ReferenceCitation: Kazani S, Rowlands DJ, Bottoli I, Milojevic J, Alcantara J, Jones I, Kulmatycki K, Machineni S, Mostovy L, Nicholls I, Nick JA, Rowe SM, Simmonds NJ, Vegesna R, Verheijen J, Danahay H, Gosling M, Ayalavajjala PS, Salman M, Strieter R. Safety and efficacy of the cystic fibrosis transmembrane conductance regulator potentiator icenticaftor (QBW251). J Cyst Fibros. 2021 Mar;20(2):250-256. doi: 10.1016/j.jcf.2020.11.002. Epub 2020 Dec 6.

family: Kazani

full_name: Shamsah Kazani

given: Shamsah

family: Rowlands

full_name: David J. Rowlands

family: Bottoli

full_name: Ivan Bottoli

given: Ivan

family: Milojevic

full_name: Julie Milojevic

given: Julie

family: Alcantara

full_name: Jose Alcantara

given: Jose

family: Jones

full_name: Ieuan Jones

given: Ieuan

family: Kulmatycki

full_name: Kenneth Kulmatycki

given: Kenneth

family: Machineni

full_name: Surendra Machineni

given: Surendra

family: Mostovy

full_name: Lidia Mostovy

given: Lidia

family: Nicholls

full_name: Ian Nicholls

given: Ian

family: Nick

full_name: Jerry A. Nick

given: Jerry A.

family: Rowe

full_name: Steven M. Rowe

given: Steven M.

family: Simmonds

full_name: Nicholas J. Simmonds

given: Nicholas J.

family: Vegesna

full_name: Raju Vegesna

given: Raju

family: Verheijen

full_name: Jeroen Verheijen

given: Jeroen

family: Danahay

full_name: Henry Danahay

given: Henry

family: Gosling

full_name: Martin Gosling

given: Martin

family: Ayalavajjala

full_name: Phaninatha Sarma Ayalavajjala

given: Phaninatha Sarma

family: Salman

full_name: Mohammed Salman

given: Mohammed

family: Strieter

full_name: Robert Strieter

given: Robert

journal_name: Journal of Cystic Fibrosis

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

location_country:
United States
France
Romania
Ireland
Belgium
Germany
United Kingdom

title: A Randomized, Double Blind Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of Single and Multiple Ascending Doses of QBW251 in Healthy Subjects and Multiple Doses in Cystic Fibrosis Patients

summary: This study is designed to assess the safety, tolerability, pharmacokinetics and preliminary pharmacodynamics (proof of concept) of QBW251 in healthy subjects and cystic fibrosis patients following single and multiple doses. This first-in-human and proof of concept study will consist of 4 parts, with Parts 1 and 2 in healthy volunteers and Parts 3 and 4 in cystic fibrosis patients.


title: Trial to Evaluate Treatment With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater Tricuspid Regurgitation (TRILUMINATE)

acronym: TRILUMINATE

summary: The primary purpose of this study is to evaluate safety and effectiveness of the Tricuspid Valve Repair System (TVRS) for treating symptomatic moderate or greater tricuspid regurgitation (TR) in patients currently on medical management and who are deemed appropriate for percutaneous transcatheter intervention.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Lurz P, Stephan von Bardeleben R, Weber M, Sitges M, Sorajja P, Hausleiter J, Denti P, Trochu JN, Nabauer M, Tang GHL, Biaggi P, Ying SW, Trusty PM, Dahou A, Hahn RT, Nickenig G; TRILUMINATE Investigators. Transcatheter Edge-to-Edge Repair for Treatment of Tricuspid Regurgitation. J Am Coll Cardiol. 2021 Jan 26;77(3):229-239. doi: 10.1016/j.jacc.2020.11.038.

family: Lurz

full_name: Philipp Lurz

given: Philipp

sequence: first

family: Stephan von Bardeleben

full_name: Ralph Stephan von Bardeleben

given: Ralph

sequence: additional

family: Weber

full_name: Marcel Weber

given: Marcel

family: Sitges

full_name: Marta Sitges

given: Marta

family: Sorajja

full_name: Paul Sorajja

given: Paul

family: Hausleiter

full_name: Jörg Hausleiter

given: Jörg

family: Denti

full_name: Paolo Denti

given: Paolo

family: Trochu

full_name: Jean-Noël Trochu

given: Jean-Noël

family: Nabauer

full_name: Michael Nabauer

given: Michael

family: Tang

full_name: Gilbert H.L. Tang

given: Gilbert H.L.

family: Biaggi

full_name: Patric Biaggi

given: Patric

family: Ying

full_name: Shih-Wa Ying

given: Shih-Wa

family: Trusty

full_name: Phillip M. Trusty

given: Phillip M.

family: Dahou

full_name: Abdellaziz Dahou

given: Abdellaziz

family: Hahn

full_name: Rebecca T. Hahn

given: Rebecca T.

family: Nickenig

full_name: Georg Nickenig

given: Georg

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of the American College of Cardiology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Nickenig G, Weber M, Lurz P, von Bardeleben RS, Sitges M, Sorajja P, Hausleiter J, Denti P, Trochu JN, Näbauer M, Dahou A, Hahn RT. Transcatheter edge-to-edge repair for reduction of tricuspid regurgitation: 6-month outcomes of the TRILUMINATE single-arm study. Lancet. 2019 Nov 30;394(10213):2002-2011. doi: 10.1016/S0140-6736(19)32600-5. Epub 2019 Nov 7. Erratum in: Lancet. 2020 Mar 14;395(10227):870.

family: von Bardeleben

given: Ralph Stephan

location_country:
Italy
United States
Switzerland
France
Spain
Germany

location_facility: Universitatsmedizin der Johannes Gutenberg-Universitat Mainz

location_facility: Ludwig-Maximilian University of Munich (LMU)

location_facility: HerzKlinik Hirslanden - Klinik Hirslanden

location_facility: Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele - Presidio Ferrarotto

location_facility: Clinical and Provincial Hospital of Barcelona


ReferenceCitation: Shemesh CS, Chan P, Legrand FA, Shames DS, Das Thakur M, Shi J, Bailey L, Vadhavkar S, He X, Zhang W, Bruno R. Pan-cancer population pharmacokinetics and exposure-safety and -efficacy analyses of atezolizumab in patients with high tumor mutational burden. Pharmacol Res Perspect. 2020 Dec;8(6):e00685. doi: 10.1002/prp2.685.

name: Clinical Pharmacology Genentech Inc. South San Francisco CA USA

family: Shemesh

full_name: Colby S. Shemesh

given: Colby S.

family: Chan

full_name: Phyllis Chan

given: Phyllis

name: Clinical Science Genentech Inc. South San Francisco CA USA

family: Legrand

full_name: Fatema A. Legrand

given: Fatema A.

name: Biomarkers Genentech Inc. South San Francisco CA USA

family: Shames

full_name: David S. Shames

given: David S.

family: Das Thakur

full_name: Meghna Das Thakur

given: Meghna

name: Safety Science F. Hoffmann‐La Roche Ltd. Shanghai China

family: Shi

full_name: Jane Shi

given: Jane

name: Safety Science Roche Products Ltd. Welwyn Garden City United Kingdom

family: Bailey

full_name: Lorna Bailey

given: Lorna

family: Vadhavkar

full_name: Shweta Vadhavkar

given: Shweta

name: Biometrics Genentech Inc. South San Francisco CA USA

family: He

full_name: Xian He

given: Xian

family: Zhang

full_name: Wei Zhang

given: Wei

name: Clinical Pharmacology Genentech‐Roche Marseille France

family: Bruno

full_name: René Bruno

given: René

currency_apc_doaj: USD

journal_name: Pharmacology Research & Perspectives

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Pan‐cancer population pharmacokinetics and exposure‐safety and ‐efficacy analyses of atezolizumab in patients with high tumor mutational burden

ReferenceCitation: Teo MY, Seier K, Ostrovnaya I, Regazzi AM, Kania BE, Moran MM, Cipolla CK, Bluth MJ, Chaim J, Al-Ahmadie H, Snyder A, Carlo MI, Solit DB, Berger MF, Funt S, Wolchok JD, Iyer G, Bajorin DF, Callahan MK, Rosenberg JE. Alterations in DNA Damage Response and Repair Genes as Potential Marker of Clinical Benefit From PD-1/PD-L1 Blockade in Advanced Urothelial Cancers. J Clin Oncol. 2018 Jun 10;36(17):1685-1694. doi: 10.1200/JCO.2017.75.7740. Epub 2018 Feb 28.

name: Min Yuen Teo, Kenneth Seier, Irina Ostrovnaya, Ashley M. Regazzi, Brooke E. Kania, Meredith M. Moran, Catharine K. Cipolla, Mark J. Bluth, Joshua Chaim, Alexandra Snyder, Maria I. Carlo, Michael F. Berger, Samuel Funt, Jedd D. Wolchok, Margaret K. Callahan, and Jonathan E. Rosenberg, Memorial Sloan Kettering Cancer Center; and Hikmat Al-Ahmadie, David B. Solit, Gopa Iyer, and Dean F. Bajorin, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY.

family: Teo

full_name: Min Yuen Teo

given: Min Yuen

family: Seier

full_name: Kenneth Seier

given: Kenneth

family: Ostrovnaya

full_name: Irina Ostrovnaya

given: Irina

family: Regazzi

full_name: Ashley M. Regazzi

given: Ashley M.

family: Kania

full_name: Brooke E. Kania

given: Brooke E.

family: Moran

full_name: Meredith M. Moran

given: Meredith M.

family: Cipolla

full_name: Catharine K. Cipolla

given: Catharine K.

family: Bluth

full_name: Mark J. Bluth

given: Mark J.

publisher: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Perez-Gracia JL, Loriot Y, Rosenberg JE, Powles T, Necchi A, Hussain SA, Morales-Barrera R, Retz MM, Niegisch G, Durán I, Théodore C, Grande E, Shen X, Wang J, Nelson B, Derleth CL, van der Heijden MS. Atezolizumab in Platinum-treated Locally Advanced or Metastatic Urothelial Carcinoma: Outcomes by Prior Number of Regimens. Eur Urol. 2018 Mar;73(3):462-468. doi: 10.1016/j.eururo.2017.11.023. Epub 2017 Dec 20. Erratum in: Eur Urol. 2019 Mar;75(3):e82-e83.

ReferenceCitation: Necchi A, Joseph RW, Loriot Y, Hoffman-Censits J, Perez-Gracia JL, Petrylak DP, Derleth CL, Tayama D, Zhu Q, Ding B, Kaiser C, Rosenberg JE. Atezolizumab in platinum-treated locally advanced or metastatic urothelial carcinoma: post-progression outcomes from the phase II IMvigor210 study. Ann Oncol. 2017 Dec 1;28(12):3044-3050. doi: 10.1093/annonc/mdx518.

ReferenceCitation: Snyder A, Nathanson T, Funt SA, Ahuja A, Buros Novik J, Hellmann MD, Chang E, Aksoy BA, Al-Ahmadie H, Yusko E, Vignali M, Benzeno S, Boyd M, Moran M, Iyer G, Robins HS, Mardis ER, Merghoub T, Hammerbacher J, Rosenberg JE, Bajorin DF. Contribution of systemic and somatic factors to clinical response and resistance to PD-L1 blockade in urothelial cancer: An exploratory multi-omic analysis. PLoS Med. 2017 May 26;14(5):e1002309. doi: 10.1371/journal.pmed.1002309. eCollection 2017 May.

repositories:
PubMed Central
bioRxiv
pdfs.semanticscholar.org

ReferenceCitation: Balar AV, Galsky MD, Rosenberg JE, Powles T, Petrylak DP, Bellmunt J, Loriot Y, Necchi A, Hoffman-Censits J, Perez-Gracia JL, Dawson NA, van der Heijden MS, Dreicer R, Srinivas S, Retz MM, Joseph RW, Drakaki A, Vaishampayan UN, Sridhar SS, Quinn DI, Durán I, Shaffer DR, Eigl BJ, Grivas PD, Yu EY, Li S, Kadel EE 3rd, Boyd Z, Bourgon R, Hegde PS, Mariathasan S, Thåström A, Abidoye OO, Fine GD, Bajorin DF; IMvigor210 Study Group. Atezolizumab as first-line treatment in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm, multicentre, phase 2 trial. Lancet. 2017 Jan 7;389(10064):67-76. doi: 10.1016/S0140-6736(16)32455-2. Epub 2016 Dec 8. Erratum in: Lancet. 2017 Aug 26;390(10097):848.

