title: A Phase IIIB/IV Randomized, Controlled, Open-label, Parallel Group Study to Compare the Efficacy of Vancomycin Therapy to Extended Duration Fidaxomicin Therapy in the Sustained Clinical Cure of Clostridium Difficile Infection in an Older Population

acronym: EXTEND

summary: The main objective of the study is to evaluate whether the extended duration fidaxomicin therapy is superior to the standard vancomycin therapy in sustained clinical cure of CDI at 30 days after end of treatment (Day 40 or Day 55).

ReferenceCitation: Cornely OA, Vehreschild MJGT, Adomakoh N, Georgopali A, Karas A, Kazeem G, Guery B. Extended-pulsed fidaxomicin versus vancomycin for Clostridium difficile infection: EXTEND study subgroup analyses. Eur J Clin Microbiol Infect Dis. 2019 Jun;38(6):1187-1194. doi: 10.1007/s10096-019-03525-y. Epub 2019 Mar 25.

ReferenceCitation: Guery B, Menichetti F, Anttila VJ, Adomakoh N, Aguado JM, Bisnauthsing K, Georgopali A, Goldenberg SD, Karas A, Kazeem G, Longshaw C, Palacios-Fabrega JA, Cornely OA, Vehreschild MJGT; EXTEND Clinical Study Group. Extended-pulsed fidaxomicin versus vancomycin for Clostridium difficile infection in patients 60 years and older (EXTEND): a randomised, controlled, open-label, phase 3b/4 trial. Lancet Infect Dis. 2018 Mar;18(3):296-307. doi: 10.1016/S1473-3099(17)30751-X. Epub 2017 Dec 19.

ipd_sharing_description: Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

location_country:
Croatia
Spain
Italy
United Kingdom
Romania
Belgium
Czechia
Poland
Portugal
Slovenia
Austria
Russian Federation
Turkey
Sweden
Switzerland
Hungary
Germany
Denmark
Greece
Ireland
Finland
France

location_facility:
Site HU36010
Site RO40001
Site TR90001
Site DK45005
Site FR33003
Site CZ42004
Site IT39010
Site FR33008
Site TR90006
Site PL48002
Site IT39002
Site HU36006
Site HU36005
Site GB44009
Site IT39007
Site FR33007
Site FR33006
Site FR33002
Site IE35304
Site PL48012
Site CZ42002
Site FR33004
Site GR30005
Site BE32005
Site TR90007
Site SE46002
Site SI38605
Site CZ42005
Site HR38505
Site DE49016
Site IT39003
Site RO40002
Site GR30002
Site SE46001
Site PL48004
Site BE32001
Site FI35801
Site CH41004
Site PL48011
Site IE35302
Site IT39001
Site DE49001
Site BE32006
Site DK45001
Site HR38506
Site GR30004
Site FI35802
Site PT35104
Site DE49012
Site HU36001
Site GB44006
Site HU36009
Site DE49011
Site PT35101
Site IT39005
Site SI38602
Site TR90003
Site PT35102
Site GB44005
Site IT39009
Site HR38501
Site AT43003
Site DE49006
Site RO40003
Site RU70003
Site HR38503
Site BE32008
Site CZ42003
Site FR33005
Site IT39006
Site PT35107
Site SI38603
Site TR90002
Site PL48003
Site GR30008
Site SE46004
Site HU36008
Site HU36004
Site GR30009
Site GB44003
Site GB44008
Site BE32007
Site HU36007
Site SI38601
Site GR30010
Site ES34003
Site AT43001
Site ES34006
Site CZ42001
Site IT39004
Site GR30001
Site ES34004
Site RU70001
Site TR90004
Site GB44010
Site CH41001
Site AT43002
Site CH41002
Site DE49008
Site PL48008
Site TR90005
Site DK45004
Site FR33009
Site FR33001
Site PT35106
Site GR30007
Site GR30006
Site SE46005
Site ES34005


type: EudraCT Number

title: CENTAUR: Efficacy and Safety Study of Cenicriviroc for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Adult Subjects With Liver Fibrosis

acronym: CENTAUR

summary: The purpose of this study is to determine whether cenicriviroc is effective and safe in the treatment of nonalcoholic steatohepatitis (NASH) in adult participants with liver fibrosis.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Qian T, Fujiwara N, Koneru B, Ono A, Kubota N, Jajoriya AK, Tung MG, Crouchet E, Song WM, Marquez CA, Panda G, Hoshida A, Raman I, Li QZ, Lewis C, Yopp A, Rich NE, Singal AG, Nakagawa S, Goossens N, Higashi T, Koh AP, Bian CB, Hoshida H, Tabrizian P, Gunasekaran G, Florman S, Schwarz ME, Hiotis SP, Nakahara T, Aikata H, Murakami E, Beppu T, Baba H, Rew Warren, Bhatia S, Kobayashi M, Kumada H, Fobar AJ, Parikh ND, Marrero JA, Rwema SH, Nair V, Patel M, Kim-Schulze S, Corey K, O'Leary JG, Klintmalm GB, Thomas DL, Dibas M, Rodriguez G, Zhang B, Friedman SL, Baumert TF, Fuchs BC, Chayama K, Zhu S, Chung RT, Hoshida Y. Molecular Signature Predictive of Long-Term Liver Fibrosis Progression to Inform Antifibrotic Drug Development. Gastroenterology. 2022 Apr;162(4):1210-1225. doi: 10.1053/j.gastro.2021.12.250. Epub 2021 Dec 22. Erratum in: Gastroenterology. 2022 Aug;163(2):536.

ReferenceCitation: Nielsen MJ, Leeming DJ, Goodman Z, Friedman S, Frederiksen P, Rasmussen DGK, Vig P, Seyedkazemi S, Fischer L, Torstenson R, Karsdal MA, Lefebvre E, Sanyal AJ, Ratziu V. Comparison of ADAPT, FIB-4 and APRI as non-invasive predictors of liver fibrosis and NASH within the CENTAUR screening population. J Hepatol. 2021 Dec;75(6):1292-1300. doi: 10.1016/j.jhep.2021.08.016. Epub 2021 Aug 27.

ReferenceCitation: Parthasarathy G, Malhi H. Macrophage Heterogeneity in NASH: More Than Just Nomenclature. Hepatology. 2021 Jul;74(1):515-518. doi: 10.1002/hep.31790. Epub 2021 May 22.

ReferenceCitation: Ratziu V, Sanyal A, Harrison SA, Wong VW, Francque S, Goodman Z, Aithal GP, Kowdley KV, Seyedkazemi S, Fischer L, Loomba R, Abdelmalek MF, Tacke F. Cenicriviroc Treatment for Adults With Nonalcoholic Steatohepatitis and Fibrosis: Final Analysis of the Phase 2b CENTAUR Study. Hepatology. 2020 Sep;72(3):892-905. doi: 10.1002/hep.31108. Epub 2020 Jul 21.

ReferenceCitation: Lefebvre E, Moyle G, Reshef R, Richman LP, Thompson M, Hong F, Chou HL, Hashiguchi T, Plato C, Poulin D, Richards T, Yoneyama H, Jenkins H, Wolfgang G, Friedman SL. Antifibrotic Effects of the Dual CCR2/CCR5 Antagonist Cenicriviroc in Animal Models of Liver and Kidney Fibrosis. PLoS One. 2016 Jun 27;11(6):e0158156. doi: 10.1371/journal.pone.0158156. eCollection 2016.

ReferenceCitation: Friedman S, Sanyal A, Goodman Z, Lefebvre E, Gottwald M, Fischer L, Ratziu V. Efficacy and safety study of cenicriviroc for the treatment of non-alcoholic steatohepatitis in adult subjects with liver fibrosis: CENTAUR Phase 2b study design. Contemp Clin Trials. 2016 Mar;47:356-65. doi: 10.1016/j.cct.2016.02.012. Epub 2016 Mar 2.

lead_sponsor: Tobira Therapeutics, Inc.

location_country:
Poland
Hong Kong
Spain
Italy
United Kingdom
Australia
United States
France
Belgium
Germany

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Identifier

title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND STUDY OF PF-05280586 VERSUS RITUXIMAB FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH CD20-POSITIVE, LOW TUMOR BURDEN, FOLLICULAR LYMPHOMA

summary: This study will compare the safety and effectiveness of PF-05280586 versus rituximab-EU in patients with CD20-positive, low tumor burden follicular lymphoma. The primary hypothesis to be tested in this study is that the effectiveness of PF-05280586, as measured by the Overall Response Rate, is similar to that of rituximab-EU.

ReferenceCitation: Courville J, Nastoupil L, Kaila N, Kelton J, Zhang J, Alcasid A, Nava-Parada P. Factors Influencing Infusion-Related Reactions Following Dosing of Reference Rituximab and PF-05280586, a Rituximab Biosimilar. BioDrugs. 2021 Jul;35(4):459-468. doi: 10.1007/s40259-021-00487-6. Epub 2021 Jun 21.

ReferenceCitation: Sharman JP, Liberati AM, Ishizawa K, Khan T, Robbins J, Alcasid A, Rosenberg JA, Aurer I. A Randomized, Double-Blind, Efficacy and Safety Study of PF-05280586 (a Rituximab Biosimilar) Compared with Rituximab Reference Product (MabThera(®)) in Subjects with Previously Untreated CD20-Positive, Low-Tumor-Burden Follicular Lymphoma (LTB-FL). BioDrugs. 2020 Apr;34(2):171-181. doi: 10.1007/s40259-019-00398-7.

ipd_sharing: Yes

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

lead_sponsor: Pfizer

location_country:
Croatia
Spain
Italy
United Kingdom
Ukraine
United States
Peru
Belgium
Philippines
Japan
Romania
South Africa
Poland
Portugal
Austria
Russian Federation
Puerto Rico
India
Turkey
Mexico
Brazil
Lebanon
Switzerland
Germany
Belarus
Greece
Georgia
Thailand
Korea, Republic of
France

location_facility: MI 'City Dnipropetrovsk Multi-field Clin. Hospital #4 of DRC',

location_facility: Hospital das Clinicas Universidade Federal de Minas Gerais

location_facility: Vely Grupo Medico Quirurgico, S.A. de C.V.

location_facility: University Hospital Center Zagreb, Department of Radiology

location_facility: Pharmacy Department, Centre Hospitalier De Jolimont - Lobbes

location_facility: Gaziantep Universitesi Sahinbey Arastirma ve Uygulama

location_facility: Pharmacy Department: Grand Hopital de Charleroi (GHdC) - site Notre-Dame

location_facility: Uniao Brasileira de Educacao e Assistencia (UBEA) - Hospital Sao Lucas da PUCRS -

location_facility: N.P. Bechtereva Institute of the Human Brain of the Russian Academy of Sciences

location_facility: National Hospital Organization Kanazawa Medical Center

location_facility: Euromedic Wroclawskie Centrum Medyczne I

location_facility: Fundacao do ABC - FMABC/ Faculdade de Medicina ABC ( CEPHO - Centro de Estudos e Pesquisas de

location_facility: Fukuoka Wajiro PET Diagnostic Imaging Clinic

location_facility: San Antonio Military Medical Center- Department of Radiology

location_facility: Yakima Valley Memorial Hospital/North Star Lodge Cancer Center

location_facility: Charite - Universitaetsmedizin Berlin, Campus Virchow-Klinikum

