acronym: CheckMate 238

summary: The purpose of this study is to determine whether nivolumab is better than ipilimumab to prevent recurrence of melanoma.

ReferenceCitation: Larkin J, Weber J, Del Vecchio M, Gogas H, Arance AM, Dalle S, Cowey CL, Schenker M, Grob JJ, Chiarion-Sileni V, Marquez-Rodas I, Butler MO, Di Giacomo AM, Middleton MR, De la Cruz-Merino L, Arenberger P, Atkinson V, Hill A, Fecher LA, Millward M, Khushalani NI, Queirolo P, Long GV, Lobo M, Askelson M, Ascierto PA, Mandala M. Adjuvant nivolumab versus ipilimumab (CheckMate 238 trial): Reassessment of 4-year efficacy outcomes in patients with stage III melanoma per AJCC-8 staging criteria. Eur J Cancer. 2022 Sep;173:285-296. doi: 10.1016/j.ejca.2022.06.041. Epub 2022 Aug 11.

ReferenceCitation: Weber JS, Ascierto PA, Middleton MR, Hennicken D, Zoffoli R, Pieters A, Amadi A, Kupas K, Kotapati S, Moshyk A, Schadendorf D. Indirect treatment comparison of nivolumab versus placebo as adjuvant treatment for resected melanoma. Eur J Cancer. 2021 Nov;158:225-233. doi: 10.1016/j.ejca.2021.08.028. Epub 2021 Oct 15.

ReferenceCitation: Mandala M, Larkin J, Ascierto PA, Del Vecchio M, Gogas H, Cowey CL, Arance A, Dalle S, Schenker M, Grob JJ, Chiarion-Sileni V, Marquez-Rodas I, Butler MO, Di Giacomo AM, Lutzky J, De La Cruz-Merino L, Atkinson V, Arenberger P, Hill A, Fecher L, Millward M, Khushalani NI, de Pril V, Lobo M, Weber J. Adjuvant nivolumab for stage III/IV melanoma: evaluation of safety outcomes and association with recurrence-free survival. J Immunother Cancer. 2021 Aug;9(8):e003188. doi: 10.1136/jitc-2021-003188. Erratum In: J Immunother Cancer. 2021 Nov;9(11):

repository_institution: University of Seville - Deposito de Investigacion Universidad de Sevilla

ReferenceCitation: Ascierto PA, Del Vecchio M, Mandala M, Gogas H, Arance AM, Dalle S, Cowey CL, Schenker M, Grob JJ, Chiarion-Sileni V, Marquez-Rodas I, Butler MO, Maio M, Middleton MR, de la Cruz-Merino L, Arenberger P, Atkinson V, Hill A, Fecher LA, Millward M, Khushalani NI, Queirolo P, Lobo M, de Pril V, Loffredo J, Larkin J, Weber J. Adjuvant nivolumab versus ipilimumab in resected stage IIIB-C and stage IV melanoma (CheckMate 238): 4-year results from a multicentre, double-blind, randomised, controlled, phase 3 trial. Lancet Oncol. 2020 Nov;21(11):1465-1477. doi: 10.1016/S1470-2045(20)30494-0. Epub 2020 Sep 19. Erratum In: Lancet Oncol. 2021 Oct;22(10):e428.

ReferenceCitation: Weber J, Mandala M, Del Vecchio M, Gogas HJ, Arance AM, Cowey CL, Dalle S, Schenker M, Chiarion-Sileni V, Marquez-Rodas I, Grob JJ, Butler MO, Middleton MR, Maio M, Atkinson V, Queirolo P, Gonzalez R, Kudchadkar RR, Smylie M, Meyer N, Mortier L, Atkins MB, Long GV, Bhatia S, Lebbe C, Rutkowski P, Yokota K, Yamazaki N, Kim TM, de Pril V, Sabater J, Qureshi A, Larkin J, Ascierto PA; CheckMate 238 Collaborators. Adjuvant Nivolumab versus Ipilimumab in Resected Stage III or IV Melanoma. N Engl J Med. 2017 Nov 9;377(19):1824-1835. doi: 10.1056/NEJMoa1709030. Epub 2017 Sep 10.

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title: A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Nivolumab Versus Ipilimumab After Complete Resection of Stage IIIb/c or Stage IV Melanoma in Subjects Who Are at High Risk for Recurrence (CheckMate 238: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 238)

location_country:
Finland
Ireland
Poland
Argentina
Australia
Japan
Czechia
Canada
France
Hungary
Switzerland
United States
Romania
Belgium
Italy
Norway
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Sweden


type: Other Identifier

type: EudraCT Number

title: A Multicenter, Randomized, Double-Blind, Placebo Controlled 24-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Biologic Disease-Modifying Antirheumatic Drug-Experienced Patients With Active Psoriatic Arthritis

summary: The main purpose of this study is to evaluate how effective and safe the study drug known as ixekizumab is in participants with active psoriatic arthritis.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Eder L, Tony HP, Odhav S, Agirregoikoa EG, Korkosz M, Schwartzman S, Sprabery AT, Gellett AM, Park SY, Bertram CC, Ogdie A. Responses to Ixekizumab in Male and Female Patients with Psoriatic Arthritis: Results from Two Randomized, Phase 3 Clinical Trials. Rheumatol Ther. 2022 Jun;9(3):919-933. doi: 10.1007/s40744-022-00445-w. Epub 2022 Apr 9.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Deodhar AA, Combe B, Accioly AP, Bolce R, Zhu D, Gellett AM, Sprabery AT, Burmester GR. Safety of ixekizumab in patients with psoriatic arthritis: data from four clinical trials with over 2000 patient-years of exposure. Ann Rheum Dis. 2022 Jul;81(7):944-950. doi: 10.1136/annrheumdis-2021-222027. Epub 2022 Apr 7.

oa_colors: green hybrid

evidence: open (via page says license)

unpaywall_oa_status: hybrid

publisher_dissemination: British Medical Journal

ReferenceCitation: Combe B, Tsai TF, Huffstutter JE, Sprabery AT, Lin CY, Park SY, Kronbergs A, Hufford MM, Nash P. Ixekizumab, with or without concomitant methotrexate, improves signs and symptoms of PsA: week 52 results from Spirit-P1 and Spirit-P2 studies. Arthritis Res Ther. 2021 Jan 27;23(1):41. doi: 10.1186/s13075-020-02388-5.

license: cc-by

license_normalized: cc-by

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

repository_institution: Griffith University, Queensland, Australia - Griffith Research Online

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

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

repository_institution: Research Square - Research Square

repository_normalized: Research Square

version: submittedVersion

repositories:
HAL
PubMed Central
Research Square
research-repository.griffith.edu.au

ReferenceCitation: Orbai AM, Gratacos J, Turkiewicz A, Hall S, Dokoupilova E, Combe B, Nash P, Gallo G, Bertram CC, Gellett AM, Sprabery AT, Birt J, Macpherson L, Geneus VJ, Constantin A. Efficacy and Safety of Ixekizumab in Patients with Psoriatic Arthritis and Inadequate Response to TNF Inhibitors: 3-Year Follow-Up (SPIRIT-P2). Rheumatol Ther. 2021 Mar;8(1):199-217. doi: 10.1007/s40744-020-00261-0. Epub 2020 Dec 5.

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

ReferenceCitation: Schweikert B, Malmberg C, Nunez M, Dilla T, Sapin C, Hartz S. Cost-effectiveness analysis of ixekizumab versus secukinumab in patients with psoriatic arthritis and concomitant moderate-to-severe psoriasis in Spain. BMJ Open. 2020 Aug 13;10(8):e032552. doi: 10.1136/bmjopen-2019-032552.

ReferenceCitation: Combe B, Rahman P, Kameda H, Canete JD, Gallo G, Agada N, Xu W, Genovese MC. Safety results of ixekizumab with 1822.2 patient-years of exposure: an integrated analysis of 3 clinical trials in adult patients with psoriatic arthritis. Arthritis Res Ther. 2020 Jan 21;22(1):14. doi: 10.1186/s13075-020-2099-0.

ReferenceCitation: Tillett W, Lin CY, Zbrozek A, Sprabery AT, Birt J. A Threshold of Meaning for Work Disability Improvement in Psoriatic Arthritis Measured by the Work Productivity and Activity Impairment Questionnaire. Rheumatol Ther. 2019 Sep;6(3):379-391. doi: 10.1007/s40744-019-0155-5. Epub 2019 Jun 1.

ReferenceCitation: Coates LC, Orbai AM, Morita A, Benichou O, Kerr L, Adams DH, Shuler CL, Birt J, Helliwell PS. Achieving minimal disease activity in psoriatic arthritis predicts meaningful improvements in patients' health-related quality of life and productivity. BMC Rheumatol. 2018 Aug 13;2:24. doi: 10.1186/s41927-018-0030-y. eCollection 2018.

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

ReferenceCitation: Gladman DD, Orbai AM, Klitz U, Wei JC, Gallo G, Birt J, Rathmann S, Shrom D, Marzo-Ortega H. Ixekizumab and complete resolution of enthesitis and dactylitis: integrated analysis of two phase 3 randomized trials in psoriatic arthritis. Arthritis Res Ther. 2019 Jan 29;21(1):38. doi: 10.1186/s13075-019-1831-0.

ReferenceCitation: Genovese MC, Combe B, Kremer JM, Tsai TF, Behrens F, Adams DH, Lee C, Kerr L, Nash P. Safety and efficacy of ixekizumab in patients with PsA and previous inadequate response to TNF inhibitors: week 52 results from SPIRIT-P2. Rheumatology (Oxford). 2018 Nov 1;57(11):2001-2011. doi: 10.1093/rheumatology/key182.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repositories:
HAL
PubMed Central
research-repository.griffith.edu.au

ReferenceCitation: Nash P, Kirkham B, Okada M, Rahman P, Combe B, Burmester GR, Adams DH, Kerr L, Lee C, Shuler CL, Genovese M; SPIRIT-P2 Study Group. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial. Lancet. 2017 Jun 10;389(10086):2317-2327. doi: 10.1016/S0140-6736(17)31429-0. Epub 2017 May 24.

