ReferenceCitation: Ravaud A, Barrios CH, Alekseev B, Tay MH, Agarwala SS, Yalcin S, Lin CC, Roman L, Shkolnik M, Anak O, Gogov S, Pelov D, Louveau AL, Melichar B. RECORD-2: phase II randomized study of everolimus and bevacizumab versus interferon α-2a and bevacizumab as first-line therapy in patients with metastatic renal cell carcinoma. Ann Oncol. 2015 Jul;26(7):1378-84. doi: 10.1093/annonc/mdv170. Epub 2015 Apr 7.

family: Ravaud

full_name: A. Ravaud

given: A.

family: Barrios

full_name: C.H. Barrios

family: Alekseev

full_name: B. Alekseev

given: B.

family: Tay

full_name: M.-H. Tay

family: Agarwala

full_name: S.S. Agarwala

family: Yalcin

full_name: S. Yalcin

given: S.

family: Lin

full_name: C.-C. Lin

family: Roman

full_name: L. Roman

given: L.

family: Shkolnik

full_name: M. Shkolnik

given: M.

family: Anak

full_name: O. Anak

given: O.

family: Gogov

full_name: S. Gogov

family: Pelov

full_name: D. Pelov

given: D.

family: Louveau

full_name: A.-L. Louveau

family: Melichar

full_name: B. Melichar

journal_name: Annals of Oncology

location_country:
Belgium
Russian Federation
Czech Republic
Taiwan
France
Thailand
Korea, Republic of
South Africa
Hong Kong
Netherlands
Switzerland
Singapore
Hungary
Germany
United Kingdom
United States
Italy
Brazil
Egypt
Spain
Turkey

location_facility: Highlands Oncology Group Dept of Highlands Oncology Grp

location_facility: Las Colinas Hematology Oncology Grapevine

location_facility: Seattle Cancer Care Alliance Dept. of SCCA

location_facility: University of California at Los Angeles Dept. of Hem/Oncology

location_facility: City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(3)

location_facility: Karmanos Cancer Institute Dept.of KarmanosCancerInst (5)

location_facility: St. Luke's Hospital and Health Network St. Luke's Cancer Network

location_facility: USC/Kenneth Norris Comprehensive Cancer Center Regulatory Contact 3

location_facility: Nevada Cancer Institute Dept. of Nevada Cancer (3)

title: A Randomized, Open-label, Multi-center Phase II Study to Compare Bevacizumab Plus RAD001 Versus Interferon Alfa-2a Plus Bevacizumab for the First-line Treatment of Patients With Metastatic Clear Cell Carcinoma of the Kidney

summary: To estimate the difference in efficacy and safety of bevacizumab and RAD001 compared to bevacizumab and interferon alfa-2a for first-line treatment of patients with metastatic carcinoma of the kidney.


title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study of ASA404 in Combination With Paclitaxel and Carboplatin as First-Line Treatment for Locally Advanced or Metastatic (Stage IIIb/IV) Non-Small Cell Lung Cancer (NSCLC)

summary: The purpose of this study is to determine if adding ASA404 to standard chemotherapy makes the cancer treatment more effective in patients with advanced lung cancer.

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Novartis Pharmaceuticals

location_country:
Greece
Belgium
Australia
Taiwan
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Sweden
Hong Kong
Netherlands
Singapore
Hungary
China
Germany
United States
United Kingdom
Italy
Brazil
Czechia
Israel
New Zealand
Spain
Turkey

location_facility: Center for Cancer Care and Research (US Oncology)

location_facility: Carolina Cancer Mgmt/Cape Fear Valley Health System/Med Onc

location_facility: Osteopathic Medical Oncology and Hematology PC

location_facility: Illinois Oncology/Warren Billhartz Cancer Ctr.

location_facility: Texas Oncology Cancer Center of the High Plains

location_facility: Pacific Oncology and Hematology Association

location_facility: Rochester General Hospital - Lipson Cancer Center

location_facility: Sinai Hospital of Baltimore - The Alvin & Lois Lapidus Cancer Institute

location_facility: Peninsula Regional Oncology and Hematology

location_facility: California Pacific Medical Research Institute

location_facility: Palm Beach Institute of Hematology & Oncology

location_facility: Advocate Illinois Masonic Medical Center

location_facility: Allegheny General Hospital/Allegheny Cancer Center

location_facility: University of Oklahoma Health Science Center

location_facility: Hematology Oncology Associates of Rockland

location_facility: Cleo Craig Memorial Cancer Ctr. & Research Clinic

location_facility: Medical Oncology & Hematology Associates of Northern Virginia

location_facility: Kansas City Veterans Affair Medical Center

location_facility: University of California Irvine Comprhensive Center

location_facility: Providence Everett Medical Center/Providence regional Cancer Partnership

location_facility: The Harry and Jeanette Weinberg Cancer Institute at Franklin Square/MedStar Health

location_facility: Loyola Cancer Care & Research Ctr. at Central Dupage Hospital

location_facility: Louisiana State University Health Sciences Center - Feist-Weiller Cancer Center

location_facility: Medical College of Wisconsin/Division of Neoplastic & Related Disorders

location_facility: St. Luke's Hospital - St Luke's Cancer Center

location_facility: University of Texas Southwestern Medical Center/Simmons Comprehensive Cancer Center

location_facility: Siouxland Hematology-Oncology Assoc., LLC

location_facility: Medical Oncology Hematology Associates, Inc. - Dayton Clinical Oncology Program

location_facility: University of Louisville - James Graham Brown Cancer Center

location_facility: Alamance Regional Medical Center-Cancer Ctr.

location_facility: University of South Alabama/Mitchell Cancer Institute

location_facility: Chattanooga Oncology Hematology Associates

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


title: A Randomized, Double-blind Study to Evaluate the Effect of Tarceva or Placebo Following Platinum-based CT on Overall Survival and Disease Progression in Patients With Advanced, Recurrent or Metastatic NSCLS Who Have Not Experienced Disease Progression or Unacceptable Toxicity During Chemotherapy

summary: This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva, compared with placebo, following platinum-based chemotherapy in patients with advanced, recurrent, or metastatic NSCLC who have not had disease progression or unacceptable toxicity during chemotherapy. Following 4 cycles of platinum-based chemotherapy, eligible patients will be randomized to receive either Tarceva 150mg po daily, or placebo daily. The anticipated time on study treatment is until disease progression; the target sample size is 500+ individuals.

status: Completed

ReferenceType: derived

ReferenceCitation: Cappuzzo F, Ciuleanu T, Stelmakh L, Cicenas S, Szczésna A, Juhász E, Esteban E, Molinier O, Brugger W, Melezínek I, Klingelschmitt G, Klughammer B, Giaccone G; SATURN investigators. Erlotinib as maintenance treatment in advanced non-small-cell lung cancer: a multicentre, randomised, placebo-controlled phase 3 study. Lancet Oncol. 2010 Jun;11(6):521-9. doi: 10.1016/S1470-2045(10)70112-1. Epub 2010 May 20.

family: Cappuzzo

full_name: Federico Cappuzzo

given: Federico

sequence: first

family: Ciuleanu

full_name: Tudor Ciuleanu

given: Tudor

sequence: additional

family: Stelmakh

full_name: Lilia Stelmakh

given: Lilia

family: Cicenas

full_name: Saulius Cicenas

given: Saulius

family: Szczésna

full_name: Aleksandra Szczésna

given: Aleksandra

family: Juhász

full_name: Erzsébet Juhász

given: Erzsébet

family: Esteban

full_name: Emilio Esteban

given: Emilio

family: Molinier

full_name: Olivier Molinier

given: Olivier

family: Brugger

full_name: Wolfram Brugger

given: Wolfram

family: Melezínek

full_name: Ivan Melezínek

given: Ivan

family: Klingelschmitt

full_name: Gaëlle Klingelschmitt

given: Gaëlle

family: Klughammer

full_name: Barbara Klughammer

given: Barbara

family: Giaccone

full_name: Giuseppe Giaccone

given: Giuseppe

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: The Lancet Oncology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Hoffmann-La Roche

location_country:
Malaysia
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Czech Republic
Ukraine
France
Poland
Lithuania
Slovakia
Canada
Slovenia
Korea, Republic of
South Africa
Chile
Netherlands
Hungary
China
Germany
United Kingdom
Italy
Austria
Venezuela
New Zealand
Spain

status_simplified: Completed


ReferenceCitation: Schuler M, Yang JC, Park K, Kim JH, Bennouna J, Chen YM, Chouaid C, De Marinis F, Feng JF, Grossi F, Kim DW, Liu X, Lu S, Strausz J, Vinnyk Y, Wiewrodt R, Zhou C, Wang B, Chand VK, Planchard D; LUX-Lung 5 Investigators. Afatinib beyond progression in patients with non-small-cell lung cancer following chemotherapy, erlotinib/gefitinib and afatinib: phase III randomized LUX-Lung 5 trial. Ann Oncol. 2016 Mar;27(3):417-23. doi: 10.1093/annonc/mdv597. Epub 2015 Dec 8.

family: Schuler

full_name: M. Schuler

family: Yang

full_name: J.C.-H. Yang

family: Park

full_name: K. Park

given: K.

family: Kim

full_name: J.-H. Kim

family: Bennouna

full_name: J. Bennouna

given: J.

family: Chen

full_name: Y.-M. Chen

family: Chouaid

full_name: C. Chouaid

given: C.

family: De Marinis

full_name: F. De Marinis

given: F.

family: Feng

full_name: J.-F. Feng

family: Grossi

full_name: F. Grossi

full_name: D.-W. Kim

family: Liu

full_name: X. Liu

given: X.

family: Lu

full_name: S. Lu

given: S.

family: Strausz

full_name: J. Strausz

family: Vinnyk

full_name: Y. Vinnyk

given: Y.

family: Wiewrodt

full_name: R. Wiewrodt

given: R.

family: Zhou

full_name: C. Zhou

family: Wang

full_name: B. Wang

given: B.

family: Chand

full_name: V.K. Chand

family: Planchard

full_name: D. Planchard

family: Ignatius Ou

full_name: SaiHong Ignatius Ou

given: SaiHong

full_name: David Planchard

given: David

full_name: Keunchil Park

given: Keunchil

full_name: Martin Schuler

given: Martin

full_name: James Yang

given: James

full_name: Vikram Chand

given: Vikram

family: Rohr

repository_normalized: University of Melbourne - Minerva Access

repositories_institution:
Imperial College London - Spiral
PubMed Central - Europe PMC

location_country:
Peru
Finland
Australia
Belgium
Russian Federation
Taiwan
Ukraine
India
France
Poland
Argentina
Korea, Republic of
Netherlands
Hungary
China
Germany
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
Spain

location_facility: Boehringer Ingelheim Investigational Site

title: Phase III Randomized Trial of BIBW 2992 Plus Weekly Paclitaxel Versus Investigator's Choice of Chemotherapy Following BIBW 2992 Monotherapy in Non-small Cell Lung Cancer Patients Failing Previous Erlotinib or Gefitinib Treatment (LUX Lung 5)

summary: The primary objective of this randomized, open-label, active-controlled, multi-center trial is to determine the efficacy of BIBW 2992 given as an add-on to chemotherapy in patients with NSCLC Stage IIIb or IV progressing after BIBW 2992 monotherapy compared to chemotherapy alone in this patient population. Patients on both treatment arms will receive best supportive care in addition to study treatment. Patients enrolled into the trial will be treated and followed until death or lost to follow-up. Additional information on the health-related quality of life (HRQOL) will be collected.


