title: A Phase 3, Randomized, Double-Blind Study of Pamrevlumab or Placebo in Combination With Either Gemcitabine Plus Nab-paclitaxel or FOLFIRINOX as Neoadjuvant Treatment in Patients With Locally Advanced, Unresectable Pancreatic Cancer

summary: This is a Phase 3, randomized, double-blind trial to evaluate the efficacy and safety of neoadjuvant treatment with pamrevlumab or placebo in combination with either gemcitabine plus nab-paclitaxel (G/NP) or FOLFIRINOX in the treatment of locally advanced, unresectable pancreatic cancer subjects.

lead_sponsor: FibroGen

location_country:
Italy
Austria
United States
Spain
Germany
France
Israel
Belgium
China
Canada
United Kingdom
Korea, Republic of

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: Huashan Hospital affiliated with Fudan University

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

location_facility: California Pacific Medical Center - Sutter Health

location_facility: Elmhurst Memorial Hospital - Nancy W. Knowles Cancer Center

location_facility: Princess Margaret Cancer Centre/University Health Network

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Institut Catalá d'Oncologia (ICO Girona). Hospital Dr. Josep Trueta

location_facility: Instituto Scientifico Romagnolog per lo Studio e la Cura dei Tumori

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Institut de Cancérologie de l'Ouest Pays de Loire

location_facility: Reading Hospital McGlinn Cancer Institute

location_facility: Klinikum der Universität München, Medizinische Klinik und Poliklinik III

location_facility: Chonnam National University Hwasun Hospital

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

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Seoul National University Budang Hospital

location_facility: Norton Cancer Institute, Audubon Hospital Campus

location_facility: Indiana University Melvin and Bren Simon Comprehensive Cancer Center

location_facility: St. Joseph's Hospital and Medical Cancer Center

location_facility: Technische Universität Dresden, Medizinische Klinik und Poliklinik I

location_facility: Grande Ospedale Metropolitano Niguarda, Oncologia Medica Falck

location_facility: Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie


ReferenceType: background

ReferenceCitation: Cardillo TM, Govindan SV, Sharkey RM, Trisal P, Arrojo R, Liu D, Rossi EA, Chang CH, Goldenberg DM. Sacituzumab Govitecan (IMMU-132), an Anti-Trop-2/SN-38 Antibody-Drug Conjugate: Characterization and Efficacy in Pancreatic, Gastric, and Other Cancers. Bioconjug Chem. 2015 May 20;26(5):919-31. doi: 10.1021/acs.bioconjchem.5b00223. Epub 2015 May 8.

ReferenceCitation: Starodub AN, Ocean AJ, Shah MA, Guarino MJ, Picozzi VJ Jr, Vahdat LT, Thomas SS, Govindan SV, Maliakal PP, Wegener WA, Hamburger SA, Sharkey RM, Goldenberg DM. First-in-Human Trial of a Novel Anti-Trop-2 Antibody-SN-38 Conjugate, Sacituzumab Govitecan, for the Treatment of Diverse Metastatic Solid Tumors. Clin Cancer Res. 2015 Sep 1;21(17):3870-8. doi: 10.1158/1078-0432.CCR-14-3321. Epub 2015 May 5.

ReferenceCitation: Goldenberg DM, Cardillo TM, Govindan SV, Rossi EA, Sharkey RM. Trop-2 is a novel target for solid cancer therapy with sacituzumab govitecan (IMMU-132), an antibody-drug conjugate (ADC). Oncotarget. 2015 Sep 8;6(26):22496-512. Erratum in: Oncotarget. 2020 Mar 10;11(10):942.

ReferenceCitation: Vlachostergios PJ, Jakubowski CD, Niaz MJ, Lee A, Thomas C, Hackett AL, Patel P, Rashid N, Tagawa ST. Antibody-Drug Conjugates in Bladder Cancer. Bladder Cancer. 2018 Jul 30;4(3):247-259. doi: 10.3233/BLC-180169. Review.

ReferenceCitation: Goldenberg DM, Stein R, Sharkey RM. The emergence of trophoblast cell-surface antigen 2 (TROP-2) as a novel cancer target. Oncotarget. 2018 Jun 22;9(48):28989-29006. doi: 10.18632/oncotarget.25615. eCollection 2018 Jun 22. Review.

ReferenceCitation: Han C, Bellone S, Schwartz PE, Govindan SV, Sharkey RM, Goldenberg DM, Santin AD. Sacituzumab Govitecan (IMMU-132) in treatment-resistant uterine serous carcinoma: A case report. Gynecol Oncol Rep. 2018 May 23;25:37-40. doi: 10.1016/j.gore.2018.05.009. eCollection 2018 Aug.

ReferenceCitation: Gray JE, Heist RS, Starodub AN, Camidge DR, Kio EA, Masters GA, Purcell WT, Guarino MJ, Misleh J, Schneider CJ, Schneider BJ, Ocean A, Johnson T, Gandhi L, Kalinsky K, Scheff R, Messersmith WA, Govindan SV, Maliakal PP, Mudenda B, Wegener WA, Sharkey RM, Goldenberg DM. Therapy of Small Cell Lung Cancer (SCLC) with a Topoisomerase-I-inhibiting Antibody-Drug Conjugate (ADC) Targeting Trop-2, Sacituzumab Govitecan. Clin Cancer Res. 2017 Oct 1;23(19):5711-5719. doi: 10.1158/1078-0432.CCR-17-0933. Epub 2017 Jul 5.

ReferenceCitation: Ocean AJ, Starodub AN, Bardia A, Vahdat LT, Isakoff SJ, Guarino M, Messersmith WA, Picozzi VJ, Mayer IA, Wegener WA, Maliakal P, Govindan SV, Sharkey RM, Goldenberg DM. Sacituzumab govitecan (IMMU-132), an anti-Trop-2-SN-38 antibody-drug conjugate for the treatment of diverse epithelial cancers: Safety and pharmacokinetics. Cancer. 2017 Oct 1;123(19):3843-3854. doi: 10.1002/cncr.30789. Epub 2017 May 30.

ReferenceCitation: Sahota S, Vahdat LT. Sacituzumab govitecan: an antibody-drug conjugate. Expert Opin Biol Ther. 2017 Aug;17(8):1027-1031. doi: 10.1080/14712598.2017.1331214. Epub 2017 May 22. Review.

ReferenceCitation: Burki TK. Sacituzumab govitecan activity in advanced breast cancer. Lancet Oncol. 2017 May;18(5):e246. doi: 10.1016/S1470-2045(17)30232-2. Epub 2017 Mar 23.

ReferenceCitation: Bardia A, Mayer IA, Diamond JR, Moroose RL, Isakoff SJ, Starodub AN, Shah NC, O'Shaughnessy J, Kalinsky K, Guarino M, Abramson V, Juric D, Tolaney SM, Berlin J, Messersmith WA, Ocean AJ, Wegener WA, Maliakal P, Sharkey RM, Govindan SV, Goldenberg DM, Vahdat LT. Efficacy and Safety of Anti-Trop-2 Antibody Drug Conjugate Sacituzumab Govitecan (IMMU-132) in Heavily Pretreated Patients With Metastatic Triple-Negative Breast Cancer. J Clin Oncol. 2017 Jul 1;35(19):2141-2148. doi: 10.1200/JCO.2016.70.8297. Epub 2017 Mar 14.

ReferenceCitation: Cardillo TM, Sharkey RM, Rossi DL, Arrojo R, Mostafa AA, Goldenberg DM. Synthetic Lethality Exploitation by an Anti-Trop-2-SN-38 Antibody-Drug Conjugate, IMMU-132, Plus PARP Inhibitors in BRCA1/2-wild-type Triple-Negative Breast Cancer. Clin Cancer Res. 2017 Jul 1;23(13):3405-3415. doi: 10.1158/1078-0432.CCR-16-2401. Epub 2017 Jan 9.

ReferenceCitation: Chang CH, Wang Y, Zalath M, Liu D, Cardillo TM, Goldenberg DM. Combining ABCG2 Inhibitors with IMMU-132, an Anti-Trop-2 Antibody Conjugate of SN-38, Overcomes Resistance to SN-38 in Breast and Gastric Cancers. Mol Cancer Ther. 2016 Aug;15(8):1910-9. doi: 10.1158/1535-7163.MCT-16-0219. Epub 2016 May 20.

ReferenceCitation: Faltas B, Goldenberg DM, Ocean AJ, Govindan SV, Wilhelm F, Sharkey RM, Hajdenberg J, Hodes G, Nanus DM, Tagawa ST. Sacituzumab Govitecan, a Novel Antibody--Drug Conjugate, in Patients With Metastatic Platinum-Resistant Urothelial Carcinoma. Clin Genitourin Cancer. 2016 Feb;14(1):e75-9. doi: 10.1016/j.clgc.2015.10.002. Epub 2015 Oct 19.

ReferenceCitation: Sharkey RM, McBride WJ, Cardillo TM, Govindan SV, Wang Y, Rossi EA, Chang CH, Goldenberg DM. Enhanced Delivery of SN-38 to Human Tumor Xenografts with an Anti-Trop-2-SN-38 Antibody Conjugate (Sacituzumab Govitecan). Clin Cancer Res. 2015 Nov 15;21(22):5131-8. doi: 10.1158/1078-0432.CCR-15-0670. Epub 2015 Jun 23.

