acronym: ExteNET

title: A Randomized, Double-Blind, Placebo-Controlled Trial Of Neratinib (HKI-272) After Trastuzumab In Women With Early-Stage HER-2/Neu Overexpressed/Amplified Breast Cancer

lead_sponsor: Puma Biotechnology, Inc.

ReferenceCitation: Iwata H, Masuda N, Kim SB, Inoue K, Rai Y, Fujita T, Chiu J, Ohtani S, Takahashi M, Miyaki T, Lu YS, Xu B, Yap YS, Bustam A, Yao B, Zhang B, Bryce R, Chan A. Neratinib after trastuzumab-based adjuvant therapy in patients from Asia with early stage HER2-positive breast cancer. Future Oncol. 2019 Jul;15(21):2489-2501. doi: 10.2217/fon-2019-0143. Epub 2019 May 29.

ReferenceCitation: Chia SKL, Martin M, Holmes FA, Ejlertsen B, Delaloge S, Moy B, Iwata H, von Minckwitz G, Mansi J, Barrios CH, Gnant M, Tomašević Z, Denduluri N, Šeparović R, Kim SB, Jakobsen EH, Harvey V, Robert N, Smith J 2nd, Harker G, Zhang B, Eli LD, Ye Y, Lalani AS, Buyse M, Chan A. PIK3CA alterations and benefit with neratinib: analysis from the randomized, double-blind, placebo-controlled, phase III ExteNET trial. Breast Cancer Res. 2019 Mar 11;21(1):39. doi: 10.1186/s13058-019-1115-2.

ReferenceCitation: Mortimer J, Di Palma J, Schmid K, Ye Y, Jahanzeb M. Patterns of occurrence and implications of neratinib-associated diarrhea in patients with HER2-positive breast cancer: analyses from the randomized phase III ExteNET trial. Breast Cancer Res. 2019 Feb 27;21(1):32. doi: 10.1186/s13058-019-1112-5.

ReferenceCitation: Delaloge S, Cella D, Ye Y, Buyse M, Chan A, Barrios CH, Holmes FA, Mansi J, Iwata H, Ejlertsen B, Moy B, Chia SKL, Gnant M, Smichkoska S, Ciceniene A, Martinez N, Filipović S, Ben-Baruch NE, Joy AA, Langkjer ST, Senecal F, de Boer RH, Moran S, Yao B, Bryce R, Auerbach A, Fallowfield L, Martin M. Effects of neratinib on health-related quality of life in women with HER2-positive early-stage breast cancer: longitudinal analyses from the randomized phase III ExteNET trial. Ann Oncol. 2019 Apr 1;30(4):567-574. doi: 10.1093/annonc/mdz016.

ReferenceCitation: Martin M, Holmes FA, Ejlertsen B, Delaloge S, Moy B, Iwata H, von Minckwitz G, Chia SKL, Mansi J, Barrios CH, Gnant M, Tomašević Z, Denduluri N, Šeparović R, Gokmen E, Bashford A, Ruiz Borrego M, Kim SB, Jakobsen EH, Ciceniene A, Inoue K, Overkamp F, Heijns JB, Armstrong AC, Link JS, Joy AA, Bryce R, Wong A, Moran S, Yao B, Xu F, Auerbach A, Buyse M, Chan A; ExteNET Study Group. Neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer (ExteNET): 5-year analysis of a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2017 Dec;18(12):1688-1700. doi: 10.1016/S1470-2045(17)30717-9. Epub 2017 Nov 13.

ReferenceCitation: Chan A, Delaloge S, Holmes FA, Moy B, Iwata H, Harvey VJ, Robert NJ, Silovski T, Gokmen E, von Minckwitz G, Ejlertsen B, Chia SKL, Mansi J, Barrios CH, Gnant M, Buyse M, Gore I, Smith J 2nd, Harker G, Masuda N, Petrakova K, Zotano AG, Iannotti N, Rodriguez G, Tassone P, Wong A, Bryce R, Ye Y, Yao B, Martin M; ExteNET Study Group. Neratinib after trastuzumab-based adjuvant therapy in patients with HER2-positive breast cancer (ExteNET): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2016 Mar;17(3):367-377. doi: 10.1016/S1470-2045(15)00551-3. Epub 2016 Feb 10.

ipd_sharing_description:
Puma Biotechnology is committed to sharing clinical trial data and information to help physicians and patients make informed treatment decisions, and to help qualified researchers advance scientific knowledge.

In accordance with legal and regulatory requirements, Puma publishes study protocol information and clinical study results on clinical trial registries, including ClinicalTrials.gov and EU Clinical Trials Register. Puma also publishes information about clinical studies in peer-reviewed scientific journals and shares data in scientific meetings.

Puma commits to safeguarding confidentiality and patient privacy throughout the clinical trial data and information sharing process. Any patient-level data will be anonymized to protect personally identifiable information.

Qualified researchers and study participants may submit requests for other study documentation and clinical trial data to clinicaltrials@pumabiotechnology.com for consideration.

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Lithuania
United States
Peru
Belgium
Bahamas
Japan
Romania
Czechia
Poland
Hong Kong
Australia
Israel
Malta
Turkey
Mexico
Malaysia
Singapore
Sweden
Slovakia
Brazil
Canada
Switzerland
Hungary
North Macedonia
China
Germany
Bulgaria
Denmark
Taiwan
Greece
New Zealand
Korea, Republic of
France
Colombia
Netherlands

location_facility: Klinicki bolnicki centar "Sestre Milosrdnice"

location_facility: Innovative Medical Research of South Florida, Inc.

location_facility: Duke University Medical Center Medical Oncology

location_facility: Hospital Madrid Norte Sanchinarro. Centro Integral Oncologico Clara Campal

location_facility: District Dispensary for Oncology Diseases Internal Unit- Plovdiv EOOD, Second

location_facility: Service d'Oncologie et de Radiotherapie, Polyclinique Francheville, 38

location_facility: Queen Mary Hospital, Department of Clinical Oncology, Professorial Block

location_facility: Hospital Clinico Universitario de Valencia

location_facility: C.H.U.M. - Hopital Notre-Dame, Departement d'Oncologie

location_facility: Desert Hematology Oncology Medical Group, Inc

location_facility: Spitalul Universitar de Urgenta Bucuresti

location_facility: Institut Curie, Département d'Oncologie Médicale

location_facility: Cancer Hospital, Chinese Academy of Medical Sciences

location_facility: University Hospital Centre Osijek, Department of Radiotherapy and Oncology

location_facility: Bialostockie Centrum Onkologii im. M. Sklodowskiej- Curie w Bialymstoku

location_facility: The Center for Cancer and Hematologic Disease

location_facility: Chinese People's Liberation Army General Hospital

location_facility: Dr. Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi

location_facility: Mid-Florida Hematology & Oncology Centers, PA

location_facility: North Mississippi Hematology and Oncology Associates, Ltd.

location_facility: University of Massachusetts Memorial Medical Center

location_facility: Seoul National University Hospital, Department of Internal Medicine

location_facility: Kurume Daiichi Social Insurance Hospital

location_facility: Clinique Sainte Anne Centre de Radiothérapie

location_facility: Centrum Medyczne Ostrobramska Niepubliczny Zaklad Opieki Zdrowotnej "Magodent"

location_facility: Charleston Hematology Oncology Associates, PA

location_facility: Institute of Oncology and Radiology of Serbia

location_facility: NorthEast Oncology Associates Carolinas Medical Center NorthEast

location_facility: The Hospital of Lithuanian University of Health Sciences Kauno klinikos Oncology and Haematology Clinic

location_facility: District Dispensary for Oncology Diseases Internal Unit- Plovdiv EOOD, Ist

location_facility: Charing Cross Hospital, Department Of Medical Oncology

location_facility: Praxis für interdisziplinaere Onkologie & Haematologie GbR

location_facility: Hospital Universitario Nuestra Señora de Candelaria

location_facility: Bacs-Kiskun Megyei Korhaz Onkoradiologiai Kozpont

location_facility: Hospital Clinico Universitario Virgen de La Victoria

location_facility: Peking Union Medical College Hospital of Chinese Academy of Medical Sciences

location_facility: Hospital Universitario Fundacion de Alcorcon

location_facility: Abington Hematology Oncology Associates, Inc

location_facility: Columbia University Medical Center, Herbert Irving Comprehensive Cancer Center

location_facility: Alliance Hematology Oncology, PA Carroll County Cancer Center

location_facility: Tokyo Metropolitan Cancer and Infectious disease Center Komagome Hp

location_facility: Oncologia Medica A, Istituti Fisioterapici Ospitalieri

location_facility: Sheba Medical Center, Oncology Institute Tel Hashomer

location_facility: The Cancer Prevention and Treatment Center

location_facility: Medicus Alliance Clinical Research Org., Inc.

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Wojewodzki Oddzial

location_facility: Avera Medical Oncology and Hematology - Avera Cancer Institute

location_facility: Klinikum St. Georg/Franziskus, Abteilung fuer Senologie

location_facility: ICO de Barcelona - Hospital Duran i Reynals, Hospitalet de Llobregat Consorci Sanitari de Terrassa

location_facility: Humber River Regional Hospital - Church Street Site

location_facility: Unita' Operativa Complessa Oncologia Medica, A.O.R.N. "Cardarelli"

location_facility: Jabboury Foundation for Cancer Research, Inc.

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

location_facility: Hospital Universitari Arnau de Vilanova de Lleida

location_facility: Azienda Ospedaliera Bianchi Melacrino Morelli

location_facility: Hospital Clinic i Provincial de Barcelona

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

location_facility: Oncologie department, Hopital albert Michalon

location_facility: Centre Hospitalier Affilie Universitaire de Quebec Hopital du St-Sacrement

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: Ventura County Hematology-Oncology Specialists

location_facility: Quincy Medical Group, Cancer Center at Blessing Hospital

location_facility: R.S. McLaughlin Durham Regional Cancer Centre

location_facility: Soroka University MC, Department of Oncology

location_facility: Interdistrict Dispensary for Oncology Diseases

location_facility: Kreiskrankenhaus Hameln, Onkologische Ambulanz

location_facility: Klinik fuer Gynaekologie und Geburtshilfe

location_facility: Klinik für Gynaekologie und gyn. Onkologie

location_facility: ICO de Girona - Hospital Universitario de Girona Dr. Josep Trueta

location_facility: University General Hospital of Alexandroupoli, Department of Medical Oncology

location_facility: Raleigh Hematology Oncology Associates Cancer Centers of North Carolina

location_facility: Cancer and Hematology Centers of Western Michigan

location_facility: Samaritan Hematology & Oncology Consultants

location_facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi

location_facility: Center for Integrative Cancer Medicine, PA

location_facility: Veszprem Megyei Csolnoky Ferenc Korhaz Nonprofit Zrt.

