth-Hitchcock Keene

location_facility: Kaiser Permanente-Woodlawn Medical Center

location_facility: Texas Tech University Health Sciences Center-El Paso

location_facility: Genesis Healthcare System Cancer Care Center

location_facility: Saint Rose Ambulatory and Surgery Center

location_facility: Wellmont Medical Associates Oncology and Hematology-Bristol

location_facility: Hattiesburg Clinic - Hematology/Oncology Clinic

location_facility: Ascension Columbia Saint Mary's Hospital - Milwaukee

location_facility: Penn State Milton S Hershey Medical Center

location_facility: Hospital Universitari de Girona Doctor Josep Trueta

location_facility: John H Stroger Jr Hospital of Cook County

location_facility: NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

location_facility: AtlantiCare Health Park-Cape May Court House

location_facility: Halifax Health Medical Center-Centers for Oncology

location_facility: Olive View-University of California Los Angeles Medical Center

location_facility: Dayton NCI Community Oncology Research Program

location_facility: OSF Saint Francis Radiation Oncology at Peoria Cancer Center

location_facility: Providence Regional Cancer System-Centralia

location_facility: UH Seidman Cancer Center at Southwest General Hospital

location_facility: Tulane University Health Sciences Center

location_facility: Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital

location_facility: Michiana Hematology Oncology PC-Mishawaka

location_facility: Metro Minnesota Community Oncology Research Consortium

location_facility: Gaston Hematology and Oncology Associates

location_facility: Sainte Genevieve County Memorial Hospital

location_facility: University of Kansas Health System Saint Francis Campus

location_facility: Central Illinois Hematology Oncology Center

location_facility: New Hanover Regional Medical Center/Zimmer Cancer Center

location_facility: Ascension Southeast Wisconsin Hospital - Saint Joseph Campus

location_facility: Valley Medical Oncology Consultants-Castro Valley

location_facility: Complejo Hospitalario Universitario de Albacete

location_facility: AtlantiCare Regional Medical Center -Main Campus

location_facility: Prisma Health Cancer Institute - Butternut

location_facility: Fort Wayne Medical Oncology and Hematology Inc-Parkview

location_facility: Mary Bird Perkins Cancer Center - Covington

location_facility: Dana-Farber/Brigham and Women's Cancer Center at South Shore

location_facility: Associates In Hematology Oncology PC-Upland

location_facility: McGill University Department of Oncology

location_facility: Mountain Blue Cancer Care Center - Swedish

location_facility: Medical Oncology Hematology Consultants PA

location_facility: PeaceHealth United General Medical Center

location_facility: Montefiore Medical Center - Moses Campus

location_facility: UPMC Jefferson Regional Radiation Oncology

location_facility: Penn State Health Saint Joseph Medical Center

location_facility: Vanderbilt-Ingram Cancer Center Cool Springs

location_facility: East Bay Medical Oncology Hematology Medical Associates Inc-Pleasant Hill

location_facility: Northwestern Medicine Cancer Center Kishwaukee

location_facility: Yale-New Haven Hospital Saint Raphael Campus

location_facility: Missouri Baptist Outpatient Center-Sunset Hills

location_facility: South Georgia Medical Center/Pearlman Cancer Center

location_facility: Dana-Farber/Brigham and Women's Cancer Center at Milford Regional

location_facility: University of Kansas Cancer Center - North

location_facility: University of Oklahoma Health Sciences Center

location_facility: Cleveland Hematology and Oncology Associates PC

location_facility: Cotton O'Neil Cancer Center / Stormont Vail Health

location_facility: Hospital Clinico Universitario de Valencia

location_facility: LSU Health Sciences Center at Shreveport

location_facility: IHA Hematology Oncology Consultants-Chelsea

location_facility: Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

location_facility: CHUM - Centre Hospitalier de l'Universite de Montreal

location_facility: Clinique Victor Hugo-Centre Jean Bernard

location_facility: North Star Lodge Cancer Center at Yakima Valley Memorial Hospital