ReferenceType: derived

ReferenceCitation: McCann KE, Hurvitz SA. Innovations in targeted therapies for triple negative breast cancer. Curr Opin Obstet Gynecol. 2021 Feb 1;33(1):34-47. doi: 10.1097/GCO.0000000000000671. Review.

family: McCann

full_name: Kelly E. McCann

given: Kelly E.

sequence: first

family: Hurvitz

full_name: Sara A. Hurvitz

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bso_classification: Chemistry

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genre: journal-article

genre_raw: journal-article

journal_name: Current Opinion in Obstetrics & Gynecology

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ReferenceCitation: Kalinsky K, Diamond JR, Vahdat LT, Tolaney SM, Juric D, O'Shaughnessy J, Moroose RL, Mayer IA, Abramson VG, Goldenberg DM, Sharkey RM, Maliakal P, Hong Q, Goswami T, Wegener WA, Bardia A. Sacituzumab govitecan in previously treated hormone receptor-positive/HER2-negative metastatic breast cancer: final results from a phase I/II, single-arm, basket trial. Ann Oncol. 2020 Dec;31(12):1709-1718. doi: 10.1016/j.annonc.2020.09.004. Epub 2020 Sep 15.

family: Kalinsky

full_name: K. Kalinsky

given: K.

family: Diamond

full_name: J.R. Diamond

family: Vahdat

full_name: L.T. Vahdat

family: Tolaney

full_name: S.M. Tolaney

family: Juric

full_name: D. Juric

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family: O'Shaughnessy

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family: Moroose

full_name: R.L. Moroose

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full_name: I.A. Mayer

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family: Sharkey

full_name: R.M. Sharkey

family: Maliakal

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family: Hong

full_name: Q. Hong

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family: Goswami

full_name: T. Goswami

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family: Wegener

full_name: W.A. Wegener

family: Bardia

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bso_classification: Medical research

journal_name: Annals of Oncology

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license_normalized: cc-by-nc-nd

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publisher: Elsevier BV

publisher_dissemination: Elsevier

ReferenceCitation: Rugo HS, Bardia A, Tolaney SM, Arteaga C, Cortes J, Sohn J, Marmé F, Hong Q, Delaney RJ, Hafeez A, André F, Schmid P. TROPiCS-02: A Phase III study investigating sacituzumab govitecan in the treatment of HR+/HER2- metastatic breast cancer. Future Oncol. 2020 Apr;16(12):705-715. doi: 10.2217/fon-2020-0163. Epub 2020 Mar 30.

name: Department of Medicine (Hematology/Oncology), University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, CA 94115, USA

name: Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA

name: Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA 02215, USA

name: Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, TX, USA

name: Medical Oncology Department, IOB Institute of Oncology, Quirosalud Group, Madrid & Barcelona, Spain and Senior clinical Researcher, Vall d´Hebron Institute of Oncology (VHIO), Barcelona, Spain

name: Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea

name: Medical Faculty Mannheim, Heidelberg University, University Hospital Mannheim, Germany

name: Immunomedics, Morris Plains, NJ 07950, USA

name: Department of Medical Oncology, Institut Gustave Roussy, Villejuif, France

name: Barts Cancer Institute, Queen Mary University of London, London, UK

repository_institution: Yonsei University Medical Library - YUHSpace

location_country:
Italy
United States
Netherlands
Germany
France
Belgium
Spain
Canada
United Kingdom

location_facility: Allina Health, Virginia Piper Cancer Institute

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center

location_facility: Emory University - Winship Cancer Institute

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Hospital Clinico Universitario de Santiago de Compostela

location_facility: University of California, Irvine Medical Center-Chao Family Comprehensive Cancer Center

location_facility: Oncology & Hematology Associates of Southwest Virginia, Inc. DBA Blue Ridge Cancer Care

location_facility: Centrum für Hämatologie und Onkologie Bethanien

location_facility: The West Clinic, PC dba West Cancer Center

location_facility: University of California, San Diego Moores Cancer Center

location_facility: Masonic Cancer Center, University of Minnesota

location_facility: Centre Hospitalier de L'Universite de Montreal - Hôpital Notre-Dame

location_facility: Laura and Isaac Perlmutter Cancer Center/NYU Langone Health

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: IFO Istituto Nazionale dei Tumori Regina Elena

location_facility: Los Angeles Hematology Oncology Medical Group

location_facility: University of Texas Southwestern Harold C. Simmons Comprehensive Cancer Center

location_facility: DIAKOVERE Krankenhaus gGmbH Henriettenstift - Standort Kirchrode

location_facility: Mercy Medical Center, Medical Oncology & Hematology

location_facility: University of Miami - Sylvester Comprehensive Cancer Center

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: UT Health San Antonio - Mays Cancer Center

location_facility: Southern California Permanente Medical Group

location_facility: Houston Methodist Hospital/Houston Methodist Cancer Center

location_facility: UCLA Department of Medicine - Hematology/Oncology

location_facility: Institut Régional du Cancer de Montpellier

location_facility: Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto

location_facility: Centre Hospitalier Universitaire de Sherbrooke - Fleurimont

location_facility: Washington University School of Medicine - Siteman Cancer Center

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Azienda Ospedaliera San Gerardo di Monza

location_facility: Nationales Centrum für Tumorerkrankungen - Heidelberg

location_facility: Hospital Quirónsalud Barcelona Instituto Oncologico Baselga

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

location_facility: Praxisklinik für Hämatologie und Onkologie Koblenz

title: Phase 3 Study of Sacituzumab Govitecan (IMMU-132) Versus Treatment of Physician's Choice (TPC) in Subjects With Hormonal Receptor-Positive (HR+) Human Epidermal Growth Factor Receptor 2 (HER2) Negative Metastatic Breast Cancer (MBC) Who Have Failed at Least Two Prior Chemotherapy Regimens

summary: The primary objective of this study is to assess and compare the efficacy and safety of sacituzumab govitecan-hzi versus treatment of physician's choice (TPC) in participants with hormonal receptor-positive (HR+) human epidermal growth factor receptor 2 (HER2-) negative metastatic breast cancer (MBC).


title: A Randomized, Open-label, Phase 3 Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma (A.R.R.O.W.2)

summary: Compare efficacy of 56 mg/m2 carfilzomib administered once-weekly in combination with lenalidomide and dexamethasone (KRd 56 mg/m2) to 27 mg/m2 carfilzomib administered twice-weekly in combination with lenalidomide and dexamethasone (KRd 27 mg/m2) in subjects with relapsed or refractory multiple myeloma (RRMM) with 1 to 3 prior lines of therapy.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: Yes

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

lead_sponsor: Amgen

location_country:
Austria
Sweden
Netherlands
Germany
Finland
France
Czechia
Bulgaria
Greece
Japan
Lithuania
Romania
Russian Federation
Slovakia
Spain
Turkey
United States

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi

location_facility: Federal centre of heart, blood and endocrinology Almazova

location_facility: Bagcilar Medipol Mega Universite Hastanesi

location_facility: Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: Institut Universitaire du Cancer Toulouse Oncopole

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

location_facility: Vilnius University Hospital Santaros Clinic Public Institution

location_facility: Spitalul Clinic Municipal de Urgenta Timisoara

location_facility: Centre Hospitalier Universitaire de Nancy - Hopital de Brabois

location_facility: Japanese Red Cross Society Himeji Hospital

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

location_facility: Spitalul Universitar de Urgenta Bucuresti

location_facility: Univerzitna nemocnica Bratislava, Nemocnica sv Cyrila a Metoda

location_facility: Hartford HealthCare Cancer Institute at The Hospital of Central Connecticut

location_facility: University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Spitalul Clinic Dr Gavril Curteanu Oradea

location_facility: National Hospital Organization Shibukawa Medical Center

location_facility: National Hospital Organization Okayama Medical Center

location_facility: Theagenion Cancer Hospital of Thessaloniki

location_facility: Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie

location_facility: Moscow State Budget Healthcare Institution City clinical Hospital 52 of Moscow Healthcare Department

location_facility: University Hospital Kyoto Prefectural University of Medicine

location_facility: Institutul Oncologic Prof Dr Ion Chiricuta

location_facility: Rocky Mountain Cancer Centers Denver Midtown

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden

location_facility: Specialized Hospital for Active Treatment of Hematology Diseases EAD

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Centre Hospitalier Universitaire Archet 2

location_facility: Spitalul Clinic Judetean de Urgenta Sibiu

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics Public Institution

location_facility: Dokuz Eylul Universitesi Arastirma Uygulama Hastanesi

location_facility: General University Hospital of Patras Panagia i Voithia

location_facility: General Hospital of Thessaloniki Georgios Papanikolaou

location_facility: SBHI of Moscow city City clinical hospital na S P Botkin of Moscow city Healthcare department

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

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Erciyes Universitesi Tip Fakultesi Mehmet Kemal Dedeman Hematoloji-Onkoloji Hastanesi

location_facility: United States Oncology Regulatory Affairs Corporate Office

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

location_facility: US Oncology Research Investigational Products Center

location_facility: Charité, Universitätsklinikum Berlin, Campus Benjamin Franklin

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


type: Other Identifier

title: A Randomized, Multicenter, Open-Label, Phase 3 Study to Compare the Efficacy and Safety of Acalabrutinib (ACP-196) in Combination With Venetoclax With and Without Obinutuzumab Compared to Investigator's Choice of Chemoimmunotherapy in Subjects With Previously Untreated Chronic Lymphocytic Leukemia Without Del(17p) or TP53 Mutation

summary: The purpose of this study is to evaluate the efficacy and safety of acalabrutinib in combination with venetoclax and acalabrutinib in combination with venetoclax with and without obinutuzumab compared to chemoimmunotherapy in subjects with previously untreated CLL.

ReferenceCitation: Davids MS, Lampson BL, Tyekucheva S, Wang Z, Lowney JC, Pazienza S, Montegaard J, Patterson V, Weinstock M, Crombie JL, Ng SY, Kim AI, Jacobson CA, LaCasce AS, Armand P, Arnason JE, Fisher DC, Brown JR. Acalabrutinib, venetoclax, and obinutuzumab as frontline treatment for chronic lymphocytic leukaemia: a single-arm, open-label, phase 2 study. Lancet Oncol. 2021 Oct;22(10):1391-1402. doi: 10.1016/S1470-2045(21)00455-1. Epub 2021 Sep 14.

family: Davids

full_name: Matthew S Davids

given: Matthew S

family: Lampson

full_name: Benjamin L Lampson

given: Benjamin L

family: Tyekucheva

full_name: Svitlana Tyekucheva

given: Svitlana

family: Wang

full_name: Zixu Wang

given: Zixu

family: Lowney

full_name: Jessica C Lowney

given: Jessica C

family: Pazienza

full_name: Samantha Pazienza

given: Samantha

family: Montegaard

full_name: Josie Montegaard

given: Josie

family: Patterson

full_name: Victoria Patterson

given: Victoria

family: Weinstock

full_name: Matthew Weinstock

given: Matthew

family: Crombie

full_name: Jennifer L Crombie

given: Jennifer L

family: Ng

full_name: Samuel Y Ng

given: Samuel Y

family: Kim

full_name: Austin I Kim

given: Austin I

family: Jacobson

full_name: Caron A Jacobson

given: Caron A

family: LaCasce

full_name: Ann S LaCasce

given: Ann S

family: Armand

full_name: Philippe Armand

given: Philippe

family: Arnason

full_name: Jon E Arnason

given: Jon E

family: Fisher

full_name: David C Fisher

given: David C

family: Brown

full_name: Jennifer R Brown

given: Jennifer R

journal_name: The Lancet Oncology

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Gordon MJ, Danilov AV. The evolving role of Bruton's tyrosine kinase inhibitors in chronic lymphocytic leukemia. Ther Adv Hematol. 2021 Jan 30;12:2040620721989588. doi: 10.1177/2040620721989588. eCollection 2021. Review.