location_facility: Medical University of South Carolina Hollings Cancer Center

location_facility: Mercy Hospital Oncology/Hematology Center

location_facility: Kaiser Permanente Northwest Region Oncology Hematology

location_facility: Department of Clinical Oncology, Tuen Mun Hospital

location_facility: Pinnacle Health Cancer Center Community Campus

location_facility: Institutul Oncologic "Prof. Dr. Ion Chiricuta"

location_facility: Osaka Medical Center for Cancer and Cardiovascular Diseases

location_facility: Sozialstiftung Bamberg Klinik fuer Haematologie und Internistische Onkologie

location_facility: Kaohsiung Medical University Chung-Ho memorial Hospital

location_facility: Zaklad Opieki Zdrowotnej MSWiA z Warminsko - Mazurskim Centrum Onkologii w

location_facility: University Hematology/Oncology Associates PLLC

location_facility: Uniwersyteckie Centrum Kliniczne w Gdansku

location_facility: Orszagos Onkologiai Intezet "B" Belgyogyaszati osztaly

location_facility: Oncology-Hematology of Lehigh Valley, PC

location_facility: VZW Jesseziekenhuis - Campus Virga Jesse

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Glendale Adventist Medical Center Cancer Services

location_facility: IRCCS Istituto Oncologico Veneto di Padova

location_facility: National Cancer Center, Center for Breast Cancer

location_facility: Ospedale Treviglio e Caravaggio, UO Oncologia Medica

location_facility: Queen Mary Hospital, Department of Medicine

location_facility: Queen Mary Hospital, Department of Medicine, Blk K

location_facility: Azienda Ospedaliera San Giuseppe Moscati

location_facility: Cancer Care Specialists of Illinois, Decatur Memorial Hospital Clinical Research

location_facility: North Adelaide Oncology Calvary Hospital North Adelaide

location_facility: Dwight David Eisenhower Army Medical Center

location_facility: Szpital Morski im. PCK Gdynskie Centrum Onkologii Oddzial Chemioterapii

location_facility: Harry and Jeanette Weinberg Cancer Center

location_facility: Kaplan Medical Center, Department of Oncology

location_facility: Presidio Ospedaliero di Summa - Antonio Perrino

location_facility: Rambam Health care campus, Oncology institute

location_facility: Borsod-Abauj-Zemplen M. Korhaz es Egyetemi Okt. K., Klin. Onk., Sugarterapias es Kozp. Szuro Centrum

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi, Ic Hastaliklari Anabilim Dali

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Fundacion Instituto Valenciano de Oncologia

location_facility: Washington University School of Medicine Siteman Cancer Center

location_facility: Stronach Regional Cancer Centre at Southlake

location_facility: Clínica Vista Alegre / Unidad de Investigacion

location_facility: CHU de Liège - Domaine Universitaire du Sart Tilman

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w

location_facility: Kaposi Mor Oktato Korhaz, Onkologiai Centrum

location_facility: Wheaton Franciscan Cancer Care-All Saints

location_facility: National Hospital Organization Osaka National Hospital

location_facility: Washington Cancer Institute at Washington Hospital Center

location_facility: Southwestern Vermont Regional Cancer Center

location_facility: Oncology Institute of Vilnius University

location_facility: Augusta Oncology Associates (ACORN), P.C.

location_facility: Texas Oncology Cancer Care and Research Center

location_facility: Birmingham Hematology and Oncology Associates, LLC

location_facility: Providence Cancer Center Oncology and Hematology Care - Westside

location_facility: Centre Hospitalier Regional de La Citadelle

location_facility: East Texas Medical Center Cancer Institute

location_facility: Massachusetts General Hospital - Gillette Center

location_facility: Willamette Valley Cancer Institute and Research Center

location_facility: Frauenklinik der J.W. Goethe-Universitaet

location_facility: Cancer Care & Hematology Specialists of Chicagoland

location_facility: AZ Groeninge ampus Maria's Voorzienigheid (MV) Oncologisch Centrum

location_facility: University Hospitals, Cleveland Medical Center

location_facility: University Health Network, Princess Margaret Hospital

location_facility: Nationales Centrum fuer Tumorerkrankungen

location_facility: Florida Cancer Specialists and Research Institute

location_facility: McLeod Oncology and Hematology Associates

location_facility: The Hospital Affiliated Academy Military Medical Science, Chinese People's

location_facility: Specialised Hospital of Active Treatment in Oncology

location_facility: Chang Gung Medical Foundation, Linkou Branch

location_facility: Szpital Wojewodzki im. Sw. Lukasza Samodzielny Publiczny Zaklad Opieki

location_facility: Helen Diller Family University of California San Francisco Comprehensive Cancer Center

location_facility: Southern Medical University Nanfang Hospital

location_facility: Josa Andras Oktatokorhaz Egeszsegugyi Szolgaltato Nonprofit Kft. / Onkoradiologiai Osztaly

location_facility: Hospital Universitario Insular de Gran Canaria

location_facility: District Dispensary for Oncology Diseases Internal Unit- Sofia EOOD

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: West Virginia University Mary Babb Randolph Cancer Center

location_facility: Fondazione per la Ricerca e la Cura dei Tumori Tommaso Campanella

location_facility: Bekes M. Kepviselotest. Pandy Kalman Korhaz, Megyei Onkol. Kp., Klin. Onkol. es Sugartherapias Oszt.

location_facility: Olsztynski Osrodek Onkologiczny Kopernik Sp. z o.o.

location_facility: Korea University Anam Hospital, Department of Oncology/Hematology

location_facility: Institut Onkologie a Reahabilitace na Plesi

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Staedtische Kliniken Frankfurt am Main-Hoechst Frauenklinik

location_facility: Azienda Ospedaliera Universitaria "Policlinico Vittorio Emanuele"

location_facility: Administradora Country S.A-Clinica del Country

location_facility: Hematology Oncology Associates of Treasure Coast

location_facility: Consorcio Hospitalario Provincial de Castellon

location_facility: UNIMED Medical Institute, Comprehensive Centre for Breast Diseases

location_facility: University Clinic for Radiotherapy and Oncology

location_facility: Capitol Comprehensive Cancer Care Clinic

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul

location_facility: Gemeinschaftspraxis fuer Haematologie und Onkologie

location_facility: Centrum Onkologii im. prof. Franciszka Łukaszczyka

location_facility: Southeast Nebraska Hematology & Oncology Consultants, PC

location_facility: Facharzt fuer Frauenheilkunde und Geburtshilfe

location_facility: Semmelweis Egyetem Radiologiai és Onkoterapias Klinika

location_facility: Medical Oncology & Hematology Mercy Medical Center

location_facility: Hakuaikai Medical Corporation Sagara Hospital

location_facility: University of Texas Southwestern Medical Center Simmons Cancer Center

summary: The purpose of this study is to investigate whether neratinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab.


status: Completed

primary_purpose: Treatment

acronym: Sprint

intervention_type: Drug

title: A Phase 2, Multicenter, Randomized Open-Label Study To Determine the Efficacy of Lenalidomide (Revlimid®) Versus Investigator's Choice in Patients With Relapsed or Refractory Mantle Cell Lymphoma

study_completion_date_type: Actual

lead_sponsor: Celgene

source: euctr

design_allocation: Randomized

study_start_date_type: Actual

study_type: Interventional

ReferenceType: background

ReferenceCitation: Trněný M, Lamy T, Walewski J, Belada D, Mayer J, Radford J, Jurczak W, Morschhauser F, Alexeeva J, Rule S, Afanasyev B, Kaplanov K, Thyss A, Kuzmin A, Voloshin S, Kuliczkowski K, Giza A, Milpied N, Stelitano C, Marks R, Trümper L, Biyukov T, Patturajan M, Bravo MC, Arcaini L; SPRINT trial investigators and in collaboration with the European Mantle Cell Lymphoma Network. Lenalidomide versus investigator's choice in relapsed or refractory mantle cell lymphoma (MCL-002; SPRINT): a phase 2, randomised, multicentre trial. Lancet Oncol. 2016 Mar;17(3):319-331. doi: 10.1016/S1470-2045(15)00559-8. Epub 2016 Feb 16.

ReferenceType: derived

ReferenceCitation: Hagner PR, Chiu H, Ortiz M, Apollonio B, Wang M, Couto S, Waldman MF, Flynt E, Ramsay AG, Trotter M, Gandhi AK, Chopra R, Thakurta A. Activity of lenalidomide in mantle cell lymphoma can be explained by NK cell-mediated cytotoxicity. Br J Haematol. 2017 Nov;179(3):399-409. doi: 10.1111/bjh.14866. Epub 2017 Aug 2.

enrollment_type: Actual

location_country:
Denmark
Poland
Spain
Greece
Italy
Netherlands
Russian Federation
United Kingdom
Sweden
France
Israel
Belgium
Germany
Czechia

location_facility: Universitaetsklinikum FreiburgInnere Med.1, Haematologie

location_facility: Polyclinique Bordeaux Nord Aquitaine Service Onco-Hematologie

location_facility: Novosibirsk State Regional Clinical Hospital

location_facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie w Warszawie

location_facility: St. Petersburg Pavlov State Medical University

location_facility: Uniwersytet Jagiellonski Collegium Medicum

location_facility: Scientific Research Institute of OncologySoft Tissue Department

location_facility: St. Petersburg Research Institute of Hematology and Blood Transfusion

location_facility: University Hospital2.Dep. of Int.med. hematology

location_facility: Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov

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

location_facility: Rigshospitalet Department of Haematology L4042

location_facility: Institution of Russian Academy of Medical Sciences Russian Oncological Research Centre n.a. N. N. Bl

location_facility: Attikon General University Hospital of Athens

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi

location_facility: Teaching Hospital BrnoHemato-oncology Dept

location_facility: The Royal Wolverhampton Hospital NHS Trust

location_facility: Centre Antoine Lacassagne Oncologie medicale et Hematologie

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: Cliniques Universitaires UCL de Mont-Godine

location_facility: Saratov Medical University Chair of Professional Pathology and Haematology

location_facility: Centre Hospitalier Departemental Les Oudrairies

location_facility: A.O.U. di Bologna Policlinico S.Orsola-Malpighi

location_facility: Volgograd Regional Clinical Oncology Dispensary 1

location_facility: Dolnoslaskie Centrum Transplantacji Komorkowych

summary: To evaluate the safety and efficacy of lenalidomide versus investigator choice in patients with relapsed or refractory mantle cell lymphoma.

lead_sponsor_type: industriel

status_simplified: Completed


ipd_sharing: Undecided

title: A Phase III Study to Evaluate the Efficacy and Safety of Pazopanib Monotherapy Versus Placebo in Women Who Have Not Progressed After First Line Chemotherapy for Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

lead_sponsor: Novartis Pharmaceuticals

type: EudraCT Number

type: Other Identifier

ReferenceCitation: Vergote I, du Bois A, Floquet A, Rau J, Kim JW, Del Campo JM, Friedlander M, Pignata S, Fujiwara K, Colombo N, Mirza MR, Monk BJ, Tsibulak I, Calvert PM, Herzog TJ, Hanker LC, Meunier J, Lee JY, Bologna A, Carrasco-Alfonso MJ, Harter P. Overall survival results of AGO-OVAR16: A phase 3 study of maintenance pazopanib versus placebo in women who have not progressed after first-line chemotherapy for advanced ovarian cancer. Gynecol Oncol. 2019 Nov;155(2):186-191. doi: 10.1016/j.ygyno.2019.08.024. Epub 2019 Sep 10.

