type: Registry Identifier

title: A Phase-2 Study To Determine Efficacy and Safety of Luspatercept in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis and Anemia With or Without Red Blood Cell-Transfusion Dependence

summary: This is a Phase 2, multicenter, open-label study to evaluate the efficacy and safety of luspatercept in subjects with MPN-associated myelofibrosis and anemia with and without RBC-transfusion dependence. The study is divided into a Screening Period, a Treatment Period (consisting of a Primary Phase, a Day 169 Disease Response Assessment, and an Extension Phase), followed by a Posttreatment Follow-up Period.

status: Completed

lead_sponsor: Celgene

location_country:
United States
Italy
United Kingdom
France

location_facility: MD Anderson Cancer Center The University of Texas

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

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Mid Florida Hematology and Oncology Centers, PA

status_simplified: Completed


study_start_date_type: Actual

intervention_type: Drug

acronym: First-line Esophageal Carcinoma Study with Chemo vs. Chemo + Pembrolizumab

lead_sponsor: Merck Sharp & Dohme LLC

summary:
The purpose of this trial is to evaluate efficacy and safety of pembrolizumab plus standard of care (SOC) chemotherapy with cisplatin and 5-fluorouracil (5-FU) versus placebo plus SOC chemotherapy with cisplatin and 5-FU as first-line treatment in participants with locally advanced or metastatic esophageal carcinoma.

The overall primary efficacy hypotheses are as follows:

In participants with esophageal squamous cell carcinoma (ESCC), participants whose tumors are programmed cell death-ligand 1 (PD-L1)-positive (defined as combined positive score [CPS] ≥10), ESCC participants whose tumors are PD-L1 positive (CPS ≥10), and in all participants, overall survival (OS) is superior with pembrolizumab plus SOC chemotherapy compared with placebo plus SOC chemotherapy.
In participants with ESCC, participants whose tumors are PD-L1 positive (CPS ≥10), and in all participants, progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by investigator is superior with pembrolizumab plus SOC chemotherapy compared with placebo plus SOC chemotherapy.

ReferenceType: derived

ReferenceCitation: Kojima T, Hara H, Tsuji A, Yasui H, Muro K, Satoh T, Ogata T, Ishihara R, Goto M, Baba H, Nishina T, Han S, Sakata T, Yatsuzuka N, Doi T, Kato K. First-line pembrolizumab + chemotherapy in Japanese patients with advanced/metastatic esophageal cancer from KEYNOTE-590. Esophagus. 2022 Oct;19(4):683-692. doi: 10.1007/s10388-022-00920-x. Epub 2022 Jun 7.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Springer-Nature

ReferenceCitation: Zhu Y, Liu K, Ding D, Zhou Y, Peng L. Pembrolizumab Plus Chemotherapy as First-Line Treatment for Advanced Esophageal Cancer: A Cost-Effectiveness Analysis. Adv Ther. 2022 Jun;39(6):2614-2629. doi: 10.1007/s12325-022-02101-9. Epub 2022 Apr 8.

oa_host_type: closed

repositories_concat: closed

ReferenceCitation: Sun JM, Shen L, Shah MA, Enzinger P, Adenis A, Doi T, Kojima T, Metges JP, Li Z, Kim SB, Cho BC, Mansoor W, Li SH, Sunpaweravong P, Maqueda MA, Goekkurt E, Hara H, Antunes L, Fountzilas C, Tsuji A, Oliden VC, Liu Q, Shah S, Bhagia P, Kato K; KEYNOTE-590 Investigators. Pembrolizumab plus chemotherapy versus chemotherapy alone for first-line treatment of advanced oesophageal cancer (KEYNOTE-590): a randomised, placebo-controlled, phase 3 study. Lancet. 2021 Aug 28;398(10302):759-771. doi: 10.1016/S0140-6736(21)01234-4. Erratum In: Lancet. 2021 Nov 20;398(10314):1874.

publisher_dissemination: Elsevier

ReferenceCitation: Kato K, Shah MA, Enzinger P, Bennouna J, Shen L, Adenis A, Sun JM, Cho BC, Ozguroglu M, Kojima T, Kostorov V, Hierro C, Zhu Y, McLean LA, Shah S, Doi T. KEYNOTE-590: Phase III study of first-line chemotherapy with or without pembrolizumab for advanced esophageal cancer. Future Oncol. 2019 Apr;15(10):1057-1066. doi: 10.2217/fon-2018-0609. Epub 2019 Feb 8.

oa_host_type: publisher

evidence: open (via free pdf)

unpaywall_oa_status: bronze

publisher_dissemination: Future Science Ltd

location_facility: National Hospital Organization Shikoku Cancer Center ( Site 0901)

location_facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto. ( Site 0203)

location_facility: Hospital Alemao Oswaldo Cruz ( Site 0207)

location_facility: The First Affiliated Hospital of Xiamen University ( Site 0119)

location_facility: Centro de Investigaciones Clinicas - Clinica Viedma ( Site 0603)

location_facility: Weill Cornell Medical College ( Site 0024)

location_facility: Hospital Privado Centro Medico Cordoba ( Site 0601)

location_facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0801)

location_facility: Institut du Cancer de Montpellier ( Site 0306)

location_facility: National Cancer Center Hospital East ( Site 0908)

location_facility: Cancer Care Langenhoven Drive Oncology Centre ( Site 2501)

location_facility: Hospital Sao Vicente de Paulo ( Site 0204)

location_facility: Kansai Medical University Hospital ( Site 0931)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 0906)

location_facility: Kaiser Permanente Southern California ( Site 0003)

location_facility: UPMC Cancer Center/Hillman Cancer Center ( Site 0015)

location_facility: Peking Union Medical College Hospital ( Site 0123)

location_facility: Hospital Universitario Reina Sofia ( Site 0706)

location_facility: Taipei Medical University Shuang Ho Hospital ( Site 1908)

location_facility: CIMCA Centro de Investigacion y Manejo del Cancer ( Site 2600)

location_facility: PLA Cancer Centre of Nanjing Bayi Hospital ( Site 0110)

location_facility: Bumrungrad International Hospital ( Site 2203)

location_facility: The Cancer Institute Hospital of JFCR ( Site 0904)

location_facility: CISSS de la Monteregie-Centre ( Site 0504)

location_facility: Osaka Medical College Hospital ( Site 0925)

location_facility: Instituto Nacional de Enfermedades Neoplasicas ( Site 1705)

location_facility: Washington University School of Medicine ( Site 0031)

location_facility: Aichi Cancer Center Hospital ( Site 0902)

location_facility: Instituto do Cancer de Sao Paulo - ICESP ( Site 0206)

location_facility: Zhongda Hospital Southeast University ( Site 0125)

location_facility: Chonnam National University Hwasun Hospital ( Site 1305)

location_facility: Roswell Park Cancer Institute ( Site 0004)

location_facility: Inst de Medicina Integral Professor Fernando Figueira- IMIP ( Site 0210)

location_facility: CHU Brest - Institut de Cancerologie et d Hematologie ( Site 0305)

location_facility: Pamela Youde Nethersole Eastern Hospital ( Site 1601)

location_facility: Spitalul Clinic Judetean De Urgenta Constanta ( Site 2402)

location_facility: Chang Gung Med Foundation. Kaohsiung Branch ( Site 1906)

location_facility: Chi Mei Medical Center Liuying ( Site 1907)

location_facility: Hospital Universitario Central de Asturias ( Site 0708)

location_facility: III. Medizinische Klinik Klinikum rechts der Isar ( Site 1506)

location_facility: Universitatsklinikum Mannheim GmbH ( Site 1504)

location_facility: The Ottawa Hospital - Cancer Care ( Site 0501)

location_facility: St Petersburg City Clinical Oncology Dispensary ( Site 0409)

location_facility: Sanatorio Allende - Cordoba ( Site 0604)

location_facility: National Cancer Center Hospital ( Site 0907)

location_facility: University Malaya Medical Centre ( Site 1802)

location_facility: Hosp. Gral. Universitari Germans Trias i Pujol ( Site 0701)

location_facility: Hospital Nacional Guillermo Almenara Irigoyen ( Site 1701)

location_facility: Osaka General Medical Center ( Site 0912)

location_facility: Seoul National University Cancer Hospital ( Site 1301)

location_facility: The Medical Oncology Centre of Rosebank ( Site 2506)

location_facility: Institut Mutualiste Montsouris ( Site 0300)

location_facility: Osaka International Cancer Institute ( Site 0923)

location_facility: Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0114)

location_facility: CHU de Saint Etienne Hopital Nord ( Site 0309)

location_facility: Pontificia Universidad Catolica de Chile ( Site 1001)

location_facility: The Affiliated Tumour Hospital of Harbin Medical University ( Site 0102)

location_facility: Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0209)

location_facility: China Medical University Hospital ( Site 1904)

location_facility: S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2404)

location_facility: Tomsk Scientific Research Institute of Oncology ( Site 0403)

location_facility: ICIMED - Instituto de Investigacion en Ciencias Medicas ( Site 2601)

location_facility: University of Tennessee Medical Center Knoxville ( Site 0017)

location_facility: National Taiwan University Hospital ( Site 1900)

location_facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0201)

location_facility: Hospital Universitario La Paz ( Site 0700)

location_facility: The Christie NHS Foundation Trust ( Site 1100)

location_facility: Fujian Provincial Cancer Hospital ( Site 0104)

location_facility: National Cheng Kung University Hospital ( Site 1905)

location_facility: Outeniqua Cancercare Oncology Unit ( Site 2504)

location_facility: Peter MacCallum Cancer Centre ( Site 2003)

location_facility: Leningrad Regional Oncology Center ( Site 0405)

location_facility: Hospital Clinico Universidad de Chile ( Site 1002)

location_facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 0914)

location_facility: Universitaetsklinikum Leipzig ( Site 1501)

location_facility: Hospital de Clinicas de Porto Alegre ( Site 0200)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0406)

location_facility: The First Affiliated Hospital of Anhui Medical University ( Site 0112)

location_facility: Istanbul Medeniyet Universitesi Goztepe EAH ( Site 0807)

location_facility: Tongji Medical College Huazhong University of Science and Technology ( Site 0109)

location_facility: Cape Town Oncology Trials Pty Ltd ( Site 2508)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0804)

location_facility: Staedtisches Klinikum Dresden ( Site 1507)

location_facility: Lothian University Hospitals NHS Trust ( Site 1101)

location_facility: Princess Margaret Hospital. ( Site 1602)

location_facility: WITS Clinical Research CMJAH Clinical Trial Site ( Site 2500)

location_facility: The University of Chicago Medical Center ( Site 0001)

location_facility: Severance Hospital Yonsei University Health System ( Site 1302)

location_facility: Niigata Cancer Center Hospital ( Site 0924)

location_facility: Princess Margaret Cancer Centre ( Site 0505)

location_facility: Hokkaido University Hospital ( Site 0916)

location_facility: Instituto Regional de Enfermedades Neoplasicas del Sur IRENSUR ( Site 1702)

