title: Observation of Clinical Routine Care for Heart Failure Patients Implanted With BIOTRONIK CRT Devices

acronym: BIO|STREAM HF

summary: The registry is primarily designed to assess outcome, efficacy and residual safety aspects of CRT based on long-term data from an unselected, real-life clinical set-up. Moreover, the observation of the patient status should help to find possible predictors for HF events and to identify areas of improvement for CRT and for CRT device settings.

study_type: Observational

time_perspective: Prospective

ipd_sharing_description: No individual participant data in planned to be shared with other researchers

lead_sponsor: Biotronik SE & Co. KG

location_country:
Austria
South Africa
Switzerland
Spain
United Kingdom
France
Czechia
Japan
Israel
Poland
Singapore
Hungary
Australia
Belgium
Slovakia
Portugal
Germany
Latvia
Taiwan

location_facility: Maria Heimsuchung - Carita-Klinik Pankow

location_facility: The National Cardiology Institute of Stefan Cardinal Wyszynski - National Research Institute

location_facility: Universitätsklinikum Giessen und Marburg

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Saitama Medical University International Medical Center

location_facility: Institute for Clinical and Experimental Medicine (IKEM)

location_facility: Hospital General Universitario de Valencia

location_facility: Städtische Kliniken Neuss -Lukaskrankenhaus- GmbH

location_facility: Centre Hospitalier Bretagne Atlantique Prosper Chubert

location_facility: Szpital Kliniczny Przemienienia Pańskiego

location_facility: Gottsegen György Országos Kardiológiai Intézet

location_facility: Hospital General Universitario de Alicante

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Universitätsklinikum Schleswig-Holstein (UKSH) - Campus Lübeck

location_facility: Schüchtermann Klinik, Herzzentrum Osnabrück-Bad Rothenfelde

location_facility: East-Slovak Cardiology Institute (VUSCH)

intervention_type: Device


design_allocation: Randomized

intervention_type: Drug

status: Terminated

study_start_date_type: Actual

study_type: Interventional

lead_sponsor: Biogen

enrollment_type: Actual

primary_purpose: Treatment

location_country:
Italy
United States
Sweden
France
Japan
Poland
Australia
Spain
Germany

acronym: TANGO

location_facility: Neuropsychiatric Research Center of Southwest Florida

location_facility: Mazowiecki Szpital Wojewódzki w Warszawie Sp z oo

location_facility: Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza

location_facility: The Research Center of Southern California

location_facility: Mary S. Easton Center for Alzheimer's Disease Research, UCLA

location_facility: Charite - Campus Berlin Buch, Experimental and Clinical Research Center (ECRC)

location_facility: The Cognitive Research Center of New Jersey

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: Irvine Center for Clinical Research, Inc.

location_facility: Emory University Cognitive Neurology Clinic & ADRC

location_facility: Azienda Ospedaliero Universitaria Policlinico Paolo

location_facility: Institut fuer Schlaganfall- und Demenzforschung (ISD)

location_facility: IRCCS Centro San Giovanni di Dio Fatebenefratelli

location_facility: New York University Medical Center PRIME

location_facility: Advanced Memory Enhancement Center of NJ

location_facility: Synexus Clinical Research US, Inc. - The Villages

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Studienzentrum fur Neurologie und Psychiatrie

location_facility: Cleveland Clinic Lou Ruvo Center for Brain Health

location_facility: Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus

location_facility: Research Center for Clinical Studies West

location_facility: Rhode Island Mood & Memory Research Institute

location_facility: Brigham and Women's Hospital Department of Neurology

location_facility: Groupe Hospitalier Pellegrin - Hôpital Pellegrin

location_facility: ISPG - Institut fuer Studien zur Psychischen Gesundheit

location_facility: Synexus Clinical Research US, Inc. - Orlando

study_completion_date_type: Actual

type: EudraCT Number

source: euctr

title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety, Tolerability, and Efficacy of BIIB092 in Subjects With Mild Cognitive Impairment Due to Alzheimer's Disease or With Mild Alzheimer's Disease

summary:
The primary objective of the placebo-controlled period is to evaluate the safety and tolerability of BIIB092 in participants with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or with mild AD. The secondary objectives of the placebo-controlled period are to evaluate the efficacy of multiple doses of BIIB092 in slowing cognitive and functional impairment in participants with MCI due to AD or with mild AD, and to evaluate the immunogenicity of BIIB092 after multiple doses in participants with MCI due to AD or with mild AD.

The primary objective of the long-term extension period is to evaluate the long-term safety and tolerability of BIIB092 in participants with MCI due to AD or with mild AD.

lead_sponsor_type: industriel

status_simplified: Unknown


title: Phase 2 Study of MCLA-128-based Combinations in Metastatic Breast Cancer (MBC): MCLA-128/Trastuzumab/Chemotherapy in HER2-positive MBC and MCLA-128/Endocrine Therapy in Estrogen Receptor Positive and Low HER2 Expression MBC

summary:
A Phase 2, open-label, multicenter international study will be performed to evaluate the efficacy of MCLA-128-based combinations. Three combination treatments will be evaluated, two in Cohort 1 and one in Cohort 2.

MCLA-128 is given in combinations in two metastatic breast cancer (MBC) populations, HER2-positive/amplified (Cohort 1) and Estrogen Receptor-positive/low HER2 expression (Cohort2).

Two combinations treatments will be evaluated in Cohort 1, the doublet and triplet. Initially MCLA-128 is given in combination with trastuzumab in the doublet. After the safety of the doublet has been assessed in 4-6 patients, MCLA-128 is given in combination with trastuzumab and vinorelbine in the triplet, in parallel to the efficacy expansion of the doublet.

The doublet and triplet combinations are both evaluated in two steps with an initial safety run-in followed by a cohort efficacy expansion. In total up to 40 patients evaluable for efficacy are included in both the doublet and triplet.

In Cohort 2 MCLA-128 is administered in combination with the same previous endocrine therapy on which progressive disease is radiologically documented. A total of up to 40 patients evaluable for efficacy are included in the Cohort 2.

status: Active, not recruiting

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

ipd_sharing: No

lead_sponsor: Merus N.V.

location_country:
Netherlands
Spain
France
Belgium
Portugal
United States
United Kingdom

location_facility: Vall D'Hebron Institute of Oncology (VHIO)

status_simplified: Ongoing


type: Other Identifier

title: A Phase 3, Randomized, Double-Blind Study of Pembrolizumab Plus Ipilimumab vs Pembrolizumab Plus Placebo in Previously Untreated, Stage IV, Metastatic Non-small Cell Lung Cancer Subjects Whose Tumors Are PD-L1 Positive (TPS ≥ 50%) (KEYNOTE-598)

summary:
The purpose of this study is to determine the efficacy of pembrolizumab given in combination with either ipilimumab or placebo as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC). The primary hypothesis of this study is that overall survival (OS) and/or progression-free survival (PFS) is prolonged in participants who receive pembrolizumab and ipilimumab compared to those who receive pembrolizumab and placebo.

With Amendment 6 (effective date: 11-Dec-2020), active participants, investigator, and sponsor personnel or delegate(s) involved in the treatment administration or clinical evaluation of the participants will be unblinded. Participants will discontinue ipilimumab and placebo and participants who remain on treatment will receive open-label pembrolizumab only.

ReferenceType: derived

ReferenceCitation: Boyer M, Şendur MAN, Rodríguez-Abreu D, Park K, Lee DH, Çiçin I, Yumuk PF, Orlandi FJ, Leal TA, Molinier O, Soparattanapaisarn N, Langleben A, Califano R, Medgyasszay B, Hsia TC, Otterson GA, Xu L, Piperdi B, Samkari A, Reck M; KEYNOTE-598 Investigators. Pembrolizumab Plus Ipilimumab or Placebo for Metastatic Non-Small-Cell Lung Cancer With PD-L1 Tumor Proportion Score ≥ 50%: Randomized, Double-Blind Phase III KEYNOTE-598 Study. J Clin Oncol. 2021 Jul 20;39(21):2327-2338. doi: 10.1200/JCO.20.03579. Epub 2021 Jan 29.

name: Chris O'Brien Lifehouse, Camperdown, NSW, Australia

family: Boyer

full_name: Michael Boyer

given: Michael

sequence: first

name: Ankara Yıldırım Beyazıt University, Faculty of Medicine and Ankara City Hospital, Ankara, Turkey

family: Şendur

full_name: Mehmet A. N. Şendur

given: Mehmet A. N.

sequence: additional

name: Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria, Universidad de Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain

family: Rodríguez-Abreu

full_name: Delvys Rodríguez-Abreu

given: Delvys

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

family: Park

full_name: Keunchil Park

given: Keunchil

family: Lee

full_name: Dae Ho Lee

given: Dae Ho

family: Çiçin

full_name: Irfan Çiçin

given: Irfan

name: Marmara University School of Medicine, Istanbul, Turkey

family: Yumuk

full_name: Perran Fulden Yumuk

given: Perran Fulden

family: Orlandi

full_name: Francisco J. Orlandi

given: Francisco J.

name: University of Wisconsin Carbone Cancer Center, Madison, WI

family: Leal

full_name: Ticiana A. Leal

given: Ticiana A.

family: Molinier

full_name: Olivier Molinier

given: Olivier

name: Mahidol University, Sriraj Hospital, Bangkok, Thailand

family: Soparattanapaisarn

full_name: Nopadol Soparattanapaisarn

given: Nopadol

name: St Mary's Hospital – ODIM, McGill University Department of Oncology, Montreal, QC, Canada

family: Langleben

full_name: Adrian Langleben

given: Adrian

name: The Christie NHS Foundation Trust, and Division of Cancer Sciences, The University of Manchester, Manchester, UK

family: Califano

full_name: Raffaele Califano

given: Raffaele

name: Veszprém Megyei Tüdőgyógyintézet Farkasgyepű, Farkasgyepű, Hungary

family: Medgyasszay

full_name: Balazs Medgyasszay

given: Balazs

name: China Medical University and China Medical University Hospital, Taichung, Taiwan

family: Hsia

full_name: Te-Chun Hsia

given: Te-Chun

name: The Ohio State University-James Comprehensive Cancer Center, Columbus, OH

family: Otterson

full_name: Gregory A. Otterson

given: Gregory A.

family: Xu

full_name: Lu Xu

given: Lu

family: Piperdi

full_name: Bilal Piperdi

given: Bilal

family: Samkari

full_name: Ayman Samkari

given: Ayman

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

family: Reck

full_name: Martin Reck

given: Martin

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Clinical Oncology

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

publisher: American Society of Clinical Oncology (ASCO)

publisher_dissemination: American Society of Clinical Oncology (ASCO)

publisher_group: American Society of Clinical Oncology (ASCO)

publisher_normalized: American Society of Clinical Oncology (ASCO)

title: Pembrolizumab Plus Ipilimumab or Placebo for Metastatic Non–Small-Cell Lung Cancer With PD-L1 Tumor Proportion Score ≥ 50%: Randomized, Double-Blind Phase III KEYNOTE-598 Study

location_country:
Peru
Australia
Taiwan
Ukraine
France
Poland
Thailand
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Chile
Hungary
Ireland
United States
Germany
United Kingdom
Italy
Brazil
Mexico
Spain
Turkey
Latvia

location_facility: Universitaetsklinikum Leipzig ( Site 0919)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 1511)

location_facility: Ege Universitesi Tip Fakultesi Hastanesi ( Site 1901)

location_facility: Centro de Investigacion Clinica del Country ( Site 0500)

location_facility: Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2003)

location_facility: LungenClinic Grosshansdorf GmbH ( Site 0908)

location_facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc ( Site 1607)

location_facility: Centro de Investigaciones Clinicas - Clinica Viedma ( Site 0202)

location_facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 1912)

location_facility: Pontificia Universidad Catolica de Chile ( Site 0404)

location_facility: Riga East Clinical University Hospital ( Site 1111)