ReferenceCitation: Friedlander M, Rau J, Lee CK, Meier W, Lesoin A, Kim JW, Poveda A, Buck M, Scambia G, Shimada M, Hilpert F, King MT, Debruyne P, Bologna A, Malander S, Monk BJ, Petru E, Calvert P, Herzog TJ, Barrett C, du Bois A. Quality of life in patients with advanced epithelial ovarian cancer (EOC) randomized to maintenance pazopanib or placebo after first-line chemotherapy in the AGO-OVAR 16 trial. Measuring what matters-patient-centered end points in trials of maintenance therapy. Ann Oncol. 2018 Mar 1;29(3):737-743. doi: 10.1093/annonc/mdx796.

ReferenceCitation: Pulford DJ, Harter P, Floquet A, Barrett C, Suh DH, Friedlander M, Arranz JA, Hasegawa K, Tada H, Vuylsteke P, Mirza MR, Donadello N, Scambia G, Johnson T, Cox C, Chan JK, Imhof M, Herzog TJ, Calvert P, Wimberger P, Berton-Rigaud D, Lim MC, Elser G, Xu CF, du Bois A. Communicating BRCA research results to patients enrolled in international clinical trials: lessons learnt from the AGO-OVAR 16 study. BMC Med Ethics. 2016 Oct 21;17(1):63.

ReferenceCitation: Kim JW, Mahner S, Wu LY, Shoji T, Kim BG, Zhu JQ, Takano T, Park SY, Kong BH, Wu Q, Wang KL, Ngan HY, Liu JH, Wei LH, Mitrica I, Zhang P, Crescenzo R, Wang Q, Cox CJ, Harter P, du Bois A. Pazopanib Maintenance Therapy in East Asian Women With Advanced Epithelial Ovarian Cancer: Results From AGO-OVAR16 and an East Asian Study. Int J Gynecol Cancer. 2018 Jan;28(1):2-10. doi: 10.1097/IGC.0000000000000602.

ReferenceCitation: Floquet A, Vergote I, Colombo N, Fiane B, Monk BJ, Reinthaller A, Calvert P, Herzog TJ, Meier W, Kim JW, del Campo JM, Friedlander M, Pisano C, Isonishi S, Crescenzo RJ, Barrett C, Wang K, Mitrica I, du Bois A. Progression-free survival by local investigator versus independent central review: comparative analysis of the AGO-OVAR16 Trial. Gynecol Oncol. 2015 Jan;136(1):37-42. doi: 10.1016/j.ygyno.2014.11.074. Epub 2014 Nov 28.

ReferenceCitation: du Bois A, Floquet A, Kim JW, Rau J, del Campo JM, Friedlander M, Pignata S, Fujiwara K, Vergote I, Colombo N, Mirza MR, Monk BJ, Kimmig R, Ray-Coquard I, Zang R, Diaz-Padilla I, Baumann KH, Mouret-Reynier MA, Kim JH, Kurzeder C, Lesoin A, Vasey P, Marth C, Canzler U, Scambia G, Shimada M, Calvert P, Pujade-Lauraine E, Kim BG, Herzog TJ, Mitrica I, Schade-Brittinger C, Wang Q, Crescenzo R, Harter P. Incorporation of pazopanib in maintenance therapy of ovarian cancer. J Clin Oncol. 2014 Oct 20;32(30):3374-82. doi: 10.1200/JCO.2014.55.7348. Epub 2014 Sep 15.

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

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

location_country:
Denmark
Taiwan
Hong Kong
Spain
Ireland
Austria
Australia
Italy
Sweden
Korea, Republic of
United States
France
China
Norway
Belgium
Japan
Germany

summary: This was a study to determine whether therapy with pazopanib was effective and safe in women with epithelial ovarian, fallopian tube, or primary peritoneal cancer whose cancer had not progressed on first line chemotherapy.


acronym: TEAMSTA Severe HTN

title: An 8-week Randomised, Double-blind Study to Compare the Fixed-dose Combination of Telmisartan 80 mg & Amlodipine 10mg Versus Telmisartan 80 mg Monotherapy or Amlodipine 10 mg Monotherapy as First Line Therapy in Patients With Severe Hypertension (Grade 3).

lead_sponsor: Boehringer Ingelheim

location_country:
Spain
Russian Federation
Czech Republic
Ukraine
Hungary
Korea, Republic of
United States
France
Romania
Bulgaria
Slovakia

location_facility: 1235.20.008 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.254 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.460 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.102A Boehringer Ingelheim Investigational Site

location_facility: 1235.20.108A Boehringer Ingelheim Investigational Site

location_facility: 1235.20.108B Boehringer Ingelheim Investigational Site

location_facility: 1235.20.252 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.457 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.109F Boehringer Ingelheim Investigational Site

location_facility: 1235.20.101A Boehringer Ingelheim Investigational Site

location_facility: 1235.20.202 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.525 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.511 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.059 Boehringer Ingelheim Investigational Site

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location_facility: 1235.20.301 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.107B Boehringer Ingelheim Investigational Site

location_facility: 1235.20.102C Boehringer Ingelheim Investigational Site

location_facility: 1235.20.353 Boehringer Ingelheim Investigational Site

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location_facility: 1235.20.107A Boehringer Ingelheim Investigational Site

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location_facility: 1235.20.052 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.204 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.102F Boehringer Ingelheim Investigational Site

location_facility: 1235.20.103E Boehringer Ingelheim Investigational Site

location_facility: 1235.20.262 Boehringer Ingelheim Investigational Site

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location_facility: 1235.20.055 Boehringer Ingelheim Investigational Site

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location_facility: 1235.20.304 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.108E Boehringer Ingelheim Investigational Site

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location_facility: 1235.20.106D Boehringer Ingelheim Investigational Site

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location_facility: 1235.20.105D Boehringer Ingelheim Investigational Site

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location_facility: 1235.20.053 Boehringer Ingelheim Investigational Site

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location_facility: 1235.20.534 Boehringer Ingelheim Investigational Site

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location_facility: 1235.20.521 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.406 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.535 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.517 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.207 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.307 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.503 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.513 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.158 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.203 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.106F Boehringer Ingelheim Investigational Site

location_facility: 1235.20.455 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.515 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.508 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.530 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.006 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.152 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.260 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.452 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.109A Boehringer Ingelheim Investigational Site

location_facility: 1235.20.461 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.107F Boehringer Ingelheim Investigational Site

location_facility: 1235.20.051 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.106B Boehringer Ingelheim Investigational Site

summary: The primary objective of this trial is to demonstrate that following eight weeks of treatment the FDC of telmisartan 80 mg plus amlodipine 10 mg (T80/A10) is superior as first line therapy in reducing mean seated trough cuff Systolic Blood Pressure [SBP] compared to the monotherapies of telmisartan 80 mg (T80) and amlodipine 10 mg (A10) in patients with severe hypertension. A key secondary objective is to identify the duration of treatment required to demonstrate the superiority of the FDC over both of the monotherapies.


title: The Effect of Insulin Detemir in Combination With Liraglutide and Metformin Compared to Liraglutide and Metformin in Subjects With Type 2 Diabetes. A 26 Week, Randomised, Open-label, Parallel-group, Multicentre, Multinational Trial With a 26 Week Extension

lead_sponsor: Novo Nordisk A/S

ReferenceType: result

ReferenceCitation: DeVries JH, Bain SC, Rodbard HW, Seufert J, D'Alessio D, Thomsen AB, Zychma M, Rosenstock J; Liraglutide-Detemir Study Group. Sequential intensification of metformin treatment in type 2 diabetes with liraglutide followed by randomized addition of basal insulin prompted by A1C targets. Diabetes Care. 2012 Jul;35(7):1446-54. doi: 10.2337/dc11-1928. Epub 2012 May 14.

ReferenceCitation: Rosenstock J, Rodbard HW, Bain SC, D'Alessio D, Seufert J, Thomsen AB, Svendsen CB, DeVries JH; Liraglutide-Detemir Study Group. One-year sustained glycemic control and weight reduction in type 2 diabetes after addition of liraglutide to metformin followed by insulin detemir according to HbA1c target. J Diabetes Complications. 2013 Sep-Oct;27(5):492-500. doi: 10.1016/j.jdiacomp.2013.04.008. Epub 2013 Jun 6.

ReferenceCitation: Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12. Review. Erratum in: Diabetes Care. 2015 Aug;38(8):1622.

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

summary: This trial is conducted in Europe and North America. The aim of this clinical trial is to assess and compare the effect of insulin detemir in combination with liraglutide and metformin versus liraglutide and metformin in subjects with type 2 diabetes. Subjects will continue their own pre-trial metformin treatment during the trial.


title: An International, Multi-Center, Double-Blind, Randomized, Phase III Trial of 90Y-Clivatuzumab Tetraxetan Plus Low-Dose Gemcitabine Versus Placebo Plus Low-Dose Gemcitabine in Patients With Metastatic (Stage IV) Pancreatic Adenocarcinoma Who Received at Least Two Prior Treatments (PANCRIT-1)

summary: The is a double-blind, randomized phase 3 study of 90Y-clivatuzumab tetraxetan with low-dose gemcitabine, versus placebo and low-dose gemcitabine in metastatic pancreatic cancer patients who have progressed on at least 2 prior therapies for metastatic cancer (1 of which was a gemcitabine-containing regimen).

status: Terminated

ReferenceCitation: Ocean AJ, Pennington KL, Guarino MJ, Sheikh A, Bekaii-Saab T, Serafini AN, Lee D, Sung MW, Gulec SA, Goldsmith SJ, Manzone T, Holt M, O'Neil BH, Hall N, Montero AJ, Kauh J, Gold DV, Horne H, Wegener WA, Goldenberg DM. Fractionated radioimmunotherapy with (90) Y-clivatuzumab tetraxetan and low-dose gemcitabine is active in advanced pancreatic cancer: A phase 1 trial. Cancer. 2012 Nov 15;118(22):5497-506. doi: 10.1002/cncr.27592. Epub 2012 May 8.

ReferenceCitation: Gulec SA, Cohen SJ, Pennington KL, Zuckier LS, Hauke RJ, Horne H, Wegener WA, Teoh N, Gold DV, Sharkey RM, Goldenberg DM. Treatment of advanced pancreatic carcinoma with 90Y-Clivatuzumab Tetraxetan: a phase I single-dose escalation trial. Clin Cancer Res. 2011 Jun 15;17(12):4091-100. doi: 10.1158/1078-0432.CCR-10-2579. Epub 2011 Apr 28.

ReferenceCitation: Sharkey RM, Karacay H, Govindan SV, Goldenberg DM. Combination radioimmunotherapy and chemoimmunotherapy involving different or the same targets improves therapy of human pancreatic carcinoma xenograft models. Mol Cancer Ther. 2011 Jun;10(6):1072-81. doi: 10.1158/1535-7163.MCT-11-0115. Epub 2011 Apr 5.