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

location_country:
Germany
Italy
Poland
United Kingdom
Australia
United States
Spain
Taiwan
Czechia
France

location_facility: Pennsylvania Regional Center for Arthritis & Osteoarthritis

location_facility: Complexo Hospitalario Universitario A Coruña, CHUAC

location_facility: Azienda Ospedaliera - Universitaria Pisana

location_facility: Chang Gung Memorial Hospital - Kaohsiung

location_facility: Albuquerque Rehabilitation & Rheumatology, PC

location_facility: Basildon and Thurrock University Hospital

location_facility: Arthritis and Osteoporosis Consultants of the Carolinas

location_facility: Universität Leipzig - Universitätsklinikum

location_facility: Allergy Asthma Immunology of Rochester, AAIR Research Ctr

location_facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

location_facility: CHU de Montpellier-Hopital Arnaud de Villeneuve

location_facility: Arthritis, Rheumatic & Back Disease Associates

location_facility: Clinical Research Center of Reading, LLC

location_facility: Washington University School of Medicine

location_facility: Hospital Regional Universitario de Málaga

location_facility: Hospital Universitario Nuestra Señora de Valme

location_facility: Arizona Arthritis & Rheumatology Research, PLLC

location_facility: Rheumatology Associates of South Florida

location_facility: Hospital Universitario Marques De Valdecilla

location_facility: PV-MEDICAL s.r.o. Revmatologicka ambulance

location_facility: Arthritis & Osteoporosis Treatment Center, PA

location_facility: Krankenhaus Dresden-Friedrichstadt Städtisches Klinikum


intervention_type: Drug

lead_sponsor: Jazz Pharmaceuticals

summary: This is a Phase 3 study to assess the long-term safety and maintenance of efficacy of JZP-110 in subjects who have completed Study 14-002, 14-003, 14-004, 15-004, 15-005, ADX-N05 201, or ADX-N05 202.

ReferenceCitation: Weaver TE, Pepin JL, Schwab R, Shapiro C, Hedner J, Ahmed M, Foldvary-Schaefer N, Strollo PJ, Mayer G, Sarmiento K, Baladi M, Bron M, Chandler P, Lee L, Malhotra A. Long-term effects of solriamfetol on quality of life and work productivity in participants with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea. J Clin Sleep Med. 2021 Oct 1;17(10):1995-2007. doi: 10.5664/jcsm.9384.

oa_host_type: repository

repository_institution: California Digital Library - eScholarship

repositories_concat: PubMed Central;escholarship.org

unpaywall_oa_status: green

publisher_dissemination: American Academy of Sleep Medicine (AASM)

ReferenceCitation: Schweitzer PK, Strohl KP, Mayer G, Rosenberg R, Chandler P, Baladi M, Lee L, Malhotra A. Effects of solriamfetol in a long-term trial of participants with obstructive sleep apnea who are adherent or nonadherent to airway therapy. J Clin Sleep Med. 2021 Apr 1;17(4):659-668. doi: 10.5664/jcsm.8992.

oa_colors: green other

evidence: open (via free pdf)

unpaywall_oa_status: bronze

ReferenceCitation: Malhotra A, Shapiro C, Pepin JL, Hedner J, Ahmed M, Foldvary-Schaefer N, Strollo PJ, Mayer G, Sarmiento K, Baladi M, Chandler P, Lee L, Schwab R. Long-term study of the safety and maintenance of efficacy of solriamfetol (JZP-110) in the treatment of excessive sleepiness in participants with narcolepsy or obstructive sleep apnea. Sleep. 2020 Feb 13;43(2):zsz220. doi: 10.1093/sleep/zsz220.

evidence: open (via crossref license)

repository_institution: PubMed Central - Europe PMC

repository_institution: University of California - eScholarship University of California

publisher_dissemination: Oxford University Press

location_facility: Mercy St. Anne & Mercy St. Charles Sleep Disorders Center

location_facility: Center for Sleep and Circadian Neurobiology

location_facility: Critical care Pulmonary & Sleep Associates, LLC

location_facility: University of Illinois at Chicago Nursing School

location_facility: Northwestern University Feinberg School of Medicine

location_facility: University of Turku , Sleep Research Centre

location_facility: Southwest Cleveland Sleep Research Center

location_facility: Clinical Research Group of St. Petersburg

location_facility: Sleep Medicine & Research center, St. Lukes Hospital

location_facility: The Research Center of Southern California

location_facility: Henry Ford Hospital Sleep Disorders & Research Center

location_facility: Sleep Med of South Carolina Clinical Research Solutions

location_facility: So Cal Institute For Respiratory Diseases, Inc.

location_facility: Stanford University Center for Narcolepsy

location_facility: Ohio Sleep Medicine & Neuroscience Institute

location_facility: Hickory Research Center, ARSM Research, LLC

title: A Long-Term Safety and Maintenance of Efficacy Study ofJZP-110 [(R)-2-amino-3 Phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or Obstructive Sleep Apnea

source: euctr

location_country:
Germany
Finland
Netherlands
United States
Canada
France

lead_sponsor_type: industriel

status_simplified: Completed


lead_sponsor: Novartis Pharmaceuticals

summary: This was a phase II, multi-center, open-label, five-arm study in which the efficacy and safety of oral ceritinib treatment was assessed in patients with NSCLC metastatic to the brain and/or to leptomeninges harboring a confirmed ALK rearrangement, using the FDA approved Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular Inc.) test and scoring algorithm (including positivity criteria). If documentation of ALK rearrangement as described above was not locally available, a test to confirm ALK rearrangement was performed by a Novartis designated central laboratory. Patients waited for the central laboratory result of the ALK rearrangement status before initiating treatment with ceritinib.

ReferenceCitation: Chow LQM, Barlesi F, Bertino EM, van den Bent MJ, Wakelee HA, Wen PY, Chiu CH, Orlov S, Chiari R, Majem M, McKeage M, Yu CJ, Garrido P, Hurtado FK, Arratia PC, Song Y, Branle F, Shi M, Kim DW. ASCEND-7: Efficacy and Safety of Ceritinib Treatment in Patients with ALK-Positive Non-Small Cell Lung Cancer Metastatic to the Brain and/or Leptomeninges. Clin Cancer Res. 2022 Jun 13;28(12):2506-2516. doi: 10.1158/1078-0432.CCR-21-1838.

evidence: oa repository (via page says license)

repositories_concat: closed

publisher_dissemination: American Association for Cancer Research

location_facility: NKI-AVL, Department of Thoracic-Oncology

location_facility: USC Kenneth Norris Comprehensive Cancer Center SC-3

location_facility: The Ohio State University Comprehensive Cancer Center Ohio State University

title: A Phase II, Multi-center, Open-label, Five-arm Study to Evaluate the Efficacy and Safety of Oral Ceritinib Treatment for Patients With ALK-positive Non-small Cell Lung Cancer (NSCLC) Metastatic to the Brain and/or to Leptomeninges

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

design_allocation: Non-Randomized

location_country:
Germany
Italy
United Kingdom
Hong Kong
Singapore
Australia
Brazil
Netherlands
Belgium
United States
Korea, Republic of
Spain
Turkey
Taiwan
Canada
Russian Federation
France

ipd_sharing: Yes


intervention_type: Other

acronym: Radium-223 dichloride long-term follow-up program

lead_sponsor: Bayer

summary: Patients will be followed up in this study after prior treatment with BAY88-8223 / Radium-223 dichloride / Xofigo .

status: Active, not recruiting

title: A Phase 4 Long-term Follow-up Study to Define the Safety Profile of Radium-223 Dichloride

primary_purpose: Other

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

study_completion_date_type: Anticipated

location_country:
Finland
Germany
Poland
Australia
Brazil
Japan
Czechia
Canada
France
Hong Kong
United States
Belgium
Italy
Norway
Singapore
United Kingdom
Sweden
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel

ipd_sharing: No

status_simplified: Ongoing


lead_sponsor: Eli Lilly and Company

summary: The main purpose of this study is to evaluate the safety and effectiveness of the study drug known as abemaciclib in participants with hormone receptor positive breast cancer, non-small cell lung cancer (NSCLC), or melanoma that has spread to the brain.

ReferenceCitation: Tolaney SM, Sahebjam S, Le Rhun E, Bachelot T, Kabos P, Awada A, Yardley D, Chan A, Conte P, Dieras V, Lin NU, Bear M, Chapman SC, Yang Z, Chen Y, Anders CK. A Phase II Study of Abemaciclib in Patients with Brain Metastases Secondary to Hormone Receptor-Positive Breast Cancer. Clin Cancer Res. 2020 Oct 15;26(20):5310-5319. doi: 10.1158/1078-0432.CCR-20-1764. Epub 2020 Jul 21. Erratum In: Clin Cancer Res. 2021 Mar 1;27(5):1582.

location_facility: University of Texas MD Anderson Cancer Center

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

location_facility: Kaiser Permanente Center for Health Research

location_facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

location_facility: University of North Carolina at Chapel Hill

title: A Phase 2 Study of Abemaciclib in Patients With Brain Metastases Secondary to Hormone Receptor Positive Breast Cancer, Non-small Cell Lung Cancer, or Melanoma

location_country:
Italy
Israel
Australia
Austria
Belgium
United States
Spain
Canada
France


lead_sponsor: Amgen

summary:
The purpose of Phase 1b of this study is to:

Asses the safety, tolerability and activity of carfilzomib, alone and in combination with induction chemotherapy, in children with relapsed or refractory acute lymphoblastic leukemia (ALL).
Determine the maximum tolerated dose (MTD) and to recommend a phase 2 dose of carfilzomib in combination with induction chemotherapy.

The purpose of Phase 2 of this study is to compare the rate of complete remission (CR) of carfilzomib in combination with vincristine, dexamethasone, PEG asparaginase, daunorubicin (VXLD) at the end of induction therapy to an appropriate external control.

sponsor_collaborators: Therapeutic Advances in Childhood Leukemia & Lymphoma (TACL) - Study Design & Execution Collaborator

sponsor_collaborators: Innovative Therapies For Children with Cancer Consortium

location_facility: Spitalul Clinic de Urgenta pentru Copii Louis Turcanu Timisoara

location_facility: West Virginia University Medicine Childrens

location_facility: Centre Hospitalier Universitaire de Toulouse - Hopital des enfants

location_facility: General University Hospital of Patras Panagia i Voithia

location_facility: Azienda Ospedaliera Universitaria Policlinico Vittorio Emanuele Presidio Ospedaliero G Rodolico

location_facility: Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca

location_facility: Levine Childrens Hospital at Carolinas Medical Center d/b/a Atrium Health

location_facility: Erciyes Universitesi Tip Fakultesi Mustafa Eraslan ve Fevzi Mercan Cocuk Hastanesi

location_facility: Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin

location_facility: The Sidney Kimmel Comprehensive Cancer Center at John Hopkins

location_facility: Cincinnati Childrens Hospital Medical Center

location_facility: FSBI N N Blokhin Russian Oncology Research Center Ministry of Health of Russian Federation

location_facility: Instituto Portugues de Oncologia de Lisboa Francisco Gentil, EPE

location_facility: General Children Hospital Panagioti and Aglaias Kyriakou

location_facility: Hospital Universitario Infantil Niño Jesus

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza Torino Ospedale Infantile Regina Margherita

location_facility: University of Texas Health Science Center at San Antonio

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

location_facility: Centro Hospitalar Universitario de Coimbra

location_facility: Childrens Healthcare of Atlanta, Egleston

location_facility: SPSK nr 1 im Prof Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego w Katowicach