ReferenceCitation: Rosenberg JE, Hoffman-Censits J, Powles T, van der Heijden MS, Balar AV, Necchi A, Dawson N, O'Donnell PH, Balmanoukian A, Loriot Y, Srinivas S, Retz MM, Grivas P, Joseph RW, Galsky MD, Fleming MT, Petrylak DP, Perez-Gracia JL, Burris HA, Castellano D, Canil C, Bellmunt J, Bajorin D, Nickles D, Bourgon R, Frampton GM, Cui N, Mariathasan S, Abidoye O, Fine GD, Dreicer R. Atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy: a single-arm, multicentre, phase 2 trial. Lancet. 2016 May 7;387(10031):1909-20. doi: 10.1016/S0140-6736(16)00561-4. Epub 2016 Mar 4.

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

location_facility: Georgetown University Medical Center Lombardi Cancer Center

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Virginia Oncology Associates - Lake Wright Cancer Center

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

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: Beth Israel Deaconess Medical Center, Harvard Medical School; Department of Medicine

location_facility: Universitätsklinikum Freiburg; Chirurgische Klinik; Abteilung Urologie

location_facility: Urology Cancer Center & GU Research Network

location_facility: Mount Sinai School of Medicine - Tisch Cancer Institute

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: University Hospital Birmingham The Cancer Centre, Queen Elizabeth Hospital

location_facility: Indiana University Health; Goshen Center for Cancer Care

location_facility: The Angeles Clinic and Research Institute - W LA Office

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

location_facility: Kaiser Permanente; Oncology Clinical Trials

location_facility: Royal Marsden Hospital; Dept of Medical Oncology

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

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Universitätsklinikum Düsseldorf; Urologische Klinik

location_facility: Charité - Universitätsmedizin Berlin; CC 8: Chirurgische Medizin; Klinik für Urologie

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: The Ottawa Hospital Cancer Centre; Oncology

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Sarah Cannon Cancer Center - Tennessee Oncology, Pllc

location_facility: Institut Gustave Roussy; Oncologie Medicale

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

location_facility: Kimmel Cancer Center Thomas Jefferson University

location_facility: Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II

location_facility: Dana Farber Cancer Inst. ; Dept. of Medical Oncology

location_facility: Willamette Valley Cancer Ctr - 520 Country Club

location_facility: University of Chicago; Hematology/Oncology

location_facility: The Netherlands Cancer Institute - Antoni Van Leeuwenhoekziekenhuis

location_facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

location_facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept

title: A Phase II, Multicenter, Single-Arm Study of Atezolizumab in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer

summary: This Phase II, single-arm study is designed to evaluate the effect of atezolizumab treatment in participants with locally advanced or metastatic urothelial bladder cancer. Participants will be enrolled into 1 of 2 cohorts. Cohort 1 will consist of participants who are treatment-naïve and ineligible for cisplatin-containing chemotherapy. The results of Cohort 1 are reported separately (NCT02951767). Cohort 2 (reported here) will contain participants who have progressed during or following a prior platinum-based chemotherapy regimen. Participants in both cohorts will be given a 1200 milligrams (mg) intravenous (IV) dose of atezolizumab on Day 1 of 21-day cycles. Treatment of participants in Cohort 1 will continue until disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or unmanageable toxicity. Treatment of participants in Cohort 2 will continue until loss of clinical benefit or unmanageable toxicity.


ReferenceCitation: Yen CJ, Kiyota N, Hanai N, Takahashi S, Yokota T, Iwae S, Shimizu Y, Hong RL, Goto M, Kang JH, Li WSK, Ferris RL, Gillison M, Endo T, Jayaprakash V, Tahara M. Two-year follow-up of a randomized phase III clinical trial of nivolumab vs. the investigator's choice of therapy in the Asian population for recurrent or metastatic squamous cell carcinoma of the head and neck (CheckMate 141). Head Neck. 2020 Oct;42(10):2852-2862. doi: 10.1002/hed.26331. Epub 2020 Jun 24.

name: Division of Hematology and Oncology, Department of Internal Medicine National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University  Tainan Taiwan

family: Yen

full_name: Chia‐Jui Yen

given: Chia‐Jui

name: Department of Medical Oncology and Hematology Kobe University Hospital  Kobe Japan

name: Cancer Center Kobe University Hospital  Kobe Japan

family: Kiyota

full_name: Naomi Kiyota

given: Naomi

name: Department of Head and Neck Surgery Aichi Cancer Center Hospital  Nagoya Japan

family: Hanai

full_name: Nobuhiro Hanai

given: Nobuhiro

name: Department of Medical Oncology Cancer Institute Hospital, Japanese Foundation for Cancer Research  Tokyo Japan

family: Takahashi

full_name: Shunji Takahashi

given: Shunji

name: Division of Gastrointestinal Oncology Shizuoka Cancer Center  Shizuoka Japan

family: Yokota

full_name: Tomoya Yokota

given: Tomoya

name: Department of Head and Neck Surgery Hyogo Cancer Center  Akashi Japan

family: Iwae

full_name: Shigemichi Iwae

given: Shigemichi

name: Department of Medical Oncology Hokkaido University Hospital  Sapporo Japan

family: Shimizu

full_name: Yasushi Shimizu

given: Yasushi

name: Department of Oncology National Taiwan University Hospital  Taipei Taiwan

family: Hong

full_name: Ruey‐Long Hong

given: Ruey‐Long

name: Cancer Chemotherapy Center Osaka Medical College Hospital  Takatsuki Japan

family: Goto

full_name: Masahiro Goto

given: Masahiro

name: Division of Medical Oncology, Department of Internal Medicine The Catholic University of Korea, Seoul St. Mary's Hospital  Seoul Republic of Korea

family: Kang

full_name: Jin‐Hyoung Kang

given: Jin‐Hyoung

name: Department of Clinical Oncology Queen Elizabeth Hospital  Hong Kong China

family: Li

full_name: Wing Sum Kenneth Li

given: Wing Sum Kenneth

name: UPMC Hillman Cancer Center University of Pittsburgh Medical Center Cancer Center  Pittsburgh Pennsylvania USA

family: Ferris

full_name: Robert L. Ferris

given: Robert L.

name: Department of Thoracic Head and Neck Medical Oncology, Division of Cancer Medicine MD Anderson Cancer Center  Houston Texas USA

family: Gillison

full_name: Maura Gillison

given: Maura

name: Section 1, Oncology Medical Affairs ONO Pharmaceutical Co., Ltd  Osaka Japan

family: Endo

full_name: Toshimitsu Endo

given: Toshimitsu

name: Oncology Clinical Development BMS, Bristol‐Myers Squibb  Princeton New Jersey USA

family: Jayaprakash

full_name: Vijayvel Jayaprakash

given: Vijayvel

name: Department of Head and Neck Medical Oncology National Cancer Center Hospital East  Kashiwa Japan

family: Tahara

full_name: Makoto Tahara

given: Makoto

journal_name: Head & Neck

oa_colors: green hybrid

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

repository_institution: Kobe University - Kobe University Repository Kernel

title: Two‐year follow‐up of a randomized phase III clinical trial of nivolumab vs. the investigator's choice of therapy in the Asian population for recurrent or metastatic squamous cell carcinoma of the head and neck ( CheckMate 141)

ReferenceCitation: Saba NF, Blumenschein G Jr, Guigay J, Licitra L, Fayette J, Harrington KJ, Kiyota N, Gillison ML, Ferris RL, Jayaprakash V, Li L, Brossart P. Nivolumab versus investigator's choice in patients with recurrent or metastatic squamous cell carcinoma of the head and neck: Efficacy and safety in CheckMate 141 by age. Oral Oncol. 2019 Sep;96:7-14. doi: 10.1016/j.oraloncology.2019.06.017. Epub 2019 Jul 3.

family: Saba

full_name: Nabil F. Saba

given: Nabil F.

family: Blumenschein

full_name: George Blumenschein

given: George

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

title: Nivolumab versus investigator’s choice in patients with recurrent or metastatic squamous cell carcinoma of the head and neck: Efficacy and safety in CheckMate 141 by age

ReferenceCitation: Cocks K, Contente M, Simpson S, DeRosa M, Taylor FC, Shaw JW. A Q-TWiST Analysis Comparing Nivolumab and Therapy of Investigator's Choice in Patients with Recurrent/Metastatic Platinum-Refractory Squamous Cell Carcinoma of the Head and Neck. Pharmacoeconomics. 2019 Aug;37(8):1041-1047. doi: 10.1007/s40273-019-00798-1.

title: A Q-TWiST Analysis Comparing Nivolumab and Therapy of Investigator’s Choice in Patients with Recurrent/Metastatic Platinum-Refractory Squamous Cell Carcinoma of the Head and Neck

ReferenceCitation: Pai SI, Faivre S, Licitra L, Machiels JP, Vermorken JB, Bruzzi P, Gruenwald V, Giglio RE, Leemans CR, Seiwert TY, Soulieres D. Comparative analysis of the phase III clinical trials of anti-PD1 monotherapy in head and neck squamous cell carcinoma patients (CheckMate 141 and KEYNOTE 040). J Immunother Cancer. 2019 Apr 3;7(1):96. doi: 10.1186/s40425-019-0578-0.

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

ReferenceCitation: Ferris RL, Blumenschein G Jr, Fayette J, Guigay J, Colevas AD, Licitra L, Harrington KJ, Kasper S, Vokes EE, Even C, Worden F, Saba NF, Docampo LCI, Haddad R, Rordorf T, Kiyota N, Tahara M, Lynch M, Jayaprakash V, Li L, Gillison ML. Nivolumab vs investigator's choice in recurrent or metastatic squamous cell carcinoma of the head and neck: 2-year long-term survival update of CheckMate 141 with analyses by tumor PD-L1 expression. Oral Oncol. 2018 Jun;81:45-51. doi: 10.1016/j.oraloncology.2018.04.008. Epub 2018 Apr 17.

title: Nivolumab vs investigator’s choice in recurrent or metastatic squamous cell carcinoma of the head and neck: 2-year long-term survival update of CheckMate 141 with analyses by tumor PD-L1 expression

ReferenceCitation: Kiyota N, Hasegawa Y, Takahashi S, Yokota T, Yen CJ, Iwae S, Shimizu Y, Hong RL, Goto M, Kang JH, Sum Kenneth Li W, Ferris RL, Gillison M, Namba Y, Monga M, Lynch M, Tahara M. A randomized, open-label, Phase III clinical trial of nivolumab vs. therapy of investigator's choice in recurrent squamous cell carcinoma of the head and neck: A subanalysis of Asian patients versus the global population in checkmate 141. Oral Oncol. 2017 Oct;73:138-146. doi: 10.1016/j.oraloncology.2017.07.023. Epub 2017 Sep 1.

title: A randomized, open-label, Phase III clinical trial of nivolumab vs. therapy of investigator’s choice in recurrent squamous cell carcinoma of the head and neck: A subanalysis of Asian patients versus the global population in checkmate 141

ReferenceCitation: Harrington KJ, Ferris RL, Blumenschein G Jr, Colevas AD, Fayette J, Licitra L, Kasper S, Even C, Vokes EE, Worden F, Saba NF, Kiyota N, Haddad R, Tahara M, Grünwald V, Shaw JW, Monga M, Lynch M, Taylor F, DeRosa M, Morrissey L, Cocks K, Gillison ML, Guigay J. Nivolumab versus standard, single-agent therapy of investigator's choice in recurrent or metastatic squamous cell carcinoma of the head and neck (CheckMate 141): health-related quality-of-life results from a randomised, phase 3 trial. Lancet Oncol. 2017 Aug;18(8):1104-1115. doi: 10.1016/S1470-2045(17)30421-7. Epub 2017 Jun 23.

ReferenceCitation: Ferris RL, Blumenschein G Jr, Fayette J, Guigay J, Colevas AD, Licitra L, Harrington K, Kasper S, Vokes EE, Even C, Worden F, Saba NF, Iglesias Docampo LC, Haddad R, Rordorf T, Kiyota N, Tahara M, Monga M, Lynch M, Geese WJ, Kopit J, Shaw JW, Gillison ML. Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck. N Engl J Med. 2016 Nov 10;375(19):1856-1867. Epub 2016 Oct 8.

