title: Phase 3 Randomized Study Comparing X-396 (Ensartinib) to Crizotinib in Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) Patients

summary: The primary purpose of this study is to evaluate the efficacy and safety of X-396 (ensartinib) vs. crizotinib in patients with ALK-positive non-small cell lung cancer that have received up to 1 prior chemotherapy regimen and no prior ALK inhibitor.

ReferenceCitation: Horn L, Wang Z, Wu G, Poddubskaya E, Mok T, Reck M, Wakelee H, Chiappori AA, Lee DH, Breder V, Orlov S, Cicin I, Cheng Y, Liu Y, Fan Y, Whisenant JG, Zhou Y, Oertel V, Harrow K, Liang C, Mao L, Selvaggi G, Wu YL. Ensartinib vs Crizotinib for Patients With Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer: A Randomized Clinical Trial. JAMA Oncol. 2021 Sep 2. doi: 10.1001/jamaoncol.2021.3523. [Epub ahead of print]

name: Division of Hematology and Oncology, Department of Medicine, Vanderbilt-Ingram Cancer Center, Nashville, Tennessee

name: Now with Global Clinical Head for Lung Cancer and Lung Cancer Strategy, AstraZeneca, Nashville, Tennessee

family: Horn

full_name: Leora Horn

given: Leora

name: Department of Thoracic Medical Oncology, Peking University Cancer Hospital and Institute, Beijing, China

family: Wang

full_name: Ziping Wang

given: Ziping

name: Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China

family: Wu

full_name: Gang Wu

given: Gang

name: Clinical Center for Oncology, I. M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia

family: Poddubskaya

full_name: Elena Poddubskaya

given: Elena

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

family: Mok

full_name: Tony Mok

given: Tony

name: Lung Clinic, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany

family: Reck

full_name: Martin Reck

given: Martin

name: Department of Medicine, Division of Oncology and Stanford Cancer Institute, Stanford University, Stanford, California

family: Wakelee

full_name: Heather Wakelee

given: Heather

name: Thoracic Oncology Program, Moffitt Cancer Center, Tampa, Florida

family: Chiappori

full_name: Alberto A. Chiappori

given: Alberto A.

name: Department of Oncology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea

family: Lee

full_name: Dae Ho Lee

given: Dae Ho

name: Department of Chemotherapy No. 17, N. N. Blokhin Russian Cancer Research Center, Moscow, Russia

family: Breder

full_name: Valeriy Breder

given: Valeriy

name: Department of Biochemistry, Pavlov First Saint Petersburg State Medical University, St Petersburg, Russia

family: Orlov

full_name: Sergey Orlov

given: Sergey

name: Department of Medical Oncology, Faculty of Medicine, Trakya University, Edirne, Turkey

family: Cicin

full_name: Irfan Cicin

given: Irfan

name: Department of Thoracic Oncology, Jilin Cancer Hospital, Changchun, China

family: Cheng

full_name: Ying Cheng

given: Ying

name: Department of Medical Oncology, The First Hospital of China Medical University, Shenyang, Liaoning, China

family: Liu

full_name: Yunpeng Liu

given: Yunpeng

name: Thoracic Tumor Center, Zhejiang Cancer Hospital, Hangzhou, China

family: Fan

full_name: Yun Fan

given: Yun

family: Whisenant

full_name: Jennifer G. Whisenant

given: Jennifer G.

name: Biometrics, Xcovery Holdings Inc, Palm Beach Gardens, Florida

family: Zhou

full_name: Yi Zhou

given: Yi

name: Clinical Operations, Xcovery Holdings Inc, Palm Beach Gardens, Florida

family: Oertel

full_name: Vance Oertel

given: Vance

family: Harrow

full_name: Kim Harrow

given: Kim

name: Clinical Science, Xcovery Holdings Inc, Palm Beach Gardens, Florida

family: Liang

full_name: Chris Liang

given: Chris

name: Clinical Development, Xcovery Holdings Inc, Palm Beach Gardens, Florida

name: Now with Sino Biopharmaceutical Ltd, Beijing, China

family: Mao

full_name: Li Mao

given: Li

family: Selvaggi

full_name: Giovanni Selvaggi

given: Giovanni

name: Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China

full_name: Yi-Long Wu

given: Yi-Long

title: Ensartinib vs Crizotinib for Patients With Anaplastic Lymphoma Kinase−Positive Non–Small Cell Lung Cancer

location_country:
Peru
Belgium
Australia
Russian Federation
France
Poland
Argentina
Canada
Korea, Republic of
Hong Kong
Netherlands
China
Germany
United States
United Kingdom
Italy
Brazil
Czechia
Israel
Spain
Turkey