location_facility: University of Maryland Medical Center ( Site 0013)

location_facility: Fudan University Shanghai Cancer Center ( Site 0108)

location_facility: Chang Gung Medical Foundation. Linkou ( Site 1903)

location_facility: Koo Foundation Sun Yat-Sen Cancer Center ( Site 1902)

location_facility: Beacon International Specialist Centre ( Site 1803)

location_facility: S.C. Radiotherapy Center Cluj S.R.L ( Site 2407)

location_facility: National Medical and Surgical Center n.a. N.I.Pirogov ( Site 0402)

location_facility: Inonu Universitesi Turgut Ozal Tip Merkezi ( Site 0803)

location_facility: Humanity Health Research Centre ( Site 1603)

location_facility: Hospital Universitari Vall d Hebron ( Site 0702)

location_facility: Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0602)

location_facility: Klinik fuer Haematologie. Onkologie und Gastroenterologie ( Site 1508)

location_facility: Hospital Regional de Concepcion Dr. Guillermo Grant Benavente ( Site 1003)

location_facility: University of Tsukuba Hospital ( Site 0910)

location_facility: The First Affiliated Hospital of Xi an Jiaotong University ( Site 0120)

location_facility: Odense Universitetshospital ( Site 2300)

location_facility: Kobe City Medical Center General Hospital ( Site 0929)

location_facility: Kumamoto University Hospital ( Site 0919)

location_facility: Centro de Investigacion Oncologica ( Site 1402)

location_facility: Complejo Hospitalario Virgen De La Victoria ( Site 0705)

location_facility: St. Marianna University School of Medicine Hospital ( Site 0903)

location_facility: Clinica de Hematologia e Oncologia Viver Ltda ( Site 0211)

location_facility: Kuang Tien General Hospital ( Site 1909)

location_facility: Haematologisch-Onkologische Praxis Eppendorf Facharztzentrum Eppendorf - Hope ( Site 1502)

location_facility: S C Oncocenter Oncologie Medicala S R L ( Site 2405)

location_facility: Princess Alexandra Hospital ( Site 2005)

location_facility: Centro Regional de Sub Especialidades Medicas SA ( Site 1403)

location_facility: Ibaraki Prefectural Central Hospital ( Site 0918)

location_facility: Medical Park Izmir Hastanesi ( Site 0800)

location_facility: CETUS Hospital Dia Oncologia ( Site 0208)

location_facility: University Hospitals Cleveland Medical Center ( Site 0002)

title: A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial of Pembrolizumab (MK-3475) in Combination With Cisplatin and 5-Fluorouracil Versus Placebo in Combination With Cisplatin and 5-Fluorouracil as First-Line Treatment in Subjects With Advanced/Metastatic Esophageal Carcinoma (KEYNOTE-590)

primary_purpose: Treatment

type: Other Identifier

type: EudraCT Number

source: euctr

enrollment_type: Actual

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
Germany
Argentina
Australia
Brazil
Costa Rica
Japan
Thailand
Turkey
Chile
Canada
France
Colombia
Hong Kong
Denmark
United States
Romania
China
Malaysia
Peru
Guatemala
United Kingdom
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation

study_type: Interventional

ipd_sharing: Yes

lead_sponsor_type: industriel


acronym: AERISTO

lead_sponsor: AstraZeneca

summary: This is a phase IIIb randomised, double-blind, double-dummy, multicentre, parallel group, 24 week study to assess the efficacy and safety of Glycopyrronium/Formoterol Fumarate (GFF) fixed-dose combination 7.2/4.8 μg 2 inhalations twice daily compared to Umeclidinium/Vilanterol (UV) 62.5/25 μg fixed-dose combination 1 inhalation once daily in Patients with moderate to very severe COPD.

ReferenceCitation: Maltais F, Ferguson GT, Feldman GJ, Deslee G, Bourdin A, Fjallbrant H, Siwek-Posluszna A, Jenkins MA, Martin UJ. A Randomized, Double-Blind, Double-Dummy Study of Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler Relative to Umeclidinium/Vilanterol Dry Powder Inhaler in COPD. Adv Ther. 2019 Sep;36(9):2434-2449. doi: 10.1007/s12325-019-01015-3. Epub 2019 Jul 2.

sponsor_collaborators: Center for Information & Study on Clinical Research Participation (CISCRP)

title: A Randomised, Double-Blind, Double-Dummy, Multicentre, Parallel Group Study to Assess the Efficacy and Safety of Glycopyrronium/Formoterol Fumarate Fixed-dose Combination Relative to Umeclidinium/Vilanterol Fixed-dose Combination Over 24 Weeks in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (AERISTO)

location_country:
Hungary
United States
Ukraine
Bulgaria
Canada
Russian Federation
France

ipd_sharing: Undecided


acronym: CANDOR

lead_sponsor: Amgen

summary: Compare carfizomib, dexamethasone, and daratumumab (KdD) to Carfilzomib and dexamethasone (Kd) in terms of progression free survival (PFS) in participants with multiple myeloma who have relapsed after 1 to 3 prior therapies.

ReferenceType: background

ReferenceCitation: Quach H, Nooka A, Samoylova O, Venner CP, Kim K, Facon T, Spencer A, Usmani SZ, Grosicki S, Suzuki K, Delimpasi S, Weisel K, Obreja M, Zahlten-Kumeli A, Mateos MV. Carfilzomib, dexamethasone and daratumumab in relapsed or refractory multiple myeloma: results of the phase III study CANDOR by prior lines of therapy. Br J Haematol. 2021 Aug;194(4):784-788. doi: 10.1111/bjh.17541. Epub 2021 May 28. No abstract available.

ReferenceCitation: Siegel D, Weisel K, Zahlten-Kumeli A, Medhekar R, Ding B, Leleu X. Health-related quality of life outcomes from the CANDOR study in patients with relapsed or refractory multiple myeloma. Leuk Lymphoma. 2021 Dec;62(12):3002-3010. doi: 10.1080/10428194.2021.1941927. Epub 2021 Jun 26.

ReferenceCitation: Suzuki K, Min CK, Kim K, Lee JJ, Shibayama H, Ko PS, Huang SY, Li SS, Ding B, Khurana M, Iida S. Carfilzomib, dexamethasone, and daratumumab in Asian patients with relapsed or refractory multiple myeloma: post hoc subgroup analysis of the phase 3 CANDOR trial. Int J Hematol. 2021 Dec;114(6):653-663. doi: 10.1007/s12185-021-03204-9. Epub 2021 Aug 19.

ReferenceCitation: Usmani SZ, Quach H, Mateos MV, Landgren O, Leleu X, Siegel D, Weisel K, Gavriatopoulou M, Oriol A, Rabin N, Nooka A, Qi M, Beksac M, Jakubowiak A, Ding B, Zahlten-Kumeli A, Yusuf A, Dimopoulos M. Carfilzomib, dexamethasone, and daratumumab versus carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma (CANDOR): updated outcomes from a randomised, multicentre, open-label, phase 3 study. Lancet Oncol. 2022 Jan;23(1):65-76. doi: 10.1016/S1470-2045(21)00579-9. Epub 2021 Dec 3.

ReferenceCitation: Landgren O, Weisel K, Rosinol L, Touzeau C, Turgut M, Hajek R, Mollee P, Kim JS, Shu N, Hu X, Li C, Usmani SZ. Subgroup analysis based on cytogenetic risk in patients with relapsed or refractory multiple myeloma in the CANDOR study. Br J Haematol. 2022 Sep;198(6):988-993. doi: 10.1111/bjh.18233. Epub 2022 May 24.

ReferenceCitation: Dimopoulos M, Quach H, Mateos MV, Landgren O, Leleu X, Siegel D, Weisel K, Yang H, Klippel Z, Zahlten-Kumeli A, Usmani SZ. Carfilzomib, dexamethasone, and daratumumab versus carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma (CANDOR): results from a randomised, multicentre, open-label, phase 3 study. Lancet. 2020 Jul 18;396(10245):186-197. doi: 10.1016/S0140-6736(20)30734-0. Erratum In: Lancet. 2020 Aug 15;396(10249):466.

ReferenceCitation: Leleu X, Beksac M, Chou T, Dimopoulos M, Yoon SS, Prince HM, Pour L, Shelekhova T, Chari A, Khurana M, Zhang J, Obreja M, Qi M, Oriol A, Siegel D. Efficacy and safety of weekly carfilzomib (70 mg/m2), dexamethasone, and daratumumab (KdD70) is comparable to twice-weekly KdD56 while being a more convenient dosing option: a cross-study comparison of the CANDOR and EQUULEUS studies. Leuk Lymphoma. 2021 Feb;62(2):358-367. doi: 10.1080/10428194.2020.1832672. Epub 2020 Oct 28.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

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

publisher_dissemination: Informa

location_facility: Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im K Marcinkowskiego w Poznaniu

location_facility: Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: General University Hospital of Patras Panagia i Voithia

location_facility: Bekes Megyei Kozponti Korhaz Dr Rethy Pal Tagkorhaz

location_facility: University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD

location_facility: University Hospital Kyoto Prefectural University of Medicine

location_facility: Severance Hospital Yonsei University Health System

location_facility: Centre Hospitalier de Versailles - Hopital Andre Mignot

location_facility: Emory University Winship Cancer Institute

location_facility: University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

location_facility: Spitalul Clinic Municipal Filantropia Craiova

location_facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Specialized Hospital for Active Treatment of Hematology Diseases EAD

location_facility: University of Chicago Medical Center - Multiple Myeloma Research Consortium

location_facility: The Catholic University of Korea Seoul St Marys Hospital

location_facility: National Hospital Organization Shibukawa Medical Center

location_facility: Centre Hospitalier Universitaire de Nancy - Hopital de Brabois

location_facility: Ziekenhuis Netwerk Antwerpen Stuivenberg

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: SBHI of Nizhny Novgorod region Regional Clinical Hospital of Nizhny Novgorod na N A Semashko

location_facility: Clinic of professional pathology and hematology

location_facility: Cancer Institute Hospital of Japanese Foundation for Cancer Research

location_facility: Profesor Dr Ion Chiricuta Institut of Oncology

location_facility: Lynn Cancer Center Boca Raton Regional Hospital, Lynn Cancer Institute

location_facility: Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie

location_facility: Centre Hospitalier RÃ©gional Universitaire de Lille - HÃ´pital Claude Huriez

location_facility: Barwon Health, University Hospital Geelong

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Centre Hospitalier DÃ©partemental les Oudairies

location_facility: Baylor Charles A Sammons Cancer Center at Dallas

location_facility: Fort Wayne Medical Oncology and Hematology

location_facility: New York Presbyterian Hospital, Weill Cornell Medical College

location_facility: National Hospital Organization Okayama Medical Center

location_facility: Chonnam National University Hwasun Hospital

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

location_facility: SBHI of Republic of Karelia Republic Hosiptal n a V A Baranov

location_facility: State Budget Educational Institution of High Professional Skills Samara State Medical University

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Centrum Onkologii Ziemi Lubelskiej im Swietego Jana z Dukli

location_facility: Ankara Universitesi Tip Fakultesi Cebeci Hastanesi

location_facility: Theagenion Cancer Hospital of Thessaloniki

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich w Chorzowie

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar

title: A Randomized, Open-label, Phase 3 Study Comparing Carfilzomib, Dexamethasone, and Daratumumab to Carfilzomib and Dexamethasone for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

location_country:
Poland
Australia
Japan
Turkey
Czechia
Canada
France
Hungary
United States
Romania
Belgium
United Kingdom
Austria
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Russian Federation


lead_sponsor: Pfizer

summary: The purpose of this international, phase 2, open-label, response rate study of talazoparib is to assess the efficacy and safety of talazoparib in men with DNA repair defects metastatic castration-resistant prostate cancer (CRPC) who previously received taxane-based chemotherapy and progressed on at least 1 novel hormonal agent (enzalutamide and/or abiraterone acetate/prednisone).