ReferenceType: background

ReferenceCitation: Dimopoulos M, Wang M, Maisnar V, Minarik J, Bensinger W, Mateos MV, Obreja M, Blaedel J, Moreau P. Response and progression-free survival according to planned treatment duration in patients with relapsed multiple myeloma treated with carfilzomib, lenalidomide, and dexamethasone (KRd) versus lenalidomide and dexamethasone (Rd) in the phase III ASPIRE study. J Hematol Oncol. 2018 Apr 4;11(1):49. doi: 10.1186/s13045-018-0583-7.

ReferenceCitation: Avet-Loiseau H, Fonseca R, Siegel D, Dimopoulos MA, Špička I, Masszi T, Hájek R, Rosiñol L, Goranova-Marinova V, Mihaylov G, Maisnar V, Mateos MV, Wang M, Niesvizky R, Oriol A, Jakubowiak A, Minarik J, Palumbo A, Bensinger W, Kukreti V, Ben-Yehuda D, Stewart AK, Obreja M, Moreau P. Carfilzomib significantly improves the progression-free survival of high-risk patients in multiple myeloma. Blood. 2016 Sep 1;128(9):1174-80. doi: 10.1182/blood-2016-03-707596. Epub 2016 Jul 20.

ReferenceCitation: Dimopoulos MA, Stewart AK, Masszi T, Špička I, Oriol A, Hájek R, Rosiñol L, Siegel D, Mihaylov GG, Goranova-Marinova V, Rajnics P, Suvorov A, Niesvizky R, Jakubowiak A, San-Miguel J, Ludwig H, Ro S, Aggarwal S, Moreau P, Palumbo A. Carfilzomib-lenalidomide-dexamethasone vs lenalidomide-dexamethasone in relapsed multiple myeloma by previous treatment. Blood Cancer J. 2017 Apr 21;7(4):e554. doi: 10.1038/bcj.2017.31.

ReferenceCitation: Dimopoulos MA, Stewart AK, Masszi T, Špička I, Oriol A, Hájek R, Rosiñol L, Siegel D, Mihaylov GG, Goranova-Marinova V, Rajnics P, Suvorov A, Niesvizky R, Jakubowiak A, San-Miguel J, Ludwig H, Palumbo A, Obreja M, Aggarwal S, Moreau P. Carfilzomib, lenalidomide, and dexamethasone in patients with relapsed multiple myeloma categorised by age: secondary analysis from the phase 3 ASPIRE study. Br J Haematol. 2017 May;177(3):404-413. doi: 10.1111/bjh.14549. Epub 2017 Feb 17.

ReferenceCitation: Hari P, Mateos MV, Abonour R, Knop S, Bensinger W, Ludwig H, Song K, Hajek R, Moreau P, Siegel DS, Feng S, Obreja M, Aggarwal SK, Iskander K, Goldschmidt H. Efficacy and safety of carfilzomib regimens in multiple myeloma patients relapsing after autologous stem cell transplant: ASPIRE and ENDEAVOR outcomes. Leukemia. 2017 Dec;31(12):2630-2641. doi: 10.1038/leu.2017.122. Epub 2017 Apr 25.

ReferenceCitation: Mateos MV, Goldschmidt H, San-Miguel J, Mikhael J, DeCosta L, Zhou L, Obreja M, Blaedel J, Szabo Z, Leleu X. Carfilzomib in relapsed or refractory multiple myeloma patients with early or late relapse following prior therapy: A subgroup analysis of the randomized phase 3 ASPIRE and ENDEAVOR trials. Hematol Oncol. 2018 Apr;36(2):463-470. doi: 10.1002/hon.2499. Epub 2018 Feb 15.

ReferenceCitation: Siegel DS, Dimopoulos MA, Ludwig H, Facon T, Goldschmidt H, Jakubowiak A, San-Miguel J, Obreja M, Blaedel J, Stewart AK. Improvement in Overall Survival With Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma. J Clin Oncol. 2018 Mar 10;36(8):728-734. doi: 10.1200/JCO.2017.76.5032. Epub 2018 Jan 17.

ReferenceCitation: Stewart AK, Dimopoulos MA, Masszi T, Špička I, Oriol A, Hájek R, Rosiñol L, Siegel DS, Niesvizky R, Jakubowiak AJ, San-Miguel JF, Ludwig H, Buchanan J, Cocks K, Yang X, Xing B, Zojwalla N, Tonda M, Moreau P, Palumbo A. Health-Related Quality-of-Life Results From the Open-Label, Randomized, Phase III ASPIRE Trial Evaluating Carfilzomib, Lenalidomide, and Dexamethasone Versus Lenalidomide and Dexamethasone in Patients With Relapsed Multiple Myeloma. J Clin Oncol. 2016 Nov 10;34(32):3921-3930. doi: 10.1200/JCO.2016.66.9648.

ReferenceCitation: Chari A, Stewart AK, Russell SD, Moreau P, Herrmann J, Banchs J, Hajek R, Groarke J, Lyon AR, Batty GN, Ro S, Huang M, Iskander KS, Lenihan D. Analysis of carfilzomib cardiovascular safety profile across relapsed and/or refractory multiple myeloma clinical trials. Blood Adv. 2018 Jul 10;2(13):1633-1644. doi: 10.1182/bloodadvances.2017015545. Review.

ReferenceCitation: Stewart AK, Rajkumar SV, Dimopoulos MA, Masszi T, Špička I, Oriol A, Hájek R, Rosiñol L, Siegel DS, Mihaylov GG, Goranova-Marinova V, Rajnics P, Suvorov A, Niesvizky R, Jakubowiak AJ, San-Miguel JF, Ludwig H, Wang M, Maisnar V, Minarik J, Bensinger WI, Mateos MV, Ben-Yehuda D, Kukreti V, Zojwalla N, Tonda ME, Yang X, Xing B, Moreau P, Palumbo A; ASPIRE Investigators. Carfilzomib, lenalidomide, and dexamethasone for relapsed multiple myeloma. N Engl J Med. 2015 Jan 8;372(2):142-52. doi: 10.1056/NEJMoa1411321. Epub 2014 Dec 6.

family: Stewart

full_name: A. Keith Stewart

given: A. Keith

family: Rajkumar

full_name: S. Vincent Rajkumar

given: S. Vincent

family: Dimopoulos

full_name: Meletios A. Dimopoulos

given: Meletios A.

family: Masszi

full_name: Tamás Masszi

given: Tamás

family: Špička

full_name: Ivan Špička

given: Ivan

family: Oriol

full_name: Albert Oriol

given: Albert

family: Hájek

full_name: Roman Hájek

given: Roman

family: Rosiñol

full_name: Laura Rosiñol

given: Laura

family: Siegel

full_name: David S. Siegel

given: David S.

family: Mihaylov

full_name: Georgi G. Mihaylov

given: Georgi G.

family: Goranova-Marinova

full_name: Vesselina Goranova-Marinova

given: Vesselina

family: Rajnics

full_name: Péter Rajnics

given: Péter

family: Suvorov

full_name: Aleksandr Suvorov

given: Aleksandr

family: Niesvizky

full_name: Ruben Niesvizky

given: Ruben

family: Jakubowiak

full_name: Andrzej J. Jakubowiak

given: Andrzej J.

family: San-Miguel

full_name: Jesus F. San-Miguel

given: Jesus F.

family: Ludwig

full_name: Heinz Ludwig

given: Heinz

full_name: Michael Wang

given: Michael

family: Maisnar

full_name: Vladimír Maisnar

given: Vladimír

family: Minarik

full_name: Jiri Minarik

given: Jiri

family: Bensinger

full_name: William I. Bensinger

given: William I.

family: Mateos

full_name: Maria-Victoria Mateos

given: Maria-Victoria

family: Ben-Yehuda

full_name: Dina Ben-Yehuda

title: Carfilzomib, Lenalidomide, and Dexamethasone for Relapsed Multiple Myeloma

location_country:
Italy
Austria
United States
Sweden
Serbia
Netherlands
Germany
France
Bulgaria
Czechia
Greece
Israel
Poland
Hungary
Belgium
Romania
Russian Federation
Spain
Canada
United Kingdom

location_facility: Hospital Universitario y Politeecnico La Fe

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: The Royal Wolverhampton Hospital NHS Trust

location_facility: Ziekenhuisnetwerk Antwerpen - AZ Stuivenberg

location_facility: Independent Public Teaching Hospital of Medical University of Silesia in Katowice

location_facility: Maria Sklodowska-Curie Institute of Oncology

location_facility: Specialized Hospital for Active Treatment of Hematological Diseases

location_facility: Clinical Hospital Center Bezanijska Kosa

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: Clinical Center Nis, Clinic of Hematology

location_facility: Wilhelminspital der Stadt Wien, Zentrum fur Onkologie und Hamatologie

location_facility: Clinical Center of Serbia, Clinic of Hematology

location_facility: General Hospital, Health Sciences Centre

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza di Torino

location_facility: UT Southwestern Medical Center at Dallas

location_facility: McGill University Health Center, Royal Victoria Hospital

location_facility: University of Szeged, Albert Szent-Gyorgi Clinical Center

location_facility: Federal State Budget Institute: Federal Almalov Medical Research Centre under Ministry of Healthcare

location_facility: St. Jude Hospital Yorba Linda dba; St. Joseph Heritage Healthcare

location_facility: University Hospital Kralovske Vinohrady - Prague

location_facility: Sir Mortimer B. Davis - Jewish General Hospital

location_facility: Azienda Ospedllero Maggiore della Carita

location_facility: Azienda Ospedaliera Pisana Ospendale Santa Chiara - Main

location_facility: Samodzielny Publ. Szp. Wojewodzki w Gorzow Wlkp.

location_facility: Indiana University Health Melvin and Bren Simon Cancer Center

location_facility: Federal State Budget Institution: Hematology Research Center under MoH