location_facility: Clinical Saint-Pierre/Centre Catalan d?Oncologie

location_facility: Cooper Hospital University Medical Center

location_facility: Skagit Valley Hospital Regional Cancer Care Center

location_facility: HealthCare Partners Medical Group Oncology/Hematology-San Martin

location_facility: Scotland Memorial Hospital-Laurinburg Cancer Center

location_facility: Kootenai Clinic Cancer Services - Post Falls

location_facility: Seattle Cancer Care Alliance at EvergreenHealth

location_facility: Cleveland Clinic Wooster Family Health and Surgery Center

location_facility: Institut Curie-Centre Rene Huguenin Saint Cloud

location_facility: Marshfield Medical Center-EC Cancer Center

location_facility: PEI Cancer Treatment Centre-Queen Elizabeth Hospital

location_facility: Saint Luke's Cancer Institute - Twin Falls

location_facility: Steward Saint Elizabeth's Medical Center

location_facility: Ottawa Regional Hospital and Healthcare Center

location_facility: Comprehensive Cancer Centers of Nevada-Horizon Ridge

location_facility: Huntsman Cancer Institute/University of Utah

location_facility: University of Cincinnati Cancer Center-UC Medical Center

location_facility: West Virginia University Charleston Division

location_facility: Novant Health Cancer Institute - Huntersville

location_facility: Cleveland Clinic Cancer Center Independence

location_facility: Green Bay Oncology Limited at Saint Mary's Hospital

location_facility: Michigan Breast Specialists-Macomb Township

location_facility: The Cancer Institute of New Jersey Hamilton

location_facility: Mercy Clinic Oncology and Hematology-Ardmore

location_facility: Hematology and Oncology Associates-Oakland

location_facility: Delaware Clinical and Laboratory Physicians PA

location_facility: Berkshire Medical Center - Cancer Center

location_facility: Prisma Health Cancer Institute - Spartanburg

location_facility: Saint Vincent Hospital Cancer Center at Saint Mary's

location_facility: Novant Health Presbyterian Medical Center

location_facility: University of Vermont and State Agricultural College

location_facility: Harbin Clinic Medical Oncology and Clinical Research

location_facility: UT Southwestern/Simmons Cancer Center-Dallas

location_facility: Comprehensive Cancer Centers of Nevada - Central Valley

location_facility: University of Texas Health Science Center at San Antonio

location_facility: UPMC-Johnstown/John P. Murtha Regional Cancer Center

location_facility: Sutter Cancer Centers Radiation Oncology Services-Vacaville

location_facility: Tacoma/Valley Radiation Oncology Centers-Jackson Hall

location_facility: Centre d'Oncologie et de Radiotherapie Pays Basque

location_facility: Wellmont Holston Valley Hospital and Medical Center

location_facility: UPMC Cancer Centers - Arnold Palmer Pavilion

location_facility: MultiCare Deaconess Cancer and Blood Specialty Center - Downtown

location_facility: Genesys Regional Medical Center-West Flint Campus

location_facility: Cleveland Clinic Cancer Center Beachwood

location_facility: Aurora Health Care Germantown Health Center

location_facility: The Don and Sybil Harrington Cancer Center

location_facility: Smilow Cancer Hospital Care Center at Saint Francis

location_facility: Saint Alphonsus Cancer Care Center-Caldwell

location_facility: Sutter Cancer Centers Radiation Oncology Services-Auburn

location_facility: Baylor All Saints Medical Center at Fort Worth

location_facility: HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills

location_facility: Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

location_facility: UPMC-Coraopolis/Heritage Valley Radiation Oncology

location_facility: Robert Wood Johnson University Hospital Somerset

location_facility: UH Seidman Cancer Center at Lake Health Mentor Campus

location_facility: Central Vermont Medical Center/National Life Cancer Treatment

location_facility: Hawaii Cancer Care Inc - Waterfront Plaza

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Seoul National University Bundang Hospital