apc_source: doaj

name: The University of Texas MD Anderson Cancer Center, Houston, USA

family: Gordon

full_name: Max J. Gordon

given: Max J.

name: City of Hope National Medical Center, 1500 E Duarte Rd, Duarte, CA 91010, USA

family: Danilov

full_name: Alexey V. Danilov

given: Alexey V.

title: The evolving role of Bruton’s tyrosine kinase inhibitors in chronic lymphocytic leukemia

location_country:
Peru
Australia
Belgium
Russian Federation
Denmark
Taiwan
Ukraine
France
Poland
Slovakia
Argentina
Canada
Korea, Republic of
South Africa
Sweden
Saudi Arabia
Netherlands
Bulgaria
Hungary
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
Spain
Turkey


ReferenceCitation: Park AM, Khadka S, Sato F, Omura S, Fujita M, Hsu DK, Liu FT, Tsunoda I. Galectin-3 as a Therapeutic Target for NSAID-Induced Intestinal Ulcers. Front Immunol. 2020 Sep 23;11:550366. doi: 10.3389/fimmu.2020.550366. eCollection 2020.

family: Park

full_name: Ah-Mee Park

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family: Khadka

full_name: Sundar Khadka

given: Sundar

family: Sato

full_name: Fumitaka Sato

given: Fumitaka

family: Omura

full_name: Seiichi Omura

given: Seiichi

family: Fujita

full_name: Mitsugu Fujita

given: Mitsugu

family: Hsu

full_name: Daniel K. Hsu

given: Daniel K.

family: Liu

full_name: Fu-Tong Liu

given: Fu-Tong

family: Tsunoda

full_name: Ikuo Tsunoda

given: Ikuo

currency_apc_doaj: USD

journal_name: Frontiers in Immunology

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

lead_sponsor: Galecto Biotech AB

location_country:
Italy
United States
Germany
France
Poland
Israel
Georgia
Ireland
Belgium
Australia
Spain
Canada
United Kingdom
Ukraine

location_facility: Dr Anees Medicine Professional Corporation

location_facility: Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

location_facility: National Research Centre for Radiation Medicine of The National Academy of Medical Sciences of UKR

location_facility: University of Texas Health Sciences Center at Houston

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Lungenfachklinik Immenhausen Department for Clinical Studies

location_facility: Advanced Research for Health Improvement

location_facility: Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi

location_facility: University of Utah Health Scieces Center

location_facility: National Institute of Phthisiology and Pulmonology n.a. F.G.Yanovsky

location_facility: Studienzentrum Dr.med Falk Brunner FA fuer Innere Medizin und Pneumologie

location_facility: Groupe Hospitalier Hopitaux Universitaires Paris-Seine-Saint-Denis-Hopital Avicenne

location_facility: AOU Città della Salute e della Scienza, PO Molinette

location_facility: Institute for Respiratory Health Sir Charles Gairdner Hospital

location_facility: Firestone Institute for Respiratory Health

location_facility: CHU de la Réunion Site SUD (Terre Sainte)

location_facility: ZMS Zentrum für medizinische Studien GmbH

location_facility: Jasper Summit Research, LLC Pulmonary & Sleep Associates

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Universitaetsklinikum Leipzig Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie, P

location_facility: Hospital Universitario Central de Asturias

location_facility: Harvard Medical School -Brigham and Womens Hospital (BWH)

location_facility: Clinical Research Centre - Respiratory North Bristol NHS Trust Southmead Hospital

location_facility: Centre Hospitalier Universitaire de Rennes Hopital Pontchaillou

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Aintree Unversity Hospital NHS Foundation Trust

location_facility: University-Hospital Policlinico Vittorio Emanuele

location_facility: Piedmont Healthcare Pulmonary and Critical Care Research

location_facility: Ospedale San Giuseppe Clinica Malattie dell Apparato Respiratorio

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital (RHH)

location_facility: Centre Hospitalier Rgional et Universitaire - Hopital Bretonneau

location_facility: Klinikum Grossadern der Ludwig-Maximilians-Universitaet Muenchen

location_facility: Pulmonary Institute Rabin Medical Center

location_facility: Istituto Mediterraneo Trapianti e Terapia Alta Specializzazione (ISMETT)

location_facility: LaPorte County Institute for Clinical Research

location_facility: Oddział Kliniczny Pulmonologii i Alergologii Szpitala Uniwersyteckiego w Krakowie

location_facility: Hopitaux Universitaires de Strasborg Service de Pneumologie Nouvel Hopital Civil

location_facility: Klifeck GmbH Praxis Med. Gerald Eckhardt

location_facility: University Hospital of Mondena-AOU - Policlinico di Modena

location_facility: Instytut Gruzlicy i Chorob Pluc, I Klinika Chorob Pluc

location_facility: University of Texas Health Centre at Houston

type: EudraCT Number

source: euctr

title: GALACTIC-1 -A Randomized, Double-blind, Multicentre, Parallel, Placebo-controlled Phase 2b Study in Subjects With Idiopathic Pulmonary Fibrosis (IPF) Investigating the Efficacy and Safety of GB0139, an Inhaled Galectin-3 Inhibitor Administered Via a Dry Powder Inhaler Over 52 Weeks

summary: This is a randomized, double-blind, placebo-controlled phase 2b trial in subjects with IPF (idiopathic pulmonary fibrosis) investigating the efficacy and safety of GB0139.


type: Registry Identifier

title: A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) in Participants With Treatment-naïve, Metastatic Nonsmall Cell Lung Cancer (NSCLC) Whose Tumors Have a Tumor Proportion Score (TPS) Greater Than or Equal to 1% (LEAP-007)

summary:
The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for lenvatinib) in treatment-naïve adults with no prior systemic therapy for their metastatic non-small cell lung cancer (NSCLC) whose tumors have a programmed cell death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) greater than or equal to 1%.

The primary study hypotheses are that: 1) the combination of pembrolizumab and lenvatinib is superior to pembrolizumab alone as assessed by Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1); and 2) the combination of pembrolizumab and lenvatinib is superior to pembrolizumab alone as assessed by Overall Survival (OS).

status: Active, not recruiting

enrollment_type: Actual

ReferenceCitation: Taylor MH, Schmidt EV, Dutcus C, Pinheiro EM, Funahashi Y, Lubiniecki G, Rasco D. The LEAP program: lenvatinib plus pembrolizumab for the treatment of advanced solid tumors. Future Oncol. 2021 Feb;17(6):637-648. doi: 10.2217/fon-2020-0937. Epub 2020 Dec 10.

name: Earle A Chiles Research Institute, Providence Portland Medical Center, Portland, OR 97213, USA

family: Taylor

full_name: Matthew H Taylor

given: Matthew H

name: Department of Clinical Oncology, Merck & Co. Inc., Kenilworth, NJ 07033, USA

family: Schmidt

full_name: Emmett V Schmidt

given: Emmett V

name: Department of Clinical Research, Eisai Inc., Woodcliff Lake, NJ 07677, USA

family: Dutcus

full_name: Corina Dutcus

given: Corina

family: Pinheiro

full_name: Elaine M Pinheiro

given: Elaine M

name: Biomarker Research Translational Science Department, Eisai Co., Ltd., Tokyo, 112-0002, Japan

family: Funahashi

full_name: Yasuhiro Funahashi

given: Yasuhiro

family: Lubiniecki

full_name: Gregory Lubiniecki

given: Gregory

name: The START Center for Cancer Care, San Antonio, TX 78229, USA

family: Rasco

full_name: Drew Rasco

given: Drew

journal_name: Future Oncology

evidence: open (via page says license)

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

lead_sponsor: Merck Sharp & Dohme Corp.

location_country:
Italy
United States
Mexico
France
Japan
Malaysia
Israel
Poland
Hungary
Australia
Russian Federation
Turkey
China
Estonia
Canada
Korea, Republic of
Taiwan
Colombia
Ukraine

location_facility: Tudogyogyintezet Torokbalint ( Site 0205)

location_facility: MI Odessa Regional Oncological Centre ( Site 0333)

location_facility: Beijing Chest Hospital Capital Medical University ( Site 0111)

location_facility: Koo Foundation Sun Yat-Sen Cancer Center ( Site 0091)

location_facility: Juntendo University Hospital ( Site 0029)

location_facility: Seoul National University Bundang Hospital ( Site 0075)

location_facility: Kyiv City Clinical Oncology Centre ( Site 0339)

location_facility: Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0185)

location_facility: Centre hospitalier Toulon Sainte-Musse ( Site 0172)

location_facility: Alaska Clinical Research Center ( Site 0511)

location_facility: Cone Health Cancer Center at Alamance Regional ( Site 0527)

location_facility: Chungbuk National University Hospital ( Site 0079)

location_facility: City Clinical Hosp.4 of DCC ( Site 0338)

location_facility: Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz ( Site 0202)

location_facility: SBHI Leningrad Regional Clinical Hospital ( Site 0263)

location_facility: The First Hospital of Jilin University ( Site 0110)

location_facility: William Osler Health System (Brampton Civic Hospital) ( Site 0402)

location_facility: Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 0381)

location_facility: National Taiwan University Hospital Hsin-Chu Branch ( Site 0087)

location_facility: Taipei Medical University Shuang Ho Hospital ( Site 0090)

location_facility: SMG-SNU Boramae Medical Center ( Site 0078)

location_facility: Instituto Nacional de Cancerologia. ( Site 0382)

location_facility: Ironwood Cancer & Research Centers ( Site 0541)

location_facility: National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0027)

location_facility: Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 0207)

location_facility: University Malaya Medical Centre ( Site 0061)

location_facility: McGill University Health Centre ( Site 0418)

location_facility: University of Kentucky School of Medicine & Hospitals ( Site 0517)

location_facility: 2nd Affil Hosp of Zhejiang University College of Medicine ( Site 0114)

location_facility: Taipei Veterans General Hospital ( Site 0089)

location_facility: Dokuz Eylul Universitesi Arastirma Uygulama Hastanesi ( Site 0314)

location_facility: Gulhane Egitim ve Arastirma Hastanesi ( Site 0316)

location_facility: The First Affiliated Hospital Zhejiang University ( Site 0106)

location_facility: Szpital Uniwersytecki im. Karola Marcinkowskiego ( Site 0247)

location_facility: Kanagawa Cardiovascular and Respiratory Center ( Site 0026)

location_facility: Centre Hospitalier de la Cote Basque ( Site 0173)

location_facility: Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 0262)

location_facility: Fundacion Centro de Investigacion Clinica CIC ( Site 0366)

location_facility: Abdurrahman Yurtaslan Onkoloji Hastanesi ( Site 0318)

