title: A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF PF- 06439535 PLUS PACLITAXEL-CARBOPLATIN AND BEVACIZUMAB PLUS PACLITAXEL -CARBOPLATIN FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED NON-SQUAMOUS NON-SMALL CELL LUNG CANCER.

summary: This is a multinational, double-blind, randomized, parallel-group Phase 3 clinical trial evaluating the efficacy and safety of bevacizumab-Pfizer plus paclitaxel and carboplatin versus bevacizumab-EU plus paclitaxel and carboplatin in first-line treatment for patients with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous NSCLC.

ReferenceCitation: Li CSW, Sweeney K, Cronenberger C. Population pharmacokinetic modeling of PF-06439535 (a bevacizumab biosimilar) and reference bevacizumab (Avastin(®)) in patients with advanced non-squamous non-small cell lung cancer. Cancer Chemother Pharmacol. 2020 Mar;85(3):487-499. doi: 10.1007/s00280-019-03946-8. Epub 2019 Nov 26.

ReferenceCitation: Reinmuth N, Bryl M, Bondarenko I, Syrigos K, Vladimirov V, Zereu M, Bair AH, Hilton F, Liau K, Kasahara K. PF-06439535 (a Bevacizumab Biosimilar) Compared with Reference Bevacizumab (Avastin(®)), Both Plus Paclitaxel and Carboplatin, as First-Line Treatment for Advanced Non-Squamous Non-Small-Cell Lung Cancer: A Randomized, Double-Blind Study. BioDrugs. 2019 Oct;33(5):555-570. doi: 10.1007/s40259-019-00363-4.

location_country:
Croatia
Spain
Italy
Ukraine
United States
Romania
Philippines
Japan
South Africa
Czechia
Poland
Russian Federation
Australia
India
Turkey
Malaysia
Brazil
Hungary
Germany
Bulgaria
Taiwan
Greece
Thailand
Korea, Republic of
France
Chile
Netherlands

location_facility: Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu Szpital Obserwacyjno-Zakazny

location_facility: "RMI ""Sumy Reg. Clin. Oncology Dispensary"". oncothoracic dep.-nt. Surny State Univ.,

location_facility: Institute of Respiratory Diseases, SMS Medical College & Hospital

location_facility: COT - Centro Oncologico do Triangulo Ltda

location_facility: S.C. Oncologia Medica-Presidio Ospedaliero Sondrio

location_facility: Federal State Budgetary Institution of Healthcare "Clinical Hospital #

location_facility: P.A.Hertsen Moscow Oncology Research Institute - Branch of the National Medical Radiological

location_facility: Division of Medical Oncology, Department of Medicine, Faculty of Medicine Siriraj Hospital,

location_facility: Chelyabinsk Regional Clinical Oncology Dispensary

location_facility: Diskapi Yildirim Beyazit Egitim ve Arastirma Hastanesi

location_facility: Clinical Research Center, Phramongkutklao Hospital

location_facility: Semmelweis Egyetem, Pulmonologiai Klinika

location_facility: SBHI "Chelyabinsk Regional Clinical Hospital"

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Medizinische Hochschule Hannover Zentralapotheke

location_facility: Universitaetsklinikum des Saarlandes - Klinik fuer Innere Medizin V - Pneumologie, Allergologie,

location_facility: National Hospital Organization Mito Medical Center

location_facility: Krankenhaus Martha-Maria Halle-Doelau gGmbH - Apotheke

location_facility: UOSD Pneumologia Oncologica - Padiglione Flaiani

location_facility: Samodzielny Publiczny Wojewodzki Szpital Zespolony w Szczecinie Szpital Wojewodzki w

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

location_facility: Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE/HSPE-FMO

location_facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii im.Eugenii i Janusza Zeylandow

location_facility: Istanbul Universitesi Onkoloji Enstitusu

location_facility: Ege Universitesi Tip Fakultesi lc Hastaliklari Anabilim Dali

location_facility: SPb SBHI "City Clinical Oncology Dispensary"

location_facility: Medical Oncology Unit, Department of Medicine, Phramongkutklao Hospital

location_facility: Hospital Universitario Fundacion Alcorcon

location_facility: Vincentius-Diakonissen-Kliniken gAG Klinik fuer Diagnostische und Interventionelle Radiologie

location_facility: Spitalul Clinic Judetean de Urgenta Targu Mures, Cardiologie

location_facility: Lviv State Oncologic Regional Treatment and Diagnostic Center

location_facility: State Budget Healthcare Institution of Arkhangelsk Region

location_facility: MI 'Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council'

location_facility: Krankenhaus Martha-Maria Halle-Doelau gGmbH

location_facility: National Hospital Organization Tokyo National Hospital

location_facility: NHI Road clinical hospital at the st. Saratov II of OJSC Russian Railways

location_facility: Spitalul Clinic Judetean de Urgenta "Sf Apostol Andrei" Constanta Clinica Oncologie Medicala

location_facility: Instituto de Oncologia de Sorocaba - ONCO Clinicas Especializadas SC Ltda

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari

location_facility: Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

location_facility: South Coast Radiology, John Flynn Private Hospital

location_facility: National Hospital Organization Mie Chuo Medical Center

location_facility: Spitalul Clinic Judetean Mures, sectia Clinica de Oncologie Medicala

location_facility: Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre - Hospital Santa Rita

location_facility: Clinical hospital n.a. S.R. Mirotvortseva of SSMU

location_facility: Csongrad Megyei Mellkasi Betegsegek Szakkorhaza

location_facility: Centre Hospitalier General De Mont De Marsan

location_facility: "Budgetary Healthcare Institution of Omsk Region ""Clinical Oncology Dispensary"""

location_facility: Centro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia

location_facility: National Hospital Organization Oita Medical Center

location_facility: Oncology Unit, Department of Medicine, Faculty of Medicine, Naresuan University

location_facility: POIS Leipzig GbR, Pneumologisch/onkologisch/internistisches Studienzentrum

location_facility: Hopital d'instruction des armees Sainte Anne

location_facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto -

location_facility: "SBHI ""Chelyabinsk Regional Clinical Oncology Dispensary"""

location_facility: FSBI "N.N.Blokhin Russian Cancer Research Center" RAMS

location_facility: LLC "Medical clinic "INNOVACIA", chemotherapy department

location_facility: Krankenhaus Martha-Maria Halle-Doelau gGmbH - Institut fuer Radiologie

location_facility: National Hospital Organization Hirosaki National Hospital

location_facility: S.G. Primushko Republican Clinical Oncology Dispensary

location_facility: Stavropol Krai State Budget Healthcare Institute "Stavropol Regional Oncology Clinic"

location_facility: FSBI 'Scientific-Research Oncology Institute n.a. N.N.Petrov' of MoH of RF

location_facility: SBEI HPE RyazSMU of MoH of Russia based on SBI of Ryazan Region

location_facility: Oncosinos (Lessa Ferreira Servicos Oncologicos Ltda)

location_facility: Centro Internacional de Estudios Clinicos (CIEC)

location_facility: Staedtisches Klinikum Braunschweig gGmbH Institut fuer Roentgendiagnostik und Nuklearmedizin

location_facility: "SAHI of Moscow ""Moscow City Oncology Hospital #62 of Health Department of Moscow"""

location_facility: Universitaetsklinikum des Saarlandes, Apotheke

location_facility: National Hospital Organization Himeji Medical Center

location_facility: Mahatma Gandhi Cancer Hospital And Research Institute

location_facility: SBHI "Regional clinical hospital #2" of MoH of Krasnodar Region

location_facility: Centrul Medical Pozimed, SC Pozitron Medical Investigation SRL

location_facility: Nemocnice Pelhrimov p.o, Radioterapeuticke oddeleni

location_facility: SBHI of Stavropol Region "Pyatigorsk Oncology Dispensary"

location_facility: SHI Oncology Dispensary #2 of Health Department of Krasnodar Region

location_facility: Limited Liability Company "Common health"

location_facility: Euromedica General Clinic of Thessaloniki

location_facility: Poltava Reg. Clinical Oncology Dispensary of PRC, thoracic department, SHEI of Ukr.