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: University Multiprofile Hospital for Active Treatment, "Dr. Georgi Stranski"

location_facility: Nottingham University Hospitals (City Campus)

location_facility: University of Alberta, Cross Cancer Institute

location_facility: University Clinical Centre, Department of Hematologii Transplantologii

location_facility: The University of Michigan - Comprehensive Cancer Center

location_facility: First Republican Clinical Hospital under the Ministry of Healthcare of the Republic of Udmurtia

location_facility: Moscow State Medical Institution Municipal City Clinical Hospital n.a. S.P. Botkin

location_facility: Multiprofile Hospital for Active Treatment "Sveta Marina"

location_facility: State Medical Institution Komi Republican Oncological Center

location_facility: The University of Texas, MD Anderson Cancer Center

location_facility: The Don & Sybil Harrington Cancer Center

location_facility: Clinical Center of Vojvodina, Clinic of Hematology

location_facility: St. Istvan and St. Laszlo Hospital of Budapest

location_facility: Federal State Budgetary Scientific Institution: N.N. Blokhin Russian Cancer Research Center

location_facility: FSBI: Russian Research Institute of Hematology and Blood Transfusion under the Ferderal Agency for M&B

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

location_facility: SHEI: First St. Petersburg State Medical University N.a.I.P Pavlov under MoH, Clinic of Bone Marrow Transplant

location_facility: Groupe Hospitalier Necker - Enfants Malades

location_facility: University Hospital Brno, Department of Internal Medicine - Hematooncology

location_facility: Karolinska Universitetssjukhuset Solna, Hematologiskt Centrum

location_facility: Froedtert & Medical College of Wisconsin

location_facility: Military Medical Academy Multiprofile Hospital for Active Treatment

location_facility: Military Medical Academy, Clinic of Hematology

location_facility: Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz

location_facility: Karolinska Universitetsjukhuset i Huddinge

location_facility: State Higher Educational Institution: St Petersburg State Medical University n.a.I.P Pavlov

location_facility: Nicolaus Copernicus Municipal Specialist Hospital

location_facility: Szpital Wojewwodzki im. dr Ludwika Rydygiera w Suwalkach

location_facility: Fundeni Clinical Institute, "Stefan Berceanu" Center for Hematology and Bone Marrow Transplantation

location_facility: Cancer Institut Universitaire de Toulouse-Oncopole (iUCT)

location_facility: University of Debrecen, Medical and Health Science Center

title: A Randomized, Multicenter, Phase 3 Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma

summary: The primary objective was to compare progression-free survival in adults with relapsed multiple myeloma who are receiving CRd vs participants receiving Rd in a randomized multicenter setting.


title: A Phase 3 Randomized, Double-Blind, Parallel-group, Multi-center Study of the Safety and Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Subjects During and Following Hospitalization.

acronym: ADOPT

summary: The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein thrombosis [DVT]) and lung (pulmonary embolism [PE]) that sometimes occur within patients hospitalized for acute medical illness, and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be studied.

primary_purpose: Prevention

ReferenceCitation: Chi G, Goldhaber SZ, Kittelson JM, Turpie AGG, Hernandez AF, Hull RD, Gold A, Curnutte JT, Cohen AT, Harrington RA, Gibson CM. Effect of extended-duration thromboprophylaxis on venous thromboembolism and major bleeding among acutely ill hospitalized medical patients: a bivariate analysis. J Thromb Haemost. 2017 Oct;15(10):1913-1922. doi: 10.1111/jth.13783. Epub 2017 Sep 4.

name: Cardiovascular Division; Departments of Medicine; Beth Israel Deaconess Medical Center; Harvard Medical School; Boston MA USA

family: Chi

full_name: G. Chi

given: G.

name: Cardiovascular Division; Brigham and Women's Hospital; Harvard Medical School; Boston MA USA

family: Goldhaber

full_name: S. Z. Goldhaber

given: S. Z.

name: Department of Biostatistics and Informatics; Colorado School of Public Health; University of Colorado Anschutz Medical Campus; Aurora CO USA

family: Kittelson

full_name: J. M. Kittelson

given: J. M.

name: Department of Medicine; Hamilton Health Sciences; General Division; Hamilton Ontario Canada

family: Turpie

full_name: A. G. G. Turpie

given: A. G. G.

name: Duke University and Duke Clinical Research Institute; Durham NC USA

family: Hernandez

full_name: A. F. Hernandez

given: A. F.

name: Division of Cardiology; R. A. H. Faculty of Medicine; University of Calgary; Calgary Alberta Canada

family: Hull

full_name: R. D. Hull

given: R. D.

name: Portola Pharmaceuticals Inc.; South San Francisco CA USA

family: Gold

full_name: A. Gold

given: A.

family: Curnutte

full_name: J. T. Curnutte

given: J. T.

name: Department of Haematological Medicine; Guy's and St Thomas' Hospitals; King's College; London UK

family: Cohen

full_name: A. T. Cohen

given: A. T.

name: Division of Cardiovascular Medicine; Department of Medicine; Stanford University; Stanford CA USA

family: Harrington

full_name: R. A. Harrington

given: R. A.

family: Gibson

full_name: C. M. Gibson

given: C. M.

journal_name: Journal of Thrombosis and Haemostasis

oa_host_type: publisher

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Marszalek J, Mehrsefat S, Chi G. The risk of stroke among acutely ill hospitalized medical patients: lessons from recent trials on extended-duration thromboprophylaxis. Expert Rev Hematol. 2017 Aug;10(8):679-684. doi: 10.1080/17474086.2017.1343662. Epub 2017 Jun 21.

name: Department of Neurology, University of Arkansas for Medical Sciences, Little Rock, AR, USA

family: Marszalek

full_name: Jolanta Marszalek

given: Jolanta

name: Division of Pulmonary and Critical Care Medicine, Johns Hopkins University, Baltimore, MD, USA

family: Mehrsefat

full_name: Sara Mehrsefat

given: Sara

name: Division of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA

full_name: Gerald Chi

given: Gerald

journal_name: Expert Review of Hematology

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ReferenceCitation: Sharma A, Chatterjee S, Lichstein E, Mukherjee D. Extended thromboprophylaxis for medically ill patients with decreased mobility: does it improve outcomes? J Thromb Haemost. 2012 Oct;10(10):2053-60. doi: 10.1111/j.1538-7836.2012.04874.x. Review.

family: SHARMA

full_name: A. SHARMA

family: CHATTERJEE

full_name: S. CHATTERJEE

given: S.

family: LICHSTEIN

full_name: E. LICHSTEIN

given: E.

ReferenceCitation: Goldhaber SZ, Leizorovicz A, Kakkar AK, Haas SK, Merli G, Knabb RM, Weitz JI; ADOPT Trial Investigators. Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients. N Engl J Med. 2011 Dec 8;365(23):2167-77. doi: 10.1056/NEJMoa1110899. Epub 2011 Nov 13.

repository_institution: University of Debrecen - University of Debrecen Electronic Archive

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

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

title: Apixaban versus Enoxaparin for Thromboprophylaxis in Medically Ill Patients

location_country:
Peru
Malaysia
Australia
Belgium
Russian Federation
Denmark
Czech Republic
Taiwan
Ukraine
India
France
Poland
Norway
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Chile
Sweden
Hong Kong
Netherlands
Philippines
Singapore
Hungary
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
Spain
Turkey

location_facility: Johns Hopkins University School Of Medicine

location_facility: Jacksonville Center For Clinical Research

location_facility: Scripps Clinic/Scripps Health And Green Hospital

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

location_facility: The Milton S Hershey Medical Center Of Penn. State Univ.

location_facility: Atlanta Institute For Medical Research, Inc

location_facility: Louisiana State University Health Sciences Center-Shreveport

location_facility: Michael E. De Bakey Veteran Affairs Medical Center

location_facility: Henry Ford Hospital, Transplant Institute

location_facility: University Of Alabama At Birmingham Hospital


title: A 52-week Treatment, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol (300 and 600 µg Once Daily) in Patients With Chronic Obstructive Pulmonary Disease, Using Formoterol (12 µg Twice Daily) as an Active Control

summary: This study was designed to assess the efficacy and long-term safety of 300 and 600 µg doses of indacaterol when delivered via a single-dose dry-powder inhaler (SDDPI) in patients with chronic obstructive pulmonary disease (COPD). Patients were randomized to receive either indacaterol 300 µg once daily, indacaterol 600 µg once daily, formoterol 12 µg twice daily, or placebo.

ReferenceCitation: Jones PW, Donohue JF, Nedelman J, Pascoe S, Pinault G, Lassen C. Correlating changes in lung function with patient outcomes in chronic obstructive pulmonary disease: a pooled analysis. Respir Res. 2011 Dec 29;12:161. doi: 10.1186/1465-9921-12-161.

family: Jones

full_name: Paul W Jones

given: Paul W

family: Donohue

full_name: James F Donohue

given: James F

family: Nedelman

full_name: Jerry Nedelman

given: Jerry

family: Pascoe

full_name: Steve Pascoe

given: Steve

family: Pinault

full_name: Gregory Pinault

given: Gregory

family: Lassen

full_name: Cheryl Lassen

given: Cheryl

currency_apc_doaj: GBP

journal_name: Respiratory Research

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

repository_institution: St George's University of London - St George's Online Research Archive

evidence: oa repository (via pmcid lookup)

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

ReferenceCitation: Bleecker ER, Siler T, Owen R, Kramer B. Bronchodilator efficacy and safety of indacaterol 150 μg once daily in patients with COPD: an analysis of pooled data. Int J Chron Obstruct Pulmon Dis. 2011;6:431-8. doi: 10.2147/COPD.S21073. Epub 2011 Aug 18.

family: Thorpe

full_name: Michelle Thorpe

given: Michelle

currency_apc_doaj: USD

journal_name: International Journal of Chronic Obstructive Pulmonary Disease

license: cc-by-nc

license_normalized: cc-by-nc

license: implied-oa

license_normalized: implied-oa

evidence: oa repository (semantic scholar lookup)

title: Bronchodilator efficacy and safety of indacaterol 150 µg once daily in patients with COPD: an analysis of pooled data

ReferenceCitation: Jones PW, Mahler DA, Gale R, Owen R, Kramer B. Profiling the effects of indacaterol on dyspnoea and health status in patients with COPD. Respir Med. 2011 Jun;105(6):892-9. doi: 10.1016/j.rmed.2011.02.013. Epub 2011 Mar 11.

ReferenceCitation: Worth H, Chung KF, Felser JM, Hu H, Rueegg P. Cardio- and cerebrovascular safety of indacaterol vs formoterol, salmeterol, tiotropium and placebo in COPD. Respir Med. 2011 Apr;105(4):571-9. doi: 10.1016/j.rmed.2010.11.027. Epub 2011 Jan 11.