ReferenceCitation: Mehra N, Fizazi K, de Bono JS, Barthelemy P, Dorff T, Stirling A, Machiels JP, Bimbatti D, Kilari D, Dumez H, Buttigliero C, van Oort IM, Castro E, Chen HC, Di Santo N, DeAnnuntis L, Healy CG, Scagliotti GV. Talazoparib, a Poly(ADP-ribose) Polymerase Inhibitor, for Metastatic Castration-resistant Prostate Cancer and DNA Damage Response Alterations: TALAPRO-1 Safety Analyses. Oncologist. 2022 Oct 1;27(10):e783-e795. doi: 10.1093/oncolo/oyac172.

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Oxford University Press

ReferenceCitation: de Bono JS, Mehra N, Scagliotti GV, Castro E, Dorff T, Stirling A, Stenzl A, Fleming MT, Higano CS, Saad F, Buttigliero C, van Oort IM, Laird AD, Mata M, Chen HC, Healy CG, Czibere A, Fizazi K. Talazoparib monotherapy in metastatic castration-resistant prostate cancer with DNA repair alterations (TALAPRO-1): an open-label, phase 2 trial. Lancet Oncol. 2021 Sep;22(9):1250-1264. doi: 10.1016/S1470-2045(21)00376-4. Epub 2021 Aug 10. Erratum In: Lancet Oncol. 2022 May;23(5):e207. Lancet Oncol. 2022 Jun;23(6):e249.

sponsor_collaborators:
Pfizer
Medivation, Inc.

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Azienda Socio Sanitaria Territoriale di Cremona (Istituti Ospitalieri di Cremona)

location_facility: Olivia Newton John Cancer Wellness & Research Centre Austin Health

location_facility: Centre Hospitalier Departemental Les Oudairies

location_facility: The Institute of Cancer Research, The Royal Marsden NHS Foundation Trust , Sycamore House

location_facility: Azienda Ospedaliero-Universitaria S. Luigi Gonzaga-SCDU Oncologia Medica

location_facility: Swedish Cancer Institute Issaquah Campus

location_facility: The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center

location_facility: SD Oncologia Clinica Sperimentale di Uro-Ginecologia

location_facility: Institut de Cancerologie Strasbourg Europe

location_facility: Hospital Universitario Quironsalud Madrid-Oncology Service

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Azienda Ospedaliero Universitari di Parma - U.O. Oncologia Medica

location_facility: Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino

location_facility: University of California, Irvine Medical Center

location_facility: Fundacao Pio XII-Hospital de Cancer de Barretos

location_facility: Weill Cornell Medical Center-New York Presbyterian Hospital

location_facility: Hospital General Vall D'Hebron-Oncology Service

location_facility: IOV - Istituto Oncologico Veneto IRCCS - U.O. Oncologia Medica 1

location_facility: Clinique Victor Hugo-Centre Jean Bernard

location_facility: UC Irvine Health Investigational Drug Pharmacy

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Medical Imaging St Vincent's Hospital Sydney

location_facility: Szabolcs- Szatmar-Bereg Megyei Korhazak es Egyetemi Oktato Korhaz

location_facility: Clinica Universidad de Navarra-Oncology Service

location_facility: Weill Cornell Medical Center - New York Presbyterian Hospital

location_facility: Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej

location_facility: Washington University School of Medicine

location_facility: Sharp Outpatient Infusion Therapy Center

location_facility: Hospital de Clinicas de Porto Alegre-HCPA

location_facility: Seoul National University Bundang Hospital

location_facility: Ordensklinikum Linz, Barmherzige Schwestern

location_facility: Orszagos Onkologiai Intezet, "C" Belgyogyaszati-Onkologiai es Klinikai Farmakogogiai Osztaly

location_facility: Froedtert Hospital/Medical College of Wisconsin

location_facility: Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza

location_facility: AULSS3 Serenissima - Ospedale dell'Angelo - Oncologia Medica

location_facility: Instituto Valenciano de Oncologia (IVO-FINCIVO)

location_facility: Intergrated Clinical Oncology Network (ICON)

location_facility: Medizinische Fakultat Mannheim der Universitat Heidelberg

location_facility: Azienda Ospedaliero Universitaria di Parma - U.O. Oncologia Medica

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

location_facility: City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

location_facility: St Vincent's Hospital Sydney, The Kinghorn Cancer Centre

location_facility: Winship Cancer Institute, Emory University

location_facility: Kyungpook National University Chilgok Hospital

title: TALAPRO-1: A PHASE 2, OPEN-LABEL, RESPONSE RATE STUDY OF TALAZOPARIB IN MEN WITH DNA REPAIR DEFECTS AND METASTATIC CASTRATION-RESISTANT PROSTATE CANCER WHO PREVIOUSLY RECEIVED TAXANE-BASED CHEMOTHERAPY AND PROGRESSED ON AT LEAST 1 NOVEL HORMONAL AGENT (ENZALUTAMIDE AND/OR ABIRATERONE ACETATE/PREDNISONE)

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

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Australia
Brazil
Netherlands
Austria
Belgium
United States
Korea, Republic of
Spain
France


title: A Phase 2, Open-Label, 2-Cohort Study of INCB050465, a PI3Kδ Inhibitor, in Subjects With Relapsed or Refractory Marginal Zone Lymphoma With or Without Prior Exposure to a BTK Inhibitor (CITADEL-204)

summary: The purpose of this study is to evaluate the safety and efficacy of two parsaclisib treatment regimens in participants diagnosed with relapsed or refractory marginal zone lymphoma (MZL) who are naive to or were previously treated with a Bruton's tyrosine kinase (BTK) inhibitor.

status: Active, not recruiting

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

ipd_sharing: No

lead_sponsor: Incyte Corporation

location_country:
Germany
Italy
Poland
Israel
Argentina
Denmark
Australia
United Kingdom
Belgium
United States
Spain
France

location_facility: Hadassah Hebrew University Medical Center Ein Karem Hadassah

location_facility: Hospices Civils de Lyon Centre Hospitalier Lyon Sud

location_facility: Szpitale Wojew�Dzkie W Gdyni Sp�?Ka Z Ograniczon? Odpowiedzialno?Ci?

location_facility: Charleston Hematology Oncology Associates Pa

location_facility: Azienda Ospedaliera San Gerardo Di Monza

location_facility: University of Miami Sylvester Comprehensive Cancer Center

location_facility: Fondazione Irccs Istituto Nazionale Dei Tumori

location_facility: COMPREHENSIVE CANCER CeNTERS OF NEVADA - TWAIN

location_facility: Azienda Ospedaliera Ospedali Riuniti "Villa Sofia - Cervello"

location_facility: Kent Oncology Centre - Maidstone Hospital

location_facility: St. Mary'S Hospital Regional Cancer Center

location_facility: Hematology Oncology Associates of Rockland

location_facility: Boca Raton Clinical Research Medical Inc.

location_facility: Rush University Medical Center - Consultants in Hematology

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: University of Washington - Seattle Cancer Care Alliance

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie

location_facility: Hospital General Universitari Vall D Hebron

location_facility: Universitaire Ziekenhuis Leuven - Gasthuisberg

location_facility: Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori

location_facility: Ospedale Delle Croci - Ematologia Ravenna

location_facility: University of Alabama At Birmingham Comprehensive Cancer Center

location_facility: Klinika Transplantacji Komorel Krwiotworczych

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

location_facility: University of Bologna, Institute of Haematology �L. E A. Ser�Gnoli�

location_facility: Robert H. Lurie Comprehensive Cancer Center of Northwestern University

status_simplified: Ongoing


title: GRAVITAS-301: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease

summary: The purpose of this study is to evaluate itacitinib or placebo in combination with corticosteroids as first-line treatment of participants with Grade II to IV acute graft-versus-host disease (aGVHD).

ReferenceCitation: Pratta M, Paczesny S, Socie G, Barkey N, Liu H, Owens S, Arbushites MC, Schroeder MA, Howell MD. A biomarker signature to predict complete response to itacitinib and corticosteroids in acute graft-versus-host disease. Br J Haematol. 2022 Aug;198(4):729-739. doi: 10.1111/bjh.18300. Epub 2022 Jun 11.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: Wiley

ReferenceCitation: Zeiser R, Socie G, Schroeder MA, Abhyankar S, Vaz CP, Kwon M, Clausen J, Volodin L, Giebel S, Chacon MJ, Meyers G, Ghosh M, Deeren D, Sanz J, Morariu-Zamfir R, Arbushites M, Lakshminarayanan M, Barbour AM, Chen YB. Efficacy and safety of itacitinib versus placebo in combination with corticosteroids for initial treatment of acute graft-versus-host disease (GRAVITAS-301): a randomised, multicentre, double-blind, phase 3 trial. Lancet Haematol. 2022 Jan;9(1):e14-e25. doi: 10.1016/S2352-3026(21)00367-7.

location_country:
Finland
Germany
Poland
New Zealand
Australia
Czechia
France
Portugal
Switzerland
United States
Belgium
Italy
United Kingdom
Austria
Korea, Republic of
Spain
Greece
Taiwan
Israel

location_facility: Instituto Catalan de Oncologia - Hospital Duran i Reynals

location_facility: Instituto Portugues de Oncologia de Lisboa Francisco Gentil EPE (IPO-Lisboa)

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: SOC Clinica Ematologica, Azienda Ospediero-Universitaria di Udine

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: University of Oklahoma - Health Sciences Center

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Hospital de la Santa Creu i Sant Pau - Servei de Hematologia Clinica

location_facility: Sarah Cannon Research Institute, LLC (SCRI)

location_facility: Universitaetsmedizin der Johannes Gutenberg

location_facility: John Theurer Cancer Center At Hackensack UMC

location_facility: University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center

location_facility: University Clinic Carl Gustav Carus, Technical University Dresden

location_facility: University of Miami - Sylvester Cancer Center

location_facility: Hopital universitaire du Sart Tilman de Liege

location_facility: University Hospitals Cleveland Medical Center

location_facility: UKGM Marburg Innere Medizin: Haematologie Onkolog

location_facility: Complejo Hospitalario Universitario de Granada - Hospital Universitario Virgen de las Nieves