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. Kopernika w Lodzi,

location_facility: Oncoclinic (Clinica de Oncologia e Atendimento de Urgencia Ltda)

location_facility: Vivantes GmbH Apotheke des Humboldt-Klinikums

location_facility: Yildirim Beyazit Universitesi Tip Fakultesi Ataturk Egitim ve Arastirma Hastanesi

location_facility: Institut Fuer Versorgungsforschung In Der Onkologie

location_facility: "RBHI ""Kursk Regional Clinical Oncology Dispensary"" of Healthcare Committee of Kursk Region"

location_facility: Oncologia Medica, Fondazione Poliambulanza Instituto Ospedaliero

location_facility: Semmelweis Egyetem Klinikai Pulmonologiai Klinikai Gyogyszertar

location_facility: Universitaetsklinikum des Saarlandes - Klinik fuer Diagnostische und Interventionelle Radiologie

location_facility: Hospital da Cidade de Passo Fundo - HCPF

location_facility: Saratov scientific research institute of traumatology and orthopedics

location_facility: Petz Aladar Megyei Oktato Korhaz, Pulmonologiai Osztaly

location_facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc w Olsztynie

location_facility: Instituto Clinico Oncologico del Sur (ICOS)

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

location_facility: General Oncology Hospital of Kifissia "Ag. Anargiroi"

location_facility: Univ. of Athens Hosp. of Chest Diseases of Athens ''Sotiria''

location_facility: University Hospital Centre "Sestre Milosrdnice"

location_facility: Institut fuer Diagnostische und Interventionelle Radiologie

location_facility: Zentrum fuer Radiologie und Nuklearmedizin am Johannisplatz (ZRN Leipzig)

location_facility: Hospital Universitario La Paz, Servicio de Oncologia

location_facility: Matrai Gyogyintezet Pulmonologiai Osztaly

location_facility: SBHI of Vladimir Region "Regional Clinical Oncology Dispensary"

location_facility: Road Clinical Hospital on the station Chelyabinsk of OJSC "RZD"

location_facility: Baskent Universitesi Tip Fakultesi Adana Hastanesi

location_facility: Cardiac Services, John Flynn Private Hospital -

location_facility: Austin Health - Olivia Newton - John Cancer & Wellness Centre

location_facility: Centro de Investigaciones Clinicas Vina del Mar Ltda.

location_facility: Wojskowy Instytut Medyczny, Klinika Onkologii

location_facility: Yedikule Gogus Hastaliklari ve Gogus Cerrahisi

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre - ISCMPA

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendelointezet, Megyei Onkologiai Kozpont

location_facility: Kanagawa Cardiovascular and Respiratory Center

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

location_facility: Seoul National University Bundang Hospital

location_facility: SBHI of Stavropol Region "Essentuki Central City Hospital"

location_facility: National Hospital Organization Tokyo Medical Center

location_facility: Wojewodzki Szpital Chorob Pluc im. dr Alojzego Pawelca

location_facility: Privolzhskiy District Medical Center of Federal Biomedical Agency

location_facility: Bradford Hill Centro de Investigaciones Clinicas

location_facility: Spitalul Clinic Judetean Mures, radiologie si imagistica medicala

location_facility: National Hospital Organization Asahikawa Medical Center

location_facility: Staedtisches Klinikum Braunschweig gGmbH Apotheke

location_facility: Hospital Bruno Born (Sociedade Beneficencia e Caridade de Lajeado)

location_facility: Vinnytsia Regional Clinical Oncology Dispensary

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

location_facility: Hiperdia Timisoara, Radiologie si imagistica medicala

location_facility: MRUKMED. Lekarz Beata Madej Mruk i Partner. Sp. p. Oddzial nr 1 w Rzeszowie

location_facility: Communal Non-Profit Enterprise "Regional Center of Oncology",

location_facility: National Hospital Organization Disaster Medical Center

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

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

location_facility: Ankara Universitesi Tip Fakultesi Cebeci Hastanesi

location_facility: lnstituto do Cancer do Estado de Sao Paulo - Octavio Frias de -

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: S.C. Centrul de Oncologie Sf. Nectarie S.R.L., Oncologie Medicala

location_facility: Instituto Clínico Oncológico del Sur (ICOS)

location_facility: Instituto COI de Pesquisa, Educacao e Gestao - COI Clinicas Barra Da Tijuca

location_facility: Consorcio Hospital Universitario General De Valencia

location_facility: SBHI of NNR Nizhniy Novgorod Regional Oncology Dispensary

location_facility: National Hospital Organization Kochi National Hospital

location_facility: Cukurova Universitesi Tip Fakultesi Balcali Hastanesi

location_facility: Sahyadri Clinical Research and Development Center (A Unit of Sahayadri hospitals Limited)

location_facility: Instituto Joinvillense de Hematologia e Oncologia SS Ltda - Clinica de Hematologia e Oncologia

location_facility: Klinisch Chemisch en Hematologisch Laboratorium (KCHL)


title: A Phase 3, Placebo-Controlled, Randomized, Double-Blind, Multi-Center Study of LJPC-501 in Patients With Catecholamine-Resistant Hypotension (CRH)

summary: This is a Phase 3, double-blind, randomized study of LJPC-501 (angiotensin II) in adult patients diagnosed with catecholamine-resistant hypotension (CRH) conducted in multiple centers globally.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Bellomo R, Forni LG, Busse LW, McCurdy MT, Ham KR, Boldt DW, Hästbacka J, Khanna AK, Albertson TE, Tumlin J, Storey K, Handisides D, Tidmarsh GF, Chawla LS, Ostermann M. Renin and Survival in Patients Given Angiotensin II for Catecholamine-Resistant Vasodilatory Shock. A Clinical Trial. Am J Respir Crit Care Med. 2020 Nov 1;202(9):1253-1261. doi: 10.1164/rccm.201911-2172OC.

ReferenceCitation: Bellomo R, Wunderink RG, Szerlip H, English SW, Busse LW, Deane AM, Khanna AK, McCurdy MT, Ostermann M, Young PJ, Handisides DR, Chawla LS, Tidmarsh GF, Albertson TE. Angiotensin I and angiotensin II concentrations and their ratio in catecholamine-resistant vasodilatory shock. Crit Care. 2020 Feb 6;24(1):43. doi: 10.1186/s13054-020-2733-x.

ReferenceCitation: Senatore F, Jagadeesh G, Rose M, Pillai VC, Hariharan S, Liu Q, McDowell TY, Sapru MK, Southworth MR, Stockbridge N. FDA Approval of Angiotensin II for the Treatment of Hypotension in Adults with Distributive Shock. Am J Cardiovasc Drugs. 2019 Feb;19(1):11-20. doi: 10.1007/s40256-018-0297-9. Erratum in: Am J Cardiovasc Drugs. 2019 Apr;19(2):227.

ReferenceCitation: Khanna A, English SW, Wang XS, Ham K, Tumlin J, Szerlip H, Busse LW, Altaweel L, Albertson TE, Mackey C, McCurdy MT, Boldt DW, Chock S, Young PJ, Krell K, Wunderink RG, Ostermann M, Murugan R, Gong MN, Panwar R, Hästbacka J, Favory R, Venkatesh B, Thompson BT, Bellomo R, Jensen J, Kroll S, Chawla LS, Tidmarsh GF, Deane AM; ATHOS-3 Investigators. Angiotensin II for the Treatment of Vasodilatory Shock. N Engl J Med. 2017 Aug 3;377(5):419-430. doi: 10.1056/NEJMoa1704154. Epub 2017 May 21.