location_facility: Northwell Health/Center for Advanced Medicine

location_facility: Garneau, Stewart C MD (UIA Investigator)

location_facility: Michiana Hematology Oncology PC-Westville

location_facility: University of Kansas Cancer Center - Lee's Summit

location_facility: Lowcountry Hematology Oncology PA-Mount Pleasant

location_facility: Instituto Nacional De Cancerologia de Mexico

location_facility: Johns Hopkins University/Sidney Kimmel Cancer Center

location_facility: City of Hope Comprehensive Cancer Center

location_facility: Maine Center for Cancer Medicine-Scarborough

location_facility: AMITA Health Cancer Institute and Outpatient Center

location_facility: UH Seidman Cancer Center at Saint John Medical Center

location_facility: State University of New York Upstate Medical University

location_facility: Southeast Nebraska Cancer Center - 68th Street Place

location_facility: Smilow Cancer Hospital-Waterbury Care Center

location_facility: Great Lakes Cancer Management Specialists-Doctors Park

location_facility: Medical Oncology and Hematology Associates-West Des Moines

location_facility: MultiCare Deaconess Cancer and Blood Specialty Center - Valley

location_facility: Dixie Medical Center Regional Cancer Center

location_facility: McLaren Cancer Institute-Central Michigan

location_facility: Mercy Clinic-Rolla-Cancer and Hematology

location_facility: Northwest NCI Community Oncology Research Program

location_facility: Institut de Cancerologie de l'Ouest- Angers

location_facility: Smilow Cancer Hospital Care Center-Trumbull

location_facility: Jewish Hospital Medical Center Northeast

location_facility: Rocky Mountain Cancer Centers-Greenwood Village

location_facility: Henry Ford Macomb Hospital-Clinton Township

location_facility: Smilow Cancer Hospital-Derby Care Center

location_facility: Heartland Hematology and Oncology Associates Incorporated

location_facility: Louisiana Hematology Oncology Associates LLC

location_facility: University Hospitals Sharon Health Center

location_facility: University of Kentucky/Markey Cancer Center

location_facility: Kaiser Permanente - Kensington Medical Center

location_facility: Smilow Cancer Hospital-Torrington Care Center


title: PLATINUM: A Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element™) for the Treatment of up to Two De Novo Coronary Artery Lesions

acronym: PLATINUM

summary:
The purpose of this study is to evaluate the safety and effectiveness of the PROMUS Element™ Everolimus-Eluting Coronary Stent System for the treatment of patients with up to 2 de novo atherosclerotic coronary artery lesions.

This clinical trial compares outcomes in patients treated with PROMUS Element to those in patients treated with a different everolimus-eluting coronary stent. The lesions are of average length in average-sized vessels ("workhorse"). A companion sub-trial evaluates outcomes in smaller vessels (SV) and another sub-trial evaluates outcomes in longer lesions (LL).

ReferenceCitation: Stone GW, Teirstein PS, Meredith IT, Farah B, Dubois CL, Feldman RL, Dens J, Hagiwara N, Allocco DJ, Dawkins KD; PLATINUM Trial Investigators. A prospective, randomized evaluation of a novel everolimus-eluting coronary stent: the PLATINUM (a Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System [PROMUS Element] for the Treatment of Up to Two de Novo Coronary Artery Lesions) trial. J Am Coll Cardiol. 2011 Apr 19;57(16):1700-8. doi: 10.1016/j.jacc.2011.02.016. Epub 2011 Apr 4.

family: Stone

full_name: Gregg W. Stone

given: Gregg W.

family: Teirstein

full_name: Paul S. Teirstein

given: Paul S.

family: Meredith

full_name: Ian T. Meredith

given: Ian T.

family: Farah

full_name: Bruno Farah

given: Bruno

family: Dubois

full_name: Christophe L. Dubois

given: Christophe L.