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

location_facility: Hospital Santa Izabel - Setor de Bioimagem

location_facility: State Healthcare Institution Republican Oncology Dispensary

location_facility: Innovative Clinical Research Institute (ICRI)

location_facility: Albert Alberts Stem Cell Transplant Centre

location_facility: Euromedic Wroclawskie Centrum Medyczne III

location_facility: Klinikum Chemnitz gGmbH - Zentralapotheke

location_facility: Servico de Radiologia do Hospital de Clinicas de Porto Alegre

location_facility: Southend University Hospital NHS Foundation Trust

location_facility: Federal State-Financed Institution 'North-Caucasian Research and Clinical Center'

location_facility: Fundacao Amaral Carvalho / Fundacao Dr. Amaral Carvalho

location_facility: South Valley Imaging Center (Imaging Only)

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Jehangir Clinical Development Centre Pvt. Ltd.

location_facility: Complejo Hospitalario de Ourense. Hematología

location_facility: University Hospital Centre "Sestre Milosrdnice"

location_facility: Gen. Hosp. of Athens "Evangelismos-Eye Hosp.-Polikliniki"

location_facility: Seoul National University Bundang Hospital

location_facility: Department of Medical Oncology, University of Pretoria, Steve Biko Academic Hospitals Complex

location_facility: Brody School of Medicine at East Carolina University

location_facility: Cancer Center,Northwestern Medicine, West Region

location_facility: Positron Emission Tomography (PET) Centre

location_facility: Charite - Universitatsmedizin Berlin, Campus Virchow-Klinikum

location_facility: DokuSan Gesellschaft fuer Medizinische Studien mbH & Co. KG

location_facility: University of Philippines Manila-Philippine General Hospital

location_facility: Phylasis Clinicas Research S. de R.L. de C.V.

location_facility: US Oncology Investigational Products Center (IPC)

location_facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eg. ve Aras.

location_facility: Integra Gurses Teshis Tedavi ve Saglik Hizmetleri A.S.

location_facility: SC Ematologia, Fondazione IRCCS Ist Nazionale dei Tumori

location_facility: Radiodiagnostic CETIR - Clinica del Pilar

location_facility: Ematologia e Centro Trapianti - AZ Osp. Ospedali Riuniti Marche Nord (AORMN) - Presidio S. Salvatore

location_facility: SBHI of Moscow City Clinical Hospital n.a. S.P.Botkin of Healthcare Department of Moscow

location_facility: U.O. Ematologia Universitaria - Dip. Di Oncologia dei Trapianti - AOU Pisana

location_facility: Non-state healthcare institution "Road Clinical Hospital of Joint Stock Company "Russian Railways"

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Saint Francis Medical Center, Saint Francis Cancer Treatment Center

location_facility: National Hospital Organization Osaka Minami Medical Center

location_facility: Saint Louise Regional Hospital Radiology Department (Radiology Only)

location_facility: Krankenhaus der Barmherzigen Schwestern Linz

location_facility: Kobe City Medical Center General Hospital

location_facility: Hospital Clinico Universitario Virgen de la Arrixaca

location_facility: Healthcare Institution 'Minsk City Clinical Oncology Dispensary'

location_facility: Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

location_facility: SI Republican Research and Practice Centre of oncology and medical radiology n.a N.N Alexandrov

location_facility: Russian Cancer Research Centre them N.N. Blokhin

location_facility: Branch office of LLC 'PET-Technology' at Ufa city

location_facility: Ueberoertliche Berufsausuebungsgemeinschaft Drs. med. Helmut Forstbauer

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.

location_facility: Pathology Department, Unique Hospital Multispeciality & Research Institute

location_facility: Hospital das Clinicas da Faculdade de Medicina da USP / Fundacao Faculdade de Medicina MEC MPAS

location_facility: Hospital do Meixoeiro Complejo Hospitalario Universitario de Vigo

location_facility: National Hospital Organization Matsumoto Medical Center

location_facility: Clinica de Hematologie-Institutul Oncologic, Prof. Dr. Ion Chiricuta

location_facility: Compassionate Care Research Group, Inc., at Compassionate Cancer Care Medical Group, Inc.

location_facility: Rocky Mountain Cancer Centers (RMCC) - Lakewood - St Anthony

location_facility: Hospital universitario Virgen de la Victoria

location_facility: Padiglione 1, Torre delle medicine, 6 piano

location_facility: FSBI 'National Medical Oncology Research Centre n.a. N.N.Petrov'

location_facility: Grand Hopital de Charleroi-Site Notre-Dame

location_facility: SBHI of Stavropol Region "Pyatigorsk Interdistrict Oncology Dispensary

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi

location_facility: Centro Universitario de Imagen Diagnostica, Radiologia e Imagen del Hospital Universitario

location_facility: Policlinica de Diagnostic Rapid, Hematologie

location_facility: National Hospital Organization Nagasaki Medical Center

location_facility: The Oncology Institute of Hope and Innovation

location_facility: Hacettepe Universitesi Tip Fakultesi Onkoloji Hastanesi

location_facility: University Hospital Center Zagreb, Department of Nuclear Medicine and Radiation Protection

location_facility: Adnan Menderes University Medical Faculty

location_facility: Institutul Oncologic Prof. Dr. Ion Chiricuta, Sectia Oncologie Medicala

location_facility: N.P. Bechtereva Institute of Human Brain of the Russian Academy of Sciences

location_facility: Gemeinschaftspraxis fuer Diagnostische Radiologie und Nuklearmedizin

location_facility: State Budgetary Institution of Healthcare "Leningrad Regional Clinical Hospital"

location_facility: Rocky Mountain Cancer Center-Lakewood (Laboratory)

location_facility: Erciyes Universitesi Tip Fakultesi Nukleer Tip Laboratuvari

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: National Hospital Organization Disaster Medical Center

location_facility: Klinikum Chemnitz gGmbH - Institut fuer Interventionelle Radiologie und Neuroradiologie

location_facility: Royal United Hospitals Bath NHS Foundation Trust

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: U.O. di Ematologia e CTMO - Istituti Ospedalieri di Cremona

location_facility: CDI - Centro de Diagnostico por Imagem do Hospital Sao Lucas da PUCRS

location_facility: IEP Sao Lucas - Instituto de Ensino e Pesquisa Sao Lucas / HEMOMED - Instituto de Oncologia e

location_facility: General Hospital of Athens "Evangelismos - Eye Hosp. - Polikliniki"

location_facility: Apteka Dolnoslaskiego Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku

location_facility: Department of Radiology, Curie Manavata Cancer Centre

location_facility: FSBI "Russian Research Centre of Radiology and Surgical Technologies named after academician

location_facility: FSBSI 'N.N.Blokhin Russian Cancer Research Center' of MoH of RF

location_facility: Drs Sulman & Partners Specialist Radiologists

location_facility: Global Cancer Research Institute (GCRI), Inc

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: A.Tsyb Medical Radiological Research Centre -

location_facility: Unidade Local de Saude de Matosinhos E.P.E. - Hospital Pedro Hispano S.A.

location_facility: "SBHI of NNR ""Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko"""

location_facility: U.O. Ematologia 1 - IRCCS AOU San Martino-IST

location_facility: PET/CT facility: Grand Hopital de Charleroi (GHdC) - site Notre-Dame

location_facility: CAEP - Centro Avancado de Estudos e Pesquisas LTDA

location_facility: Institutul Oncologic Prof. Dr. Ion Chiricuta, Laborator Radiologie si Imagistica Medicala

location_facility: Charite - Universitatsmedizin Berlin - Campus Benjamin Franklin

location_facility: Unidade Funcional Apoio Diagnostico e terapeutica por Imagem do HC/UFMG - CT Scan

location_facility: LTD "Research Institute of Clinical Medicine"

location_facility: FSBI 'Russian Research Centre of Radiology and Surgical Technologies

location_facility: Spitalul Clinic Coltea, Clinica de Hematologie

location_facility: Showa University Northern Yokohama Hospital

location_facility: SI 'Republican Research and Practice Centre of Oncology and Medical Radiology n.a. N.N. Alexandrov'

location_facility: "Central City Clinical Hospital, City Oncology Center, SHEI ""Uzhhorod National University"", Chair

location_facility: Los Angeles Hematology Oncology Medical Group

location_facility: Hospital Clínico Universitario Virgen de la Arrixaca

location_facility: Inonu Universitesi Tip Fakultesi Turgut Ozal Tip Merkezi

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

location_facility: Hospital e Maternidade Madre Theodora LTDA

location_facility: Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku

location_facility: Central de Misturas Intravenosas do Hospital de Clinicas de Porto Alegre

location_facility: Rajiv Gandhi Cancer Institute & Research Center (RGCIRC)

location_facility: Lewis Hall Singletary Oncology Center At John D. Archbold Memorial Hospital

location_facility: Klinikum Stuttgart, Klinik fuer Nuklearmedizin

location_facility: Hospital Universitario Sanitas La Zarzuela

location_facility: Podilskyy Regional Oncology Center, Chemotherapy Department

location_facility: Stauferklinikum Schwaebisch Gmuend, Apotheke

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: "Dipartimento di Biotecnologie Cellulari ed Ematologia, Universita ""Sapienza""

location_facility: Cardiology Unit,Department of Medicine, Faculty of Medicine, Ramathibodi Hospital,

location_facility: GBUZ of Yaroslavl Region "Regional Clinical Hospital"

location_facility: Clinica Ematologica - A.O.U. Ospedali Riuniti di Ancona

location_facility: Private medical institution "Euromedservice"

location_facility: Kliniken Ostalb, Stauferklinikum Schwaebisch Gmuend, Zentrum fuer Innere Medizin

location_facility: Cirurgia y Ginecobstetricia de Oaxaca, S.A de C.V.