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Universitaet zu Koln - Universitaetsklinikum Koeln (Uniklinik Koeln)

location_facility: Azienda Ospedaliero Universitaria (AOU) Policlinico - Vittorio Emanuele - Presidio Ospedaliero Ferrarotto Alessi

location_facility: Hospital Clinico de Santiago de Compostela

location_facility: Wake Forest Baptist Medical Center - Wake Forest University School of Medicine

location_facility: Institut Claudius Regaud-Universitaire du Cancer Toulouse Oncopol

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Advocate Lutheran General Hospital - Oncology Specialists SC

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano

location_facility: General Hospital Sint-Jan Brugge-Oostend

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

location_facility: C.T.M.O. Ospedale Roberto Binaghi ATS Cagliari

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: A.O.U. Città della Salute e della Scienza di Torino

location_facility: Hadassah Hebrew University Medical Center Ein Karem

location_facility: Klinika Transplantacji Komorek Krwiotworczych - Instytut Hematologii i Transfuzjologii

location_facility: Indiana University (IU) Melvin and Bren Simon Cancer Center

location_facility: Universtity Hospital Basel - Haematology

location_facility: University of California, San Diego (UCSD) - Moores Cancer Center

location_facility: Azienda Unità Sanitaria Locale di Reggio Emilia

location_facility: Washington University School of Medicine

location_facility: Hospital Clinico Universitario de Valencia

location_facility: General Hospital of Thessaloniki G. Papanikolaou - Hematology Department

location_facility: Azienda Ospedaliera Bianchi-Melacrino-Morelli Ospedali Riuniti

location_facility: Oregon Health & Science University (OHSU)

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: Universitatsklinikum Freiburg - Klinik fur Innere Medizin I

location_facility: University of California, Los Angeles (UCLA) - Medical Center

location_facility: Clinica Ematologica CTA, Ospedale "San Gerardo" di Monza

location_facility: University of Colorado - Aurora Cancer Center

location_facility: University of Florida (UF) - Division of Hematology & Oncology

location_facility: Centro Hospitalar Lisboa Norte - Hospital de Santa Maria

location_facility: Hopital Haut Leveque - CHU Bordeaux - Maladies du sang

location_facility: University of Mississippi Medical Center

location_facility: UHKT Prague - Institute of Hematology and Blood Transfusion

location_facility: Universitatsklinikum Hamburg - Eppendorf

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

location_facility: Universitaetsspital Zuerich - Klinik fuer Haematology


title: Phase Ib /II Clinical Trial of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab in Pediatric Subjects With High Grade Primary CNS Malignancies

acronym: CheckMate 908

summary: The purpose of this study is to determine the safety and effectiveness of nivolumab alone and in combination with ipilimumab in pediatric patients with high grade primary central nervous system (CNS) malignancies.

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
Poland
Israel
Hong Kong
Norway
Australia
Brazil
Netherlands
Sweden
United Kingdom
United States
Spain
Canada
Russian Federation
France

location_facility: Cincinnati Children'S Hospital Medical Center

intervention_type: Biological


acronym: EUROMAX

lead_sponsor: The Medicines Company

summary: To show that the early administration of bivalirudin improves 30 day outcomes when compared to the current standard of care in participants with ST segment elevation acute coronary syndrome (STE-ACS), intended for a primary percutaneous coronary intervention (PCI) management strategy, presenting either via ambulance or to centers where PCI is not performed.

ReferenceCitation: Huber K, Ducrocq G, Hamm CW, van 't Hof A, Lapostolle F, Coste P, Gordini G, Steinmetz J, Verheugt FWA, Adgey J, Nibbe L, Kanic V, Clemmensen P, Zeymer U, Bernstein D, Prats J, Deliargyris EN, Gabriel Steg P. Early clinical outcomes as a function of use of newer oral P2Y12 inhibitors versus clopidogrel in the EUROMAX trial. Open Heart. 2017 Nov 28;4(2):e000677. doi: 10.1136/openhrt-2017-000677. eCollection 2017.

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

repository_institution: Radboud University - Radboud Repository

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

publisher_dissemination: British Medical Journal

ReferenceCitation: Fabris E, Kilic S, Van't Hof AWJ, Ten Berg J, Ayesta A, Zeymer U, Hamon M, Soulat L, Bernstein D, Anthopoulos P, Deliargyris EN, Steg PG. One-Year Mortality for Bivalirudin vs Heparins Plus Optional Glycoprotein IIb/IIIa Inhibitor Treatment Started in the Ambulance for ST-Segment Elevation Myocardial Infarction: A Secondary Analysis of the EUROMAX Randomized Clinical Trial. JAMA Cardiol. 2017 Jul 1;2(7):791-796. doi: 10.1001/jamacardio.2016.5975.

oa_colors: green other

repository_institution: Imperial College London - Spiral

repository_institution: University of Trieste https://www.units.it/ - ArTS Archivio della ricerca di Trieste

version: submittedVersion

publisher_dissemination: American Medical Association

ReferenceCitation: Ducrocq G, Steg PG, Van't Hof A, Zeymer U, Mehran R, Hamm CW, Bernstein D, Prats J, Deliargyris EN, Stone GW. Utility of post-procedural anticoagulation after primary PCI for STEMI: insights from a pooled analysis of the HORIZONS-AMI and EUROMAX trials. Eur Heart J Acute Cardiovasc Care. 2017 Oct;6(7):659-665. doi: 10.1177/2048872616650869. Epub 2016 Jun 10.

evidence: open (via free article)

ReferenceCitation: Dangas GD, Schoos MM, Steg PG, Mehran R, Clemmensen P, van 't Hof A, Prats J, Bernstein D, Deliargyris EN, Stone GW. Early Stent Thrombosis and Mortality After Primary Percutaneous Coronary Intervention in ST-Segment-Elevation Myocardial Infarction: A Patient-Level Analysis of 2 Randomized Trials. Circ Cardiovasc Interv. 2016 May;9(5):e003272. doi: 10.1161/CIRCINTERVENTIONS.115.003272.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Kilic S, Van't Hof AW, Ten Berg J, Lopez AA, Zeymer U, Hamon M, Soulat L, Bernstein D, Deliargyris EN, Steg PG. Frequency and prognostic significance of access site and non-access site bleeding and impact of choice of antithrombin therapy in patients undergoing primary percutaneous coronary intervention. The EUROMAX trial. Int J Cardiol. 2016 May 15;211:119-23. doi: 10.1016/j.ijcard.2016.02.131. Epub 2016 Mar 3.

ReferenceCitation: Hamon M, Coste P, Van't Hof A, Ten Berg J, Clemmensen P, Tabone X, Benamer H, Kristensen SD, Cavallini C, Marzocchi A, Hamm C, Kanic V, Bernstein D, Anthopoulos P, Deliargyris EN, Steg PG. Impact of arterial access site on outcomes after primary percutaneous coronary intervention: prespecified subgroup analysis from the EUROMAX trial. Circ Cardiovasc Interv. 2015 Jun;8(6):e002049. doi: 10.1161/CIRCINTERVENTIONS.114.002049.

ReferenceCitation: Stone GW, Mehran R, Goldstein P, Witzenbichler B, Van't Hof A, Guagliumi G, Hamm CW, Genereux P, Clemmensen P, Pocock SJ, Gersh BJ, Bernstein D, Deliargyris EN, Steg PG. Bivalirudin versus heparin with or without glycoprotein IIb/IIIa inhibitors in patients with STEMI undergoing primary percutaneous coronary intervention: pooled patient-level analysis from the HORIZONS-AMI and EUROMAX trials. J Am Coll Cardiol. 2015 Jan 6;65(1):27-38. doi: 10.1016/j.jacc.2014.10.029.

ReferenceCitation: Steg PG, van 't Hof A, Clemmensen P, Lapostolle F, Dudek D, Hamon M, Cavallini C, Gordini G, Huber K, Coste P, Thicoipe M, Nibbe L, Steinmetz J, Ten Berg J, Eggink GJ, Zeymer U, Campo dell' Orto M, Kanic V, Deliargyris EN, Day J, Schuette D, Hamm CW, Goldstein P. Design and methods of European Ambulance Acute Coronary Syndrome Angiography Trial (EUROMAX): an international randomized open-label ambulance trial of bivalirudin versus standard-of-care anticoagulation in patients with acute ST-segment-elevation myocardial infarction transferred for primary percutaneous coronary intervention. Am Heart J. 2013 Dec;166(6):960-967.e6. doi: 10.1016/j.ahj.2013.08.025. Epub 2013 Nov 7.

ReferenceCitation: Steg PG, van 't Hof A, Hamm CW, Clemmensen P, Lapostolle F, Coste P, Ten Berg J, Van Grunsven P, Eggink GJ, Nibbe L, Zeymer U, Campo dell' Orto M, Nef H, Steinmetz J, Soulat L, Huber K, Deliargyris EN, Bernstein D, Schuette D, Prats J, Clayton T, Pocock S, Hamon M, Goldstein P; EUROMAX Investigators. Bivalirudin started during emergency transport for primary PCI. N Engl J Med. 2013 Dec 5;369(23):2207-17. doi: 10.1056/NEJMoa1311096. Epub 2013 Oct 30.

location_facility: Herzzentrum Duisburg, Klinik Fur Kardiologie And Angiologie

location_facility: Ch Sud Francilien - Site Corbeil, Pharmacie

location_facility: Regional Ambulance Service Gelderland Midden

location_facility: Service Gelderland-Zuid Klinisch Geneesmiddelonderzoek Klinsche Farmacie Afd Klinsche Farmacie

location_facility: Centre Hospitalier De Vienne Centre Hospitalier Lucien Hussel

location_facility: Medizinische Hochschule Hannover, Carl Neuberg Str. 1

location_facility: Polsko-Amerykanskie Kliniki Serca, Szpital Powiatowy

location_facility: Regional Ambulance Service Gelderland Zuid

location_facility: Stadtisches Klinikum Luneburg, Bogelstr. 1

location_facility: Splosna Bolnisnica Novo Mesto/ Community Hospital Novo Mesto, Smihelska Cesta 1

location_facility: Chi Le Raincy - Montfermeil Site De Montfermeil

location_facility: Zdravstveni Dom Dr. Adolfa Drolca Maribor

location_facility: Hospital Avicenne, Pharmacie -Gestion Des Essais Cliniques

location_facility: Sana Klinikum Lichtenberg Oskar Ziethen Krankenhaus, Fanningerstrasse 32

location_facility: Emergency Rescue & Mobile Als Unit, Lanciarini Pub

location_facility: Cardiologic Hospital - Coronary Care Unit, University of Bordeaux