ReferenceCitation: Schmull S, Wang Z, Gao L, Lv J, Li J, Xue S. Angiotensins and Their Receptors in Cardiac and Vascular Injury. Curr Hypertens Rev. 2016;12(3):170-180. doi: 10.2174/1573402112666160302101545. Review.

lead_sponsor: La Jolla Pharmaceutical Company

location_country:
United Kingdom
Australia
New Zealand
Finland
Canada
Switzerland
United States
France
Belgium
Germany

location_facility: Rutgers Robert Wood Johnson Medical Center

location_facility: South Health Campus & Rockyview General Hospital

location_facility: Methodist Hospital, Indiana University Health Physicians

location_facility: Los Angeles County + University of Southern California Medical Center

location_facility: Montefiore Medical Center, Weiler Division

location_facility: Norfolk and Norwich University Hospitals

location_facility: John Peter Smith Hospital - JPS Health Network

location_facility: University of California, Irvine Medical Center

location_facility: Joseph M. Still Research Foundation, Inc.

location_facility: Virginia Commonwealth University Medical Center

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A 28 Week, Randomized, Double-blind, Placebo-controlled, Two-part, Multi-center, Parallel Group Dose Range Finding Study to Assess the Effect of Monthly Doses of Bimagrumab 70, 210, and 700 mg on Skeletal Muscle Strength and Function in Older Adults With Sarcopenia (InvestiGAIT)

summary: The purpose of this study was to determine the efficacy of repeat dosing with multiple dose levels of bimagrumab on patient physical function, skeletal muscle mass and strength in older adults with sarcopenia. In addition, this study generated data on the safety, tolerability, and pharmacokinetics of bimagrumab in older adults with sarcopenia.

study_start_date_type: Actual

ReferenceCitation: Rooks D, Swan T, Goswami B, Filosa LA, Bunte O, Panchaud N, Coleman LA, Miller RR, Garcia Garayoa E, Praestgaard J, Perry RG, Recknor C, Fogarty CM, Arai H, Chen LK, Hashimoto J, Chung YS, Vissing J, Laurent D, Petricoul O, Hemsley S, Lach-Trifilieff E, Papanicolaou DA, Roubenoff R. Bimagrumab vs Optimized Standard of Care for Treatment of Sarcopenia in Community-Dwelling Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2020 Oct 1;3(10):e2020836. doi: 10.1001/jamanetworkopen.2020.20836.

ipd_sharing: Undecided

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Denmark
Taiwan
Spain
Russian Federation
Australia
Switzerland
Korea, Republic of
United States
France
Belgium
Japan
Germany
Czechia

intervention_type: Other


title: A Multistage, Phase II Study Evaluating the Safety and Efficacy of Cobimetinib Plus Paclitaxel, Cobimetinib Plus Atezolizumab Plus Paclitaxel, or Cobimetinib Plus Atezolizumab Plus Nab-Paclitaxel as First-Line Treatment for Patients With Metastatic Triple-Negative Breast Cancer

lead_sponsor: Hoffmann-La Roche

type: EudraCT Number

source: euctr

ReferenceCitation: Barteselli G, Goodman GR, Patel Y, Caro I, Xue C, McCallum S. Characterization of Serous Retinopathy Associated with Cobimetinib: Integrated Safety Analysis of Four Studies. Drug Saf. 2022 Oct 30. doi: 10.1007/s40264-022-01248-2. [Epub ahead of print]

location_country:
Taiwan
Romania
Spain
Italy
Latvia
Australia
United Kingdom
Korea, Republic of
United States
France
Israel
Belgium
Czechia

location_facility: Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer

location_facility: Riga East Clinical University Hospital Latvian Oncology Centre

location_facility: Centro Di Riferimento Oncologico; SOC Oncologia Medica C

location_facility: Hospital Universitario Infanta Cristina; Servicio de Oncologia

location_facility: Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque

location_facility: A.O.U Policlinico S. Orsola Malpighi di Bologna U.O di Medicina Interna Borghi - Pad.2

location_facility: Fundacion Jimenez Diaz; Servicio de Oncologia

location_facility: Azienda Ospedaliero - Universitaria Pisana U.O. Oncologia Medica 2 Universitaria - Polo Oncologico

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Hospital Clinico San Carlos; Servicio de Nefrologia

location_facility: Mercy Hospital, a Campus of Plantation General Hospital

location_facility: Yonsei University Health System/Severance Hospital

location_facility: Peter MacCallum Cancer Centre; Medical Oncology

location_facility: Organización Sanitaria Integrada Bilbao Basurto

location_facility: Nottingham University Hospitals City Campus

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

location_facility: National Cancer Center; Medical Oncology

location_facility: Azienda Ospedaliero Universitaria Seconda Università Degli Studi Di Napoli

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

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Hosp. Regional Univ. de Malaga - Hospital Materno Infantil; Hospital Materno Infantil de Malaga

location_facility: St John of God Murdoch Hospital; Oncology West

summary: This three-cohort, multi-stage, randomized, Phase II, multicenter trial will evaluate the safety and tolerability and estimate the efficacy of cobimetinib plus paclitaxel versus placebo plus paclitaxel in Cohort I, of cobimetinib plus atezolizumab plus paclitaxel in Cohort II, and of cobimetinib plus atezolizumab plus nab-paclitaxel in Cohort III in participants with metastatic or locally advanced, triple-negative adenocarcinoma of the breast who have not received prior systemic therapy for metastatic breast cancer (MBC). Participants may continue on study treatment until the development of progressive disease (PD) or the loss of clinical benefit, unacceptable toxicity, and/or consent withdrawal. The Cohort I target sample size is 12 participants for the safety run-in stage and approximately 90 participants in the expansion stage. Each of Cohorts II and III will consist of a safety run-in stage of approximately 15 participants followed by an expansion stage of approximately 15 participants.


status: Active, not recruiting

title: A Single-Arm Open-Label Multi-Centre Extension Study of Pertuzumab Administered As a Single Agent or in Combination With Other Anti-Cancer Therapies in Patients Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Study

study_completion_date_type: Anticipated

location_country:
Poland
Brazil
Portugal
Spain
Italy
Russian Federation
Ukraine
Korea, Republic of
Costa Rica
France
China
Peru
Mexico
Japan
Germany

location_facility: Zhejiang Cancer Hospital; Breast Surgery

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

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Az. Osp. S. Orsola Malpighi; Istituto Di Oncologia Seragnoli

location_facility: Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU; Chair of Oncology and Medical Radiology

location_facility: Instituto de Oncologia de Sorocaba - CEPOS

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

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

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hospital Metropolitano (Sede Lindora-Santa Ana); Centro de Cancer

location_facility: Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica

location_facility: Centro de Investigación En Oncología Y Medicina Interna de La Clínica Santa Beatriz

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

location_facility: Praxis für Ambulante Onkologie im Krankenhaus Jerusalem

location_facility: Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology

location_facility: National Cancer Center Hospital East; Gastroenterology

location_facility: Instituto Nacional de Cancerologia; Oncology

location_facility: Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional

location_facility: Kursk Regional Clinical Oncology Dispensary

location_facility: Clinica Anglo Americana - Centro de Investigacion Oncologia CAA

location_facility: Centre Henri Becquerel; Oncologie Medicale

location_facility: SBI of Healthcare Samara Regional Clinical Oncology Dispensary

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

location_facility: State Oncology Regional Treatment-Diagnostic Center; Chemotherapy Department

location_facility: ICO L'Hospitalet; Servicio de oncologia medica

location_facility: Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica

location_facility: Studienzentrum UnterEms; Onkologische Schwerpunktpraxis Leer; Dr. med. Lothar Müller

location_facility: Clinique Armoricaine Radiologie; Cons Externes

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: AUSL - IRCCS Santa Maria Nuova; U.O. Day Hospital di Oncologia

location_facility: Cancerologia de Queretaro; Oncologia; Investigación

location_facility: Hospital de Basurto; Servicio de Oncologia

location_facility: Consultorio de Medicina Especializada; Dentro de Condominio San Francisco

location_facility: Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: Gifu University Hospital; Digestive Surgery

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA

location_facility: Hospital Universitari i Politecnic La Fe; Oncologia

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

location_facility: Centre Rene Huguenin; CONSULT SPECIALISEES

location_facility: Praxis für Interdisziplinäre Onkologie und Hämatologie GbR

location_facility: Samodzielny Publiczny Kliniczny Nr 1 W Lublinie; Klinika Chirurgii Onkologicznej

location_facility: Hospital Universitario de Canarias;servicio de Oncologia

location_facility: IPO de Coimbra; Servico de Oncologia Medica

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

location_facility: Onkologische Praxis Neumarkt (Dr. med. Ekkehart Ladda)

location_facility: Harbin Medical University Cancer Hospital

summary: This is a single-arm, multi-center, open-label extension study designed to provide continued pertuzumab therapy to patients receiving pertuzumab as an investigational medicinal product (IMP) in a Roche-sponsored global study and who continue to receive pertuzumab at the end of the Parent study, as well as to collect long-term safety and efficacy data of pertuzumab therapy. Patients with solid tumors who have not experienced progressive disease in the Parent study and, in the investigator's opinion, may potentially benefit from continued pertuzumab treatment, will continue to receive pertuzumab until disease progression, unacceptable toxicity, investigator/patient decision, patient non-compliance, patient death, patient request to withdraw, or study termination by the Sponsor, whichever occurs first.

status_simplified: Ongoing


title: Open-Label, Randomized Study of Daclatasvir, Sofosbuvir, and Ribavirin for 12 vs. 16 Weeks in Treatment Naive and Treatment Experienced Patients With Genotype 3 Chronic Hepatitis C Infection Subjects With Compensated Advanced Fibrosis/Cirrhosis (F3/F4)

lead_sponsor: Bristol-Myers Squibb

location_country: Australia France

summary: The purpose of the study is to determine if the combination of Daclatasvir, Sofosbuvir and Ribavirin for 12 or 16 weeks is safe and effective in the treatment of Genotype 3 Chronic Hepatitis C (HCV) in patients with advanced fibrosis or compensated cirrhosis. Patients in this study may have already been treated prior for HCV or may have never received treatment for their HCV.


title: A Phase 3 Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALN TTRSC in Patients With Transthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC)

summary: The purpose of this study was to evaluate the safety and efficacy of revusiran (ALN-TTRSC) in patients with transthyretin (TTR) mediated Familial Amyloidotic Cardiomyopathy. Dosing has been discontinued; patients are being followed-up for safety.