location_facility: Klinikum Chemnitz gGmbH - Klinik fuer Nuklearmedizin

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: "Municipal Institution ""Chernivtsi Regional Clinical Oncology Center"",

location_facility: Hopital Morvan-CHU Brest- Service Hematologie Clinique

location_facility: "State Budget Healthcare Institution ""Chelyabinsk Regional Clinical Center of Oncology

location_facility: IRCSS A.O.U. San Martino - IST - UO Clinica Ematologica

location_facility: Gen. Hosp. of Athens "Evangelismos-Eye Hosp. - Polikliniki"

location_facility: Hospital Universitario Sanitas La Moraleja

location_facility: Municipal Establishment 'Zaporizhzhia Regional Clinical Oncology Dispensary'

location_facility: "LTD ""M. Zodelava's Hematology Centre"""

location_facility: Willamette Valley Cancer Institute and Research Center

location_facility: Torrance Health Association DBA, Torrance Memorial Physician, Network/Cancer Care Associates

location_facility: San Antonio Military Medical Center- Department of Pharmacy

location_facility: FSBI "Russian Research Centre of Radiology and Surgical Technologies" of MoH of RF

location_facility: High Technology Medical Center, University Clinic

location_facility: FSBI "Russian Research Centre of Radiology and Surgical Technologies n.a. A.M. Granov" of MoH of RF

location_facility: Centre Hospitalier Universitaire Cote de Nacre

location_facility: Casa de Saude Santa Marcelina (Centro de Pesquisa Santa Marcelina)

location_facility: Hammoud Hospital, University Medical Center

location_facility: Onkologiezentrum Thun-Berner Oberland Spital Sts Ag

location_facility: Gen.Hosp.of Athens "Evangelismos-Eye Hosp.-polikiliniki"

location_facility: City Hospitals Sunderland NHS Foundation Trust-Sunderland Royal Hospital

location_facility: Department of Radiology, Ramathibodi Hospital

location_facility: Hospital de Clinicas de Porto Alegre - Centro de Pesquisa Clinica

location_facility: State Budgetary Healthcare Institution "Republican Clinical Oncology Dispensary of the Ministry

location_facility: University Hospital Center Zagreb, Department of Pathology and Cytology

location_facility: EGE-RAD Bilgisayarli Tomografi Ozel Saglik Hizmetleri ve Malzemeleri Tic.Ltd.Sti.

location_facility: Healthcare Institution "Brest Regional Oncologic Dispensary"

location_facility: Centro Hospitalar do Porto-Hospital de Santo Antonio E.P.E.

location_facility: Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi

location_facility: Ege Universitesi Tip Fakultesi Ic Hastaliklari Anabilim Dali

location_facility: Hospital Santa Izabel / Santa Casa de Misericordia da Bahia

location_facility: National Hospital Organization Tokyo Medical Center

location_facility: Gen. Hosp. of Athens "Evangelismos - Eye Hosp.- Polikliniki"

location_facility: SC Ematologia - SC Ematologia - Arcispedale Santa Maria Nuova - IRCCS

location_facility: R.K. Birla Cancer Center, Sawai Man Singh Hospital

location_facility: Comprehensive Cancer Center at Desert Regional Medical Center

location_facility: Hospital das Clinicas da Universidade Federal de Goias \ Centro de Pesquisa Clinica

location_facility: Oaxaca Site Management Organization S.C.

location_facility: Euromedic Wroclawskie Centrum Medyczne II

location_facility: Municipal Non-Profit Enterprise "Regional Oncology Centre"

location_facility: Klinika Nowotworow Ukladu Chlonnego Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie

location_facility: Centro de Imagens da Faculdade de Medicina - INCT Medicina Nuclear - PET/CT

location_facility: Policlinico Universitario Campus Bio- Medico-U.O.C. di Ematologia Trapianto Cellule Staminali

location_facility: Erciyes Universitesi Tip Fakultesi Radyoloji Laboratuvari

location_facility: InsCer - Instituto do Cerebro do Rio Grande do Sul - PUCRS

intervention_type: Biological


acronym: BERENICE

title: A Multicenter, Multinational, Phase II Study to Evaluate Perjeta in Combination With Herceptin and Standard Neoadjuvant Anthracycline-Based Chemotherapy in Patients With HER2-Positive, Locally Advanced, Inflammatory, or Early-Stage Breast Cancer

lead_sponsor: Hoffmann-La Roche

source: euctr

design_allocation: Non-Randomized

ReferenceCitation: Swain SM, Ewer MS, Viale G, Delaloge S, Ferrero JM, Verrill M, Colomer R, Vieira C, Werner TL, Douthwaite H, Bradley D, Waldron-Lynch M, Kiermaier A, Eng-Wong J, Dang C; BERENICE Study Group. Pertuzumab, trastuzumab, and standard anthracycline- and taxane-based chemotherapy for the neoadjuvant treatment of patients with HER2-positive localized breast cancer (BERENICE): a phase II, open-label, multicenter, multinational cardiac safety study. Ann Oncol. 2018 Mar 1;29(3):646-653. doi: 10.1093/annonc/mdx773.

location_country:
Denmark
Poland
Portugal
Spain
Italy
United Kingdom
Canada
United States
France
Mexico
Norway
Germany

location_facility: Northwest Georgia Oncology Centers PC - Marietta

location_facility: Herlev Hospital; Afdeling for Kræftbehandling

location_facility: Centre D'Oncologie de Gentilly; Oncology

location_facility: Wielkopolskie Centrum Onkologii; im. Marii Skłodowskiej-Curie

location_facility: Ospedale Della Misericordia; U.O. Di Medicina Ia - Oncologia Medica

location_facility: Cite de La Sante de Laval; Hemato-Oncologie

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Hospital Universitario Virgen Macarena; Servicio de Oncologia

location_facility: Churchill Hospital; Oxford Cancer and Haematology Centre

location_facility: University of Utah; Huntsman Cancer Hospital

location_facility: Ospedale Santa Maria Annunziata; Oncologia

location_facility: Institut Gustave Roussy; Departement Oncologie Medicale

location_facility: Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej

location_facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

location_facility: University of South Alabama; Mitchell Cancer Institute

location_facility: Peterborough City Hospital, Edith Cavell Campus; Oncology Department

location_facility: Royal United Hospital; Oncology Department

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Royal Marsden Hospital - Fulham; Oncology Department

location_facility: Mount Sinai Beth Israel Comprehensive Cancer Center

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

location_facility: Hospital Beatriz Angelo; Departamento de Oncologia

location_facility: Centro Oncológico Gallego José Antonio Quiroga y Piñeiro, Servicio de Oncologia

location_facility: Centre Antoine Lacassagne; Hopital De Jour A2

location_facility: A.O. Città della Salute e della Scienza - Presidio Molinette; divisione oncologia medica

location_facility: Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche

location_facility: Universitätsklinikum "Carl Gustav Carus"; Frauenheilkunde und Geburtshilfe

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Freeman Hospital; Northern Centre For Cancer Care

location_facility: Asl Le-Ospedale "Vito Fazzi";U.O. Oncologia

location_facility: MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center)

location_facility: Allina Health, Virginia Piper Cancer Institute

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

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Ruppiner Kliniken, Klinik fuer Gynaekologie und Geburtshilfe

location_facility: Regional Cancer Care Associates LLC - Morristown

location_facility: Oslo universitetssykehus HF, Ullevål, Kreftsenteret

location_facility: Washington Cancer Institute at MedStar Washington Hospital Center.

location_facility: Haukeland Universitetssjukehus; Klinisk forskningspost

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

location_facility: Centro Clinico Champalimaud; Oncologia Medica

location_facility: Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia

location_facility: Centre Oscar Lambret; Cancerologie Gynecologique

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Royal Marsden Hospital; Dept of Medical Oncology

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

location_facility: Hospital Universitario de la Princesa; Servicio de Oncologia

location_facility: Casa Di Cura Di Alta Specialita La Maddalena; Dept. Oncologico Di Iii Livello

location_facility: Centro de Diagnóstico y Tratamiento Integral de Mama, Hospital San José Tec de Monterrey

location_facility: Guys & St Thomas Hospital; Department of Oncology

summary: This multicenter, non-randomized, open-label, phase 2 study is designed to evaluate the safety and efficacy of pertuzumab (Perjeta) in combination with trastuzumab (Herceptin) and anthracycline-based chemotherapy as neoadjuvant treatment in participants with HER2-positive locally advanced, inflammatory, or early-stage breast cancer. Each investigator will choose a treatment regimen (A or B) for all of their participants to follow. Treatment regimen A (for Cohort A) will include dose-dense doxorubicin and cyclophosphamide (ddAC), followed by paclitaxel, with pertuzumab and trastuzumab given from the start of paclitaxel. Treatment regimen B (for Cohort B) will include 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), followed by docetaxel, with pertuzumab and trastuzumab given from the start of docetaxel. Participants in both cohorts will subsequently undergo surgical treatment and then resume pertuzumab and trastuzumab treatment.


title: A Randomized, Multicenter, Open-Label, Two-Arm, Phase III Neoadjuvant Study Evaluating Trastuzumab Emtansine Plus Pertuzumab Compared With Chemotherapy Plus Trastuzumab and Pertuzumab for Patients With HER2-Positive Breast Cancer

ReferenceCitation: Hurvitz SA, Martin M, Jung KH, Huang CS, Harbeck N, Valero V, Stroyakovskiy D, Wildiers H, Campone M, Boileau JF, Fasching PA, Afenjar K, Spera G, Lopez-Valverde V, Song C, Trask P, Boulet T, Sparano JA, Symmans WF, Thompson AM, Slamon D. Neoadjuvant Trastuzumab Emtansine and Pertuzumab in Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: Three-Year Outcomes From the Phase III KRISTINE Study. J Clin Oncol. 2019 Sep 1;37(25):2206-2216. doi: 10.1200/JCO.19.00882. Epub 2019 Jun 3.

ReferenceCitation: Hurvitz SA, Martin M, Symmans WF, Jung KH, Huang CS, Thompson AM, Harbeck N, Valero V, Stroyakovskiy D, Wildiers H, Campone M, Boileau JF, Beckmann MW, Afenjar K, Fresco R, Helms HJ, Xu J, Lin YG, Sparano J, Slamon D. Neoadjuvant trastuzumab, pertuzumab, and chemotherapy versus trastuzumab emtansine plus pertuzumab in patients with HER2-positive breast cancer (KRISTINE): a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 2018 Jan;19(1):115-126. doi: 10.1016/S1470-2045(17)30716-7. Epub 2017 Nov 23.

location_country:
Taiwan
Spain
Russian Federation
Canada
Ukraine
Korea, Republic of
United States
France
Belgium
Germany

location_facility: Railway Clinical Hospital on Saratov - 2 Station Oao "Rzhd"

location_facility: CHU de Québec - Hôpital du Saint-Sacrement / ONCOLOGY

location_facility: IInstituto Oncologico de San Sebastian, Oncologikoa; Servicio de Oncologia

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Hospital Quiron de Madrid; Servicio de Oncologia

location_facility: Saint-Petersburg City Clinical Oncology Dispensary

location_facility: Hospital Universitari de Lleida Arnau de Vilanova

location_facility: Mackay Memorial Hospital; Dept of Surgery

location_facility: Comprehensive Cancer Centers of Nevada - Henderson

location_facility: Hospital Nuestra Señora de Sonsoles; servicio de Oncologia

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

location_facility: Seoul National University Bundang Hospital

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología

location_facility: Roper Bon Secours St. Francis Cancer Center

location_facility: State Inst. Of Healthcare Orenburg Regional Clinical Oncology Dis

location_facility: St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr

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

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: S.I. Russian Oncological Research Center n.a. N.N. Blokhin

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: Regional Oncology Hospital Of Kursk; Chemotherapy

location_facility: Cross Cancer Institute ; Dept of Medical Oncology

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery

summary:
This is a randomized, multicenter, open-label, two-arm study in treatment-naive participants with operable, locally advanced, or inflammatory, centrally-assessed HER2-positive early breast cancer (EBC) whose primary tumors were greater than or equal to (>/=) 2 centimeters (cm). The study was designed to evaluate the efficacy and safety of trastuzumab emtansine + pertuzumab (experimental arm; T-DM1 + P) versus chemotherapy, trastuzumab + pertuzumab (control arm; TCH + P). The study comprised a neoadjuvant treatment period, followed by surgery, and an adjuvant treatment period.