ReferenceCitation: Dahl R, Chung KF, Buhl R, Magnussen H, Nonikov V, Jack D, Bleasdale P, Owen R, Higgins M, Kramer B; INVOLVE (INdacaterol: Value in COPD: Longer Term Validation of Efficacy and Safety) Study Investigators. Efficacy of a new once-daily long-acting inhaled beta2-agonist indacaterol versus twice-daily formoterol in COPD. Thorax. 2010 Jun;65(6):473-9. doi: 10.1136/thx.2009.125435.

name: on behalf of the INVOLVE (INdacaterol: Value in COPD: Longer Term Validation of Efficacy and Safety) Study Investigators

repository_institution: University of Oxford - Oxford Academic Notes & Queries

title: Efficacy of a new once-daily long-acting inhaled 2-agonist indacaterol versus twice-daily formoterol in COPD

location_country:
Peru
Romania
Russian Federation
Denmark
Czech Republic
Ecuador
France
Lithuania
Slovakia
Argentina
Korea, Republic of
Turkey
Colombia
Chile
Switzerland
Netherlands
Hungary
Germany
United Kingdom
Italy
Israel
Egypt
Spain
Estonia
Latvia

location_facility:
Novartis Investigator Site
Novartis Investigative Site
Novartis


title: Solifenacin Succinate in a Flexible Dose Regimen With Simplified Bladder Training Versus Solifenacin Succinate in a Flexible Dose Regimen Alone in a Prospective, Randomized, Parallel Group, Overactive Bladder Symptom Study

acronym: SOLAR

summary: This study will look at a drug for OAB (solifenacin) in combination with a non drug treatment (bladder training) compared to the drug on its own. The study will compare the symptoms of OAB by assessing patient diaries and other patient reported outcomes.

ReferenceCitation: Mattiasson A, Masala A, Morton R, Bolodeoku J; SOLAR Study Group. Efficacy of simplified bladder training in patients with overactive bladder receiving a solifenacin flexible-dose regimen: results from a randomized study. BJU Int. 2010 Apr;105(8):1126-35. doi: 10.1111/j.1464-410X.2009.08910.x. Epub 2009 Oct 10.

lead_sponsor: Astellas Pharma Inc

location_country:
Italy
Netherlands
France
Poland
Hungary
Belgium
Australia
Russian Federation
Spain
Turkey
Czech Republic

intervention_type: Behavioral


title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Examine the Efficacy and Safety of Early Pramipexole (PPX) Treatment Versus Delayed Pramipexole Treatment in Patients With New Onset Parkinson's Disease.

summary: This is a double blind, placebo-controlled clinical trial of 15 months duration designed to examine early Mirapex (pramipexole) treatment vs. delayed Mirapex (pramipexole) treatment in patients with new onset Parkinsons disease

ReferenceCitation: Schapira AH, McDermott MP, Barone P, Comella CL, Albrecht S, Hsu HH, Massey DH, Mizuno Y, Poewe W, Rascol O, Marek K. Pramipexole in patients with early Parkinson's disease (PROUD): a randomised delayed-start trial. Lancet Neurol. 2013 Aug;12(8):747-55. doi: 10.1016/S1474-4422(13)70117-0. Epub 2013 May 31.

family: Schapira

full_name: Anthony HV Schapira

given: Anthony HV

family: McDermott

full_name: Michael P McDermott

given: Michael P

family: Barone

full_name: Paolo Barone

given: Paolo

family: Comella

full_name: Cynthia L Comella

given: Cynthia L

family: Albrecht

full_name: Stefan Albrecht

given: Stefan

family: Hsu

full_name: Helen H Hsu

given: Helen H

family: Massey

full_name: Daniel H Massey

given: Daniel H

family: Mizuno

full_name: Yoshikuni Mizuno

given: Yoshikuni

family: Poewe

full_name: Werner Poewe

given: Werner

family: Rascol

full_name: Olivier Rascol

given: Olivier

family: Marek

full_name: Kenneth Marek

given: Kenneth

journal_name: The Lancet Neurology

oa_colors: green hybrid

evidence: open (via crossref license)

lead_sponsor: Boehringer Ingelheim

location_country:
Italy
Austria
Sweden
Germany
Finland
France
Japan
Spain
United States
United Kingdom

location_facility: 248.595.0119 Boehringer Ingelheim Investigational Site

location_facility: 248.595.44002 Boehringer Ingelheim Investigational Site

location_facility: 248.595.49008 Boehringer Ingelheim Investigational Site

location_facility: 248.595.46004 Boehringer Ingelheim Investigational Site

location_facility: 248.595.3306A Centre Hospitalier du Pays d'Aix

location_facility: 248.595.3306B Centre Hospitalier du Pays d'Aix

location_facility: 248.595.46001 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0129 Boehringer Ingelheim Investigational Site

location_facility: 248.595.43001 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0106 Boehringer Ingelheim Investigational Site

location_facility: 248.595.34002 Nuevo Hospital de Sant Pau

location_facility: 248.595.46002 Boehringer Ingelheim Investigational Site

location_facility: 248.595.39007 Ospedale Evangelico Valdese

location_facility: 248.595.39012 Azienda Ospedaliera Pisana- Università degli Studi di Pisa

location_facility: 248.595.44008 Boehringer Ingelheim Investigational Site

location_facility: 248.595.39004 Università degli Studi di Bari

location_facility: 248.595.81002 Kagawa Prefectural Central Hospital

location_facility: 248.595.0141 Boehringer Ingelheim Investigational Site

location_facility: 248.595.34001 Hospital Clinic i Provincial of Barcelona

location_facility: 248.595.0121 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0115 Boehringer Ingelheim Investigational Site

location_facility: 248.595.49005 Boehringer Ingelheim Investigational Site

location_facility: 248.595.49011 Boehringer Ingelheim Investigational Site

location_facility: 248.595.43004 Boehringer Ingelheim Investigational Site

location_facility: 248.595.49006 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0136 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0113 Boehringer Ingelheim Investigational Site

location_facility: 248.595.43003 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0109 Boehringer Ingelheim Investigational Site

location_facility: 248.595.49014 Boehringer Ingelheim Investigational Site

location_facility: 248.595.35801 Boehringer Ingelheim Investigational Site

location_facility: 248.595.49001 Boehringer Ingelheim Investigational Site

location_facility: 248.595.35804 Boehringer Ingelheim Investigational Site

location_facility: 248.595.44001 Boehringer Ingelheim Investigational Site

location_facility: 248.595.49004 Boehringer Ingelheim Investigational Site

location_facility: 248.595.49012 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0122 Boehringer Ingelheim Investigational Site

location_facility: 248.595.39010 Ospedale Maggiore Policlinico Mangigalli e Regina Elena

location_facility: 248.595.0124 Boehringer Ingelheim Investigational Site

location_facility: 248.595.35803 Boehringer Ingelheim Investigational Site

location_facility: 248.595.3306C Centre Hospitalier du Pays d'Aix

location_facility: 248.595.0116 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0112 Boehringer Ingelheim Investigational Site

location_facility: 248.595.49010 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0120 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0137 Boehringer Ingelheim Investigational Site

location_facility: 248.595.46005 Boehringer Ingelheim Investigational Site

location_facility: 248.595.46007 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0101 Boehringer Ingelheim Investigational Site

location_facility: 248.595.44003 Boehringer Ingelheim Investigational Site

location_facility: 248.595.44011 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0134 Boehringer Ingelheim Investigational Site

location_facility: 248.595.43002 Boehringer Ingelheim Investigational Site

location_facility: 248.595.44010 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0118 Boehringer Ingelheim Investigational Site

location_facility: 248.595.39001 Azienda Ospedaliera Istituti Clinici di Perfezionamento

location_facility: 248.595.0104 Boehringer Ingelheim Investigational Site

location_facility: 248.595.39006 Policlinico Universitario Molinette

location_facility: 248.595.39014 Boehringer Ingelheim Investigational Site

location_facility: 248.595.44005 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0111 Boehringer Ingelheim Investigational Site

location_facility: 248.595.81001 Juntendo University Hospital

location_facility: 248.595.39005 Ospedale della Misericordia

location_facility: 248.595.0133 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0103 Boehringer Ingelheim Investigational Site

location_facility: 248.595.34005 Hospital Mutua de Terrassa

location_facility: 248.595.0123 Boehringer Ingelheim Investigational Site

location_facility: 248.595.44004 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0127 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0102 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0107 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0105 Boehringer Ingelheim Investigational Site

location_facility: 248.595.49009 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0108 Boehringer Ingelheim Investigational Site

location_facility: 248.595.46006 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0131 Boehringer Ingelheim Investigational Site

location_facility: 248.595.49015 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0114 Boehringer Ingelheim Investigational Site

location_facility: 248.595.43005 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0140 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0139 Boehringer Ingelheim Investigational Site

location_facility: 248.595.49007 Boehringer Ingelheim Investigational Site

location_facility: 248.595.49016 Boehringer Ingelheim Investigational Site

location_facility: 248.595.39011 Ospedale S. Raffaele - IRCCS


title: Real Life: Treatment Response in Patients With Symptoms Due to Gastroesophageal Reflux Disease Either With or Without Esophagitis Treated With Pantoprazole Sodium 40 mg o.d. Over 8 Weeks

summary: The aim of the present study is to identify factors (such as symptom patterns and symptom scores) that influence the response to treatment with pantoprazole using different evaluation methods (e.g., ReQuest™ questionnaire, patient and investigator assessment). Pantoprazole will be administered once daily in the morning at one dose level. The study duration consists of a treatment period of 8 weeks. The study will provide further data on safety and tolerability of pantoprazole.

design_allocation: Non-Randomized

enrollment_type: Anticipated

ReferenceCitation: Goh KL, Choi KD, Choi MG, Hsieh TY, Jung HY, Lien HC, Menon J, Mesenas S, Park H, Sheu BS, Wu JC. Factors influencing treatment outcome in patients with gastroesophageal reflux disease: outcome of a prospective pragmatic trial in Asian patients. BMC Gastroenterol. 2014 Sep 9;14:156. doi: 10.1186/1471-230X-14-156.

family: Goh

full_name: Khean Lee Goh

given: Khean Lee

family: Choi

full_name: Kee Don Choi

given: Kee Don

full_name: Myung-Gyu Choi

given: Myung-Gyu

family: Hsieh

full_name: Tsai-Yuan Hsieh

given: Tsai-Yuan

family: Jung

full_name: Hwoon-Yong Jung

given: Hwoon-Yong

family: Lien

full_name: Han-Chung Lien

given: Han-Chung

family: Menon

full_name: Jayaram Menon

given: Jayaram

family: Mesenas

full_name: Steven Mesenas

given: Steven

family: Park

full_name: Hyojin Park

given: Hyojin

family: Sheu

full_name: Bor-Shyang Sheu

given: Bor-Shyang

family: Wu

full_name: Justin CY Wu

given: Justin CY

journal_name: BMC Gastroenterology

ReferenceCitation: Heading RC, Mönnikes H, Tholen A, Schmitt H. Prediction of response to PPI therapy and factors influencing treatment outcome in patients with GORD: a prospective pragmatic trial using pantoprazole. BMC Gastroenterol. 2011 May 11;11:52. doi: 10.1186/1471-230X-11-52.