ReferenceCitation: Tokh M, Bathini V, Saif MW. First-line treatment of metastatic pancreatic cancer. JOP. 2012 Mar 10;13(2):159-62. Review.

ReferenceCitation: Gold DV, Newsome G, Liu D, Goldenberg DM. Mapping PAM4 (clivatuzumab), a monoclonal antibody in clinical trials for early detection and therapy of pancreatic ductal adenocarcinoma, to MUC5AC mucin. Mol Cancer. 2013 Nov 20;12(1):143. doi: 10.1186/1476-4598-12-143.

ReferenceCitation: Gold DV, Gaedcke J, Ghadimi BM, Goggins M, Hruban RH, Liu M, Newsome G, Goldenberg DM. PAM4 enzyme immunoassay alone and in combination with CA 19-9 for the detection of pancreatic adenocarcinoma. Cancer. 2013 Feb 1;119(3):522-8. doi: 10.1002/cncr.27762. Epub 2012 Aug 16.

ReferenceCitation: Gold DV, Goggins M, Modrak DE, Newsome G, Liu M, Shi C, Hruban RH, Goldenberg DM. Detection of early-stage pancreatic adenocarcinoma. Cancer Epidemiol Biomarkers Prev. 2010 Nov;19(11):2786-94. doi: 10.1158/1055-9965.EPI-10-0667. Epub 2010 Sep 1.

ReferenceCitation: Gold DV, Goldenberg DM, Karacay H, Rossi EA, Chang CH, Cardillo TM, McBride WJ, Sharkey RM. A novel bispecific, trivalent antibody construct for targeting pancreatic carcinoma. Cancer Res. 2008 Jun 15;68(12):4819-26. doi: 10.1158/0008-5472.CAN-08-0232.

ReferenceCitation: Gold DV, Karanjawala Z, Modrak DE, Goldenberg DM, Hruban RH. PAM4-reactive MUC1 is a biomarker for early pancreatic adenocarcinoma. Clin Cancer Res. 2007 Dec 15;13(24):7380-7.

ReferenceCitation: Gold DV, Modrak DE, Ying Z, Cardillo TM, Sharkey RM, Goldenberg DM. New MUC1 serum immunoassay differentiates pancreatic cancer from pancreatitis. J Clin Oncol. 2006 Jan 10;24(2):252-8. Epub 2005 Dec 12.

ReferenceCitation: Gold DV, Modrak DE, Schutsky K, Cardillo TM. Combined 90Yttrium-DOTA-labeled PAM4 antibody radioimmunotherapy and gemcitabine radiosensitization for the treatment of a human pancreatic cancer xenograft. Int J Cancer. 2004 Apr 20;109(4):618-26.

ReferenceCitation: Gold DV, Schutsky K, Modrak D, Cardillo TM. Low-dose radioimmunotherapy ((90)Y-PAM4) combined with gemcitabine for the treatment of experimental pancreatic cancer. Clin Cancer Res. 2003 Sep 1;9(10 Pt 2):3929S-37S.

ReferenceCitation: Cardillo TM, Blumenthal R, Ying Z, Gold DV. Combined gemcitabine and radioimmunotherapy for the treatment of pancreatic cancer. Int J Cancer. 2002 Jan 20;97(3):386-92.

ReferenceCitation: Cardillo TM, Ying Z, Gold DV. Therapeutic advantage of (90)yttrium- versus (131)iodine-labeled PAM4 antibody in experimental pancreatic cancer. Clin Cancer Res. 2001 Oct;7(10):3186-92.

ReferenceCitation: Gold DV, Cardillo T, Goldenberg DM, Sharkey RM. Localization of pancreatic cancer with radiolabeled monoclonal antibody PAM4. Crit Rev Oncol Hematol. 2001 Jul-Aug;39(1-2):147-54.

ReferenceCitation: Gold DV, Cardillo T, Vardi Y, Blumenthal R. Radioimmunotherapy of experimental pancreatic cancer with 131I-labeled monoclonal antibody PAM4. Int J Cancer. 1997 May 16;71(4):660-7.

ReferenceCitation: Mariani G, Molea N, Bacciardi D, Boggi U, Fornaciari G, Campani D, Salvadori PA, Giulianotti PC, Mosca F, Gold DV, et al. Initial tumor targeting, biodistribution, and pharmacokinetic evaluation of the monoclonal antibody PAM4 in patients with pancreatic cancer. Cancer Res. 1995 Dec 1;55(23 Suppl):5911s-5915s.

ReferenceCitation: Alisauskus R, Wong GY, Gold DV. Initial studies of monoclonal antibody PAM4 targeting to xenografted orthotopic pancreatic cancer. Cancer Res. 1995 Dec 1;55(23 Suppl):5743s-5748s.

ReferenceCitation: Gold DV, Lew K, Maliniak R, Hernandez M, Cardillo T. Characterization of monoclonal antibody PAM4 reactive with a pancreatic cancer mucin. Int J Cancer. 1994 Apr 15;57(2):204-10.

lead_sponsor: Gilead Sciences

location_country:
Poland
Spain
Austria
Canada
United States
France
Israel
Belgium

location_facility: New York Presbyterian Hospital/Weill Cornell Medical Center

location_facility: Indiana University Health Goshen Center for Cancer Care

location_facility: University of Tennessee Medical Center, Cancer Institute

location_facility: Centre Hospitalier Université de Sherbrooke

location_facility: Michael and Dianne Bienes Comprehensive Cancer Center - Holy Cross Hospital

location_facility: Oncology Hematology West P.C. dba Nebraska Cancer Specialists

location_facility: Mountain States Tumor Institute at St. Luke's Regional Medical Center

location_facility: Centrum Onkologii Instytut im. M. Sklodowskiej-Curie - Warszawa

location_facility: Centre Léon Bérard Cancerologie Medicale

location_facility: Masonic Cancer Center, University of Minnesota

location_facility: University of Mississippi Medical Center

location_facility: University of Pittsburgh Medical Center/Hillman Cancer Center

location_facility: University of North Carolina Hospitals, Lineberger Comprehensive Cancer Center

location_facility: The Ohio State University - Comprehensive Cancer Center

location_facility: The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center

location_facility: University of Pennsylvania Abramson Cancer Center

location_facility: Indiana University Melvin and Bren Simon Cancer Center

status_simplified: Unknown


title: A Prospective, Single-arm, Multicenter, Uncontrolled, Open-label Phase II Trial of Refametinib (BAY86-9766) in Combination With Sorafenib as First Line Treatment in Patients With RAS Mutant Hepatocellular Carcinoma (HCC)

summary:
This is a study to investigate the potential clinical benefit of refametinib when given in combination with sorafenib as first line treatment in patients with unresectable or metastatic HCC carrying a RAS mutation. The study will be conducted in 2 stages. Approximately 95 patients (15 at Stage 1/ 80 at Stage 2) will be accrued to this study to receive treatment. Stage 2 of the trial will only be conducted if at least 5 out of 15 patients at Stage 1 show at least partial response according to an objective criteria to evaluate tumor size based on contrast enhancement [modified response evaluation criteria in solid tumors (mRECIST)] assessed by external independent radiologists.

Refametenib is an oral (i.e. taken by mouth) protein kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. By specifically targeting these proteins, refametinib in combination with sorafenib may stop cancer growth. The growth of the tumor may be decreased by preventing these specific proteins from functioning.

The primary endpoint (the most meaningful result to be tracked) of this study is based on the rate of response, i.e. the disease getting smaller. The aim is to show that the therapy with refametinib in combination with sorafenib improves the response rate in this patient population compared to historical results observed with the sorafenib only.

lead_sponsor: Bayer

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Hong Kong
Austria
Israel
Turkey
Singapore
Switzerland
Hungary
China
Germany
Taiwan
New Zealand
Thailand
Korea, Republic of
France


title: A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) vs Placebo in Subjects With Hepatocellular Carcinoma Who Have Received Prior Sorafenib

acronym: CELESTIAL

summary: The purpose of this study is to evaluate the effect of Cabozantinib (XL184) compared with placebo on overall survival in subjects with advanced hepatocellular carcinoma who have received prior sorafenib.

ReferenceCitation: Freemantle N, Mollon P, Meyer T, Cheng AL, El-Khoueiry AB, Kelley RK, Baron AD, Benzaghou F, Mangeshkar M, Abou-Alfa GK. Quality of life assessment of cabozantinib in patients with advanced hepatocellular carcinoma in the CELESTIAL trial. Eur J Cancer. 2022 Jun;168:91-98. doi: 10.1016/j.ejca.2022.03.021. Epub 2022 Apr 26.

ReferenceCitation: El-Khoueiry AB, Meyer T, Cheng AL, Rimassa L, Sen S, Milwee S, Kelley RK, Abou-Alfa GK. Safety and efficacy of cabozantinib for patients with advanced hepatocellular carcinoma who advanced to Child-Pugh B liver function at study week 8: a retrospective analysis of the CELESTIAL randomised controlled trial. BMC Cancer. 2022 Apr 9;22(1):377. doi: 10.1186/s12885-022-09453-z.

ReferenceCitation: Kelley RK, Miksad R, Cicin I, Chen Y, Klümpen HJ, Kim S, Lin ZZ, Youkstetter J, Hazra S, Sen S, Cheng AL, El-Khoueiry AB, Meyer T, Abou-Alfa GK. Efficacy and safety of cabozantinib for patients with advanced hepatocellular carcinoma based on albumin-bilirubin grade. Br J Cancer. 2022 Mar;126(4):569-575. doi: 10.1038/s41416-021-01532-5. Epub 2021 Oct 7.

ReferenceCitation: Trojan J, Mollon P, Daniele B, Marteau F, Martín L, Li Y, Xu Q, Piscaglia F, Zaucha R, Sarker D, Lim HY, Venerito M. Comparative Efficacy of Cabozantinib and Ramucirumab After Sorafenib for Patients with Hepatocellular Carcinoma and Alpha-fetoprotein ≥ 400 ng/mL: A Matching-Adjusted Indirect Comparison. Adv Ther. 2021 May;38(5):2472-2490. doi: 10.1007/s12325-021-01700-2. Epub 2021 Apr 6.

ReferenceCitation: Kelley RK, Ryoo BY, Merle P, Park JW, Bolondi L, Chan SL, Lim HY, Baron AD, Parnis F, Knox J, Cattan S, Yau T, Lougheed JC, Milwee S, El-Khoueiry AB, Cheng AL, Meyer T, Abou-Alfa GK. Second-line cabozantinib after sorafenib treatment for advanced hepatocellular carcinoma: a subgroup analysis of the phase 3 CELESTIAL trial. ESMO Open. 2020 Aug;5(4). pii: e000714. doi: 10.1136/esmoopen-2020-000714.