location_facility: SBEI of HPE Saint Petersburg State Medical University na academic I P Pavlov of MoH of RF

location_facility: Childrens Hospital and Clinics of Minnesota

location_facility: Centre Hospitalier Regional Universitaire de Lille

location_facility: Fondazione IRCCS San Gerardo dei Tintori

location_facility: Pusan National University Yangsan Hospital

location_facility: Ippokrateio General Hospital of Thessaloniki

location_facility: Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo

location_facility: Uniwersytecki Szpital Dzieciecy w Krakowie

location_facility: Fundacao Pio 12 Hospital de Amor de Barretos

location_facility: Uniwersytecki Szpital Kliniczny im Jana Mikulicza-Radeckiego we Wroclawiu

location_facility: Centre Hospitalier Universitaire de Nancy - Hopital Enfants de Brabois

location_facility: FSBI FSCC of pediatric hematology, oncology and immunology n a Dmitry Rogachev

location_facility: Ankara Universitesi Tip Fakultesi Hastanesi

location_facility: Itaci Instituto de Tratamento do Cancer Infantil

location_facility: CSK Uniwersytetu Medycznego w Lodzi Uniwersyteckie Centrum Pediatrii im Marii Konopnickiej

location_facility: Centre Hospitalier Universitaire Sainte-Justine

location_facility: University of Utah Medical Center Primary Childrens Medical Center

location_facility: Hospital da Crianca Santo Antonio Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari

location_facility: Sociedad de Oncologia y Hematologia del Cesar

location_facility: Childrens Hospital of New York Presbyterian

location_facility: University of California San Francisco Benioff Childrens Hospital Oakland

location_facility: Prinses Maxima Centrum voor Kinderoncologie

location_facility: Instituto de Medicina Integral Professor Fernando Figueira

location_facility: Uck wum dzieciecy szpital kliniczny im jozefa polikarpa brudzinskiego

location_facility: Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE

location_facility: Azienda Ospedaliera di Rilievo Nazionale Santobono Pausilipon

location_facility: University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna-ISUL EAD

status: Recruiting

title: Phase 1b/2 Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia

enrollment_type: Anticipated

location_country:
Poland
Argentina
Australia
Brazil
Thailand
Turkey
Chile
Czechia
Canada
France
Colombia
Portugal
Hong Kong
Denmark
United States
Romania
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Saudi Arabia
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


title: Nab-paclitaxel (Abraxane) Plus Gemcitabine in Subjects With Locally Advanced Pancreatic Cancer (LAPC): An International, Open-label, Multi-center, Phase 2 Study (LAPACT).

acronym: LAPACT

summary: This clinical study is in subjects who are 18 years old or older with locally advanced pancreatic cancer who have not received prior treatment for their pancreatic cancer. The study treats all subjects with nab-Paclitaxel plus gemcitabine for approximately 6 months of treatment. Subjects who complete the treatment will choose, with their treating physicians, what additional treatment should be given: more nab-Paclitaxel plus gemcitabine, Chemoradiation therapy, or surgery to treat the locally advanced pancreatic cancer.

ReferenceCitation: Philip PA, Lacy J, Portales F, Sobrero A, Pazo-Cid R, Manzano Mozo JL, Kim EJ, Dowden S, Zakari A, Borg C, Terrebonne E, Rivera F, Sastre J, Bathini V, Lopez-Trabada D, Asselah J, Saif MW, Shiansong Li J, Ong TJ, Nydam T, Hammel P. Nab-paclitaxel plus gemcitabine in patients with locally advanced pancreatic cancer (LAPACT): a multicentre, open-label phase 2 study. Lancet Gastroenterol Hepatol. 2020 Mar;5(3):285-294. doi: 10.1016/S2468-1253(19)30327-9. Epub 2020 Jan 14.

oa_host_type: closed

publisher_dissemination: Elsevier

lead_sponsor: Celgene

location_country:
Italy
United States
Spain
Canada
France

location_facility: Centre Regional de lutte contre le cancer Paul Papin

location_facility: Karmanos Cancer Center Wayne State University

location_facility: Ospedale Sacro Cuore di Gesu FatebeneFratelli

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: State University of New York Upstate Medical Center

location_facility: Cancer Treatment Centers of America - Southeastern Regional Medical Center

location_facility: Smilow Cancer Hospital At Yale-New Haven

location_facility: Policlinico Universitario Campus Biomedico Di Roma

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: Georgetown University Medical Center Lombardi Cancer Center


acronym: FLAURA

lead_sponsor: AstraZeneca

summary: To assess the efficacy and safety of AZD9291 versus a standard of care epidermal growth factor receptor tyrosine kinase inhibitor in patients with locally advanced or Metastatic Non Small Cell Lung Cancer

ReferenceCitation: Walding A, Skaltsa K, Casamayor M, Ryden A. Time to deterioration of patient-reported outcomes in non-small cell lung cancer: exploring different definitions. Qual Life Res. 2022 Aug;31(8):2535-2543. doi: 10.1007/s11136-022-03088-0. Epub 2022 Jan 31. Erratum In: Qual Life Res. 2022 Mar 24;:

ReferenceCitation: Cheng Y, He Y, Li W, Zhang HL, Zhou Q, Wang B, Liu C, Walding A, Saggese M, Huang X, Fan M, Wang J, Ramalingam SS. Osimertinib Versus Comparator EGFR TKI as First-Line Treatment for EGFR-Mutated Advanced NSCLC: FLAURA China, A Randomized Study. Target Oncol. 2021 Mar;16(2):165-176. doi: 10.1007/s11523-021-00794-6. Epub 2021 Feb 5.

ReferenceCitation: Leighl NB, Karaseva N, Nakagawa K, Cho BC, Gray JE, Hovey T, Walding A, Ryden A, Novello S. Patient-reported outcomes from FLAURA: Osimertinib versus erlotinib or gefitinib in patients with EGFR-mutated advanced non-small-cell lung cancer. Eur J Cancer. 2020 Jan;125:49-57. doi: 10.1016/j.ejca.2019.11.006. Epub 2019 Dec 12.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Yonsei University Medical Library - YUHSpace

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

ReferenceCitation: Ramalingam SS, Vansteenkiste J, Planchard D, Cho BC, Gray JE, Ohe Y, Zhou C, Reungwetwattana T, Cheng Y, Chewaskulyong B, Shah R, Cobo M, Lee KH, Cheema P, Tiseo M, John T, Lin MC, Imamura F, Kurata T, Todd A, Hodge R, Saggese M, Rukazenkov Y, Soria JC; FLAURA Investigators. Overall Survival with Osimertinib in Untreated, EGFR-Mutated Advanced NSCLC. N Engl J Med. 2020 Jan 2;382(1):41-50. doi: 10.1056/NEJMoa1913662. Epub 2019 Nov 21.

evidence: open (via free article)

repository_institution: University of Zurich - Zurich Open Repository and Archive

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Brown H, Vansteenkiste J, Nakagawa K, Cobo M, John T, Barker C, Kohlmann A, Todd A, Saggese M, Chmielecki J, Markovets A, Scott M, Ramalingam SS. Programmed Cell Death Ligand 1 Expression in Untreated EGFR Mutated Advanced NSCLC and Response to Osimertinib Versus Comparator in FLAURA. J Thorac Oncol. 2020 Jan;15(1):138-143. doi: 10.1016/j.jtho.2019.09.009. Epub 2019 Oct 9.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories_concat: LIRIAS (KU Leuven)

ReferenceCitation: Gray JE, Okamoto I, Sriuranpong V, Vansteenkiste J, Imamura F, Lee JS, Pang YK, Cobo M, Kasahara K, Cheng Y, Nogami N, Cho EK, Su WC, Zhang G, Huang X, Li-Sucholeiki X, Lentrichia B, Dearden S, Jenkins S, Saggese M, Rukazenkov Y, Ramalingam SS. Tissue and Plasma EGFR Mutation Analysis in the FLAURA Trial: Osimertinib versus Comparator EGFR Tyrosine Kinase Inhibitor as First-Line Treatment in Patients with EGFR-Mutated Advanced Non-Small Cell Lung Cancer. Clin Cancer Res. 2019 Nov 15;25(22):6644-6652. doi: 10.1158/1078-0432.CCR-19-1126. Epub 2019 Aug 22.

repositories_concat: LIRIAS (KU Leuven);PubMed Central;aacr.figshare.com;www.repositoriosalud.es

ReferenceCitation: Planchard D, Boyer MJ, Lee JS, Dechaphunkul A, Cheema PK, Takahashi T, Gray JE, Tiseo M, Ramalingam SS, Todd A, McKeown A, Rukazenkov Y, Ohe Y. Postprogression Outcomes for Osimertinib versus Standard-of-Care EGFR-TKI in Patients with Previously Untreated EGFR-mutated Advanced Non-Small Cell Lung Cancer. Clin Cancer Res. 2019 Apr 1;25(7):2058-2063. doi: 10.1158/1078-0432.CCR-18-3325. Epub 2019 Jan 18.

ReferenceCitation: Ohe Y, Imamura F, Nogami N, Okamoto I, Kurata T, Kato T, Sugawara S, Ramalingam SS, Uchida H, Hodge R, Vowler SL, Walding A, Nakagawa K. Osimertinib versus standard-of-care EGFR-TKI as first-line treatment for EGFRm advanced NSCLC: FLAURA Japanese subset. Jpn J Clin Oncol. 2019 Jan 1;49(1):29-36. doi: 10.1093/jjco/hyy179.

ReferenceCitation: Soria JC, Ohe Y, Vansteenkiste J, Reungwetwattana T, Chewaskulyong B, Lee KH, Dechaphunkul A, Imamura F, Nogami N, Kurata T, Okamoto I, Zhou C, Cho BC, Cheng Y, Cho EK, Voon PJ, Planchard D, Su WC, Gray JE, Lee SM, Hodge R, Marotti M, Rukazenkov Y, Ramalingam SS; FLAURA Investigators. Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer. N Engl J Med. 2018 Jan 11;378(2):113-125. doi: 10.1056/NEJMoa1713137. Epub 2017 Nov 18.

repository_institution: RCAAP Project by FCT - Portuguese National Funding Agency for Science, Research and Technology - RCAAP Search Portal

title: A Phase III, Double-blind, Randomised Study to Assess the Safety and Efficacy of AZD9291 Versus a Standard of Care Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor as First Line Treatment in Patients With Epidermal Growth Factor Receptor Mutation Positive, Locally Advanced or Metastatic Non Small Cell Lung Cancer.