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0312)

location_facility: St Vincents Hospital Melbourne ( Site 2101)

location_facility: Seoul National University Hospital ( Site 2303)

location_facility: Avix Investigacion Clinica S.C. ( Site 0600)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1906)

location_facility: Hospital Nacional Cayetano Heredia ( Site 0706)

location_facility: University of Stellenbosch and Tygerberg Hospital ( Site 1810)

location_facility: Karadeniz Teknik Universitesi ( Site 1910)

location_facility: Clinica Peruano Americana S.A. ( Site 0703)

location_facility: Instituto Nacional del Cancer ( Site 0406)

location_facility: MI Odessa Regional Oncological Centre ( Site 2004)

location_facility: The Ohio State University Wexner Medical Center ( Site 0016)

location_facility: Northwest Cancer Specialists, P.C. ( Site 8001)

location_facility: The Royal Marsden NHS Foundation Trust. ( Site 1326)

location_facility: GVI Oncology Clinical Research Centre ( Site 1802)

location_facility: Petz Aladar Megyei Oktato Korhaz ( Site 1505)

location_facility: Severance Hospital Yonsei University Health System ( Site 2300)

location_facility: Clinica Universidad Catolica del Maule ( Site 0413)

location_facility: Hospital Nossa Senhora da Conceicao ( Site 0306)

location_facility: Universitas Annex National Hospital ( Site 1800)

location_facility: Royal Wolverhampton Hospitals NHS Trust ( Site 1323)

location_facility: Lahey Hospital & Medical Center ( Site 0020)

location_facility: Pauls Stradins Clinical University Hospital ( Site 1100)

location_facility: Disney Family Cancer Center ( Site 0035)

location_facility: Escola Paulista de Medicina - UNIFESP ( Site 0304)

location_facility: Centre Hopitalier Intercommunal Creteil ( Site 0802)

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 1504)

location_facility: Centro Especializado de Enfermedades Neoplasicas SRL-CEEN SRL ( Site 0710)

location_facility: Chang Gung Medical Foundation - Kaohsiung ( Site 2404)

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1908)

location_facility: Uludag Universitesi Tip Fakultesi ( Site 1914)

location_facility: University Hospital Limerick ( Site 1403)

location_facility: MI Prykarpatskyi Clinical Oncology Centrum ( Site 2009)

location_facility: The Royal Marsden NHS Foundation Trust.. ( Site 1327)

location_facility: Orszagos Onkologiai Intezet ( Site 1509)

location_facility: CEPON Centro de Pesquisa Oncológicas ( Site 0307)

location_facility: CIUSSS du Saguenay-Lac-St-Jean ( Site 0115)

location_facility: Texas Oncology-Longview Cancer Center ( Site 8009)

location_facility: Hospital Clinico Vina del Mar ( Site 0400)

location_facility: Dnipropetrovsk City Multidiscipline Clinical Hosp.4 of DRC ( Site 2000)

location_facility: Texas Oncology-Arlington South ( Site 8006)

location_facility: John Wayne Cancer Institute ( Site 0021)

location_facility: University of Wisconsin Carbone Cancer Center ( Site 0004)

location_facility: University of Tennessee Erlanger Oncology & Hematology ( Site 0026)

location_facility: Icahn School of Medicine at Mount Sinai ( Site 0034)

location_facility: Mercy Health-Paducah Medical Oncology and Hematology ( Site 0018)

location_facility: HELIOS Klinikum Emil von Behring ( Site 0905)

location_facility: Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 0506)

location_facility: MI Kryviy Rih Center of Dnipropetrovsk Regional Council ( Site 2005)

location_facility: Mid Ohio Oncology/Hematology Inc. ( Site 0003)

location_facility: Royal Free NHS Foundation Trust ( Site 1324)

location_facility: Florida Hospital Cancer Institute ( Site 0009)

location_facility: Virginia Mason Memorial- North Star Lodge Cancer Center ( Site 0033)

location_facility: The Christie NHS Foundation Trust ( Site 1301)

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0603)

location_facility: C.H.R.U de Lille - Hopital Calmette ( Site 0805)

location_facility: Veszprem Megyei Tudogyogyintezet ( Site 1503)

location_facility: Texas Oncology-Methodist Dallas Cancer Center ( Site 8000)

location_facility: Instituto Regional de Enfermedades Neoplasicas del Sur IRENSUR ( Site 0704)

location_facility: CISSS-CA Hotel-Dieu de Levis ( Site 0108)

location_facility: Sandton Oncology Medical Group PTY LTD ( Site 1807)

location_facility: Ospedale San Gerardo ASST Monza ( Site 1002)

location_facility: Instituto de Oncologia de Rosario ( Site 0200)

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1609)

location_facility: Hospital Privado Centro Medico Cordoba ( Site 0206)

location_facility: Universitaetsklinikum Heidelberg ( Site 0900)

location_facility: Hospital Alemao Oswaldo Cruz ( Site 0311)

location_facility: PP PPC Acinus Medical and Diagnostic Centre ( Site 2002)

location_facility: Hospital Germans Trias i Pujol ( Site 1207)

location_facility: Dolnoslaskie Centrum Onkologii. ( Site 1616)

location_facility: CHU de Brest. Hopital Morvan ( Site 0800)

location_facility: Ospedale Santa Maria della Misericordia ( Site 1008)

location_facility: Evangelische Lungenklinik Berlin ( Site 0903)

location_facility: Centro Oncologico Riojano Integral ( Site 0203)

location_facility: Clinica Internacional Sede San Borja ( Site 0701)

location_facility: Changhua Christian Hospital ( Site 2406)

location_facility: New England Cancer Specialists ( Site 0019)

location_facility: St. Georges University Hospital NHS Foundation Trust ( Site 1321)

location_facility: CISSS de la Monteregie-Centre ( Site 0100)

location_facility: Inst de Medicina Integral Professor Fernando Figueira- IMIP ( Site 0302)

location_facility: Instituto Cancerologico de Narino Ltda ( Site 0504)

location_facility: Texas Oncology-Flower Mound ( Site 8007)

location_facility: Oncologica de Puebla SA de CV ( Site 0606)

location_facility: Hospital Universitario Insular de Gran Canaria ( Site 1203)

location_facility: Clinica de Hematologia e Oncologia Viver Ltda ( Site 0305)

location_facility: Bekes Megyei Pandy Kalman Korhaz. ( Site 1507)

location_facility: Inonu Universitesi Tip Fakultesi ( Site 1907)

location_facility: Hospital San Pedro de Alcantara ( Site 1208)

location_facility: St-Jerome Medical Research Inc ( Site 0113)

location_facility: Istituto Europeo di Oncologia ( Site 1007)

location_facility: Hospital Nacional Guillermo Almenara Irigoyen ( Site 0705)

location_facility: Charlotte Maxeke Johannesburg Academic Hospital ( Site 1806)

location_facility: Chang Gung Memorial Hospital - Linkou Branch ( Site 2402)

location_facility: Universitaetsklinikum Schleswig Holstein. ( Site 0918)

location_facility: Hospital Universitario Virgen del Rocio ( Site 1200)

location_facility: Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie ( Site 1600)

location_facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1501)

location_facility: Hospital do Servidor Publico do Estado ( Site 0308)

location_facility: Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 1502)

location_facility: Kocaeli Universitesi Tip Fakultesi ( Site 1909)

location_facility: Humanitas Research Hospital ( Site 1004)

location_facility: Providence Cancer Institute, Franz Clinic - Eastside ( Site 0031)

location_facility: Hospital Universitari Vall d Hebron ( Site 1211)

location_facility: Hospital Fundacion Jimenez Diaz - Clin. Concepcion ( Site 1209)

location_facility: Dr G.A. Landers Specialist Oncologist ( Site 1803)

location_facility: National Cancer Institute of the MoH of Ukraine ( Site 2015)

location_facility: Tennessee Cancer Specialists ( Site 0017)

location_facility: China Medical University Hospital ( Site 2403)

location_facility: National Cheng Kung University Hospital ( Site 2401)

location_facility: IRCCS Casa Sollievo della Sofferenza ( Site 1009)

location_facility: Powiatowe Centrum Zdrowia w Brzezinach ( Site 1615)

location_facility: Kyiv City Clinical Oncological Center ( Site 2014)

location_facility: Medical Park Izmir Hospital ( Site 1900)

location_facility: AORN dei Colli Plesso Monaldi ( Site 1003)

location_facility: CIUSSS Ouest de l'Ile - St-Mary's Hospital ( Site 0107)

location_facility: National Taiwan University Hospital ( Site 2400)

location_facility: Soc. Prosalud Montes y Orlandi Ltda (Orlandi Oncologia) ( Site 0401)

location_facility: CHU de Toulouse - Hopital Larrey ( Site 0801)

location_facility: Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 1506)

location_facility: Regional Clinical Onco Dispensary_ State Medical University ( Site 2012)

location_facility: Medical College of Wisconsin Clinical Cancer Center ( Site 0027)

location_facility: Instituto do Cancer de Sao Paulo - ICESP ( Site 0300)

location_facility: Medical Care and Research S.A. de C.V. ( Site 0602)

location_facility: Szpital Wojewodzki w Koszalinie im. Mikolaja Kopernika ( Site 1614)


title: A Pilot Study of Personalized Biomarker-based Treatment Strategy or Immunotherapy in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

acronym: UPSTREAM

summary: This is a biomarker-driven trial that will enroll patients with recurrent or metastatic squamous cell carcinoma of the head and neck progressing after first-line platinum-based chemotherapy. Based on potential biomarkers and molecular alterations identified in the biopsy from the central platform, patients will be allocated in different cohorts. There will be biomarker-positive patient cohorts and immunotherapy cohorts.

status: Recruiting

enrollment_type: Anticipated

ReferenceCitation: Galot R, Le Tourneau C, Guigay J, Licitra L, Tinhofer I, Kong A, Caballero C, Fortpied C, Bogaerts J, Govaerts AS, Staelens D, Raveloarivahy T, Rodegher L, Laes JF, Saada-Bouzid E, Machiels JP. Personalized biomarker-based treatment strategy for patients with squamous cell carcinoma of the head and neck: EORTC position and approach. Ann Oncol. 2018 Dec 1;29(12):2313-2327. doi: 10.1093/annonc/mdy452. Review.

family: Galot

full_name: R. Galot

given: R.

family: Le Tourneau

full_name: C. Le Tourneau

given: C.

family: Guigay

full_name: J. Guigay

given: J.

family: Licitra

full_name: L. Licitra

given: L.

family: Tinhofer

full_name: I. Tinhofer

given: I.

family: Kong

full_name: A. Kong

given: A.

family: Caballero

full_name: C. Caballero

family: Fortpied

full_name: C. Fortpied

family: Bogaerts

full_name: J. Bogaerts

family: Govaerts

full_name: A.-S. Govaerts

family: Staelens

full_name: D. Staelens

given: D.

family: Raveloarivahy

full_name: T. Raveloarivahy

given: T.

family: Rodegher

full_name: L. Rodegher

family: Laes

full_name: J.-F. Laes

family: Saada-Bouzid

full_name: E. Saada-Bouzid

given: E.

family: Machiels

full_name: J.-P. Machiels

journal_name: Annals of Oncology

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

license_normalized: no license

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

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country:
Italy
United Kingdom
Belgium
France

location_facility: Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet

location_facility: Institut de Cancerologie Strasbourg Europe

location_facility: Guy's and St Thomas' NHS - Guy s and St Thomas' NHS - Guy's Hospital

location_facility: Oxford University Hospitals NHS Trust - Churchill Hospital

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: AZ Groeninge Kortrijk - Campus Kennedylaan

location_facility: Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"

location_facility: GasthuisZusters Antwerpen - Sint-Augustinus

location_facility: CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital

location_facility: Institut de Cancerologie de l'Ouest (ICO) - Centre Rene Gauducheau

location_facility: Grand Hopital de Charleroi - Grand Hôpital de Charleroi - Site Notre Dame

location_facility: NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital

location_facility: University Hospitals Birmingham NHS Foundation Trust (UHB) - UHB-Queen Elisabeth Medical Centre


type: Registry Identifier

title: A Phase 1/2 Study of the Highly-selective RET Inhibitor, BLU-667, in Patients With Thyroid Cancer, Non-Small Cell Lung Cancer (NSCLC) and Other Advanced Solid Tumors

acronym: ARROW

summary: This is a Phase 1/2, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antineoplastic activity of pralsetinib (BLU-667) administered orally in patients with medullary thyroid cancer, RET-altered NSCLC and other RET-altered solid tumors.