family: Feldman

full_name: Robert L. Feldman

given: Robert L.

family: Dens

full_name: Joseph Dens

given: Joseph

family: Hagiwara

full_name: Nobuhisa Hagiwara

given: Nobuhisa

family: Allocco

full_name: Dominic J. Allocco

given: Dominic J.

family: Dawkins

full_name: Keith D. Dawkins

given: Keith D.

journal_name: Journal of the American College of Cardiology

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

title: A Prospective, Randomized Evaluation of a Novel Everolimus-Eluting Coronary Stent

ReferenceCitation: Kelly CR, Teirstein PS, Meredith IT, Farah B, Dubois CL, Feldman RL, Dens J, Hagiwara N, Rabinowitz A, Carrié D, Pompili V, Bouchard A, Saito S, Allocco DJ, Dawkins KD, Stone GW. Long-Term Safety and Efficacy of Platinum Chromium Everolimus-Eluting Stents in Coronary Artery Disease: 5-Year Results From the PLATINUM Trial. JACC Cardiovasc Interv. 2017 Dec 11;10(23):2392-2400. doi: 10.1016/j.jcin.2017.06.070.

family: Kelly

full_name: Christopher R. Kelly

given: Christopher R.

family: Rabinowitz

full_name: Abram Rabinowitz

given: Abram

family: Carrié

ipd_sharing_description: The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html).

location_country:
Austria
United Kingdom
Netherlands
Germany
Finland
France
Japan
Malaysia
Poland
Singapore
Australia
Belgium
New Zealand
Portugal
Denmark
United States
Latvia

location_facility: Cooper Hospital/University Medical Center

location_facility: Jewish Hospital and St. Mary's Healthcare

location_facility: Institut Cardiovasculaire - Paris Sud / Institut Hospitalier Jacques Cartier

location_facility: Japan Community Health Care Organization Hokkaido Hospital

location_facility: Moses H. Cone Memorial Hospital/LeBauer Cardiovascular Research Foundation

location_facility: St. Mary's Duluth Clinic Regional Heart Center

location_facility: Sakakibara Heart Institute, Japan Research Promotion Society for Cardiovascular Diseases

location_facility: St. Luke's Hospital / Mid America Heart Institute

location_facility: Southern Illinois University Memorial Medical Center

location_facility: Medical Center of the Rockies (Loveland)

location_facility: Saiseikai Yokohama-City Eastern Hospital

location_facility: Penn State Milton S Hershey Medical Center

location_facility: University of California Davis Medical Center

location_facility: Washington University School of Medicine

location_facility: MediQuest Research Group Inc. at Munroe Regional Medical Center

location_facility: Guys and St. Thomas NHS Foundation Trust St. Thomas Hospital

location_facility: Banner Good Samaritan Regional Medical Center

location_facility: Providence Health & Services - Washington

location_facility: Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH

location_facility: Wake Forest University School of Medicine

location_facility: Aspirus Heart and Vascular Institute - Research and Education

location_facility: Lindner Center for Research and Education at The Christ Hospital

location_facility: Ohio Health Research and Innovation Institute

location_facility: Tokyo Women's Medical University Hospital


ReferenceCitation: Kollef MH, Ricard JD, Roux D, Francois B, Ischaki E, Rozgonyi Z, Boulain T, Ivanyi Z, János G, Garot D, Koura F, Zakynthinos E, Dimopoulos G, Torres A, Danker W, Montgomery AB. A Randomized Trial of the Amikacin Fosfomycin Inhalation System for the Adjunctive Therapy of Gram-Negative Ventilator-Associated Pneumonia: IASIS Trial. Chest. 2017 Jun;151(6):1239-1246. doi: 10.1016/j.chest.2016.11.026. Epub 2016 Nov 24.

family: Kollef

full_name: Marin H. Kollef

given: Marin H.