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 0217)

location_facility: Peking Union Medical College Hospital ( Site 0105)

location_facility: Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 0331)

location_facility: Nippon Medical School Hospital ( Site 0024)

location_facility: Oregon Health Sciences University ( Site 0544)

location_facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 0243)

location_facility: Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0374)

location_facility: Anne Arundel Medical Center Oncology and Hematology ( Site 0514)

location_facility: Ballarat Oncology and Haematology Services ( Site 0008)

location_facility: Zhongshan Hospital Fudan University ( Site 0100)

location_facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0203)

location_facility: Xiangya Hospital of Central South University ( Site 0115)

location_facility: Institut Kanser Negara - National Cancer Institute ( Site 0063)

location_facility: Wollongong Private Hospital ( Site 0005)

location_facility: Billings Clinic Cancer Center ( Site 0508)

location_facility: Centro di Riferimento Oncologico CRO ( Site 0235)

location_facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0266)

location_facility: Hospital General de Medellin Luz Castro de Gutierrez ( Site 0368)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0252)

location_facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 0250)

location_facility: Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 0341)

location_facility: Northwest Georgia Oncology Centers PC ( Site 0518)

location_facility: Institut Curie - Centre Rene Huguenin ( Site 0181)

location_facility: Consultorios de Medicina Especializada del Sector Privado ( Site 0388)

location_facility: Hangzhou First People's Hospital ( Site 0109)

location_facility: National Hospital Organization Kyushu Medical Center ( Site 0015)

location_facility: 1st Affil Hosp of Med College of Xi'an Jiaotong University ( Site 0103)

location_facility: SA Tartu Ulikooli Kliinikum ( Site 0160)

location_facility: National Taiwan University Hospital ( Site 0088)

location_facility: Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 0233)

location_facility: Presidio Ospedaliero San Vincenzo ( Site 0231)

location_facility: Aichi Cancer Center Hospital ( Site 0018)

location_facility: St John of God Murdoch Medical Clinic ( Site 0001)

location_facility: Azienda Ospedaliera San Giuseppe Moscati ( Site 0234)

location_facility: Antalya Memorial Hospital Department of Medical Oncology ( Site 0324)

location_facility: Ospedale Santa Maria delle Croci ( Site 0232)

location_facility: SPZOZ USK nr 1 im. Norberta Barlickiego UM w Lodzi ( Site 0256)

location_facility: Centro Medico Imbanaco de Cali S.A ( Site 0369)

location_facility: Podillya Regional Center of Oncology ( Site 0343)

location_facility: Samsun Medical Park Hastanesi ( Site 0320)

location_facility: SA Pohja-Eesti Regionaalhaigla ( Site 0162)

location_facility: Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 0253)

location_facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 0321)

location_facility: Okayama University Hospital ( Site 0020)

location_facility: CHU de Grenoble - Hopital Michallon ( Site 0169)

location_facility: Ukranian Center of TomoTherapy ( Site 0344)

location_facility: Osaka International Cancer Institute ( Site 0019)

location_facility: West China Hospital of Sichuan University ( Site 0117)

location_facility: Windsor Regional Cancer Program ( Site 0404)

location_facility: Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 0323)

location_facility: City Clinical Oncology Center ( Site 0260)

location_facility: Centrum Medyczne Pratia Ostroleka ( Site 0242)

location_facility: University of Missouri Health Care ( Site 0555)

location_facility: Policlinico Gemelli di Roma ( Site 0237)

location_facility: National Cheng Kung University Hospital ( Site 0086)

location_facility: The First Affiliated Hospital of Anhui Medical University ( Site 0113)

location_facility: Petz Aladar Megyei Oktato Korhaz ( Site 0213)

location_facility: Oaxaca Site Management Organization SC ( Site 0389)

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0269)

location_facility: SBHI Samara Regional Clinical Oncology Dispensary ( Site 0265)

location_facility: Hospital Tengku Ampuan Afzan ( Site 0062)

location_facility: Akdeniz Universitesi Tip Fakultesi ( Site 0322)

location_facility: Regional Centre of Oncology-Thoracic organs ( Site 0337)

location_facility: MI Precarpathian Clinical Oncology Center ( Site 0346)

location_facility: Baskent Universitesi Ankara Hastanesi ( Site 0319)

location_facility: Park Nicollet Frauenshuh Cancer Center ( Site 0554)

location_facility: Central Texas Veterans Healthcare System ( Site 0533)

location_facility: The Prince Charles Hospital ( Site 0011)


location_country:
Italy
Austria
United States
Brazil
Chile
South Africa
Sweden
Spain
Switzerland
Germany
France
Poland
Israel
Australia
China
Canada
United Kingdom
Korea, Republic of

acronym: Pembrolizumab plus Lenvatinib as First-line Intervention for Advanced Melanoma

location_facility: PERSONAL - Oncologia de Precisao e Personalizada ( Site 0399)

location_facility: Hospital Universitario La Paz ( Site 0184)

location_facility: Hospital Universitario Marques de Valdecilla ( Site 0181)

location_facility: Instituto Nacional de Cancer Hospital do Cancer II ( Site 0394)

location_facility: University of Colorado Cancer Center ( Site 0708)

location_facility: Sociedad Medica Aren y Bachero Limitada ( Site 0426)

location_facility: CHU de la Miletrie Poitiers ( Site 0011)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0652)

location_facility: California Pacific Medical Center Research Institute ( Site 0705)

location_facility: Melanoma Institute Australia ( Site 0452)

location_facility: The Angeles Clinic and Research Institute ( Site 0707)

location_facility: Sunnybrook Research Institute ( Site 0654)

location_facility: Uniwersyteckie Centrum Kliniczne ( Site 0281)

location_facility: Azienda Ospedaliera Universitaria Senese ( Site 0065)

location_facility: CHRU Lille - Hopital Claude Huriez ( Site 0004)

location_facility: Institut Claudius Regaud IUCT Oncopole ( Site 0003)

location_facility: Centro Investigación del Cáncer James Lind ( Site 0425)

location_facility: Hospital Duran i Reinals ICO de Hospitalet ( Site 0187)

location_facility: Universitaetsspital Zuerich ( Site 0092)

location_facility: Sahlgrenska Universitetssjukhuset ( Site 0212)

location_facility: Centre Hospitalier Victor Dupouy ( Site 0012)

location_facility: Severance Hospital Yonsei University Health System ( Site 0552)

location_facility: Inova Schar Cancer Institute ( Site 0739)

location_facility: Istituto Europeo di Oncologia ( Site 0067)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0064)

location_facility: Istituto Nazionale Tumori Fondazione Pascale ( Site 0061)

location_facility: Complejo Hospitalario Universitario A Coruna. CHUAC ( Site 0182)

location_facility: Tianjin Medical University Cancer Institute & Hospital ( Site 0606)

location_facility: Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 0273)

location_facility: Universitaetsklinikum Leipzig ( Site 0040)

location_facility: Universitaetsklinikum Erlangen ( Site 0044)

location_facility: Pontificia Universidad Catolica de Chile ( Site 0422)

location_facility: Kyungpook National University Chilgok Hospital ( Site 0553)

location_facility: Nanjing Drum Tower Hospital ( Site 0609)

location_facility: SRH Wald-Klinikum Gera GmbH ( Site 0042)

location_facility: Hadassah Ein Karem Hebrew University Medical Center ( Site 0305)

location_facility: Hospital Universitario Insular de Gran Canaria ( Site 0189)

location_facility: Hospital Clinic i Provincial Barcelona ( Site 0190)

location_facility: Medizinische Universitat Wien ( Site 0778)

location_facility: Guys and St Thomas NHS Foundation Trust ( Site 0126)

location_facility: Hospital Universitario Carlos Haya ( Site 0186)

location_facility: University of North Carolina - Cancer Hospital ( Site 0751)

location_facility: Hospital Sao Vicente de Paulo ( Site 0396)

location_facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0397)

location_facility: Seoul National University Hospital ( Site 0554)

location_facility: Sandton Oncology Medical Group PTY LTD ( Site 0802)

location_facility: Cancer Care Langenhoven Drive Oncology Centre ( Site 0805)

location_facility: Norrlands Universitetssjukhus ( Site 0216)

location_facility: John Wayne Cancer Institute ( Site 0706)

location_facility: The First Hospital Of Jilin University ( Site 0603)

location_facility: Szpital Kliniczny im. Heliodora Swiecickiego Uniwers Medyczn ( Site 0272)

location_facility: Universitaetsklinikum Wuerzburg-Department of Dermatology ( Site 0036)

location_facility: Fujian Provincial Cancer Hospital ( Site 0612)

location_facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0278)

location_facility: Minnesota Oncology Specialist, PA ( Site 0766)

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0704)

location_facility: Sun Yat-Sen University Cancer Center ( Site 0602)

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel ( Site 0033)

location_facility: Hospital de Caridade de Ijui ( Site 0391)

location_facility: Hospital Universitario Ramon y Cajal ( Site 0183)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 0191)

location_facility: LKH Universitatsklinikum Graz ( Site 0776)

location_facility: Universitaetsklinikum Carl Gustav Carus ( Site 0041)

location_facility: Cape Town Oncology Trials Pty Ltd ( Site 0803)

location_facility: OHSU Center for Health & Healing ( Site 0731)

location_facility: Fudan University Shanghai Cancer Center ( Site 0607)

location_facility: BC Cancer-Kelowna - Sindi Ahluwalia Hawkins Centre ( Site 0661)

location_facility: St. Vincent Frontier Cancer Center ( Site 0724)

location_facility: Baptist MD Anderson Cancer Center ( Site 0767)

location_facility: McGill University Health Centre ( Site 0651)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 0421)

location_facility: Princess Alexandra Hospital ( Site 0454)

location_facility: Shamir Medical Center-Assaf Harofeh ( Site 0308)

location_facility: Klinik fur Dermatologie Allergologie und Venerologie ( Site 0035)

location_facility: Hopital Ambroise Pare Boulogne ( Site 0007)

location_facility: Karolinska Universitetssjukhuset ( Site 0211)

title: A Phase 3 Randomized, Placebo-controlled Trial to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) and Lenvatinib (E7080/MK-7902) Versus Pembrolizumab Alone as First-line Intervention in Participants With Advanced Melanoma (LEAP-003)

summary:
The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for lenvatinib) as first-line treatment in adults with no prior systemic therapy for their advanced melanoma.