ReferenceCitation: Subbiah V, Hu MI, Wirth LJ, Schuler M, Mansfield AS, Curigliano G, Brose MS, Zhu VW, Leboulleux S, Bowles DW, Baik CS, Adkins D, Keam B, Matos I, Garralda E, Gainor JF, Lopes G, Lin CC, Godbert Y, Sarker D, Miller SG, Clifford C, Zhang H, Turner CD, Taylor MH. Pralsetinib for patients with advanced or metastatic RET-altered thyroid cancer (ARROW): a multi-cohort, open-label, registrational, phase 1/2 study. Lancet Diabetes Endocrinol. 2021 Aug;9(8):491-501. doi: 10.1016/S2213-8587(21)00120-0. Epub 2021 Jun 9. Erratum in: Lancet Diabetes Endocrinol. 2021 Oct;9(10):e4.

family: Subbiah

full_name: Vivek Subbiah

given: Vivek

family: Hu

full_name: Mimi I Hu

given: Mimi I

family: Wirth

full_name: Lori J Wirth

given: Lori J

family: Schuler

full_name: Martin Schuler

family: Mansfield

full_name: Aaron S Mansfield

given: Aaron S

family: Curigliano

full_name: Giuseppe Curigliano

given: Giuseppe

family: Brose

full_name: Marcia S Brose

given: Marcia S

family: Zhu

full_name: Viola W Zhu

given: Viola W

family: Leboulleux

full_name: Sophie Leboulleux

given: Sophie

family: Bowles

full_name: Daniel W Bowles

given: Daniel W

family: Baik

full_name: Christina S Baik

given: Christina S

family: Adkins

full_name: Douglas Adkins

given: Douglas

family: Keam

full_name: Bhumsuk Keam

given: Bhumsuk

family: Matos

full_name: Ignacio Matos

given: Ignacio

family: Garralda

full_name: Elena Garralda

given: Elena

family: Gainor

full_name: Justin F Gainor

given: Justin F

family: Lopes

full_name: Gilberto Lopes

given: Gilberto

family: Lin

full_name: Chia-Chi Lin

given: Chia-Chi

family: Godbert

full_name: Yann Godbert

given: Yann

family: Sarker

full_name: Debashis Sarker

given: Debashis

family: Miller

full_name: Stephen G Miller

given: Stephen G

family: Clifford

full_name: Corinne Clifford

given: Corinne

family: Zhang

ReferenceCitation: Gainor JF, Curigliano G, Kim DW, Lee DH, Besse B, Baik CS, Doebele RC, Cassier PA, Lopes G, Tan DSW, Garralda E, Paz-Ares LG, Cho BC, Gadgeel SM, Thomas M, Liu SV, Taylor MH, Mansfield AS, Zhu VW, Clifford C, Zhang H, Palmer M, Green J, Turner CD, Subbiah V. Pralsetinib for RET fusion-positive non-small-cell lung cancer (ARROW): a multi-cohort, open-label, phase 1/2 study. Lancet Oncol. 2021 Jul;22(7):959-969. doi: 10.1016/S1470-2045(21)00247-3. Epub 2021 Jun 9. Erratum in: Lancet Oncol. 2021 Aug;22(8):e347.

location_country:
Italy
United States
Hong Kong
Netherlands
Spain
France
Singapore
Belgium
China
Germany
United Kingdom
Korea, Republic of
Taiwan

location_facility: Maryland Oncology Hematology, PA - Columbia

location_facility: Guy's Hospital St. Thomas NHS Foundation Trust

location_facility: Hospital Universitario 12 de Octubre Servicio de Oncologia Medica

location_facility: Nanfang Hospital of Southern Medical University

location_facility: Istituto Europeo di Oncologia Sviluppo Nuovi Farmaci per Terapie Innovative

location_facility: University of Miami Hospitals and Clinics, Sylvester Comprehensive Cancer Center

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

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: CHRU de Lille - Hôpital Claude Hurier Servide d'Endocrinologie et Diabétologie

location_facility: NIHR UCLH Clinical Research Facility, University College of London NHS Foundation Trust

location_facility: Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis

location_facility: First Affiliated Hospital of Gannan Medical University

location_facility: Washington University School of Medicine, Siteman Cancer Center

location_facility: University of Washington, Seattle Cancer Care Alliance

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


lead_sponsor: Hoffmann-La Roche

location_country:
Greece
Australia
Belgium
Russian Federation
Denmark
Taiwan
France
Japan
Poland
Canada
Korea, Republic of
Switzerland
Hungary
China
United States
Germany
United Kingdom
Italy
Austria
Czechia
Spain

location_facility: Hopital Charles Lemoyne; Centre Integre de Lutte Contre Le Cancer de La Monteregie

location_facility: Odense Universitetshospital, Onkologisk Afdeling R

location_facility: Aalborg Universitetshospital, Klinik Kirurgi-Kræft, Onkologisk afd.

location_facility: Miami Cancer Institute of Baptist Health, Inc.

location_facility: Universitätsklinikum Freiburg; Chirurgische Klinik; Abteilung Urologie

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Hospital Universitari Vall d'Hebron; Oncology

location_facility: ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico

location_facility: Virginia Cancer Specialists - Alexandria

location_facility: University Hospital of Patras Medical Oncology

location_facility: Medizinische Hochschule Hannover; Klinik für Urologie und Onkologische Urologie

location_facility: Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine

location_facility: Urologisches Zentrum Euregio; Würselen, Urologische Praxis am Wasserturm

location_facility: Irccs Istituto Europeo Di Oncologia (IEO); Cure Mediche

location_facility: Kantonsspital St. Gallen; Onkologie/Hämatologie

location_facility: Nebraska Cancer Specialists; Oncology Hematology West, PC

location_facility: Kaiser Permanente San Diego - Los Angeles

location_facility: Texas Oncology - Methodist Dallas Cancer Center

location_facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

location_facility: Centre Oscar Lambret; Chir Cancerologie General

location_facility: Russian Scientific Center of Roentgenoradiology

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2

location_facility: IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima

location_facility: Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont

location_facility: Urology Cancer Center & GU Research Network

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

location_facility: National Taiwan University Hospital, Department of Urology

location_facility: University of Pittsburgh Cancer Institute; Division of Medical Oncology

location_facility: Hopital Saint Louis, Service D Oncologie Medicale

location_facility: Universitätsklinikum Münster, Klinik für Urologie und Kinderurologie

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: IRCCS AOU San Martino - IST; Oncologia Medica 1

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Chang Gung Memorial Hospital-LinKou; Urology

location_facility: Universitätsklinikum Tübingen; Klinik für Urologie

location_facility: Institut Catala d´Oncologia Hospital Germans Trias i Pujol

location_facility: Medical University of Bialystok; Oncology clinic

location_facility: Friendship Hospital, Capital Medical University

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

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: University Hospital Kyoto Prefectural University of Medicine

location_facility: SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF

location_facility: Ospedale Area Aretina Nord; U.O.C. Oncologia

location_facility: Concord Repatriation General Hospital; Concord Cancer Centre

location_facility: IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia

location_facility: Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.

location_facility: Medizinische Universität Wien; Universitätsklinik für Urologie

location_facility: Royal Marsden Hospital; Institute of Cancer Research

location_facility: Herlev Hospital; Afdeling for Kræftbehandling

location_facility: Orszagos Onkologiai Intezet; "C" Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály

location_facility: Athens Medical Center; Dept. of Oncology

location_facility: A.O. Istituti Ospitalieri - Cremona; S.C. Oncologia

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: TAIPEI VETERANS GENERAL HOSPITAL, Urology

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

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: CHU de Québec - Université Laval - Hôtel-Dieu de Québec

location_facility: Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica

location_facility: Ordensklinikum Linz Elisabethinen; Abteilung für Urologie und Andrologie

location_facility: Semmelwies University of Medicine; Urology Dept.

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Hospital Clínic i Provincial; Servicio de Oncología

location_facility: Alexandras Hospital; Dept. of Clin. Therapeutics, Athens Uni School of Medicine

location_facility: Niigata University Medical & Dental Hospital

location_facility: Szpital Sw. Elzbiety - Mokotowskie Centrum Medyczne Sp. z o.o.

location_facility: Przychodnia Lekarska KOMED, Roman Karaszewski

location_facility: Lynn Cancer Institute/Boca Raton Regional Hospital

location_facility: Woj. Wielospec. Centrum Onkologii i Traumatologii

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarawskiego

location_facility: University of Colorado; Division of Medical Oncology

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

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

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

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Papageorgiou General Hospital; Medical Oncology

location_facility: Taichung Veterans General Hospital; Division of Urology

location_facility: Royal Brisbane & Women's Hosp; Cancer Care Serv

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

location_facility: Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica

location_facility: Debreceni Egyetem Klinikai Kozpont ; Department of Oncology

location_facility: Hopital d'Instruction des Armees de Begin

location_facility: Inselspital Bern; Universitätsklinik für medizinische Onkologie

location_facility: James Cancer Hospital;Solove Research Institute

title: A Phase III, Multicenter, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Enzalutamide Versus Enzalutamide Alone in Patients With Metastatic Castration-Resistant Prostate Cancer After Failure of an Androgen Synthesis Inhibitor and Failure of, Ineligibility for, or Refusal of a Taxane Regimen

summary: This Phase III, multicenter, randomized, open-label study will evaluate the safety and efficacy of atezolizumab (anti-programmed death-ligand 1 [anti-PD-L1] antibody) in combination with enzalutamide compared with enzalutamide alone in participants with mCRPC after failure of an androgen synthesis inhibitor (e.g., abiraterone) and failure of, ineligibility for, or refusal of a taxane regimen. Participants will be randomized to one of the two treatment arms (atezolizumab in combination with enzalutamide, and enzalutamide alone) in a 1:1 ratio (experimental to control arm) in global randomized phase. Participants will receive treatment until investigator-assessed confirmed radiographic disease progression per Prostate Cancer Working Group 3 (PCWG3) criteria or unacceptable toxicity.


title: TRITON3: A Multicenter, Randomized, Open Label Phase 3 Study of Rucaparib Versus Physician's Choice of Therapy for Patients With Metastatic Castration Resistant Prostate Cancer Associated With Homologous Recombination Deficiency

summary: The purpose of this study is to determine how patients with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib versus treatment with physician's choice of abiraterone acetate, enzalutamide, or docetaxel.

lead_sponsor: Clovis Oncology, Inc.

location_country:
Italy
United States
Germany
France
Israel
Ireland
Belgium
Australia
Spain
Denmark
Canada
United Kingdom

location_facility: Apotheke des Städtischen Klinikums Braunschweig

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: Medizinischen Fakultät Mannheim der Universität Heidelberg

location_facility: VA Greater Los Angeles Healthcare System

location_facility: Hospital General Universitario de Guadalajara

location_facility: Walter Reed National Military Medical Center

location_facility: The Tel Aviv Sourasky Medical Center (Ichilov Hospital)