location_facility: Szpital Powiatowy Im. Jana Pawla Ii W Kolbuszowej

location_facility: Jagiellonian University Medical College,

location_facility: Regional Ambulance Service Gelderland-Zuid Distributiecentrum

location_facility: Oddzial Kardiologii Al.Lotnikow Polskich 18

location_facility: Splosna Bolnisnica Ptuj, Interni Odelek, Potrceva Cesta 23

location_facility: Hopital Andre Mignot - Centre Hospitalier De Versailles

location_facility: Charite Universitatsmedizin Berlin Campus Virchow-Klinikum

location_facility: Szpital Specjalistyczny Im Szpitalny Oddzial Ratunkowy

location_facility: Cwz Klinisch Geneesmiddelonderzoek Klinische

location_facility: Samodzielna Publiczna Stacja Pogotowia Ratunkowego, Samodzielna Publiczna Stacja Pogotowia Ratunkowego W Niepolomicach

location_facility: Tav Trial Team, Isala Klinieken Ioc Weezenlanden Afd

location_facility: Klinikum Der Johann Wolfgang Goethe Universitat

location_facility: Helios Klinik Der Universitat Witten Herdecke

location_facility: Spzoz Szpital Im. J.Dietla W Krynicy Zdroj

location_facility: Oddzial Polskiej-Amerikanskiej Kliniki Serca

location_facility: Universitatsklinikum Benjamin Franklin, Hindenburgdamm 30

location_facility: Centre Hospitalier Universitaire De Caen

location_facility: Akutlaegebil Kobenhavn, Hc Andersens Boulevard 23

location_facility: Chu De Toulouse - Hopital Paule De Viguier

location_facility: Szpital Powiatowy W Sedziszowie Malopolskim

title: Multi-centre, Multi-national, Prospective, Randomised, Open-label, Comparison of Bivalirudin to Other Guideline Based Current Therapies (Excluding Bivalirudin)

location_country:
Germany
Italy
Poland
Slovenia
Denmark
Netherlands
Austria
Czech Republic
France


title: Prospective Observational Study on Predictors of Early On-treatment Response and Sustained Virological Response in a Cohort of Treatment naïve HCV-infected Patients Treated With Pegylated Interferons.

summary: This observational study will assess predictors of early on-treatment and sustained virological response in treatment-naïve patients with chronic hepatitis C initiated on treatment with Pegasys (peginterferon alfa-2a) and ribavirin. Data will be collected during the treatment period (24 or 48 weeks) and 12 and 24 weeks after the end of treatment. Target sample size is <5000.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Ascione A, Bruno S, Coppola C, Mangia A, Orlandini A, Schmitz M, Deodato B, Puoti M. Treatment Outcomes and Predictors of Response in Treatment-Naive HCV Patients Treated with Peginterferon Alfa/Ribavirin in Real-World Italian Clinics: Sub-Analysis from the PROPHESYS Cohort. Hepatogastroenterology. 2014 Jun;61(132):1094-106.

ReferenceCitation: Ferenci P, Aires R, Ancuta I, Arohnson A, Cheinquer H, Delic D, Gschwantler M, Larrey D, Tallarico L, Schmitz M, Tatsch F, Ouzan D. A tool for selecting patients with a high probability of sustained virological response to peginterferon alfa-2a (40kD)/ribavirin. Liver Int. 2014 Nov;34(10):1550-9. doi: 10.1111/liv.12439. Epub 2014 Jan 9.

lead_sponsor: Hoffmann-La Roche

location_country: Macedonia, The Former Yugoslav Republic of


title: A Phase 1/2, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements (TRIDENT-1)

summary:
Phase 1 dose escalation will determine the first cycle dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD), the biologically effective dose and recommended Phase 2 dose (RP2D) of repotrectinib given to adult subjects with advanced solid malignancies harboring an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.

Midazolam DDI substudy will examine effect of of repotrectinib on CYP3A induction.

Phase 2 will determine the confirmed Overall Response Rate (ORR) as assessed by Blinded Independent Central Review (BICR) of repotrectinib in each subject population expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. The secondary objective will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS) and clinical benefit rate (CBR) of repotrectinib in each expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.

status: Recruiting

enrollment_type: Anticipated

ReferenceCitation: Yun MR, Kim DH, Kim SY, Joo HS, Lee YW, Choi HM, Park CW, Heo SG, Kang HN, Lee SS, Schoenfeld AJ, Drilon A, Kang SG, Shim HS, Hong MH, Cui JJ, Kim HR, Cho BC. Repotrectinib Exhibits Potent Antitumor Activity in Treatment-Naive and Solvent-Front-Mutant ROS1-Rearranged Non-Small Cell Lung Cancer. Clin Cancer Res. 2020 Jul 1;26(13):3287-3295. doi: 10.1158/1078-0432.CCR-19-2777. Epub 2020 Apr 8.

repository_institution: Yonsei University Medical Library - YUHSpace

version: acceptedVersion

evidence: oa repository (via page says license)

repositories_concat: PubMed Central;ir.ymlib.yonsei.ac.kr

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Drilon A, Ou SI, Cho BC, Kim DW, Lee J, Lin JJ, Zhu VW, Ahn MJ, Camidge DR, Nguyen J, Zhai D, Deng W, Huang Z, Rogers E, Liu J, Whitten J, Lim JK, Stopatschinskaja S, Hyman DM, Doebele RC, Cui JJ, Shaw AT. Repotrectinib (TPX-0005) Is a Next-Generation ROS1/TRK/ALK Inhibitor That Potently Inhibits ROS1/TRK/ALK Solvent- Front Mutations. Cancer Discov. 2018 Oct;8(10):1227-1236. doi: 10.1158/2159-8290.CD-18-0484. Epub 2018 Aug 9.

ipd_sharing_description: There are no plans to share individual participant data with other researchers.

lead_sponsor: Turning Point Therapeutics, Inc.

sponsor_collaborators:
Turning Point Therapeutics, Inc.
Zai Lab (Shanghai) Co., Ltd.

location_country:
Germany
Poland
Australia
Japan
Canada
France
Hungary
Hong Kong
Denmark
United States
Belgium
China
Italy
Korea, Democratic People's Republic of
United Kingdom
Singapore
Netherlands
Korea, Republic of
Spain
Taiwan

location_facility: The Ohio State University Wexner Medical Center

location_facility: Baptist Memorial Hospital Baptist Cancer Center

location_facility: Georgetown University Medical Center - Lombardi Comprehensive Cancer Center

location_facility: University of Washington-Seattle Cancer Care Alliance

location_facility: The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: Washington University Infusion Center Pharmacy


title: A Phase 3, Multicenter, Randomized, Double-blind Study Evaluating the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis

acronym: ECLIPSE

summary: The purpose of this study is to evaluate the efficacy of guselkumab compared with secukinumab for the treatment of participants with moderate to severe plaque-type psoriasis.

ReferenceCitation: Reich K, Armstrong AW, Langley RG, Flavin S, Randazzo B, Li S, Hsu MC, Branigan P, Blauvelt A. Guselkumab versus secukinumab for the treatment of moderate-to-severe psoriasis (ECLIPSE): results from a phase 3, randomised controlled trial. Lancet. 2019 Sep 7;394(10201):831-839. doi: 10.1016/S0140-6736(19)31773-8. Epub 2019 Aug 8.

lead_sponsor: Janssen Research & Development, LLC

location_country:
Germany
Poland
Hungary
Australia
United States
Spain
Czechia
Canada
France

location_facility: NZOZ Poradnia Dermatologiczno-Wenerologiczna Mediderm

location_facility: San Luis Dermatology & Laser Clinic, Inc

location_facility: Suzanne Bruce and Associates - The Center for Skin Research

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

location_facility: NZOZ Osteo-Medic S.C. Artur Racewicz i Jerzy Supronik

location_facility: Atlanta Dermatology, Vein & Research Center

location_facility: Charite Universitatsmedizin Berlin, Campus Mitte (CCM) Allergie Center

location_facility: Szpital Uniwersytecki nr 1 im. Dr A. Jurasza

location_facility: Dermatology Clinical Research Center of San Antonio

location_facility: St George Dermatology & Skin Cancer Centre

location_facility: University of Pittsburgh Department of Dermatology

location_facility: Groupe Hospitalier La Rochelle - Re - Aunis

location_facility: Universitatsklinikum Schleswig-Holstein - Kiel

location_facility: Southern California Permanente Medical Group


summary: This double-blind, parallel, two-arm study will evaluate the potential to reduce cardiovascular risk, the tolerability and long-term safety profile of aleglitazar compared to placebo on top of standard care in patients with recent acute coronary syndrome (ACS) and type 2 diabetes mellitus. Patients will be randomized to receive either aleglitazar or placebo once daily as oral doses. The study will last until at least 950 events occur, but time on study treatment will be for at least 2.5 years.

ReferenceCitation: Schrieks IC, Nozza A, Stahli BE, Buse JB, Henry RR, Malmberg K, Neal B, Nicholls SJ, Ryden L, Mellbin L, Svensson A, Wedel H, Weichert A, Lincoff AM, Tardif JC, Grobbee DE, Schwartz GG. Adiponectin, Free Fatty Acids, and Cardiovascular Outcomes in Patients With Type 2 Diabetes and Acute Coronary Syndrome. Diabetes Care. 2018 Aug;41(8):1792-1800. doi: 10.2337/dc18-0158. Epub 2018 Jun 14.

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

repository_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

repository_institution: University of Zurich - Zurich Open Repository and Archive

publisher_dissemination: American Diabetes Association

ReferenceCitation: Lincoff AM, Tardif JC, Schwartz GG, Nicholls SJ, Ryden L, Neal B, Malmberg K, Wedel H, Buse JB, Henry RR, Weichert A, Cannata R, Svensson A, Volz D, Grobbee DE; AleCardio Investigators. Effect of aleglitazar on cardiovascular outcomes after acute coronary syndrome in patients with type 2 diabetes mellitus: the AleCardio randomized clinical trial. JAMA. 2014 Apr 16;311(15):1515-25. doi: 10.1001/jama.2014.3321.