The primary study hypotheses are that: 1) The combination of pembrolizumab and lenvatinib is superior to pembrolizumab and placebo as assessed by Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), and 2) The combination of pembrolizumab and lenvatinib is superior to pembrolizumab and placebo as assessed by Overall Survival (OS). For this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.


title: A Non-interventional Cross-sectional Study to Capture the Prevalence of Cardiovascular Disease in Patients With Type 2 Diabetes in Selected Countries in Europe

acronym: EU-CAPTURE

summary: The purpose of the study is to register the occurrence of cardiovascular disease among type 2 diabetes (T2DM) patients across five selected countries in Europe. Participants will be asked to give information about their health. Participants will continue their normal way of life and will not get any medication other than what has been prescribed to them by their doctor. Participants' participation will be one day/one visit at study doctor. The study will last for about 3 months in total.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Mosenzon O, Alguwaihes A, Leon JLA, Bayram F, Darmon P, Davis TME, Dieuzeide G, Eriksen KT, Hong T, Kaltoft MS, Lengyel C, Rhee NA, Russo GT, Shirabe S, Urbancova K, Vencio S; CAPTURE Study Investigators. CAPTURE: a multinational, cross-sectional study of cardiovascular disease prevalence in adults with type 2 diabetes across 13 countries. Cardiovasc Diabetol. 2021 Jul 27;20(1):154. doi: 10.1186/s12933-021-01344-0.

family: Mosenzon

full_name: Ofri Mosenzon

given: Ofri

family: Alguwaihes

full_name: Abdullah Alguwaihes

given: Abdullah

family: Leon

full_name: Jose Luis Arenas Leon

given: Jose Luis Arenas

family: Bayram

full_name: Fahri Bayram

given: Fahri

family: Darmon

full_name: Patrice Darmon

given: Patrice

family: Davis

full_name: Timothy M. E. Davis

given: Timothy M. E.

family: Dieuzeide

full_name: Guillermo Dieuzeide

given: Guillermo

family: Eriksen

full_name: Kirsten T. Eriksen

given: Kirsten T.

family: Hong

full_name: Tianpei Hong

given: Tianpei

family: Kaltoft

full_name: Margit S. Kaltoft

given: Margit S.

family: Lengyel

full_name: Csaba Lengyel

given: Csaba

family: Rhee

full_name: Nicolai A. Rhee

given: Nicolai A.

family: Russo

full_name: Giuseppina T. Russo

given: Giuseppina T.

family: Shirabe

full_name: Shinichiro Shirabe

given: Shinichiro

family: Urbancova

full_name: Katerina Urbancova

given: Katerina

family: Vencio

full_name: Sergio Vencio

given: Sergio

currency_apc_doaj: GBP

journal_name: Cardiovascular Diabetology

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

repository_institution: University of Szeged - SZTE Publicatio Repozitórium - SZTE - Repository of Publications

version: acceptedVersion

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com


title: Open-label Extension Study of Relamorelin for the Treatment of Diabetic Gastroparesis

summary: This open-label study is to assess the safety of continued treatment with Relamorelin for participants who previously completed the RLM-MD-03 or RLM-MD-04 study and to provide treatment for these participants until Relamorelin becomes commercially available or the Sponsor terminates development.

status: Terminated

ipd_sharing: No

lead_sponsor: Allergan

location_country:
Malaysia
Romania
Australia
Belgium
Russian Federation
Denmark
Ukraine
India
France
Poland
Thailand
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Philippines
Bulgaria
Singapore
Hungary
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
Spain
Latvia

location_facility: Dr. Jivraj Mehta Smarak Health Foundation Bakeri Medical Res

location_facility: Innovative Research of West Florida, Inc.

location_facility: Kyiv Railway Clinical Hospital #2 of Branch Healthcare Center of the PJSC Ukranian Railway, Endocrynology Department

location_facility: ClinTrial Medical Center, Pulmonology Department

location_facility: DRRI-Vinnytsia National Pirogov Memorial Medical University

location_facility: Texas Tech University Health Sciences, Center Division of Gastroenterology

location_facility: Faculty of Medicine, Siriraj Hospital, Mahidol University

location_facility: Eternal Hospital, Unit of Eternal Heart Care Centre and Research Institute Pvt. Ltd.

location_facility: Long Island Gastrointestinal Research Group LLP

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: Woodholme Gastroenterology Associates, P.A.

location_facility: Moscow Regional Research Clinical Institute named by MF Vladimirski

location_facility: Family Practice Center of Wadsworth, Inc. DBA New Venture Medical Research

location_facility: Medical Center Asklepion - Humane Medicine Research EOOD

location_facility: Scientific Institute of Clinical and Experimental Lymphology

location_facility: Lifecare Clinic and Research Centre - Internal Med/Diabetolo

location_facility: IRCCS S.Matteo Hospital Foundation, University of Pavia

location_facility: Indiana University Health University Hospital

location_facility: Unidad de Investigación Clínica Cardiometabolica de Occidente

location_facility: Kyiv city clinical endocrinology center, department of general endocrine pathology and metabolism, c. Kyiv

location_facility: Azienda Ospedaliera Rilievo Nazionale Alta Specialita (ARNAS) Garibaldi

location_facility: Synexus Helderberg Clinical Research Centre

location_facility: Instituto Catarinense de Endocrinologia e Diabetes (ICED)

location_facility: Instituto de Investigaciones Clínicas de Rosario

location_facility: Ternopil University Hospital, Regional Center for Gastroenterology with Hepatology, Department of Gastroenterology

location_facility: 6th City Clinical Hospital, c. Zaporizhzhia

location_facility: Mid Essex Hospital Services NHS Trust Broomfield Hospital

location_facility: Municipal nonprofit entity "Chernigiv city hospital #2" of Chernigiv municipal council, therapeutic department

location_facility: Nizhegorodsky Regional Clinical Hospital named after N. A. Semashko

location_facility: Oö. Gesundheits- und Spitals-AG/LKH Steyr

location_facility: Instituto de hematología y medicina clínica "Dr. Rubén Dávoli"

location_facility: Gruppo Humanitas - Humanitas Research Hospital

location_facility: Universitätsklinikum Giessen und Marburg GmbH

location_facility: "Kryvyi Rih City Hospital #3" of Dnipropetrovsk Regional Council

location_facility: State Institution Ukrainian State Research Institute

location_facility: Diabetes and Endocrinology Consultants, PC

location_facility: Hospices Civils de Lyon - Hôpital Edouard Herrriot

location_facility: S.P.Medical College & Group of Hospitals Bikaner

location_facility: Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska

location_facility: North-Western State Medical University named after I. I. Mechnikov

location_facility: Municipal Institution-Zaporizhzhia Regional Clinical Hospital

location_facility: Southern Illinois University School of Medicine

location_facility: Preferred Primary Care Physicians, Jacob Murphy

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

location_facility: Ivano-Frankivsk National Medical University

location_facility: Oddzial Gastroenterologii Mazowieckie Centrum Rehabilitacji Stocer sp. Z o.o.

location_facility: Policlinico Gemelli, Divisione di Endocrinologia e Malattie del Metabolismo

location_facility: Clinical Endocrinology of SI V.Danilevsky Institute for endocrine pathology problems National Academy of Medical sciences of Ukraine

location_facility: Instituto de Pesquisa Clínica em Campinas

location_facility: Communal Institution "Odesa Regional Clinical Hospital", Out-patient department

location_facility: Medical Center of the Limited Liability Company "Health Clinic", Medical Clinical Research Center, Department of Gastroenterology, Hepatology and Endocrinology

location_facility: FSBI National medical endocrinology research centre

location_facility: Carolina Digestive Health Associates, PA

location_facility: Service d'hépato-gastroentérologie - 7°D

location_facility: Dr. Anil K. Gupta Medicine Professional Corporation

location_facility: First Department of Medicine, University of Szeged

location_facility: Gastroenterology Associates of Western Michigan

location_facility: M. S. Ramaiah medical College and Hospitals - Gastroenterolo

location_facility: Surat Institute of Digestive Sciences Hospitals

location_facility: New Orleans Research Institute - Metropolitan Gastroenterology Associates

location_facility: Vinnytsia Regional Clinical highly specialized Endocrinology Centre

location_facility: Regional Public Organization Chernivtsi Regional Endocrinology Center

location_facility: Gastroenterology Associates of Fairfield County, P.C.

location_facility: Madras Medical College & Rajiv Gandhi Govt. General Hospital

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion

location_facility: Saint-Petersburg City Pokrovskaya Hospital

location_facility: Centex Studies, Inc. - Lake Charles- Clinical Trials of SWLA, LLC

location_facility: Szpital Uniwestytetu Medycznego w Bialymstoku

location_facility: Centro Universitario de Investigacion en Farmacologia Clinic

location_facility: Chopda Medicare & Research Centre Pvt.Ltd, Magnum Heart Institute

location_facility: Connecticut Clinical Research Foundation

location_facility: Grant Medical Foundation Ruby Hall Clinic

location_facility: Hospital Universitário João de Barros Barreto - UFPA

location_facility: San Juan De Dios Educational Foundation, Inc.

location_facility: Sanggye Paik Hospital, Inje University College of Medicine

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino

location_facility: Valley View Wellness and Medical Center - VVCRD Clinical Research

location_facility: SAGACT PLLC., San Antonio Gastroenterology Associates, PA

location_facility: Digestive Health Specialist of the South East

location_facility: Municipal Institution of Sumy Regional Council Sumy Regional Clinical Hospital

location_facility: Torrance Clinical Research Institute, Inc.