Treatment can be stopped due to disease recurrence, unacceptable toxicity, withdrawal of consent, or study termination.


title: A MULTICENTER PHASE 3 RANDOMIZED, OPEN-LABEL STUDY OF BOSUTINIB VERSUS IMATINIB IN ADULT PATIENTS WITH NEWLY DIAGNOSED CHRONIC PHASE CHRONIC MYELOGENOUS LEUKEMIA

ReferenceCitation: Brümmendorf TH, Cortes JE, Milojkovic D, Gambacorti-Passerini C, Clark RE, le Coutre P, Garcia-Gutierrez V, Chuah C, Kota V, Lipton JH, Rousselot P, Mauro MJ, Hochhaus A, Hurtado Monroy R, Leip E, Purcell S, Yver A, Viqueira A, Deininger MW; BFORE study investigators. Bosutinib versus imatinib for newly diagnosed chronic phase chronic myeloid leukemia: final results from the BFORE trial. Leukemia. 2022 Jul;36(7):1825-1833. doi: 10.1038/s41375-022-01589-y. Epub 2022 May 28.

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

ReferenceCitation: Chuah C, Koh LP, Numbenjapon T, Zang DY, Ong KH, Do YR, Ohkura M, Ono C, Viqueira A, Cortes JE, Brümmendorf TH. Efficacy and safety of bosutinib versus imatinib for newly diagnosed chronic myeloid leukemia in the Asian subpopulation of the phase 3 BFORE trial. Int J Hematol. 2021 Jul;114(1):65-78. doi: 10.1007/s12185-021-03144-4. Epub 2021 Apr 13.

ReferenceCitation: Cortes JE, Gambacorti-Passerini C, Deininger MW, Mauro MJ, Chuah C, Kim DW, Dyagil I, Glushko N, Milojkovic D, le Coutre P, Garcia-Gutierrez V, Reilly L, Jeynes-Ellis A, Leip E, Bardy-Bouxin N, Hochhaus A, Brümmendorf TH. Bosutinib Versus Imatinib for Newly Diagnosed Chronic Myeloid Leukemia: Results From the Randomized BFORE Trial. J Clin Oncol. 2018 Jan 20;36(3):231-237. doi: 10.1200/JCO.2017.74.7162. Epub 2017 Nov 1.

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
South Africa
Czechia
Poland
Australia
Israel
Mexico
Norway
Singapore
Sweden
Slovakia
Canada
Hungary
Germany
Denmark
Taiwan
Finland
Thailand
Korea, Republic of
France
Netherlands

location_facility: private Practice of Dr. Viviane Dubruille

location_facility: Department of Haematology The Royal Hallamshire Hospital

location_facility: Division of Hematology, Department of Medicine, Faculty of Medicine Siriraj Hospital

location_facility: Universytet Medyczny im. Piastów Śląskich we Wrocławiu Katedra i

location_facility: NYU Winthrop Hospital - Oncology / Hematology department

location_facility: SPSK, Klinika Hematoonkologii i Transplantacji Szpiku w Lublinie

location_facility: PHARMACY Department Franciscan St. Francis Health ATTN:Jill Leslie, Pharm D

location_facility: Hematology Department, Rambam Medical Centre

location_facility: Department of Haematology at UZ Leuven (7 th Floor)

location_facility: Hospital Clínico Universitario de Valencia

location_facility: IRCCS - AOU San Martino_IST, Ematologia 1

location_facility: Szegedi Tudományegyetem, AOK, Szent-Györgyi Albert Klinikai Központ, II. sz.

location_facility: Klinika Hematologii i Transplantologii Uniwersyteckie Centrum Kliniczne

location_facility: Regional Clinical Hospital in Ivano-Frankivsk, Hematology Department

location_facility: Kyiv City Clinical Hospital #9, Hematology department #1,

location_facility: Catherine Lewis Centre, Hammersmith Hospital

location_facility: North Mississippi Medical Center Hematology and Oncology Clinic

location_facility: Debreceni Egyetem Klinikai Központ, Belgyógyászati Inézet Hematológiai Tanszék

location_facility: transplantation department of hemotology and transplantology division within Clinical Radiology

location_facility: Universitätsklinikum Jena, Klinik für Innere Medizin II

location_facility: USC Ematologia, A. O. Papa Giovanni XXIII

location_facility: Jász-Nagykun-Szolnok Megyei Hetényi, Géza Kórház-Rendelőintézet

location_facility: State Institution "Institute of Blood Pathology and Transfusion Medicine NAMS of Ukraine"

location_facility: Schwerpunktpraxis für Hämatologie und Onkologie

location_facility: St George Hospital - Hematology Department

location_facility: HSHS St. Vincent Hospital Regional Cancer Center at HSHS St. Mary's Hospital Medical Center

location_facility: Unità di Ricerca Clinica, U.O. Ematologia Adulti

location_facility: University of Massachusetts Memorial Medical Center, ONC/Research Pharmacy

location_facility: Petz Aladár Megyei OktatóKórház, II. Belgyógyászati Osztály és Haematológiai Részleg

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

location_facility: Pr Mauricette Michallet Centre Hospitalier Lyon Sud

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Saint Alphonsus Caldwell Cancer Care Center

location_facility: University of Rochester Investigational Drug Pharmacy

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Haukeland University Hospital Department of Hematology

location_facility: John H. Stroger, Jr. Hospital of Cook County

location_facility: Charité, CVK, Med. Klinik m.S Hämatologie und Onkologie

location_facility: St. Joseph Mercy Hospital - Inpatient Pharmacy

location_facility: HSHS St. Vincent Hospital Regional Cancer Center at HSHS St. Vincent Hospital

location_facility: Cancer & Haematology Centre, Churchill Hospital

location_facility: Cancer Center of Acadiana at Lafayette General Medical Center

location_facility: Universitätsklinikum Hamburg-Eppendorf, Onkologisches Zentrum

location_facility: State Institution "National research center for radiation medicine of NAMS of Ukraine",

location_facility: Saint Alphonsus Regional Medical Center, Cancer Care Center

location_facility: Department of Medical Oncology, University of Pretoria and Steve Biko

location_facility: SPZOZ ZSM w Chorzowie Oddzial Hematologiczny

location_facility: The University of Texas, MD Anderson Cancer Center

location_facility: Winship Cancer Institute, Emory University

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: A.O.U. Policlinico Università degli Studi di Napoli "Federico II"

location_facility: Samodzielny Publiczny Szpital Kliniczny im. A Mielęckiego, ŚUM w Katowicach

location_facility: Institut de Cancérologie du Gard - Hématologie Clinique

location_facility: Hematology Div. Davidoff Cancer Center, Rabin Medical Center

location_facility: St. John Hospital&Medical Center-Van Elslander Cancer Center

location_facility: Universitätsklinikum Freiburg, Klinik für Innere Medizin I

location_facility: MI "Cherkasy Regional Oncological Dispensary " of Cherkasy Regional Council

location_facility: Froedtert Hospital and the Medical College of Wisconsin

location_facility: MUSC University of South Carolina, Investigational Drug Services

location_facility: Indiana Blood and Marrow Transplantation

location_facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Hematologii

location_facility: private Practice of Pr Philippe Rousselot

location_facility: National University Hospital, Main Building

location_facility: Khmelnytskyi Regional Hospital, Hematology Department

location_facility: Hospital (Universitari(o)) Germans Trias i Pujol

location_facility: NYU Winthrop Hospital - Pharmacy Department

location_facility: Horizon Health Network - The Moncton Hospital

location_facility: Azienda Ospedaliero-Universitaria "Policlinico - Vittorio Emanuele" - P.O. G. Rodolico

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

location_facility: Division of Hematology, Department of Internal Medicine, Maharaj Nakorn Chiang Mai Hospital

location_facility: Hospital Angeles del Pedregal (S.A. de C.V.)

location_facility: Wojewódzki Szpital Specjalistyczny im M. Kopernika, Klinika Hematologii Uniwersytetu Medycznego

location_facility: Univerzitná Nemocnica Bratislava-Nemocnica sv. Cyrila a Metoda

summary: Phase 3, 2-arm, randomized, open label trial. Patients will be randomized to receive bosutinib or imatinib for the duration of the study.


title: A Phase IIb Study Evaluating a Long-Acting Intramuscular Regimen of GSK1265744 Plus TMC278 For The Maintenance of Virologic Suppression Following an Induction of Virologic Suppression on an Oral Regimen of GSK1265744 Plus Abacavir/Lamivudine in HIV-1 Infected, Antiretroviral Therapy-Naive Adult Subjects

summary:
This study is a Phase IIb, randomized, multicentre, parallel group, open-label, study having an overall objective to evaluate the antiviral activity, tolerability, and safety of two intramuscular (IM) dosing regimens of GSK744 LA plus TMC278 LA, relative to GSK744 30 milligram (mg) plus Abacavir/Lamivudine (ABC/3TC) given orally once daily (QD), in HIV-1 infected antiretroviral-naïve subjects. GSK744 is the oral formulation of GSK1265744 (cabotegravir), GSK744 LA is the long acting injectable formulation of GSK1265744 and TMC278 LA is the long acting injectable formulation of TMC278.

The study will consist of three parts: an Induction Period, Maintenance Period and Extension Period. There is also a Long-Term Follow Up Period for subjects who withdraw from the study and have received at least one dose of GSK744 LA and / or TMC278 LA. In the Induction Period, eligible subjects will receive a combination of an oral regimen of 30 mg of GSK744 and 600/300 mg of ABC/3TC, once daily for 20 weeks. In the Maintenance Period, eligible subjects will be randomized 2:2:1 at Day 1 to receive an IM regimen of GSK744 LA 400 mg + TMC278 LA 600 mg every 4 weeks for 96 weeks (Q4W), an IM regimen of GSK744 LA 600 mg + TMC278 LA 900 mg every 8 weeks for 96 weeks (Q8W), or to continue on the oral Induction Period regimen of GSK744 30 mg + ABC/3TC once daily for 96 weeks (or 104 weeks if continuing on to the Extension Period). The Extension Period will allow for a collection of longer term efficacy and safety and tolerability data from subjects receiving GSK744 LA and TMC278 LA.

The study will involve sufficient subjects at screening in order to ensure a total of approximately 265 subjects at the beginning of the Induction Period and approximately 225 subjects randomized into the Maintenance Period.