ReferenceCitation: Lincoff AM, Tardif JC, Neal B, Nicholls SJ, Ryden L, Schwartz GG, Malmberg K, Buse JB, Henry RR, Wedel H, Weichert A, Cannata R, Grobbee DE. Evaluation of the dual peroxisome proliferator-activated receptor alpha/gamma agonist aleglitazar to reduce cardiovascular events in patients with acute coronary syndrome and type 2 diabetes mellitus: rationale and design of the AleCardio trial. Am Heart J. 2013 Sep;166(3):429-34. doi: 10.1016/j.ahj.2013.05.013. Epub 2013 Jul 26.

title: A Safety and Efficacy Study to Evaluate the Potential of Aleglitazar to Reduce Cardiovascular Risk in Coronary Heart Disease (CHD) Patients With a Recent Acute Coronary Syndrome (ACS) Event and Type 2 Diabetes Mellitus (T2D)

location_country:
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Brazil
Thailand
Grenada
Canada
France
Czech Republic
Hungary
Denmark
United States
India
Romania
China
Malaysia
Italy
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
Russian Federation
Sweden


title: A Double-blind, Comparative, Superiority, Multi-centre Investigation Evaluating the Efficacy of an Absorbent Foam Dressing Containing Silver (Mepilex Ag) Versus the Same Dressing Without Silver Used on Subjects With Venous Leg Ulcers or Mixed Ulcers

summary: Compare the efficacy of using an absorbent foam silver dressing (Mepilex Ag) versus the equivalent dressing without silver in subjects suffering from venous leg ulcer or mixed ulcer with an ABPI ≥ 0.8 and with inflammatory signs. Efficacy will be defined as absolute wound size reduction.

lead_sponsor: Molnlycke Health Care AB

location_country:
France
Netherlands
Germany
Czech Republic

location_facility: Dermatovenerologická klinike, Univerzita Karlova

location_facility: Hopital Robert Debré Service de Dermatologie

location_facility: Dermatology Department, University Hospital, Hopital Sud

location_facility: Universitätsklinikum Schleswig-Holstein Campus Lübeck

location_facility: Maison de Santé Protestante de Bordeaux-Bagatelle

location_facility: Hôpital Albert Michallon Service de médecine vasculaire

location_facility: Dermatovenerologická klinika, University Hospital Bohunice,

location_facility: Hopital Beauregard / Secrétariat de Dermatologie

location_facility: Hôpital privé d'Antony Service de Dermatologie

location_facility: CHG La Roche-sur-Yon Service de D'Angiologie,Les Oudairies

location_facility: Service de Dermatologie, Centre Hospitalier Regional Universitaire

location_facility: Fakultní nemocnice U svate Anny, St. Anne´s University Hospital

location_facility: Polyclinique de Picardie Service d'Angiologie Phlébologie

location_facility: Centre Hospitalier le Mans Service de Dermatologie

location_facility: Venenzentrum der Dermatologischen und Gefäßchirurgischen Kliniken -

location_facility: Cabinet d'Angiologie, 1 bis rue de Salgareda

location_facility: chirugické oddělení, Fakultní nemocnice Královské Vinohrady

location_facility: Universtätsmedizin Charité Klinik für Dermatologie, Allergologie und Venerologie

location_facility: Universität klinikum Jena, Klinik für dermatologie und dermatologische

intervention_type: Device


title: A Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of INCMGA00012 in Patients With Advanced Solid Tumors

summary:
The primary goal of this Phase 1 study is to characterize the safety and tolerability of INCMGA00012 and establish the maximum tolerated dose (MTD) of INCMGA00012 administered on either every two week or every four week schedules of administration among patients with solid tumors. Pharmacokinetics, pharmacodynamics, and the anti-tumor activity of INCMGA00012 will also be assessed.

The purpose of Amendment 5 is to obtain additional safety experience at the newly defined recommended Phase 2 dose of 500 mg every 4 weeks in patients with endometrial cancer, specifically either microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). Additionally, every 3 week (Q3W) flat-dosing will be studied in an additional tumor agnostic cohort.

location_country:
Finland
Germany
Italy
Lithuania
Poland
New Zealand
United Kingdom
Australia
Belgium
United States
China
Latvia
Spain
Bulgaria
Ukraine
France

location_facility: Fondazione Del Piemonte Per L'Oncologia Ircc Candiolo

location_facility: Regional Clinical Oncology Center Facility of State Higher Educational Institution

location_facility: Sun Yat-Sen Memorial Hospital Sun Yat-Sen University

location_facility: Xiangya Hospital Central South University

location_facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte

location_facility: The Fourth Hospital of Hebei Medical University

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti

location_facility: The Second Hospital of Shanxi Medical University

location_facility: Podillia Regional Center of Oncology - Chemotherapy Department

location_facility: The First Affiliated Hospital Sun Yat-Sen University

location_facility: Hospital General Universitario Vall D Hebron

location_facility: Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau

location_facility: Centre Hospitalier Universitaire de Liege - Sart Tilman

location_facility: STADTISCHE KLINIKUM MUNCHEN ï¿½ NEUPERLACH KLINIK FUR HAMATOLOGIE UND ONKOLOGIE

location_facility: Szpital Kliniczny Przemienienia Panskiego

location_facility: Groupe Hospitalier Diaconesses Croix Saint-Simon

location_facility: Istituto Nazionale Tumori Irccs Fondazione Pascale

location_facility: Centrum Onkologii - Instytut Im. Marii Sklodowskiej - Curie

location_facility: Tongji Hospital Huazhong University of Science and Technology

location_facility: SZPITALE WOJEWï¿½DZKIE W GDYNI SPï¿½LKA Z OGRANICZONA ODPOWIEDZIALNOSCIA

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

location_facility: The Royal Marsden Nhs Foundation Trust - Chelsea

location_facility: Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore

location_facility: University Hospital Krakow, Department of Oncology

location_facility: South Texas Accelerated Research Therapeutics

location_facility: The First Affiliated Hospital of Xiamen University

location_facility: Medical University of Warsaw - 2Nd Department Obstetric and Gynecology

location_facility: Virginia Commonwealth University Massey Cancer Center

location_facility: Katedra I Klinika Onkologii Um W Poznaniu Oddzial Ginekologii Onkologicznej

location_facility: The First Affiliated Hospital of Xian Jiaotong University

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Msw Z W-McO W Olsztynie

location_facility: University of Texas Md Anderson Cancer Center

location_facility: University Clinic Carl Gustav Carus Technical University Dresden

location_facility: Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole

location_facility: Uzhgorod National University Clinical Base Uzhgorod Central City Clinical Hospital

location_facility: Rmi Sumy Regional Clinical Oncology Dispensary

location_facility: Ko-Med Centra Kliniczne Osrodek Badan Klinicznych W Lublinie

location_facility: Centro Integral Oncologico Clara Campal (Ciocc)


acronym: SPIRIT

lead_sponsor: Novartis Pharmaceuticals

summary:
This study was a 2-treatment period, randomized, multicenter parallel-group study. The overall purpose of this study was to provide long- term safety data for fevipiprant (QAW039) (Dose 1 and Dose 2), compared with placebo, when added to the Global Initiative for Asthma (GINA) steps 3, 4, and 5 standard-of-care (SoC) asthma therapy (GINA 2016), in patients with moderate-to- severe asthma.

The purpose of this study was to provide long-term safety data for QAW039 150 mg once daily and 450 mg once daily, compared with placebo, when added to GINA steps 3, 4, and 5 standard-of-care asthma therapy (GINA 2020) in adult and adolescent (≥12 years) patients with moderate-to-severe asthma. The study included 2 cohorts of patients:

Rollover patients who had completed any of the four Phase 3 pivotal efficacy studies with QAW039 (QAW039A2307, QAW039A2314, QAW039A2316, or QAW039A2317, hereafter referred to as Studies A2307, A2314, A2316, and A2317), thus providing data for a longer duration of exposure, and
New patients who had not previously participated in a study of QAW039, permitting an increase in the number of patients with long-term exposure to QAW039.

By including these 2 categories of patients, the total number of patients treated with QAW039 as well as the duration of exposure to QAW039 treatment was substantially increased, supporting evaluation of the safety profile of QAW039.

ReferenceCitation: Maspero J, Agache IO, Kamei T, Yoshida M, Boone B, Felser JM, Kawakami F, Knorr B, Lawrence D, Lehmann T, Wang W, Pedinoff AJ. Long-term safety and exploratory efficacy of fevipiprant in patients with inadequately controlled asthma: the SPIRIT randomised clinical trial. Respir Res. 2021 Dec 11;22(1):311. doi: 10.1186/s12931-021-01904-8.

status: Terminated

title: A 2-treatment Period, Randomized, Placebo-controlled, Multicenter Parallel-group Study to Assess the Safety of QAW039 When Added to Existing Asthma Therapy in GINA Steps 3, 4 and 5 Patients With Uncontrolled Asthma.

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

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

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Japan
Turkey
Czechia
Canada
Serbia
France
Lithuania
Colombia
Slovakia
Hungary
Switzerland
United States
Latvia
India
Romania
Lebanon
Belgium
China
Malaysia
Peru
Estonia
Puerto Rico
Philippines
Guatemala
United Kingdom
Singapore
Netherlands
Austria
Mexico
Saudi Arabia
Spain
Greece
Taiwan
Bulgaria
Russian Federation
Israel

status_simplified: Unknown


title: Phase 2b, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of IV VIS410 in Addition to Oseltamivir Compared With Oseltamivir Alone in Hospitalized Adults With Influenza A Infection Requiring Oxygen Support

summary: This study is to compare the efficacy and safety of VIS410 in combination with oseltamivir vs oseltamivir alone in severely ill subjects with influenza A infection requiring oxygen support.

lead_sponsor: Visterra, Inc.

location_country:
New Zealand
Australia
Thailand
Turkey
Canada
Serbia
France
Belarus
United States
Latvia
Ukraine
Belgium
Malaysia
Estonia
Singapore
Spain
South Africa
Bulgaria
Georgia
Russian Federation


summary: This is a Phase III, global, double-blind, 2-arm randomized study designed to compare the efficacy and safety of atezolizumab + paclitaxel + carboplatin + bevacizumab versus placebo + paclitaxel + carboplatin + bevacizumab. Study participants will have Stage 3 or 4 ovarian cancer (OC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) with macroscopic residual disease postoperatively (i.e., after primary tumor reductive surgery) or who will undergo neoadjuvant therapy followed by interval surgery.

ReferenceCitation: Moore KN, Bookman M, Sehouli J, Miller A, Anderson C, Scambia G, Myers T, Taskiran C, Robison K, Maenpaa J, Willmott L, Colombo N, Thomes-Pepin J, Liontos M, Gold MA, Garcia Y, Sharma SK, Darus CJ, Aghajanian C, Okamoto A, Wu X, Safin R, Wu F, Molinero L, Maiya V, Khor VK, Lin YG, Pignata S. Atezolizumab, Bevacizumab, and Chemotherapy for Newly Diagnosed Stage III or IV Ovarian Cancer: Placebo-Controlled Randomized Phase III Trial (IMagyn050/GOG 3015/ENGOT-OV39). J Clin Oncol. 2021 Jun 10;39(17):1842-1855. doi: 10.1200/JCO.21.00306. Epub 2021 Apr 23. Erratum In: J Clin Oncol. 2021 Jul 20;39(21):2420.

evidence: open (via page says license)

repository_institution: Koç University - Digital Collections portal

repositories_institution: Koç University - Digital Collections portal

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Moore KN, Pignata S. Trials in progress: IMagyn050/GOG 3015/ENGOT-OV39. A Phase III, multicenter, randomized study of atezolizumab versus placebo administered in combination with paclitaxel, carboplatin, and bevacizumab to patients with newly-diagnosed stage III or stage IV ovarian, fallopian tube, or primary peritoneal cancer. Int J Gynecol Cancer. 2019 Jan 10:ijgc-2018-000071. doi: 10.1136/ijgc-2018-000071. Online ahead of print.