ReferenceCitation: Abou-Alfa GK, Meyer T, Cheng AL, El-Khoueiry AB, Rimassa L, Ryoo BY, Cicin I, Merle P, Chen Y, Park JW, Blanc JF, Bolondi L, Klümpen HJ, Chan SL, Zagonel V, Pressiani T, Ryu MH, Venook AP, Hessel C, Borgman-Hagey AE, Schwab G, Kelley RK. Cabozantinib in Patients with Advanced and Progressing Hepatocellular Carcinoma. N Engl J Med. 2018 Jul 5;379(1):54-63. doi: 10.1056/NEJMoa1717002.

lead_sponsor: Exelixis

location_country:
Poland
Taiwan
Hong Kong
Romania
Spain
Ireland
Italy
Australia
Netherlands
Canada
New Zealand
United Kingdom
Korea, Republic of
United States
France
Singapore
Turkey
Belgium
Germany


title: A Phase III, Randomized, Open Label, Multicenter, Controlled Trial of Niraparib Versus Physician's Choice in Previously-treated, HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients

acronym: BRAVO

summary: The purpose of this study is to compare progression-free survival (PFS) in patients with advanced/metastatic breast cancer who have a BRCA mutation when treated with niraparib as compared to those treated with physician's choice

ipd_sharing: No

lead_sponsor: Tesaro, Inc.

location_country:
Poland
Portugal
Spain
Greece
Italy
United Kingdom
Canada
Hungary
United States
France
Israel
Belgium
Iceland
Netherlands


title: Efficacy and Safety of Semaglutide Once-weekly Versus Exenatide ER 2.0 mg Once-weekly as add-on to 1-2 Oral Antidiabetic Drugs (OADs) in Subjects With Type 2 Diabetes (SUSTAIN™ 3 - vs. QW GLP-1)

acronym: SUSTAIN™ 3

summary: This trial is conducted in Europe and North and South America. The aim of the trial is to investigate the efficacy and safety of semaglutide once-weekly versus exenatide ER (extended release) 2.0 mg once-weekly as add-on to 1-2 oral antidiabetic drugs (OADs) in subjects with type 2 diabetes.

ReferenceCitation: Fonseca VA, Capehorn MS, Garg SK, Jódar Gimeno E, Hansen OH, Holst AG, Nayak G, Seufert J. Reductions in insulin resistance are mediated primarily via weight loss in subjects with type 2 diabetes on semaglutide. J Clin Endocrinol Metab. 2019 Apr 2. pii: jc.2018-02685. doi: 10.1210/jc.2018-02685. [Epub ahead of print] Erratum in: J Clin Endocrinol Metab. 2020 Jan 1;105(1):.

ReferenceCitation: Rodbard HW, Bellary S, Hramiak I, Seino Y, Silver R, Damgaard LH, Nayak G, Zacho J, Aroda VR. GREATER COMBINED REDUCTIONS IN HbA(1C) ≥1.0% AND WEIGHT ≥5.0% WITH SEMAGLUTIDE VERSUS COMPARATORS IN TYPE 2 DIABETES. Endocr Pract. 2019 Jun;25(6):589-597. doi: 10.4158/EP-2018-0444. Epub 2019 Mar 13.

ReferenceCitation: Ahmann AJ, Capehorn M, Charpentier G, Dotta F, Henkel E, Lingvay I, Holst AG, Annett MP, Aroda VR. Efficacy and Safety of Once-Weekly Semaglutide Versus Exenatide ER in Subjects With Type 2 Diabetes (SUSTAIN 3): A 56-Week, Open-Label, Randomized Clinical Trial. Diabetes Care. 2018 Feb;41(2):258-266. doi: 10.2337/dc17-0417. Epub 2017 Dec 15.

ReferenceCitation: Warren M, Chaykin L, Trachtenbarg D, Nayak G, Wijayasinghe N, Cariou B. Semaglutide as a therapeutic option for elderly patients with type 2 diabetes: Pooled analysis of the SUSTAIN 1-5 trials. Diabetes Obes Metab. 2018 Sep;20(9):2291-2297. doi: 10.1111/dom.13331. Epub 2018 Jun 7.

ReferenceCitation: Petri KCC, Ingwersen SH, Flint A, Zacho J, Overgaard RV. Exposure-response analysis for evaluation of semaglutide dose levels in type 2 diabetes. Diabetes Obes Metab. 2018 Sep;20(9):2238-2245. doi: 10.1111/dom.13358. Epub 2018 Jun 15.

ReferenceCitation: Ahrén B, Atkin SL, Charpentier G, Warren ML, Wilding JPH, Birch S, Holst AG, Leiter LA. Semaglutide induces weight loss in subjects with type 2 diabetes regardless of baseline BMI or gastrointestinal adverse events in the SUSTAIN 1 to 5 trials. Diabetes Obes Metab. 2018 Sep;20(9):2210-2219. doi: 10.1111/dom.13353. Epub 2018 Jun 12.

ReferenceCitation: DeVries JH, Desouza C, Bellary S, Unger J, Hansen OKH, Zacho J, Woo V. Achieving glycaemic control without weight gain, hypoglycaemia, or gastrointestinal adverse events in type 2 diabetes in the SUSTAIN clinical trial programme. Diabetes Obes Metab. 2018 Oct;20(10):2426-2434. doi: 10.1111/dom.13396. Epub 2018 Jul 9.

ReferenceCitation: Carlsson Petri KC, Ingwersen SH, Flint A, Zacho J, Overgaard RV. Semaglutide s.c. Once-Weekly in Type 2 Diabetes: A Population Pharmacokinetic Analysis. Diabetes Ther. 2018 Aug;9(4):1533-1547. doi: 10.1007/s13300-018-0458-5. Epub 2018 Jun 15.

ReferenceCitation: Malkin SJP, Russel-Szymczyk M, Liidemann G, Volke V, Hunt B. Once-Weekly Semaglutide Versus Once-Daily Liraglutide for the Treatment of Type 2 Diabetes: A Long-Term Cost-Effectiveness Analysis in Estonia. Diabetes Ther. 2019 Feb;10(1):159-176. doi: 10.1007/s13300-018-0542-x. Epub 2018 Dec 7.

ReferenceCitation: Aroda VR, Ahmann A, Cariou B, Chow F, Davies MJ, Jódar E, Mehta R, Woo V, Lingvay I. Comparative efficacy, safety, and cardiovascular outcomes with once-weekly subcutaneous semaglutide in the treatment of type 2 diabetes: Insights from the SUSTAIN 1-7 trials. Diabetes Metab. 2019 Oct;45(5):409-418. doi: 10.1016/j.diabet.2018.12.001. Epub 2019 Jan 4. Review.

ReferenceCitation: Overgaard RV, Lindberg SØ, Thielke D. Impact on HbA1c and body weight of switching from other GLP-1 receptor agonists to semaglutide: A model-based approach. Diabetes Obes Metab. 2019 Jan;21(1):43-51. doi: 10.1111/dom.13479. Epub 2018 Aug 23.

ReferenceCitation: Mosenzon O, Capehorn MS, De Remigis A, Rasmussen S, Weimers P, Rosenstock J. Impact of semaglutide on high-sensitivity C-reactive protein: exploratory patient-level analyses of SUSTAIN and PIONEER randomized clinical trials. Cardiovasc Diabetol. 2022 Sep 2;21(1):172. doi: 10.1186/s12933-022-01585-7.

ReferenceCitation: Husain M, Bain SC, Holst AG, Mark T, Rasmussen S, Lingvay I. Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials. Cardiovasc Diabetol. 2020 Sep 30;19(1):156. doi: 10.1186/s12933-020-01106-4.

ReferenceCitation: Lingvay I, Capehorn MS, Catarig AM, Johansen P, Lawson J, Sandberg A, Shaw R, Paine A. Efficacy of Once-Weekly Semaglutide vs Empagliflozin Added to Metformin in Type 2 Diabetes: Patient-Level Meta-analysis. J Clin Endocrinol Metab. 2020 Dec 1;105(12):e4593-604. doi: 10.1210/clinem/dgaa577.

ReferenceCitation: Capehorn M, Ghani Y, Hindsberger C, Johansen P, Jódar E. Once-Weekly Semaglutide Reduces HbA(1c) and Body Weight in Patients with Type 2 Diabetes Regardless of Background Common OAD: a Subgroup Analysis from SUSTAIN 2-4 and 10. Diabetes Ther. 2020 May;11(5):1061-1075. doi: 10.1007/s13300-020-00796-z. Epub 2020 Mar 19.

ReferenceCitation: Husain M, Bain SC, Jeppesen OK, Lingvay I, Sørrig R, Treppendahl MB, Vilsbøll T. Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk. Diabetes Obes Metab. 2020 Mar;22(3):442-451. doi: 10.1111/dom.13955. Epub 2020 Feb 5.

ReferenceCitation: DeSouza C, Cariou B, Garg S, Lausvig N, Navarria A, Fonseca V. Efficacy and Safety of Semaglutide for Type 2 Diabetes by Race and Ethnicity: A Post Hoc Analysis of the SUSTAIN Trials. J Clin Endocrinol Metab. 2020 Feb 1;105(2). pii: dgz072. doi: 10.1210/clinem/dgz072.

ReferenceCitation: Jendle J, Birkenfeld AL, Polonsky WH, Silver R, Uusinarkaus K, Hansen T, Håkan-Bloch J, Tadayon S, Davies MJ. Improved treatment satisfaction in patients with type 2 diabetes treated with once-weekly semaglutide in the SUSTAIN trials. Diabetes Obes Metab. 2019 Oct;21(10):2315-2326. doi: 10.1111/dom.13816. Epub 2019 Jul 12.

location_country:
Croatia
Serbia
United Kingdom
Greece
Italy
Netherlands
Argentina
Finland
Switzerland
Puerto Rico
United States
France
Germany


title: A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Patients With Active Ankylosing Spondylitis

acronym: SPIRIT A1

summary: This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to placebo in participants with active AS.

status: Withdrawn

study_completion_date_type: Anticipated

lead_sponsor: Eli Lilly and Company

location_country:
Poland
Spain
United Kingdom
Russian Federation
Mexico
Netherlands
Argentina
Czech Republic
Canada
Ukraine
Hungary
United States
France
Belgium
Germany

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, PCI-32765 (Ibrutinib), in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma

summary: The purpose of this study is to evaluate if ibrutinib administered in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) improves the clinical outcome in newly diagnosed patients with non-germinal center B-cell subtype (GCB) of diffuse large B-cell lymphoma (DLBCL) selected by immunohistochemistry (IHC) or newly diagnosed patients with activated B cell-like (ABC) subtype of DLBCL identified by gene expression profiling (GEP) or both populations.

ReferenceCitation: Wilson WH, Wright GW, Huang DW, Hodkinson B, Balasubramanian S, Fan Y, Vermeulen J, Shreeve M, Staudt LM. Effect of ibrutinib with R-CHOP chemotherapy in genetic subtypes of DLBCL. Cancer Cell. 2021 Dec 13;39(12):1643-1653.e3. doi: 10.1016/j.ccell.2021.10.006. Epub 2021 Nov 4.