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

acronym: CheckMate 141: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 141

location_facility: Ist.Scient. Romagnolo Per Lo Studio E Cura Tumori

location_facility: Centro Para La Atencion Integral Del Paciente Oncologico

location_facility: Ohio State University Comprehensive Cancer Center

location_facility: British Columbia Cancer Agency-Vancouver Ctr

title: An Open Label, Randomized Phase 3 Clinical Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Platinum-refractory Squamous Cell Carcinoma of the Head and Neck (SCCHN)

summary: The purpose of this study is to find out whether Nivolumab will significantly improve overall survival as compared to therapy of investigator's choice in patients with recurrent or metastatic head and neck carcinoma.


title: A Retrospective, Non-interventional, Epidemiologic Study of the Natural History of Patients With Juvenile-onset Hypophosphatasia (HPP)

summary: The purpose of this study is to characterize the natural history of HPP in patients with Juvenile-onset HPP.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

lead_sponsor: Alexion Pharmaceuticals

location_country:
United States
Netherlands
France
Australia
Russian Federation
Turkey
Canada
United Kingdom

lead_sponsor_type: industriel

status_simplified: Completed


type: EudraCT Number

title: A Multi-center, Open Label, First in Human Phase I Dose Escalation Study of Single Agent RO5503781, a Small Molecule MDM2 Antagonist, Administered Orally in Patients With Advanced Malignancies, Except Leukemia

summary: This multicenter, open label, dose-escalating study will evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of RO5503781, administered once daily (QD) or once weekly (QW) in participants with advanced malignancies except leukemia. Participants will receive multiple escalating oral doses in two different dosing schedules (Sch) until disease progression or unacceptable toxicity occurs.

design_allocation: Non-Randomized

ReferenceCitation: Italiano A, Miller WH Jr, Blay JY, Gietema JA, Bang YJ, Mileshkin LR, Hirte HW, Higgins B, Blotner S, Nichols GL, Chen LC, Petry C, Yang QJ, Schmitt C, Jamois C, Siu LL. Phase I study of daily and weekly regimens of the orally administered MDM2 antagonist idasanutlin in patients with advanced tumors. Invest New Drugs. 2021 Dec;39(6):1587-1597. doi: 10.1007/s10637-021-01141-2. Epub 2021 Jun 28.

family: Italiano

full_name: Antoine Italiano

given: Antoine

family: Miller

full_name: Wilson H. Miller

given: Wilson H.

suffix: Jr

family: Blay

full_name: Jean-Yves Blay

given: Jean-Yves

family: Gietema

full_name: Jourik A. Gietema

given: Jourik A.

family: Bang

full_name: Yung-Jue Bang

given: Yung-Jue

family: Mileshkin

full_name: Linda R. Mileshkin

given: Linda R.

family: Hirte

full_name: Hal W. Hirte

given: Hal W.

family: Higgins

full_name: Brian Higgins

given: Brian

family: Blotner

full_name: Steven Blotner

given: Steven

family: Nichols

full_name: Gwen L. Nichols

given: Gwen L.

family: Chen

full_name: Lin Chi Chen

given: Lin Chi

family: Petry

full_name: Claire Petry

given: Claire

family: Yang

full_name: Qi Joy Yang

given: Qi Joy

family: Schmitt

full_name: Christophe Schmitt

given: Christophe

family: Jamois

full_name: Candice Jamois

given: Candice

family: Siu

full_name: Lillian L. Siu

given: Lillian L.

journal_name: Investigational New Drugs

repository_normalized: University of Melbourne - Minerva Access

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

publisher: Springer Science and Business Media LLC

location_country:
Netherlands
France
Australia
Canada
Korea, Republic of


title: A Phase 1B, Multi-Center, Open-Label Study of Novel Combinations of CC-122, CC-223, CC-292, and Rituximab in Diffuse Large B-Cell Lymphoma and Follicular Lymphoma

summary: First study, at multiple clinical centers, exploring the effects of different combinations of compounds (CC-122, CC-223 ,CC-292 and rituximab) to treat Diffuse Large B Cell Lymphoma (DLBCL) and Follicular Lymphoma

lead_sponsor: Celgene

location_country:
Italy
United States
Canada
France

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: University of Wisconsin Osteoporosis Clinical Center and Research Program

location_facility: Rocky Mountain Cancer Centers, LLP [Boulder-COBO]

location_facility: Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest

location_facility: Azienda Sanitaria Ospedaliera San Giovanni Battista Molinette

intervention_type: Drug

status_simplified: Ongoing


title: A Proof of Concept, Open-label, Forced Titration, Multi-center Study to Assess the Safety/Tolerability and Efficacy of 10-weeks Treatment of LCI699 in Patients With Cushing's Disease

summary:
This exploratory study is a proof of concept study to determine whether LCI699 can safely reduce the level of urinary free cortisol in patients with Cushing's disease.

In addition, this study evaluated the long term efficacy and safety of LCI699 including an additional 12 week of treatment followed by a 12 month long term optional extension.

A second extension provided patients who were clinically benefitting from LCI699 an opportunity to continue to have access to the drug until LCI699 was commercially available and reimbursed or through the availability of a local access program.

ReferenceCitation: Bertagna X, Pivonello R, Fleseriu M, Zhang Y, Robinson P, Taylor A, Watson CE, Maldonado M, Hamrahian AH, Boscaro M, Biller BM. LCI699, a potent 11β-hydroxylase inhibitor, normalizes urinary cortisol in patients with Cushing's disease: results from a multicenter, proof-of-concept study. J Clin Endocrinol Metab. 2014 Apr;99(4):1375-83. doi: 10.1210/jc.2013-2117. Epub 2013 Dec 11.

name: Department of Endocrinology (X.B.), Centre de Référence des Maladies Rares de la Surrénale, Hôpital Cochin, Faculté de Médecine Paris Descartes, Université Paris 5, Paris 75014, France

family: Bertagna

full_name: Xavier Bertagna

given: Xavier

name: Dipartimento di Medicina Clinica e Chirurgia (R.P.), Università Federico II di Napoli, IT-80131, Naples, Italy

family: Pivonello

full_name: Rosario Pivonello

given: Rosario

name: Department of Medicine and Neurological Surgery (M.F.), Northwest Pituitary Center, Oregon Health and Science University, Portland, Oregon 97239-3098

family: Fleseriu

full_name: Maria Fleseriu

given: Maria

name: Novartis Pharmaceuticals Corporation (Y.Z.), East Hanover, New Jersey 07936

family: Zhang

full_name: Yiming Zhang

given: Yiming

name: Novartis Pharmaceuticals UK Limited (P.R.), Horsham, West Sussex, RH12 5AB, United Kingdom

family: Robinson

full_name: Paul Robinson

given: Paul

name: Novartis Institutes for BioMedical Research (A.T., C.E.W.), Cambridge, Massachusetts 02139

family: Taylor

full_name: Ann Taylor

given: Ann

family: Watson

full_name: Catherine E. Watson

given: Catherine E.

name: Clinical Development (M.M.), Oncology Business Unit, Novartis Pharma AG, CH-4002 Basel, Switzerland

family: Maldonado

full_name: Mario Maldonado

given: Mario

name: Department of Endocrinology, Diabetes, and Metabolism (A.H.H.), Cleveland Clinic Foundation, Cleveland, Ohio 44106

family: Hamrahian

full_name: Amir H. Hamrahian

given: Amir H.

name: Division of Endocrinology (M.B.), Polytechnic University of Marche, 60121 Ancona, Italy

family: Boscaro

full_name: Marco Boscaro

given: Marco

name: Neuroendocrine Clinical Center (B.M.K.B.), Massachusetts General Hospital, Boston, Massachusetts 02114

family: Biller

full_name: Beverly M. K. Biller

given: Beverly M. K.

journal_name: The Journal of Clinical Endocrinology & Metabolism

oa_host_type: publisher

evidence: open (via free pdf)

publisher: The Endocrine Society

publisher_dissemination: The Endocrine Society

publisher_group: The Endocrine Society

publisher_normalized: The Endocrine Society

title: LCI699, a Potent 11β-hydroxylase Inhibitor, Normalizes Urinary Cortisol in Patients With Cushing's Disease: Results From a Multicenter, Proof-of-Concept Study

ipd_sharing: Yes

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
United States
France
Japan

location_facility: Massachusetts General Hospital Neuroendocrine Unit

location_facility: Northwestern University Endo, Metabolism and Molecular


title: A 2-year, Multicenter, Double-masked, Randomized, Parallel Study of the Safety of LUMIGAN® 0.1 mg/mL Compared With LUMIGAN® 0.3 mg/mL in Patients With Glaucoma or Ocular Hypertension

summary: This study will evaluate the long-term safety of bimatoprost 0.01% ophthalmic solution compared with bimatoprost 0.03% ophthalmic solution in patients with glaucoma or ocular hypertension.

design_allocation: Randomized

lead_sponsor: Allergan

location_country:
Italy
France
Czechia
Poland
Israel
Hungary
Belgium
Spain
Germany
United Kingdom

location_facility: Osrodek Badan Klinicznych Euromedis Sp. z o.o.

location_facility: Huntingdon Glaucoma Diagnostic & Research Centre

location_facility: University of Szeged Szent-Gyorgyi Albert Clinical Center

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu

location_facility: Glaucoma Service The Rabin Medical Center

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Dipartimento di Scienze Otorino-Odonto-Oftalmologiche e Cerv

location_facility: Fundacion Oftalmologica Del Mediterraneo

location_facility: Department of Ophthalmology, University of Tuebingen

location_facility: Akad. Med. w Warszawie - Ketedra I Klin. Okulistki Wyzialu L

location_facility: Fondazione G.B. Bietti per l'Oftalmologia I.R.C.C.S.

location_facility: Azlenda Ospedaliero Universitaria Careggi Viale


title: Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel-group, 24-week Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension

summary: Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH).

ReferenceType: result

ReferenceCitation: Ghofrani HA, Simonneau G, D'Armini AM, Fedullo P, Howard LS, Jaïs X, Jenkins DP, Jing ZC, Madani MM, Martin N, Mayer E, Papadakis K, Richard D, Kim NH; MERIT study investigators. Macitentan for the treatment of inoperable chronic thromboembolic pulmonary hypertension (MERIT-1): results from the multicentre, phase 2, randomised, double-blind, placebo-controlled study. Lancet Respir Med. 2017 Oct;5(10):785-794. doi: 10.1016/S2213-2600(17)30305-3. Epub 2017 Sep 11.