family: Ricard

full_name: Jean-Damien Ricard

given: Jean-Damien

family: Roux

full_name: Damien Roux

given: Damien

family: Francois

full_name: Bruno Francois

family: Ischaki

full_name: Eleni Ischaki

given: Eleni

family: Rozgonyi

full_name: Zsolt Rozgonyi

given: Zsolt

family: Boulain

full_name: Thierry Boulain

given: Thierry

family: Ivanyi

full_name: Zsolt Ivanyi

family: János

full_name: Gál János

given: Gál

family: Garot

full_name: Denis Garot

given: Denis

family: Koura

full_name: Firas Koura

given: Firas

family: Zakynthinos

full_name: Epaminondas Zakynthinos

given: Epaminondas

family: Dimopoulos

full_name: George Dimopoulos

given: George

family: Torres

full_name: Antonio Torres

given: Antonio

family: Danker

full_name: Wayne Danker

given: Wayne

family: Montgomery

full_name: A. Bruce Montgomery

given: A. Bruce

journal_name: Chest

lead_sponsor: Cardeas Pharma

location_country:
France
Greece
Hungary
Puerto Rico
Spain
Turkey
United States

acronym: IASIS

ipd_sharing: Undecided

source: euctr

title: A Randomized Blinded, Placebo-Controlled, Phase 2 Study of Aerosolized Amikacin and Fosfomycin Delivered Via the Investigational eFlow® Inline System in Mechanically Ventilated Patients With Gram-negative Bacterial Pneumonia (IASIS)

summary: To demonstrate the safety and efficacy of adjunctive therapy with the Amikacin fosfomycin inhalation system (AFIS) versus aerosolized placebo to treat Gram-negative pneumonia in mechanically ventilated patients receiving IV antibiotics.


title: A Phase 1b, Open-Label Study of Eftozanermin Alfa (ABBV-621) in Combination With Bortezomib and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

summary:
Multiple myeloma (MM) is a rare cancer caused by abnormal survival of plasma cells (blood cells). Most trial participants with MM relapse (cancer has come back) or become non- responsive to treatment and remission gets shorter after each line of treatment. This is a study to determine recommended Phase 2 dose and change in disease symptoms of eftozanermin alfa in combination with bortezomib and dexamethasone to assess how efficient the treatment is in adult participants with relapsed/refractory (R/R) MM.

Eftozanermin alfa (ABBV-621) is an investigational drug being developed for the treatment of R/R Multiple Myeloma (MM). Study doctors put the participants in 1 of the 2 groups, called treatment arms. Each group receives a different treatment. Participants in one arm will receive different doses of eftozanermin alfa in combination with bortezomib and dexamethasone to determine phase 2 dose (RP2D). Participants in the other arm will receive eftozanermin alfa at RP2D in combination with bortezomib and dexamethasone. Around 40 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 20 sites across the world.

Participants will receive eftozanermin alfa as an infusion into the vein in combination with bortezomib as an infusion into the vein or an injection under the skin and oral dexamethasone tablets for 12 cycles. Each cycle is 21 days for cycles 1-8 and 35 days for cycles 9-12.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects.

location_country:
Italy
United States
France
Japan
Spain
Germany

location_facility: Emory University, Winship Cancer Institute /ID# 222922

location_facility: Universitaetsklinikum Muenster /ID# 222504

location_facility: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRCCS /ID# 223839

location_facility: University of Texas Southwestern Medical Center /ID# 223811

location_facility: Dana-Farber Cancer Institute /ID# 222174

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 222303

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 222372

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 223224

location_facility: National Cancer Center Hospital East /ID# 239436

location_facility: Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 223014

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 222302

location_facility: Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 222258

location_facility: Nagoya City University Hospital /ID# 222408


title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Atogepant for the Prophylaxis of Migraine in Participants With Episodic Migraine Who Have Previously Failed 2 to 4 Classes of Oral Prophylactic Treatments (ELEVATE)

acronym: ELEVATE

summary: This study will assess the safety, tolerability, and efficacy of Atogepant 60 mg compared with placebo in episodic migraines in participants who previously failed 2 to 4 classes of oral prophylactic treatments.