ReferenceCitation: Judge DP, Kristen AV, Grogan M, Maurer MS, Falk RH, Hanna M, Gillmore J, Garg P, Vaishnaw AK, Harrop J, Powell C, Karsten V, Zhang X, Sweetser MT, Vest J, Hawkins PN. Phase 3 Multicenter Study of Revusiran in Patients with Hereditary Transthyretin-Mediated (hATTR) Amyloidosis with Cardiomyopathy (ENDEAVOUR). Cardiovasc Drugs Ther. 2020 Jun;34(3):357-370. doi: 10.1007/s10557-019-06919-4. Erratum in: Cardiovasc Drugs Ther. 2020 Jun 16;:.

lead_sponsor: Alnylam Pharmaceuticals

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


type: Other Identifier

title: A Study Evaluating the Pregnancy Outcomes and Safety of Interrupting Endocrine Therapy for Young Women With Endocrine Responsive Breast Cancer Who Desire Pregnancy

acronym: POSITIVE

summary: The best available evidence suggests that pregnancy after breast cancer does not increase a woman's risk of developing a recurrence from her breast cancer. In particular, the most recent data suggest that this is the case also in women with a hormone receptor-positive breast cancer. There is also no indication of increased risk for delivery complications or for the newborn. The aim of the study is to investigate if temporary interruption of endocrine therapy, with the goal to permit pregnancy, is associated with a higher risk of breast cancer recurrence.The study aims also to evaluate different specific indicators related to fertility, pregnancy and breast cancer biology in young women. A psycho-oncological companion study on fertility concerns, psychological well-being and decisional conflicts will be conducted in interested Centers.

ReferenceType: background

ReferenceCitation: Brinton LA, Sherman ME, Carreon JD, Anderson WF. Recent trends in breast cancer among younger women in the United States. J Natl Cancer Inst. 2008 Nov 19;100(22):1643-8. doi: 10.1093/jnci/djn344. Epub 2008 Nov 11.

ReferenceCitation: Leclère B, Molinié F, Trétarre B, Stracci F, Daubisse-Marliac L, Colonna M; GRELL Working Group. Trends in incidence of breast cancer among women under 40 in seven European countries: a GRELL cooperative study. Cancer Epidemiol. 2013 Oct;37(5):544-9. doi: 10.1016/j.canep.2013.05.001. Epub 2013 Jun 12. Erratum in: Cancer Epidemiol. 2014 Feb;38(1):106. GRELL Working Group [added]; multiple investigator names added.

ReferenceCitation: Bentzon N, Düring M, Rasmussen BB, Mouridsen H, Kroman N. Prognostic effect of estrogen receptor status across age in primary breast cancer. Int J Cancer. 2008 Mar 1;122(5):1089-94.

ReferenceCitation: Anders CK, Hsu DS, Broadwater G, Acharya CR, Foekens JA, Zhang Y, Wang Y, Marcom PK, Marks JR, Febbo PG, Nevins JR, Potti A, Blackwell KL. Young age at diagnosis correlates with worse prognosis and defines a subset of breast cancers with shared patterns of gene expression. J Clin Oncol. 2008 Jul 10;26(20):3324-30. doi: 10.1200/JCO.2007.14.2471. Erratum in: J Clin Oncol. 2011 Sep 20;29(27):3721.

ReferenceCitation: Perachino M, Poggio F, Arecco L, Blondeaux E, Spinaci S, Marrocco C, Levaggi A, Lambertini M. Update on Pregnancy Following Breast Cancer Diagnosis and Treatment. Cancer J. 2022 May-Jun 01;28(3):176-182. doi: 10.1097/PPO.0000000000000599. Review.

lead_sponsor: ETOP IBCSG Partners Foundation

location_country:
Serbia
Spain
Italy
United States
Belgium
Japan
Portugal
Slovenia
Austria
Australia
Israel
Norway
Lebanon
Canada
Switzerland
Hungary
Denmark
Greece
Ireland
Korea, Republic of
France
Netherlands

location_facility: Women and Infants Hospital of Rhode Island

location_facility: Abbott-Northwestern Hospital, 800 East 28th Street

location_facility: Istituto Oncologico della Svizzera Italiana (IOSI)

location_facility: Montefiore Medical Center - Moses Campus, 111 East 210th Street

location_facility: John H Stroger Jr Hospital of Cook County

location_facility: Leiden University Medical Centre, Albinusdreef 2, Postbus 9600

location_facility: UNC Lineberger Comprehensive Cancer Center

location_facility: NorthShore University HealthSystem-Evanston Hospital

location_facility: NHO Kyushu Cancer Centre, 3-1-1 Notame Minami-ku Fukuoka-shi

location_facility: Yale-New Haven Hospital North Haven Medical Center

location_facility: University of Colorado Cancer Centre - Anschutz Cancer Pavilion

location_facility: Weill Medical College of Cornell University

location_facility: Cliniques Universitaires Saint-Luc Brussels

location_facility: NorthShore Unversity Health System - Highland Park Hospital

location_facility: Smilow Cancer Hospital Care Center-Fairfield

location_facility: Huntsman Cancer Institute / University of Utah

location_facility: Greenville Health System Cancer Institute-Seneca

location_facility: AO Universitaria Ospedale Di Circolo e Fondazione

location_facility: Hospital Universitario HM Sanchinarro - Centro Integral Oncologico Clara Campal (CIOCC)

location_facility: National Cancer Center for Global Medicine

location_facility: Bon Secours Saint Francis Medical Centre

location_facility: Hospital Clinico Universitario Virgen de la Arrixaca

location_facility: Montefiore Medical Center - Einstein Campus, 1695 Eastchester Road

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: Champalimaud Cancer Center - Breast Cancer Unit

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

location_facility: Laso General Hospital, First Department of Medical Oncology

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: Hospital General Universitario de Valencia - Servico Oncologia

location_facility: American University of Beirut Medical Center

location_facility: Smilow Cancer Hospital-Torrington Care Center

location_facility: Norwegian Radium Hospital (Oslo University)

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: U.O Medicina Oncologica Ospedale di Carpi

location_facility: CHCVs Hôpital de Sion - Service d'oncologie ambulatoire

location_facility: Greenville Health System Cancer Institute-Eastside

location_facility: Institute of Oncology Ljubljana - Medical Oncology Department

location_facility: Instituto Catalán de Oncología de Gerona Hospital

location_facility: Dartmouth Hitchcock Medical Center/Norris Cotton Cancer Center

location_facility: Greenville Health System Cancer Institute-Butternut

location_facility: Spital STS AG Onkologiezentrum Thun-Berner Oberland

location_facility: University Hospital of Lausanne (CHUV) BH06 - Oncology Department

location_facility: Regional Hematology Oncology Practice Associates

location_facility: Salvatore Maugeri Foundation - Medical Oncology Unit

location_facility: Greenville Health System Cancer Institute-Greer

location_facility: Institute of Oncology & Radiology of Serbia

location_facility: Montefiore Medical Center-Weiler Hospital

location_facility: Smilow Cancer Hospital Care Center at Saint Francis

location_facility: Univ. Klinik f. Frauenheilkunde Innsbruck

location_facility: Smilow Cancer Hospital-Orange Care Center

location_facility: Smilow Cancer Hospital-Waterbury Care Center

location_facility: Brustzentrum Thurgau - Obstetrics and Gynecology

location_facility: Greenville Health System Cancer Institute-Faris

location_facility: Odette Cancer Centre - Sunnybrook Health Sciences Centre

location_facility: Smilow Cancer Hospital-Derby Care Center

location_facility: Istituto scientifico Romagnolo per lo studio e la cura

location_facility: Christiana Care Health System-Christiana Hospital

location_facility: NorthShore University Health System - Glenbrook Hospital

location_facility: Greenville Health System Cancer Institute-Spartanburg

location_facility: Ospedale degli Infermi - S. C. Oncologia Medica

location_facility: Univ. Klinik f. Frauenheilkunde u. Geburtshilfe

location_facility: Hennepin County Medical Center - Cancer Center

location_facility: Social Medical Corporation Hakuaikai Sagara Hospital

location_facility: University General Hospital of Heraklion

location_facility: Hospital Universitario Central de Asturias

location_facility: Sanford USD Medical Centre - Sioux Falls

location_facility: Medical Oncology Hematology Consultants PA

location_facility: IHA Hematology Oncology Consultants-Ann Arbor

location_facility: Bon Secours Memorial Regional Medical Centre

location_facility: St Marianna University School of Medicine Hospital

location_facility: Smilow Cancer Hospital Care Center-Trumbull


title: The COMPASS Study: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of ISIS 304801 Administered Subcutaneously to Patients With Hypertriglyceridemia

summary: The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 26 weeks in participants with Hypertriglyceridemia.