family: Ghofrani

full_name: Hossein-Ardeschir Ghofrani

given: Hossein-Ardeschir

family: Simonneau

full_name: Gérald Simonneau

given: Gérald

family: D'Armini

full_name: Andrea M D'Armini

given: Andrea M

family: Fedullo

full_name: Peter Fedullo

given: Peter

family: Howard

full_name: Luke S Howard

given: Luke S

family: Jaïs

full_name: Xavier Jaïs

family: Jenkins

full_name: David P Jenkins

given: David P

family: Jing

full_name: Zhi-Cheng Jing

given: Zhi-Cheng

family: Madani

full_name: Michael M Madani

given: Michael M

family: Martin

full_name: Nicolas Martin

given: Nicolas

family: Mayer

full_name: Eckhard Mayer

given: Eckhard

family: Papadakis

full_name: Kelly Papadakis

given: Kelly

family: Richard

full_name: Dominik Richard

given: Dominik

family: Kim

full_name: Nick H Kim

given: Nick H

family: Lang

full_name: Irene Lang

given: Irene

family: Kähler

full_name: Christian Kähler

given: Christian

family: Delcroix

full_name: Marion Delcroix

given: Marion

family: Bshouty

full_name: Zoheir Bshouty

given: Zoheir

family: Varela

full_name: Pablo Sepulveda Varela

given: Pablo Sepulveda

full_name: Yuanhua Yang

given: Yuanhua

family: Liu

full_name: Jinming Liu

given: Jinming

full_name: Gangcheng Zhang

given: Gangcheng

location_country:
Switzerland
Mexico
France
Czechia
Lithuania
Poland
Thailand
Hungary
Belgium
Russian Federation
China
Turkey
Germany
United Kingdom
Korea, Republic of
Ukraine

location_facility: Thoraxklinik am Universitätsklinikum Heidelberg

location_facility: State Institute of Phthisiology and Pulmonology n.a. F.G. Yanovskiy of AMS Ukraine

location_facility: Severance Hospital, YonSei University Health System

location_facility: E.N.Meshalkin Novosibirsk State Research Institute Of Circulation Pathology Rosmedtechnology

location_facility: Wojewódzki Szpital Specjalistyczny we Wrocawiu

location_facility: Papworth Hospital NHS Trust, Pulmonary Vascular Diseases Unit

location_facility: University Hospital Gasthuisberg / Interne Geneeskunde - I.G. Pneumologie

location_facility: Federal State Budgetary Institution "Scientific Research Institute of Systemic Problems of Cardiovascular Diseases", Siberian branch of RAMS

location_facility: The General Hospital of Shenyang Military Region,Congenital Heart Disease Department

location_facility: Federal State Budgetary Institution "Research Institute for Cardiology" of Siberian Branch under the Russian Academy of Medical Sciences / Cardiovascular Surgery Department

location_facility: ngShanghai Pulmonary Hospital, Department of Pulmonary Circulation

location_facility: MAHARAJ NAKORN CHIANG MAI HOSPITAL, Department of Internal Medicine

location_facility: Beijing Chao-Yang Hospital-Department of Respiration

location_facility: King Chulalongkorn Memorial Hospital, Division of Respiratory and Respiratory Critical Care Medicine

location_facility: Federal State Institution "Federal center of Heart, Blood and Endocrinology named after V.A.Almazov Rosmedtekhnologies"

location_facility: Federal State Budgetary Institution "Russian Cardiology Scientific and Production Complex" of the Ministry of Health Care of the Russian Federation

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital, Pulmonary Vascular Medicine

location_facility: Instituto Nacional de Cardiologia (INC) Ignacio Chavez

location_facility: Lviv Regional Clinical Hospital, Cardiosurgery Department

location_facility: Hôpital Européen Georges Pompidou Service de Pneumologie, soins intensifs et endoscopies bronchiques

location_facility: Centre for PPH, Charles University , II Interni klinika1.LF a VFN

location_facility: The first affiliated hospital of guangzhou medical university-respiratory department

location_facility: Siriraj Hospital, Division of Respiratory Disease and Tuberculosis

location_facility: Cardiovascular institute & Fuwai Hospital- Thrombus Center

location_facility: Debreceni Egyetem Orvos- és Egészségtudományi Centrum, Kardiológiai Klinika

location_facility: Istanbul University İstanbul Faculty Medicine Pulmonology Department

location_facility: Lietuvos Sveikatos Mokslų Universiteto Ligoninės Kauno Klinikos Pulmonologijos-Imunologijos Klinika

location_facility: Missionsärztliche Klinik gGmbH Akademisches Lehrkrankenhaus der Julius-Maximilians-Universität

location_facility: Wojewódzki Szpital Specjalistyczny w Lublinie im. Stefana Kardynała Wyszyńskiego SPZOZ Oddział Kardiologii - Pododdział Intensywnego Nadzoru Kardiologicznego


title: A Phase IIb, Randomized, Multi-Center, Double-Blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Clazakizumab in Subjects With Moderate to Severe Active Rheumatoid Arthritis Who Have Experienced an Inadequate Response to TNF Inhibitors

summary: The primary purpose of this study is to identify an appropriate dose of study medication.

lead_sponsor: CSL Behring

location_country:
Italy
United States
South Africa
Mexico
France
Japan
Hungary
Argentina
Canada

location_facility: Paramount Medical Research & Consulting, Llc

location_facility: Cividino Medicine Professional Corporation

location_facility: Rheumatology Associates Of North Alabama, P.C.

location_facility: Dr. Latha Naik Medical Professional Corporation

location_facility: Cincinnati Rheumatic Disease Study Group

location_facility: Arthritis & Rheumatology Center Of Oklahoma Pllc

location_facility: Joint And Muscle Medical Care And Research Institute (Jmmcri)

location_facility: Valerius Med Group & Res Ctr Of Greater Long Beach, Inc.


ReferenceCitation: Hoeper MM, Klinger JR, Benza RL, Simonneau G, Langleben D, Naeije R, Corris PA. Rationale and study design of RESPITE: An open-label, phase 3b study of riociguat in patients with pulmonary arterial hypertension who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors. Respir Med. 2017 Jan;122 Suppl 1:S18-S22. doi: 10.1016/j.rmed.2016.11.001. Epub 2016 Nov 5.

family: Hoeper

full_name: Marius M. Hoeper

given: Marius M.

family: Klinger

full_name: James R. Klinger

given: James R.

family: Benza

full_name: Raymond L. Benza

given: Raymond L.

family: Simonneau

full_name: Gerald Simonneau

given: Gerald

family: Langleben

full_name: David Langleben

given: David

family: Naeije

full_name: Robert Naeije

given: Robert

family: Corris

full_name: Paul A. Corris

given: Paul A.

journal_name: Respiratory Medicine

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

ReferenceCitation: Hoeper MM, Simonneau G, Corris PA, Ghofrani HA, Klinger JR, Langleben D, Naeije R, Jansa P, Rosenkranz S, Scelsi L, Grünig E, Vizza CD, Chang M, Colorado P, Meier C, Busse D, Benza RL. RESPITE: switching to riociguat in pulmonary arterial hypertension patients with inadequate response to phosphodiesterase-5 inhibitors. Eur Respir J. 2017 Sep 9;50(3). pii: 1602425. doi: 10.1183/13993003.02425-2016. Print 2017 Sep.

full_name: Gérald Simonneau

given: Gérald

family: Ghofrani

full_name: Hossein-Ardeschir Ghofrani

given: Hossein-Ardeschir

family: Jansa

full_name: Pavel Jansa

given: Pavel

family: Rosenkranz

full_name: Stephan Rosenkranz

given: Stephan

family: Scelsi

full_name: Laura Scelsi

given: Laura

family: Grünig

full_name: Ekkehard Grünig

given: Ekkehard

family: Vizza

full_name: Carmine Dario Vizza

given: Carmine Dario

family: Chang

full_name: MiKyung Chang

given: MiKyung

family: Colorado

full_name: Pablo Colorado

given: Pablo

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

location_country:
Italy
United States
Switzerland
Germany
France
Czechia
Belgium
Canada
United Kingdom

title: An Open-label, International, Multicenter, Single-arm, Uncontrolled, Phase IIIb Study of Riociguat in Patients With Pulmonary Arterial Hypertension (PAH) Who Demonstrate an Insufficient Response to Treatment With Phosphodiesterase-5 Inhibitors (PDE-5i)

summary:
BAY63-2521 Riociguat leads to the relaxation of smooth muscle cells in pulmonary arteria and may also inhibit abnormal remodeling of lung blood vessels. In patients with pulmonary arterial hypertension Riociguat showed to reduce the pulmonary blood pressure and improved the right heart function without unacceptable side effects. Here dose of Riociguat will be adjusted over 8 weeks then a Maintenance Phase of 16 weeks follows. Patients with Pulmonary Arterial Hypertension treated with stable doses of Phosphodiesterase Type-5 Inhibitors (Eg Sildenafil, Tadalafil) not appropriately responding to therapy will be included. Based on previous evidence and on the different modes of action an improvement of exercise capacity, heart function and quality of life may be expected if PDE5i treatment is transitioned to riociguat.

Where Riociguat is pending market approval or reimbursement once the treatment phase is completed drug can be made available for another 18 months (Extended Drug Supply Phase - EDSP) under study conditions. Patients may also transition at the end of the maintenance period or any time during the EDSP to any program that is intended to provide riociguat until drug approval/reimbursement, e.g. a long-term extension study, compassionate use or named patient program. Study termination is also possible at any time.


ReferenceCitation: de Schepper J, Rasmussen MH, Gucev Z, Eliakim A, Battelino T. Long-acting pegylated human GH in children with GH deficiency: a single-dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics. Eur J Endocrinol. 2011 Sep;165(3):401-9. doi: 10.1530/EJE-11-0536. Epub 2011 Jul 1.

family: de Schepper

full_name: Jean de Schepper

given: Jean

family: Rasmussen

full_name: Michael Højby Rasmussen

given: Michael Højby

family: Gucev

full_name: Zoran Gucev

given: Zoran

family: Eliakim

full_name: Alon Eliakim

given: Alon

family: Battelino

full_name: Tadej Battelino

given: Tadej

journal_name: European Journal of Endocrinology

publisher: Bioscientifica

publisher_dissemination: Bioscientifica

publisher_group: Bioscientifica

publisher_normalized: Bioscientifica

ReferenceCitation: Papathanasiou T, Agersø H, Damholt BB, Højby Rasmussen M, Kildemoes RJ. Population Pharmacokinetics and Pharmacodynamics of Once-Daily Growth Hormone Norditropin(®) in Children and Adults. Clin Pharmacokinet. 2021 Sep;60(9):1217-1226. doi: 10.1007/s40262-021-01011-3. Epub 2021 Apr 17.

family: Papathanasiou

full_name: Theodoros Papathanasiou

given: Theodoros

family: Agersø

full_name: Henrik Agersø

given: Henrik

family: Damholt

full_name: Birgitte Bentz Damholt

given: Birgitte Bentz

family: Højby Rasmussen

given: Michael

family: Kildemoes

full_name: Rasmus Juul Kildemoes

given: Rasmus Juul

journal_name: Clinical Pharmacokinetics

license: cc-by-nc

license_normalized: cc-by-nc

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: Population Pharmacokinetics and Pharmacodynamics of Once-Daily Growth Hormone Norditropin® in Children and Adults

lead_sponsor: Novo Nordisk A/S

location_country: Macedonia, The Former Yugoslav Republic of

source: euctr

title: A Randomised, Open-labelled, Single Dose, Dose-escalation Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pegylated Long-acting Human Growth Hormone (NNC126-0083) Compared to Norditropin NordiFlex® in Growth Hormone Deficient Children

summary: This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics (the determination of the concentration of the administered medication in blood over time) and pharmacodynamics (the determination of the effect over time and the duration of action) of a long-acting growth hormone (NNC126-0083) in growth hormone deficient children.


title: Clinical Investigation of the Freedom SOLO Stentless Heart Valve

summary: This is a trial to demonstrate the safety and effectiveness of the Freedom SOLO heart valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.

enrollment_type: Anticipated

ReferenceCitation: Thalmann M, Grubitzsch H, Matschke K, Glauber M, Tan E, Francois K, Amorim MJ, Hensens AG, Cesari F, Feyrer R, Diegeler A, Veit F, Repossini A; Freedom Solo Investigators. A European Multicenter Study of 616 Patients Receiving the Freedom Solo Stentless Bioprosthesis. Ann Thorac Surg. 2016 Jan;101(1):100-8. doi: 10.1016/j.athoracsur.2015.06.096. Epub 2015 Oct 9.

family: Thalmann

full_name: Markus Thalmann

given: Markus

family: Grubitzsch

full_name: Herko Grubitzsch

given: Herko

family: Matschke

full_name: Klaus Matschke

given: Klaus

family: Glauber

full_name: Mattia Glauber

given: Mattia

family: Tan

full_name: Erwin Tan

given: Erwin

family: Francois

full_name: Katrien Francois

given: Katrien

family: Amorim

full_name: Mario J. Amorim

given: Mario J.

family: Hensens

full_name: Ab.G. Hensens

family: Cesari

full_name: Francesco Cesari

given: Francesco

family: Feyrer

full_name: Richard Feyrer

given: Richard

family: Diegeler

full_name: Anno Diegeler

given: Anno

family: Veit

full_name: Franz Veit

given: Franz

family: Repossini

full_name: Alberto Repossini

given: Alberto

family: Wisser

full_name: Wlifried Wisser

given: Wlifried

family: El Khoury

full_name: Gebrine El Khoury

given: Gebrine

family: Leguerrier

full_name: Alain Leguerrier

given: Alain

family: Livi

full_name: Ugolino Livi

given: Ugolino

family: Driessen

full_name: A.H.G. Driessen

family: van Swieten

full_name: H.A. van Swieten

family: Carrel

full_name: Thierry Carrel

given: Thierry

journal_name: The Annals of Thoracic Surgery

lead_sponsor: LivaNova

location_country: Italy Austria Switzerland Netherlands France Belgium Portugal Germany

location_facility: Universitätsklinikum Erlangen, Klinik für Herzchirurgie

location_facility: Ospedale del Cuore, Fondazione G. Monasterio

location_facility: Herzzentrum Dresden Universitätsklinik an der Technischen Universität Dresden

intervention_type: Device


title: An Open Label, Single-arm, Baseline-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Immunogenicity of Subcutaneous HX575 Administered Once a Week (qw) and Once Every Two Weeks (q2w) in the Treatment of Anemia Associated With Chronic Kidney Disease in Pre-dialysis and Dialysis Subjects

acronym: SWEEP

summary:
This is an open-label, single-arm, baseline-controlled, multicenter efficacy and safety switch study involving 500 CKD subjects suffering from anemia and treated previously with a stable dose of ESA s.c.