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

location_country:
Germany
Poland
Australia
Brazil
Japan
Thailand
Vietnam
Turkey
Czechia
Canada
France
Portugal
Hungary
Switzerland
United States
Ukraine
Romania
Belgium
China
Malaysia
Philippines
Italy
United Kingdom
Sweden
Korea, Republic of
Spain
Taiwan
Bulgaria
Russian Federation
Israel


title: A Phase 2, Randomized, Double-Blind Study of Ipilimumab Administered at 3 mg/kg vs 10 mg/kg in Adult Subjects With Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer Who Are Asymptomatic or Minimally Symptomatic

summary: The purpose of this study is to examine the safety and effectiveness (how well the drug works) of two different doses (3 mg/kg and 10 mg/kg) of Ipilimumab (Yervoy™) in patients with metastatic castration resistant prostate cancer.

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
Italy
United Kingdom
Australia
Netherlands
United States
Spain
Chile
France

location_facility: George Washington University Medical Center

location_facility: University of Pittsburgh Cancer Institute Cancer Services

location_facility: Urologische Gemeinschaftspraxis Dres Stammel U. Garcia

location_facility: Istituto Nazionale Tumori Fondazione Pascale


lead_sponsor: Hoffmann-La Roche

summary: This study is a multicenter, open-label study of polatuzumab vedotin administered by intravenous (IV) infusion in combination with standard doses of bendamustine (B) and rituximab (R) or obinutuzumab (G) in participants with relapsed or refractory follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL). The study comprises two stages: a Phase Ib safety run-in stage and a Phase II stage. The anticipated time on treatment is 18 weeks for participants with DLBCL and 24 weeks for participants with FL.

ReferenceCitation: Herrera AF, Tracy S, Croft B, Opat S, Ray J, Lovejoy AF, Musick L, Paulson JN, Sehn LH, Jiang Y. Risk profiling of patients with relapsed/refractory diffuse large B-cell lymphoma by measuring circulating tumor DNA. Blood Adv. 2022 Mar 22;6(6):1651-1660. doi: 10.1182/bloodadvances.2021006415.

publisher_dissemination: American Society of Hematology

ReferenceCitation: Sehn LH, Hertzberg M, Opat S, Herrera AF, Assouline S, Flowers CR, Kim TM, McMillan A, Ozcan M, Safar V, Salles G, Ku G, Hirata J, Chang YM, Musick L, Matasar MJ. Polatuzumab vedotin plus bendamustine and rituximab in relapsed/refractory DLBCL: survival update and new extension cohort data. Blood Adv. 2022 Jan 25;6(2):533-543. doi: 10.1182/bloodadvances.2021005794.

ReferenceCitation: Betts KA, Thuresson PO, Felizzi F, Du EX, Dieye I, Li J, Schulz M, Masaquel AS. US cost-effectiveness of polatuzumab vedotin, bendamustine and rituximab in diffuse large B-cell lymphoma. J Comp Eff Res. 2020 Oct;9(14):1003-1015. doi: 10.2217/cer-2020-0057. Epub 2020 Oct 8. Erratum In: J Comp Eff Res. 2021 Mar;10(4):337.

oa_host_type: publisher

publisher_dissemination: Becaris Publishing Limited

ReferenceCitation: Shi R, Lu T, Ku G, Ding H, Saito T, Gibiansky L, Agarwal P, Li X, Jin JY, Girish S, Miles D, Li C, Lu D. Asian race and origin have no clinically meaningful effects on polatuzumab vedotin pharmacokinetics in patients with relapsed/refractory B-cell non-Hodgkin lymphoma. Cancer Chemother Pharmacol. 2020 Sep;86(3):347-359. doi: 10.1007/s00280-020-04119-8. Epub 2020 Aug 8.

ReferenceCitation: Lu T, Gibiansky L, Li X, Li C, Shi R, Agarwal P, Hirata J, Miles D, Chanu P, Girish S, Jin JY, Lu D. Exposure-safety and exposure-efficacy analyses of polatuzumab vedotin in patients with relapsed or refractory diffuse large B-cell lymphoma. Leuk Lymphoma. 2020 Dec;61(12):2905-2914. doi: 10.1080/10428194.2020.1795154. Epub 2020 Jul 24.

publisher_dissemination: Informa

ReferenceCitation: Sehn LH, Herrera AF, Flowers CR, Kamdar MK, McMillan A, Hertzberg M, Assouline S, Kim TM, Kim WS, Ozcan M, Hirata J, Penuel E, Paulson JN, Cheng J, Ku G, Matasar MJ. Polatuzumab Vedotin in Relapsed or Refractory Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2020 Jan 10;38(2):155-165. doi: 10.1200/JCO.19.00172. Epub 2019 Nov 6.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

location_facility: Monash Medical Centre; Haematology Research

location_facility: Semmelweis University, First Dept of Medicine

location_facility: Irccs Istituto Europeo Di Oncologia (IEO); Emato-Oncologia

location_facility: University of Debrecen Medical and Health Science Center, Institute of Internal medicine Building B

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

location_facility: Hospital Clinico Universitario de Salamanca;Servicio de Hematologia

location_facility: Ondokuzmayis University Medical Faculty Heamatology Department

location_facility: Karadeniz Technical Uni School of Medicine; Hematology

location_facility: Joh. Wesling Klinikum Minden; Klinik fuer Hämatologie und Onkologie

location_facility: Hospital Universitario la Paz; Servicio de Hematologia

location_facility: Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika

location_facility: Centre Hospitalier Departemental Les Oudairies

location_facility: Nottingham City Hospital; Dept of Haematology

location_facility: Queen Elizabeth II Health Sciences Centre; Oncology

location_facility: HELIOS Klinikum Erfurt - Innere Medizin - 4. Medizinische Klinik, Hämatologie

location_facility: Regional Cancer Care Associates LLC - Morristown

location_facility: Joliet Oncology-Hematology; Associates, Ltd.

location_facility: Hospital Clinic i Provincial de Barcelona; Hematology

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Hematologia

location_facility: A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: CHU Saint Eloi; Service d'Hématologie Clinique

location_facility: National Institute of Oncology, A Dept of Internal Medicine

location_facility: Ospedale Civile SS. Antonio E Biagio DI Alessandria; Ematologia

location_facility: Gemeinschaftspraxis für Hämatologie und Onkologie

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

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: KINGS COLLEGE HOSPITAL; Commercial R&D Amendments, Kings Health Partners Clinical Trials Office

location_facility: Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica

location_facility: Southampton General Hospital; Somers Cancer Research Building

location_facility: I Interni klinika; Vseobecna fakultni nemocnice

location_facility: Klinik der Uni Regensburg; Hämatologie/Onkologie, Studienzentrale

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Abt. für Hämatologie und Onkologie

location_facility: Fakultní nemocnice Ostrava Klinika hematoonkologie

title: A Phase IB/II Study Evaluating The Safety, Tolerability and Anti-Tumor Activity of Polatuzumab Vedotin in Combination With Rituximab (R) or Obinutuzumab (G) Plus Bendamustine (B) in Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma

location_country:
Germany
Italy
Hungary
United Kingdom
Australia
Netherlands
United States
Korea, Republic of
Spain
Turkey
Czechia
Canada
France


title: Study DB2116961, A Multicentre, Randomised, Blinded, Parallel Group Study to Compare UMEC/VI (Umeclidinium/Vilanterol) in a Fixed Dose Combination With Indacaterol Plus Tiotropium in Symptomatic Subjects With Moderate to Very Severe COPD

summary: This is a Phase IIIb multicentre, randomised, blinded, triple dummy, parallel group study to evaluate the efficacy and safety of UMEC/VI inhalation powder (62.5/25 microgram [mcg] Once daily [QD]) when administered via ELLIPTA® Dry Powder Inhaler (DPI) compared to indacaterol plus tiotropium (150 mcg/18 mcg respectively QD) administered via individual inhalers over a treatment period of 12 weeks in participants with moderate to very severe Chronic Obstructive Pulmonary Disease (COPD). The purpose of this study is to demonstrate that UMEC/VI (delivered via ELLIPTA DPI), when used in symptomatic moderate to very severe COPD participants, is non-inferior to the combination of indacaterol (delivered via BREEZHALER® inhaler) plus tiotropium (delivered via HANDIHALER® inhaler) on measures of trough forced expiratory volume in one second (FEV1) after 12 weeks of treatment. Participants who met the eligibility criteria at screening (Visit 1) will complete a 5 to 7 day run in period prior to randomisation at Visit 2. Clinic visits will follow at day 2, week 2, week 4, week 8 and week 12 of treatment, plus week 12 + 1 day (Visits 3 to 8). The total duration of study participation will be approximately 14 weeks. ELLIPTA is a registered trademark of the GSK group of companies. HANDIHALER is a registered trademark of Boehringer Ingelheim Pharma GmbH & Co. KG. BREEZHALER is a registered trademark of Novartis AG.

ReferenceCitation: Kalberg C, O'Dell D, Galkin D, Newlands A, Fahy WA. Dual Bronchodilator Therapy with Umeclidinium/Vilanterol Versus Tiotropium plus Indacaterol in Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial. Drugs R D. 2016 Jun;16(2):217-27. doi: 10.1007/s40268-016-0131-2.

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Italy
Poland
Slovakia
Hungary
Argentina
Romania
Chile
Peru
Estonia
Russian Federation
France


acronym: SPECTRI

summary: This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled study evaluating the efficacy and safety of lampalizumab administered by intravitreal injections in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

ReferenceCitation: Heier JS, Pieramici D, Chakravarthy U, Patel SS, Gupta S, Lotery A, Lad EM, Silverman D, Henry EC, Anderesi M, Tschosik EA, Gray S, Ferrara D, Guymer R; Chroma and Spectri Study Investigators. Visual Function Decline Resulting from Geographic Atrophy: Results from the Chroma and Spectri Phase 3 Trials. Ophthalmol Retina. 2020 Jul;4(7):673-688. doi: 10.1016/j.oret.2020.01.019. Epub 2020 Jan 31.

ReferenceCitation: Holz FG, Sadda SR, Busbee B, Chew EY, Mitchell P, Tufail A, Brittain C, Ferrara D, Gray S, Honigberg L, Martin J, Tong B, Ehrlich JS, Bressler NM; Chroma and Spectri Study Investigators. Efficacy and Safety of Lampalizumab for Geographic Atrophy Due to Age-Related Macular Degeneration: Chroma and Spectri Phase 3 Randomized Clinical Trials. JAMA Ophthalmol. 2018 Jun 1;136(6):666-677. doi: 10.1001/jamaophthalmol.2018.1544.