ReferenceCitation: Gouni-Berthold I, Alexander VJ, Yang Q, Hurh E, Steinhagen-Thiessen E, Moriarty PM, Hughes SG, Gaudet D, Hegele RA, O'Dea LSL, Stroes ESG, Tsimikas S, Witztum JL; COMPASS study group. Efficacy and safety of volanesorsen in patients with multifactorial chylomicronaemia (COMPASS): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Diabetes Endocrinol. 2021 May;9(5):264-275. doi: 10.1016/S2213-8587(21)00046-2. Epub 2021 Mar 30.

ipd_sharing: No

lead_sponsor: Ionis Pharmaceuticals, Inc.

location_country:
United Kingdom
Netherlands
Canada
United States
France
Germany


title: A Phase 2, International, Multicenter, Randomized, Open-label, Parallel Group to Evaluate the Efficacy and Safety of Cc-486 (Oral Azacitidine) Alone in Combination With Durvalumab (MEDI4736) in Subjects With Myelodysplastic Syndromes Who Fail to Achieve an Objective Response to Treatment With Azacitidine for Injection or Decitabine

lead_sponsor: Celgene

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

location_facility: Azienda Ospedaliera Santi Antonio Biagio E Cesare Arrigo

location_facility: King's College HospitalSchool of Medicine

location_facility: University of Miami Miller School of Medicine

location_facility: University of Iowa Hospitals and Clinics

location_facility: Medizinische Klinik III Klinikum der Universität München-Großhadern

location_facility: H Lee Moffitt Cancer Center and Research Institute

location_facility: Universitatsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital

location_facility: Institut Calatà d'Oncologia, L'Hospitalet

location_facility: Zaklad Opieki Zdrowotnej MSW z Warminsko-Mazurskim Centrum Onkologii

location_facility: Centre Hospitalier Universitaire de Liege

location_facility: Hospital Universitario Virgen De La Victoria

location_facility: Cancer Care Centers of South Texas - HOAST

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi

summary:
Evaluate the safety and efficacy of oral azacitidne (CC-486) twice daily (BID) in subjects with myelodysplastic syndromes who failed to achieve an objective response post injectable hypomethylating agent (iHMA) treatment

Reason for removing the combination arm: Due to difficulties with dose-finding, the durvalumab plus CC-486 combination arm was closed to enrollment.

Extension:

An Extension Phase (EP) has been added to allow subjects who are currently receiving oral azacitidine BID and who are demonstrating clinical benefit as assessed by the Investigator, to continue receiving oral azacitidine until the subject meets the criteria for study discontinuation.


ipd_sharing: Yes

title: A Single Arm, Open-label, Long-term Efficacy and Safety Study of Romiplostim in Thrombocytopenic Pediatric Subjects With Immune Thrombocytopenia (ITP)

lead_sponsor: Amgen

ReferenceCitation: Tarantino MD, Despotovic J, Roy J, Grainger J, Cooper N, Beam D, Raj A, Maschan A, Kim J, Eisen M. Romiplostim treatment for children with immune thrombocytopenia: Results of an integrated database of five clinical trials. Pediatr Blood Cancer. 2020 Nov;67(11):e28630. doi: 10.1002/pbc.28630. Epub 2020 Sep 9.

ReferenceCitation: Grainger J, Bussel JB, Tarantino MD, Cooper N, Beam D, Despotovic JM, Maschan A, Wang K, Eisen M, Bowers C. A Single-Arm, Long-Term Efficacy and Safety Study of Subcutaneous Romiplostim in Children with Immune Thrombocytopenia. Blood Adv. 2022 Apr 12:bloodadvances.2021006014. doi: 10.1182/bloodadvances.2021006014. Online ahead of print.

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

location_country:
Poland
Brazil
Spain
United Kingdom
Russian Federation
Australia
Mexico
Canada
Switzerland
Hungary
United States
France
Israel
South Africa
Belgium
Turkey
Czechia

summary: This is a phase 3b single arm, open label, multicenter study describing the percentage of time pediatric participants with ITP have a platelet response while receiving romiplostim, defined as a platelet count ≥ 50 x 10^9/L in the absence of ITP rescue medications for the past 4 weeks.


title: BIOTRONIK - A Prospective, International, Mulit-centre, Post-market All-comers Registry to Assess the Clinical Performance of the Passeo-18 Lux Paclitaxel Releasing Balloon Catheter in Infrainguinal Arteries - III

summary: BIOLUX P-III is a prospective, international, multi-centre, postmarket all-comers registry to collect clinical performance data on the Passeo-18 Lux paclitaxel releasing balloon catheter in the treatment of atherosclerotic disease of the infrainguinal arteries.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Barry IP, Macarulay R, Brodmann M, Zeller T, Moscovic M, Dahm J, Troisi N, Tepe G, Wong J, Mwipatayi BP; BIOLUX P-III Global Registry Investigators. Sex-Related Outcomes Following Drug Balloon Angioplasty in Patients from the BIOLUX P-III Registry: A Subgroup Analysis. Cardiovasc Intervent Radiol. 2022 Jul;45(7):918-928. doi: 10.1007/s00270-022-03135-w. Epub 2022 Apr 20.

ReferenceCitation: Mwipatayi BP, Barry IP, Brodmann M, Zeller T, Varcoe RL, Moscovic M, Chian JWC, Christensen JK, Yahaya SA, Oshin OA, Tepe G; BIOLUX P-III Global Registry Investigators. Twenty-Four-Month Outcomes of Drug-Coated Balloon in Diabetic Patients in the BIOLUX P-III Registry: A Subgroup Analysis. Ann Vasc Surg. 2021 Aug;75:237-252. doi: 10.1016/j.avsg.2021.02.050. Epub 2021 Apr 5.

ReferenceCitation: Tepe G, Zeller T, Moscovic M, Corpataux JM, Christensen JK, Keirse K, Nano G, Schroeder H, Binkert CA, Brodmann M. Paclitaxel-Coated Balloon Angioplasty for the Treatment of Infrainguinal Arteries: 24-Month Outcomes in the Full Cohort of BIOLUX P-III Global Registry. Cardiovasc Intervent Radiol. 2021 Feb;44(2):207-217. doi: 10.1007/s00270-020-02663-7. Epub 2020 Oct 20. Erratum in: Cardiovasc Intervent Radiol. 2021 Jul;44(7):1155-1156.

ReferenceCitation: Tepe G, Wang J, Corpataux JM, Pua U, Binkert CA, Moscovic M, Ghotbi R, Keirse K, Robertson D, Brodmann M. BIOLUX P-III Passeo-18 Lux All-Comers Registry: 24-Month Results in Below-the-Knee Arteries. Cardiovasc Intervent Radiol. 2021 Jan;44(1):10-18. doi: 10.1007/s00270-020-02586-3. Epub 2020 Sep 22. Erratum in: Cardiovasc Intervent Radiol. 2021 Aug;44(8):1307.