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Rambam Health Care Campus (RHCC), Rambam Medical Center

location_facility: Alegent Health Bergan Mercy Hospital , GU Research Network

location_facility: Presidio Ospedaliero Santa Chiara di Trento

location_facility: Lakeridge Health Medical Specialty Medical Oncology

location_facility: Northwest Cancer Specialist DBA Compass Oncology

location_facility: Hospital Universitario Central de Asturias

location_facility: MultiCare Regional Cancer Center - Gig Harbor

location_facility: Centre Armoricain de Radiotherapie, Imagerie medicale et Oncologie, CARIO

location_facility: Medical Oncology Hematology Consultants - USOR

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

location_facility: Oxford Cancer Centre, Medical Oncology Unit

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: Clinique Victor Hugo Centre Jean Bernard

location_facility: Marques de Valdecilla University Hospital (HUMV)

location_facility: University of Washington Fred Hutchinson Cancer Research Center

location_facility: University of North Carolina Lineberger Cancer Center

location_facility: Premier MEdical Group of the Hudson Valley PC

location_facility: Azienda Ospedaliera San Camillo-Forlanini

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: University of Florida Health Cancer Center

location_facility: Centre Hospitalier Universitaire Dr-Georges-L.-Dumont

location_facility: Adelaide & Meath Hospital, Incorporating the National Children's Hospital

location_facility: Romagnolo per lo Studio e la Cura dei Tumori IRST-IRCCS - Oncologia medica

location_facility: Polyclinique de Gentilly (Centre D'Oncologie De Gentilly)

location_facility: Barwon Health, University Hospital Geelong


title: Risk-based, Response-adapted, Phase II Open-label Trial of Nivolumab + Brentuximab Vedotin (N + Bv) for Children, Adolescents, and Young Adults With Relapsed/Refractory (R/R) CD30 + Classic Hodgkin Lymphoma (cHL) After Failure of First-line Therapy, Followed by Brentuximab + Bendamustine (Bv + B) for Participants With a Suboptimal Response (CheckMate 744: CHECKpoint Pathway and Nivolumab Clinical Trial Evaluation)

acronym: CheckMate 744

summary: The purpose of this study is to determine whether nivolumab plus brentuximab vedotin (followed by brentuximab vedotin plus bendamustine in patient with suboptimal response) is safe and effective in treating patients with Hodgkin's lymphoma (cHL). Eligible patients are children, adolescents, and young adults relapsed or refractory to first line.

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
United States
Netherlands
France
Czechia
Poland
Ireland
Spain
Germany
United Kingdom
Canada

location_facility: University Of Oklahoma Health Sciences Center

location_facility: Smilow Cancer Hospital At Yale New Haven Hospital

location_facility: Dell Children'S Medical Center Of Central Texas

location_facility: Lucile Packard Children'S Research Hospital/Stanford Univ

location_facility: Childrens Hospital Of Pittsburgh Of Upmc

location_facility: Fondazione Monza e Brianza per il Bambino e la sua Mamma MBBM

location_facility: Nemours / A. I. duPont Hospital for Children

location_facility: Cincinnati Children'S Hospital Medical Center

location_facility: Southern California Permanente Medical Group

location_facility: Indiana University - Riley Children'S Hospital

location_facility: Children'S Hospital & Research Center At Oakland

location_facility: The Montreal Children's Hospital of the MUHC

location_facility: University Of Mississippi Medical Center

location_facility: Washington University School Of Medicine

intervention_type: Biological


status: Completed

lead_sponsor: Astex Pharmaceuticals, Inc.

location_country:
Italy
United States
Sweden
Germany
France
Japan
Poland
Hungary
Belgium
Spain
Denmark
Canada
United Kingdom
Korea, Republic of
Ukraine

location_facility: National Hospital Organization Disaster Medical Center

location_facility: The University of Chicago Medical Center

location_facility: A.S.U Integrata di Udine - Presidio Ospedaliero Santa Maria della Misericordia

location_facility: Medizinischen Fakultät Mannheim der Universität Heidelberg

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Groupe Hospitalier de la Région de Mulhouse et Sud Alsace

location_facility: The Japanese Red Cross Nagasaki Genbaku Hospital

location_facility: Hospital of the University of Pennsylvania

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: East Kent Hospitals University NHS Foundation Trust - Kent and Canterbury Hospital

location_facility: University of New Mexico School of Medicine

location_facility: Hospital Universitario Central de Asturias

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

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

location_facility: Heart of England NHS Foundation Trust - Heartlands Hospital

location_facility: University Hospital, Kyoto Prefectural University of Medicine

location_facility: West Virginia University Hospitals, Inc.

location_facility: Poltava Regional Clinical Hospital named after M. V. Sklifosovskoho

location_facility: CHU Hopitaux de Bordeaux - Hôpital Haut-Lévêque

location_facility: Kobe City Medical Center General Hospital

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: University Hospitals Bristol NHS Foundation Trust - Bristol Haematology and Oncology Centre

title: A Phase 3, Multicenter, Randomized, Open-Label Study of Guadecitabine (SGI-110) Versus Treatment Choice in Adults With Previously Treated Acute Myeloid Leukemia

summary:
Multicenter, randomized, open-label, parallel-group study of guadecitabine vs treatment choice (TC). Subjects will be randomly assigned in a 1:1 ratio to either guadecitabine or TC. TC options include the 8 high or low intensity, locally available regimens below; or Best supportive Care (BSC) alone:

High intensity (intermediate or high dose cytarabine [HiDAC]; mitoxantrone, etoposide, and cytarabine [MEC]; or fludarabine, cytarabine, granulocyte colony stimulating factor [G-CSF], +/- idarubicin [FLAG/FLAG-Ida]).
Low intensity (low dose cytarabine [LDAC], decitabine, or azacitidine).
BSC.

status_simplified: Completed


ReferenceCitation: Singh AK, Carroll K, Perkovic V, Solomon S, Jha V, Johansen KL, Lopes RD, Macdougall IC, Obrador GT, Waikar SS, Wanner C, Wheeler DC, Więcek A, Blackorby A, Cizman B, Cobitz AR, Davies R, Dole J, Kler L, Meadowcroft AM, Zhu X, McMurray JJV; ASCEND-D Study Group. Daprodustat for the Treatment of Anemia in Patients Undergoing Dialysis. N Engl J Med. 2021 Nov 5. doi: 10.1056/NEJMoa2113379. [Epub ahead of print]

name: From Brigham and Women’s Hospital (A.K.S., S.S.), Harvard Medical School (A.K.S., S.S.), Boston University School of Medicine (S.S.W.), and Boston Medical Center (S.S.W.) — all in Boston; KJC Statistics, Cheadle (K.C.), School of Public Health, Imperial College London (V.J.), King’s College Hospital (I.C.M.), and the Department of Renal Medicine, University College London (D.C.W.), London, GlaxoSmithKline, Brentford (L.K. X.Z.), and the British Heart Foundation Cardiovascular Research Centre, University...

family: Singh

full_name: Ajay K. Singh

given: Ajay K.

family: Carroll

full_name: Kevin Carroll

given: Kevin

family: Perkovic

full_name: Vlado Perkovic

given: Vlado

family: Solomon

full_name: Scott Solomon

given: Scott

family: Jha

full_name: Vivekanand Jha

given: Vivekanand

family: Johansen

full_name: Kirsten L. Johansen

given: Kirsten L.

full_name: Renato D. Lopes

given: Renato D.

family: Macdougall

full_name: Iain C. Macdougall

given: Iain C.

family: Obrador

full_name: Gregorio T. Obrador

given: Gregorio T.

family: Waikar

full_name: Sushrut S. Waikar

given: Sushrut S.

family: Wanner

full_name: Christoph Wanner

given: Christoph

family: Wheeler

full_name: David C. Wheeler

given: David C.

family: Więcek

full_name: Andrzej Więcek

given: Andrzej

family: Blackorby

full_name: Allison Blackorby

given: Allison

family: Cizman

full_name: Borut Cizman

given: Borut

family: Cobitz

full_name: Alexander R. Cobitz

given: Alexander R.

family: Davies

full_name: Rich Davies

given: Rich

family: Dole

full_name: Jo Dole

given: Jo

family: Kler

full_name: Lata Kler

given: Lata

family: Meadowcroft

full_name: Amy M. Meadowcroft

given: Amy M.

full_name: Xinyi Zhu

given: Xinyi

family: McMurray

full_name: John J.V. McMurray

given: John J.V.

journal_name: New England Journal of Medicine

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

location_country:
Malaysia
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Taiwan
Ukraine
India
France
Poland
Norway
Argentina
Canada
Korea, Republic of
Turkey
South Africa
Sweden
Netherlands
Bulgaria
Singapore
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
New Zealand
Spain
Estonia

acronym: Anemia Studies in CKD: Erythropoiesis via a Novel PHI Daprodustat-Dialysis (ASCEND-D)

title: A Phase 3 Randomized, Open-label (Sponsor-blind), Active-controlled, Parallel-group, Multi-center, Event Driven Study in Dialysis Subjects With Anemia Associated With Chronic Kidney Disease to Evaluate the Safety and Efficacy of Daprodustat Compared to Recombinant Human Erythropoietin, Following a Switch From Erythropoietin-stimulating Agents

summary: The purpose of this multi-center event-driven study in participants with anemia associated with chronic kidney disease (CKD) to evaluate the safety and efficacy of daprodustat.


title: Randomized Efficacy and Safety Trial With Oral S 44819 After Recent Ischemic Cerebral Event. International, Multi-centre, Randomized, Doubleblind Placebo-controlled Phase II Study. (RESTORE BRAIN Study)

summary: The purpose of this study is to assess the efficacy and safety of S 44819 in enhancing functional recovery after an ischemic stroke.

ReferenceType: background

ReferenceCitation: Chabriat H, Bassetti CL, Marx U, Picarel-Blanchot F, Sors A, Gruget C, Saba B, Wattez M, Audoli ML, Hermann DM. Randomized Efficacy and Safety Trial with Oral S 44819 after Recent ischemic cerebral Event (RESTORE BRAIN study): a placebo controlled phase II study. Trials. 2020 Feb 3;21(1):136. doi: 10.1186/s13063-020-4072-2.