ReferenceCitation: Younes A, Sehn LH, Johnson P, Zinzani PL, Hong X, Zhu J, Patti C, Belada D, Samoilova O, Suh C, Leppä S, Rai S, Turgut M, Jurczak W, Cheung MC, Gurion R, Yeh SP, Lopez-Hernandez A, Dührsen U, Thieblemont C, Chiattone CS, Balasubramanian S, Carey J, Liu G, Shreeve SM, Sun S, Zhuang SH, Vermeulen J, Staudt LM, Wilson W; PHOENIX investigators. Randomized Phase III Trial of Ibrutinib and Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Non-Germinal Center B-Cell Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2019 May 20;37(15):1285-1295. doi: 10.1200/JCO.18.02403. Epub 2019 Mar 22.

lead_sponsor: Janssen Research & Development, LLC

location_country:
Spain
United Kingdom
Ukraine
United States
Belgium
Japan
Czechia
Poland
Russian Federation
Australia
Argentina
Israel
Turkey
Mexico
Norway
Sweden
Brazil
Canada
Hungary
China
Germany
Denmark
Taiwan
Finland
Korea, Republic of
France
Netherlands


title: A Phase III, Randomized, Multicentre, Double-blind, Double-dummy, Parallel-group Comparative Study to Determine the Efficacy, Safety And Tolerability of Ceftazidime-Avibactam Versus Meropenem in the Treatment of Nosocomial Pneumonia Including Ventilator-Associated Pneumonia in Hospitalized Adults

summary: The purpose of the study is to evaluate the effects of Ceftazidime-Avibactam compared to Meropenem for treating hospitalized adults with nosocomial pneumonia including ventilator-associated pneumonia

ReferenceCitation: Cheng K, Newell P, Chow JW, Broadhurst H, Wilson D, Yates K, Wardman A. Safety Profile of Ceftazidime-Avibactam: Pooled Data from the Adult Phase II and Phase III Clinical Trial Programme. Drug Saf. 2020 Aug;43(8):751-766. doi: 10.1007/s40264-020-00934-3.

ReferenceCitation: Tichy E, Torres A, Bassetti M, Kongnakorn T, Di Virgilio R, Irani P, Charbonneau C. Cost-effectiveness Comparison of Ceftazidime/Avibactam Versus Meropenem in the Empirical Treatment of Hospital-acquired Pneumonia, Including Ventilator-associated Pneumonia, in Italy. Clin Ther. 2020 May;42(5):802-817. doi: 10.1016/j.clinthera.2020.03.014. Epub 2020 Apr 27.

ReferenceCitation: Stone GG, Bradford PA, Tawadrous M, Taylor D, Cadatal MJ, Chen Z, Chow JW. In Vitro Activity of Ceftazidime-Avibactam against Isolates from Respiratory and Blood Specimens from Patients with Nosocomial Pneumonia, Including Ventilator-Associated Pneumonia, in a Phase 3 Clinical Trial. Antimicrob Agents Chemother. 2020 Apr 21;64(5). pii: e02356-19. doi: 10.1128/AAC.02356-19. Print 2020 Apr 21.

ReferenceCitation: Li J, Lovern M, Green ML, Chiu J, Zhou D, Comisar C, Xiong Y, Hing J, MacPherson M, Wright JG, Riccobene T, Carrothers TJ, Das S. Ceftazidime-Avibactam Population Pharmacokinetic Modeling and Pharmacodynamic Target Attainment Across Adult Indications and Patient Subgroups. Clin Transl Sci. 2019 Mar;12(2):151-163. doi: 10.1111/cts.12585. Epub 2018 Sep 28.

ReferenceCitation: Nichols WW, Stone GG, Newell P, Broadhurst H, Wardman A, MacPherson M, Yates K, Riccobene T, Critchley IA, Das S. Ceftazidime-Avibactam Susceptibility Breakpoints against Enterobacteriaceae and Pseudomonas aeruginosa. Antimicrob Agents Chemother. 2018 Oct 24;62(11). pii: e02590-17. doi: 10.1128/AAC.02590-17. Print 2018 Nov.

ReferenceCitation: Stone GG, Newell P, Gasink LB, Broadhurst H, Wardman A, Yates K, Chen Z, Song J, Chow JW. Clinical activity of ceftazidime/avibactam against MDR Enterobacteriaceae and Pseudomonas aeruginosa: pooled data from the ceftazidime/avibactam Phase III clinical trial programme. J Antimicrob Chemother. 2018 Sep 1;73(9):2519-2523. doi: 10.1093/jac/dky204.

ReferenceCitation: Torres A, Zhong N, Pachl J, Timsit JF, Kollef M, Chen Z, Song J, Taylor D, Laud PJ, Stone GG, Chow JW. Ceftazidime-avibactam versus meropenem in nosocomial pneumonia, including ventilator-associated pneumonia (REPROVE): a randomised, double-blind, phase 3 non-inferiority trial. Lancet Infect Dis. 2018 Mar;18(3):285-295. doi: 10.1016/S1473-3099(17)30747-8. Epub 2017 Dec 16.

lead_sponsor: Pfizer

location_country:
Spain
Italy
United Kingdom
Ukraine
Peru
Romania
Philippines
Japan
South Africa
Czechia
Poland
Slovenia
Russian Federation
Argentina
India
Turkey
Mexico
Brazil
Hungary
China
Bulgaria
Taiwan
Latvia
Vietnam
Korea, Republic of
France


title: An Open Label, Multi-center Pasireotide Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Pasireotide Study and Are Judged by the Investigator to Benefit From Continued Pasireotide Treatment

summary: The purpose of this study is to allow continued use of pasireotide in patients who are on pasireotide treatment in a Novartis-sponsored study and are benefiting from the treatment as judged by the investigator.

status: Active, not recruiting

design_allocation: Non-Randomized

lead_sponsor: RECORDATI GROUP

location_country:
Spain
Italy
United States
Peru
Belgium
Japan
Romania
Poland
Portugal
Russian Federation
Argentina
India
Israel
Turkey
Mexico
Malaysia
Brazil
Canada
Switzerland
Hungary
Germany
Bulgaria
Taiwan
Greece
Thailand
Korea, Republic of
France
Netherlands

location_facility: Stanford Universtiy Medical Center Stanford Hospital & Clinics

location_facility: Swedish Cancer Institute Swedish Cancer Institute (SC)

location_facility: University of Michigan Comprehensive Cancer Center SC-2

location_facility: Cedars Sinai Medical Center Cedars Sinai 4

location_facility: Memorial Sloan-Kettering Cancer Center SC

status_simplified: Ongoing


acronym: Igloo

title: A Phase 2 Randomized, Double Blind, Placebo Controlled, Parallel Arm Study to Investigate the Efficacy and Safety of Inhaled Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Adults With Symptomatic Influenza A or B Infection

lead_sponsor: Biota Scientific Management Pty Ltd

type: Other Grant/Funding Number

location_country:
United Kingdom
Colombia
Latvia
Australia
Estonia
Canada
Mexico
New Zealand
Hungary
United States
France
Peru
South Africa
Belgium
Germany
Bulgaria

location_facility: The Asthma & Allergy Center, P.C. master

location_facility: University of Pretoria Clinical Research Unit

location_facility: Gemeinschaftspraxis Dres. Kleinecke-Pohl, Kirsch, Benner-Hemsen

location_facility: Diagnostic Consultative Center II - Sofia OOD

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Centro de Investigaction y Transferencia en Salud del Tecnologico de Monterrey

location_facility: Gemeinschaftspraxis Dr. med. Reinhold Jerwan-Keim, Renate Metz

location_facility: Gemeinschaftspraxis Dres. Hagemann, Duerfeld und Breiderhoff

location_facility: Clinica Colsanitas S.A. sede Clinica Universitaria Columbia

location_facility: ABX-CRO advanced pharmaceuticals Forschungsqesellschaft mbH

location_facility: Centro de Investigacion Clinica GRAMEL S.C

location_facility: Clinique Medicale St-Louis (Recherche) Inc

location_facility: Syzygy Clinical Research Services Wilgers

location_facility: CSALADGYOGYYASZ Szolgaltato es Oktato Bt.

location_facility: Nucleo Victoria de Investigacion Clinica S.C.

location_facility: Synexus SA, Stanza Bopape Clinical Research Centre

location_facility: Facultad Mexicana de Medicina, Universidad La Salle A.C.

location_facility: Clinexpert Egeszsegugyi Szolg. es Ker. Kft.

location_facility: Phylasis Clinicas Research S de RL de CV

location_facility: Hometown Urgent Care & Occupational Health

location_facility: Centro de Investigacion Medico Biologica y Terapia Avanzada (CIMBYTA)

location_facility: University of Massachusetts Medical Center

location_facility: Synexus SA - Watermeyer Clinical Research Centre

location_facility: Centro de Investigacion Clinica Acelerada, S.C.

location_facility: Southeast Clinical Research, LLC - Parent

location_facility: Jimboomba Junction Family Practice & Skin Cancer Clinic

location_facility: Institut fuer Praeventive Medizin Freiburg

location_facility: San Diego Sports Medicine & Family Health Center

location_facility: Bethesda Allergy, Asthma & Research Center, LLC

location_facility: DCT-Stone Oak, LLC dba Discovery Clinical Trials

location_facility: Hospital Nacional Carlos Alberto Seguin Escobedo

location_facility: QUALICLINIC Eu-i Szolg. es Kutatasszervezo Kft

location_facility: Hospital Nacional Adolfo Guevara Velasco

location_facility: Dr. Anil K. Gupta Medicine Professional Corporation

location_facility: Oaxaca Site Management Organization S.C.

location_facility: Mexico Centre for Clinical Research S.A. de C.V

location_facility: BRCR Medical Center, Inc DBA Boca Raton Clinical Research

location_facility: DCT - FMC, LLC, d/b/a Discovery Clinical Trials

location_facility: Hospital de Especialidades Centro Medico Puerta de Hierro

location_facility: Vital Prospects Clinical Research Institute, P.C.

location_facility: Allergy Diagnostic & Clinical Research Unit

summary: This Phase 2 protocol is designed to compare two dose levels of laninamivir octanoate versus placebo. The objectives are to obtain safety and efficacy in adults aged 18 to 64 years who present to clinic with symptomatic presumptive influenza A or B infection.


acronym: Post Authorization Safety Study (PASS)

title: A Randomized, Controlled, Open-Label, Multi-Centre, Parallel-Group Study To Assess All-Cause Mortality And Cardiovascular Morbidity In Patients With Chronic Kidney Disease On Dialysis And Those Not On Renal Replacement Therapy Under Treatment With MIRCERA® Or Reference ESAs.

lead_sponsor: Hoffmann-La Roche

ReferenceCitation: Locatelli F, Hannedouche T, Fishbane S, Morgan Z, Oguey D, White WB. Cardiovascular Safety and All-Cause Mortality of Methoxy Polyethylene Glycol-Epoetin Beta and Other Erythropoiesis-Stimulating Agents in Anemia of CKD: A Randomized Noninferiority Trial. Clin J Am Soc Nephrol. 2019 Dec 6;14(12):1701-1710. doi: 10.2215/CJN.01380219. Epub 2019 Aug 16.