ReferenceCitation: Tepe G, Zeller T, Moscovic M, Corpataux JM, Christensen JK, Keirse K, Nano G, Schroeder H, Binkert CA, Brodmann M. Paclitaxel-Coated Balloon for the Treatment of Infrainguinal Disease: 12-Month Outcomes in the All-Comers Cohort of BIOLUX P-III Global Registry. J Endovasc Ther. 2020 Apr;27(2):304-315. doi: 10.1177/1526602819898804. Epub 2020 Jan 28. Erratum in: J Endovasc Ther. 2021 Jun;28(3):489.

lead_sponsor: Biotronik AG

location_country: Denmark Portugal Spain Italy Austria Australia Latvia Finland Netherlands Switzerland France Malaysia Singapore Belgium Germany Slovakia

location_facility: P.Stradins Clinical University Hospital, Institute of Diagnostic

location_facility: Department Radiologie, Universitätsklinik für Radiodiagnostik

location_facility: Department of Angiology at Universitats- Herzzentrum Freiburg

location_facility: Hospital. Universitario Germans Trias i Pujol

location_facility: Centre Hopsitalier Universitaire Vaudois

location_facility: Institute of Cardiovascular diseases Kosice, Dpt. of Angiology

location_facility: Universitätsklinikum Giessen und Marburg GmbH

intervention_type: Device


title: Six-Month, Randomized, Open-Label, Parallel-group Comparison of SAR342434 to Humalog® in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine, With a 6-month Safety Extension Period

summary:
Primary Objective:

To demonstrate non-inferiority of SAR342434 versus Humalog in glycated haemoglobin A1c (HbA1c) change from baseline to Week 26 in participants with type 1 diabetes mellitus (T1DM) also using insulin glargine.

Secondary Objectives:

To assess the immunogenicity of SAR342434 and Humalog in terms of positive/negative status and antibody titers at baseline and during the course of the study.

To assess the relationship of anti-insulin antibodies with efficacy and safety including during the safety extension.

To assess the efficacy of SAR342434 and Humalog in terms of proportion of participants reaching target HbA1c (<7%), Fasting plasma glucose (FPG), self-measured plasma glucose (SMPG) profiles, and insulin dose.

To assess safety of SAR342434 and Humalog.

ReferenceCitation: Garg SK, Wernicke-Panten K, Rojeski M, Pierre S, Kirchhein Y, Jedynasty K. Efficacy and Safety of Biosimilar SAR342434 Insulin Lispro in Adults with Type 1 Diabetes Also Using Insulin Glargine-SORELLA 1 Study. Diabetes Technol Ther. 2017 Sep;19(9):516-526. doi: 10.1089/dia.2017.0117. Epub 2017 Aug 30. Erratum in: Diabetes Technol Ther. 2017 Dec;19(12):753.

lead_sponsor: Sanofi

location_country:
Poland
Spain
Russian Federation
Hungary
United States
France
Japan
Germany

location_facility:
Investigational Site Number 840027
Investigational Site Number 392006
Investigational Site Number 840006
Investigational Site Number 643006
Investigational Site Number 840022
Investigational Site Number 392003
Investigational Site Number 840012
Investigational Site Number 840028
Investigational Site Number 840040
Investigational Site Number 840030
Investigational Site Number 840051
Investigational Site Number 643007
Investigational Site Number 840013
Investigational Site Number 616005
Investigational Site Number 724005
Investigational Site Number 392004
Investigational Site Number 724003
Investigational Site Number 840018
Investigational Site Number 840045
Investigational Site Number 724004
Investigational Site Number 348011
Investigational Site Number 250001
Investigational Site Number 250005
Investigational Site Number 250003
Investigational Site Number 643002
Investigational Site Number 840059
Investigational Site Number 616002
Investigational Site Number 840061
Investigational Site Number 840004
Investigational Site Number 348003
Investigational Site Number 276007
Investigational Site Number 276005
Investigational Site Number 840033
Investigational Site Number 276003
Investigational Site Number 348010
Investigational Site Number 840046
Investigational Site Number 840026
Investigational Site Number 840002
Investigational Site Number 840003
Investigational Site Number 276001
Investigational Site Number 840014
Investigational Site Number 840041
Investigational Site Number 840037
Investigational Site Number 840048
Investigational Site Number 840029
Investigational Site Number 643003
Investigational Site Number 392005
Investigational Site Number 840020
Investigational Site Number 616001
Investigational Site Number 276008
Investigational Site Number 840031
Investigational Site Number 392001
Investigational Site Number 276004
Investigational Site Number 348005
Investigational Site Number 840060
Investigational Site Number 840042
Investigational Site Number 840038
Investigational Site Number 616004
Investigational Site Number 616003
Investigational Site Number 840007
Investigational Site Number 840011
Investigational Site Number 840015
Investigational Site Number 276006
Investigational Site Number 276002
Investigational Site Number 840062
Investigational Site Number 840016
Investigational Site Number 840036
Investigational Site Number 840019
Investigational Site Number 840054
Investigational Site Number 840021
Investigational Site Number 250002
Investigational Site Number 840039
Investigational Site Number 840034
Investigational Site Number 348002
Investigational Site Number 392002
Investigational Site Number 724002
Investigational Site Number 840043
Investigational Site Number 840057
Investigational Site Number 840009
Investigational Site Number 840023
Investigational Site Number 348007
Investigational Site Number 643005
Investigational Site Number 724001
Investigational Site Number 643001
Investigational Site Number 840050
Investigational Site Number 643004
Investigational Site Number 840049
Investigational Site Number 348001
Investigational Site Number 840005


title: A Modular Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ceralasertib in Combination With Cytotoxic Chemotherapy and/or DNA Damage Repair/Novel Anti-cancer Agents in Patients With Advanced Solid Malignancies.

summary: This is a modular, phase I/ phase 1 b, open-label, multicentre study of ceralasertib administered orally in combination with cytotoxic chemotherapy regimens and/or novel anti-cancer agents, to patients with advanced malignancies. The study design allows an investigation of optimal combination dose of ceralasertib with other anti-cancer treatments, with intensive safety monitoring to ensure the safety of the patients. The initial combination to be investigated is ceralasertib with carboplatin. The second combination to be investigated is ceralasertib with Olaparib. The third combination to be investigated is ceralasertib with durvalumab

status: Recruiting

design_allocation: Non-Randomized

enrollment_type: Anticipated

ReferenceCitation: Smith G, Alholm Z, Coleman RL, Monk BJ. DNA Damage Repair Inhibitors-Combination Therapies. Cancer J. 2021 Nov-Dec 01;27(6):501-505. doi: 10.1097/PPO.0000000000000561. Review.

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.

lead_sponsor: AstraZeneca

location_country:
Korea, Republic of
United States
United Kingdom
France


title: A Randomized, Multi-center, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib in Combination With Obinutuzumab Versus Chlorambucil in Combination With Obinutuzumab in Subjects With Treatment-naïve Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

summary: The primary objective of this study is to evaluate the efficacy of ibrutinib in combination with obinutuzumab compared to chlorambucil in combination with obinutuzumab based on the Independent Review Committee (IRC) assessment of progression free survival (PFS). Efficacy will be evaluated according to 2008 International Workshop for Chronic Lymphocytic Leukemia (IWCLL) criteria with the modification for treatment-related lymphocytosis, in subjects with treatment-naive CLL or SLL.

ReferenceType: result

ReferenceCitation: Moreno C, Greil R, Demirkan F, Tedeschi A, Anz B, Larratt L, Simkovic M, Samoilova O, Novak J, Ben-Yehuda D, Strugov V, Gill D, Gribben JG, Hsu E, Lih CJ, Zhou C, Clow F, James DF, Styles L, Flinn IW. Ibrutinib plus obinutuzumab versus chlorambucil plus obinutuzumab in first-line treatment of chronic lymphocytic leukaemia (iLLUMINATE): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2019 Jan;20(1):43-56. doi: 10.1016/S1470-2045(18)30788-5. Epub 2018 Dec 3. Erratum in: Lancet Oncol. 2019 Jan;20(1):e10.

ReferenceCitation: Moreno C, Greil R, Demirkan F, Tedeschi A, Anz B, Larratt L, Simkovic M, Novak J, Strugov V, Gill D, Gribben JG, Kwei K, Dai S, Hsu E, Dean JP, Flinn IW. First-line treatment of chronic lymphocytic leukemia with ibrutinib plus obinutuzumab versus chlorambucil plus obinutuzumab: final analysis of the randomized, phase III iLLUMINATE trial. Haematologica. 2022 Sep 1;107(9):2108-2120. doi: 10.3324/haematol.2021.279012.