ReferenceType: result

ReferenceCitation: Chabriat H, Bassetti CL, Marx U, Audoli-Inthavong ML, Sors A, Lambert E, Wattez M, Hermann DM; RESTORE BRAIN study investigators. Safety and efficacy of GABA(A) α5 antagonist S44819 in patients with ischaemic stroke: a multicentre, double-blind, randomised, placebo-controlled trial. Lancet Neurol. 2020 Mar;19(3):226-233. doi: 10.1016/S1474-4422(20)30004-1.

family: Chabriat

full_name: Hugues Chabriat

given: Hugues

family: Bassetti

full_name: Claudio L Bassetti

given: Claudio L

family: Marx

full_name: Ute Marx

given: Ute

family: Audoli-Inthavong

full_name: Marie-Laure Audoli-Inthavong

given: Marie-Laure

family: Sors

full_name: Aurore Sors

given: Aurore

family: Lambert

full_name: Estelle Lambert

given: Estelle

family: Wattez

full_name: Marine Wattez

given: Marine

family: Hermann

full_name: Dirk M Hermann

given: Dirk M

family: ALTHAUS

full_name: Katharina ALTHAUS

given: Katharina

family: AMARO

full_name: Sergi AMARO

given: Sergi

family: BAE

full_name: Hee-Joon BAE

given: Hee-Joon

family: BAK

full_name: Zbigniew BAK

given: Zbigniew

family: BARBARINI

full_name: Leonardo BARBARINI

given: Leonardo

family: BASSI

full_name: Pietro BASSI

given: Pietro

family: BAZAN

full_name: Rodrigo BAZAN

given: Rodrigo

family: BERECZKI

full_name: Daniel BERECZKI

given: Daniel

family: BERKOWICZ

full_name: Tomasz BERKOWICZ

given: Tomasz

family: BERROUSCHOT

full_name: Joerg BERROUSCHOT

given: Joerg

family: BLACQUIERE

full_name: Dylan BLACQUIERE

given: Dylan

family: BROLA

full_name: Waldemar BROLA

given: Waldemar

family: BUTCHER

full_name: Kenneth BUTCHER

given: Kenneth

family: CARDONA

full_name: Pere CARDONA

given: Pere

family: CHA

title: Safety and efficacy of GABAA α5 antagonist S44819 in patients with ischaemic stroke: a multicentre, double-blind, randomised, placebo-controlled trial

ipd_sharing_description:
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

They can ask all interventional clinical studies:

submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.

lead_sponsor: Institut de Recherches Internationales Servier

location_country:
Italy
Brazil
Sweden
Netherlands
Germany
France
Czechia
Poland
Hungary
Belgium
Australia
Spain
Canada
United Kingdom
Korea, Republic of

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie Oddzial Neurologii

location_facility: Universitätsklinikum Erlangen Neurologische Klinik

location_facility: Petz Aladar Megyei Oktato Korhaz Neurologiai Osztaly

location_facility: Irmandade Santa Casa de Misericordia de Sao Paulo Ambulatório de Neurologia

location_facility: Royal United Hospital Older People's Unit

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgy Albert Klinikai Kozpont

location_facility: Vivantes Klinikum Neukölln Klinik für Neurologie mit Stroke Unit

location_facility: H. Germans Trias I Pujol Servicio de Neurología

location_facility: Chonnam National University Hospital Department of Neurology

location_facility: Royal Stoke University Hospital Stroke Team Office

location_facility: St George's University Hospitals Stroke Research office

location_facility: CHU-Hôpital de la Milétrie Service de Neurologie

location_facility: H. Virgen del Rocío Servicio de Neurología

location_facility: CHU-Hôpital Gui de Chaulliac Unité de Neuropshysiologie Clinique

location_facility: Royal Melbourne Hospital Department of Neurology

location_facility: Universitätsklinikum Ulm Neurologische Klinik (RKU)

location_facility: CHU Bdx-Hôpital Pellegrin-Tripode Service de Neurologie

location_facility: Canisius Wilhelmina Ziekenhuis Afdeling Neurologie

location_facility: Vseobecna fakultni nemocnice II. interni klinika VFN a 1. LF UK

location_facility: Royal Brisbane & Women's Hospital Department of Neurology

location_facility: Hôpital Lariboisière, Fernand-Vidal Service de Neurologie

location_facility: Hospital das Clinicas da Fac. de Med. de Ribeirao Preto Unidade de Emergencia - Centro de Estudo

location_facility: Universitätsklinik der Eberhard-Karls Universtiät Tübingen Hertie-Institut für Klinische Hirnforschung

location_facility: UNIFESP - Universidade Federal de Sao Paulo Centro de Pesquisa em Neurologia

location_facility: H. General de Albacete Servicio de Neurología

location_facility: Clínica Neurológica e Neurocirúrgica de Joinville

location_facility: H. Universitario de Donosti Servicio de Neurología

location_facility: Hospital Quinta D'or Departamento de Neurologia

location_facility: H. Universitario La Princesa Servicio de Neurología

location_facility: Lyell McEwin Hospital Neurology Department

location_facility: Instytut Psychiatrii i Neurologii II Klinika Neurologiczna

location_facility: Sint Andries Ziekenhuis Dienst Neurologie

location_facility: Kanizsai Dorottya Korhaz Neurologiai Osztaly

location_facility: Soproni Erzsebet Oktato Korhaz Neurologiai Osztaly

location_facility: Hôpital Sud-Francilien Unité Neurovasculaire

location_facility: Policlinico Umberto I Emergency Department Stroke Unit

location_facility: Hospital das Clinicas da Fac. de med. de Ribeirao Preto Unidade de Emergiancia

location_facility: ASAN Medical Center Department of Neurology

location_facility: Dong-A University Medical Center Department of Neurology

location_facility: Klinikum Altenburger Land GmbH Neurologische Klinik

location_facility: Zuyderland Medisch Centrum Afdeling Neurologie

location_facility: Seoul National University Bundang Hospital Department of Orthopaedic

location_facility: H. Clinic de Barcelona Comprehensive Stroke Center

location_facility: Ospedale San Giuseppe UOC di Neurologia e Stroke Unit

location_facility: Szpital Specjalistyczny sw. Lukasza Oddzial Neurologii i Oddzial Udarowy

location_facility: Kyungpook National University Hospital Department of Neurology

location_facility: Fakultni nemocnice u sv. Anny Neurologicka klinika

location_facility: Akademiska Sjukhuset Strokeavdelningen 85B

location_facility: Pecsi Tudomanyegyetem Klinikai Kozpont Neurologiai Klinika

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Klinik und Poliklinik für

location_facility: Ospedale Sacro Cuore Don Calabria Negrar NEUROLOGY DEPT

location_facility: H. Valle de Hebrón Servicio de Neurología

location_facility: Miejskie Centrum Medyczne Jonscher Szpital Dr K. Jonschera

location_facility: Gosford Hospital Neurosciences Department

location_facility: Fakultni nemocnice Brno Neurologicka klinika

location_facility: Royal Adelaide Hospital Department of Neurology

location_facility: Samodzielny Publiczny Szpital Kliniczny nr7 SUM w Katowicach Oddzial Neurologii z Pododdzialem Udarowym

location_facility: Hospital Universitario La Fe Servicio de Neurología

location_facility: Universitaetsklinikum Essen Neurologische Universitätsklinik Essen

location_facility: Leicester Royal Infirmary Dpt of Neurology

location_facility: Wojewodzki Szpital Specjalistyczny SPZOZ nr 3 w Rybniku

location_facility: B-A-Z Megyei Korhaz es Egyetemi Oktato Korhaz Stroke, Er- es Neurologiai, Toxikologiai Osztaly

location_facility: Szpital Specjalistyczny Ducha Swietego w Sandomierzu Oddzial Neurologii

location_facility: Hospital Carlos Fernando Malzone Departamento de Neurologia

location_facility: Samodzielny Publiczny Wojewodzki Szpital Specjalistyczny Oddzial Neurologiczny i Oddzial Udarowy

location_facility: Josa Andras Oktatokorhaz Neurologiai Osztaly

location_facility: Charles LeMoyne Hospital-CISSS de la Monteregie-Centre

location_facility: Istituto Neurologico mediterraneo NEUROMED Dipartimento di Medicina Riabilitativa e Specialistica Repar

location_facility: M. Kopernika Provincial Specialist Hospital Dpt of Neurology

location_facility: University Hospital Department of Neurology

location_facility: Hospital Universitari de Bellvitge Servicio de Neurología-Unidad de Ictus-Planta 9

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital

location_facility: Orszagos Idegsebeszeti Tudomanyos Intezet

location_facility: Hospital Sao Lucas da Pontificia Universidade Catolica RS Setor de Pesquisa Clínica

location_facility: Hassleholms Sjukhus Stroke- och rehabiliteringsavdelningen 9

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz Neurologiai Osztaly

location_facility: IMV Pesquisa Neurológica Setor de Pesquisa Clinica

location_facility: Kreisklinikum Siegen Klinik fuer Neurologie

location_facility: Hospital das Clinicas da Faculdade de Medicina de Botucatu

location_facility: Johannes Wesling Klinik Minden Klinik für Neurologie

location_facility: Bajcsy-Zsilinszky Korhaz es Rendelointezet Neurologiai Osztaly

location_facility: Monash Medical Centre Department of Neurology

location_facility: CHRU-Hôpital Roger Salengro Service de Neurologie

location_facility: Hôpital Sainte-Anne Service de Neurologie


ReferenceCitation: Singh AK, Carroll K, McMurray JJV, Solomon S, Jha V, Johansen KL, Lopes RD, Macdougall IC, Obrador GT, Waikar SS, Wanner C, Wheeler DC, Więcek A, Blackorby A, Cizman B, Cobitz AR, Davies R, DiMino TL, Kler L, Meadowcroft AM, Taft L, Perkovic V; ASCEND-ND Study Group. Daprodustat for the Treatment of Anemia in Patients Not Undergoing Dialysis. N Engl J Med. 2021 Nov 5. doi: 10.1056/NEJMoa2113380. [Epub ahead of print]

name: From Brigham and Women’s Hospital (A.K.S., S.S.), Harvard Medical School (A.K.S., S.S.), and Boston University School of Medicine and Boston Medical Center (S.S.W.) — all in Boston; KJC Statistics, Cheadle (K.C.), the British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow (J.J.V.M.), the School of Public Health, Imperial College London (V.J.), King’s College Hospital (I.C.M.), and the Department of Renal Medicine, University College London (D.C.W.), London, and...

family: Singh

full_name: Ajay K. Singh

given: Ajay K.

family: Carroll

full_name: Kevin Carroll

given: Kevin

family: McMurray

full_name: John J.V. McMurray

given: John J.V.

family: Solomon

full_name: Scott Solomon

given: Scott

family: Jha

full_name: Vivekanand Jha

given: Vivekanand

family: Johansen

full_name: Kirsten L. Johansen

given: Kirsten L.

family: Lopes

full_name: Renato D. Lopes

given: Renato D.

family: Macdougall

full_name: Iain C. Macdougall

given: Iain C.

family: Obrador

full_name: Gregorio T. Obrador

given: Gregorio T.

family: Waikar

full_name: Sushrut S. Waikar

given: Sushrut S.

family: Wanner

full_name: Christoph Wanner

given: Christoph

family: Wheeler

full_name: David C. Wheeler

given: David C.

family: Więcek

full_name: Andrzej Więcek

given: Andrzej

family: Blackorby

full_name: Allison Blackorby

given: Allison

family: Cizman

full_name: Borut Cizman

given: Borut

family: Cobitz

full_name: Alexander R. Cobitz

given: Alexander R.

family: Davies

full_name: Rich Davies

given: Rich

family: DiMino

full_name: Tara L. DiMino

given: Tara L.

family: Kler

full_name: Lata Kler

given: Lata

family: Meadowcroft

full_name: Amy M. Meadowcroft

given: Amy M.

family: Taft

full_name: Lin Taft

given: Lin

family: Perkovic

full_name: Vlado Perkovic

given: Vlado

location_country:
Malaysia
Greece
Romania
Belgium
Australia
Russian Federation
Denmark
Taiwan
Ukraine
India
France
Poland
Thailand
Argentina
Canada
Korea, Republic of
Turkey
Colombia
South Africa
Sweden
Hong Kong
Netherlands
Philippines
Vietnam
Bulgaria
Singapore
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Czechia
Israel
New Zealand
Spain
Estonia

acronym: Anemia Studies in CKD: Erythropoiesis via a Novel PHI Daprodustat-Non Dialysis (ASCEND-ND)

title: A Phase 3 Randomized, Open-label (Sponsor-blind), Active-controlled, Parallel-group, Multi-center, Event Driven Study in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease to Evaluate the Safety and Efficacy of Daprodustat Compared to Darbepoetin Alfa

summary: The purpose of this multi-center event-driven study in non-dialysis (ND) participants with anemia associated with chronic kidney disease (CKD) is to evaluate the safety and efficacy of daprodustat compared to darbepoetin alfa.