location_facility: City Hospital #1, department of endocrinology, c. Mykolayiv

location_facility: Troy Gastroenterology, PC dba Center for Digestive Health

location_facility: Regional municipal institution "Chernivtsi's regional clinical hospital", gastroenterological department, Higher state educational establishment of Ukraine "Bukovinian state medical university", department of internal medicine and infectious diseases, c.C

location_facility: Rocky Mountain Diabetes and Osteoporosis Center, PA

location_facility: Victoria Hospital Bangalore Medical College and Research Ins

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: Specjalistyczny Gabinet Neurologiczny Marta Banach

location_facility: Private Small-Scale Enterprise Medical Center Pulse

location_facility: Toronto Western Hospital, University Health Network

location_facility: Centro de Investigacion Morales Vargas - CIMOVA

location_facility: Hospital Clinico Universitario San Carlos

location_facility: Universita degli Studi di Napoli Federico II

location_facility: Professional Research Network of Kansas, LLC

location_facility: Instituto de Estudos e Pesquisas Clínicas do Ceará - IEP/CE - Oncology

location_facility: SU Clinic of medical academy of SI Dnepropetrovsk medical cacadamy of MoH of Ukraine

location_facility: Instituto de Diabetes Obesidad y Nutrición SC

location_facility: Medical Center Universal Clinic OberigMedical Center Universal Clinic Oberig / Medical Center "Universal Clininc "Oberig" of LLC "Capital", Gastroenterological Center, c. Kyiv

location_facility: Cotton-O'Neil Clinical Research Center - Digestive Health

location_facility: University of North Carolina at Chapel Hill

location_facility: NZOZ Vita - Diabetica Malgorzata Buraczyk, Diabetes Clinic,

location_facility: West Visayas State University Medical Center

location_facility: Markhot Ferenc Oktatokorhaz es Rendelointezet

location_facility: S.R. Kalla Memorial Gastro and General Hospital

location_facility: M.V. Hospital for Diabetes & Diabetes Research Centre

location_facility: Kindred Medical Institute for Clinical Trials, LLC

location_facility: Institute of Endocrinology and Metabolism im. V. P. Komisarenka NAMS Ukraine

location_facility: The Ohio State University, Wexner Medical Center

location_facility: Clinical Applications Laboratories, Inc.

location_facility: Wojewodzki Szpital Specjalistyczny w Olsztynie

location_facility: Universita' Di Salerno- Aou Ruggi D'aragona

location_facility: NYU Winthrop Hospital, Clinical Trials Center

location_facility: Pauls Stradins Clinical University Hospital, Endokrinologijas nodala

location_facility: Universidade de Sao Paulo (USP) - Hospital das Clinicas da F

location_facility: Family Medical Associates, Research Department

location_facility: Odessa Railway Clinical Hospital of Branch of HC JSC Ukrzaliznytsia, Odessa National Medical University

location_facility: Polyclinic of medical services and rehabilitation department of State Joint-Stock Holding Company Artem, day-patient unit

location_facility: Municipal Institution Lutsk City Clinical Hospital

location_facility: "Municipal Institution ""City Hospital #7"", polyclinic department, c. Zaporizhzhia"

location_facility: Communal Institution Kherson City Clinical Hospital

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: "State Institution "National Institute of Therapy named after. L.T. Maloi NAMNU" / Government Institution "L.T.Malaya Therapy National Institute of the National Academy of Medical Sciences of Ukraine", Department of the study of diseases of the digestive

location_facility: Medical Research Center of Connecticut, LLC

location_facility: Ivano-Frankivsk Central City Clinical Hospital

location_facility: Universitair Ziekenhuis Antwerpen, Gastro-Enterologie,

location_facility: B. J. Government Medical College and Sassoon General Hospitals

location_facility: Hospital Universitario Principe de Asturias

location_facility: Centro Especializado en Investigación Clínica S.C.

location_facility: Biopharma Informatic Inc., Research Center

location_facility: Limited Liability Company "Medical and Diagnostic Center "ADONIS Plus", outpatient department, c. Kyiv

location_facility: Municipal nonprofit entity "Vinnytsia's city clinical hospital #1", gastroenterological department, Vinnytsia National Pirogov Memorial Medical University, department of propedeutics of internal medicine, c. Vinnytsia

location_facility: Millitary-medical Academy, department of hospital therapy

location_facility: Unidad de Investigación clínica y atención Médica HEPA S.C.

location_facility: Maffei Centro Medico-Investigacion Clinica Aplicada

location_facility: Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research

location_facility: Royal Adelaide Hospital - Central Adelaide Local Health Network Incorporated

location_facility: CIADEN (Centro de Investigación y Atención de Diabetes, Endocrinología y Nutrición)

location_facility: Municipal nonprofit entity "City clinical hospital #2 n.a. Prof.O.O.Shalimov" of Kharkiv municipal council, department of endocrinology

location_facility: Baylor College of Medicine Medical Center

status_simplified: Unknown


title: A Phase 3 Multicenter, Open-Label, Randomized, Controlled Study of Oral Infigratinib Versus Gemcitabine With Cisplatin in Subjects With Advanced/Metastatic or Inoperable Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations: The PROOF Trial

summary: Infigratinib is an oral drug which selectively binds to fibroblast growth factor receptor (FGFR) 2 and is being developed to treat participants with FGFR2 mutated cholangiocarcinoma. The purpose of the study is to evaluate the efficacy and safety of the investigational agent oral infigratinib vs standard of care chemotherapy (gemcitabine plus cisplatin) in first-line treatment of participants with unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion/rearrangement. Subjects will be randomized 2:1 to receive infigratinib or gemcitabine plus cisplatin.

ReferenceCitation: Makawita S, K Abou-Alfa G, Roychowdhury S, Sadeghi S, Borbath I, Goyal L, Cohn A, Lamarca A, Oh DY, Macarulla T, T Shroff R, Howland M, Li A, Cho T, Pande A, Javle M. Infigratinib in patients with advanced cholangiocarcinoma with FGFR2 gene fusions/translocations: the PROOF 301 trial. Future Oncol. 2020 Oct;16(30):2375-2384. doi: 10.2217/fon-2020-0299. Epub 2020 Jun 25.

name: Division of Cancer Medicine, M.D. Anderson Cancer Center, Houston, TX 77030, USA

family: Makawita

full_name: Shalini Makawita

given: Shalini

name: Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA

name: Department of Medicine, Weill Cornell Medical College, New York, NY 10065, USA

family: K Abou-Alfa

full_name: Ghassan K Abou-Alfa

given: Ghassan

name: Division of Medical Oncology, Department of Internal Medicine, The James Cancer Hospital & Comprehensive Cancer Center, The Ohio State University, Columbus, OH 43210, USA

family: Roychowdhury

full_name: Sameek Roychowdhury

given: Sameek

name: Department of Medicine, Division of Hematology/Oncology, University of California, Los Angeles, CA 90404, USA

family: Sadeghi

full_name: Saeed Sadeghi

given: Saeed

name: Department of Gastroenterology & Digestive Oncology, Cliniques Universitaires Saint-Luc & Université Catholique de Louvain, Brussels, Belgium

family: Borbath

full_name: Ivan Borbath

given: Ivan

name: Cancer Center, Massachusetts General Hospital, Boston, MA 02114, USA

name: Department of Medicine, Harvard Medical School, Boston, MA 02115, USA

family: Goyal

full_name: Lipika Goyal

given: Lipika

name: Rocky Mountain Cancer Center & US Oncology Research, Denver, CO 80218, USA

family: Cohn

full_name: Allen Cohn

given: Allen

name: Department of Medical Oncology, The Christie NHS Foundation Trust, Division of Cancer Sciences, University of Manchester, Manchester, UK

family: Lamarca

full_name: Angela Lamarca

given: Angela

name: Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea

family: Oh

full_name: Do-Youn Oh

given: Do-Youn

name: Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology & IOB quirón, Barcelona, Spain

family: Macarulla

full_name: Teresa Macarulla

given: Teresa

name: Division of Hematology/Oncology, University of Arizona Cancer Center, Tucson, AZ 85724, USA

family: T Shroff

full_name: Rachna T Shroff

given: Rachna

name: QED Therapeutics, San Francisco, CA, USA

family: Howland

full_name: Michael Howland

given: Michael

family: Li

full_name: Ai Li

given: Ai

family: Cho

full_name: Terry Cho

given: Terry

family: Pande

full_name: Amit Pande

given: Amit

name: Department of Gastrointestinal Medical Oncology, M.D. Anderson Cancer Center, Houston, TX 77030, USA

family: Javle

full_name: Milind Javle

given: Milind

ipd_sharing: Undecided

lead_sponsor: QED Therapeutics, Inc.

location_country:
Italy
United States
Spain
Germany
France
Thailand
Belgium
Australia
Puerto Rico
Portugal
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Peninsula & South Eastern Haematology and Oncology Group

location_facility: University of Arkansas for Medical Sciences

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Centro Hospitalar do Porto - Hospital de Santo António

location_facility: Severance Hospital Yonsei University Health System

location_facility: Frederick Regional Healthcare Systems/James M. Stockman Cancer Institute

location_facility: The Christie NHS Foundation Trust - PPDS

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

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Instituto Português de Oncologia Francisco Gentil Centro Regional de Oncologia de Coimbra EPE

location_facility: Songklanagarind Hospital, Prince of Songkla University

location_facility: Maharaj Nakorn Chiang Mai Chiang Mai University

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Centro Hospitalar E Universitário de Coimbra EPE

location_facility: The Oncology Institute of Hope and Innovation

location_facility: Complejo Asistencial Universitario de Salamanca - Hospital Clinico

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

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS

location_facility: UF Health Cancer Center at Orlando Health

location_facility: Illinois Cancer Specialists (Arlington Heights)

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

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

location_facility: Barbara Ann Karmanos Cancer Institute - Lawrence and Idell Weisberg Cancer Treatment Center

location_facility: Seoul National University Bundang Hospital

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: National Taiwan University Hospital - YunLin Branch

location_facility: Azienda Ospedaliero Universitaria Di Modena Policlinico

location_facility: Azienda Socio Sanitaria Territoriale di Cremona (ASST)

location_facility: Cancer and Hematology Centers of Western Michigan

location_facility: Chang Gung Memorial Hospital - Kaohsiung

location_facility: Instituto Catalan de Oncologio ICO I'Hospitalet

location_facility: Policlinico Universitario Campus Biomedico Di Roma

location_facility: Hospital Universitario HM Sanchinarro - CIOCC

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

location_facility: Chang Soon-Shiong Institute for Medicine

location_facility: Hopital Claude Huriez Rue Michel Polonovski (CHRU) Lille

location_facility: Hospital Oncologico, Puerto Rico Medical Center

location_facility: Hospital Universitario Vall d'Hebrón - PPDS

location_facility: Ohio State University Comprehensive Cancer Center

location_facility: University of Texas Southwestern Medical Center


title: An Open Label, Multicenter Extension Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (IMbrella B)

acronym: IMbrella B

summary: This is an open-label, multicenter, extension study. Patients who are receiving clinical benefit from atezolizumab monotherapy or atezolizumab in combination with other agent(s) or comparator agent(s) during participation in a Genentech or Roche-sponsored study (the parent study), who are eligible to continue treatment and who do not have access to the study treatment locally, may continue to receive study treatment in this extension study following roll-over from the parent study.