family: Heading

full_name: Robert C Heading

given: Robert C

family: Mönnikes

full_name: Hubert Mönnikes

given: Hubert

family: Tholen

full_name: Anne Tholen

given: Anne

family: Schmitt

full_name: Holger Schmitt

given: Holger

location_country:
Malaysia
Australia
Belgium
Taiwan
India
France
Poland
Argentina
Canada
Korea, Republic of
South Africa
Hong Kong
Switzerland
Singapore
Portugal
Germany
United Kingdom
Italy
Austria
Brazil
Mexico
Spain


status: Recruiting

study_start_date_type: Actual

lead_sponsor: VectivBio AG

location_country:
Italy
Sweden
Germany
France
Czechia
Japan
Israel
Poland
Belgium
Argentina
Spain
United States
Korea, Republic of
Taiwan

acronym: STARS

location_facility: Vanderbilt University Medical Center, Center for Human Nutrition

location_facility: Hospital of the University of Pennsylvania

location_facility: Citta della salute e della Scienza di Torino Hospital

location_facility: Universitair Ziekenhuis Leuven - Gasthuisberg

location_facility: Fakultní nemocnice Královské Vinohrady, II. Interní klinika

location_facility: M. Pirogow Provincial Specialized Hospital

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

location_facility: China Medical University Hospital (CMUH)

location_facility: Keimyung University Dongsan Medical Center

location_facility: University General Hospital Gregorio Maranon

location_facility: National University Corportation Tohoku University Tohoku University Hospital

location_facility: Stadmedica, Non-Public Healthcare Facility

location_facility: Rennes University Hospital Center - Hospital Pontchaillou

location_facility: Froedtert Hospital and the Medical College of Wisconsin

location_facility: University of Illinois, Outpatient Care Center

study_completion_date_type: Anticipated

type: EudraCT Number

source: euctr

title: A Multicenter, Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Apraglutide in Adult Subjects With Short Bowel Syndrome and Intestinal Failure (SBS-IF)

summary: The primary objective of the trial is the confirmation of the efficacy of apraglutide to evaluate the efficacy of weekly subcutaneous apraglutide in reducing parenteral support dependency.

status_simplified: Ongoing


ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
Italy
Netherlands
Spain
Germany
France
Bulgaria
Japan
Singapore
Australia
China
United States
Korea, Republic of
Taiwan

location_facility: Kliniken der Stadt Koeln gGmbH Lungenklinik Merheim

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Chang Gung Memorial Hospital CGMH - Kaohsiung Branch

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Azienda Ospedaliero-Universitaria San Luigi Gonzaga

location_facility: Hospital Regional Universitario Carlos Haya

location_facility: The Catholic University of Korea, Seoul St. Marys Hospital

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Moores Cancer Center at the UC San Diego Health

location_facility: University of Maryland - Marlene and Stewart Greenebaum Cancer Center

location_facility: Henry Ford Cancer Institute/Henry Ford Hospital

location_facility: Catalan Institute of Badalona Hospital Germans Trias i Pujol ICO

location_facility: University of Colorado Denver - Anschutz Medical Campus

location_facility: Chang Gung Memorial Hospital - Linkou Branch

location_facility: OncoCare Cancer Centre- Gleneagles Medical Centre

location_facility: Seoul National University Bundang Hospital

location_facility: Beth Israel Deaconess Medical Center, Harvard Medical School

location_facility: Hospital Universitario Puerta de Hierro de Majadahonda

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: University of Virginia Cancer Center - Emily Couric Clinical Cancer Center

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: University of Washington/Seattle Cancer Care Alliance

location_facility: Sarah Cannon HCA Midwest Healthcare - Kansas City

location_facility: Sarah Cannon Research Institute at Tennessee Oncology - Chattanooga

location_facility: Massachusetts General Hospital (MGH) - Hematology/Oncology

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Fondazione IRCCS Istituto Nazionale Tumori

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: IRCCS - Istituto Scientifico Romagnolo per lo Studio e La Cura Dei Tumori ISRT

location_facility: National Taiwan University Hospital NTUH

location_facility: Hospital Clinico Universitario Lozano Bleza

location_facility: National University Cancer Institute National University Hospital

location_facility: University Hospital of Nantes - Thoracic Oncology

location_facility: Ohio State University Comprehensive Cancer Center

location_facility: University of Texas Southwestern Medical Center

ipd_sharing: Yes

title: HERTHENA-Lung01: A Phase 2 Randomized Open-Label Study of Patritumab Deruxtecan (U3-1402) in Subjects With Previously Treated Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer (NSCLC)

summary: This study is designed to evaluate the antitumor activity of patritumab deruxtecan in participants with metastatic or locally advanced NSCLC with an activating EGFR mutation (exon 19 deletion or L858R) who have received and progressed on or after at least 1 EGFR TKI and 1 platinum-based chemotherapy-containing regimen.


intervention_type: Other

status: Active, not recruiting

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Vaccines & Prevention B.V.

location_country:
Brazil
South Africa
Philippines
Germany
France
Belgium
Spain
United States
United Kingdom
Colombia

acronym: ENSEMBLE 2

location_facility: Asistencia Cientifica de Alta Complejidad S.A.S

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Instituto Nacional de Infectologia Evandro Chagas (INI) - FIOCRUZ

location_facility: Allergy Asthma Immunology of Rochester, PC (AAIR) - Research Center

location_facility: The South Bend Clinic Center for Research

location_facility: Hospital federal dos servidores do estado

location_facility: Central Manchester University Hospitals NHS Foundation Trust

location_facility: IPS Centro Cientifico Asisitencial Jose Luis Accini S.A.S.

location_facility: CTI Clinical Trial and Consulting Services

location_facility: Centro de Referencia E Treinamento Dst/Aids

location_facility: Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: Washington University School of Medicine

location_facility: West Visayas State University Medical Center

location_facility: Groupe Hospitalier Sud Hôpital Haut-Leveque Service d'hematologie

location_facility: Brighton & Sussex University Hospitals NHS Trust

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: Velocity Clinical Research, Hallandale Beach

location_facility: Paradigm Clinical Research Centers, Inc.

location_facility: Centre of Tuberculosis Research Innovation

location_facility: Imperial College London and Imperial College Healthcare NHS Trust

location_facility: Quality of Life Medical & Research Center, LLC

location_facility: Powys Teaching Local Health Board - Bronllys Hospital

type: Other Identifier

title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older

summary: The study will enroll up to 30,000 participants in order to evaluate the efficacy of Ad26.COV2.S in the prevention of molecularly confirmed moderate to severe/critical coronavirus disease-2019 (COVID-19), as compared to placebo, in adult participant in the double-blind phase and to evaluate the efficacy of two dose schedule of Ad26.COV2.S in the prevention of molecularly confirmed, moderate to severe/critical coronavirus disease-2019 (COVID 19), as compared to one dose schedule and compared to the booster dose schedule of Ad26.COV2.S, in SARS CoV-2 seronegative adults in the open-label phase.


title: A Phase 2 Multinational, Randomized, Double-blind, Parallel-group, 16-week Placebo-controlled Study With a 36-Week Extension to Investigate the Use of Benralizumab for Patients With Moderate to Severe Atopic Dermatitis Despite Treatment With Topical Medications (The HILLIER Study)

summary: The purpose of the study is to compare the efficacy and safety of benralizumab versus placebo and to compare benralizumab dosing regimens during extension period.

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:
France
Czechia
Bulgaria
Poland
Australia
Spain
United States
Korea, Republic of

intervention_type: Biological


title: A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Visual Impairment Due to Treatment-naïve Macular Edema Secondary to Retinal Vein Occlusion (RVO)

acronym: BEACON

summary: This Phase 3 study will evaluate the efficacy, durability, and safety of KSI-301 compared to aflibercept, in participants with macular edema due to treatment-naïve branch (BRVO) or central retinal vein occlusion (CRVO).

ipd_sharing: No

lead_sponsor: Kodiak Sciences Inc

location_country:
Italy
United States
France
Czechia
Poland
Israel
Slovakia
Hungary
Puerto Rico
Spain
Germany
Latvia

location_facility: Centre Hospitalier Universitaire de Bordeaux, Hopital Pellegrin

location_facility: Hôpital Lariboisière - Service Pharmacie

location_facility: Fakultna nemocnica s poliklinikou F. D. Roosevelta

location_facility: Northern California Retina Vitreous Associates

location_facility: Retina Consultants of Southern California

location_facility: Dr Nowosielska Okulistyka i Chirurgia Oka

location_facility: Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowi

location_facility: Riga Eastern Clinical University Hospital Clinic Bikernieki

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

location_facility: Dietrich Bonhoeffer Klinikum Neubrandenburg

location_facility: Hospital Universitari General de Catalunya - Grupo Quironsalud

location_facility: Instituto Clinico Quirurgico de Oftalmologia

location_facility: Miriam Kannenbaeumer or Andrea Koschinski

location_facility: Bajcsy-Zsilinszky Korhaz es Rendelointezet

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Azienda Sanitaria Universitaria Integrata di Udine - PO Universitario Santa Maria della Misericordia

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Specjalistyczny Szpital im. Alfreda Sokolowskiego

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Charlotte Eye Ear Nose & Throat Associates, P.A.

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Retina Consultants of Texas - (Woodlands)

location_facility: Emanuelli Research & Development Center LLC

location_facility: Cleveland Clinic Foundation, Cole Eye Institute

location_facility: Jahn Ferenc Dél-Pesti Kórház és Rendelointézet

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: The Macula Center/ Blue Ocean Clinical Research

location_facility: Signes Ozolinas Doctor Praxis In Ophthalmology

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: Gabinet Okulistyczny Prof. Edward Wylegala


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH

summary: The objectives of this study are to evaluate the efficacy and safety of sotatercept treatment (plus background PAH therapy) versus placebo (plus background PAH therapy) at 24 weeks in adults with PAH.

ipd_sharing_description: Acceleron is committed to sharing clinical trial data following completion of a clinical study. All data provided are de-identified to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

lead_sponsor: Acceleron Pharma Inc.

location_country:
Sweden
Switzerland
Spain
Germany
France
Poland
Israel
Belgium
Argentina
Australia
New Zealand
United States
United Kingdom

location_facility: University of California Davis Medical Center

location_facility: University of California San Diego Medical Center

location_facility: CHRU de Lille Hôpital Cardiologique-Institut Coeur Poumon Service de Cardiologie

location_facility: Universitätsspital Zürich, Klinik für Pneumologie

location_facility: Hospital Provincial Dr. José María Cullen

location_facility: Centre Hospitalier Universitaire de Bicêtre

location_facility: Universitaetsklinikum Giessen und Marburg GmbH

location_facility: Washington University School of Medicine

location_facility: Europejskie Centrum Zdrowia Otwock Klinika Krazenia Plucnego Chorob Zakrzepowo-Zatotowych Centrum Medyczne Kstalcenia Podyplomowego