sponsor_collaborators: European Network of Gynaecological Oncological Trial Groups (ENGOT)

location_facility: Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica

location_facility: Ospedale Mauriziano Umberto 1; Ginecologia - Oncologia

location_facility: Krankenhaus Der Barmherzigen Brüder Graz; Gynäkologie

location_facility: Women's hospital school of medicine Zhejiang University

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

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

location_facility: The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Northeast Georgia Medical Center; Oncology Research Dept-5C

location_facility: Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie;Klinika Ginekologii Onkologicznej

location_facility: University of Pennsylvania Health System; Cancer Center

location_facility: Maine Medical Partners Women's Health; Gyn-Oncology

location_facility: Texas Oncology San Antonio Medical Center

location_facility: Southwest Gynecologic Oncology Associates, Inc.

location_facility: Policlinico S.Orsola-Malpighi; Istituto Oncologia R. Addarii

location_facility: Dell Seton Medical Center at UT-Seton Infusion Center; Research Department

location_facility: Fairview Hospital; Cleveland Clinic Cancer Center

location_facility: Universitätsklinikum Hamburg-Eppendorf (UKE); Klinik und Poliklinik für Gynäkologie

location_facility: Tianjin Central Hospital of Gynecology Obstetrics.

location_facility: University of Kentucky; Gynecologic Oncology

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: University of Colorado Hospital - Anschutz Cancer Pavilion

location_facility: Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde

location_facility: Istanbul University Cerrahpasa Medical Faculty; Obstetrics and Gynecology

location_facility: Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia

location_facility: National Hospital Organization Hokkaido Cancer Center

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

location_facility: St.Vincent Health System; Gynecologic Oncology

location_facility: Karolinska Hospital; Oncology - Radiumhemmet

location_facility: Ospedale Silvestrini; Oncologia ed Ematologia

location_facility: Centro Integral Oncologico Clara Campal; Servicio de Oncología

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: Oslo Universitetssykehus HF; Radiumhospitalet

location_facility: Universitätsklinikum Ulm Am Michelsberg; Frauenklinik

location_facility: Universitätsklinikum Dresden; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Onkologicka klinika UK 2.LF a FN v Motole

location_facility: Clinical Oncology Dispensary of Ministry of Health of Tatarstan

location_facility: Kliniken Essen Mitte Evang. Huyssens Stiftung/Knappschaft GmbH

location_facility: Universitätsklinikum Greifswald; Klinik für Frauenheilkunde und Brustzentrum

location_facility: A.O.Spedali Civili; Ostetricia e Ginecologia

location_facility: Turku Uni Central Hospital; Gynaecology Dept

location_facility: St. Petersburg Oncology & Gynecology; City Clinical Oncology Dispensary

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Chaim Sheba Medical Center; Obstetrics and Gynecology

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

location_facility: Niigata University Medical & Dental Hospital

location_facility: The Royal North Shore Hospital; Northern Sydney Cancer Centre

location_facility: Landeskrankenhaus Salzburg; Gynäkologie Und Onkologie

location_facility: Ohio State University, Arthur James Cancer Hospital

location_facility: Guangxi Cancer Hospital of Guangxi Medical University

location_facility: Policlinico A. Gemelli e C.I.C.; Area Salute della Donna

location_facility: Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu; Oddzia? Ginekologii Onkologicznej

location_facility: Clinique Sainte Catherine; Hopital De Semaine

location_facility: Abington Mem Hosp-Abington; Rose. Can Ctr,Gyn Onc Ins

location_facility: Oncology Associates of Oregon, P.C.; Willamette Valley Cancer Institute

location_facility: Sarasota Memorial Health Care System; Cancer Research Program

location_facility: Eastern Connecticut Hematology and Oncology Associates; (ECHO)

location_facility: Hospital Universitario la Fe; Servicio de Oncologia

location_facility: Forsythe Memorial Hospital Inc., dba Novant Health Oncology Specialists

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

location_facility: Azienda Ospedaliera Universitaria Federico II

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

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Metro-Minnesota Community Oncology Research Consortium

location_facility: Monument Health Rapid City Hospital, Inc.

location_facility: University Hospital of Patras Medical Oncology

location_facility: Oklahoma Cancer Specialists and Research Institute

location_facility: Ctr Jean Bernard Clin V. Hugo; Service d'Oncologie Méd

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

location_facility: Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)

location_facility: Arcispedale Santa Maria Nuova; Oncologia

location_facility: Meir Medical Center; Obstetrics and Gynecology

location_facility: University of Oklahoma; Stephenson Oklahoma Canc Ctr

location_facility: Koc University Medical Faculty; Department of Gynecology & Obstetrics

location_facility: Uni Hospital of Ioannina; Oncology Dept.

location_facility: Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde

location_facility: University of Iowa Hospital & Clinic; Division of Hematology/Oncology

location_facility: Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda

location_facility: New York Univ Medical Center; Obstetrics & Gynecolog

location_facility: Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe

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

location_facility: IRCCS S. Raffaele; Ginecologia Oncologica

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

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

location_facility: HELIOS Dr. Horst Schmidt Kliniken Wiesbaden; Klinik für Gynäkologie und gynäkologische Onkologie

location_facility: Fundacion Hospital de Alcorcon; Servicio de Oncologia

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Harbin Medical University Cancer Hospital

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: California Pacific Medical Center Research Institute

location_facility: Campus Virchow-Klinikum Charité; Centrum 17; Klinik für Gynäkologie

location_facility: Ankara University Medical Faculty; Medikal Onkoloji

location_facility: Cooper Health System; MD Anderson Cancer Center

location_facility: Novant Health Presbyterain Medical Center

location_facility: Uni Hospital Linkoeping; Dept. of Oncology

location_facility: Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology

location_facility: University Hospital Ostrava; Fakultní nemocnice

location_facility: N.N.Burdenko Main Military Clinical Hospital; Oncology Dept

location_facility: University of Washington Seattle Cancer Care Alliance

location_facility: Shaare Zedek Medical Center; Oncology Dept

location_facility: Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica

location_facility: Memorial Sloan Kettering Cancer Center; MSK Monmouth

location_facility: Miami Cancer Institute of Baptist Health, Inc.

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

location_facility: A. O. Città della Salute e della Scienza; Unità di Oncologia Ginecologica

location_facility: Universitätsklinikum Essen; Zentrum Für Frauenheilkunde

location_facility: Zhongda Hospital Affiliated to Southeast University

location_facility: Baskent Universitesi Ankara Hastanesi; T?bbi Onkoloji Bölümü

location_facility: Ospedale Antonio Perrino; Oncologia Medica

location_facility: Moores Cancer Center at UC San Diego Health

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Centre Léon Bérard; Centre régional; le cancer Rhône-Alpes

location_facility: Centre Rene Huguenin; CONSULT SPECIALISEES

location_facility: Centrum Onkologii Instytut im. M.Sklodowskiej-Curie; Klinika Ginekologii Onkologicznej

location_facility: St. Elizabeth Edgewood; Cancer Care Center? for Account St. Elizabeth Edgewood

location_facility: University of California San Francisco Cancer Center

location_facility: EUROMEDICA General Clinic of Thessaloniki; Medical Oncology Dept - Oncomedicare

location_facility: UT Southwestern Medical Center at Dallas; Department of Pathology

location_facility: Ospedale Degli Infermi - Faenza; Oncologia Medica

location_facility: Universitätsklinikum Heidelberg; Nationales Centrum für Tumorerkrankungen (NCT)

location_facility: Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica

title: A Phase III, Multicenter, Randomized, Study of Atezolizumab Versus Placebo Administered in Combination With Paclitaxel, Carboplatin, and Bevacizumab to Patients With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

location_country:
Finland
Germany
Poland
Australia
Brazil
Japan
Turkey
Czechia
France
Denmark
United States
Belgium
China
Italy
Norway
Sweden
Austria
Korea, Republic of
Spain
Greece
Russian Federation
Israel


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 participants with medullary thyroid cancer (MTC), RET-altered NSCLC and other RET-altered solid tumors.

ReferenceCitation: Subbiah V, Cassier PA, Siena S, Garralda E, Paz-Ares L, Garrido P, Nadal E, Vuky J, Lopes G, Kalemkerian GP, Bowles DW, Seetharam M, Chang J, Zhang H, Green J, Zalutskaya A, Schuler M, Fan Y, Curigliano G. Pan-cancer efficacy of pralsetinib in patients with RET fusion-positive solid tumors from the phase 1/2 ARROW trial. Nat Med. 2022 Aug;28(8):1640-1645. doi: 10.1038/s41591-022-01931-y. Epub 2022 Aug 12.

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

repositories_concat: PubMed Central;air.unimi.it

ReferenceCitation: Popat S, Liu SV, Scheuer N, Hsu GG, Lockhart A, Ramagopalan SV, Griesinger F, Subbiah V. Addressing challenges with real-world synthetic control arms to demonstrate the comparative effectiveness of Pralsetinib in non-small cell lung cancer. Nat Commun. 2022 Jun 17;13(1):3500. doi: 10.1038/s41467-022-30908-1.

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.

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

location_facility: University of Colorado Anschutz Medical Campus

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

location_facility: Severance Hospital, Yonsei University Health System; Oncology

location_facility: The affiliated Cancer Hospital, School of Medicine, UESTC

location_facility: Washington University School of Medicine in St. Louis

location_facility: Asst Grande Ospedale Metropolitano Niguarda

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

location_facility: Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez

location_facility: First Affiliated Hospital of Gannan Medical University

location_facility: Pius-Hospital; Klinik fuer Haematologie und Onkologie

location_facility: University College London Hospitals NHS Foundation Trust; NIHR UCLH Clinical Research Facility

location_facility: Sylvester Comprehensive Cancer Center; University of Miami School of Medicine

location_facility: IEO; Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Weill Cornell Medical College-New York Presbyterian Hospital

location_facility: Tianjin Medical University Cancer Institute & Hospital

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

location_facility: Vall d?Hebron Institute of Oncology (VHIO), Barcelona

location_facility: Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia


summary: This is a Phase III, multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of atezolizumab versus placebo in participants with RCC who are at high risk of disease recurrence following nephrectomy.

ReferenceCitation: Pal SK, Uzzo R, Karam JA, Master VA, Donskov F, Suarez C, Albiges L, Rini B, Tomita Y, Kann AG, Procopio G, Massari F, Zibelman M, Antonyan I, Huseni M, Basu D, Ci B, Leung W, Khan O, Dubey S, Bex A. Adjuvant atezolizumab versus placebo for patients with renal cell carcinoma at increased risk of recurrence following resection (IMmotion010): a multicentre, randomised, double-blind, phase 3 trial. Lancet. 2022 Oct 1;400(10358):1103-1116. doi: 10.1016/S0140-6736(22)01658-0. Epub 2022 Sep 10.