location_facility: Hospital Haroldo Juaçaba - Instituto do Cancêr do Ceará

location_facility: Maastricht University Medical Centre (MUMC)

location_facility: Klinik m. S. Infektiologie & Pneumologie

location_facility: Klinik Löwenstein gGmbH Med. Klinik II Onkologie

location_facility: The University of Hong Kong, Queen Mary Hospital

location_facility: Istanbul University Cerrahpasa Medical Faculty

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

location_facility: Institut de Cancérologie de l'Ouest (ICO)

location_facility: Fourth Hospital of Hebei Medical University

location_facility: Federal State Budgetary Scientific Institution Russian Oncological Scientific Center named after N.N. Blokhin

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

location_facility: The Second Affiliated Hospital of Nanchang University

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: The First Bethune Hospital of Jilin University

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: The Affiliated Hospital of Qingdao University

location_facility: ICO Girona - Hospital Doctor Josep Trueta

location_facility: Hospital de Câncer de Barretos - Fundação Pio XII

location_facility: North Shore Hematology-Oncology Associates, PC

location_facility: IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

location_facility: Instituto do Câncer do Estado de São Paulo

location_facility: Tianjin Medical University General Hospital Mailing No.154 Anshan Avenue Heping District

location_facility: University of Wisconsin Clinical Science Center

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

location_facility: Praxis Hämatologie und Onkologie Stolberg

location_facility: Union Hospital of Tongji Medical College of Huazhong Science and Techology University

location_facility: Washington University School of Medicine

location_facility: Trakya University Balkan Oncology Hospital

location_facility: Beijing Chest Hospital,Capital Medical University

location_facility: Krajská zdravotní, a.s., Masarykova nemocnice

location_facility: The University of Hong Kong/Queen Mary Hospital

location_facility: Azienda Socio Sanitaria Territoriale (ASST) della Valtellina e dell'Alto Laria

location_facility: BHI of Omsk region "Clinical Oncology Dispensary"

location_facility: Fundacao do ABC Faculdade de Medicina do ABC

location_facility: Centro Riferimento Oncologico CRO Aviano

location_facility: State Budgetary Institution of Healthcare of the city of Moscow "MOSCOW CITY ONCOLOGY HOSPITAL # 62"

location_facility: Rambam Health Care Campus/ Oncology Institute

location_facility: Centro Operativo Studi Clinici S.C.Oncologia Medica

location_facility: Kaiser Permanente Hawaii- Moanalua Medical Center

location_facility: Rabin Medical Center Institute of Oncology, Davidoff Center


title: Phase IIIb/IV, Randomized, Double Blinded, Study of Nivolumab 3 mg/kg in Combination With Ipilimumab 1 mg/kg vs Nivolumab 1 mg/kg in Combination With Ipilimumab 3 mg/kg in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma

summary: The purpose of this study is to evaluate two different dose combinations of nivolumab and ipilimumab in the treatment of melanoma.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Lebbé C, Meyer N, Mortier L, Marquez-Rodas I, Robert C, Rutkowski P, Menzies AM, Eigentler T, Ascierto PA, Smylie M, Schadendorf D, Ajaz M, Svane IM, Gonzalez R, Rollin L, Lord-Bessen J, Saci A, Grigoryeva E, Pigozzo J. Evaluation of Two Dosing Regimens for Nivolumab in Combination With Ipilimumab in Patients With Advanced Melanoma: Results From the Phase IIIb/IV CheckMate 511 Trial. J Clin Oncol. 2019 Apr 10;37(11):867-875. doi: 10.1200/JCO.18.01998. Epub 2019 Feb 27.

name: Saint-Louis Hospital, Institut National de la Santé et de la Recherche Médicale U976, Université Paris Diderot, Paris, France

family: Lebbé

full_name: Celeste Lebbé

given: Celeste

sequence: first

name: Université Paul Sabatier-Toulouse III, Institut National de la Santé et de la Recherche Médicale Unité Mixte de Recherche 1037-CRCT, Toulouse, France

family: Meyer

full_name: Nicolas Meyer

given: Nicolas

sequence: additional

name: Université de Lille, Institut National de la Santé et de la Recherche Médicale U1189, Lille, France

family: Mortier

full_name: Laurent Mortier

given: Laurent

name: Hospital General Universitario Gregorio Marañón, Madrid, Spain

family: Marquez-Rodas

full_name: Ivan Marquez-Rodas

given: Ivan

name: Gustave Roussy, Institut National de la Santé et de la Recherche Médicale U981, Paris, France

family: Robert

full_name: Caroline Robert

given: Caroline

name: Maria Skłodowska-Curie Institute–Oncology Center, Warsaw, Poland

family: Rutkowski

full_name: Piotr Rutkowski

given: Piotr

name: Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia

family: Menzies

full_name: Alexander M. Menzies

given: Alexander M.