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Univeristätsklinik und Poliklonik für Innere Medizin I

location_facility: Thoraxklinik Heidelberg gGmbH Zentrum für pulmonale Hypertonie

location_facility: Instituto de Investigaciones Clinicas Quilmes SRL

location_facility: Centre Hospitalier Universitaire de Saint Etienne - Hospital

location_facility: Krakowski Szpital spec. im. Jana Pawła II Oddziały Kliniczny Chorob Serca i Naczyn z Pododdzialem Intensywnego Nadzrou Kardiologicznego

location_facility: Renown Institute for Heart & Vascular Health

location_facility: Hospital Universitario Vall d'Hebrón - PPDS

location_facility: The George Washington University Medical Faculty Associates

location_facility: Wexner Medical Center at the Ohio State University

location_facility: Waikato District Health Board - Hospital

location_facility: Weill Cornell Medicine-New York Presbyterian Hospital

location_facility: The Carl and Edyth Linder Center for Research at the Christ Hospital


type: Registry Identifier

title: A Phase 2/3, Randomized, Placebo-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MK-4482 in Non-Hospitalized Adults With COVID-19.

summary: This study aims to evaluate the safety, tolerability and efficacy of molnupiravir (MK-4482) compared to placebo. The primary hypothesis is that molnupiravir is superior to placebo as assessed by the percentage of participants who are hospitalized and/or die through Day 29

lead_sponsor: Merck Sharp & Dohme Corp.

location_country:
Guatemala
Russian Federation
Taiwan
Ukraine
France
Japan
Poland
Argentina
Canada
Colombia
South Africa
Chile
Sweden
Philippines
United States
Germany
United Kingdom
Italy
Brazil
Mexico
Israel
Egypt
Spain

location_facility: Central Clinical Hospital with Polyclinic ( Site 1105)

location_facility: Hospital Universitario La Paz ( Site 1300)

location_facility: Strategic Medical System LLC ( Site 1114)

location_facility: Hopital Bichat Claude Bernard ( Site 0503)

location_facility: Open Joint Stock Company Clinical and Diagnostic Center Euromedservice ( Site 1122)

location_facility: St.Petersburg Outpatient Clinic No. 109 ( Site 1119)

location_facility: Fundacion Hospital Alcorcon de Madrid ( Site 1314)

location_facility: Caja de Compensación Familiar CAFAM. Sede Centro de Atención en Salud CAFAM Floresta ( Site 0406)

location_facility: Enhancing Care Foundation-DICRS ( Site 1216)

location_facility: McGill University Health Centre ( Site 0204)

location_facility: Hospital Universitario Ramon y Cajal ( Site 1301)

location_facility: Newcastle upon Tyne Hospitals NHS Foundation Trust ( Site 1704)

location_facility: ASST Fatebenefratelli-Ospedale Sacco ( Site 0601)

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez ( Site 0803)

location_facility: Amici Clinical Research LLC ( Site 2507)

location_facility: Michigan Center of Medical Research ( Site 2500)

location_facility: National Taiwan University Hospital ( Site 3100)

location_facility: ZIBP-Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH ( Site 2301)

location_facility: Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 0606)

location_facility: Hospital de Clinicas da Universidade Federal do Parana ( Site 0154)

location_facility: Hospital Universitari Germans Trias i Pujol ( Site 1303)

location_facility: University of Nebraska Medical Center ( Site 2414)

location_facility: Azienda Sanitaria Universitaria Friuli Centrale -ASU FC ( Site 0607)

location_facility: University of New Mexico, Health Sciences Center ( Site 1819)

location_facility: The Crofoot Research Center, Inc. ( Site 1812)

location_facility: Centre Hospitalier de Tourcoing ( Site 0502)

location_facility: University Health Network - Toronto General Hospital ( Site 0201)

location_facility: Ospedale Amedeo di Savoia, Malattie Infettive ( Site 0602)

location_facility: National Center for allergies and chest ( Site 3320)

location_facility: Köhler & Milstein Research S.A. de C.V. ( Site 0809)

location_facility: Central Scientific Research Institute of Epidemiology ( Site 1104)

location_facility: SPb SBHI City outpatient clinic 4 ( Site 1131)

location_facility: Limited liability company "Scientific research center Eco-safety" ( Site 1117)

location_facility: Indago Research & Health Center, Inc ( Site 1809)

location_facility: Instituto de Infectologia Emilio Ribas ( Site 0153)

location_facility: Universitaetsklinikum Frankfurt ( Site 2302)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 1302)

location_facility: CHU de la Reunion - Groupe Hospitalier Sud ( Site 0514)

location_facility: Fundacion Santa Fe de Bogota ( Site 0412)

location_facility: Quirino Memorial Medical Center ( Site 0903)

location_facility: Instituto Medico de la Fundacion Estudios Clinicos ( Site 3401)

location_facility: Krakowskie Centrum Medyczne Sp. z o.o ( Site 1008)

location_facility: Jadestone Clinical Research, LLC ( Site 2502)

location_facility: ARTEM. State Holding Company ( Site 1618)

location_facility: Clinica Privada Dr. Jose Francisco Flores Lopez ( Site 2600)

location_facility: NZOZ Centrum Medyczne Szpital Swietej Rodziny ( Site 1006)

location_facility: Fundacion Cardiovascular de Colombia ( Site 0402)

location_facility: ICARO Investigaciones en Medicina ( Site 0812)

location_facility: Limited Liability Company Medical center Healthy Happy ( Site 1625)

location_facility: Midway Immunology and Research Center ( Site 1837)

location_facility: Pitie Salpetriere University Hospital-Infectious Disease - Tropical Diseases ( Site 0504)

location_facility: Centro Medico Imbanaco de Cali S.A ( Site 0415)

location_facility: Centro de Pesquisa Clinica II - ICHC - FMUSP ( Site 0152)

location_facility: Policlinico S. Orsola-Malpighi ( Site 0604)

location_facility: Medical Center Health Clinic ( Site 1623)

location_facility: Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital ( Site 1605)

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0800)

location_facility: Republican Clinical Infectious Hospital n.a. A.F. Agafonov ( Site 1100)

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0802)

location_facility: PCNE Kharkiv City polyclinic 9 of the Kharkiv City Council ( Site 1627)

location_facility: Carbon Health Technologies Inc ( Site 2505)

location_facility: Centrum Medyczne Pulawska Sp. z o.o. ( Site 1007)

location_facility: Hamilton Medical Research Group ( Site 0207)

location_facility: Accellacare South London Quality Research Centre ( Site 1709)

location_facility: City Hospital No.33 of Leninsky ( Site 1127)

location_facility: Saint Hope Foundation, Inc. ( Site 1830)

location_facility: AOU Policlinico Paolo Giaccone ( Site 0609)

location_facility: Hospital Regional de Alta Especialidad del Bajio ( Site 0807)

location_facility: Right To Care Research - Esizayo ( Site 1229)

location_facility: Centro de Investigacion Clinica UC CICUC ( Site 0309)

location_facility: IRCCS Ospedale Policlinico San Martino ( Site 0603)

location_facility: Universitaetsklinikum Essen ( Site 2305)

location_facility: MNE Ivano-Frankivsk Regional Phthisiology-Pulmonology Center ( Site 1603)

location_facility: Municipal Noncommercial Enterprise Lviv 4th City Clinical Hospital ( Site 1622)

location_facility: ClinSmart Sweden AB.Uppsala ( Site 1402)

location_facility: Clinical Research Institute S.C. ( Site 0813)

location_facility: Clinica Universidad de los Andes ( Site 0302)

location_facility: Lung Center of the Philippines ( Site 0902)

location_facility: Limpopo Clinical Research Initiative ( Site 1227)

location_facility: Wits Baragwanath Clinical Trial Site ( Site 1214)

location_facility: MNCE -Odesa regional clinical hospital of Odesa regional council ( Site 1626)

location_facility: Clinical Research Partners, LLC. ( Site 2503)

location_facility: Ruane Clinical Research Group, Inc. ( Site 2406)

location_facility: Centrum Medyczne MEDYK Sp. z o.o. Sp.k. ( Site 1009)

location_facility: Smorodintsev Research Institute of Influenza ( Site 1129)

location_facility: Medical College Of Wisconsin ( Site 2510)

location_facility: Swedish Medical Center First Hill ( Site 1807)

location_facility: Groupe Hospitalier Pellegrin ( Site 0511)

location_facility: Karolinska Universitetssjukhuset Solna ( Site 1400)

location_facility: Mzansi Ethical Research Centre ( Site 1225)

location_facility: Advanced Research For Health Improvement LLC ( Site 1813)

location_facility: Municipal Enterprise Poltava Regional Clinical Infectious Hospital ( Site 1614)

location_facility: Royal Free London NHS Foundation Trust ( Site 1700)

location_facility: Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani ( Site 0600)

location_facility: Desmond Tutu HIV Foundation Clinical Trial Unit ( Site 1219)

location_facility: Santa Casa de Misericordia de Belo Horizonte ( Site 0150)

location_facility: Centro Cientifico Asistencial Jose Luis Accini ( Site 0416)

location_facility: Centro de Investigacion y Avances Medicos Especializados -CIAME ( Site 0810)

location_facility: Medical Research Institute LLC ( Site 1116)

location_facility: Hospital Universitario Infanta Leonor ( Site 1310)

location_facility: Smolensk State Medical University ( Site 1110)

location_facility: FUNFARME Hospital de Base Centro Integrado de Pesquisa ( Site 0151)

location_facility: Emerson Clinical Research Institute ( Site 1828)

location_facility: CNE Central city clinical hospital of Ivano-Frankivsk city council ( Site 1604)

location_facility: Non profit municipal enterprise City hospital student of Kharkiv city council ( Site 1621)

location_facility: Center Hospital of the National Center for Global Health and Medicine ( Site 0700)

location_facility: Advanced Medical Research, LLC ( Site 1864)

location_facility: ICH Study Center GmbH & Co.KG ( Site 2306)

location_facility: Chiba Aoba Municipal Hospital ( Site 0702)

location_facility: Centro de Atencion e Investigacion Medica CAIMED ( Site 0413)

location_facility: C.H.U. de Toulouse Hopital Purpan ( Site 0501)

location_facility: SPb SBHI City outpatient clinic 112 ( Site 1128)

location_facility: Clinical Projects Research Centre ( Site 1215)

location_facility: Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 2601)

location_facility: National Hepatology & Tropical Medicine Research Institute (NHTMRI) ( Site 3300)

location_facility: Fred Hutchinson Cancer Center ( Site 1829)

location_facility: Kyiv railway clinical hospital 2 of Branch Health center ( Site 1602)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0200)

location_facility: Advanced Research For Health Improvement LLC ( Site 1816)

location_facility: Sahlgrenska Universitetssjukhuset Ostra ( Site 1401)

location_facility: Hadassah Medical Center. Ein Kerem ( Site 2100)

location_facility: Clinical Research Chile SpA ( Site 0308)

location_facility: Fundacion Arturo Lopez Perez ( Site 0305)

location_facility: Oaxaca Site Management Organization S.C. ( Site 0811)


title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)

summary: The objectives of this study are to evaluate the safety and efficacy of ravulizumab administered by intravenous (IV) infusion compared to placebo and demonstrate proof-of-concept of the efficacy of terminal complement inhibition in participants with LN (LN Cohort) or IgAN (IgAN Cohort).

lead_sponsor: Alexion Pharmaceuticals

location_country:
Italy
United States
Sweden
Germany
France
Poland
Singapore
Australia
Spain
Canada
Korea, Republic of
Taiwan


title: A Phase III, Randomized, Double-Blind, Placebo Controlled, Multi-Center, International Study of Durvalumab Given Concurrently With Definitive Chemoradiation Therapy in Patients With Locally Advanced, Unresectable Esophageal Squamous Cell Carcinoma (KUNLUN)

acronym: KUNLUN

summary: This is a Phase III, randomized, double-blind, placebo-controlled, multi-center international study to assess the efficacy and safety of durvalumab administered concurrently with dCRT in patients with locally advanced, unresectable esophageal squamous cell carcinoma (ESCC).