lead_sponsor: Allergan

location_country:
Italy
United States
Sweden
Netherlands
Germany
France
Czechia
Poland
Hungary
Australia
Russian Federation
Spain
Denmark
Canada
United Kingdom

location_facility: Universitaetsklinikum Tuebingen Medizinische Klinik /ID# 226529

location_facility: Ottawa Headache Centre Research Inc /ID# 226257

location_facility: University Clinical Hospital of Valladolid /ID# 226528

location_facility: Aggarwal and Associates Limited /ID# 226321

location_facility: AP-HP - Hopital Lariboisière /ID# 226221

location_facility: Amici Clinical Research - Raritan /ID# 226282

location_facility: Universitaetsmedizin Rostock /ID# 226517

location_facility: Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 226235

location_facility: King's College Hospital NHS Foundation Trusts /ID# 226525

location_facility: CHU de Quebec-Université Laval hôpital CHUL /ID# 226403

location_facility: Hospital Clinico Universitario Lozano Blesa /ID# 226395

location_facility: Bashkir State Medical University /ID# 226552

location_facility: Austin Clinical Trial Partners /ID# 228387

location_facility: Queen Elizabeth University Hospital /ID# 226492

location_facility: Centrum Medyczne CLW-Med Aneta Cichomska i Joanna Luka-Wendrowska /ID# 241692

location_facility: Pharmakologisches Studienzentrum Chemnitz GmbH /ID# 226202

location_facility: Klinische Forschung Hannover-Mitte GmbH /ID# 226195

location_facility: Klinische Forschung Dresden GmbH /ID# 226194

location_facility: Stortorgets Neurologmottagning /ID# 226237

location_facility: Azienda Ospedaliero Universitaria Careggi /ID# 226502

location_facility: Northwest Clinical Research Center /ID# 226228

location_facility: Ospedale Ss. Filippo e Nicola /ID# 226530

location_facility: FutureSearch Trials of Neurology /ID# 226423

location_facility: Centrum Leczenia Padaczki i Migreny /ID# 226543

location_facility: Canisius-Wilhelmina Ziekenhuis /ID# 226488

location_facility: Karolinska university hospital, Huddinge /ID# 226215

location_facility: Hull University Teaching Hospitals NHS Trust /ID# 226198

location_facility: Kazan State Medical University /ID# 226498

location_facility: Vall d'Hebron University Hospital /ID# 226230

location_facility: AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 226503

location_facility: St Pancras Clinical Research /ID# 226551

location_facility: Re:Cognition Health - London /ID# 226540

location_facility: Policlinico Universitario Campus Bio-Medico /ID# 226361

location_facility: Univ. of Bologna-IRCCS-Istituto delle Scienze Neurologiche /ID# 226475

location_facility: Universitaetsklinikum Jena Klinik fuer Neurologie /ID# 226439

location_facility: Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 226441

location_facility: ZorgSaam Zorggroep Zeeuws-Vlaanderen /ID# 226317

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 226485

location_facility: Azienda Ospedaliero Universitaria Pisana-Stabilimento di Santa Chiara /ID# 226372

location_facility: CHU de SAINT ETIENNE - Hopital Nord /ID# 226397

location_facility: Pharmacology Research Institute (PRI) - Encino (Wake) /ID# 226434

location_facility: CHU Nice - Hopital de Cimiez /ID# 226401

location_facility: The Royal Melbourne Hospital /ID# 226402

location_facility: Department of Neurology, University of Szeged /ID# 226442

location_facility: Hospital Santa Creu i Sant Pau /ID# 226550

location_facility: Narsjukvardskliniken Hassleholms Sjukhus /ID# 226362

location_facility: Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226388

location_facility: Re:Cognition Health - Guildford /ID# 226539

location_facility: Diex Recherche Sherbrooke Inc. /ID# 226375

location_facility: Guy's and St Thomas' NHS Foundation Trust /ID# 226250

location_facility: Albuquerque Clinical Trials, Inc /ID# 233445

location_facility: Allied Physicians - Fort Wayne Neurological Center /ID# 226350