name: University Hospital Tübingen, Tübingen, Germany

family: Eigentler

full_name: Thomas Eigentler

given: Thomas

name: Istituto Nazionale Tumori–Istituto di Ricovero e Cura a Carattere Scientifico Fondazione G. Pascale, Naples, Italy

family: Ascierto

full_name: Paolo A. Ascierto

given: Paolo A.

name: Cross Cancer Institute, Edmonton, Alberta, Canada

family: Smylie

full_name: Michael Smylie

given: Michael

name: German Cancer Consortium, Heidelberg, Germany

family: Schadendorf

full_name: Dirk Schadendorf

given: Dirk

name: St George’s University Hospitals National Health Service Foundation Trust, Tooting, London, United Kingdom

family: Ajaz

full_name: Mazhar Ajaz

given: Mazhar

name: Herlev Hospital, University of Copenhagen, Herlev, Denmark

family: Svane

full_name: Inge Marie Svane

given: Inge Marie

family: Gonzalez

full_name: Rene Gonzalez

given: Rene

family: Rollin

full_name: Linda Rollin

given: Linda

family: Lord-Bessen

full_name: Jennifer Lord-Bessen

given: Jennifer

family: Saci

full_name: Abdel Saci

given: Abdel

family: Grigoryeva

full_name: Elena Grigoryeva

given: Elena

name: Veneto Institute of Oncology–Istituto di Ricovero e Cura a Carattere Scientifico, Padua, Italy

family: Pigozzo

full_name: Jacopo Pigozzo

given: Jacopo

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Clinical Oncology

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

repository_institution: University of Copenhagen - Research at the University of Copenhagen

repositories:
PubMed Central
Pure (Denmark)
pdfs.semanticscholar.org

publisher: American Society of Clinical Oncology (ASCO)

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

location_facility: University Medical Center Groningen (Umcg)

location_facility: Azienda Ospedaleira Universitaria Senese S. Maria Alle Scott

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Uniwersyteckie Centrum Kliniczne Klinika Onkologii I Radiote

location_facility: Klinika Nowotworow Ukladowych i Uogolnionych

location_facility: Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow

location_facility: Istituto Nazionale Tumori Fondazione Pascale

location_facility: Washington University School Of Medicine


type: Other Identifier

type: EudraCT Number

title: A Randomized, Open-label, Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Patients With Relapsed or Refractory Mature B-cell Non-Hodgkin Lymphoma

summary: The purpose of this study is to confirm that the pharmacokinetics of ibrutinib in pediatric participants is consistent with that in adults (part 1) and to assess efficacy (event-free survival [EFS]) of ibrutinib in combination with rituximab, ifosfamide, carboplatin, and etoposide (RICE) or rituximab, vincristine, ifosfamide, carboplatin, and idarubicin (RVICI) background therapy compared to RICE or RVICI background therapy alone (part 2).

status: Completed

study_completion_date_type: Actual

ReferenceCitation: Chu Y, Lee S, Shah T, Yin C, Barth M, Miles RR, Ayello J, Morris E, Harrison L, Van de Ven C, Galardy P, Goldman SC, Lim MS, Hermiston M, McAllister-Lucas LM, Giulino-Roth L, Perkins SL, Cairo MS. Ibrutinib significantly inhibited Bruton's tyrosine kinase (BTK) phosphorylation,in-vitro proliferation and enhanced overall survival in a preclinical Burkitt lymphoma (BL) model. Oncoimmunology. 2018 Oct 11;8(1):e1512455. doi: 10.1080/2162402X.2018.1512455. eCollection 2019.

name: Department of Pediatrics, New York Medical College, Valhalla, NY, USA

family: Chu

full_name: Yaya Chu

given: Yaya

name: Department of Cell Biology & Anatomy, New York Medical College, Valhalla, NY, USA

family: Lee

full_name: Sanghoon Lee

given: Sanghoon

family: Shah

full_name: Tishi Shah

given: Tishi

family: Yin

full_name: Changhong Yin

given: Changhong

name: Department of Pediatrics, University of Buffalo, Buffalo, NY, USA

family: Barth

full_name: Matthew Barth

given: Matthew

name: Department of Pathology, University of Utah, Salt Lake City, UT, USA

family: Miles

full_name: Rodney R. Miles

given: Rodney R.