Correction of anemia will be maintained by s.c. administration of HX575 in two frequencies (i.e. qw and q2w), in order to maintain an Hb target range of 10.0-12.0 g/dL.

status: Withdrawn

lead_sponsor: Sandoz

location_country: France Bulgaria Romania Spain Germany

location_facility: Centre Hospitalier Universitaire Limoges, Hôpital Dupuytren

location_facility: Nierenzentrum Weinheim Kreiskrankenhaus Weinheim

location_facility: Gemeinschaftspraxis Dr. Spitthöver, Dr. Knee, Dr. Gröschel

location_facility: Spitalul Universitar de Urgenta Bucuresti

location_facility: Gesundheitszentrum Alzey Internistische Gemeinschaftspraxis

location_facility: Spitalul Clinic de Nefrologie Dr. Carol Davila

location_facility: Spitalul Clinic Municipal "Dr. Gavril Curteanu"

status_simplified: Unknown


ReferenceCitation: Eisen T, Joensuu H, Nathan PD, Harper PG, Wojtukiewicz MZ, Nicholson S, Bahl A, Tomczak P, Pyrhonen S, Fife K, Bono P, Boxall J, Wagner A, Jeffers M, Lin T, Quinn DI. Regorafenib for patients with previously untreated metastatic or unresectable renal-cell carcinoma: a single-group phase 2 trial. Lancet Oncol. 2012 Oct;13(10):1055-62. doi: 10.1016/S1470-2045(12)70364-9. Epub 2012 Sep 6.

family: Eisen

full_name: Tim Eisen

given: Tim

family: Joensuu

full_name: Heikki Joensuu

given: Heikki

family: Nathan

full_name: Paul D Nathan

given: Paul D

family: Harper

full_name: Peter G Harper

given: Peter G

family: Wojtukiewicz

full_name: Marek Z Wojtukiewicz

given: Marek Z

family: Nicholson

full_name: Steve Nicholson

given: Steve

family: Bahl

full_name: Amit Bahl

given: Amit

family: Tomczak

full_name: Piotr Tomczak

given: Piotr

family: Pyrhonen

full_name: Seppo Pyrhonen

given: Seppo

family: Fife

full_name: Kate Fife

given: Kate

family: Bono

full_name: Petri Bono

given: Petri

family: Boxall

full_name: Jane Boxall

given: Jane

family: Wagner

full_name: Andrea Wagner

given: Andrea

family: Jeffers

full_name: Michael Jeffers

given: Michael

family: Lin

full_name: Tiffany Lin

given: Tiffany

family: Quinn

full_name: David I Quinn

given: David I

journal_name: The Lancet Oncology

lead_sponsor: Bayer

location_country:
United States
Finland
France
Poland
Germany
United Kingdom

title: A Phase II Uncontrolled Study of BAY73-4506 in Previously Untreated Patients With Metastatic or Unresectable Renal Cell Cancer (RCC)

summary: This is a uncontrolled, open-label, non-randomized Phase II study of oral BAY73-4506 to evaluate the response rate of BAY73-4506 in previously untreated patients with metastatic or unresectable renal cell cancer (RCC).


ReferenceCitation: Li K, Strauss R, Marano C, Greenbaum LE, Friedman JR, Peyrin-Biroulet L, Brodmerkel C, De Hertogh G. A Simplified Definition of Histologic Improvement in Ulcerative Colitis and its Association With Disease Outcomes up to 30 Weeks from Initiation of Therapy: Post Hoc Analysis of Three Clinical Trials. J Crohns Colitis. 2019 Aug 14;13(8):1025-1035. doi: 10.1093/ecco-jcc/jjz022.

name: Janssen Research & Development, LLC, Immunology Therapeutic Area, Spring House, Pennsylvania, USA

family: Li

full_name: Katherine Li

given: Katherine

family: Strauss

full_name: Richard Strauss

given: Richard

family: Marano

full_name: Colleen Marano

given: Colleen

name: Novartis Institutes for Biomedical Research, East Hanover, New Jersey, USA

family: Greenbaum

full_name: Linda E Greenbaum

given: Linda E

family: Friedman

full_name: Joshua R Friedman

given: Joshua R

name: INSERM Unité 954 and Department of Hepato-Gastroenterology, University Hospital of Nancy, Nancy, France

family: Peyrin-Biroulet

full_name: Laurent Peyrin-Biroulet

given: Laurent

family: Brodmerkel

full_name: Carrie Brodmerkel

given: Carrie

name: Department of Imaging & Pathology, Translational Cell & Tissue Research, University Hospitals Leuven, Leuven, Belgium

family: De Hertogh

full_name: Gert De Hertogh

given: Gert

journal_name: Journal of Crohn's and Colitis

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Telesco SE, Brodmerkel C, Zhang H, Kim LL, Johanns J, Mazumder A, Li K, Baribaud F, Curran M, Strauss R, Paxson B, Plevy S, Davison T, Knight L, Dibben S, Schreiber S, Sandborn W, Rutgeerts P, Siegel CA, Reinisch W, Greenbaum LE. Gene Expression Signature for Prediction of Golimumab Response in a Phase 2a Open-Label Trial of Patients With Ulcerative Colitis. Gastroenterology. 2018 Oct;155(4):1008-1011.e8. doi: 10.1053/j.gastro.2018.06.077. Epub 2018 Jul 4.

family: Telesco

full_name: Shannon E. Telesco

given: Shannon E.

family: Zhang

full_name: Hongyan Zhang

given: Hongyan

family: Kim

full_name: Lilianne (Lee-Lian) Kim

given: Lilianne (Lee-Lian)

family: Johanns

full_name: Jewel Johanns

given: Jewel

family: Mazumder

full_name: Abhijit Mazumder

given: Abhijit

family: Baribaud

full_name: Frédéric Baribaud

given: Frédéric

family: Curran

full_name: Mark Curran

given: Mark

family: Paxson

full_name: Bethany Paxson

given: Bethany

family: Plevy

full_name: Scott Plevy

given: Scott

family: Davison

full_name: Timothy Davison

given: Timothy

family: Knight

full_name: Laura Knight

given: Laura

family: Dibben

location_country:
United States
Netherlands
Germany
France
Bulgaria
Poland
Hungary
Belgium
Russian Federation
Canada
Czech Republic
Ukraine

title: A Phase 2a Open-Label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects With Moderately to Severely Active Ulcerative Colitis

summary: The purpose of this study is to evaluate the accuracy of a subset of the length-109 probe set panel (a genetic test) in predicting response to golimumab treatment in participants with moderately to severely active ulcerative colitis (UC).


title: A Double-blind, Randomized, Multicenter Study to Evaluate the Safety and Efficacy of Evolocumab, Compared With Ezetimibe, in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor Due to Muscle Related Side Effects

summary: The primary objective of this study was to evaluate the effect of 24 weeks of evolocumab administered subcutaneously (SC) every month, compared with ezetimibe, on low-density lipoprotein cholesterol (LDL-C) levels in adults with high cholesterol who are unable to tolerate an effective dose of a statin due to muscle-related side effects (MRSE).

ReferenceType: background

ReferenceCitation: Cho L, Dent R, Stroes ESG, Stein EA, Sullivan D, Ruzza A, Flower A, Somaratne R, Rosenson RS. Persistent Safety and Efficacy of Evolocumab in Patients with Statin Intolerance: a Subset Analysis of the OSLER Open-Label Extension Studies. Cardiovasc Drugs Ther. 2018 Aug;32(4):365-372. doi: 10.1007/s10557-018-6817-7.

ReferenceCitation: Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10:CD011748. doi: 10.1002/14651858.CD011748.pub3.

name: Institute of Cardiovascular Science; University College London; London UK

name: Department of Cardiology, Division Heart and Lungs; UMC Utrecht; Utrecht Netherlands

family: Schmidt

full_name: Amand F Schmidt

given: Amand F

name: Department of Clinical Pharmacology and Therapeutics; University College London Hospital; London UK

family: Carter

full_name: John-Paul L Carter

given: John-Paul L

name: Department of Non-communicable Disease Epidemiology; London School of Hygiene & Tropical Medicine; London UK

family: Pearce

full_name: Lucy S Pearce

given: Lucy S

name: The Department of Medicine (Cardiology) and the Department of Preventive Medicine; Northwestern University Feinberg School of Medicine; Chicago Illinois USA

family: Wilkins

full_name: John T Wilkins

given: John T

name: Medicines Discovery Catapult; Alderly Edge UK

family: Overington

full_name: John P Overington

given: John P

family: Hingorani

full_name: Aroon D Hingorani

given: Aroon D

name: Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC); VA Boston Healthcare System; Boston Massachusetts USA

family: Casas

full_name: JP Casas

given: JP

journal_name: Cochrane Database of Systematic Reviews

oa_host_type: repository

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

version: acceptedVersion

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

ReferenceCitation: Nissen SE, Stroes E, Dent-Acosta RE, Rosenson RS, Lehman SJ, Sattar N, Preiss D, Bruckert E, Ceška R, Lepor N, Ballantyne CM, Gouni-Berthold I, Elliott M, Brennan DM, Wasserman SM, Somaratne R, Scott R, Stein EA; GAUSS-3 Investigators. Efficacy and Tolerability of Evolocumab vs Ezetimibe in Patients With Muscle-Related Statin Intolerance: The GAUSS-3 Randomized Clinical Trial. JAMA. 2016 Apr 19;315(15):1580-90. doi: 10.1001/jama.2016.3608.

family: Nissen

full_name: Steven E. Nissen

given: Steven E.

name: University of Amsterdam Faculty of Medicine, Amsterdam, the Netherlands

family: Stroes

full_name: Erik Stroes

given: Erik

family: Dent-Acosta

full_name: Ricardo E. Dent-Acosta

given: Ricardo E.

name: School of Medicine at Mount Sinai, New York, New York

family: Rosenson

full_name: Robert S. Rosenson

given: Robert S.

name: Flinders University, Bedford Park, SA, Australia

family: Lehman

full_name: Sam J. Lehman

given: Sam J.

name: University of Glasgow, Glasgow, United Kingdom

family: Sattar

full_name: Naveed Sattar

given: Naveed

name: Clinical Trial Service Unit, University of Oxford, Oxford, United Kingdom8Epidemiological Services Unit, University of Oxford, Oxford, United Kingdom

name: University Hospital of Paris 6, Paris, France

name: Charles University in Prague, Prague, Czech Republic11General University Hospital in Prague, Prague, Czech Republic

name: David Geffen School of Medicine at the University of California, Los Angeles

name: Baylor College of Medicine, Houston, Texas

name: Center for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Cologne, Germany

name: Metabolic and Atherosclerosis Research Center, Cincinnati, Ohio

location_country:
Italy
United States
South Africa
Netherlands
Germany
France
Czechia
Norway
Australia
New Zealand
Denmark
Canada
United Kingdom


ReferenceCitation: Pal SK, McDermott DF, Atkins MB, Escudier B, Rini BI, Motzer RJ, Fong L, Joseph RW, Oudard S, Ravaud A, Bracarda S, Suárez C, Lam ET, Choueiri TK, Ding B, Quach C, Hashimoto K, Schiff C, Piault-Louis E, Powles T. Patient-reported outcomes in a phase 2 study comparing atezolizumab alone or with bevacizumab vs sunitinib in previously untreated metastatic renal cell carcinoma. BJU Int. 2020 Jul;126(1):73-82. doi: 10.1111/bju.15058. Epub 2020 Apr 24.