location_country:
Greece
Romania
Belgium
Russian Federation
France
Poland
Argentina
Canada
Chile
Switzerland
Netherlands
Hungary
United States
Germany
United Kingdom
Italy
Brazil
Mexico
Czechia
Spain
Turkey

location_facility: Kentucky One Health St. Joseph East Cancer Center

location_facility: Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-Centre-du-Quebec

location_facility: Texas Oncology Cancer Care And Research Center

location_facility: Klinika Nowotworow Pluca i Klatki Piersiowej

location_facility: University Of Arkansas For Medical Sciences

location_facility: Centro Internacional de Estudios Clinicos

location_facility: CISSS du Bas-Saint-Laurent Hopital Regional de Rimouski

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Arizona Oncol Assoc Dba (Hem Onc Physicians&Extenders) Hope

location_facility: Texas Oncology, PA - South Austin Cancer Center

location_facility: Los Angeles Hematology/Oncology Medical Group

location_facility: Gene Upshaw Memorial Tahoe Forest Cancer Center

location_facility: Prof. Dr. Ion Chiricuta Institute Of Oncology Day Care Dep

location_facility: St. Mary's Hospital Regional Cancer Center

location_facility: Charleston Hematology Oncology Associates, Pa

location_facility: Central Coast Medical Oncology Corporation

title: A Phase 3b/4 Safety Trial of Flat Dose Nivolumab In Combination With Ipilimumab in Participants With Non-Small Cell Lung Cancer

summary: A study to evaluate the safety of Nivolumab given in combination with Ipilimumab in patients with advanced cancers. The initial group will enroll patients with newly diagnosed Stage 4 or non-small cell lung cancer that has come back.


title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema Following Large Hemispheric Infarction

acronym: CHARM

summary:
The primary objective of Part 1 of the study is to determine if BIIB093 improves functional outcome at Day 90 as measured by the modified Rankin Scale (mRS) when compared with placebo in participants with Large Hemispheric Infarction (LHI). The secondary objectives of Part 1 of the study are to determine if BIIB093 improves overall survival at Day 90 when compared with placebo, if BIIB093 improves functional outcome at Day 90 on the mRS dichotomized 0-4 vs. 5-6 when compared with placebo, if BIIB093 reduces midline shift at 72 hours (or at time of decompressive craniectomy [DC] or comfort measures only [CMO], if earlier) when compared with placebo, and to evaluate the safety and tolerability of BIIB093 in participants with LHI.

The objectives of Part 2 of the study are to evaluate long-term disability following LHI, to evaluate long-term outcome measures of clinical function, quality of life, and healthcare utilization, and to assess the safety of BIIB093 in subjects with LHI during the follow-up period.

location_country:
Finland
Belgium
Australia
Russian Federation
Denmark
Taiwan
Croatia
France
Japan
Lithuania
Canada
Korea, Republic of
Switzerland
Hungary
China
Portugal
United States
Germany
United Kingdom
Italy
Brazil
Czechia
Israel
Spain

location_facility:
Research SIte
Reserch Site
Reseach Site
Research Site


location_country:
Italy
Brazil
Hong Kong
Germany
France
Czechia
Japan
Israel
Singapore
Hungary
Russian Federation
United States
Canada

acronym: CheckMate 647

location_facility: H. Lee Moffitt Cancer Center & Research Inst, Inc

location_facility: I. interni klinika - klinika hematologie 1. LF UK a VFN v Praze

location_facility: Instituto Do Cancer Mae De Deus / Cor Hospital Mae De Deus

location_facility: Fundacao Pio Xii Hosp Cancer De Barretos

location_facility: Fondazione Policlinico Universitario A. Gemelli

title: A Phase 2, Open-label, Single-arm, Two-cohort Study of Nivolumab in Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) or Relapsed/Refractory Primary Testicular Lymphoma (PTL)

summary: The purpose of this study is to determine whether Nivolumab is effective in the treatment of Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory Primary Testicular Lymphoma (PTL)


lead_sponsor: Janssen Research & Development, LLC

location_country:
United States
Brazil
Sweden
Netherlands
France
Israel
Belgium
Australia
Russian Federation
Spain
Denmark
Canada
United Kingdom
Korea, Republic of
Taiwan

acronym: Galahad

title: A Phase 2 Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies

summary: The purpose of this study is to assess the efficacy, safety, and pharmacokinetics of niraparib in men with metastatic castration-resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies.


title: NonInterventional, Multicenter, Prospective, European Study to Describe the Effectiveness of Trabectedin + PLD in the Treatment of Relapsed Ovarian Cancer (ROC) Patients According to SmPC Regardless of Previous Use of an Antiangiogenic Drug

acronym: NIMES-ROC

summary: Non-interventional, multicenter, prospective, European study to describe the effectiveness of trabectedin + PLD in the treatment of relapsed ovarian cancer (ROC) patients according to SmPC regardless of previous use of an antiangiogenic drug

lead_sponsor: PharmaMar

location_country: Italy France Belgium Spain Germany

location_facility: Klinikum Arnsberg, Karolinen Hospital, Frauenheilkunde

location_facility: Strasbourg Oncologie Libérale Centre de radiothérapie

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: Policlinico Universitario Agostino Gemelli Università Cattolica di Roma

location_facility: Uniklinik Homburg - Klinik Für Frauenheilkunde, Geburtshilfe und Reproduktionsmedizin

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Franziskus-Hospital Harderberg Internistische Onkologie und Hämatologie

location_facility: Policlinico Universitario Monserrato - Presidio Policlinico Duilio Casula

location_facility: Hospital Clínico Universitario Lozano Blesa

location_facility: Centre d'Oncologie et de Radiothérapie du Parc

location_facility: Instirtut für klinische Forschung (IKF) Städtisches Klinikum München GmbH

location_facility: Institut d'Oncologie Hauts-de-Seine Nord


title: A Double-Blind, Randomized, Two Arm Phase 2 Study of Nivolumab in Combination With Ipilimumab Versus Nivolumab in Combination With Ipilimumab Placebo in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

acronym: CheckMate 714

summary: A study in patients with metastatic or recurrent squamous cell cancer of the head and neck to evaluate the effectiveness of Nivolumab plus Ipilumumab vs. Nivolumab alone (CheckMate 714)

location_country:
Finland
Romania
Belgium
Russian Federation
France
Norway
Argentina
Canada
South Africa
Chile
Sweden
Netherlands
Ireland
United States
United Kingdom
Italy
Brazil
Mexico
Czechia
Spain
Turkey

location_facility: CHU de Quebec - Universite Laval - Hopital de l'Enfant Jesus

location_facility: University Health Network - Princess Margaret Cancer Centre

location_facility: Centre Hospitalier De L'Universite De Montreal

location_facility: Istituto Nazionale Tumori Fondazione Pascale

location_facility: Centro de Investigacion Pergamino SA- Clinica Pergamino

intervention_type: Other


title: A Multicenter, Open-label, Randomized, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination With Everolimus or Pembrolizumab Versus Sunitinib Alone in First-Line Treatment of Subjects With Advanced Renal Cell Carcinoma (CLEAR)

acronym: CLEAR

summary: This is a multicenter, randomized, open-label, Phase 3 study to compare the efficacy and safety of lenvatinib in combination with everolimus (Arm A) or pembrolizumab (Arm B) versus sunitinib (Arm C) as first-line treatment in participants with advanced renal cell carcinoma.

ReferenceCitation: Motzer R, Alekseev B, Rha SY, Porta C, Eto M, Powles T, Grünwald V, Hutson TE, Kopyltsov E, Méndez-Vidal MJ, Kozlov V, Alyasova A, Hong SH, Kapoor A, Alonso Gordoa T, Merchan JR, Winquist E, Maroto P, Goh JC, Kim M, Gurney H, Patel V, Peer A, Procopio G, Takagi T, Melichar B, Rolland F, De Giorgi U, Wong S, Bedke J, Schmidinger M, Dutcus CE, Smith AD, Dutta L, Mody K, Perini RF, Xing D, Choueiri TK; CLEAR Trial Investigators. Lenvatinib plus Pembrolizumab or Everolimus for Advanced Renal Cell Carcinoma. N Engl J Med. 2021 Apr 8;384(14):1289-1300. doi: 10.1056/NEJMoa2035716. Epub 2021 Feb 13.

name: From Memorial Sloan Kettering Cancer Center, New York (R.M.); P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.), the State Institution of Health Care Regional Clinical Oncology Dispensary, Omsk (E.K.), the State Budgetary Health Care Institution Novosibirsk Regional Clinical Oncology Dispensary, Novosibirsk (V.K.), and Prevoljskiy Region Medical Center, Novgorod (A.A.) — all in Russia; Yonsei Cancer Center, Yonsei University Health System (S.Y.R.), Seoul St. Mary’s Hospital, Catholic...

family: Motzer

full_name: Robert Motzer

given: Robert

family: Alekseev

full_name: Boris Alekseev

given: Boris

family: Rha

full_name: Sun-Young Rha

given: Sun-Young

family: Porta

full_name: Camillo Porta

given: Camillo

family: Eto

full_name: Masatoshi Eto

given: Masatoshi

family: Powles

full_name: Thomas Powles

given: Thomas

family: Grünwald

full_name: Viktor Grünwald

given: Viktor

family: Hutson

full_name: Thomas E. Hutson

given: Thomas E.

family: Kopyltsov

full_name: Evgeny Kopyltsov

given: Evgeny

family: Méndez-Vidal

full_name: María J. Méndez-Vidal

given: María J.

family: Kozlov

full_name: Vadim Kozlov

given: Vadim

family: Alyasova

full_name: Anna Alyasova

given: Anna

family: Hong

full_name: Sung-Hoo Hong

given: Sung-Hoo

family: Kapoor

full_name: Anil Kapoor

given: Anil

family: Alonso Gordoa

full_name: Teresa Alonso Gordoa

given: Teresa

family: Merchan

full_name: Jaime R. Merchan

given: Jaime R.

family: Winquist

full_name: Eric Winquist

given: Eric

family: Maroto

full_name: Pablo Maroto

given: Pablo

family: Goh

full_name: Jeffrey C. Goh

given: Jeffrey C.

family: Kim

full_name: Miso Kim

given: Miso

family: Gurney

full_name: Howard Gurney

given: Howard

family: Patel

full_name: Vijay Patel

given: Vijay

family: Peer

ReferenceCitation: Hofmann F, Hwang EC, Lam TB, Bex A, Yuan Y, Marconi LS, Ljungberg B. Targeted therapy for metastatic renal cell carcinoma. Cochrane Database Syst Rev. 2020 Oct 14;10:CD012796. doi: 10.1002/14651858.CD012796.pub2.

name: Department of Urology; Sunderby Sjukhus, Umeå University; Luleå Sweden

name: Department of Urology; Chonnam National University Medical School, Chonnam National University Hwasun Hospital; Hwasun Korea, South

name: Academic Urology Unit; University of Aberdeen; Aberdeen UK

name: Department of Urology and UCL Division of Surgery and Interventional Science; Royal Free London NHS Foundation Trust; London UK

name: Department of Medicine, Division of Gastroenterology; McMaster University; Hamilton Canada

name: Department of Urology and Renal Transplantation; Centro Hospitalar e Universitario de Coimbra; Coimbra Portugal

name: Department of Surgical and Perioperative Sciences; Umeå University; Umeå Sweden

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

repository_institution: Aberdeen University - Aberdeen University Research Archive

location_country:
Italy
Austria
United States
Switzerland
Netherlands
Germany
France
Czechia
Greece
Israel
Japan
Poland
Ireland
Australia
Belgium
Russian Federation
Spain
Canada
United Kingdom
Korea, Republic of