family: Ayello

full_name: Janet Ayello

given: Janet

family: Morris

full_name: Erin Morris

given: Erin

family: Harrison

full_name: Lauren Harrison

given: Lauren

family: Van de Ven

full_name: Carmella Van de Ven

given: Carmella

name: Department of Pediatrics, Mayo Clinic, Rochester, MN, USA

family: Galardy

full_name: Paul Galardy

given: Paul

name: Division of Pediatric Hematology/Oncology, Medical City Children’s Hospital, Dallas, TX, USA

family: Goldman

full_name: Stanton C. Goldman

given: Stanton C.

name: Department of Pathology and Laboratory Medicine, University of Pennsylvania, PA, USA

family: Lim

full_name: Megan S. Lim

given: Megan S.

name: Department of Pediatrics, University of California, San Francisco, CA, USA

family: Hermiston

full_name: Michelle Hermiston

given: Michelle

name: Department of Pediatrics, University of Pittsburgh, Pittsburgh, PA, USA

family: McAllister-Lucas

full_name: Linda M. McAllister-Lucas

given: Linda M.

name: Departments of Pediatrics and Pathology and Laboratory Medicine, Weill Cornell Medical College, NY, NY, USA

family: Giulino-Roth

full_name: Lisa Giulino-Roth

given: Lisa

family: Perkins

full_name: Sherrie L. Perkins

given: Sherrie L.

name: Department of Microbiology & Immunology, New York Medical College, Valhalla, NY, USA

name: Department of Medicine, New York Medical College, Valhalla, NY, USA

name: Department of Pathology, New York Medical College, Valhalla, NY, USA

family: Cairo

full_name: Mitchell S. Cairo

given: Mitchell S.

currency_apc_doaj: GBP

journal_name: OncoImmunology

oa_colors: green gold

evidence: open (via free pdf)

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

title: Ibrutinib significantly inhibited Bruton’s tyrosine kinase (BTK) phosphorylation,in-vitroproliferation and enhanced overall survival in a preclinical Burkitt lymphoma (BL) model

location_country:
Brazil
United States
Sweden
Netherlands
Germany
France
Bulgaria
Czechia
Poland
Romania
Hungary
Belgium
Russian Federation
Spain
Turkey
Canada
United Kingdom
Korea, Republic of
Taiwan
Ukraine


title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

acronym: UNIFI

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

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

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

name: University of California San Diego, La Jolla, CA, USA

family: Sandborn

full_name: William J Sandborn

given: William J

name: Robarts Clinical Trials, Robarts Research Institute, Western University, London, Ontario, Canada

family: Feagan

full_name: Brian G Feagan

given: Brian G

name: Humanitas Clinical Research Center-IRCCS and Humanitas University, Department of Biomedical Sciences, Milan, Italy

family: Danese

full_name: Silvio Danese

given: Silvio

name: Janssen Research & Development, LLC, Spring House, PA, USA

family: O’Brien

full_name: Christopher D O’Brien

given: Christopher D

name: Janssen Scientific Affairs, LLC, Horsham, PA, USA

family: Ott

full_name: Elyssa Ott

given: Elyssa

family: Marano

full_name: Colleen Marano

given: Colleen

family: Baker

full_name: Thomas Baker

given: Thomas

family: Zhou

full_name: Yiying Zhou

given: Yiying

family: Volger

full_name: Sheri Volger

given: Sheri

family: Tikhonov

full_name: Ilia Tikhonov

given: Ilia

family: Gasink

full_name: Christopher Gasink

given: Christopher

name: Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA

family: Sands

full_name: Bruce E Sands

given: Bruce E

name: Institute of Translational Medicine and NIHR Biomedical Research Center, University of Birmingham, United Kingdom

family: Ghosh

full_name: Subrata Ghosh

given: Subrata

journal_name: Inflammatory Bowel Diseases

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

evidence: oa repository (via pmcid lookup)

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

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

family: Li

full_name: Katherine Li

given: Katherine

family: Zhang

full_name: Hongyan Zhang

given: Hongyan

family: Yang

full_name: Feifei Yang

given: Feifei

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

name: From the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Division of Gastroenterology, University of California, San Diego, La Jolla (W.J.S.), and the F. Widjaja Foundation Inflammatory Bowel and Immunobiology Research Institute, Cedars–Sinai Medical Center, Los Angeles (S.T.) — both in California; the Departments of Medicine and Community Health Sciences, University of Calgary, Calgary, AB, Canada (R.P.); Janssen Research and...

repository_institution: University of Debrecen - University of Debrecen Electronic Archive

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

repository_institution: University of Liège - ORBi - Open Repository and Bibliography of the University of Liège

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