name: Department of Medical Oncology and Experimental Therapeutics City of Hope Comprehensive Cancer Center Duarte CA USA

family: Pal

full_name: Sumanta K. Pal

given: Sumanta K.

name: Beth Israel Deaconess Medical Center Harvard Medical School Boston MA USA

family: McDermott

full_name: David F. McDermott

given: David F.

name: Georgetown Lombardi Comprehensive Cancer Center Georgetown University Washington DC USA

family: Atkins

full_name: Michael B. Atkins

given: Michael B.

family: Escudier

full_name: Bernard Escudier

given: Bernard

name: Taussig Cancer Institute, Cleveland Clinic Cleveland OH USA

family: Rini

full_name: Brian I. Rini

given: Brian I.

name: Memorial Sloan Kettering Cancer Center New York NY USA

family: Motzer

full_name: Robert J. Motzer

given: Robert J.

name: School of Medicine University of California, San Francisco San Francisco CA USA

family: Fong

full_name: Lawrence Fong

given: Lawrence

name: Mayo Clinic Hospital Jacksonville FL USA

family: Joseph

full_name: Richard W. Joseph

given: Richard W.

name: Department of Medical Oncology Georges Pompidou Hospital Paris Descartes University Paris France

family: Oudard

full_name: Stephane Oudard

given: Stephane

name: CHU H__pitaux de Bordeaux Hôpital Saint‐André Bordeaux France

family: Ravaud

full_name: Alain Ravaud

given: Alain

name: Azienda Ospedaliera S. Maria Terni Italy

family: Bracarda

full_name: Sergio Bracarda

given: Sergio

name: Vall d'Hebron University Hospital and Institute of Oncology Barcelona Spain

family: Suárez

full_name: Cristina Suárez

given: Cristina

name: Anschutz Medical Campus University of Colorado Aurora CO USA

family: Lam

full_name: Elaine T. Lam

given: Elaine T.

name: Dana‐Farber Cancer Institute Boston MA USA

family: Choueiri

full_name: Toni K. Choueiri

given: Toni K.

name: Genentech, Inc. South San Francisco CA USA

family: Ding

full_name: Beiying Ding

given: Beiying

family: Quach

full_name: Caroleen Quach

given: Caroleen

name: Roche Products Ltd Welwyn Garden City UK

family: Hashimoto

full_name: Kenji Hashimoto

given: Kenji

family: Schiff

full_name: Christina Schiff

given: Christina

family: Piault‐Louis

full_name: Elisabeth Piault‐Louis

given: Elisabeth

name: Barts Cancer Institute Royal Free Hospital Queen Mary University of London London UK

family: Powles

full_name: Thomas Powles

given: Thomas

journal_name: BJU International

title: Patient‐reported outcomes in a phase 2 study comparing atezolizumab alone or with bevacizumab vs sunitinib in previously untreated metastatic renal cell carcinoma

location_country:
Italy
United States
France
Czechia
Poland
Romania
Spain
Germany
United Kingdom

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

location_facility: Cleveland Clinic Foundation; Taussig Cancer Center

location_facility: Klinikum d.Universität München Campus Großhadern

location_facility: Klinikum rechts der Isar der TU München; Klinikapotheke

location_facility: Yale Uni School of Medicine; Section of Medical Oncology

location_facility: HonorHealth Research Institute - Bisgrove

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

location_facility: Texas Oncology-Baylor Sammons Cancer Center

location_facility: Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale

location_facility: Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: Rocky Mountain Cancer Ctr - Denver (Williams)

location_facility: Institut Gustave Roussy; Departement Oncologie Medicale

location_facility: Prof. Dr. I. Chiricuta Institute of Oncology

location_facility: Tennessee Oncology PLLC - Nashville (20th Ave)

location_facility: Hosp de Madrid Norte Sanchinarro; Centro Integral; Onco Clara Campal

location_facility: Hospital Clinic de Barcelona. Unidad de Nuevas Terapias;Oncology Department

title: A Phase II, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Administered as Monotherapy or in Combination With Bevacizumab Versus Sunitinib in Patients With Untreated Advanced Renal Cell Carcinoma

summary: This multicenter, randomized, open-label study will evaluate the efficacy, safety and tolerability of atezolizumab as monotherapy or in combination with bevacizumab versus sunitinib in participants with histologically confirmed, inoperable, locally advanced or metastatic renal cell carcinoma who have not received prior systemic therapy either in the adjuvant or metastatic setting.


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Untreated Chronic Lymphocytic Leukemia

summary:
The primary objective of this study is to evaluate the progression-free survival in participants with previously untreated chronic lymphocytic leukemia (CLL) who would otherwise be suitable for bendamustine and rituximab treatment as standard of care.

An increased rate of deaths and serious adverse events (SAEs) among participants with front-line CLL and early-line indolent non-Hodgkin lymphoma (iNHL) treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA).

status: Terminated

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

lead_sponsor: Gilead Sciences

location_country:
Italy
United States
Croatia
Czechia
France
Poland
Romania
Hungary
Belgium
Australia
Spain
Canada
United Kingdom

location_facility: Azienda Ospedaliero Universitaria Policlinico di Modena

location_facility: Hematology /Oncology Associates of Northern New Jersey

location_facility: Franciscan Physician Network Oncology & Hematology

location_facility: Szegedi Tudomanyegyetem AOK - Szent-Gyorgyi Albert Klinikai Kozpont, II. Belgyógyászati Klinika

location_facility: Siouxland Hematology-Oncology Associates, LLP

location_facility: Haematology and Bone Marrow Transplant Unit, Royal Adelaide Hospital

location_facility: East Kent Hospitals University NHS Foundation Trust

location_facility: Centrum Onkologii-Instytut Marii Sklodowskiej -Curie klinika Nowotworow Ukladu Chlonnego

location_facility: Dolnoslakie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku

location_facility: Kaposi Mor Oktato Korhaz, Intezeti Gyogyszertar,

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika Klinika Hematologii

location_facility: Royal Wolverhampton Hospital NHS Trust, New Cross Hospital

location_facility: University of Debrecen HSC Institute of internal Medicine, Department of Hematology

location_facility: University Hospital Southampton NHS Trust

location_facility: Royal Liverpool & Broadgreen Univ. Hospitals NHS Trust

location_facility: Flinders Medical Centre, Department of Haematology, Level 6

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu Klinika i Katedra Hematologii,Nowotworow Krwi i Transplantacji Szpiku

location_facility: St. Jude Heritage Healthcare Virginia K. Crosson Cancer Center

location_facility: Emergency County Clinical Hospital Brasov

location_facility: Barwon Health, University Hospital Geelong

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

location_facility: Centralny Szpital Kliniczny MSW w Warszawie Klinika Onkologii i Hematologii

location_facility: CHU de Québec - Hôpital de l'Enfant-Jésus


type: Registry Identifier

title: A Multicenter, Single-arm, Open-label, Postmarketing Safety Study to Evaluate the Risk of Seizure Among Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) Treated With Enzalutamide Who Are at Potential Increased Risk of Seizure

acronym: UPWARD

summary: The objective of this study was to evaluate the incidence of seizures and monitor the safety of enzalutamide treatment in participants with metastatic castration-resistant prostate cancer (mCRPC) known to have risk factor(s) for seizure.

ipd_sharing_description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

lead_sponsor: Astellas Pharma Global Development, Inc.

location_country:
Italy
United States
Chile
Sweden
Spain
Germany
Finland
France
Czechia
Israel
Singapore
Hungary
Belgium
Argentina
Australia
New Zealand
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility:
Site AR54001
Site AR54004
Site BE32004
Site ES34006
Site CA15004
Site AU61001
Site BE32001
Site TW88601
Site SE46001
Site AU61012
Site AR54005
Site CL56002
Site US10025
Site KR82004
Site KR82001
Site US10008
Site CZ42004
Site US10026
Site FI35801
Site US10014
Site CL56001
Site CA15001
Site IL97202
Site SG65002
Site ES34003
Site IT39003
Site IT39001
Site FI35802
Site ES34005
Site NZ64001
Site IL97203
Site CL56003
Site AR54006
Site IL97205
Site FR33005
Site IL97206
Site US10016
Site KR82007
Site ES34007
Site IL97207
Site AU61011
Site SE46002
Site IL97201
Site GB44002
Site CA15005
Site AR54003
Site DE49009
Site DE49003
Site IL97208
Site AU61004
Site CA15014
Site ES34001
Site DE49001
Site BE32003
Site FR33004
Site IT39002
Site ES34004
Site US10024
Site FI35803
Site KR82006
Site TW88603
Site AR54002
Site US10005
Site AU61002
Site AU61007
Site US10039
Site IT39005
Site CA15010
Site KR82003
Site CL56004
Site HU36002
Site AU61005
Site IL97204
Site US10001
Site CZ42002
Site FR33002


type: Other Identifier

title: A Randomised, Double-Blind, Placebo-Controlled, Multicentre Phase II Study to Compare the Efficacy, Safety and Tolerability of Olaparib Versus Placebo When Given in Addition to Abiraterone Treatment in Patients With Metastatic Castrate-Resistant Prostate Cancer Who Have Received Prior Chemotherapy Containing Docetaxel

summary: This is a 2-part study in patients with metastatic CRPC. Part A is an open-label safety run-in study to assess the safety, tolerability and pharmacokinetics (PK) of olaparib when given in addition to abiraterone 1000 mg once daily. Part B is a randomised, double-blind, placebo controlled comparison of the efficacy, safety and tolerability of the dose of olaparib selected from Part A when given in addition to abiraterone, versus placebo given in addition to abiraterone. Abiraterone is indicated in combination with prednisone or prednisolone for the treatment of patients with metastatic CRPC. Prednisone or prednisolone 5 mg twice daily (bid) will be administered with the abiraterone in this study.

ReferenceCitation: Clarke N, Wiechno P, Alekseev B, Sala N, Jones R, Kocak I, Chiuri VE, Jassem J, Fléchon A, Redfern C, Goessl C, Burgents J, Kozarski R, Hodgson D, Learoyd M, Saad F. Olaparib combined with abiraterone in patients with metastatic castration-resistant prostate cancer: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Oncol. 2018 Jul;19(7):975-986. doi: 10.1016/S1470-2045(18)30365-6. Epub 2018 Jun 4.

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

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

lead_sponsor: AstraZeneca

location_country:
Italy
United States
Netherlands
France
Czechia
Poland
Belgium
Russian Federation
Spain
Canada
United Kingdom


title: A Randomized, Double-blind, Placebo-controlled, Parallel-Group, 26-Week, Phase 3 Study of 2 Doses of EVP-6124 or Placebo in Subjects With Mild to Moderate Alzheimer's Disease Currently or Previously Receiving an Acetylcholinesterase Inhibitor Medication

summary: The purpose of this study is to evaluate the safety and efficacy of 2 fixed doses of EVP-6124 compared to placebo for 26 weeks in subjects with mild to moderate Alzheimer's disease currently receiving stable treatment or previously treated with an acetylcholinesterase inhibitor.

lead_sponsor: FORUM Pharmaceuticals Inc

location_country:
Italy
United States
South Africa
United Kingdom
Mexico
Netherlands
Germany
France
Argentina
Australia
Spain
Canada
Czech Republic
Korea, Republic of


title: A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose-response Study Evaluating the Efficacy and Safety of JNJ-54781532 in Subjects With Moderately to Severely Active Ulcerative Colitis

summary: The purpose of the study is to evaluate dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC).

name: Janssen Research & Development, LLC, Immunology Therapeutic Area, Spring House, Pennsylvania, USA

family: Li

full_name: Katherine Li

given: Katherine

family: Strauss

full_name: Richard Strauss

given: Richard

family: Marano

full_name: Colleen Marano

given: Colleen

name: Novartis Institutes for Biomedical Research, East Hanover, New Jersey, USA

family: Greenbaum

full_name: Linda E Greenbaum

given: Linda E

family: Friedman

full_name: Joshua R Friedman

given: Joshua R

name: INSERM Unité 954 and Department of Hepato-Gastroenterology, University Hospital of Nancy, Nancy, France

family: Peyrin-Biroulet

full_name: Laurent Peyrin-Biroulet

given: Laurent

family: Brodmerkel

full_name: Carrie Brodmerkel

given: Carrie

name: Department of Imaging & Pathology, Translational Cell & Tissue Research, University Hospitals Leuven, Leuven, Belgium

family: De Hertogh

full_name: Gert De Hertogh

given: Gert

title: A Simplified Definition of Histologic Improvement in Ulcerative Colitis and its Association With Disease Outcomes up to 30 Weeks from Initiation of Therapy: Post Hoc Analysis of Three Clinical Trials

ReferenceCitation: Sands BE, Sandborn WJ, Feagan BG, Lichtenstein GR, Zhang H, Strauss R, Szapary P, Johanns J, Panes J, Vermeire S, O'Brien CD, Yang Z, Bertelsen K, Marano C; Peficitinib-UC Study Group. Peficitinib, an Oral Janus Kinase Inhibitor, in Moderate-to-severe Ulcerative Colitis: Results From a Randomised, Phase 2 Study. J Crohns Colitis. 2018 Nov 9;12(10):1158-1169. doi: 10.1093/ecco-jcc/jjy085.