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceType: background

ReferenceCitation: Kerrigan D, Mantsios A, Gorgolas M, Montes ML, Pulido F, Brinson C, deVente J, Richmond GJ, Beckham SW, Hammond P, Margolis D, Murray M. Experiences with long acting injectable ART: A qualitative study among PLHIV participating in a Phase II study of cabotegravir + rilpivirine (LATTE-2) in the United States and Spain. PLoS One. 2018 Jan 5;13(1):e0190487. doi: 10.1371/journal.pone.0190487. eCollection 2018.

ReferenceCitation: Smith GHR, Henry WK, Podzamczer D, Masiá MDM, Bettacchi CJ, Arasteh K, Jaeger H, Khuong-Josses MA, Montes-Ramírez ML, Stellbrink HJ, Yazdanpanah Y, Richmond GJ, Sutton KC, Zhang F, McCoig CC, St Clair MH, Vandermeulen K, Van Solingen-Ristea R, Smith KY, Margolis DA, Spreen WR. Efficacy, Safety, and Durability of Long-Acting Cabotegravir and Rilpivirine in Adults With Human Immunodeficiency Virus Type 1 Infection: 5-Year Results From the LATTE-2 Study. Open Forum Infect Dis. 2021 Aug 25;8(9):ofab439. doi: 10.1093/ofid/ofab439. eCollection 2021 Sep.

ReferenceCitation: Letendre SL, Mills A, Hagins D, Swindells S, Felizarta F, Devente J, Bettacchi C, Lou Y, Ford S, Sutton K, Shaik JS, Crauwels H, D'Amico R, Patel P. Pharmacokinetics and antiviral activity of cabotegravir and rilpivirine in cerebrospinal fluid following long-acting injectable administration in HIV-infected adults. J Antimicrob Chemother. 2020 Mar 1;75(3):648-655. doi: 10.1093/jac/dkz504.

ReferenceCitation: Murray M, Pulido F, Mills A, Ramgopal M, LeBlanc R, Jaeger H, Canon V, Dorey D, Griffith S, Mrus J, Spreen W, Margolis D. Patient-reported tolerability and acceptability of cabotegravir + rilpivirine long-acting injections for the treatment of HIV-1 infection: 96-week results from the randomized LATTE-2 study. HIV Res Clin Pract. 2019 Aug - Oct;20(4-5):111-122. doi: 10.1080/25787489.2019.1661696. Epub 2019 Sep 18.

ReferenceCitation: Margolis DA, Gonzalez-Garcia J, Stellbrink HJ, Eron JJ, Yazdanpanah Y, Podzamczer D, Lutz T, Angel JB, Richmond GJ, Clotet B, Gutierrez F, Sloan L, Clair MS, Murray M, Ford SL, Mrus J, Patel P, Crauwels H, Griffith SK, Sutton KC, Dorey D, Smith KY, Williams PE, Spreen WR. Long-acting intramuscular cabotegravir and rilpivirine in adults with HIV-1 infection (LATTE-2): 96-week results of a randomised, open-label, phase 2b, non-inferiority trial. Lancet. 2017 Sep 23;390(10101):1499-1510. doi: 10.1016/S0140-6736(17)31917-7. Epub 2017 Jul 24.

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

lead_sponsor: ViiV Healthcare

location_country:
Spain
Canada
United States
France
Germany

status_simplified: Ongoing


title: A Multicenter Single-arm Extension Study to Describe the Long-term Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis

summary: This is a multicenter, single-arm, extension study to characterize the long-term safety and tolerability of etelcalcetide in the treatment of Secondary Hyperparathyroidism (SHPT) in adults with Chronic Kidney Disease (CKD) on hemodialysis.

lead_sponsor: Amgen

location_country:
Spain
Italy
Lithuania
United States
Belgium
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Israel
Turkey
Sweden
Canada
Switzerland
Hungary
Germany
Denmark
Greece
Latvia
New Zealand
France
Netherlands


title: Treatment of Cardiovascular Disease With Low Dose Rivaroxaban in Advanced Chronic Kidney Disease

acronym: TRACK

summary:
The TRACK trial is an investigator-initiated, multicentre, prospective, randomised, quadruple-blind (participant, healthcare provider, data collector, outcomes assessor), placebo-controlled trial. TRACK is a global trial and will be conducted in renal units that provide comprehensive CKD care. Approximately 2000 participants will be recruited.

The TRACK trial will assess a strategy of administering low dose rivaroxaban to reduce the risk of major adverse cardiac event (MACE) in people with Chronic Kidney Disease (CKD) stages 4 or 5 or dialysis-dependent kidney failure, and elevated cardiovascular (CV) risk (marked by a history of CAD or PAD, or non-haemorrhagic non-lacunar stroke OR diabetes mellitus OR age ≥65 years).

status: Recruiting

enrollment_type: Anticipated

ipd_sharing_description:
Trial data will be disseminated in the form of a publication to a relevant clinical journal and presentation at appropriate scientific conferences.

Individual participant data that underlie the results reported, after de-identification (text, tables, figures, and appendices), may be shared with Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.

lead_sponsor: The George Institute

location_country:
Taiwan
Saudi Arabia
Australia
Canada
Tunisia
India
France
Singapore
Malaysia

location_facility: Nizam's Institute of Medical Sciences, Hyderabad

location_facility: Hôpital de la Maison Blanche, (CHU Reims)

location_facility: All India Institute of Medical Sciences, Bathinda

location_facility: Institute of Post-Graduate Medical Education and Research

location_facility: Hôpital de la Cavale Blanche, (CHU Brest)

location_facility: Centre Hospitalier Régional Universitaire de Nancy

location_facility: All India Institute Of Medical Sciences, Raipur

location_facility: Kasturba Medical College and Hospital, Manipal

location_facility: Postgraduate Institute of Medical Education and Research, Chandigarh

location_facility: Chang Gung Memorial Hospital, Linkou Medical Center

location_facility: ialysis Centre - King Abdul Aziz Medical City (KAMC)

location_facility: CH Boulogne-sur-Mer, (CH Boulogne-sur-Mer)

location_facility: Aykai Super Speciality Hospital, Ludhiana

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: KG Hospital, K.Govindaswamy Naidu Medical Trust

location_facility: King Abdullah International Medical Research Center

intervention_type: Other


title: Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Idalopirdine in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil

acronym: STARBEAM

summary: To establish efficacy of Idalopirdine as adjunctive therapy to donepezil for symptomatic treatment of patients with mild-to-moderate Alzheimer's disease (AD).

ReferenceCitation: Ballard C, Atri A, Boneva N, Cummings JL, Frölich L, Molinuevo JL, Tariot PN, Raket LL. Enrichment factors for clinical trials in mild-to-moderate Alzheimer's disease. Alzheimers Dement (N Y). 2019 May 20;5:164-174. doi: 10.1016/j.trci.2019.04.001. eCollection 2019.

ReferenceCitation: Cummings JL, Atri A, Ballard C, Boneva N, Frölich L, Molinuevo JL, Raket LL, Tariot PN. Insights into globalization: comparison of patient characteristics and disease progression among geographic regions in a multinational Alzheimer's disease clinical program. Alzheimers Res Ther. 2018 Nov 24;10(1):116. doi: 10.1186/s13195-018-0443-2.

ReferenceCitation: Atri A, Frölich L, Ballard C, Tariot PN, Molinuevo JL, Boneva N, Windfeld K, Raket LL, Cummings JL. Effect of Idalopirdine as Adjunct to Cholinesterase Inhibitors on Change in Cognition in Patients With Alzheimer Disease: Three Randomized Clinical Trials. JAMA. 2018 Jan 9;319(2):130-142. doi: 10.1001/jama.2017.20373.

lead_sponsor: H. Lundbeck A/S

location_country:
Croatia
Poland
Brazil
Portugal
Taiwan
Ireland
Italy
Estonia
United Kingdom
Argentina
Canada
Finland
Lithuania
Hungary
Korea, Republic of
United States
France
Israel
Czechia


title: SUNRISE: A Phase III, Randomized, Double-Blind, Placebo-Controlled Multicenter Trial of Bavituximab Plus Docetaxel Versus Docetaxel Alone in Patients With Previously Treated Stage IIIb/IV Non-Squamous Non Small-Cell Lung Cancer

acronym: SUNRISE

summary: The primary purpose of this research study is to see whether adding bavituximab (an investigational drug) to the standard chemotherapy drug docetaxel, will improve the results of the treatment for non-small-cell lung cancer.

ReferenceCitation: Gerber DE, Horn L, Boyer M, Sanborn R, Natale R, Palmero R, Bidoli P, Bondarenko I, Germonpre P, Ghizdavescu D, Kotsakis A, Lena H, Losonczy G, Park K, Su WC, Tang M, Lai J, Kallinteris NL, Shan JS, Reck M, Spigel DR. Randomized phase III study of docetaxel plus bavituximab in previously treated advanced non-squamous non-small-cell lung cancer. Ann Oncol. 2018 Jul 1;29(7):1548-1553. doi: 10.1093/annonc/mdy177.

lead_sponsor: Peregrine Pharmaceuticals

location_country:
Taiwan
Romania
Spain
Greece
Italy
Australia
Russian Federation
Ukraine
Hungary
Korea, Republic of
United States
France
Belgium
Germany

location_facility: Peregrine Pharmaceuticals Investigational Site


title: A Phase II, Randomized, Double-Blind, Placebo Controlled, Multicenter Trial to Assess the Oral Corticosteroid-Sparing Effect of Lebrikizumab in Patients With Severe Corticosteroid Dependent Asthma

summary: This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy of lebrikizumab compared with placebo, as measured by the ability of participants to achieve lower daily doses of OCS, among those with severe corticosteroid-dependent asthma. Prednisone/prednisolone will be the OCS therapy prescribed. Participants will be randomized to receive lebrikizumab or matching placebo for 44 weeks in a double-blind, placebo-controlled (DBPC) period. Those who complete the 44-week period may continue into a 32-week active treatment extension (ATE) period, during which all participants will receive lebrikizumab treatment. Following completion of the ATE period, participants who have both tolerated and derived benefit from treatment with lebrikizumab may continue their lebrikizumab treatment into a long-term extension (LTE) period. Participants will transition to 24 weeks of safety follow-up upon discontinuation of study drug.