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.

location_country:
Brazil
United States
Netherlands
Spain
France
Japan
Poland
Thailand
Belgium
Russian Federation
China
Canada
Korea, Republic of
Taiwan

intervention_type: Radiation


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

location_country:
Peru
Greece
Belgium
Russian Federation
Denmark
Ukraine
France
Poland
Argentina
Canada
Switzerland
Bulgaria
Hungary
Puerto Rico
Portugal
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Czechia
Spain
Turkey

location_facility: Hospital Geral de Santo Antonio; Servico de Neurologia

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Neurologia

location_facility: ASST PAPA GIOVANNI XXIII Neurologia USS Malattie Autoimmuni Centro Sclerosi Multipla

location_facility: Clinica Neurologica; Neurocirurgica de Joinville

location_facility: AOU Città della Salute e della Scienza; Neurologia 1

location_facility: University of California Davis Health System; Department of Neurology

location_facility: St.In.Inst. of Neurol.Psych.and Narcol.of the AMSU; Dept. of Neuroinfection and Multiply Sclerosis

location_facility: Hospital Eginition; First Department of Neurology

location_facility: Federal center of brain research and neurotechnologies

location_facility: Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis

location_facility: Petz Aladar Megyei Oktato Korhaz; Neurologiai Osztaly

location_facility: Michigan Institute for Neurological Disorders

location_facility: Universitätsmedizin Greifswald; Klinik und Poliklinik für Neurologie

location_facility: Hopital Hautepierre - CHU Strasbourg; Service de Neurologie

location_facility: Mersin University Medical Faculty; Neurology

location_facility: Fakultni nemocnice u sv. Anny; Neurologicka klinika

location_facility: Universität Leipzig; Innere Medizin, Neurologie, Dermatologie

location_facility: Gesundheitszentrum St. Johannes Hospital; Neurolog. Gemeinschaftspraxis Dres. Schmidt, Neudecker etc

location_facility: CHU Hopital Gabriel Montpied; Service de Neurologie

location_facility: Baskent Universitesi Ankara Hastanesi; Noroloji Bolumu

location_facility: Hospital Santo Antonio dos Capuchos; Servico de Neurologia

location_facility: Ondokuz Mayis University School of Medicine; Neurology

location_facility: Krankenhaus der Barmherzigen Brüder Trier; Neurologie, Neurophysiol. neurolog.Reha/Schlaganfalleinh

location_facility: Neurozentrum Stuttgart Mitte Sophienstraße; Neurologische Gemeinschaftspraxis

location_facility: Wojskowy Instytut Medyczny Centralny Szpital Kliniczny MON

location_facility: Selcuk University Medical Faculty; Norology department

location_facility: State Institution Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine

location_facility: Universitaetsklinikum Marburg; Klinik fuer Neurologie

location_facility: Szpital Specjalistyczny im. Rydygiera w Krakowie; Oddzial Neurologii i Udarow Mozgu

location_facility: Cumhuriyet Universitesi Tip Fakultesi; Noroloji Bolumu

location_facility: Mountain Neurological Research Center; Roaring Fork Neurologt, P.C.

location_facility: Aalborg Universitetshospital; Neurologisk Afdeling og Neurofysiologisk Afdeling; Skleroseamb.

location_facility: IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla

location_facility: Atrium Health Neurosciences Institute - Charlotte

location_facility: Ospedale Binaghi; Centro Sclerosi Multipla

location_facility: Hopital Cote De Nacre; Unite Neurologie Generale

location_facility: AOU Seconda Università degli Studi; Dip.Assistenziale Integrato Medicina Int-I Clinica Neurologica

location_facility: Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional Council

location_facility: FSBIH Siberian Regional Medical Centre of FMBA of Russia

location_facility: Rigshospitalet Glostrup; Neurologisk Klinik

location_facility: Universitätsklinikum Tübingen, Zentrum für Neurologie

location_facility: Ospedale Regionale di Lugano - Civico; Neurologia

location_facility: Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.

location_facility: Neuro Institute of New England P.C.; Research

location_facility: Instytut Psychiatrii i Neurologii II Klinika Neurologiczna

location_facility: Medical Center of Private Execution First Private Clinic

location_facility: Hospital de Braga; Centro Clínico Académico (Piso 1, Ala E)

location_facility: L2 Ip Instituto de Pesquisas Clinicas Ltda ME; Centro Medico Hospitalar

location_facility: Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali

location_facility: A. O. U. Federico II; Dip Neuroscienze, Scienze Riproduttive ed Odontostomatologiche

location_facility: Medizinische Hochschule Hannover, Klinik für Neurologie

location_facility: Erciyes Universitesi; Pediatric Neurology

location_facility: KI Health Partners, LLC; New England Institute for Clinical Research

location_facility: Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.

location_facility: University of Cincinnati; Department of Neurology

location_facility: New Orleans Center for Clinical Research

location_facility: Ospedale S.Camillo Forlanini; UOSD Day Hospital Neurologico e Neurochirurgico

location_facility: COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddział Neurologiczny

location_facility: City Clinical Hospital #24; Multipal Sclerosis department

location_facility: National Hospital for Neurology and Neurosurgery,; MRC Centre for Neuromuscular Diseases

location_facility: Neurologiczny Niepubliczny ZOZ Centrum Leczenia SM Osrodek Badań Klinicznych

location_facility: Inselspital Bern Medizin Neurologie; Neurologische Poliklinik

location_facility: Kocaeli University Hospital; Department of Neurology

location_facility: Washington University School of Medicine

location_facility: Universitätsklinikum Schleswig-Holstein; Klinik für Neurologie

location_facility: State Autonomous Healthcare Institution "Republican Clinical Neurological Center

location_facility: AOU Senese; UOC Clinica Neurologica e Malattie neurometaboliche

location_facility: Municipal Nonprofit Enterprise of Kharkiv Regional Council Regional Clinical Hospital

location_facility: Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften

location_facility: Medical Clinical Research Center of Medical Center LLC Health Clinic

location_facility: Odense Universitetshospital, Neurologisk Afdeling N; Neurologisk Ambulatorium N5; Skleroseklinikken

location_facility: MS and Neuromuscular Center of Excellence

location_facility: UMHAT Dr. Georgi Stranski; 2nd Neurology Clinic, Occupational Diseases

location_facility: CHU Brest Hopital La Cavale Blanche; Neurologie

location_facility: University General Hospital of Larisa; Neurology Clinic

location_facility: AHEPA Univ. General Hospital of Thessaloniki; B' Neurology Dept.

location_facility: Regional Clinical Hospital; Neurology Department

location_facility: Universitätsklinikum Jena, Klinik für Neurologie

location_facility: Universitätsklinikum Ulm; Klinik für Neurologie

location_facility: Municipal Institution Cherkasy Regional Hospital of Cherkasy Regional Council

location_facility: University of Massachusetts Medical School

location_facility: FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency

location_facility: National Center of Social Significant Disease

location_facility: Instituto Nacional de Ciencias Neurológicas - Hospital Mogrovejo; Peru

location_facility: Regional clinical hospital named after prof. S.V. Ochapovsky

location_facility: Hospital Universitario Virgen de Arrixaca; Servicio de Neurología

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz; Department of Neurology

location_facility: Sancaktepe Training and Research Hospital; Neurology

location_facility: Wheaton Franciscan Healthcare - St. Francis Outpatient Center; Center for Neurological Disorders

location_facility: Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie

location_facility: Texas Institute for Neurological Disorders

location_facility: Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.

location_facility: Orszagos Mentalis, Ideggyogyaszati es Idegsebeszeti Intezet; Neurology

location_facility: Stanford University Medical Center; Stanford Neuroscience Health Center

location_facility: Deutsche Klinik für Diagnostik; DKD Helios Klinik Wiesbaden, Abt. Neurologie

location_facility: Haseki Training and Research Hospital; Department of Neurology

location_facility: Hospital Garcia de Orta; Servico de Neurologia

location_facility: SHI Sverdlovsk Regional Clinical Hospital #1;Neurology

location_facility: Hopital Central - CHU de Nancy; Service de Neurologie

location_facility: Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia

location_facility: Hospital Nacional Guillermo Almenara Irigoyen

location_facility: Hospital Vall de Hebrón; Servicio de Neurologia. Centre d'Esclerosi Multiple de Catalunya CEMCAT

location_facility: Kantonsspital Aarau AG Medizin Neurologie; Neurologie

location_facility: Hospital Quiron de Madrid; Servicio de Neurologia

location_facility: 401 Military Hospital of Athens; Neurology Department

location_facility: CHU de Besancon Hopital Jean Minjoz; Service de Neurologie

location_facility: Los Angeles Biomedical Research Institute at Harbor-UCLA

location_facility: Centro Hospitalar de Lisboa Ocidental - Hospital Egas Moniz; Neurologia

location_facility: City Hospital #40 of Kurortniy Administrative District

location_facility: IRCCS Istituto Neurologico C. Mondino-Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla

location_facility: N.P. Bechtereva Institute of the Human Brain

title: A Phase IIIB Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis

summary: This is a randomized, double blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and pharmacokinetics of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks in participants with PPMS, in comparison to the approved 600 mg dose of ocrelizumab.