lead_sponsor: Hoffmann-La Roche

location_country:
Guatemala
Greece
Romania
Belgium
Australia
Russian Federation
Denmark
Taiwan
Ukraine
France
Japan
Poland
Slovakia
Norway
Canada
Korea, Republic of
Chile
Hong Kong
Switzerland
Bulgaria
Singapore
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Czechia
Spain
Latvia

location_facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc; Oddzial onkologii z pododdzialem chemioterapii

location_facility: Universitätsklinikum Freiburg;Klinik für Innere Medizin I

location_facility: Narodny Onkologicky Ustav; Oddelenie klinickej onkologie A

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Orszagos Onkologiai Intezet; Borgyogyaszati Osztaly

location_facility: Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology

location_facility: Communal Non profit Enterprise Regional Center of Oncology; Oncosurgical dept of thoracic organs

location_facility: Pontificia Universidad Catolica de Chile; Centro Del Cáncer

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: SRH Wald-Klinikum Gera; Zentrum fur klinische Studien (ZKS)

location_facility: CHU Timone; Centre d'Essais Précoces en Cancérologie de Marseille (CEPCM)

location_facility: University of Texas Health Sciences Center in San Antonio

location_facility: ME Kryviy Rih Oncology Dispensary of Dnipropetrovs'k Regional Council; Chemotherapy Department

location_facility: Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu.

location_facility: Hospital Lucus Augusti; Servicio de Oncologia

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Hospital General Universitario Gregorio Mara

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii

location_facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz; Pulmonologiai Osztaly

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Arkhangelsk Regional Clinical Oncology Dispensary

location_facility: Asan Medical Center; Internal Dept / Gastorenterology

location_facility: Russian Oncology Research Center n.a. N.N. Blokhin

location_facility: The Prince Charles Hospital; Oncology Dept.

location_facility: Smilow Cancer Hospital at Yale New Haven

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

location_facility: Multiprofile Hospital for Active Treatment Central Onco Hospital OOD; Dept. of Medical Oncology

location_facility: University of Pittsburgh Medical Center Cancer Center; Investigational Drug Service

location_facility: University Hospital of Larissa; Oncology

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Lungenfachklinik Immenhausen; Zentrum fur Pneumologie

location_facility: SCRI Florida Cancer Specialists North; Research Office North Region.

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

location_facility: St. Joseph Mercy Hospital; Cancer Care Center.

location_facility: Multiprofile Hospital for Active Treatment Serdika EOOD; Medical Oncology Department

location_facility: SLK-Kliniken Heilbronn GmbH; Klinik für Innere Medizin III; Schwerpunkt Häma./Onko./Palliativm.

location_facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

location_facility: Municipal Institution Podilskiy Regional Center of Oncology; Department of Chemotherapy

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

location_facility: Ivanovo Regional Oncology Dispensary; Chemotherapy Department

location_facility: Riga's East Hosp Latvian Oncol; Medical Oncology

location_facility: Yale University School Of Medicine; Yale Cancer Center

location_facility: University of Colorado; Anschutz Cancer Pavilion

location_facility: HM Sanchinarro - CIOCC; Servicio de Oncologia

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

location_facility: Hospital Regional Universitario de Málaga - Hospital General

location_facility: National Cancer Institute MOH of Ukraine

location_facility: HonorHealth Research Institute - Pima - Virginia G. Piper Cancer Care Network

location_facility: Fort Wayne Medical Oncology and Hematology, Inc

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

location_facility: University Hospital Bratislava; Department of Oncology

location_facility: Centro Hospitalar do Porto - Hospital de Santo António; Oncologia

location_facility: Hôpital d'Instruction des Armées de Sainte Anne; Service de Pneumologie

location_facility: Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary; Sumy State Uni, Med Inst

location_facility: Levine Cancer Institute-Carolinas Medical Center; Levine Cancer Institute-Carolinas Medical Center

location_facility: Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology

location_facility: Petz Aladar Megyei Oktato Korhaz; Pulmonologiai Osztaly

location_facility: Krankenhaus Barmherzige Bruder Regensburg

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

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: University of Washington - Seattle Cancer Care Alliance; Medical Oncology

location_facility: Niigata University Medical & Dental Hospital

location_facility: Institutul Regional de Oncologie Iasi; Clinica de Hematologie

location_facility: MI Dnipropetrovsk City Multifield Clinical Hospital 4 of Dnipropetrovsk Regional Council

location_facility: University of Arkansas for Medical Sciences; Winthrop Rockefeller Cancer Institute

location_facility: Przychodnia Lekarska KOMED, Roman Karaszewski

location_facility: Centro Integral Oncologico Clara Campal; Servicio de Oncología

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

location_facility: Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca; Oncologie Medicala

location_facility: Universitätsklinik Tübingen; Frauenklinik & Poliklinik

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: Univ of Alabama at Birmingham; UAB Comprehensive Cancer Ctr

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

location_facility: St Georges University Hospitals NHS Foundation Trust

location_facility: Szegedi Tudományegyetem; Onkoterápiás Klinika

location_facility: University Of Chicago Medical Center; Section Of Hematology/Oncology

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: Pecsi Tudomanyegyetem AOK; Borgyogyaszati Klinika

location_facility: Memorial Sloan Kettering - Basking Ridge

location_facility: Hopital d'Instruction des Armees de Begin

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

location_facility: Hematology Oncology Associates of the Treasure Coast

location_facility: Mercy Hospital, a Campus of Plantation General Hospital

location_facility: MI of the Lviv Regional Council Lviv Oncology Regional Treatment and Diagnostic Centre; Chemotherapy

location_facility: Országos Onkológiai Intézet; Onkológiai Képalkotó és Invazív Diagnosztikai Központ

location_facility: Seoul National University College of Medicine, Liver Research Institute


title: A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy

acronym: PROTECT

summary: To determine the long-term (approximately 2 years) nephroprotective potential of treatment with sparsentan as compared to an angiotensin receptor blocker in patients with immunoglobulin A nephropathy (IgAN).

lead_sponsor: Travere Therapeutics, Inc.

location_country:
Italy
Hong Kong
Spain
Germany
Croatia
Czechia
France
Lithuania
Poland
Belgium
Australia
New Zealand
Portugal
Estonia
United States
United Kingdom
Korea, Republic of
Taiwan


ReferenceCitation: Strambu IR, Fagard L, Ford P, Van Der Aa T, De Haas-Amatsaleh A, Santermans E, Seemayer C. (2020). Idiopathic pulmonary fibrosis (IPF): observations from a Phase 2 trial of GLPG1205 (PINTA). Abstract for European Respiratory Society International Congress 7-9 September 2020.

lead_sponsor: Galapagos NV

location_country: Sweden Finland Croatia Bulgaria France Slovakia Romania Oman Ukraine

acronym: PINTA

location_facility: National Institute of Tuberculosis, Pulmonary Diseases and Chest Surgery

location_facility: Communal Nonprofit Enterprise City Clinical Hospital

location_facility: The Ivano-Frankivsk National Medical Univeristy

location_facility: National Oncology Centre - The Royal Hospital Muscat

location_facility: Akademiska Sjukhuset - Uppsala Centrum for Cystisk Fibros

location_facility: Hôpital Européen Georges Pompidou (HEGP)

location_facility: SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.

location_facility: Spitalul Clinic de Pneumoftiziologie Iasi

location_facility: Dnipropetrovsk State Medical Academy - Dnipropetrovsk City Clinical Hospital No. 6

location_facility: Municipal Institution "Kherson city clinical hospital named after E.E. Karabelesh"

location_facility: Vinnitsa Regional Clinical Hospital im. N.I. Pirogov

location_facility: Spitalul Clinic De Pneumoftiziologie Leon Daniello Cluj-Napoca

location_facility: Acibadem City Clinic Tokuda Hospital, EAD

location_facility: Institutul de Pneumoftiziologie Marius Nasta

location_facility: Hôpitaux Prives de Metz (HPMetz) - Hôpital Robert Schuman

location_facility: Klinički Bolnički Centar Zagreb - Klinika Za Plućne Bolesti Jordanovac

location_facility: National Institute of Phthisiology and Pulmonology named after F.G. Yanovskyi of NAMS of Ukraine

location_facility: Helsinki University Hospital Heart and Lung Center

location_facility: Specialized Hospital for Active Treatment Pleven

title: A Phase II Randomized, Double-blind, Placebo-controlled, 26-week Study to Evaluate the Efficacy, Safety and Tolerability of GLPG1205 in Subjects With Idiopathic Pulmonary Fibrosis

summary: This is a randomized, double-blind, parallel-group, placebo-controlled, multicenter, exploratory Phase 2 study including participants with Idiopathic Pulmonary Fibrosis (IPF), investigating GLPG1205 in addition to the local standard of care (defined as receiving nintedanib, pirfenidone, or neither nintedanib nor pirfenidone).

status_simplified: Completed


intervention_type: Other

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:
Italy
United States
Netherlands
France
Czechia
Israel
Belgium
Russian Federation
Spain
Canada

acronym: SPROUT

location_facility: Saint Petersburg State Pediatric Medical University

location_facility: Republican Clinical Dermatology and Venerology Dispensary

location_facility: Centre Hospitalier de Cornouaille - Hopital Laennec

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Moscow Scientific Practical Center of Dermatology Venerology and Cosmetology

location_facility: State Scientific Center for Dermatovenereology and Cosmetology

location_facility: Centre Hospitalier Universitaire Saint Pierre

location_facility: Cincinnati Childrens Hospital Medical Center

location_facility: J Woodson Dermatology and Associates Ltd

location_facility: Azienda Ospedaliera Universitaria di Cagliari

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: National Medical Research Center for Children's Health

location_facility: Istituto Dermatologico San Gallicano IRCCS Dermatologia Clinica

location_facility: Azienda Ospedaliera di Reggio Emilia Arcispedale Santa Maria Nuova

location_facility: Hospital Universitario Virgen del Rocio - PPDS

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: Ural Scientific Research Institute of Dermatovenereology and Immunopathology

location_facility: Pierre Wolkenshtein Skin Diseases Clinic LLC

location_facility: Centre Hospitalier Universitaire de Toulouse - Hopital Larrey

location_facility: Clinical Dispensary of Dermatology and Venereology of Krasnodar Territory of the Ministry of Health

location_facility: Hospital General Universitario de Alicante

location_facility: Azienda Ospedaliero Universitaria Di Bologna Policlinico S Orsola Malpighi

location_facility: Hospital Universitari Germans Trias i Pujol Can Ruti

location_facility: Centre Hospitalier Victor Dupouy Argenteuil

location_facility: Chelyabinsk Regional Clinical Skin and Venereal Dispensary

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: University of South Florida Health Morsani Center for Advanced Healthcare

location_facility: Centre Hospitalier Universitaire de Nice

title: A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) IN PEDIATRIC SUBJECTS FROM 6 THROUGH 17 YEARS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

summary:
This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast (CC-10004) in pediatric subjects with moderate to severe plaque psoriasis.