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

family: Sands

full_name: Bruce E Sands

given: Bruce E

name: Department of Medicine, Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA

family: Sandborn

full_name: William J Sandborn

given: William J

name: Robarts Clinical Trials Inc., Western University, London, ON, Canada

family: Feagan

full_name: Brian G Feagan

given: Brian G

name: Division of Gastroenterology, University of Pennsylvania, Philadelphia, PA, USA

family: Lichtenstein

full_name: Gary R Lichtenstein

given: Gary R

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

family: Zhang

full_name: Hongyan Zhang

given: Hongyan

family: Szapary

full_name: Philippe Szapary

given: Philippe

family: Johanns

full_name: Jewel Johanns

given: Jewel

name: Department of Gastroenterology, Hospital Clinic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain

family: Panes

full_name: Julian Panes

given: Julian

name: Departments of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium

family: Vermeire

full_name: Severine Vermeire

given: Severine

family: O’Brien

full_name: Christopher D O’Brien

given: Christopher D

family: Yang

full_name: Zijiang Yang

given: Zijiang

location_country:
United States
Netherlands
Germany
France
Bulgaria
Poland
Israel
Romania
Hungary
Belgium
Australia
Russian Federation
Canada
Ukraine


title: A Randomized, Open-label, Multicenter, Controlled, Parallel Arm, Phase III Study Assessing the Efficacy and Safety of AOP2014 vs. Hydroxyurea in Patients With Polycythemia Vera

acronym: PROUD-PV

summary: Phase III study to compare the efficacy and safety of the novel monopegylated interferon alpha 2b AOP2014 versus Hydroxyurea (the current licensed therapy for this disease). One year treatment of patients with polycythemia vera. Objective is to demonstrate non-inferiority of AOP2014 vs. HU in terms of disease response rate in both HU naïve and currently treated patients, diagnosed with Polycythemia Vera. Response is measured as normalisation of key lab parameters as well as normalized spleen size.

ReferenceCitation: Verger E, Soret-Dulphy J, Maslah N, Roy L, Rey J, Ghrieb Z, Kralovics R, Gisslinger H, Grohmann-Izay B, Klade C, Chomienne C, Giraudier S, Cassinat B, Kiladjian JJ. Ropeginterferon alpha-2b targets JAK2V617F-positive polycythemia vera cells in vitro and in vivo. Blood Cancer J. 2018 Oct 4;8(10):94. doi: 10.1038/s41408-018-0133-0.

family: Verger

full_name: Emmanuelle Verger

given: Emmanuelle

family: Soret-Dulphy

full_name: Juliette Soret-Dulphy

given: Juliette

family: Maslah

full_name: Nabih Maslah

given: Nabih

family: Roy

full_name: Lydia Roy

given: Lydia

family: Rey

full_name: Jerome Rey

given: Jerome

family: Ghrieb

full_name: Zineb Ghrieb

given: Zineb

family: Kralovics

full_name: Robert Kralovics

given: Robert

family: Gisslinger

full_name: Heinz Gisslinger

given: Heinz

family: Grohmann-Izay

full_name: Barbara Grohmann-Izay

given: Barbara

family: Klade

full_name: Christoph Klade

given: Christoph

family: Chomienne

full_name: Christine Chomienne

given: Christine

family: Giraudier

full_name: Stéphane Giraudier

given: Stéphane

family: Cassinat

full_name: Bruno Cassinat

given: Bruno

family: Kiladjian

full_name: Jean-Jacques Kiladjian

given: Jean-Jacques

currency_apc_doaj: GBP

journal_name: Blood Cancer Journal

repository_institution: PubMed Central - Europe PMC

ipd_sharing: No

lead_sponsor: AOP Orphan Pharmaceuticals AG

location_country:
Italy
Austria
France
Bulgaria
Poland
Slovakia
Romania
Hungary
Belgium
Russian Federation
Spain
Germany
Czech Republic
Ukraine

location_facility: Andrzej Mielecki Independent Public Clinical Hospital of Medical University of Silesia in Katowice

location_facility: Independent Public Teaching Hospital No.1 in Lublin

location_facility: Saint Cyril and Metod University Hospital Bratislava

location_facility: University Hospital with Outpatient Clinic F.D. Roosevelt

location_facility: Institute of Hematology and Blood Transfusion

location_facility: Emergency Clinical County Hospital Brasov

location_facility: University Multiprofile Hospital for Active Treatment "Sveti Georgi"

location_facility: University of Szeged, Albert Szent-Gyorgyi Clinical Center, Koranyi fasor 6

location_facility: University Hospital Bonn, Center for Internal Medicine, Medical Clinic and Outpatient Clinic III

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Fryderyk Chopin Provincial Specialized Hospital

location_facility: National Research Center for Radiation Medicine, Institute of Clinical Radiology

location_facility: "Prof. Dr. Ion Chiricuta" Institute of Oncology

location_facility: O.F. Herbachevskyi Regional Clinical Hospital

location_facility: St Istvan and St Laszlo Hospital of Budapest

location_facility: Cherkasy Regional Oncology Center, Regional Treatment and Diagnostics Hematology Center

location_facility: Institute of Blood Pathology and Transfusion Medicine

location_facility: Dnipropetrovsk City Multispecialty Clinical Hospital #4

location_facility: First Pavlov State Medical University of St. Petersburg

location_facility: Multiprofile Hospital for Active Treatment "Sveta Marina"

location_facility: Samara Kalinin Regional Clinical Hospital

location_facility: Multiprofile Hospital for Active Treatment - Hristo Botev, Vratsa, First Department of Internal Medicine

location_facility: Nicolaus Copernicus Municipal Specialist Hospital

location_facility: Aachen University Hospital, Medical Clinic IV

location_facility: Institute of Hematology and Transfusion Medicine

location_facility: University Hospital Carl Gustav Carus, Medical Clinic and Polyclinic I

location_facility: Specialized Hospital for Active Treatment of Hematological Diseases

location_facility: Bekes County Pandy Kalman Hospital, 1st Department of Medicine, Hematology


ReferenceCitation: Chatelain P, Malievskiy O, Radziuk K, Senatorova G, Abdou MO, Vlachopapadopoulou E, Skorodok Y, Peterkova V, Leff JA, Beckert M; TransCon GH Working Group. A Randomized Phase 2 Study of Long-Acting TransCon GH vs Daily GH in Childhood GH Deficiency. J Clin Endocrinol Metab. 2017 May 1;102(5):1673-1682. doi: 10.1210/jc.2016-3776.

name: Collège of Paediatrics, Université Claude Bernard Lyon 1, 69230 Saint-Genis-Laval, France

family: Chatelain

full_name: Pierre Chatelain

given: Pierre

name: Department of Pediatrics, Bashkir State Medical University, Ufa, 450000, Russia

family: Malievskiy

full_name: Oleg Malievskiy

given: Oleg

name: Department of Psychophysiology, Belarusian Institute of Law, 220004 Minsk, Belarus

name: Department of Endocrinology, Second City Children Clinical Hospital, 220090 Minsk, Belarus

family: Radziuk

full_name: Klaudziya Radziuk

given: Klaudziya

name: Pediatrics 1 and Neonatology, Kharkiv National Medical University, Kharkiv, 61093, Ukraine

family: Senatorova

full_name: Ganna Senatorova

given: Ganna

name: Endocrinology Department, El Shatby University Hospital, 21526 Alexandria, Egypt

family: Abdou

full_name: Magdy O. Abdou

given: Magdy O.

name: Endocrinology Department, Children’s Hospital P. A. Kyriakou, 11527 Athens, Greece

family: Vlachopapadopoulou

full_name: Elpis Vlachopapadopoulou

given: Elpis

name: Pediatrics and Endocrinology, St. Petersburg State Pediatric Medical University, St. Petersburg, 194100, Russia

family: Skorodok

full_name: Yulia Skorodok

given: Yulia

name: Endocrinology Centre of Science, Federal Official Body of RosMedTechnology, Institute of Children's Endocrinology, Moscow, 117036, Russia

family: Peterkova

full_name: Valentina Peterkova

given: Valentina

name: Ascendis Pharma, Palo Alto, California 94301

family: Leff

full_name: Jonathan A. Leff

given: Jonathan A.

family: Beckert

full_name: Michael Beckert

given: Michael

lead_sponsor: Ascendis Pharma A/S

location_country:
France
Bulgaria
Greece
Poland
Slovenia
Romania
Hungary
Russian Federation
Egypt
Belarus
Turkey
Germany
Czech Republic
Ukraine

location_facility: Donetsk Regional Children Clinical Hospital

location_facility: Children's Hospital of Athens "P. A. Kyriakou"

location_facility: Ukrainian Children Specialized Clinical Hospital

location_facility: University Multiprofile Hospital for Active Treatment (UMHAT) "Sv. Marina"

location_facility: Children's Memorial Health Institute Warsaw

location_facility: Institute of Endocrinology and Metabolism

location_facility: Louis Turcanu Emergency Hospital for Children Timisoara

location_facility: St. Spiridon County Clinic Emergency Hospital

location_facility: University Children's Hospital Magdeburg

location_facility: St. Petersburg State Pediatric Medical Academy

title: A Multicenter, Phase 2, Randomized, Open Label, Active-controlled, Parallel-group Study Investigating the Safety, Tolerability, and Efficacy of Different Dose Levels of ACP-001 Administered Once Weekly Versus Standard Daily rhGH Replacement Therapy in Pre-pubertal Children With Growth Hormone Deficiency (GHD)

summary: A six month study of ACP-001, a long-acting growth hormone product, versus standard human growth hormone therapy. ACP-001 will be given once-a-week, standard human growth hormone (hGH) will be given on a daily basis. The primary aim is to demonstrate safety, pharmacokinetics and pharmacodynamics over a period of six months. A secondary objective is the comparison of height velocity (HV) of the ACP-001 treated groups to the daily hGH treatment group.


title: Phase Ib/II Multicenter Study of Buparlisib Plus Carboplatin or Lomustine in Patients With Recurrent Glioblastoma Multiforme

summary:
This is a multi-center, phase Ib/ II study (two parts) with patients that had recurrent glioblastoma multiforme. The first part (phase Ib) was to investigate the maximum tolerated dose/Recommended phase ll dose (MTD/RP2D) of once daily buparlisib in combination with every-three-week carboplatin or buparlisib once daily in combination with every-six-week lomustine (CCNU) using a Bayesian model. Once MTD/ RP2D is established in either of the 2 arms, the corresponding phase II portion of the study was to start. Phase II was to assess the treatment effect of buparlisib in combination with carboplatin in terms of Progression Free Survival (PFS) and was to compare the treatment effect of buparlisib with lomustine versus lomustine plus placebo in terms of PFS.

A preliminary assessment for both combinations (buparlisib plus carboplatin or lomustine) demonstrated that there was not enough antitumor activity compared to historical data with single agent carboplatin or lomustine. Based on the overall safety profile, and preliminary anti-tumor activity observed in this study, Novartis decided that no additional patients would be enrolled into this study. As a consequence, the Phase II part of the study was not conducted.