location_country:
Denmark
Poland
Slovenia
Spain
United Kingdom
Australia
Mexico
Canada
New Zealand
Puerto Rico
United States
France
Belgium
Netherlands
Slovakia
Czechia

location_facility: Southampton General Hospital; Respiratory Department

location_facility: St Bartholomew's Hospital (Barts); Respiratory Department

location_facility: CHU de Grenoble - Hôpital André Michallon

location_facility: Hospital Clinico Universitario de Salamanca; Servicio de Neumologia

location_facility: Belfast City Hospital; Respiratory Department

location_facility: Specjalistyczny Osrodek Alergologiczno-Internistyczny ALL-MED

location_facility: Centro Investigacion Medico Biologica y Terapia Avanzada

location_facility: Wythenshawe Hospital; North West Lung Research Centre

location_facility: Monash Medical Centre; Respiratory and Sleep Medicine

location_facility: Freeman Hospital; Respiratory Department

location_facility: Medical Research Inst. of New Zealand; Respiratory

location_facility: Clinical Trials Unit, Bay of Plenty District Health Board

location_facility: Heartlands Hospital; Respiratory Department

location_facility: EMC Instytut Medyczny SA; Przychodnia przy ulicy Łowieckiej

location_facility: Hopital Bichat Claude Bernard ; Service de Pneumologie

location_facility: University Clinic of Pulmonary and Allergic Diseases Golnik

location_facility: San Juan Bautista School of Medicine-Clinical Research Unit

location_facility: Glenfield Hospital; Respiratory -Allergy Unit

location_facility: Sheffield Clinical Research Facility; National Institute for Health Research

location_facility: Klinika Chorób Wewnetrznych i Alergologii MSW

location_facility: Academisch Medisch Centrum; Afdeling Longziekten, F5-258

location_facility: Complejo Hospitalario Universitario de Santiago; Servicio de Neumología

location_facility: New Lister Buliding, Level 1; Clinical Research Facility

location_facility: Allergy & Asthma Care Center of Southern California

location_facility: Nouvel Hôpital Civil; Pôle de Pathologie Thoracique

location_facility: Spaarne Ziekenhuis Hoofddorp; Long Geneeskunde

location_facility: Antonius Ziekenhuis; Dept of Lung Diseases

location_facility: Princess Alexandra Hospital, Department of Respiratory and Sleep Medicine

location_facility: CHU Nantes - Hôpital Laennec; Service de Pneumologie

location_facility: Gartnavel General Hospital; Respiratory Department

location_facility: Derriford Hospital; The Lind Research Department

location_facility: Instituto Jalisciense de Investigacion Clinica S.A. de C.V.

location_facility: Royal Brompton Hospital; Respiratory Department

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

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej PROFILAKTYKA Wladyslaw Pierzchala


status: Unknown status

title: A Randomized Phase II Study to Evaluate the Efficacy and Safety of Chemotherapy (CT) vs Androgen Deprivation Therapy (ADT) in Patients With Recurrent and/or Metastatic, Androgen Receptor (AR) Expressing, Salivary Gland Cancer (SGCs)

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

location_country: Greece Austria Italy Netherlands Hungary France Belgium Germany

location_facility: Spaarne Gasthuis - Vrije Universiteit Medisch Centrum

location_facility: Athens University - Attikon University General Hospital

location_facility: Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: Azienda Provinciale per i Servizi Sanitari - Ospedale Santa Chiara

location_facility: Medical University Vienna - General Hospital AKH

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

location_facility: Universitaetsklinikum Jena-Radiation Therapy and Radiooncology Clinic

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Assistance Publique - Hopitaux de Paris - Hopital Tenon

location_facility: Radboud University Medical Center Nijmegen

location_facility: Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole - Institut Claudius Regaud

location_facility: University Medical Center Groningen (UMCG)

location_facility: Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet

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

summary:
Salivary Gland (SG) Cancers are a rare and heterogeneous group of tumors, usually approached by multidisciplinary teams in high specialized centers. Until today no standard of care exists to treat these cancers. The identification of a target, the androgen receptor, in SG tumors has allowed for new treatment strategies options for this rare group of diseases. As a matter of fact, strong positivity for androgen expression has been found in salivary duct carcinoma and adenocarcinomas. The purpose of this study is therefore to evaluate the efficacy and safety of chemotherapy versus androgen deprivation therapy (ADT) in patients with recurrent and/or metastatic AR expressing SGCs.

The study will include two cohorts of patients: Cohort A, which comprises chemo-naïve patients, and Cohort B, which comprises pretreated patients.

status_simplified: Unknown


status: Terminated

acronym: COAST

title: A Randomized, Double-blind, Placebo-controlled Phase-III Study of Adjuvant Regorafenib Versus Placebo for Patients With Stage IV Colorectal Cancer After Curative Treatment of Liver Metastases

lead_sponsor: Bayer

location_country:
Brazil
Portugal
Spain
Italy
United Kingdom
Australia
Canada
United States
France
China
Israel
Belgium
Japan
Germany

location_facility: Fujian Medical University Union Hospital

summary: To evaluate and compare the efficacy and safety of regorafenib versus placebo in subjects with colorectal cancer (CRC) after curative resection of liver metastasis and completion of all planned chemotherapy.


title: A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal, Parallel Group Study of Patiromer for the Management of Hyperkalemia in Subjects Receiving Renin Angiotensin Aldosterone System Inhibitor (RAASi) Medications for the Treatment of Heart Failure (DIAMOND)

acronym: DIAMOND

summary: The purpose of this study is to assess the effects of patiromer compared with placebo on serum K+ in HF patients.

primary_purpose: Prevention

ReferenceCitation: Butler J, Anker SD, Lund LH, Coats AJS, Filippatos G, Siddiqi TJ, Friede T, Fabien V, Kosiborod M, Metra M, Piña IL, Pinto F, Rossignol P, van der Meer P, Bahit C, Belohlavek J, Böhm M, Brugts JJ, Cleland JGF, Ezekowitz J, Bayes-Genis A, Gotsman I, Goudev A, Khintibidze I, Lindenfeld J, Mentz RJ, Merkely B, Montes EC, Mullens W, Nicolau JC, Parkhomenko A, Ponikowski P, Seferovic PM, Senni M, Shlyakhto E, Cohen-Solal A, Szecsödy P, Jensen K, Dorigotti F, Weir MR, Pitt B. Patiromer for the management of hyperkalemia in heart failure with reduced ejection fraction: the DIAMOND trial. Eur Heart J. 2022 Nov 1;43(41):4362-4373. doi: 10.1093/eurheartj/ehac401.

ReferenceCitation: Bolaños JA, Seliger SL. Recurrent Hyperkalemia in Renin-Angiotensin-Aldosterone System Inhibitor (RAASi) Treatment: Stuck between a Rock and a Hard Place. Clin J Am Soc Nephrol. 2021 Mar 8;16(3):345-347. doi: 10.2215/CJN.00950121. Epub 2021 Feb 19.

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

lead_sponsor: Vifor Pharma, Inc.

location_country:
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Czechia
Poland
Russian Federation
Argentina
Israel
Mexico
Brazil
Canada
Hungary
Germany
Bulgaria
Georgia
France
Netherlands