At least 230 pediatric subjects (ages 6 through 17 years) will be randomized 2:1 to receive either apremilast or placebo for the first 16 weeks and then all subjects will receive apremilast during the 36 week Extension Phase for a total of 52 weeks. Randomization to apremilast arm or placebo arm will be stratified by age group (6 to 11 years or 12 to 17 years). Subjects will receive apremilast treatment of either 20 mg twice daily (BID) or 30 mg BID, depending on weight. This Phase 3 study is being conducted to evaluate the safety and efficacy of apremilast in the treatment of pediatric subjects.


ReferenceCitation: Young B, Tan TT, Leo YS. The place for remdesivir in COVID-19 treatment. Lancet Infect Dis. 2021 Jan;21(1):20-21. doi: 10.1016/S1473-3099(20)30911-7. Epub 2020 Nov 26.

family: Young

full_name: Barnaby Young

given: Barnaby

family: Tan

full_name: Thuan Tong Tan

given: Thuan Tong

family: Leo

full_name: Yee Sin Leo

given: Yee Sin

journal_name: The Lancet Infectious Diseases

oa_colors: green hybrid

evidence: open (via free pdf)

title: The place for remdesivir in COVID-19 treatment

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Peru
Finland
Romania
Belgium
Australia
Ukraine
France
Japan
Argentina
Canada
Korea, Republic of
Turkey
Sweden
Hong Kong
Netherlands
Bulgaria
Singapore
China
Germany
United States
Brazil
Serbia
Mexico
Czechia
Israel
New Zealand
Spain
Estonia

location_facility: Rambam Health Corporation; Oncology Institute

location_facility: New York-Presbyterian Brooklyn Methodist Hospital; Department of Emergency Medicine

location_facility: Multiprofile District Hospital for Active Treatment Dr. Stefan Cherkezov AD; Pharmacy

location_facility: Salem Veterans Affairs Medical Center - NAVREF; Pharmacy

location_facility: Hospital Nacional Adolfo Guevara Velasco - ESSALUD; Servicio de Cardiología

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Hospital Universitario Dr. Jose Eleuterio González; Enfermedades Pulmonares Crónicas

location_facility: Tokyo Shinagawa Hospital Medical Corporation Association Tokyokyojuno-kai

location_facility: Centre Hospitalier Departemental de Vendee

location_facility: Nagata Hospital; Department of pulmonary medicine

location_facility: National Hospital Organization Kanazawa Medical Center

location_facility: Royal Brisbane & Womens Hospital; Pharmacy Department

location_facility: Institut Universitaire de Cardiologie et de Pneumologie

location_facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)

location_facility: Multiprofile Hospital For Active Treatment Sveta Ekaterina Dimitrovgrad EOOD; Internal Diseases

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: National Hospital Organaization Shibukawa Medical Center

location_facility: Municipal Institution City Clinical Infectious Diseases Hospital

location_facility: Ternopil City Municipal Emergency Hospital; Infectious Department

location_facility: Klinikum Mannheim GmbH Universitätsklinikum

location_facility: Multiprofile Hospital for Active Treatment - Samokov EOOD

location_facility: Hopital Erasme; Chest Medicine, Cardiac & Thoracic Surgery

location_facility: Clinical Center Nis; Clinic for Pulmonary Diseases and Tuberculosis Knez Selo

location_facility: Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran; Hamatologia y Oncologia

location_facility: Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia; Pharmacy

location_facility: Zuyderland Medisch Centrum - Sittard Geleen

location_facility: Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD

location_facility: ZIV Medical Center; Department Of Internal Medicine A

location_facility: Kuopion Yliopistollinen Sairaala; Silmätaudit

location_facility: National Hospital Organization Ibarakihigashi National Hospital; Center for Clinical Research

location_facility: Hallym University Kangnam Sacred Heart Hospital

location_facility: Multiprofile Hospital For Active Treatment Sliven То Military Hospital Sofia; Pharmacy

location_facility: St. Josefskrankenhaus - Freiburg; Klinik fur Pneumologieund Beatmungsmedizin

location_facility: Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Vratsa; Pharmacy

location_facility: National Multiprofile Transport Hospital Tzar Boris Ill; Clinic of Internal Diseases

location_facility: Temple University Hospital ; Lung Center

location_facility: Universitatsklinikum Schleswig-Holstein; Klinik fuer Innere Medizin I

location_facility: Communal Non-Commercial Enterprise "Vinnytsia City Clinical Hospital №1"; Infectious Department

location_facility: Social Corporation Keigakukai Minamiosaka Hosupital

location_facility: Baruch Padeh Poria Medical Center; Pharmacy

location_facility: London Health Sciences Center; Pharmacy Dept.

location_facility: Hospital Universitario Fundacion Jimenez Diaz.

location_facility: MI Dnipropetrovsk City Clinical Hospital #21 n.a. Prof. Popkova of DRC; The First Department

location_facility: Canisius Wilhelmina Ziekenhuis; Department Hematology

location_facility: General Hospital Dr Radivoj Simonovic Sombor

location_facility: National Hospital Organization Minami Kyoto Hospital

location_facility: Cliniques Universitaires Saint-Luc; Hematology

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: Centro de Estudos Clinicos do Interior Paulista

location_facility: Leids Universitair Medisch Centrum; C5-P Stafcentrum Hartziekten

location_facility: Sf.Cuv. Parascheva Infectious Diseases Clinical Hospital

location_facility: Beijing Youan Hospital, Capital Medical University; Center for Infectious Diseases

location_facility: Tel Aviv Sourasky Medical Center; Pharmacy

location_facility: Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD; Pharmacy

location_facility: Washington University School of Medicine

location_facility: Skånes Universitetssjukhus Malmö; Infektionskliniken

location_facility: Seoul National University Bundang Hospital

location_facility: Hospital Sant Joan de Deu - PIN; Unitat de Recerca - Farmacia

location_facility: Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases Dr. D. Gramatikov - Ruse

location_facility: Selcuk University Medical Faculty; Internal Medicine

location_facility: Santa Casa de Misericordia; de Belo Horizonte

location_facility: Regional Municipal Institution Chernivtsi Regional Clinical Hospital

location_facility: Groupe Hospitalier Pitie Salpetriere; Service De Pneumologie

location_facility: Krankenhaus Donaustauf der LVA Niederbayern Oberpfalz

location_facility: First Multiprofile Hospital for Active Treatment - Sofia EAD

location_facility: Prof. Dr. Matei Bals Institute of Infectious Diseases

location_facility: MI Vinnytsia Regional Clinical Children's Infectious Hospital; Infectiuos Box department

location_facility: Hospital Civil Fray Antonio Alcalde; Instituto de Patologia Infecciosa

location_facility: The 1st Affiliated Hospital of Nanchang Unversity

location_facility: Spitalul Clinic de Boli Infectioase "Sfanta Parascheva" Iasi

location_facility: Regional Municipal Institution Sumy Regional Infectious Clinical Hospital n.a. Z.Y. Krasovytskyi

location_facility: Uniklinik Koln; Klinik I fur Innere Medizin

location_facility: Sf. Ioan cel Nou Emergency County Hospital

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

location_facility: Beijing Ditan Hospital Capital Medical University

location_facility: Hospital General Universitario Reina Sofia; Servicio de Nefrologia

location_facility: University Mulitiprofile Hospital for Active Treatment Sveti Georgi EAD; Pharmacy

location_facility: Sibiu Emergency Clinical County Hospital

location_facility: Froedtert and The Medical College of Wisconsin

location_facility: Toronto East General Hospital; Main Pharmacy G Wing Basement

location_facility: Kyiv Oleksandrivska Clinical Hospital; Infectious Box Department #2

location_facility: Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika

location_facility: Fifth Multiprofile Hospital for Active Treatment - Sofia EAD; Pharmacy

location_facility: Center Hospital of the National Center for Global Health and Medicine

location_facility: Karadeniz Technical University Faculty of Medicine

location_facility: Chaim Sheba Medical Center; Allergy and Clinical Immunology Unit

location_facility: Local incorporated administrative agency Shizuoka City Shizuoka Hospital

location_facility: Oulun Yliopistollinen Sairaala; Teho-osasto

location_facility: Japan Community Health care Organization Nihonmatsu hospital

location_facility: Royal Children's Hospital Melbourne - PIN

location_facility: The First Affiliated Hospital of College of Medicine, Zhejiang University

location_facility: Atlanta Institute For Medical Research, Inc; DeKalb Medical Pharmacy

location_facility: Dr. Victor Babes Clinical Hospital For Tropical and Infectious Diseases

title: A Phase III, Randomized, Double-Blind Placebo-Controlled, Multicenter Study To Evaluate the Efficacy and Safety of Baloxavir Marboxil in Combination With Standard-of-Care Neuraminidase Inhibitor in Hospitalized Participants With Severe Influenza

summary: This study will evaluate the efficacy, safety, and pharmacokinetics of baloxavir marboxil in combination with a standard-of-care (SOC) neuraminidase inhibitor (NAI) (i.e., oseltamivir, zanamivir, or peramivir) compared with a matching placebo in combination with a SOC NAI in hospitalized patients with influenza.