ipd_sharing_description:
Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Peru
Greece
Australia
Belgium
Russian Federation
Denmark
Taiwan
Ukraine
France
Japan
Poland
Thailand
Argentina
Canada
Korea, Republic of
Hong Kong
Hungary
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
New Zealand
Spain
Turkey

location_facility: Ryazan Regional clinical oncology dispensary

location_facility: Odense Universitetshospital, Onkologisk Afdeling R

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Katip Celebi University Ataturk Training and Research Hospital; Oncology

location_facility: IRCCS Istituto Regina Elena (IFO); Oncologia Medica B

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Hospital de Donostia; Servicio de Oncologia Medica

location_facility: Honvédelmi Minisztérium Állami Egészségügyi Központ; Onkológiai Osztály; Oncology department

location_facility: Municipal Institution City Clinical Hospital #4 of Dnipro City Council

location_facility: IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia

location_facility: Centro Oncologico MD Anderson Internacional; Servicio de Oncologia

location_facility: Chaim Sheba Medical Center; Oncology Dept

location_facility: Memorial Sloan Kettering Cancer Center at Nassau

location_facility: SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU

location_facility: Kaiser Permanente - San Leandro Medical Center

location_facility: Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis

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

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

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

location_facility: Memorial Sloan Kettering Cancer Center Basking Ridge

location_facility: Centre Alexis Vautrin; Oncologie Medicale

location_facility: National Taiwan Uni Hospital; Dept of Oncology

location_facility: Mackay Memorial Hospital; Dept of Surgery

location_facility: Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department

location_facility: Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina

location_facility: Klinikum Magdeburg gGmbH, Brustzentrum; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie

location_facility: Universitätsfrauen- und Poliklinik am Klinikum Suedstadt

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Lahn-Dill Kliniken GmbH Klinikum Wetzlar Gynäkologie/Geburtshilfe

location_facility: Calvary Mater Newcastle; Medical Oncology

location_facility: Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg

location_facility: Presbyterian Rust Medical Center/Jorgensen Cancer Center

location_facility: Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet

location_facility: Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi

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

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: VETERANS GENERAL HOSPITAL; Department of General Surgery

location_facility: Songklanagarind Hospital; Department of Oncology

location_facility: Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: Maidstone Hospital; Kent Oncology Centre

location_facility: Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: China Medical University Hospital; Surgery

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie

location_facility: CHD DE VENDEE; Unité de Recherche Clinique Onco-Hematologie

location_facility: National Cheng Kung Uni Hospital; Dept of Hematology and Oncology

location_facility: Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH

location_facility: Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr

location_facility: Velindre Cancer Centre; Clinical Trials Unit

location_facility: Medipol University MF; Oncology Department

location_facility: Texas Oncology-Baylor Sammons Cancer Center

location_facility: Klinikum Esslingen; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna

location_facility: Coventry and Warwickshire Partnership NHS Trust

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

location_facility: Sjællands Universitetshospital, Næstved; Onkologisk Afdeling

location_facility: Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt

location_facility: Podolsk City Clinical Hospital; Hematology

location_facility: Universite de Montreal - Hopital Maisonneuve-Rosemont

location_facility: IPO de Lisboa; Servico de Oncologia Medica

location_facility: Fairview Hospital; Cleveland Clinic Cancer Center

location_facility: Kyungpook National University Medical Center

location_facility: GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)

location_facility: Rajavithi Hospital; Division of Medical Oncology

location_facility: Peterborough City Hospital; Oncology Research Department 018

location_facility: Guys & St Thomas Hospital; Department of Oncology

location_facility: Herlev Hospital; Afdeling for Kræftbehandling

location_facility: HM Sanchinarro - CIOCC; Servicio de Oncologia

location_facility: New Mexico Oncology Hematology Consultants

location_facility: Klinikum Chemnitz gGmbH; Frauen- und Kinderklinik

location_facility: Maryland Oncology Hematology; Maryland Oncology Hematology, PA

location_facility: Marien-Hospital Witten; Frauenklinik Brustzentrum

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

location_facility: US oncology research at Minnesota Oncology

location_facility: Uniklinikum Salzburg, LKH; Univ.Klinik f. Innere Medizin III der PMU

location_facility: National Hospital Organization Osaka National Hospital

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

location_facility: Praxis Köppler, Heymann, Weide, Thomalla; Fä Für Innere Medizin

location_facility: The First Affiliated Hospital of Xian Jiao Tong University

location_facility: University Hospital of Larissa;Department of Medical Oncology

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Gemeinschaftspraxis für Hämatologie und Onkologie

location_facility: Princess Alexandra Hospital; Division of Cancer Services

location_facility: William Osler Health System Brampton Civic Hospital

location_facility: Städtisches Klinikum Brandenburg GmbH; Klinik für Gynäkologie und Geburtshilfe

location_facility: Instituto de Investigaciones Metabolicas (Idim)

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Seoul National University Bundang Hospital

location_facility: Hospital da Luz; Departamento de Oncologia Medica

location_facility: Universitätsklinikum Essen; Zentrum Für Frauenheilkunde

location_facility: Azienda ULSS 8 Berica; Oncologia Medica - Ospedlae di Vicenza

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: Peter MacCallum Cancer Centre-East Melbourne

location_facility: Ivano-Frankivsk Regional Oncology Center

location_facility: Landesklinikum Wiener Neustadt; Innere Medizin, Hämatologie u. internistische Onkologie

location_facility: Szpital Morski im. PCK; Poradnia Onkologiczna

location_facility: Centre Eugene Marquis; Service d'oncologie

location_facility: Maharaj Nakorn Chiang Mai Hosp; Surgery/Oncology

location_facility: Flinders Medical Centre; Medical Oncology

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: University of Miami; Dept Sylvester Cancer Center

location_facility: Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters

location_facility: Strongsville Hospital; Cleveland Clinic Cancer Center

location_facility: Austin Health; Cancer Clinical Trial Centre

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

location_facility: Institut Jean Godinot; Oncologie Medicale

location_facility: Florida Cancer Specialists - Fort Myers (Broadway)

location_facility: Harbin Medical University Cancer Hospital

location_facility: West China Hospital, Sichuan University; Department of Breast

location_facility: 19 Mayis University Medical Faculty; Medical Oncology Department

location_facility: California Cancer Associates for Research & Excellence, Inc.

location_facility: The First Affiliated Hospital, Sun Yat-sen University; Thyroid and Breast Surgery

location_facility: Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

location_facility: Hillcrest Hospital; Hirsch Cancer Center

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale

location_facility: Studienzentrum Onkologie Ravensburg GbR; Onkologie Ravensburg

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Centre Hospitalier de l'Université de Montréal (CHUM)

location_facility: Chulalongkorn Hospital, Faculty of Medicine; Dept. of Medicine

location_facility: Instituto Regional de Enfermedades Neoplasicas - IREN Norte

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

location_facility: Pamela Youde Nethersole Eastern Hospital; Clinical Oncology

location_facility: Kinghorn Cancer Centre; St Vincents Hospital

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"

location_facility: Kocaeli University Faculty of Medicine; Medical oncology

location_facility: Royal Marsden Hosp NHS Fnd; Medicine - Breast Unit

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

location_facility: Medeniyet University Goztepe Training and Research Hospital.

location_facility: Northwest Georgia Oncology Centers PC - Marietta

location_facility: Auckland City Hospital; Clinical Oncology

location_facility: Fiona Stanley Hospital - Medical Oncology

location_facility: A.Ö. Lhk; Ii. Medizinische Abt. Mit Schwerpunkt Gaströnter. & Onkologie

location_facility: CEMER Centro Medico de Enfermedades Respiratorias

location_facility: Clínica San Gabriel; Unidad de Investigación Oncológica de la Clínica San Gabriel

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

location_facility: Memorial Sloan Kettering Cancer Center at Bergen

location_facility: Memorial Sloan Kettering Cancer Center at Westchester

location_facility: Woj. Wielospecjalistyczne Centrum Onkol. i Traumat. im.M.Kopernika; Woj. Przychodnia Onkologiczna

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: Centre Hospitalier de La Cote Basque; Oncologie

location_facility: Sir Run Run Shaw Hospital Zhejiang University

location_facility: St. Luke's Internat. Hospital, Breast Surgical Oncology

location_facility: Fujian Medical University Union Hospital

location_facility: Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine

location_facility: Leicester Royal Infirmary; Infectious Disease Unit

location_facility: Fondazione del Piemonte per l'Oncologia (IRCCS)

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I

location_facility: Hospital Araujo Jorge; Departamento de Ginecologia E Mama

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

location_facility: The Center for Cancer and Blood Disorders - Fort Worth

title: A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Patients With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

summary: This Phase III, randomized, double-blind, placebo-controlled, multicenter study will evaluate the efficacy and safety of giredestrant combined with palbociclib compared with letrozole combined with palbociclib in patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative locally advanced (recurrent or progressed) or metastatic breast cancer.


location_country:
Italy
United States
Netherlands
France
Japan
Poland
Israel
Russian Federation
Spain
Germany
United Kingdom
Canada

acronym: MESSINA

title: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo Controlled Study to Investigate the Use of Benralizumab for Eosinophilic Esophagitis

summary: The aim of this Phase 3 study is to investigate the use of benralizumab as a treatment for patients with EoE. The effect of doses of benralizumab on EoE histologic signs and symptoms will be assessed over a 52-week treatment period (including a 24-week double-blind placebo-controlled treatment period and a 28-week open-label treatment period). It is proposed that benralizumab will deplete eosinophils from GI tissue(s), improve the symptoms of dysphagia, and improve endoscopy scores as well as other markers of disease activity. Upon completion of the initial 52-week treatment period, patients will be offered an additional Open Label Extension period of at least 1 year, with benralizumab treatment and ongoing study assessments.


title: A Phase IIIb, Randomized, Multicenter, Active-controlled, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine Administered Every Two Months From a Bictegravir/Emtricitabine/Tenofovir Alafenamide Single Tablet Regimen in HIV-1 Infected Adults Who Are Virologically Suppressed

summary:
Human immunodeficiency virus (HIV)/Acquired Immunodeficiency Syndrome (AIDS) is a worldwide epidemic that continues to grow significantly causing new infections and related deaths per year. Chronic HIV infection in adults continues to be characterized by increased development and transmission of resistant virus and issues associated with long-term toxicity of antiretroviral therapy (ART). The current paradigm in the treatment of HIV involves life-long therapy with multiple antiretrovirals (ARVs). This dependency on medical therapy requires a need for continuous improvement on the durability, tolerability and convenience of all antiretroviral classes. This is a Phase IIIb, randomized, open-label, active-controlled, multicenter, parallel-group, non-inferiority study (SOLAR: Switch Onto Long Acting Regimen). It is designed to assess the antiviral activity and safety of a two-drug regimen of CAB LA + RPV LA administered every 2 months (Q2M) compared with maintenance of BIK. Approximately 654 adult HIV-1 infected participants who are on the stable ARV regimen BIK will be randomized in a 2:1 ratio to either be switched to the CAB LA + RPV LA regimen or continue BIK through 12 months. The study will continue with an Extension Phase after Month 12 Oral Lead-In (OLI) and BIK/Month 11 Direct to Injection (D2I).

BIKTARVY is a registered trademark of Gilead Sciences.

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

lead_sponsor: ViiV Healthcare

location_country:
Italy
Austria
United States
Switzerland
Netherlands
Germany
France
Japan
Ireland
Australia
Belgium
Spain
Canada
United Kingdom