ReferenceCitation: Burger JA, Robak T, Demirkan F, Bairey O, Moreno C, Simpson D, Munir T, Stevens DA, Dai S, Cheung LWK, Kwei K, Lal I, Hsu E, Kipps TJ, Tedeschi A. Up to 6.5 years (median 4 years) of follow-up of first-line ibrutinib in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma and high-risk genomic features: integrated analysis of two phase 3 studies. Leuk Lymphoma. 2022 Jun;63(6):1375-1386. doi: 10.1080/10428194.2021.2020779. Epub 2022 Jan 11.

ReferenceCitation: Allan JN, Shanafelt T, Wiestner A, Moreno C, O'Brien SM, Li J, Krigsfeld G, Dean JP, Ahn IE. Long-term efficacy of first-line ibrutinib treatment for chronic lymphocytic leukaemia in patients with TP53 aberrations: a pooled analysis from four clinical trials. Br J Haematol. 2022 Feb;196(4):947-953. doi: 10.1111/bjh.17984. Epub 2021 Dec 5.

ReferenceCitation: Greil R, Tedeschi A, Moreno C, Anz B, Larratt L, Simkovic M, Gill D, Gribben JG, Flinn IW, Wang Z, Cheung LWK, Nguyen AN, Zhou C, Styles L, Demirkan F. Pretreatment with ibrutinib reduces cytokine secretion and limits the risk of obinutuzumab-induced infusion-related reactions in patients with CLL: analysis from the iLLUMINATE study. Ann Hematol. 2021 Jul;100(7):1733-1742. doi: 10.1007/s00277-021-04536-6. Epub 2021 May 20.

ipd_sharing_description: Requests for access to individual participant data from clinical studies conducted by Pharmacyclics LLC, an AbbVie Company, can be submitted through Yale Open Data Access (YODA) Project site at the following link.

lead_sponsor: Pharmacyclics LLC.

location_country:
Poland
Spain
Italy
Austria
Australia
New Zealand
Canada
Russian Federation
United Kingdom
United States
France
Israel
Turkey
Belgium
Sweden
Czechia

location_facility:
Site Reference ID/Investigator# 0844
Site Reference ID/Investigator# 0854
Site Reference ID/Investigator# 0881
Site Reference ID/Investigator# 0365
Site Reference ID/Investigator# 071
Site Reference ID/Investigator# 018
Site Reference ID/Investigator# 0170
Site Reference ID/Investigator# 0850
Site Reference ID/Investigator# 0732
Site Reference ID/Investigator# 0866
Site Reference ID/Investigator# 0584
Site Reference ID/Investigator# 0868
Site Reference ID/Investigator# 0856
Site Reference ID/Investigator# 0632
Site Reference ID/Investigator# 0775
Site Reference ID/Investigator# 0870
Site Reference ID/Investigator# 304
Site Reference ID/Investigator #0503
Site Reference ID/Investigator# 0524
Site Reference ID/Investigator# 0575
Site Reference ID/Investigator# 0769
Site Reference ID/Investigator# 0534
Site Reference ID/Investigator# 0875
Site Reference ID/Investigator# 0859
Site Reference ID/Investigator# 0241
Site Reference ID/Investigator# 0520
Site Reference ID/Investigator# 0586
Site Reference ID/Investigator# 0708
Site Reference ID/Investigator# 710
Site Reference ID/Investigator# 0860
Site Reference ID/Investigator# 662
Site Reference ID/Investigator# 0536
Site Reference ID/Investigator# 0564
Site Reference ID/Investigator# 0559
Site Reference ID/Investigator# 0864
Site Reference ID/Investigator# 0867
Site Reference ID/Investigator# 0601
Site Reference ID/Investigator# 0531
Site Reference ID/Investigator# 0855
Site Reference ID/Investigator# 0577
Site Reference ID/Investigator# 606
Site Reference ID/Investigator# 0123
Site Reference ID/Investigator# 0352
Site Reference ID/Investigator# 0581
Site Reference ID/Investigator# 0631
Site Reference ID/Investigator# 0543
Site Reference ID/Investigator# 0707
Site Reference ID/Investigator# 0888
Site Reference ID/Investigator# 0712
Site Reference ID/Investigator# 0523
Site Reference ID/Investigator# 0678
Site Reference ID/Investigator# 0650
Site Reference ID/Investigator# 0193
Site Reference ID/Investigator# 0845
Site Reference ID/Investigator# 0579
Site Reference ID/Investigator# 0537
Site Reference ID/Investigator# 0889
Site Reference ID/Investigator# 0869
Site Reference ID/Investigator# 0790
Site Reference ID/Investigator# 0763
Site Reference ID/Investigator# 0604
Site Reference ID/Investigator# 0535
Site Reference ID/Investigator# 0865
Site Reference ID/Investigator# 0608
Site Reference ID/Investigator# 0592
Site Reference ID/Investigator# 0874
Site Reference ID/Investigator# 0663
Site Reference ID/Investigator# 0533
Site Reference ID/Investigator# 0633
Site Reference ID/Investigator# 0582
Site Reference ID/Investigator# 0573


title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in Hematopoietic Cell Transplant (HCT) Recipients With Respiratory Syncytial Virus (RSV) Infection of the Upper Respiratory Tract

summary: The primary objective of this study is to evaluate the effect of presatovir on respiratory syncytial virus (RSV) viral load in autologous or allogeneic hematopoietic cell transplant (HCT) recipients with an acute RSV upper respiratory tract infection (URTI), the effect of presatovir on development of lower respiratory tract complication, being free of any supplemental oxygen progression to respiratory failure, and pharmacokinetics (PK), safety, and tolerability of presatovir.

ReferenceCitation: Chemaly RF, Dadwal SS, Bergeron A, Ljungman P, Kim YJ, Cheng GS, Pipavath SN, Limaye AP, Blanchard E, Winston DJ, Stiff PJ, Zuckerman T, Lachance S, Rahav G, Small CB, Mullane KM, Patron RL, Lee DG, Hirsch HH, Waghmare A, McKevitt M, Jordan R, Guo Y, German P, Porter DP, Gossage DL, Watkins TR, Marty FM, Chien JW, Boeckh M. A Phase 2, Randomized, Double-blind, Placebo-Controlled Trial of Presatovir for the Treatment of Respiratory Syncytial Virus Upper Respiratory Tract Infection in Hematopoietic-Cell Transplant Recipients. Clin Infect Dis. 2020 Dec 31;71(11):2777-2786. doi: 10.1093/cid/ciz1166.

lead_sponsor: Gilead Sciences

location_country:
Taiwan
Brazil
Spain
United Kingdom
Australia
Netherlands
Canada
Switzerland
Sweden
Korea, Republic of
United States
France
Israel
Singapore
Germany

location_facility: Instituto Brasileiro de Controle do Câncer-IBCC

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Chang Gung Medical Foundation-LinKou Branch

location_facility: Fundação Antonio Prudente - Hospital do Câncer AC Camargo

location_facility: New York Presbyterian Hospital Cornell Medical Center

location_facility: University of Massachusetts Memorial Cancer Center

location_facility: Fundacao Faculdade Regional Medicina de Sao Jose do Rio Preto

location_facility: Institut Universitaire du Cancer Oncopole

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital


title: A Phase 1/2 Dose Escalation and Cohort Expansion Study of the Safety and Tolerability of Urelumab Administered in Combination With Nivolumab in Advanced/Metastatic Solid Tumors and B-cell Non-Hodgkins Lymphoma

summary: The purpose of this study is to determine which doses of Urelumab and Nivolumab are safe and tolerable when they are given together.

status: Terminated

location_country:
Germany
United States
Spain
France

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

intervention_type: Biological

status_simplified: Unknown


primary_purpose: Health Services Research

acronym: Long term Safety TOPAMAX monotherapy in pediatric patients

title: A Randomized, Active-Controlled, Open-Label, Flexible-Dose Study to Assess the Safety and Tolerability of Topiramate as Monotherapy Compared With Levetiracetam as Monotherapy in Pediatric Subjects With New or Recent-Onset Epilepsy

lead_sponsor: Janssen Research & Development, LLC

location_country:
Poland
Taiwan
Austria
Australia
Russian Federation
Argentina
Canada
Hungary
United States
France
South Africa
Belgium
Philippines
Germany

summary: The purpose of this study is to evaluate the safety of topiramate monotherapy compared with levetiracetam another standard antiepileptic drug (AED), as monotherapy for new-onset or recent-onset epilepsy (seizure disorder) on pediatric growth and maturation, bone mineralization, and kidney stone formation in children aged 2 to 15 years.


acronym: TERIKIDS

title: A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients With Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension

lead_sponsor: Genzyme, a Sanofi Company

ReferenceCitation: Chitnis T, Banwell B, Kappos L, Arnold DL, Gücüyener K, Deiva K, Skripchenko N, Cui LY, Saubadu S, Hu W, Benamor M, Le-Halpere A, Truffinet P, Tardieu M; TERIKIDS Investigators. Safety and efficacy of teriflunomide in paediatric multiple sclerosis (TERIKIDS): a multicentre, double-blind, phase 3, randomised, placebo-controlled trial. Lancet Neurol. 2021 Dec;20(12):1001-1011. doi: 10.1016/S1474-4422(21)00364-1.