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repository_institution: Leiden University - Leiden Repository

publisher_dissemination: American Medical Association

location_facility: Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie

location_facility: Radboud University Nijmegen Medical Centre; Ophthalmology

location_facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik

location_facility: Semmelweis Egyetem AOK, Szemeszeti Klinika

location_facility: Uniwersytecki Szpital Kliniczny; Klinika Okulistyki

location_facility: Dokuz Eylul University Medical Faculty; Department of Ophthalmology

location_facility: Ankara University Medical Faculty; Department of Ophthalmology

location_facility: Irccs Ospedale San Raffaele;U.O. Oculistica

location_facility: Univerzitna nemocnica Bratislava, Nemocnica sv. Cyrila a Metoda Ocna klinika SZU a UNB

location_facility: Ankara Baskent University Medical Faculty; Department of Ophthalmology

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oftalmologia

location_facility: Retina & Vitreous Center of Southern Oregon

location_facility: Macular Treatment Centre; Royal Eye Hospital

location_facility: Hopital Hotel Dieu Et Hme; Clinique Ophtalmologique

location_facility: Moorfields Eye Hospital NHS Foundation Trust

location_facility: Universitätsklinikum Freiburg, Klinik für Augenheilkunde

location_facility: Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR

location_facility: Gloucestershire Hospitals NHS Foundation Trust

location_facility: Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre

location_facility: Hacettepe University Medical Faculty; Department of Ophthalmology

location_facility: Clinica Universitaria de Navarra; Servicio de Oftalmologia

location_facility: FNsP F. D. Roosevelta Banska Bystrica, II.Ocna klinika SZU

location_facility: Istanbul University Istanbul Medical Faculty; Department of Ophthalmology

location_facility: Hospital Perpetuo Socorro; Servicio de Oftalmología

location_facility: Hopital de la croix rousse; Ophtalmologie

location_facility: Glostrup Hospital, Øjenafdelingen, Forskningsafsnit Ø37

location_facility: University of California, Davis, Eye Center

location_facility: Klinikum rechts der Isar der TU München; Augenklinik

location_facility: A.S.L. to1 Presidio Ospedaliero Sperino Oftalmico

location_facility: SAHI "Republic clinical ophthalmological hospial of Ministry of Heal of Tatarstan Republic"

location_facility: University of Michigan, Kellogg Eye Center

location_facility: St. Educ.Inst. of High Prof.Education "Samara State Medical University"; Chair of ophathalmology

location_facility: LMU Klinikum der Universität, Augenklinik

location_facility: Inselspital Bern, Universitätsklinik für Augenheilkunde

location_facility: A.O. Universitaria S. Maria Della Misericordia Di Udine; Clinica Oculistica

location_facility: Centre Paradis Monticelli; Ophtalmologie

location_facility: FSBI "Scientific Research Institute of Eye Diseases" of Russian Academy of medical Sciences

location_facility: Szpital Specjalistyczny nr 1; Oddzial Okulistyki

location_facility: Southeastern Retina Associates Chattanooga

location_facility: ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik

location_facility: Instituto Mexicano de Oftalmologia I.A.P.

location_facility: Hospital de Sao Joao; Servico de Oftalmologia

location_facility: UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.;CLINICA OCULISTICA

location_facility: The Royal Wolverhampton Hospitals NHS Trust

location_facility: Duke University Eye Center; Vitreoretinal

location_facility: AIBILI - Association for Innovation and Biomedical Research on Light

location_facility: Universitätsklinikum Regensburg, Klinik & Poliklinik für Augenheilkunde

location_facility: Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica

location_facility: Hospital de Santa Maria; Servico de Oftalmologia

location_facility: Mid Atlantic Retina - Wills Eye Hospital

location_facility: Ege University Medical Faculty; Department of Ophthalmology

location_facility: Hospital Universitario la Fe: Servicio de Oftalmologia

status: Terminated

title: A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study to Assess the Efficacy and Safety of Lampalizumab Administered Intravitreally to Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration

location_country:
Germany
Poland
Argentina
Australia
Turkey
France
Portugal
Slovakia
Hungary
Denmark
Switzerland
United States
Belgium
Peru
Italy
United Kingdom
Netherlands
Austria
Mexico
Spain
Russian Federation
Sweden

status_simplified: Unknown


acronym: CHROMA

ReferenceCitation: Miere A, Capuano V, Kessler A, Zambrowski O, Jung C, Colantuono D, Pallone C, Semoun O, Petit E, Souied E. Deep learning-based classification of retinal atrophy using fundus autofluorescence imaging. Comput Biol Med. 2021 Mar;130:104198. doi: 10.1016/j.compbiomed.2020.104198. Epub 2020 Dec 28.

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

evidence: open (author manuscript)

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repositories_concat: HAL

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

repositories_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

location_facility: University Health Network Toronto Western Hospital

location_facility: Radboud University Nijmegen Medical Centre; Ophthalmology

location_facility: SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej

location_facility: Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Augenheilkunde

location_facility: Cleveland Clinic Foundation; Cole Eye Institute

location_facility: Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche

location_facility: Gabinet Okulistyczny Prof Edward Wylegala

location_facility: Sjællands Universitetshospital, Roskilde; Øjenafdelingen

location_facility: Academisch Medisch Centrum Universiteit Amsterdam

location_facility: FISABIO. Fundación Oftalmologica del Mediterraneo

location_facility: Centre Ophtalmologique; Imagerie et laser

location_facility: Augenabteilung am St. Franziskus-Hospital

location_facility: Hospital Universitario Rio Hortega; Servicio de Oftalmologia

location_facility: VISSUM Instituto Oftalmológico de Alicante

location_facility: Retina-Vitreous Associates Medical Group

location_facility: Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Augenheilkunde

location_facility: University Retina and Macula Associates, PC

location_facility: CLINICA RICARDO PALMA; Oftalmologos Contreras

location_facility: Uni of Alabama At Birmingham Clinical Research Unit

location_facility: Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica

location_facility: Hospital Universitari de Bellvitge; Servicio de Oftalmologia

location_facility: Eye Surgeons of Richmond Inc. dba Virginia Eye Institute

location_facility: Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika

location_facility: Medizinische Hochschule Hannover, Klinik für Augenheilkunde

location_facility: Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie

location_facility: The Gavin Herbert Eye Institute - UC, Irvine

location_facility: Universitätskliniikum Schleswig-Holstein, Campus Lübeck, Klinik für Augenheilkunde

location_facility: Northwestern Medical Group/Northwestern University

location_facility: CHU Poitiers - CHR La Miletrie; Ophtalmologie

location_facility: Instituto Clinico Quirurgico de Oftalmologia - ICQO

location_facility: Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico

location_facility: Azienda Ospedaliero Universitaria Di Sassari;U.O. Oculistica

location_facility: Centre Odeon; Exploration Ophtalmologique

location_country:
Germany
Poland
Argentina
Australia
Canada
France
Slovakia
Hungary
Denmark
Switzerland
United States
Belgium
Peru
Italy
United Kingdom
Netherlands
Austria
Mexico
Spain


title: A PHASE 4 SAFETY AND EFFICACY STUDY OF BOSUTINIB (BOSULIF (REGISTERED)) IN PATIENTS WITH PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOID LEUKEMIA PREVIOUSLY TREATED WITH ONE OR MORE TYROSINE KINASE INHIBITORS

summary: The purpose of this study is to fulfill the post-authorization commitment made by Pfizer to the European Medicines Agency in providing additional safety and efficacy data in approximately 150 Philadelphia Chromosome Positive Chronic Myeloid Leukemia patients with high unmet medical need, including 75 Chronic Phase, Accelerated Phase or Blast Phase patients in the fourth or later line treatment setting (i.e., after treatment with at least 3 other Tyrosine Kinase Inhibitors).

ReferenceCitation: Takahashi N, Cortes JE, Sakaida E, Ishizawa K, Ono T, Doki N, Matsumura I, Garcia-Gutierrez V, Rosti G, Ono C, Ohkura M, Tanetsugu Y, Viqueira A, Brummendorf TH. Safety profile of bosutinib in Japanese versus non-Japanese patients with chronic myeloid leukemia: a pooled analysis. Int J Hematol. 2022 Jun;115(6):838-851. doi: 10.1007/s12185-022-03314-y. Epub 2022 Mar 2.

ReferenceCitation: Hochhaus A, Gambacorti-Passerini C, Abboud C, Gjertsen BT, Brummendorf TH, Smith BD, Ernst T, Giraldo-Castellano P, Olsson-Stromberg U, Saussele S, Bardy-Bouxin N, Viqueira A, Leip E, Russell-Smith TA, Leone J, Rosti G, Watts J, Giles FJ; BYOND Study Investigators. Bosutinib for pretreated patients with chronic phase chronic myeloid leukemia: primary results of the phase 4 BYOND study. Leukemia. 2020 Aug;34(8):2125-2137. doi: 10.1038/s41375-020-0915-9. Epub 2020 Jun 22.

repository_institution: Washington University School of Medicine - Digital Commons@Becker

repository_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

sponsor_collaborators:
Pfizer
Developmental Therapeutics Consortium

location_country:
Germany
Italy
Norway
Sweden
Austria
United States
Spain
France

location_facility: Centre Hospitalier de Versailles (CHV)-Hopital Andre Mignot Service d'Hematologie Clinique- Oncology

location_facility: AOU Policlinico Vittorio Emanuele-P.O.G. Rodolico

location_facility: Azienda Socio Sanitaria Territoriale - ASST Monza

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Indiana Blood and Marrow Transplantation-Clinic

location_facility: AOU San Luigi Gonzaga SCDU Medicina Interna II ad indirizzo Ematologico

location_facility: AOU Policlinico Consorziale di Bari - UO Ematologia con Trapianto

location_facility: Centre Regional De Lutte Contre Le Cancer

location_facility: A.O. Ospedale Niguarda Ca Granda - SC Ematologia

location_facility: Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)

location_facility: RWTH Uniklinik Aachen Klinik fur Onkologie, Hamatologie und Stammzelltransplantation

location_facility: Weill Cornell Medical College - New York-Presbyterian Hospital

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: III. Medizinische Klinik Universitaetsmedizin Mannheim

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: Ordensklinikum Linz Gmbh Barmherzige Schwestern

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole


title: A Clinical Study Comparing Symbicort 'as Needed' With Pulmicort Twice Daily Plus Terbutaline 'as Needed' in Adult and Adolescent Patients With Asthma

summary: The purpose of this study is to test if Symbicort (budesonide/formoterol) Turbuhaler is effective in treating asthma when used 'as needed' in patients with milder asthma. The efficacy of Symbicort 'as needed' will be compared with Pulmicort (budesonide) Turbuhaler twice daily plus terbutaline Turbuhaler 'as needed'

ReferenceCitation: FitzGerald JM, O'Byrne PM, Bateman ED, Barnes PJ, Zheng J, Ivanov S, Lamarca R, Larsdotter U, Emerath U, Jansen G, Puu M, Alagappan VKT, Surmont F, Reddel HK. Safety of As-Needed Budesonide-Formoterol in Mild Asthma: Data from the Two Phase III SYGMA Studies. Drug Saf. 2021 Apr;44(4):467-478. doi: 10.1007/s40264-020-01041-z. Epub 2021 Feb 6.