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Hospital Universitario Clinico San Carlos

location_facility: Institut Regional du Cancer de Montpellier

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

location_facility: Azienda Ospedaliera Santa Maria Degli Angeli

location_facility: Krankenhaus der barmherzigen Schwestern Linz

location_facility: Azienda Ospedaliera Universitaria Policlinico SantOrsola Malpighi

location_facility: Centre de santé et de services sociaux Champlain-Charles-Le Moyne

location_facility: Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli

location_facility: Mission Hospital_ Cancer Care of Western North Carolina

location_facility: Adelaide and Meath Hospital Incorp The National Children's Hospital

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: FSBSI Russian Oncological Scientific Center n.a. N.N. Blokhin - Department of Oncology

location_facility: FBHI Privolzhskiy District Medical Centre FMBA of Russia

location_facility: Sunnybrook Research Institute - University of Toronto

location_facility: Severance Hospital, Yonsei University Health System

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

location_facility: FSBSI Russian Oncological Scientific Center n.a. N.N. Blokhin - Department of Urology

location_facility: Weill Cornell Medical College New York Presbyterian Hospital

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Asan Medical Center: Medical Oncology Department

location_facility: Hospital Universitario Central de Asturias

location_facility: Istituto Nazionale per la Ricerca sul Cancro di Genova

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC

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

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

location_facility: GZA Ziekenhuizen - Campus Sint-Augustinus

location_facility: SBHI of Novosibirsk region "Novosibirsk Regional Oncological Dispensary"

location_facility: FSBI "Moscow scientific research oncology institute n.a. P.A. Gertsen" of MoH of RF

location_facility: FSBI "National Medical Research Radiological Center" of the MoH of the RF

location_facility: BHI of Omsk region "Clinical Oncology Dispensary"

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Hospital Universitario HM Madrid Sanchinarro

location_facility: Florida Cancer Specialists ( North Region)

location_facility: SPWSZ w Szczecinie im. Marii Sklodowskiej-Curie

location_facility: ICO l'Hospitalet - Hospital Duran I Reynals

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Fakultni nemocnice Olomouc, Neurologicka klinika

location_facility: Department of Internal Medicine Division of Hematology/Oncology Cancer center 11F


lead_sponsor: Boehringer Ingelheim

location_country:
Italy
Austria
Germany
Finland
France
Japan
Greece
Poland
Norway
Hungary
Spain
United States
United Kingdom
Canada

location_facility: Non-Public Outpatient Clinic Neuro-Kard Ilkowski & Partners

location_facility: Private Practice for Psychiatry and Neurology

location_facility: ANI Neurology, PLLC, dba Alzheimer's Memory Center

location_facility: True North Clinical Research Halifax, Inc.

location_facility: University General Hospital of Thessaloniki AHEPA

location_facility: National Hospital Organization Hizen Psychiatric Center

location_facility: St. Olavs Hospital, Universitetssykehuset i Trondheim

location_facility: Zentrum für klinische Forschung Dr. med. Irma Schöll & Kollegen

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: University of Eastern Finland, Brain Research Unit

location_facility: National Center Neurology and Psychiatry

location_facility: Hospital Universitari General de Catalunya

location_facility: Northeastern Pennsylvania Memory and Alzheimer Center

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: CHU La Grave-Casselardit - Cité de la Santé

location_facility: Podlassian Center of Psychogeriatry, Bialystok

location_facility: Clin.Research Centre Clinsante SC Ewa Galczak-Nowak,Torun

location_facility: True North Clinical Research Kentville, Inc.

location_facility: Oslo Universitetssykehus HF, Hukommelsesklinikken

location_facility: Non-Public Outpat. Clinic "Dom Sue Ryder", PALLMED Sp. z o.o

location_facility: Azienda Ospedaliera Universitaria di Padova

title: A Multi-centre, Double-blind, Parallel-group, Randomised Controlled Study to Investigate Efficacy and Safety of Orally Administered BI 425809 During a 12-week Treatment Period Compared to Placebo in Patients With Cognitive Impairment Due to Alzheimer's Disease.

summary: The study is designed to compare the effects of BI 425809 compared to placebo in patients with cognitive impairment due to Alzheimer's Disease.


ReferenceCitation: Long GV, Dummer R, Hamid O, Gajewski TF, Caglevic C, Dalle S, Arance A, Carlino MS, Grob JJ, Kim TM, Demidov L, Robert C, Larkin J, Anderson JR, Maleski J, Jones M, Diede SJ, Mitchell TC. Epacadostat plus pembrolizumab versus placebo plus pembrolizumab in patients with unresectable or metastatic melanoma (ECHO-301/KEYNOTE-252): a phase 3, randomised, double-blind study. Lancet Oncol. 2019 Aug;20(8):1083-1097. doi: 10.1016/S1470-2045(19)30274-8. Epub 2019 Jun 17.

family: Long

full_name: Georgina V Long

given: Georgina V

family: Dummer

full_name: Reinhard Dummer

given: Reinhard

family: Hamid

full_name: Omid Hamid

given: Omid

family: Gajewski

full_name: Thomas F Gajewski

given: Thomas F

family: Caglevic

full_name: Christian Caglevic

given: Christian

family: Dalle

full_name: Stephane Dalle

given: Stephane

family: Arance

full_name: Ana Arance

given: Ana

family: Carlino

full_name: Matteo S Carlino

given: Matteo S

family: Grob

full_name: Jean-Jacques Grob

given: Jean-Jacques

full_name: Tae Min Kim

given: Tae Min

family: Demidov

full_name: Lev Demidov

given: Lev

family: Robert

full_name: Caroline Robert

given: Caroline

family: Larkin

full_name: James Larkin

given: James

family: Anderson

full_name: James R Anderson

given: James R

family: Maleski

full_name: Janet Maleski

given: Janet

family: Jones

full_name: Mark Jones

given: Mark

family: Diede

full_name: Scott J Diede

given: Scott J

family: Mitchell

full_name: Tara C Mitchell

given: Tara C

journal_name: The Lancet Oncology

lead_sponsor: Incyte Corporation

location_country:
Belgium
Australia
Russian Federation
Denmark
France
Japan
Poland
Canada
Korea, Republic of
South Africa
Chile
Sweden
Switzerland
Netherlands
Ireland
United States
Germany
United Kingdom
Italy
Mexico
Israel
New Zealand
Spain

acronym: Phase 3 Study of Epacadostat and Pembrolizumab in Melanoma

title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Pembrolizumab (MK-3475) in Combination With Epacadostat or Placebo in Subjects With Unresectable or Metastatic Melanoma (Keynote-252 / ECHO-301)

summary: The purpose of the study is to assess the efficacy, safety, and tolerability when combining pembrolizumab with epacadostat or placebo in participants with unresectable or metastatic melanoma


ReferenceCitation: Kelly RJ, Ajani JA, Kuzdzal J, Zander T, Van Cutsem E, Piessen G, Mendez G, Feliciano J, Motoyama S, Lièvre A, Uronis H, Elimova E, Grootscholten C, Geboes K, Zafar S, Snow S, Ko AH, Feeney K, Schenker M, Kocon P, Zhang J, Zhu L, Lei M, Singh P, Kondo K, Cleary JM, Moehler M; CheckMate 577 Investigators. Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer. N Engl J Med. 2021 Apr 1;384(13):1191-1203. doi: 10.1056/NEJMoa2032125.

name: From the Charles A. Sammons Cancer Center at Baylor University Medical Center, Dallas (R.J.K.), and the University of Texas M.D. Anderson Cancer Center, Houston (J.A.A.); Jagiellonian University Medical College, John Paul II Hospital, Krakow, Poland (J.K., P.K.); the University Hospital Cologne, Department of Internal Medicine, Center for Integrated Oncology Aachen–Bonn–Cologne–Duesseldorf, Gastrointestinal Cancer Group Cologne, Cologne (T.Z.), and University Medical Center of Johannes...

family: Kelly

full_name: Ronan J. Kelly

given: Ronan J.

family: Ajani

full_name: Jaffer A. Ajani

given: Jaffer A.

family: Kuzdzal

full_name: Jaroslaw Kuzdzal

given: Jaroslaw

family: Zander

full_name: Thomas Zander

given: Thomas

family: Van Cutsem

full_name: Eric Van Cutsem

given: Eric

family: Piessen

full_name: Guillaume Piessen

given: Guillaume

family: Mendez

full_name: Guillermo Mendez

given: Guillermo

family: Feliciano

full_name: Josephine Feliciano

given: Josephine

family: Motoyama

full_name: Satoru Motoyama

given: Satoru

family: Lièvre

full_name: Astrid Lièvre

given: Astrid

family: Uronis

full_name: Hope Uronis

given: Hope

family: Elimova

full_name: Elena Elimova

given: Elena

family: Grootscholten

full_name: Cecile Grootscholten

given: Cecile

family: Geboes

full_name: Karen Geboes

given: Karen

family: Zafar

full_name: Syed Zafar

given: Syed

family: Snow

full_name: Stephanie Snow

given: Stephanie

family: Ko

full_name: Andrew H. Ko

given: Andrew H.

family: Feeney

full_name: Kynan Feeney

given: Kynan

family: Schenker

full_name: Michael Schenker

given: Michael

family: Kocon

full_name: Piotr Kocon

given: Piotr

family: Zhang

full_name: Jenny Zhang

given: Jenny

family: Zhu

full_name: Lili Zhu

given: Lili

family: Lei

full_name: Ming Lei

given: Ming

family: Singh

full_name: Prianka Singh

given: Prianka

family: Kondo

full_name: Kaoru Kondo

given: Kaoru

location_country:
Peru
Romania
Belgium
Australia
Russian Federation
Denmark
Taiwan
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Hong Kong
Netherlands
Switzerland
Singapore
Hungary
Ireland
Puerto Rico
China
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Czechia
Israel
Spain
Turkey

location_facility: N.N. Blokhin National Medical Research Center of Oncology

location_facility: Hospital De Base De Sao Jose Do Rio Preto

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi Onkoloji

location_facility: Centro de Estudios y Prevencion Del Cancer, AC

location_facility: Fondazione Policlinico Universitario A. Gemelli

location_facility: Fundeni Clinical Institute Gastroenterology; Hepatology Clin

location_facility: Centro de Pesquisas Oncologicas de Santa Catarina-CEPON

location_facility: Oddzial Kliniczny Chirurgii Klatki Piersiowej

location_facility: The University Of Texas MD Anderson Cancer Center

location_facility: Centro Para La Atencion Integral Del Paciente Oncologico

location_facility: University Of Miami Sylvester Comprehensive Cancer Center

location_facility: British Columbia Cancer Agency-Vancouver Ctr

location_facility: Mass General/North Shore Cancer Center for Outpatient Care

location_facility: Instituto Nacional De Enfermedades Neoplasicas

location_facility: Hospital Nacional Daniel Alcides Carrion

location_facility: Nova Scotia Health Authority QEII Health Sciences Centre

location_facility: Saint-Petersburg Medical University Named After I.P.Pavlov

location_facility: Washington University School of Medicine

location_facility: Liga Paranaense De Combate Ao Cancer Erasto Gaertner

location_facility: PERSONAL Oncologia de Precisao e Personalizada

location_facility: Florida Cancer Specialists - NORTH - SCRI - PPDS

location_facility: Arcispedale S. Maria Nuova - A.O. Reggio Emilia

location_facility: Hospital Municipal De Gastroenterologia Dr.Udaondo

location_facility: Fundacao Pio Xii Hosp Cancer De Barretos

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: Albert Einstein Cancer Center At The Montefiore Medical Park

location_facility: Oddzial Onkologii Klinicznej i Doswiadczalnej

location_facility: Univ. Of Southern Calif. /Norris Comprehensive Cancer Center

location_facility: II Klinika Chirurgii Ogolnej, Gastroenterologicznej i Nowotworow Ukladu Pokarmowego

location_facility: Instituto Medico Especialazado Alexander Fleming

location_facility: Instituto Nacional De Ciencias Medicas Y Nutricion S.Z.

title: A Randomized, Multicenter, Double Blind, Phase III Study of Adjuvant Nivolumab or Placebo in Subjects With Resected Esophageal, or Gastroesophageal Junction Cancer

summary: The primary purpose of this study is to determine whether Nivolumab will improve disease-free survival compared with placebo.


title: Randomized, Double-Blind, Phase 2 Study of Ramucirumab or Merestinib or Placebo Plus Cisplatin and Gemcitabine as First-Line Treatment in Patients With Advanced or Metastatic Biliary Tract Cancer

summary: The main purpose of this study is to evaluate the efficacy and safety of ramucirumab or merestinib or placebo plus cisplatin and gemcitabine in participants with advanced or metastatic biliary tract cancer.