location_facility:
Investigator Site 34-013
Investigator Site 67-005
Investigator Site 21-005
Investigator Site 33-008
Investigator Site 33-001
Investigator Site 11-177
Investigator Site 66-007
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Investigator Site 32-004
Investigator Site 36-001
Investigator Site 35-011
Investigator Site 33-012
Investigator Site 12-004
Investigator Site 12-010
Investigator Site 37-025
Investigator Site 64-001
Investigator Site 11-148
Investigator Site 21-011
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Investigator Site 64-009
Investigator Site 11-188
Investigator Site 39-007
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Investigator Site 11-120
Investigator Site 65-021
Investigator Site 33-022
Investigator Site 11-109
Investigator Site 62-013
Investigator Site 32-008
Investigator Site 68-009
Investigator Site 37-015
Investigator Site 11-075
Investigator Site 11-060
Investigator Site 11-121
Investigator Site 11-085
Investigator Site 39-004
Investigator Site 68-015
Investigator Site 65-003
Investigator Site 37-020
Investigator Site 39-015
Investigator Site 44-003
Investigator Site 32-012
Investigator Site 33-016
Investigator Site 11-179
Investigator Site 39-009
Research Site 11-002
Investigator Site 11-022
Investigator Site 33-013
Investigator Site 11-133
Investigator Site 33-002
Investigator Site 11-015
Investigator Site 21-017
Investigator Site 65-008
Investigator Site 32-018
Investigator Site 68-017
Investigator Site 35-016
Investigator Site 44-009
Investigator Site 66-016
Investigator Site 65-001
Investigator Site 22-024
Investigator Site 44-006
Investigator Site 11-174
Investigator Site 11-074
Investigator Site 21-010
Investigator Site 39-013
Investigator Site 61-003
Investigator Site 63-003
Investigator Site 21-008
Investigator Site 11-117
Investigator Site 12-012
Investigator Site 68-005
Investigator Site 37-013
Investigator Site 22-004
Investigator Site 66-008
Investigator Site 62-015
Investigator Site 11-111
Investigator Site 11-098
Investigator Site 62-005
Investigator Site 61-008
Investigator Site 44-008
Investigator Site 11-147
Investigator Site 63-006
Investigator Site 23-011
Investigator Site 35-010
Investigator Site 11-053
Investigator Site 34-014
Investigator Site 44-001
Investigator Site 11-176
Investigator Site 34-007
Investigator Site 68-004
Investigator Site 62-016
Investigator Site 39-016
Investigator Site 39-008
Investigator Site 36-003
Investigator Site 11-149
Investigator Site 64-002
Investigator Site 32-010
Investigator Site 65-011
Investigator Site 11-151
Investigator Site 21-021
Investigator Site 11-160
Investigator Site 62-011
Investigator Site 11-107
Investigator Site 11-097
Investigator Site 34-005
Investigator Site 11-189
Investigator Site 36-009
Investigator Site 66-003
Investigator Site 67-004
Investigator Site 11-137
Investigator Site 11-086
Investigator Site 36-014
Investigator Site 11-049
Investigator Site 67-007
Investigator Site 35-006
Investigator Site 21-014
Investigator Site 66-014
Investigator Site 22-014
Investigator Site 37-026
Investigator Site 11-162
Investigator Site 11-080
Investigator Site 34-003
Investigator Site 32-006
Investigator Site 33-004
Investigator Site 37-016
Investigator Site 11-124
Investigator Site 33-020
Investigator Site 11-087
Investigator Site 35-001
Investigator Site 35-002
Investigator Site 32-019
Investigator Site 11-054
Investigator Site 22-009
Investigator Site 35-014
Investigator Site 11-165
Investigator Site 32-016
Investigator Site 23-006
Investigator Site 11-169
Investigator Site 33-019
Investigator Site 11-069
Investigator Site 11-068
Investigator Site 62-004
Investigator Site 62-009
Investigator Site 62-018
Investigator Site 22-017
Investigator Site 66-012
Investigator Site 11-125
Investigator Site 11-116
Investigator Site 22-007
Investigator Site 12-002
Investigator Site 37-014
Investigator Site 37-009
Investigator Site 22-003
Investigator Site 21-015
Investigator Site 64-010
Investigator Site 61-010
Investigator Site 11-061
Investigator Site 36-012
Investigator Site 33-015
Investigator Site 11-005
Investigator Site 61-004
Investigator Site 36-007
Investigator Site 21-003
Investigator Site 63-001
Investigator Site 21-009
Investigator Site 65-005
Investigator Site 11-101
Investigator Site 11-046
Investigator Site 22-015
Investigator Site 11-090
Investigator Site 11-028
Investigator Site 11-136
Investigator Site 11-045
Investigator Site 44-007
Investigator Site 62-010
Investigator Site 33-014
Investigator Site 11-171
Investigator Site 32-017
Investigator Site 11-132
Investigator Site 37-022
Investigator Site 11-112
Investigator Site 12-013
Investigator Site 68-016
Investigator Site 11-052
Investigator Site 11-138
Investigator Site 61-005
Investigator Site 33-018
Investigator Site 11-123
Investigator Site 63-004
Investigator Site 11-023
Investigator Site 33-006
Investigator Site 11-092
Investigator Site 62-012
Investigator Site 37-007
Investigator Site 68-002
Investigator Site 21-019
Investigator Site 68-001
Investigator Site 36-002
Investigator Site 11-083
Investigator Site 22-008
Investigator Site 66-017
Investigator Site 11-032
Investigator Site 68-012
Investigator Site 22-013
Investigator Site 32-015
Investigator Site 65-012
Research Site 11-001
Investigator Site 66-013
Investigator Site 23-012
Investigator Site 11-095
Investigator Site 66-018
Investigator Site 64-007
Investigator Site 32-013
Investigator Site 11-034
Investigator Site 11-164
Investigator Site 32-005
Investigator Site 61-002
Investigator Site 22-010
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Investigator Site 35-012
Investigator Site 39-012
Investigator Site 62-017
Investigator Site 12-009
Investigator Site 12-005
Investigator Site 33-011
Investigator Site 35-007
Investigator Site 37-005
Investigator Site 66-005
Investigator Site 11-157
Investigator Site 68-010
Investigator Site 68-011
Investigator Site 35-009
Investigator Site 11-158
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Investigator Site 11-029
Investigator Site 67-010
Investigator Site 32-014
Investigator Site 34-010
Investigator Site 63-008
Investigator Site 35-013
Investigator Site 11-115
Investigator Site 63-002
Investigator Site 11-044
Investigator Site 37-003
Investigator Site 34-004
Investigator Site 11-156
Investigator Site 11-072
Investigator Site 37-001
Investigator Site 23-001
Investigator Site 11-127
Investigator Site 11-178
Investigator Site 34-012
Investigator Site 63-012
Investigator Site 32-002
Investigator Site 65-014
Investigator Site 37-008
Investigator Site 44-005
Investigator Site 34-009
Investigator Site 11-106
Investigator Site 21-018
Investigator Site 37-012
Investigator Site 67-008
Investigator Site 11-183
Investigator Site 11-021
Investigator Site 23-002
Investigator Site 37-006
Investigator Site 11-070
Investigator Site 23-010
Investigator Site 11-146
Investigator Site 22-021
Investigator Site 33-021
Investigator Site 11-142
Investigator Site 11-018
Investigator Site 37-018
Investigator Site 39-003
Investigator Site 11-102
Investigator Site 63-011
Investigator Site 11-081
Investigator Site 62-001
Investigator Site 35-003
Investigator Site 21-007
Investigator Site 65-019
Investigator Site 68-013
Investigator Site 34-002
Investigator Site 61-006
Investigator Site 11-161
Investigator Site 11-078
Investigator Site 63-010
Investigator Site 65-020
Investigator Site 11-129
Investigator Site 36-011
Investigator Site 65-018
Investigator Site 36-006
Investigator Site 33-010
Investigator Site 35-005
Investigator Site 11-144
Investigator Site 11-170
Investigator Site 11-089
Investigator Site 68-003
Investigator Site 11-041
Investigator Site 23-007
Investigator Site 61-009
Investigator Site 36-013
Investigator Site 22-018
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Investigator Site 32-007
Investigator Site 33-007
Investigator Site 66-010
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Investigator Site 63-009
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Investigator Site 37-004
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Investigator Site 39-011
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Investigator Site 11-004
Investigator Site 64-005
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Investigator Site 35-008
Investigator Site 32-020
Investigator Site 22-020
Investigator Site 67-002
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Investigator Site 37-023
Investigator Site 11-091
Investigator Site 66-009
Investigator Site 11-145
Investigator Site 11-135
Investigator Site 11-126
Investigator Site 65-007
Investigator Site 11-099
Investigator Site 11-119
Investigator Site 65-015
Investigator Site 11-042
Investigator Site 65-010
Investigator Site 37-002
Investigator Site 22-002
Investigator Site 22-011
Investigator Site 66-001
Investigator Site 11-003
Investigator Site 68-014
Investigator Site 11-073
Investigator Site 22-025
Investigator Site 66-011
Investigator Site 66-004
Investigator Site 67-003
Investigator Site 22-019
Investigator Site 44-010
Investigator Site 68-007
Investigator Site 37-021
Investigator Site 11-153
Investigator Site 67-001
Investigator Site 68-008
Investigator Site 33-023
Investigator Site 11-122
Investigator Site 32-003
Investigator Site 12-006
Investigator Site 33-005
Investigator Site 11-035
Investigator Site 63-007
Investigator Site 21-004
Investigator Site 62-019
Investigator Site 21-006
Investigator Site 44-002
Investigator Site 22-012
Investigator Site 39-010
Investigator Site 11-056
Investigator Site 22-022
Investigator Site 32-011
Investigator Site 23-005
Investigator Site 66-002
Investigator Site 37-010
Investigator Site 11-088
Investigator Site 22-016
Investigator Site 11-048
Investigator Site 21-012
Investigator Site 11-134
Investigator Site 37-024
Investigator Site 34-001
Investigator Site 32-009
Investigator Site 11-185
Investigator Site 66-015
Investigator Site 36-004
Investigator Site 63-005
Investigator Site 23-004
Investigator Site 11-082
Investigator Site 11-128
Investigator Site 33-024
Investigator Site 11-168
Investigator Site 44-004
Investigator Site 11-094
Investigator Site 33-017
Investigator Site 37-011
Investigator Site 22-005
Investigator Site 12-008
Investigator Site 11-040
Investigator Site 11-076
Investigator Site 39-005
Investigator Site 11-163
Investigator Site 11-058
Investigator Site 22-023
Investigator Site 11-027
Investigator Site 11-063
Investigator Site 11-140
Investigator Site 11-051
Investigator Site 36-015
Investigator Site 11-064
Investigator Site 64-006


title: A Phase III, Multicenter, Randomized, Open-label Study of Oral LDK378 Versus Standard Chemotherapy in Adult Patients With ALK-rearranged (ALK-positive) Advanced Non-small Cell Lung Cancer Who Have Been Treated Previously With Chemotherapy (Platinum Doublet) and Crizotinib

summary: The primary purpose of the study was to compare the antitumor activity of LDK378 vs. chemotherapy in patients previously treated with chemotherapy (platinum doublet) and crizotinib.

ReferenceCitation: Kiura K, Imamura F, Kagamu H, Matsumoto S, Hida T, Nakagawa K, Satouchi M, Okamoto I, Takenoyama M, Fujisaka Y, Kurata T, Ito M, Tokushige K, Hatano B, Nishio M. Phase 3 study of ceritinib vs chemotherapy in ALK-rearranged NSCLC patients previously treated with chemotherapy and crizotinib (ASCEND-5): Japanese subset. Jpn J Clin Oncol. 2018 Apr 1;48(4):367-375. doi: 10.1093/jjco/hyy016.

ReferenceCitation: Shaw AT, Kim TM, Crinò L, Gridelli C, Kiura K, Liu G, Novello S, Bearz A, Gautschi O, Mok T, Nishio M, Scagliotti G, Spigel DR, Deudon S, Zheng C, Pantano S, Urban P, Massacesi C, Viraswami-Appanna K, Felip E. Ceritinib versus chemotherapy in patients with ALK-rearranged non-small-cell lung cancer previously given chemotherapy and crizotinib (ASCEND-5): a randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2017 Jul;18(7):874-886. doi: 10.1016/S1470-2045(17)30339-X. Epub 2017 Jun 9.

ipd_sharing: Undecided

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:
Hong Kong
Portugal
Spain
Ireland
Italy
Lebanon
Netherlands
Canada
Russian Federation
Switzerland
United Kingdom
Korea, Republic of
United States
France
Israel
Singapore
Belgium
Japan
Germany
Turkey

location_facility: Texas Oncology Cancer Care and Research Center

location_facility: Virginia Cancer Specialists SC Virginia Cancer Specialists

location_facility: Loyola University Medical Center /Cardinal Bernardin Cancer SC

location_facility: University of Iowa Hospitals and Clinics Comprehensive Cancer Center

location_facility: Oklahoma Cancer Specialists and Research Institute SC-2


title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Positive, Antiretroviral Treatment-Naïve Adults

summary: The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) in HIV-1 positive, antiretroviral treatment-naive adults.

ReferenceType: result

ReferenceCitation: Sax PE, Wohl D, Yin MT, Post F, DeJesus E, Saag M, Pozniak A, Thompson M, Podzamczer D, Molina JM, Oka S, Koenig E, Trottier B, Andrade-Villanueva J, Crofoot G, Custodio JM, Plummer A, Zhong L, Cao H, Martin H, Callebaut C, Cheng AK, Fordyce MW, McCallister S; GS-US-292-0104/0111 Study Team. Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, phase 3, non-inferiority trials. Lancet. 2015 Jun 27;385(9987):2606-15. doi: 10.1016/S0140-6736(15)60616-X. Epub 2015 Apr 15. Erratum in: Lancet. 2016 Apr 30;387(10030):1816.

ReferenceCitation: Margot N, Cox S, Das M, McCallister S, Miller MD, Callebaut C. Rare emergence of drug resistance in HIV-1 treatment-naïve patients receiving elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide for 144 weeks. J Clin Virol. 2018 Jun;103:37-42. doi: 10.1016/j.jcv.2018.03.012. Epub 2018 Apr 2.

ReferenceCitation: Arribas JR, Thompson M, Sax PE, Haas B, McDonald C, Wohl DA, DeJesus E, Clarke AE, Guo S, Wang H, Callebaut C, Plummer A, Cheng A, Das M, McCallister S. Brief Report: Randomized, Double-Blind Comparison of Tenofovir Alafenamide (TAF) vs Tenofovir Disoproxil Fumarate (TDF), Each Coformulated With Elvitegravir, Cobicistat, and Emtricitabine (E/C/F) for Initial HIV-1 Treatment: Week 144 Results. J Acquir Immune Defic Syndr. 2017 Jun 1;75(2):211-218. doi: 10.1097/QAI.0000000000001350.

ReferenceCitation: Margot N, Cox S, Das M, McCallister S, Miller MD, Callebaut C. Infrequent development of drug resistance in HIV-1-infected treatment-naive subjects after 96 weeks of treatment with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate. Antivir Ther. 2017;22(5):443-446. doi: 10.3851/IMP3125. Epub 2017 Jan 11.

ReferenceCitation: Margot NA, Kitrinos KM, Fordyce M, McCallister S, Miller MD, Callebaut C. Rare emergence of drug resistance in HIV-1 treatment-naïve patients after 48 weeks of treatment with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide. HIV Clin Trials. 2016 Mar;17(2):78-87. doi: 10.1080/15284336.2016.1142731.