ReferenceCitation: Bateman ED, Reddel HK, O'Byrne PM, Barnes PJ, Zhong N, Keen C, Jorup C, Lamarca R, Siwek-Posluszna A, FitzGerald JM. As-Needed Budesonide-Formoterol versus Maintenance Budesonide in Mild Asthma. N Engl J Med. 2018 May 17;378(20):1877-1887. doi: 10.1056/NEJMoa1715275.

ReferenceCitation: O'Byrne PM, FitzGerald JM, Zhong N, Bateman E, Barnes PJ, Keen C, Almqvist G, Pemberton K, Jorup C, Ivanov S, Reddel HK. The SYGMA programme of phase 3 trials to evaluate the efficacy and safety of budesonide/formoterol given 'as needed' in mild asthma: study protocols for two randomised controlled trials. Trials. 2017 Jan 10;18(1):12. doi: 10.1186/s13063-016-1731-4.

repository_institution: Imperial College London - Spiral

repository_institution: University of Cape Town - Open University of Cape Town

repository_normalized: localhost

ReferenceCitation: Reddel HK, Busse WW, Pedersen S, Tan WC, Chen YZ, Jorup C, Lythgoe D, O'Byrne PM. Should recommendations about starting inhaled corticosteroid treatment for mild asthma be based on symptom frequency: a post-hoc efficacy analysis of the START study. Lancet. 2017 Jan 14;389(10065):157-166. doi: 10.1016/S0140-6736(16)31399-X. Epub 2016 Nov 30.

location_country:
Germany
Poland
New Zealand
Australia
Brazil
Thailand
Vietnam
Chile
Czechia
France
Colombia
Slovakia
Hungary
Ukraine
Romania
Peru
Philippines
Mexico
Korea, Republic of
Saudi Arabia
Spain
South Africa
Bulgaria
Russian Federation
Sweden


title: An Open-label, Non-randomised, Multicentre, Comparative, Phase I Study to Determine the Pharmacokinetics, Safety and Tolerability of AZD9291 Following a Single Oral Dose to Patients With Advanced Solid Tumours and Normal Hepatic Function or Mild or Moderate Hepatic Impairment

summary: This is a 2-part study in patients with advanced solid tumours. Part A will investigate the pharmacokinetics (PK) of AZD9291 in patients with mild or moderate hepatic impairment compared to patients with normal hepatic function; Part B will allow any patient with mild or moderate hepatic impairment or normal hepatic function, who completes Part A, continued access to AZD9291 after the PK phase and will provide additional safety data.

ReferenceCitation: Grande E, Harvey RD, You B, Batlle JF, Galbraith H, Sarantopoulos J, Ramalingam SS, Mann H, So K, Johnson M, Vishwanathan K. Pharmacokinetic Study of Osimertinib in Cancer Patients with Mild or Moderate Hepatic Impairment. J Pharmacol Exp Ther. 2019 May;369(2):291-299. doi: 10.1124/jpet.118.255919. Epub 2019 Mar 14.

publisher_dissemination: American Society for Pharmacology & Experimental Therapeutics

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


title: A Randomized, Double-blind, Placebo-controlled, Phase III, Multi-centre Study of Eltrombopag or Placebo in Combination With Azacitidine in Subjects With IPSS Intermediate-1, Intermediate 2 and High-risk Myelodysplastic Syndromes (MDS) SUPPORT: A StUdy of eltromboPag in myelodysPlastic SyndrOmes Receiving azaciTidine

summary: Eltrombopag olamine (SB-497115-GR) is an orally bioavailable, small molecule thrombopoietin receptor agonist that may be beneficial in medical disorders associated with thrombocytopenia. Eltrombopag has been shown to increase platelet counts in patients with thrombocytopenia from various etiologies (Idiopathic thrombocytopenic purpura [ITP], liver disease, aplastic anemia and chemotherapy induced thrombocytopenia). Approximately 350 subjects will be randomized in a 1:1 ratio (175 into the eltrombopag arm and 175 into the placebo arm). Approximately 55 subjects will be enrolled into the azacitidine. Subjects with intermediate-1, intermediate-2 or high risk MDS by IPSS, and baseline platelet count of <75 Giga (10^9) per liter (Gi/L) will only be enrolled. This is a randomized, double-blind, parallel group, placebo-controlled study designed to explore the platelet supportive care effects of eltrombopag versus placebo in combination with the standard of care hypomethylating agent, azacitidine. The primary objective of this study is to determine the effect of eltrombopag versus placebo on the proportion of subjects who are platelet transfusion free during the first 4 cycles of azacitidine therapy. Key secondary endpoints include overall survival, disease response, and disease progression.

ReferenceCitation: Dickinson M, Cherif H, Fenaux P, Mittelman M, Verma A, Portella MSO, Burgess P, Ramos PM, Choi J, Platzbecker U; SUPPORT study investigators. Azacitidine with or without eltrombopag for first-line treatment of intermediate- or high-risk MDS with thrombocytopenia. Blood. 2018 Dec 20;132(25):2629-2638. doi: 10.1182/blood-2018-06-855221. Epub 2018 Oct 10.

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Thailand
Turkey
Czechia
Canada
France
Hungary
Hong Kong
Denmark
Switzerland
United States
Belgium
Peru
Puerto Rico
Italy
Norway
Sweden
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel


title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in Hospitalized Adults With Respiratory Syncytial Virus (RSV) Infection

summary:
The primary objective of this study is to evaluate the effects of presatovir on respiratory syncytial virus (RSV) viral load in RSV-positive adults who have been hospitalized with acute respiratory infectious symptoms.

Participants will receive 1 dose of presatovir on Day 1 and followed for 27 days postdose. Nasal swabs will be collected at each study visit (excluding Day 28) and assayed for change in viral load as the primary endpoint.

lead_sponsor: Gilead Sciences

location_country:
France
Italy
Poland
New Zealand
United Kingdom
Australia
Netherlands
Belgium
United States
Korea, Republic of
Israel

location_facility: Hopital Saint Louis - Service de Pneumologie

location_facility: Southampton University Hospitals NHS Trust

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: Universite Liebre de Bruxelles - Hopital Erasme


lead_sponsor: Boehringer Ingelheim

summary: Phase Ib / II study to determine the Maximum Tolerated Dose and Recommended Phase II Dose, and to evaluate the safety and antitumour activity, of BI 836845 and everolimus in combination with exemestane in women with HR+/HER2- advanced breast cancer

ReferenceCitation: Schmid P, Sablin MP, Bergh J, Im SA, Lu YS, Martinez N, Neven P, Lee KS, Morales S, Perez-Fidalgo JA, Adamson D, Goncalves A, Prat A, Jerusalem G, Schlieker L, Espadero RM, Bogenrieder T, Huang DC, Crown J, Cortes J. A phase Ib/II study of xentuzumab, an IGF-neutralising antibody, combined with exemestane and everolimus in hormone receptor-positive, HER2-negative locally advanced/metastatic breast cancer. Breast Cancer Res. 2021 Jan 15;23(1):8. doi: 10.1186/s13058-020-01382-8.

repository_institution: Seoul National University - Seoul National University Open Repository

repositories:
LIRIAS (KU Leuven)
PubMed Central
s-space.snu.ac.kr

repositories_concat: LIRIAS (KU Leuven);PubMed Central;s-space.snu.ac.kr

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Charleroi - HOSP Grand Hôpital de Charleroi

location_facility: CHU UCL Namur - Site De Sainte-Elisabeth

title: A Phase Ib/II Randomized Study of BI 836845 in Combination With Exemestane and Everolimus Versus Exemestane and Everolimus Alone in Women With Locally Advanced or Metastatic Breast Cancer

ipd_sharing_description:
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

location_country:
Ireland
United Kingdom
Sweden
Netherlands
Austria
Belgium
Korea, Republic of
Spain
Taiwan
France


title: A Randomized, Double-Blind Study of Ruxolitinib or Placebo in Combination With Regorafenib in Subjects With Relapsed or Refractory Metastatic Colorectal Cancer

summary: The purpose of this study was to determine if ruxolitinib, in combination with regorafenib, is safe and effective in the treatment of metastatic colorectal cancer.

lead_sponsor: Incyte Corporation

location_country:
Germany
France
Korea, Democratic People's Republic of
United Kingdom
Australia
United States
Spain
Israel


acronym: VIABLE

intervention_type: Biological

lead_sponsor: SOTIO a.s.

summary: The VIABLE study sought to confirm the hypothesis that the combination of docetaxel with DCVAC/PCa followed by a maintenance therapy with DCVAC/PCa would improve overall survival in patients with metastatic castration-resistant prostate cancer.

ReferenceCitation: Hensler M, Rakova J, Kasikova L, Lanickova T, Pasulka J, Holicek P, Hraska M, Hrnciarova T, Kadlecova P, Schoenenberger A, Sochorova K, Rozkova D, Sojka L, Drozenova J, Laco J, Horvath R, Podrazil M, Hongyan G, Brtnicky T, Halaska MJ, Rob L, Ryska A, Coosemans A, Vergote I, Garg AD, Cibula D, Bartunkova J, Spisek R, Fucikova J. Peripheral gene signatures reveal distinct cancer patient immunotypes with therapeutic implications for autologous DC-based vaccines. Oncoimmunology. 2022 Jul 22;11(1):2101596. doi: 10.1080/2162402X.2022.2101596. eCollection 2022.