ReferenceCitation: Valle JW, Vogel A, Denlinger CS, He AR, Bai LY, Orlova R, Van Cutsem E, Adeva J, Chen LT, Obermannova R, Ettrich TJ, Chen JS, Wasan H, Girvan AC, Zhang W, Liu J, Tang C, Ebert PJ, Aggarwal A, McNeely SC, Moser BA, Oliveira JM, Carlesi R, Walgren RA, Oh DY. Addition of ramucirumab or merestinib to standard first-line chemotherapy for locally advanced or metastatic biliary tract cancer: a randomised, double-blind, multicentre, phase 2 study. Lancet Oncol. 2021 Oct;22(10):1468-1482. doi: 10.1016/S1470-2045(21)00409-5. Erratum in: Lancet Oncol. 2021 Nov;22(11):e472.

family: Valle

full_name: Juan W Valle

given: Juan W

family: Vogel

full_name: Arndt Vogel

given: Arndt

family: Denlinger

full_name: Crystal S Denlinger

given: Crystal S

family: He

full_name: Aiwu Ruth He

given: Aiwu Ruth

family: Bai

full_name: Li-Yuan Bai

given: Li-Yuan

family: Orlova

full_name: Rashida Orlova

given: Rashida

family: Van Cutsem

full_name: Eric Van Cutsem

given: Eric

family: Adeva

full_name: Jorge Adeva

given: Jorge

family: Chen

full_name: Li-Tzong Chen

given: Li-Tzong

family: Obermannova

full_name: Radka Obermannova

given: Radka

family: Ettrich

full_name: Thomas J Ettrich

given: Thomas J

full_name: Jen-Shi Chen

given: Jen-Shi

family: Wasan

full_name: Harpreet Wasan

given: Harpreet

family: Girvan

full_name: Allicia C Girvan

given: Allicia C

full_name: Wei Zhang

given: Wei

family: Liu

full_name: Jiangang Liu

given: Jiangang

family: Tang

full_name: Chunlao Tang

given: Chunlao

family: Ebert

full_name: Philip J Ebert

given: Philip J

family: Aggarwal

full_name: Amit Aggarwal

given: Amit

family: McNeely

full_name: Samuel C McNeely

given: Samuel C

family: Moser

full_name: Brian A Moser

given: Brian A

family: Oliveira

full_name: Joana M Oliveira

given: Joana M

family: Carlesi

full_name: Roberto Carlesi

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:
Austria
Sweden
Mexico
Spain
Germany
France
Czechia
Japan
Hungary
Argentina
Australia
Belgium
Russian Federation
Turkey
Denmark
United States
United Kingdom
Korea, Republic of
Taiwan

location_facility: Arkhangelsk Regional Clinical Oncology Dispensary

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Central Roentgenoradiological Research Institute MZ RF

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: University of Southern Florida School of Medicine


location_country: Austria Finland France Denmark Slovenia

acronym:
Fixed dose combination versus free combination of tiotropium and olodaterol in COPD

 Comparaison de l’association fixe du tiotropium et de l’olodatérol versus association libre en BPCO

location_facility: Univ. Clinic of Respiratory and Allergic Diseases, Golnik

location_facility: Verboten Kopriva Renata - Private practice, Litija

location_facility: Ordination Dr. Robert Voves, 8330 Feldbach

title: A 4-week, Randomised, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Tiotropium + Olodaterol Fixed Dose Combination (5/5 µg) Delivered by the Respimat® Inhaler Versus the Free Combination of Tiotropium 5 µg and Olodaterol 5 µg Delivered by Separate Respimat® Inhalers in Patients With Chronic Obstructive Pulmonary Disease (COPD)

summary:
This is a 4-week, multicenter, randomized, double-blind, parallel group and active controlled study.

Patients will be randomized (1 to 1 ratio) to a 4-week double-blind treatment period of either FDC (fixed-dose combination) of tiotropium + olodaterol (5/5 µg) plus placebo or the free combination of tiotropium 5 µg and olodaterol 5 µg; all administered via the Respimat® inhaler. The purpose is to show non-inferiority between the FDC and the free combination of tiotropium and olodaterol in patients with COPD.


title: A Phase 1b/2 Open-label, Randomized Study of 2 Combinations of Isocitrate Dehydrogenase (IDH) Mutant Targeted Therapies Plus Azacitidine: Oral AG-120 Plus Subcutaneous Azacitidine and Oral AG-221 Plus SC Azacitidine in Subjects With Newly Diagnosed Acute Myeloid Leukemia Harboring an IDH1 or an IDH2 Mutation, Respectively, Who Are Not Candidates to Receive Intensive Induction Chemotherapy

summary: This Phase 1b/2 study is an open-label, randomized, multicenter trial to evaluate the safety and efficacy of oral AG-120 + Subcutaneous (SC) azacitidine and oral AG-221 + SC azacitidine in subjects with newly diagnosed AML with an IDH1 or an IDH2 mutation, respectively. The study population consists of subjects who are not candidates to receive intensive Inductive chemotherapy (IC). The study comprises a Phase 1b dose-finding and AG-120 expansion stage and a Phase 2 randomized stage.

status: Unknown status

ReferenceCitation: DiNardo CD, Schuh AC, Stein EM, Montesinos P, Wei AH, de Botton S, Zeidan AM, Fathi AT, Kantarjian HM, Bennett JM, Frattini MG, Martin-Regueira P, Lersch F, Gong J, Hasan M, Vyas P, Döhner H. Enasidenib plus azacitidine versus azacitidine alone in patients with newly diagnosed, mutant-IDH2 acute myeloid leukaemia (AG221-AML-005): a single-arm, phase 1b and randomised, phase 2 trial. Lancet Oncol. 2021 Nov;22(11):1597-1608. doi: 10.1016/S1470-2045(21)00494-0. Epub 2021 Oct 18.

family: DiNardo

full_name: Courtney D DiNardo

given: Courtney D

family: Schuh

full_name: Andre C Schuh

given: Andre C

family: Stein

full_name: Eytan M Stein

given: Eytan M

family: Montesinos

full_name: Pau Montesinos

given: Pau

family: Wei

full_name: Andrew H Wei

given: Andrew H

family: de Botton

full_name: Stéphane de Botton

given: Stéphane

family: Zeidan

full_name: Amer M Zeidan

given: Amer M

family: Fathi

full_name: Amir T Fathi

given: Amir T

family: Kantarjian

full_name: Hagop M Kantarjian

given: Hagop M

family: Bennett

full_name: John M Bennett

given: John M

family: Frattini

full_name: Mark G Frattini

given: Mark G

family: Martin-Regueira

full_name: Patricia Martin-Regueira

given: Patricia

family: Lersch

full_name: Frederik Lersch

given: Frederik

family: Gong

full_name: Jing Gong

given: Jing

family: Hasan

full_name: Maroof Hasan

given: Maroof

family: Vyas

full_name: Paresh Vyas

given: Paresh

family: Döhner

full_name: Hartmut Döhner

given: Hartmut

ReferenceCitation: DiNardo CD, Stein AS, Stein EM, Fathi AT, Frankfurt O, Schuh AC, Döhner H, Martinelli G, Patel PA, Raffoux E, Tan P, Zeidan AM, de Botton S, Kantarjian HM, Stone RM, Frattini MG, Lersch F, Gong J, Gianolio DA, Zhang V, Franovic A, Fan B, Goldwasser M, Daigle S, Choe S, Wu B, Winkler T, Vyas P. Mutant Isocitrate Dehydrogenase 1 Inhibitor Ivosidenib in Combination With Azacitidine for Newly Diagnosed Acute Myeloid Leukemia. J Clin Oncol. 2021 Jan 1;39(1):57-65. doi: 10.1200/JCO.20.01632. Epub 2020 Oct 29. Erratum in: J Clin Oncol. 2021 Feb 1;39(4):341.

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

full_name: Courtney D. DiNardo

given: Courtney D.

full_name: Anthony S. Stein

given: Anthony S.

name: Memorial Sloan Kettering Cancer Center, New York, NY

full_name: Eytan M. Stein

given: Eytan M.

name: Massachusetts General Hospital Cancer Center, Boston, MA

full_name: Amir T. Fathi

name: Princess Margaret Cancer Centre, Toronto, Ontario, Canada

name: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy

name: University of Texas Southwestern Medical Center, Dallas, TX

name: Royal Perth Hospital, Perth, Western Australia, Australia

name: Institut Gustave Roussy, Villejuif, France

name: Dana-Farber Cancer Institute, Boston, MA

name: Celgene International, Boudry, Switzerland

name: University of Oxford, Oxford, United Kingdom

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

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

location_facility: Zentrum Innere Medizin Klinik fur Hamatologie

location_facility: Institut Universitaire du Cancer Oncopole

location_facility: Centre Hospitalier Universitaire Vaudois CHUV BH-04

location_facility: Medizinische Klinik III Klinikum der Universität München-Großhadern

location_facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord AORMN

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

location_facility: Instituto Portugues de Oncologia do Porto

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: Centre Hospitalier Universitaire de Nantes

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

location_facility: Barts Cancer Institute, Queen Mary University of London, Charterhouse Square

location_facility: Azienda Ospedaliera Universitaria S. Martino di Genova

location_facility: UT Southwestern Medical Center at Dallas

location_facility: Instituto Portugues de Oncologia de Lisboa

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Queen Elizabeth Hospital UHB NHS Foundation Trust

location_facility: Azienda Ospedaliera S. Andrea - Università La Sapienza

location_facility: Princess Margaret Hospital, Medical Oncology

location_facility: The Catholic University of Korea Seoul - Saint Mary's Hospital

location_facility: Centro Hospitalar de Lisboa Central - Hospital de Santo António dos Capuchos


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

summary: This study aims to assess efficacy of Niraparib (GSK3985771) as maintenance treatment in participants with Stage III or IV ovarian cancer. Participants must have completed front-line platinum based regimen with complete (CR) or partial response (PR). Data collection for Secondary Outcome measures is ongoing and the approximate duration of the study will be 7 years.

ReferenceCitation: González-Martín A, Pothuri B, Vergote I, DePont Christensen R, Graybill W, Mirza MR, McCormick C, Lorusso D, Hoskins P, Freyer G, Baumann K, Jardon K, Redondo A, Moore RG, Vulsteke C, O'Cearbhaill RE, Lund B, Backes F, Barretina-Ginesta P, Haggerty AF, Rubio-Pérez MJ, Shahin MS, Mangili G, Bradley WH, Bruchim I, Sun K, Malinowska IA, Li Y, Gupta D, Monk BJ; PRIMA/ENGOT-OV26/GOG-3012 Investigators. Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer. N Engl J Med. 2019 Dec 19;381(25):2391-2402. doi: 10.1056/NEJMoa1910962. Epub 2019 Sep 28.

lead_sponsor: Tesaro, Inc.

location_country:
Italy
United States
Sweden
Switzerland
Germany
Finland
France
Czechia
Poland
Israel
Norway
Hungary
Belgium
Ireland
Russian Federation
Spain
Denmark
Canada
United Kingdom
Ukraine