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Lithuania
Belgium
Philippines
Czechia
Poland
Russian Federation
Australia
Argentina
Israel
Panama
Turkey
Mexico
Malaysia
Singapore
Sweden
Brazil
Germany
Taiwan
Greece
Thailand
Korea, Republic of
France

location_facility: SBEI of HPE "Northwestern State Medical University n.a. I.I.Mechnikov" of MoH of RF

location_facility: Ospedale Civile; Servizio Di Nefrologia E Dialisi

location_facility: Fresenius Nephrocare Polska Sp. z o.o., Centrum Dializ Fresenius, Osrodek Dializ nr 53 w Pabianicach

location_facility: Hospital of Lithuanian University of Health. Sciences Kaunas Clinics

location_facility: Ospedale S. Marta S. Venera Nuovo; U.O. Nefrologia Dialisi

location_facility: Centro Especializado San Fernando; Nefrología, Diálisis y Trasplante Renal

location_facility: General Hospital Karlovac; Dept of Haemodialysis

location_facility: Uni Hospital of Ioannina; Nephrology Dept.

location_facility: Launceston General Hospital; Diabetes and Renal Research Unit

location_facility: Nemocnice Strahov; Interni Oddeleni-Strahov

location_facility: Robert-Bosch-Krankenhaus; Allgemeine Innere Medizin und Nephrologie

location_facility: Derriford Hospital; Department Of Renal Medicine

location_facility: Universidade Federal de Sao Paulo - UNIFESP

location_facility: St.Petersburg State Budget Institution of Healthcare "City Hospital Saint Hosiomartyr Elisabeth".

location_facility: Universitätsklinikum Bonn; Medizinische Klinik und Poliklinik I; Allgemeine Innere Medizin

location_facility: ASST SANTI PAOLO E CARLO; U.O.S. Nefrologia e Dialisi

location_facility: Powiatowy Szpital Specjalistyczny w Stalowej Woli; Oddział Nefrologii i Dializoterapii

location_facility: P.O. Di Conegliano; U.O. Di Nefrologia E Dialisi

location_facility: Maharaj Nakorn Chiang Mai Hospital; Dept. of Medicine, Renal Division

location_facility: Chang Gung Medical Fundation Kaohsiung Branch; Nephrology

location_facility: Universitaetsklinikum des Saarlandes; Klinik f. Innere Medizin IV

location_facility: Hospital das Clinicas - FMUSP; Nefrologia

location_facility: A.O. Universitaria S. Martino Di Genova; Nefrologia

location_facility: Ospedale Provinciale S. Maria delle Croci; Divisione Nefrologia e Dialsi

location_facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V.; KfH-Nierenzentrum

location_facility: Royal Free & University College Medical School; Centre for Nephrology

location_facility: KFH Nierenzentrum Bad Hersfeld; Nephrologie

location_facility: Azienda Ospedaliera Sant'Anna Unità Operativa Complessa di Nefrologia Dialisi

location_facility: A.O. Santa Maria Nuova Di Reggio Emilia; Unita Operativa Di Nefrologia E Dialisi

location_facility: Clinical Center of Serbia; Clinic of Urology

location_facility: Complejo Hospitalario de Jaen- Hospital Universitario Medico Quirurgico

location_facility: Klinicki Bolnicki Centar Zagreb; Dialysis

location_facility: Clinical Hospital Osijek; Dept of Haemodialysis

location_facility: General Hospital Josip Bencevic; Department of Haemodialysis

location_facility: Centre Hospitalier Du Dr Duchenes; Service De Nephrologie & Hemodialyse

location_facility: Fresenius Nephrocare Polska Sp. z o.o., Centrum Dializ Fresenius, Osrodek Dializ numer 71 w Poznaniu

location_facility: Hopital Civil; Nephrologie Clinique Medicale B

location_facility: Presidio Ospedaliero Maggiore Policlinico Fondazione IRCCS; Pad Croff Div Nefrologia Dialisi

location_facility: St.Petersburg State Budget Institution of Healthcare "City Mariinskaya Hospital"

location_facility: National Taiwan Uni Hospital; Nephrology Dept

location_facility: SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF

location_facility: Centre Hospitalier Uni Ire Gaston Doumergue; Service D'Hemodialyse

location_facility: Clinica de Medicina Interna e Nefrologia (CMIN)

location_facility: Uni Hospital of Alexandroupoli; Nephrology Dept.

location_facility: University Malaya Medical Centre; Division of Nephrology, Department of Medicine

location_facility: Buddhachinaraj Hospital Renal Division; Dept of Medicine

location_facility: Hospital Kuala Lumpur; Department of Medicine

location_facility: Azienda Ospedaliera Santa Maria Misericordia; Divisione Nefrologia Dialisi

location_facility: UNI-Klinikum Campus Kiel Klinik f.Innere Medizin IV

location_facility: DaVita Clinical Research Deutschland GmbH

location_facility: Hospital del Mar; Servicio de Nefrologia

location_facility: Clinical Center Nis; Clinic for Nephrology and Hemodialysis

location_facility: Universita' Di Tor Vergata; Clinica Nefrologia Dialisi

location_facility: NZOZ Stacja Dializ Hand-Prod w Gorlicach

location_facility: Univeristy Hospital of Larissa; Nephrology

location_facility: NZOZ Stacja Dializ Hand-Prod w Limanowej

location_facility: Presidio Ospedaliero Di Lodi; U.O. Nefrologia E Dialisi

location_facility: Hopital Pellegrin; Departement Nephrologie

location_facility: Gemeinschaftspraxis Dr. Stefan Zinn und Steffen Hengst

location_facility: ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Dipartimento di Nefrologia e Dialisi

location_facility: Az. Osp. Di Padova; U.O. Nefrologia 2 E Dialisi

location_facility: Hospital Txagorritxu; Servicio de Nefrologia

location_facility: Royal Devon & Exeter Hospital; Dept of Nephrology

location_facility: Dres. Roland Erwin Winkler Ann Michelsen Dietmar Sehland u.w.

location_facility: ROYAL ADELAIDE HOSPITAL; Renal Clinical Trials, CNARTS

location_facility: Institut Klinicke A Experimentalni Mediciny Klinika Nefrologie

location_facility: Hopital Rangueil; Nephrologie Hemodialyse

location_facility: National Kidney and Transplant Institute

location_facility: Seoul National Uni Hospital; Internal Medicine

location_facility: Ospedale Bernardo Ramazzi; U.O. Di Nefrologia E Dialisi

location_facility: Hospital de Navarra; Servicio de Nefrologia

location_facility: Azienda Ospedaliera Cannizzaro Unità Operativa Nefrologia

location_facility: Complejo Hospitalario Torrecardenas; Servicio de Nefrologia

location_facility: Hospital de Cruces; Servicio de Nefrologia

location_facility: Wojewodzki Szpital Zespolony, Stacja Dializ, Skierniewice

location_facility: University Hospital of Wales; Institute of Nephrology

location_facility: Fresenius Nephrocare Polska Sp zo.o. Centrum Dializ Fresenius Osrodek Dializ Nr 42 w Jasle

location_facility: Salford Royal Foundation Trust; Department Of Nephrology

location_facility: Fondazione Salvatore Maugeri; Divisione Di Nefrologia E Dialisi

location_facility: Fresenius Nephrocare Polska Sp.zo.o.Centrum Dializ FreseniusOśrodek Dializ Nr 62 w Sandomierzu

location_facility: Hospital de Galdakano; Servicio de Nefrologia

location_facility: Nephrologische Schwerpunktpraxis; Hamburg Barmbek

location_facility: Hospital Clinico San Carlos; Servicio de Nefrologia

location_facility: Hospital Ramon y Cajal; Servicio de Nefrologia

location_facility: ASST LARIANA; Divisione di Nefrologia e Dialisi

location_facility: Azienda Ospedaliera San Salvatore; Divisione Nefrologia E Dialisi

location_facility: Universitätsklinikum Erlangen; Medizinische Klinik 4; Nephrologie und Hypertensiologie

location_facility: Samsung Medical Center; Nephrology Department

location_facility: Uppsala University Hospital; Department of Internal Medicine, Nephrology Section

location_facility: Universitätsklinikum Duesseldorf; Klinik fuer Nephrologie

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: Clinical Hospital Center Rijeka; Dialysis

location_facility: King Chulalongkorn Memorial Hospital; Renal Unit, Department of Medicine

location_facility: Hopital Louis Pasteur; Nephrologie - Hemodialyse

location_facility: Akademia Medyczna; Klinika Nefrologii I Chorob Wewnetrznych

location_facility: Monash Medical Centre; Renal Transplant Unit

location_facility: Royal Preston Hospital; Department of Renal Medicine

location_facility: Fresenius Nephrocare Polska Sp zo.o.Centrum Dializ Fresenius Osrodek Dializ Nr 45 w Dabrowie Tarn

location_facility: Clinique Lambert; Service de Néphrologie dialyse

location_facility: Hospital Infanta Sofia; Servico de Nefrologia

location_facility: National University Hospital; Dept of Medicine

location_facility: Clinical Center Voivodina; Clinic for Immunology and Nephrology

location_facility: A.O. Universitaria Policlinico Di Modena; Nefrologia E Dialisi

location_facility: Fakultni Nemocnice Kralovske Vinohrady (FNKV); Interni Hematologicka Klinika

location_facility: Specjalistyczny Szpital Wojewodzki w Ciechanowie; Oddzial Nefrologiczny

location_facility: Ospedale Caduti Bollatesi; U.O. Nefrologia E Dialisi

location_facility: Hospital de Basurto; Servicio de Nefrologia

location_facility: Gold Coast Hospital Department of Pharmacology & Therapeutics

location_facility: University Hospital Coventry And Warwickshire Nhs Trust; Department Of Nephrology

location_facility: A.O.U. Policlinico G.Martino; U.O.C. Nefrologia e Dialisi

location_facility: Vilnius University Hospital Santariskiu Clinic, Nephrology Center

location_facility: Cukurova University School of Medicine; Nefrology Department

location_facility: Tan Tock Seng Hospital; Department of Renal Medicine

location_facility: Singapore General Hospital; Renal Medicine

location_facility: S.P. Szpital Wojewodzki im. Papieza Jana Pawla II

location_facility: Ospedale Civile; Divisione de Nefrologia E Dialisi

location_facility: Service de Nephrologie & D'Immunologie; Clinique

location_facility: Ospedale S. Giacomo; U.O. Di Nefrologia e Dialisi

location_facility: Hopital Edouard-Herriot; Nephrologie - Hemodialyse

location_facility: A.O. Cà Foncello; U.O.Nefrologia, Dialisi e Centro Trapianti

location_facility: Hospital Severo Ochoa; Servicio de Nefrologia

location_facility: Klinikum Hann. Münden, Nephrologisches Zentrum Niedersachsen

location_facility: Baskent University Hospital; Transplantation

location_facility: Centre Hospitalier Les Chanaux; Service de Néphrologie Unité 12

location_facility: Specjalistyczny Szpital im A.Sokołowskiego w Wałbrzychu; Oddzial Nefrologiczny

location_facility: Ospedale Maggiore; U.O.Complessa di Nefrologia e Dialisi

location_facility: Hospital Univ. Pedro Ernesto - Hupe; Nefrologia

location_facility: The Ipswich Hospital Nhs Trust; The Renal Unit

location_facility: Stacja Dializ NZOZ Centrum Medyczne MEDYK

location_facility: Leicester General Hospital; Dept of Nephrology

summary: This 2 arm safety study will compare the outcome with respect to a composite endpoint of all-cause mortality and non-fatal cardiovascular events (myocardial infarction, stroke) in CKD participants either on dialysis or not receiving renal replacement therapy under treatment with methoxy polyethylene glycol-epoetin beta or reference ESAs. Participants will be randomized to receive intravenous (iv) or subcutaneous (sc) methoxy polyethylene glycol-epoetin beta at the following doses: for participants not already receiving ESA treatment, methoxy polyethylene glycol-epoetin beta will be administered at a starting dose of 0.6 micrograms per kilograms every 2 weeks (mcg/kg/2wks) iv or sc; for participants receiving maintenance ESA treatment, iv or sc methoxy polyethylene glycol-epoetin beta will be administered at an initial monthly dose of 120, 200 or 360 micrograms (mcg) depending on the weekly dose of ESA received prior to first methoxy polyethylene glycol-epoetin beta administration. Participants randomized to reference ESA treatment will receive iv or sc ESAs in accordance with their prescribed dosing information.