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 226399

location_facility: Alpine Clinical Research Center /ID# 226201

location_facility: Hospital Clinico Universitario de Valencia /ID# 226472

location_facility: Velocity Clinical Research - Boise /ID# 226320

location_facility: Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226405

location_facility: Specjalistyczne Gabinety Sp. z o.o. /ID# 226266

location_facility: Hospital Unversitario Marques de Valdecilla /ID# 226239

location_facility: Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 231767

location_facility: Klinikum der Ludwig-Maximilians-Universitaet Muenchen Neurologische Kl /ID# 226351

location_facility: Gabinet Lekarski Jacek Rozniecki /ID# 226323

location_facility: Leeds Teaching Hospitals NHS Trust /ID# 226538

location_facility: FutureSearch Trials of Dallas, LP /ID# 226493

location_facility: Neurology Department, Raigmore Hospital, NHS Highlands /ID# 226542

location_facility: Hospital Clinico Universitario San Carlos /ID# 226483

location_facility: Deaconess Clinic - Gateway Health Center /ID# 226481

location_facility: CTI Clinical Trial and Consulting /ID# 226281

location_facility: Centrum Medyczne Pratia Gdynia /ID# 226437


title: A Phase 1 First in Human, Multicenter, Open-Label Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics, and RP2D of ABBV-184 in Subjects With Previously Treated Cancers

summary:
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. This study focuses on two types of cancers: Acute Myeloid Leukemia (AML) and Non-Small Cell Lung Cancer (NSCLC). AML (blood cancer) is cancer of the white blood cells (WBC). NSCLC (solid tumor) is a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to determine recommended phase 2 dose (RP2D) and to see if the study drug is safe and able to treat patients who have AML and NSCLC.

ABBV-184 is an investigational drug being developed for treatment of cancer. The study has two arms and two phases: AML arm and NSCLC arm; dose escalation and dose expansion phase. Adult participants with diagnosis of AML or NSCLC will be enrolled. In dose escalation phase, around 36 participants will be enrolled in each arm. In dose expansion phase, around 20 participants will be enrolled in each arm. The study will be conducted in approximately 50 sites across 10 countries.

Participants will receive weight based intravenous (IV) infusion of ABBV-184 once a week. At the beginning of the study, visits will occur daily during hospitalization followed by less frequently over time.

There will be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of treatment will be checked by medical assessments, blood tests, checking for side effects, and questionnaires.

status: Terminated

location_country:
France
Japan
Israel
United States
United Kingdom

location_facility: Gabrail Cancer Center Research /ID# 215667

location_facility: National Cancer Center Hospital East /ID# 216467

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 217508

location_facility: Tel Aviv Sourasky Medical Center /ID# 222749

location_facility: Oxford University Hospitals NHS Foundation Trust /ID# 217252

location_facility: CHU Bordeaux - Hopital Haut Lévêque /ID# 224998

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 215703

location_facility: Centre Antoine Lacassagne - Nice /ID# 218014

location_facility: Aichi Cancer Center Hospital /ID# 216469

location_facility: National Cancer Center Hospital /ID# 216466

location_facility: Rutgers Cancer Institute of New Jersey /ID# 230597

location_facility: AdventHealth Medical Group Blood & Marrow Transplant at Orlando /ID# 226159

location_facility: Duplicate_Cardiff & Vale University Health Board /ID# 217250

location_facility: O'Neal Comprehensive Cancer Center at UAB /ID# 226163

status_simplified: Unknown