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

ReferenceCitation: Vogelzang NJ, Beer TM, Gerritsen W, Oudard S, Wiechno P, Kukielka-Budny B, Samal V, Hajek J, Feyerabend S, Khoo V, Stenzl A, Csoszi T, Filipovic Z, Goncalves F, Prokhorov A, Cheung E, Hussain A, Sousa N, Bahl A, Hussain S, Fricke H, Kadlecova P, Scheiner T, Korolkiewicz RP, Bartunkova J, Spisek R; VIABLE Investigators. Efficacy and Safety of Autologous Dendritic Cell-Based Immunotherapy, Docetaxel, and Prednisone vs Placebo in Patients With Metastatic Castration-Resistant Prostate Cancer: The VIABLE Phase 3 Randomized Clinical Trial. JAMA Oncol. 2022 Apr 1;8(4):546-552. doi: 10.1001/jamaoncol.2021.7298.

location_facility: Desert Hematology Oncology Medical Group

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointeszet

location_facility: Instituto de Investigaciones Sanitarias (IIS), Fundacíon Jimenez Díaz (FJD)

location_facility: University of Kansas Cancer Center & Medical Pavilion

location_facility: Institute of Oncology and Radiology of Serbia

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: University of South Alabama Mitchell Cancer Institute

location_facility: Specialized Hospital for Active Treatment of Oncology Diseases

location_facility: Azienda Ospedialiera Universitaria Senese

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

location_facility: Multifunctional Hospital for Active Treatment Serdika

location_facility: California Cancer Associates for Research and Excellence

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

location_facility: West Virginia University Mary Babb Randolph Cancer Center

location_facility: Winship Cancer Institute of Emory University

location_facility: University Hospital Center Sisters of Charity

location_facility: Urologicka ambulancia Uroexam, spol. s r.o.

location_facility: UT Health, Internal Medicine, Division of Oncology

location_facility: Praxigemeinschaft fur Onkologie und Urologie

location_facility: Centro Integral Oncológico Clara Campal (CIOCC)

location_facility: Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego

location_facility: Urologic Consultants of Southeastern Pennsylvania

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Oncology Institute of Hope and Innovation

location_facility: N.N. Alexandrov National Research Center

location_facility: Lithuanian University of Health Science Oncology Institute

location_facility: New Jersey Hematology Oncology Associates

location_facility: Klinika onkologie a radioterapie, Fakultni nemocnice

location_facility: Clinique d'Oncologie Medicale Institut Jules Bordet

location_facility: Universitatsklinikum fur Urologie und Andrologie

location_facility: St. Luke's Cancer Centre Royal Surrey County Hospital NHS Foundation Trust

location_facility: Fakultna nemocnica s poliklinikou Zilina

location_facility: Specialized Hospital for Active treatment in Oncology

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Cliniques Universitaires Saint Luc- Urologie

location_facility: Eastern CT Hematology and Oncololgy Associates

location_facility: Comprehensive Cancer Research Centers of Nevada

location_facility: Premier Urology Associates, LLC / AdvanceMed Research

location_facility: Urology Department St. Elizabeth Ziekenhuis

location_facility: Northern Centre for Cancer Care, Freeman Hospital

location_facility: Cancer Care Associates St. Luke's University and Health Network

location_facility: Hospital Universitario Puerta de Hierro de Majadahonda

location_facility: Paula Stradina Kliniska Universitates slimnica

location_facility: Hospital Universitario Príncipe de Asturias

location_facility: Hospital General Universitario Gregorio Maranón

location_facility: Univ. of Miami, Sylvester Comprehensive Cancer Center

title: A Randomized, Double Blind, Multicenter, Parallel-group, Phase III Study to Evaluate Efficacy and Safety of DCVAC/PCa Versus Placebo in Men With Metastatic Castration Resistant Prostate Cancer Eligible for 1st Line Chemotherapy

location_country:
Germany
Poland
Croatia
Czechia
Serbia
France
Belarus
Lithuania
Portugal
Slovakia
Hungary
Denmark
United States
Latvia
Belgium
Italy
United Kingdom
Netherlands
Austria
Spain
Bulgaria
Sweden


lead_sponsor: CSL Behring

summary: This is a multicenter randomized, double-blind, placebo-controlled, parallel-group, dose-ranging phase 2b study to investigate the hepatic and renal safety and tolerability of multiple dose administration of two dose levels of CSL112 compared with placebo in subjects with acute myocardial infarction (AMI).

ReferenceCitation: Zheng B, Duffy D, Tricoci P, Kastrissios H, Pfister M, Wright SD, Gille A, Tortorici MA. Pharmacometric analyses to characterize the effect of CSL112 on apolipoprotein A-I and cholesterol efflux capacity in acute myocardial infarction patients. Br J Clin Pharmacol. 2021 Jun;87(6):2558-2571. doi: 10.1111/bcp.14666. Epub 2020 Dec 23.

publisher_dissemination: Wiley

ReferenceCitation: Michael Gibson C, Korjian S, Tricoci P, Daaboul Y, Yee M, Jain P, Alexander JH, Steg PG, Lincoff AM, Kastelein JJ, Mehran R, D'Andrea DM, Deckelbaum LI, Merkely B, Zarebinski M, Ophuis TO, Harrington RA. Safety and Tolerability of CSL112, a Reconstituted, Infusible, Plasma-Derived Apolipoprotein A-I, After Acute Myocardial Infarction: The AEGIS-I Trial (ApoA-I Event Reducing in Ischemic Syndromes I). Circulation. 2016 Dec 13;134(24):1918-1930. doi: 10.1161/CIRCULATIONAHA.116.025687. Epub 2016 Nov 15.

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

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Gibson CM, Korjian S, Tricoci P, Daaboul Y, Alexander JH, Steg PG, Lincoff AM, Kastelein JJ, Mehran R, D'Andrea D, Merkely B, Zarebinski M, Ophius TO, Harrington RA. Rationale and design of Apo-I Event Reduction in Ischemic Syndromes I (AEGIS-I): A phase 2b, randomized, placebo-controlled, dose-ranging trial to investigate the safety and tolerability of CSL112, a reconstituted, infusible, human apoA-I, after acute myocardial infarction. Am Heart J. 2016 Oct;180:22-8. doi: 10.1016/j.ahj.2016.06.017. Epub 2016 Jul 5.

location_facility:
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Study Site - 23004
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Study Site 14012
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Study Site 18001
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Study Site 15005
Study Site 17014
Study Site 12017
Study Site 14006
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Study Site - 24010
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Study Site 18009
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Study Site - 25005
Study Site 10002
Study Site 18006
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Study Site 21015
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Study Site - 24009
Study Site 15003
Study Site - 13017
Study Site 14014
Study Site 19007
Study Site - 24003
Study Site 18005
Study Site 21010
Study Site 16147
Study Site 16039
Study Site 12019
Study Site 20001
Study Site - 22007
Study Site 16241
Study Site 14009
Study Site 16079
Study Site - 13014

title: A Phase 2b, Multi-center, Randomized, Placebo-controlled, Dose-ranging Study to Investigate the Safety and Tolerability of Multiple Dose Administration of CSL112 in Subjects With Acute Myocardial Infarction.

primary_purpose: Prevention

location_country:
Germany
Italy
Poland
Hungary
Israel
Denmark
Australia
United Kingdom
Netherlands
Austria
United States
Spain
Czechia
Bulgaria
Canada
France


acronym: Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (Orbit 4)

lead_sponsor: Aradigm Corporation

summary: This study (ARD-3150-1202, ORBIT-4) will evaluate the safety and efficacy of inhaled Pulmaquin (ciprofloxacin dispersion for inhalation) compared to inhaled placebo in subjects who have a confirmed diagnosis of non-cystic fibrosis (non-CF) bronchiectasis with a history of pulmonary exacerbations and chronic P. aeruginosa infections.

ReferenceCitation: Chalmers JD, Cipolla D, Thompson B, Davis AM, O'Donnell A, Tino G, Gonda I, Haworth C, Froehlich J. Changes in respiratory symptoms during 48-week treatment with ARD-3150 (inhaled liposomal ciprofloxacin) in bronchiectasis: results from the ORBIT-3 and -4 studies. Eur Respir J. 2020 Oct 22;56(4):2000110. doi: 10.1183/13993003.00110-2020. Print 2020 Oct.

repository_institution: University of Dundee - Discovery Research Portal

publisher_dissemination: European Respiratory Society

ReferenceCitation: Haworth CS, Bilton D, Chalmers JD, Davis AM, Froehlich J, Gonda I, Thompson B, Wanner A, O'Donnell AE. Inhaled liposomal ciprofloxacin in patients with non-cystic fibrosis bronchiectasis and chronic lung infection with Pseudomonas aeruginosa (ORBIT-3 and ORBIT-4): two phase 3, randomised controlled trials. Lancet Respir Med. 2019 Mar;7(3):213-226. doi: 10.1016/S2213-2600(18)30427-2. Epub 2019 Jan 15. Erratum In: Lancet Respir Med. 2019 Jan 25;:

sponsor_collaborators:
Aradigm Corporation
Grifols Therapeutics LLC

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections With Pseudomonas Aeruginosa in Patients With Non-Cystic Fibrosis Bronchiectasis, Including 28 Day Open-Label Extension

location_country:
Former Serbia and Montenegro
Italy
Poland
New Zealand
Hungary
Israel
Romania
Australia
United Kingdom
United States
Korea, Republic of
Spain
Peru
Canada
Georgia
France


title: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase 3 Efficacy and Safety Study of Benralizumab (MEDI-563) to Reduce Oral Corticosteroid Use in Patients With Uncontrolled Asthma on High Dose Inhaled Corticosteroid Plus Long-acting β2 Agonist and Chronic Oral Corticosteroid Therapy (ZONDA)

summary: The purpose of this trial is to confirm if benralizumab can reduce the use of maintenance OCS in systemic corticosteroid dependent patients with severe refractory asthma with elevated eosinophils.

ReferenceType: background

ReferenceCitation: Nair P, Wenzel S, Rabe KF, Bourdin A, Lugogo NL, Kuna P, Barker P, Sproule S, Ponnarambil S, Goldman M; ZONDA Trial Investigators. Oral Glucocorticoid-Sparing Effect of Benralizumab in Severe Asthma. N Engl J Med. 2017 Jun 22;376(25):2448-2458. doi: 10.1056/NEJMoa1703501. Epub 2017 May 22.

ReferenceCitation: Menzies-Gow A, Hoyte FL, Price DB, Cohen D, Barker P, Kreindler J, Jison M, Brooks CL, Papeleu P, Katial R. Clinical Remission in Severe Asthma: A Pooled Post Hoc Analysis of the Patient Journey with Benralizumab. Adv Ther. 2022 May;39(5):2065-2084. doi: 10.1007/s12325-022-02098-1. Epub 2022 Mar 14.

repository_institution: Aberdeen University - Aberdeen University Research Archive

repositories_concat: PubMed Central;aura.abdn.ac.uk

ReferenceCitation: Menzies-Gow A, Corren J, Bel EH, Maspero J, Heaney LG, Gurnell M, Wessman P, Martin UJ, Siddiqui S, Garcia Gil E. Corticosteroid tapering with benralizumab treatment for eosinophilic asthma: PONENTE Trial. ERJ Open Res. 2019 Sep 25;5(3):00009-2019. doi: 10.1183/23120541.00009-2019. eCollection 2019 Jul.

license: unspecified-oa

license_normalized: unspecified-oa

repository_institution: PubMed Central - Europe PMC

repository_institution: Queen's University Belfast - Research Portal

repository_institution: University of Cambridge - Apollo

ReferenceCitation: Chupp G, Lugogo NL, Kline JN, Ferguson GT, Hirsch I, Goldman M, Zangrilli JG, Trudo F. Rapid onset of effect of benralizumab on morning peak expiratory flow in severe, uncontrolled asthma. Ann Allergy Asthma Immunol. 2019 May;122(5):478-485. doi: 10.1016/j.anai.2019.02.016. Epub 2019 Feb 23.

location_country:
Germany
Poland
Argentina
United States
Korea, Republic of
Spain
Turkey
Chile
Ukraine
Bulgaria
Canada
France


title: A Phase 3, Randomized, Placebo-controlled, Multicenter, Double-blind Study to Evaluate the Safety and Efficacy of Telotristat Etiprate (LX1606) in Patients With Carcinoid Syndrome

acronym: TELECAST

summary: The purpose of the study is to evaluate the effect of telotristat etiprate versus placebo on the incidence of treatment-emergent adverse events and on 5-hydroxyindoleacetic acid (5-HIAA) levels.