ReferenceCitation: Rosenthal M, Clement PM, Campone M, Gil-Gil MJ, DeGroot J, Chinot O, Idbaih A, Gan H, Raizer J, Wen PY, Pineda E, Donnet V, Mills D, El-Hashimy M, Mason W. Buparlisib plus carboplatin or lomustine in patients with recurrent glioblastoma: a phase Ib/II, open-label, multicentre, randomised study. ESMO Open. 2020 Jul;5(4). pii: e000672. doi: 10.1136/esmoopen-2020-000672.

family: Rosenthal

full_name: Mark Rosenthal

given: Mark

family: Clement

full_name: Paul M. Clement

given: Paul M.

family: Campone

full_name: Mario Campone

given: Mario

family: Gil-Gil

full_name: Miguel J. Gil-Gil

given: Miguel J.

family: DeGroot

full_name: John DeGroot

given: John

family: Chinot

full_name: Olivier Chinot

given: Olivier

family: Idbaih

full_name: Ahmed Idbaih

given: Ahmed

family: Gan

full_name: Hui Gan

given: Hui

family: Raizer

full_name: Jeffrey Raizer

given: Jeffrey

family: Wen

full_name: Patrick Yung Wen

given: Patrick Yung

family: Pineda

full_name: Estela Pineda

given: Estela

family: Donnet

full_name: Valerie Donnet

given: Valerie

family: Mills

full_name: David Mills

given: David

family: El-Hashimy

full_name: Mona El-Hashimy

given: Mona

family: Mason

full_name: Warren Mason

given: Warren

currency_apc_doaj: EUR

journal_name: ESMO Open

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

location_country:
United States
France
Belgium
Australia
Spain
Canada

location_facility: MD Anderson Cancer Center/University of Texas

location_facility: Barrow Neurological Insitute St. Joseph's Hospital


ReferenceCitation: Orrell C, Hagins DP, Belonosova E, Porteiro N, Walmsley S, Falcó V, Man CY, Aylott A, Buchanan AM, Wynne B, Vavro C, Aboud M, Smith KY; ARIA study team. Fixed-dose combination dolutegravir, abacavir, and lamivudine versus ritonavir-boosted atazanavir plus tenofovir disoproxil fumarate and emtricitabine in previously untreated women with HIV-1 infection (ARIA): week 48 results from a randomised, open-label, non-inferiority, phase 3b study. Lancet HIV. 2017 Dec;4(12):e536-e546. doi: 10.1016/S2352-3018(17)30095-4. Epub 2017 Jul 17. Erratum in: Lancet HIV. 2017 Dec;4(12 ):e535.

family: Orrell

full_name: Catherine Orrell

given: Catherine

family: Hagins

full_name: Debbie P Hagins

given: Debbie P

family: Belonosova

full_name: Elena Belonosova

given: Elena

family: Porteiro

full_name: Norma Porteiro

given: Norma

family: Walmsley

full_name: Sharon Walmsley

given: Sharon

family: Falcó

full_name: Vicenç Falcó

given: Vicenç

family: Man

full_name: Choy Y Man

given: Choy Y

family: Aylott

full_name: Alicia Aylott

given: Alicia

family: Buchanan

full_name: Ann M Buchanan

given: Ann M

family: Wynne

full_name: Brian Wynne

given: Brian

family: Vavro

full_name: Cindy Vavro

given: Cindy

family: Aboud

full_name: Michael Aboud

family: Smith

full_name: Kimberly Y Smith

given: Kimberly Y

family: Cahn

full_name: Pedro Enrique Cahn

given: Pedro Enrique

family: Cassetti

full_name: Lidia Isabel Cassetti

given: Lidia Isabel

family: Porteiro Barreira

full_name: Norma Porteiro Barreira

family: Angel

full_name: Jonathan Benjamin Angel

given: Jonathan Benjamin

family: de Pokomandy

full_name: Alexandra de Pokomandy

given: Alexandra

family: Harris

full_name: Marianne Harris

given: Marianne

family: Rachlis

full_name: Anita R. Rachlis

given: Anita R.

full_name: Sharon L. Walmsley

given: Sharon L.

family: Allavena

full_name: Clotilde Allavena

given: Clotilde

family: Bouchaud

full_name: Oliver Bouchaud

given: Oliver

family: Gatey

full_name: Caroline Gatey

given: Caroline

family: Rami

full_name: Agathe Rami

given: Agathe

location_country:
Italy
United States
South Africa
Mexico
Spain
France
Thailand
Argentina
Puerto Rico
Russian Federation
Portugal
Canada
United Kingdom

title: A Phase IIIb, Randomized, Open-label Study of the Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine Once Daily Compared to Atazanavir and Ritonavir Plus Tenofovir/Emtricitabine Once Daily in HIV-1 Infected Antiretroviral Therapy Naïve Women

summary: This study is designed to demonstrate the non-inferior antiviral activity of DTG/ABC/3TC fixed dose combination (FDC) once daily (OD) compared to atazanavir plus ritonavir (ATV+RTV) and tenofovir disoproxil fumarate/emtricitabine fixed dose combination (TDF/FTC FDC) OD in HIV-1 infected, ART-naïve women over 48 weeks. This study will also characterize the safety and tolerability of DTG/ABC/3TC FDC compared to ATV+RTV+TDF/FTC FDC. Sufficient number of subjects will be screened in order to ensure a total of approximately 474 subjects will be randomized (237 in each study arm)


title: A Randomised, Double-blind, Double-dummy, Active-controlled Study Evaluating the Efficacy, Safety and Tolerability of Twice-daily Aclidinium Bromide/Formoterol Fumarate Compared With Twice-daily Salmeterol/Fluticasone Propionate for 24 Weeks Treatment in Symptomatic Patients With Chronic Obstructive Pulmonary Disease (COPD)

summary: The purpose of the study is to compare the efficacy, safety and tolerability of aclidinium bromide/formoterol fumarate and salmeterol/fluticasone propionate in patients with chronic obstructive pulmonary disease (COPD)

ReferenceCitation: Vogelmeier C, Paggiaro PL, Dorca J, Sliwinski P, Mallet M, Kirsten AM, Beier J, Seoane B, Segarra RM, Leselbaum A. Efficacy and safety of aclidinium/formoterol versus salmeterol/fluticasone: a phase 3 COPD study. Eur Respir J. 2016 Oct;48(4):1030-1039. doi: 10.1183/13993003.00216-2016. Epub 2016 Aug 4.

family: Vogelmeier

full_name: Claus Vogelmeier

given: Claus

family: Paggiaro

full_name: Pier Luigi Paggiaro

given: Pier Luigi

family: Dorca

full_name: Jordi Dorca

given: Jordi

family: Sliwinski

full_name: Pawel Sliwinski

given: Pawel

family: Mallet

full_name: Marcel Mallet

given: Marcel

family: Kirsten

full_name: Anne-Marie Kirsten

given: Anne-Marie

family: Beier

full_name: Jutta Beier

given: Jutta

family: Seoane

full_name: Beatriz Seoane

given: Beatriz

family: Segarra

full_name: Rosa Maria Segarra

given: Rosa Maria

family: Leselbaum

full_name: Anne Leselbaum

given: Anne

journal_name: European Respiratory Journal

publisher: European Respiratory Society (ERS)

publisher_dissemination: European Respiratory Society

publisher_group: European Respiratory Society

publisher_normalized: European Respiratory Society

location_country:
Italy
Austria
South Africa
United Kingdom
Netherlands
Germany
France
Bulgaria
Lithuania
Poland
Hungary
Spain
Canada
Czech Republic


ReferenceCitation: Juul Kildemoes R, Højby Rasmussen M, Agersø H, Overgaard RV. Optimal Monitoring of Weekly IGF-I Levels During Growth Hormone Therapy With Once-Weekly Somapacitan. J Clin Endocrinol Metab. 2021 Jan 23;106(2):567-576. doi: 10.1210/clinem/dgaa775.

family: Papathanasiou

full_name: Theodoros Papathanasiou

given: Theodoros

family: Agersø

full_name: Henrik Agersø

given: Henrik

family: Damholt

full_name: Birgitte Bentz Damholt

given: Birgitte Bentz

family: Højby Rasmussen

full_name: Michael Højby Rasmussen

given: Michael

family: Kildemoes

full_name: Rasmus Juul Kildemoes

given: Rasmus Juul

title: Population Pharmacokinetics and Pharmacodynamics of Once-Daily Growth Hormone Norditropin® in Children and Adults

ReferenceCitation: Juul RV, Rasmussen MH, Agersø H, Overgaard RV. Pharmacokinetics and Pharmacodynamics of Once-Weekly Somapacitan in Children and Adults: Supporting Dosing Rationales with a Model-Based Analysis of Three Phase I Trials. Clin Pharmacokinet. 2019 Jan;58(1):63-75. doi: 10.1007/s40262-018-0662-5.

family: Juul

full_name: Rasmus Vestergaard Juul

given: Rasmus Vestergaard

family: Rasmussen

given: Michael Højby

family: Overgaard

full_name: Rune Viig Overgaard

given: Rune Viig

evidence: open (via page says license)

ReferenceCitation: Battelino T, Rasmussen MH, De Schepper J, Zuckerman-Levin N, Gucev Z, Sävendahl L; NN8640-4042 Study Group. Somapacitan, a once-weekly reversible albumin-binding GH derivative, in children with GH deficiency: A randomized dose-escalation trial. Clin Endocrinol (Oxf). 2017 Oct;87(4):350-358. doi: 10.1111/cen.13409. Epub 2017 Aug 8.

name: Faculty of Medicine; UMC-University Children's Hospital; University of Ljubljana; Ljubljana Slovenia

family: Battelino

full_name: Tadej Battelino

given: Tadej

name: Global Development; Novo Nordisk A/S; Bagsvaerd Denmark

name: Division of Paediatric Endocrinology; UZ Brussel; Brussels Belgium

family: De Schepper

full_name: Jean De Schepper

given: Jean

name: Pediatric and Obesity Clinic; Rambam Medical Center and Bruce Rappaport Faculty of Medicine; Haifa Israel

name: University Children's Hospital; Skopje Macedonia

name: Department of Women's and Children's Health; Karolinska Institutet; Pediatric Endocrinology Unit; Karolinska University Hospital; Stockholm Sweden

repository_institution: Ghent University - Ghent University Academic Bibliography

location_country:
Austria
Sweden
Switzerland
North Macedonia
France
Israel
Norway
Belgium
Spain
Slovenia

title: A Randomised, Open-labelled, Active-controlled, Multinational, Dose-escalation Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (NNC0195-0092, Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency

summary: This trial is conducted in Europe and Asia. The aim of the trial is to investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of a single dose of long-acting growth hormone (NNC0195-0092, somapacitan) compared to daily dosing of Norditropin® SimpleXx® (somatropin) in children with growth hormone deficiency.


title: A Phase Ib/II, Multicenter Study of the Combination of LEE011 and BYL719 With Letrozole in Adult Patients With Advanced ER+ Breast Cancer

summary:
The purpose of this trial is to inform the future clinical development of the two investigational agents in ER+ breast cancer, LEE011 (CDK4/6 inhibitor) and BYL719 (PI3K-alpha inhibitor).

This is a multi-center, open-label Phase Ib study. The Phase Ib dose escalation will estimate the MTD and/or RP2D for three regimens: two double combinations, LEE011 with letrozole and BYL719 with letrozole, followed by triple combinations of LEE011 + BYL719 with letrozole (Arms 3 and 4).

The Phase Ib dose escalation part will be followed by Phase Ib dose expansions to further characterize the safety, tolerability, PK and preliminary clinical anti-tumor activity of the combinations. Optional crossover for patients who have progressed while on dose escalation or dose expansion with doublet treatment on Arms 1 or 2 to be treated with the triplet combination (Arm 3) after the determination of the RP2D for Arm 3; is no longer permitted after protocol amendment 6.

Approximately 270 adult women with ER+/HER2- locally advanced or metastatic breast cancer will be enrolled.

location_country:
Italy
Switzerland
France
Australia
Spain
United States
United Kingdom
Korea, Republic of

location_facility: Cancer Therapy and Research Center UT Health Science Center Dept of Onc

location_facility: University of California at San Diego, Moores Cancer Ctr Dept. of Moores Cancer Center

location_facility: H Lee Moffitt Cancer Center and Research Institute H. Lee Moffitt Cancer Center

location_facility: Vanderbilt University Medical Center Vanderbilt - Thompson Ln

location_facility: Northwest Medical Specialties Northwest Medical Specialties