type: Registry Identifier

type: U.S. NIH Grant/Contract

title: A Pilot Trial of AVD and Brentuximab Vedotin (SGN-35) in the Treatment of Stage II-IV HIV-Associated Hodgkin Lymphoma

summary: This pilot phase I/II trial studies the side effects and the best dose of brentuximab vedotin when given together with combination chemotherapy and to see how well they work in treating patients with stage II-IV human immunodeficiency virus (HIV)-associated Hodgkin lymphoma. Brentuximab vedotin is a monoclonal antibody, called brentuximab, linked to a chemotherapy drug called vedotin. Brentuximab attaches to CD30-positive cancer cells in a targeted way and delivers vedotin to kill them. Drugs used in chemotherapy, such as doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving brentuximab vedotin together with combination chemotherapy may kill more cancer cells.

ReferenceCitation: Rubinstein PG, Moore PC, Rudek MA, Henry DH, Ramos JC, Ratner L, Reid E, Sharon E, Noy A; AIDS Malignancy Consortium (AMC). Brentuximab vedotin with AVD shows safety, in the absence of strong CYP3A4 inhibitors, in newly diagnosed HIV-associated Hodgkin lymphoma. AIDS. 2018 Mar 13;32(5):605-611. doi: 10.1097/QAD.0000000000001729.

lead_sponsor: National Cancer Institute (NCI)

location_country:
United States
France

location_facility: Montefiore Medical Center-Einstein Campus

location_facility: Washington University School of Medicine

location_facility: Siteman Cancer Center at Washington University

location_facility: John H Stroger Jr Hospital of Cook County

location_facility: Johns Hopkins University/Sidney Kimmel Cancer Center

location_facility: Louisiana State University Health Science Center

location_facility: University of Miami Miller School of Medicine-Sylvester Cancer Center

location_facility: UCLA Center for Clinical AIDS Research and Education

location_facility: UCLA / Jonsson Comprehensive Cancer Center

location_facility: University of California Davis Comprehensive Cancer Center

location_facility: Centre Hospitalier Universitaire (CHU) de Toulouse

intervention_type: Other


title: A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients With Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment With Adalimumab and MTX

acronym: RA-COMPARE

summary:
Primary Objective:

To demonstrate the treatment effect of sarilumab and methotrexate (MTX) compared to etanercept and MTX in participants with rheumatoid arthritis (RA) and an inadequate response to adalimumab and MTX by evaluation of the Disease Activity Score for 28 joints (DAS28).

Secondary Objectives:

To assess the signs and symptoms of RA in participants taking sarilumab in combination with MTX.

To assess the quality of life of participants with RA taking sarilumab in combination with MTX.

To assess the safety and tolerability of sarilumab in combination with MTX in participants with RA.

lead_sponsor: Sanofi

location_country:
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Peru
Romania
South Africa
Czechia
Poland
Russian Federation
Australia
Argentina
Israel
Mexico
Malaysia
Brazil
Hungary
Germany
Taiwan
Greece
Latvia
New Zealand
Ecuador
Finland
Thailand
Korea, Republic of
France
Chile
Colombia

location_facility:
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Investigational Site Number 643022
Investigational Site Number 410020
Investigational Site Number 428001
Investigational Site Number 158012
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Investigational Site Number 440006
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Investigational Site Number 250002
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Investigational Site Number 604005
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Investigational Site Number 484013
Investigational Site Number 554011
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Investigational Site Number 643030
Investigational Site Number 724001
Investigational Site Number 804027
Investigational Site Number 203001
Investigational Site Number 076016
Investigational Site Number 643021
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Investigational Site Number 616053
Investigational Site Number 804010
Investigational Site Number 348001
Investigational Site Number 643057
Investigational Site Number 036004
Investigational Site Number 032053
Investigational Site Number 076001
Investigational Site Number 804031
Investigational Site Number 380005


title: Treatment of Sleep-Disordered Breathing With Predominant Central Sleep Apnea by Adaptive Servo Ventilation in Patients With Heart Failure

acronym: Serve-HF

summary: The purpose of this trial is to evaluate the long-term effects and cost-effectiveness of adaptive servo-ventilation (ASV) on the mortality and morbidity of patients with stable heart failure due to left ventricular systolic dysfunction, already receiving optimal medical therapy, who have sleep disordered breathing (SDB) that is predominantly central sleep apnea. Assumptions: the intervention reduces the hazard rate by 20%. The event rate in the control group is 35% in the first year. It is assumed that the hazard rate is constant over time.

ReferenceCitation: Cowie MR, Wegscheider K, Teschler H. Adaptive Servo-Ventilation for Central Sleep Apnea in Heart Failure. N Engl J Med. 2016 Feb 18;374(7):690-1. doi: 10.1056/NEJMc1515007.

ReferenceCitation: Eulenburg C, Wegscheider K, Woehrle H, Angermann C, d'Ortho MP, Erdmann E, Levy P, Simonds AK, Somers VK, Zannad F, Teschler H, Cowie MR. Mechanisms underlying increased mortality risk in patients with heart failure and reduced ejection fraction randomly assigned to adaptive servoventilation in the SERVE-HF study: results of a secondary multistate modelling analysis. Lancet Respir Med. 2016 Nov;4(11):873-881. doi: 10.1016/S2213-2600(16)30244-2. Epub 2016 Aug 31.

ReferenceCitation: Woehrle H, Cowie MR, Eulenburg C, Suling A, Angermann C, d'Ortho MP, Erdmann E, Levy P, Simonds AK, Somers VK, Zannad F, Teschler H, Wegscheider K. Adaptive servo ventilation for central sleep apnoea in heart failure: SERVE-HF on-treatment analysis. Eur Respir J. 2017 Aug 31;50(2). pii: 1601692. doi: 10.1183/13993003.01692-2016. Print 2017 Aug.

ReferenceCitation: Shafazand S, Badr MS. Adaptive Servo-Ventilation and Central Apnea Associated with Systolic Heart Failure. J Clin Sleep Med. 2016 Jan;12(1):147-50. doi: 10.5664/jcsm.5420.

ReferenceCitation: Cowie MR, Woehrle H, Wegscheider K, Angermann C, d'Ortho MP, Erdmann E, Levy P, Simonds AK, Somers VK, Zannad F, Teschler H. Adaptive Servo-Ventilation for Central Sleep Apnea in Systolic Heart Failure. N Engl J Med. 2015 Sep 17;373(12):1095-105. doi: 10.1056/NEJMoa1506459. Epub 2015 Sep 1.

lead_sponsor: ResMed

location_country:
Denmark
United Kingdom
Australia
Netherlands
Finland
Switzerland
Sweden
France
Norway
Germany
Czechia

location_facility: Universitätsklinikum Schleswig-Holstein Campus Lübeck-Schlaflabor

location_facility: Universitätsklinikum Schleswig-Holstein Campus Lübeck-Kardiologie

location_facility: Gemeinschaftspraxis Dres. Wauer / Windstetter

location_facility: Charité Campus Mitte CCM- Schlafmedizinisches Zentrum

location_facility: Universitätsklinikum Gießen / Marburg, Standort Marburg-Schlafmedizin

location_facility: Fachärzte für Innere Medizin Dres Ritter, Richter, Mehrer, Kahl

location_facility: Augusta-Kranken-Anstalt gGmbH Thoraxzentrum Ruhrgebiet

location_facility: Kardiologische Praxis Dr. Burkhard-Meier

location_facility: Hospices Civils de Lyon, Hopital de la Croix-Rousse

location_facility: Oslo University Hospital, Rikshospitalet

location_facility: CH de Forbach, Hospitalor, Hopital Marie Madeleine-Pneumology

location_facility: Kardiologische Praxis Dr. Rudolf/ Dr. Bernhardt

location_facility: Centre Hospitalier d'Antibes Juan-les-Pins

location_facility: Westdeutsches Herzzentrum, Universitätsklinikum Essen

location_facility: Kardiologische Praxis Dr. Siegfried Frickel

location_facility: Klinikum der Johannes Gutenberg-Universität Mainz

location_facility: Schwerpunktpraxis Kardiologie Drs. Ophoff/Fritzsch

location_facility: Tampere University Hospital, Pirkanmaa sairaanhoitopiiri

location_facility: Universitätsklinikum Gießen/Marburg Standort Marburg-Kardiologie

location_facility: Gemeinschaftspraxis Kardiologie Dr. Becker

location_facility: Gemeinschaftspraxis Dres. Brandt / Jakobs

location_facility: Kardiologie Gemeinschaftspraxis Dres Tenholt&Metzger&Dexling

location_facility: Ambulantes Zentrum für Lungenkrankheiten&Schlafmedizin

intervention_type: Device


title: Patient Perception of Symptom Variability. A Cross-sectional Study of Patients With Severe COPD.

summary: This study is investigating how patients with severe stable state COPD perceive the variability of their symptoms throughout the day, the week and the year; the impact of these variations on their daily activities or sleep quality and how they deal with their treatments. For this purpose patients will be asked to answer a questionnaire over the phone

study_type: Observational

time_perspective: Cross-Sectional

enrollment_type: Anticipated

ReferenceCitation: Kessler R, Partridge MR, Miravitlles M, Cazzola M, Vogelmeier C, Leynaud D, Ostinelli J. Symptom variability in patients with severe COPD: a pan-European cross-sectional study. Eur Respir J. 2011 Feb;37(2):264-72. doi: 10.1183/09031936.00051110. Epub 2010 Nov 29.

lead_sponsor: AstraZeneca

location_country:
Denmark
Portugal
Spain
Greece
Austria
Ireland
Italy
Finland
Netherlands
Switzerland
United Kingdom
Sweden
France
Turkey
Belgium
Norway
Germany