ReferenceCitation: Srirajaskanthan R, Pavel M, Kulke M, Clement D, Houchard A, Keeber L, Weickert MO. Weight Maintenance up to 48 Weeks in Patients With Carcinoid Syndrome Treated With Telotristat Ethyl: Pooled Data From the Open-Label Extensions of the Phase III Clinical Trials TELESTAR and TELECAST. Clin Ther. 2021 Oct;43(10):1779-1785. doi: 10.1016/j.clinthera.2021.08.014. Epub 2021 Sep 28.

ReferenceCitation: Dillon JS, Kulke MH, Horsch D, Anthony LB, Warner RRP, Bergsland E, Welin S, O'Dorisio TM, Kunz PL, McKee C, Lapuerta P, Banks P, Pavel M. Time to Sustained Improvement in Bowel Movement Frequency with Telotristat Ethyl: Analyses of Phase III Studies in Carcinoid Syndrome. J Gastrointest Cancer. 2021 Mar;52(1):212-221. doi: 10.1007/s12029-020-00375-2.

repository_institution: Uppsala University - Uppsala University Publications

repositories_concat: DiVA.org;PubMed Central

repositories_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

ReferenceCitation: Pavel M, Gross DJ, Benavent M, Perros P, Srirajaskanthan R, Warner RRP, Kulke MH, Anthony LB, Kunz PL, Horsch D, Weickert MO, Lapuerta P, Jiang W, Kassler-Taub K, Wason S, Fleming R, Fleming D, Garcia-Carbonero R. Telotristat ethyl in carcinoid syndrome: safety and efficacy in the TELECAST phase 3 trial. Endocr Relat Cancer. 2018 Mar;25(3):309-322. doi: 10.1530/ERC-17-0455. Epub 2018 Jan 12.

repository_institution: University of Kentucky - UKnowledge

repository_institution: Universitätsbibliothek der Freien Universität Berlin - Refubium

repository_institution: Newcastle Univesity - Newcastle University ePrints

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

repository_normalized: dnet

evidence: oa repository (semantic scholar lookup)

publisher_dissemination: Bioscientifica

lead_sponsor: Lexicon Pharmaceuticals

location_country:
Germany
Israel
United Kingdom
Australia
Sweden
Netherlands
Belgium
United States
Spain
Canada
France

location_facility:
Lexicon Investigational Site
Lexicon Investigative Site


title: A 48 Weeks Study of Three Different Dose Regimens of BI 655066 Administered Subcutaneously in Patients With Moderate to Severe Chronic Plaque Psoriasis (Randomised, Dose-ranging, Active-comparator-controlled (Ustekinumab), Double-blind Within Dose Groups of BI 655066)

summary: The overall purpose of this trial is to assess clinical efficacy and safety of different subcutaneous doses of BI 655066 in adult patients with chronic plaque psoriasis in order to select doses for further clinical trials.

ReferenceCitation: Suleiman AA, Khatri A, Oberoi RK, Othman AA. Exposure-Response Relationships for the Efficacy and Safety of Risankizumab in Japanese Subjects with Psoriasis. Clin Pharmacokinet. 2020 May;59(5):575-589. doi: 10.1007/s40262-019-00829-2.

publisher_dissemination: Springer-Nature

ReferenceCitation: Suleiman AA, Minocha M, Khatri A, Pang Y, Othman AA. Population Pharmacokinetics of Risankizumab in Healthy Volunteers and Subjects with Moderate to Severe Plaque Psoriasis: Integrated Analyses of Phase I-III Clinical Trials. Clin Pharmacokinet. 2019 Oct;58(10):1309-1321. doi: 10.1007/s40262-019-00759-z.

ReferenceCitation: Papp KA, Blauvelt A, Bukhalo M, Gooderham M, Krueger JG, Lacour JP, Menter A, Philipp S, Sofen H, Tyring S, Berner BR, Visvanathan S, Pamulapati C, Bennett N, Flack M, Scholl P, Padula SJ. Risankizumab versus Ustekinumab for Moderate-to-Severe Plaque Psoriasis. N Engl J Med. 2017 Apr 20;376(16):1551-1560. doi: 10.1056/NEJMoa1607017.

location_country:
Germany
Finland
Norway
Sweden
United States
Canada
France

location_facility: 1311.2.10009 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.47001 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.10004 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.10003 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.10012 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.20004 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.49004 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.10013 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.20005 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.33005 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.49003 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.49001 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.10005 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.20002 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.33006 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.33002 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.33004 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.33003 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.10001 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.10007 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.10006 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.49005 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.10002 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.49002 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.46001 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.35801 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.20003 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.35802 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.47002 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.10010 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.10011 Boehringer Ingelheim Investigational Site

location_facility: 1311.2.33001 Boehringer Ingelheim Investigational Site


title: Phase 1/2 Study of TAS-120 in Patients With Advanced Solid Tumors Harboring FGF/FGFR Aberrations

summary:
This is an open-label, nonrandomized, Phase 1/2 study for the fibroblast growth factor receptor (FGFR) inhibitor futibatinib (TAS-120). The purpose of the study is to evaluate the safety, tolerability, PK, pharmacodynamic, and anti-tumor activity of futibatinib in patients with advanced solid tumors with and without genomic FGF/FGFR abnormalities. The study will be conducted in 3 parts:

Dose escalation portion to determine the MTD and/ or RP2D of futibatinib.
Phase 1 expansion portion to further evaluate the safety and efficacy of futibatinib in patients with tumors harboring FGF/FGFR aberrations, including patients with cholangiocarcinoma (CCA), primary CNS tumors, urothelial carcinoma, breast cancer, gastric cancer.
Phase 2 study portion to confirm ORR of futibatinib in intrahepatic CCA patients with tumors harboring FGFR2 gene rearrangements (incl fusions).

status: Unknown status

ReferenceCitation: Bahleda R, Meric-Bernstam F, Goyal L, Tran B, He Y, Yamamiya I, Benhadji KA, Matos I, Arkenau HT. Phase I, first-in-human study of futibatinib, a highly selective, irreversible FGFR1-4 inhibitor in patients with advanced solid tumors. Ann Oncol. 2020 Oct;31(10):1405-1412. doi: 10.1016/j.annonc.2020.06.018. Epub 2020 Jul 2.

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories_concat: PubMed Central;UCL Discovery;University of Melbourne - Minerva Access

lead_sponsor: Taiho Oncology, Inc.

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

location_facility: Mary Crowley Cancer Research - Medical City

location_facility: Sidney Kimmel Cancer Center at Jefferson

location_facility: Cancer Treatment Centers of America Zion, IL

location_facility: Yonsei University, Severance Hospital (Seoul)

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

location_facility: UOC Oncologia Medica 1 I"V - Istituto Oncologico Veneto - IRCCS

location_facility: The University of Arizona Cancer Center - North Campus

location_facility: Centro Integral Oncológico Clara Campal - Hospital Universitario Madrid Sanchinarro

location_facility: Hospital Clinic i Provincial de Barcelona,

location_facility: Wayne State Universtity (Karmanos Cancer Institute)

location_facility: University of Utah, Huntsman Cancer Hospital

location_facility: University of Wisconsin Clinical Science Center

location_facility: Hospital of the University of Pennsylvania

location_facility: University Hospital Essen, West German Cancer Center, Department of Medical Oncology

location_facility: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center. Mission Bay

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: University of Pittsburgh Medical Center Hillman Cancer Center

location_facility: Kyoto University Hospital, Department of Clinical Pharmacology and Therapeutics

location_facility: Greenville Health System ITOR,Clinical Research Unit


acronym: CheckMate 026: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 026

summary: The purpose of this study is to show that Nivolumab will improve progression free survival in subjects with strongly Stage IV or Recurrent PD-L1+ non-small cell lung cancer when compared to chemotherapy

ReferenceCitation: Carbone DP, Reck M, Paz-Ares L, Creelan B, Horn L, Steins M, Felip E, van den Heuvel MM, Ciuleanu TE, Badin F, Ready N, Hiltermann TJN, Nair S, Juergens R, Peters S, Minenza E, Wrangle JM, Rodriguez-Abreu D, Borghaei H, Blumenschein GR Jr, Villaruz LC, Havel L, Krejci J, Corral Jaime J, Chang H, Geese WJ, Bhagavatheeswaran P, Chen AC, Socinski MA; CheckMate 026 Investigators. First-Line Nivolumab in Stage IV or Recurrent Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Jun 22;376(25):2415-2426. doi: 10.1056/NEJMoa1613493.

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

repository_institution: Université de Lausanne - SERVAL

sponsor_collaborators:
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd

location_facility: University Of North Carolina At Chapel Hill

title: An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
Hungary
Switzerland
United States
Romania
Belgium
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Sweden


type: Registry Identifier

title: A Randomized, Double-blind, Placebo-controlled, Phase 2 Clinical Trial of Alisertib (MLN8237) in Combination With Paclitaxel Versus Placebo in Combination With Paclitaxel as Second Line Therapy for Small Cell Lung Cancer (SCLC).

summary: This is a two-arm, randomized, double-blind, placebo-controlled, multicenter, phase 2 study designed to is to determine if the combination treatment can improve progression free survival (defined as the time from the date of randomization to the date of first documentation of disease progression or death, whichever occurs first) when compared with placebo + paclitaxel.

ReferenceCitation: Owonikoko TK, Niu H, Nackaerts K, Csoszi T, Ostoros G, Mark Z, Baik C, Joy AA, Chouaid C, Jaime JC, Kolek V, Majem M, Roubec J, Santos ES, Chiang AC, Speranza G, Belani CP, Chiappori A, Patel MR, Czebe K, Byers L, Bahamon B, Li C, Sheldon-Waniga E, Kong EF, Williams M, Badola S, Shin H, Bedford L, Ecsedy JA, Bryant M, Jones S, Simmons J, Leonard EJ, Ullmann CD, Spigel DR; C14018 study investigators. Randomized Phase II Study of Paclitaxel plus Alisertib versus Paclitaxel plus Placebo as Second-Line Therapy for SCLC: Primary and Correlative Biomarker Analyses. J Thorac Oncol. 2020 Feb;15(2):274-287. doi: 10.1016/j.jtho.2019.10.013. Epub 2019 Oct 23.

repository_institution: KU Leuven - Lirias

lead_sponsor: Millennium Pharmaceuticals, Inc.

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