ReferenceCitation: Funderburg NT, McComsey GA, Kulkarni M, Bannerman T, Mantini J, Thornton B, Liu HC, Zhang Y, Song Q, Fang L, Dinoso J, Cheng A, McCallister S, Fordyce MW, Das M. Equivalent Decline in Inflammation Markers with Tenofovir Disoproxil Fumarate vs. Tenofovir Alafenamide. EBioMedicine. 2016 Nov;13:321-327. doi: 10.1016/j.ebiom.2016.10.009. Epub 2016 Oct 11.

ReferenceCitation: Wohl D, Oka S, Clumeck N, Clarke A, Brinson C, Stephens J, Tashima K, Arribas JR, Rashbaum B, Cheret A, Brunetta J, Mussini C, Tebas P, Sax PE, Cheng A, Zhong L, Callebaut C, Das M, Fordyce M; GS-US-2,92-01040111 and Study Team. Brief Report: A Randomized, Double-Blind Comparison of Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate, Each Coformulated With Elvitegravir, Cobicistat, and Emtricitabine for Initial HIV-1 Treatment: Week 96 Results. J Acquir Immune Defic Syndr. 2016 May 1;72(1):58-64. doi: 10.1097/QAI.0000000000000940.

ReferenceCitation: Custodio JM, Garner W, Callebaut C, Fordyce M, Plummer A, Zhong L, et al. The Pharmacokinetics of Tenofovir and Tenofovir Diphosphate Following Administration of Tenofovir Alafenamide vs Tenofovir Disoproxil Fumarate [Oral Abstract #6]. The 16th International Workshop on Clinical Pharmacology of HIV & Hepatitis Therapy. Washington DC, USA, May 26-28, 2015.

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.

lead_sponsor: Gilead Sciences

location_country:
Portugal
United Kingdom
Italy
Dominican Republic
Canada
Sweden
Puerto Rico
United States
France
Mexico
Netherlands

location_facility: University of California, Davis Medical Center

location_facility: Infectious Disease Research Institute Inc.

location_facility: Instituto Dominicano de Estudios Virologicos--IDEV

location_facility: Kaiser Permanente - Los Angeles Medical Center

location_facility: Brownlee Centre, Gartnavel General Hospital

location_facility: Universitaria di Bologna-Policlicnico S' Orsola Malpighi

location_facility: University Health Network/Toronto General Hospital

location_facility: Community Research Initiative of New England

location_facility: North Texas Infectious Diseases Consultants

location_facility: Research Institute of McGill University Health Care

location_facility: University of Hawaii - Hawaii Center for AIDS

location_facility: Trinity Health & Wellness Center / AIDS Arms, Inc.

location_facility: La Playa Medical Group and Clinical Research

location_facility: Tarrant County Infectious Disease Associates

location_facility: Rush University Medical Center, Section of Infectious Diseases

location_facility: Los Angeles Biomedical Research Institute at Harbor - UCLA Medical Center

location_facility: Carolinas Medical Center Myer's Park Clinic

location_facility: East Carolina University The Brody School of Medicine

location_facility: Clinical Alliance for Research & Education - Infectious Diseases (CARE-ID)

location_facility: Karolinska University Hospital, Huddinge

location_facility: St. Joseph's Comprehensive Research Institute

location_facility: Serviço de Doenças Infecciosas, HUC-CHUC, EPE

location_facility: Insituto Nacional De Enfermedades Respiratorias "Ismael Cosio Villegas"

location_facility: University of North Carolina AIDS Clinical Trials Unit

location_facility: Southwest Infectious Disease Clinical Research, Inc.

location_facility: Infectious Disease Specialist of Atlanta

location_facility: Centro Hospitalar do Porto - Hospital Joaquim Urbano

location_facility: Archet 1 CHU de Nice, Department of Infectiology

location_facility: Saint Louis Hospital of Infectious Diseases

location_facility: University Hospital of Montpellier (CHU-Gui de Chauliac)

location_facility: Brighton and Sussex University Hospitals NHS Trust

location_facility: University of Southern California AIDS Clinical Trials Group

location_facility: North Shore University Hospital - Division of Infectious Diseases


acronym: EORTC protocol 1209-EnTF

title: A Phase II Study Exploring the Safety and Efficacy of Nintedanib (BIBF1120) as Second Line Therapy for Patients With Either Differentiated or Medullary Thyroid Cancer Progressing After First Line Therapy.

location_country:
Denmark
Poland
Spain
Italy
United Kingdom
Netherlands
France
Belgium
Germany

location_facility: Azienda Ospedaliera Universitaria "Federico II"

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

location_facility: Maria Sklodowska-Curie Memorial Cancer Centre

location_facility: Assistance Publique - Hopitaux de Paris - La Pitié Salpétrière

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Radboud University Medical Center Nijmegen

location_facility: Ludwig-Maximilians-Universitaet Muenchen - Klinikum der Universitaet Muenchen - Campus Grosshadern

location_facility: Assitance Publique - Hopitaux de Paris - Hopital Saint-Louis

location_facility: Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet

summary:
For the treatment of thyroid cancer with the so called targeted therapy the angiogenesis pathway has several potential targets. The Receptors for Vascular endothelial growth factor (VEGF) and especially VEGFR-2 is considered to be crucial for the initiation of the formation as well as the maintenance of tumor vasculature.

In thyroid cancer these VEGF receptors (VEGFR-1, VEGFR-2), VEGF itself and receptors of the fibroblast growth factor (FGF) and for the platelet-derived growth factor (PDGF) are often overexpressed. Other cells as pericytes and smooth muscle cells that are also involved in tumor angiogenesis express these receptors as well.

Inhibitors of the VEGFR or PDGFR pathway have been tested in thyroid cancer with positive results. However there is no treatment that is generally considered as standard of care for patients with differentiated thyroid cancer (DTC) or medullar thyroid cancer (MTC) who have progressed on one line of therapy. The classical cytotoxic chemotherapy has not shown a clinically meaningful benefit yet.

Nintedanib is a triple angiogenesis inhibitor which inhibits receptors of VEGF, FGF and PDGF. Therefore it might act not only on endothelial cells but also on pericytes and smooth muscle cells. Nintedanib also interacts with other kinases such as RET. Because of this multi-kinase activity rationale exists to investigate the effect in MTC and DTC.

Because it targets these three major angiogenesis signaling pathways it might prevent further tumor growth and related tumor escape mechanisms. Therefore nintedanib may be active in patients who have progressed on agents that target only one pathway.


title: An Open-label Phase IIIb Study of Riociguat in Patients With In-operable CTEPH, or Recurrent or Persisting PH After Surgical Treatment Who Are Not Satisfactorily Treated and Cannot Participate in Any Other CTEPH Trial

acronym: EAS

summary: The aim of the study is to assess safety, tolerability and clinical effects of different doses of riociguat in patients with inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and who are not satisfactorily treated and cannot participate in any other CTEPH trial. In the US the study runs as an Expanded Access program under 21 CFR 312.320.

status: No longer available

study_type: Expanded Access

ReferenceCitation: McLaughlin VV, Jansa P, Nielsen-Kudsk JE, Halank M, Simonneau G, Grünig E, Ulrich S, Rosenkranz S, Gómez Sánchez MA, Pulido T, Pepke-Zaba J, Barberá JA, Hoeper MM, Vachiéry JL, Lang I, Carvalho F, Meier C, Mueller K, Nikkho S, D'Armini AM. Riociguat in patients with chronic thromboembolic pulmonary hypertension: results from an early access study. BMC Pulm Med. 2017 Dec 28;17(1):216. doi: 10.1186/s12890-017-0563-7.

location_country:
Denmark
Belgium
Portugal
Spain
Italy
Austria
Mexico
Netherlands
Canada
Czech Republic
Russian Federation
Switzerland
Sweden
United States
France
Turkey
United Kingdom
Colombia
Japan
Germany


title: A Randomized, Open-label, Active-controlled, 3-arm Parallel-group, 26-week Study Comparing the Efficacy and Safety of Lixisenatide to That of Insulin Glulisine Once Daily and Insulin Glulisine Three Times Daily in Patients With Type 2 Diabetes Insufficiently Controlled With Insulin Glargine With or Without Metformin

summary:
Primary Objective:

- To compare lixisenatide versus insulin glulisine in terms of glycosylated hemoglobin (HbA1c) reduction and body weight change at Week 26 in type 2 diabetic participants not adequately controlled on insulin glargine ± metformin.

Secondary Objectives:

- To compare the treatments/regimens on:

The percentage of participants reaching the target of HbA1c <7% or ≤6.5%,
Body weight,
Self-Monitored Glucose profiles,
Fasting Plasma Glucose (FPG),
Post-prandial plasma glucose (PPG) /glucose excursions during a standardized meal test (subset of participants),
Daily doses of insulins,
Safety and tolerability.

ReferenceCitation: Rosenstock J, Guerci B, Hanefeld M, Gentile S, Aronson R, Tinahones FJ, Roy-Duval C, Souhami E, Wardecki M, Ye J, Perfetti R, Heller S; GetGoal Duo-2 Trial Investigators. Prandial Options to Advance Basal Insulin Glargine Therapy: Testing Lixisenatide Plus Basal Insulin Versus Insulin Glulisine Either as Basal-Plus or Basal-Bolus in Type 2 Diabetes: The GetGoal Duo-2 Trial. Diabetes Care. 2016 Aug;39(8):1318-28. doi: 10.2337/dc16-0014. Epub 2016 May 23.

ReferenceCitation: Tabák ÁG, Anderson J, Aschner P, Liu M, Saremi A, Stella P, Tinahones FJ, Wysham C, Meier JJ. Efficacy and Safety of iGlarLixi, Fixed-Ratio Combination of Insulin Glargine and Lixisenatide, Compared with Basal-Bolus Regimen in Patients with Type 2 Diabetes: Propensity Score Matched Analysis. Diabetes Ther. 2020 Jan;11(1):305-318. doi: 10.1007/s13300-019-00735-7. Epub 2019 Dec 17.

ReferenceCitation: Rosenstock J, Handelsman Y, Vidal J, Ampudia Blasco FJ, Giorgino F, Liu M, Perfetti R, Meier JJ. Propensity-score-matched comparative analyses of simultaneously administered fixed-ratio insulin glargine 100 U and lixisenatide (iGlarLixi) vs sequential administration of insulin glargine and lixisenatide in uncontrolled type 2 diabetes. Diabetes Obes Metab. 2018 Dec;20(12):2821-2829. doi: 10.1111/dom.13462. Epub 2018 Aug 13.

lead_sponsor: Sanofi

location_country:
Poland
Romania
Spain
Italy
Latvia
Estonia
Russian Federation
Canada
Czech Republic
Lithuania
Ukraine
United Kingdom
Hungary
United States
Chile
France
Mexico
Germany

location_facility:
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