ReferenceCitation: Marconi L, Sun M, Beisland C, Klatte T, Ljungberg B, Stewart GD, Dabestani S, Choueiri TK, Bex A. Prevalence, Disease-free, and Overall Survival of Contemporary Patients With Renal Cell Carcinoma Eligible for Adjuvant Checkpoint Inhibitor Trials. Clin Genitourin Cancer. 2021 Apr;19(2):e92-e99. doi: 10.1016/j.clgc.2020.12.005. Epub 2021 Jan 7.

location_facility: Universitätsklinikum des Saarlandes; Klinik für Urologie und Kinderurologie

location_facility: Tokyo Medical and Dental University Hospital

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: University of California Irvine Medical Center

location_facility: Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii

location_facility: Ankara Uni School of Medicine; Medical Oncology

location_facility: Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary

location_facility: Institut Mutualiste Montsouris; Oncologie

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

location_facility: CHU Henri Mondor; Service d'Oncologie Medicale

location_facility: Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

location_facility: Fairview Hospital; Cleveland Clinic Cancer Center

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Sociedad de Investigaciones Medicas Ltda (SIM)

location_facility: Clinic for Urology; Military Medical Academy

location_facility: Taichung Veterans General Hospital; Division of Urology

location_facility: Chaim Sheba medical center, Oncology division

location_facility: Herlev Hospital; Afdeling for Kræftbehandling

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

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Tokyo Women?s Medical University Adachi Medical Center

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: University of Texas Southwestern Medical Center

location_facility: Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4

location_facility: Vanderbilt University Medical Center; Vanderbilt University

location_facility: Cleveland Clinic Foundation; Hematology and Oncology

location_facility: VU Medisch Centrum; VU University Medical Center

location_facility: BC Cancer ? Kelowna (Sindi Ahluwalia Hawkins Centre)

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

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

location_facility: Fondazione IRCCS Policlinico San Matteo, Oncologia

location_facility: Hospital Clínic i Provincial; Servicio de Oncología

location_facility: Landeskrankenhaus Salzburg; Universitätsklinik für Urologie und Andrologie der PMU

location_facility: Queen Elizabeth II Health Sciences Centre; Oncology

location_facility: Niigata University Medical & Dental Hospital

location_facility: Maharaj Nakorn Chiangmai Hospital; Department of Surgery/ Urology unit

location_facility: Altai Region Oncology Dispensory; Oncology

location_facility: Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia

location_facility: Bradford Hill Centro de Investigaciones Clinicas

location_facility: University of Rochester Medical Center; Urology

location_facility: Clinic for Urology, Clinical Center of Serbia; Clinic for Urology

location_facility: Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica

location_facility: Division of Urological surgery; Department of surgery, Chulalongkorn University

location_facility: University of North Carolina at Chapel Hill

location_facility: Narodowy Inst.Onkol.im.Sk?odowskiej-Curie Pa?stw.Inst.Badawczy Kraków; Klinika Onkologii Klinicznej

location_facility: Ordensklinikum Linz Elisabethinen; Abteilung für Urologie und Andrologie

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

location_facility: Hillcrest Hospital; Hirsch Cancer Center

location_facility: Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu; Oddzia? Chemioterapii

location_facility: Chang Gung Medical Foundation-Linkou, Urinary Oncology

location_facility: Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.

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

location_facility: University of Oklahoma; Stephenson Oklahoma Canc Ctr

location_facility: Florida Cancer Specialists-Broadway, Fort Myers

location_facility: Hadassah Ein Karem Hospital; Oncology Dept

location_facility: The University of Chicago Biological Sciences; Dept. of Medicine, Section of Hematology/Oncology

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: China Medical University Hospital; Urology

location_facility: Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie

location_facility: Laura and ISAAC Perlmutter Cancer Center at NYU Langone.

location_facility: Nouvel Hopital Civil - CHU Strasbourg; Urologie

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

location_facility: The Ottawa Hospital Cancer Centre; Oncology

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital; Oncology Day Unit

location_facility: Centre Hospitalier universitaire de Québec/ Hotel Dieu de Québec

location_facility: National Taiwan University Hospital, Department of Urology

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen

location_facility: Sourasky Medical Center; Oncology Department

location_facility: TAIPEI VETERANS GENERAL HOSPITAL, Urology

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

location_facility: Lviv Com. City Clinical Hospital #8; Cardiol.Dept. for Pat. with Myocard.Infarction

location_facility: Sint Franciscus Gasthuis; Inwendige Geneeskunde

location_facility: General University Hospital; CLINIC OF ONCOLOGY

location_facility: McGill University Health Centre - Glen Site

location_facility: Loyola University Medical Center, Cardinal Bernardin Cancer Center

location_facility: University of Utah; Huntsman Cancer Hospital

location_facility: Emory Uni - Winship Cancer Center; Hematology/Oncology

location_facility: Fudan University Shanghai Cancer Center; Medical Oncology

location_facility: Medizinische Hochschule Hannover; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie

location_facility: North York General Hospital; Inpatient Pharmacy

location_facility: Gazi University Medical Faculty; Department of ?nternal Medicine

location_facility: Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont

location_facility: Medizinische Universität Wien; Universitätsklinik für Urologie, Arbeitsgruppe Nierenzellkarzinome

location_facility: Belinson Medical Center, Division of Oncology

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: Centrum Onkologii Ziemi Lubelskiej im. ?w. Jana z Dukli

location_facility: Universitätsklinikum Tübingen; Klinik für Urologie

location_facility: Fox Chase Cancer Center; Hematology/Oncology

location_facility: Calvary Mater Newcastle; Medical Oncology

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

location_facility: Hospital Univ. Central de Asturias; Servicio de Oncologia

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

location_facility: New York Oncology Hematology at Albany Medical Center

location_facility: CI Dnipropetrovsk CMCH #4 MA of MOHU Ch of Oncology and MR

title: A Phase III, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of Atezolizumab (Anti-PD-L1 Antibody) as Adjuvant Therapy in Patients With Renal Cell Carcinoma at High Risk of Developing Metastasis Following Nephrectomy

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Thailand
Turkey
Chile
Czechia
Canada
Serbia
France
Denmark
United States
Ukraine
Belgium
China
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel


title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Ranging, Phase 2b Study of the Safety and Efficacy of Continuous 48-Hour Intravenous Infusions of BMS-986231 in Hospitalized Patients With Heart Failure and Impaired Systolic Function

acronym: STANDUP AHF

summary: A Study to Evaluate Safety and Efficacy of Continuous 48-Hour Intravenous Infusions of HNO Donor in Hospitalized Patients with Heart Failure and Impaired Systolic Function

ReferenceCitation: Felker GM, McMurray JJV, Cleland JG, O'Connor CM, Teerlink JR, Voors AA, Belohlavek J, Bohm M, Borentain M, Bueno H, Cole RT, DeSouza MM, Ezekowitz JA, Filippatos G, Lang NN, Kessler PD, Martinez FA, Mebazaa A, Metra M, Mosterd A, Pang PS, Ponikowski P, Sato N, Seiffert D, Ye J. Effects of a Novel Nitroxyl Donor in Acute Heart Failure: The STAND-UP AHF Study. JACC Heart Fail. 2021 Feb;9(2):146-157. doi: 10.1016/j.jchf.2020.10.012. Epub 2020 Nov 25.

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

repository_institution: The University of Glasgow - Enlighten: Publications

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

ReferenceCitation: Cowart D, Venuti RP, Lynch K, Guptill JT, Noveck RJ, Foo SY. A Phase 1 Randomized Study of Single Intravenous Infusions of the Novel Nitroxyl Donor BMS-986231 in Healthy Volunteers. J Clin Pharmacol. 2019 May;59(5):717-730. doi: 10.1002/jcph.1364. Epub 2019 Jan 31.

location_country:
Germany
Italy
Poland
United Kingdom
Argentina
Japan
Netherlands
United States
Spain
Greece
Czechia
Canada
France

location_facility: Medical University of South Carolina - PPDS

location_facility: Indiana University Health Methodist Hospital

location_facility: Wexner Medical Center at The Ohio State University

location_facility: University of North Carolina at Chapel Hill

location_facility: University of Texas Southwestern Medical Center

location_facility: University of Arizona Sarver Heart Center


title: Randomized, OpenLabel, Phase 3 Trial of Nivolumab Plus Ipilimumab or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Early Stage NSCLC

acronym: CheckMate 816

summary:
The purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus ipilimumab's safety and effectiveness in treating resectable NSCLC.

This study has multiple primary endpoints.

ReferenceCitation: Forde PM, Spicer J, Lu S, Provencio M, Mitsudomi T, Awad MM, Felip E, Broderick SR, Brahmer JR, Swanson SJ, Kerr K, Wang C, Ciuleanu TE, Saylors GB, Tanaka F, Ito H, Chen KN, Liberman M, Vokes EE, Taube JM, Dorange C, Cai J, Fiore J, Jarkowski A, Balli D, Sausen M, Pandya D, Calvet CY, Girard N; CheckMate 816 Investigators. Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer. N Engl J Med. 2022 May 26;386(21):1973-1985. doi: 10.1056/NEJMoa2202170. Epub 2022 Apr 11.

publisher_dissemination: Massachusetts Medical Society

sponsor_collaborators:
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd

location_country:
Italy
Hungary
Argentina
Romania
Japan
Brazil
United States
China
Korea, Republic of
Spain
Greece
Turkey
Taiwan
Canada
France

location_facility: Fundacao Pio Xii Hosp Cancer De Barretos


lead_sponsor: Eisai Co., Ltd.

summary: The name of this trial is MissionAD1. This phase 3 study consists of a Core and Open Label Extension (OLE) Phase in participants with Early Alzheimer's Disease (EAD), and will be conducted to evaluate the efficacy and safety of E2609. The Core is a 24-month treatment, multicenter, double blind, placebo controlled parallel group study. The OLE is a 24-month treatment, one group study. The data for the studies E2609-G000-301 (NCT02956486, MissionAD1) and E2609-G000-302 (NCT03036280, MissionAD2) will be pooled.

ReferenceCitation: Bullich S, Mueller A, De Santi S, Koglin N, Krause S, Kaplow J, Kanekiyo M, Roe-Vellve N, Perrotin A, Jovalekic A, Scott D, Gee M, Stephens A, Irizarry M. Evaluation of tau deposition using 18F-PI-2620 PET in MCI and early AD subjects-a MissionAD tau sub-study. Alzheimers Res Ther. 2022 Jul 27;14(1):105. doi: 10.1186/s13195-022-01048-x.

sponsor_collaborators:
Eisai Co., Ltd.
Biogen

location_facility:
Facility #8
Facility #9
Facility #1
Eisai Trial Site 1
Facility #5
Facility #11
Eisai Trial site 5
Facility #3
Facility #2
Eisai Trial Site 2
Facility #4
Eisai Trial Site 3
Facility #10
Eisai Trial site 2
Eisai Trial Site 4
Facility #7
Facility #6
Eisai Trail Site 1

title: A Placebo-Controlled, Double-Blind, Parallel-Group, 24 Month Study With an Open-Label Extension Phase to Evaluate the Efficacy and Safety of Elenbecestat (E2609) in Subjects With Early Alzheimer's Disease

location_country:
Germany
Poland
Portugal
Slovakia
United Kingdom
Argentina
Australia
Japan
Austria
United States
Korea, Republic of
Spain
Greece
Czechia
Bulgaria
Canada
Russian Federation
France