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

location_country:
Serbia
Spain
United Kingdom
Lithuania
Ukraine
United States
Belgium
Portugal
Russian Federation
Tunisia
Israel
Turkey
Lebanon
Canada
China
Bulgaria
Greece
Estonia
France
Netherlands
Morocco

location_facility:
Investigational Site Number :840004
Investigational Site Number :124001
Investigational Site Number :250003
Investigational Site Number :724002
Investigational Site Number :250005
Investigational Site Number :792006
Investigational Site Number :156001
Investigational Site Number :156012
Investigational Site Number :233001
Investigational Site Number :056002
Investigational Site Number :840012
Investigational Site Number :826003
Investigational Site Number :156010
Investigational Site Number :156007
Investigational Site Number :643002
Investigational Site Number :250002
Investigational Site Number :826001
Investigational Site Number :643001
Investigational Site Number :792002
Investigational Site Number :620001
Investigational Site Number :528001
Investigational Site Number :100001
Investigational Site Number :156006
Investigational Site Number :376001
Investigational Site Number :156004
Investigational Site Number :504004
Investigational Site Number :792008
Investigational Site Number :056001
Investigational Site Number :792007
Investigational Site Number :643003
Investigational Site Number :788001
Investigational Site Number :840003
Investigational Site Number :840002
Investigational Site Number :156008
Investigational Site Number :250001
Investigational Site Number :156002
Investigational Site Number :156011
Investigational Site Number :643005
Investigational Site Number :688002
Investigational Site Number :376003
Investigational Site Number :156003
Investigational Site Number :300002
Investigational Site Number :504005
Investigational Site Number :788004
Investigational Site Number :643004
Investigational Site Number :156009
Investigational Site Number :792001
Investigational Site Number :422001
Investigational Site Number :792003
Investigational Site Number :804002
Investigational Site Number :156005
Investigational Site Number :440001
Investigational Site Number :300001
Investigational Site Number :788002
Investigational Site Number :804001

summary:
Primary Objective:

To assess the effect of teriflunomide in comparison to placebo on disease activity measured by time to first clinical relapse after randomization in children and adolescents 10 to 17 years of age with relapsing forms of multiple sclerosis (MS).

Secondary Objective:

To assess the effect of teriflunomide in comparison to placebo on disease activity/progression measured by brain magnetic resonance imaging (MRI) and on cognitive function.
To evaluate the safety and tolerability of teriflunomide in comparison to placebo.
To evaluate the pharmacokinetics (PK) of teriflunomide.


acronym: PREDICTRA

title: A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected Via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) Subjects (PREDICTRA)

lead_sponsor: AbbVie

ReferenceCitation: Emery P, Burmester GR, Naredo E, Sinigaglia L, Lagunes I, Koenigsbauer F, Conaghan PG. Adalimumab dose tapering in patients with rheumatoid arthritis who are in long-standing clinical remission: results of the phase IV PREDICTRA study. Ann Rheum Dis. 2020 Aug;79(8):1023-1030. doi: 10.1136/annrheumdis-2020-217246. Epub 2020 May 13.

ReferenceCitation: Emery P, Burmester GR, Naredo E, Zhou Y, Hojnik M, Conaghan PG. Design of a phase IV randomised, double-blind, placebo-controlled trial assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) patients (PREDICTRA). BMJ Open. 2018 Feb 28;8(2):e019007. doi: 10.1136/bmjopen-2017-019007.

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

location_country:
Spain
Greece
Austria
Australia
Ireland
Canada
Italy
Netherlands
United Kingdom
Sweden
Hungary
United States
France
Germany

location_facility: Hosp Sant J. Despi-Moises Brog /ID# 135368

location_facility: Guy's and St Thomas' NHS Found /ID# 132965

location_facility: Debreceni Egyetem Klinikai Koz /ID# 134715

location_facility: Hospital General Universitario Gregorio Maranon /ID# 133889

location_facility: St Vincent's University Hosp /ID# 129210

location_facility: Low Country Rheumatology, PA /ID# 154198

location_facility: Hosp General Univ de Valencia /ID# 134488

location_facility: Hospital Universitario Basurto /ID# 135529

location_facility: A.O.U.I. di Verona Policlinico /ID# 132973

location_facility: A.O. Univ Consorziale Policlin /ID# 133932

location_facility: Groupe de Recherche en Maladies Osseuses /ID# 129057

location_facility: Hosp Clinico Virgen Arrixaca /ID# 137020

location_facility: Westlake Medical Research (WMR) Clinical Trials /ID# 155386

location_facility: West Tennessee Research Inst /ID# 148391

location_facility: North Mississippi Med Clinics /ID# 149443

location_facility: Orszagos Reumatologiai es Fizi /ID# 134710

location_facility: CHU de Grenoble - Albet Michal /ID# 135953

location_facility: The Arthritis & Diabetes Clinic, Inc. /ID# 149017

location_facility: Hospital Parc de Salut del Mar /ID# 148670

location_facility: Azienda Istituto Gaetano Pini /ID# 132964

location_facility: Hospital Universitario La Paz /ID# 135369

location_facility: Royal Prince Alfred Hospital /ID# 154649

location_facility: Mid Essex Hospitals NHS Trust /ID# 151636

location_facility: Optimus Clinical Research Pty. /ID# 133881

location_facility: North Georgia Rheumatology Grp /ID# 155225

location_facility: University General Hospital "Attikon" /ID# 134709

location_facility: Charité Universitätsmedizin Campus Mitte /ID# 129142

location_facility: The Arthritis Program Res Grp /ID# 129056

location_facility: Institut de Rhum. de Montreal /ID# 129055

location_facility: Fondazione IRCCS Policlinico /ID# 133886

summary: The primary objective of the study was to investigate the association between residual disease activity at Baseline as detected by Magnetic Resonance Imaging (MRI) and the occurrence of flares in participants with rheumatoid arthritis (RA) randomized to an adalimumab dose tapering regimen controlled by adalimumab withdrawal.


title: A 2-Month, Observational, Rollover Trial to Evaluate the Safety of Subjects With Agitation Associated With Dementia of the Alzheimer's Type Who Were Previously Treated With Brexpiprazole (OPC 34712) or Placebo in a Phase 3, Double-blind Trial

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
Croatia
Serbia
Slovenia
Spain
Russian Federation
United Kingdom
Canada
Ukraine
United States
France
Germany
Bulgaria

summary: To follow-up on the safety of subjects who were previously treated in a double-blind trial of brexpiprazole.


type: Registry Identifier

title: A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Multiple Rising Doses of MLN9708 for the Treatment of Subjects With ISN / RPS Class III or IV Lupus Nephritis

summary: The purpose of this study is to characterize the safety and tolerability of ixazomib when administered as multiple oral doses at escalating dose levels in participants with lupus nephritis.

ipd_sharing_description: Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

lead_sponsor: Takeda

location_country:
Spain
Italy
Russian Federation
United Kingdom
United States
France
Germany


title: A Randomized, Double Blind, Placebo-controlled, Multicenter Phase II Study to Evaluate Efficacy and Safety of Roniciclib in Subjects With Extensive-stage Disease Small Cell Lung Cancer (SCLC) Who Are Receiving Cisplatin + Etoposide or Carboplatin + Etoposide as First-line Therapy

acronym: CONCEPT-SCLC

summary:
This is a study to investigate the potential clinical benefit of roniciclib when given in combination with chemotherapy Carboplatin / Etoposide or Cisplatin / Etoposide as first line treatment in patients with extensive disease small cell lung cancer. Approximately 140 patients will be randomized (1:1) to receive treatment with either roniciclib or placebo in combination with chemotherapy.

Roniciclib 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. The growth of the tumor may be decreased by preventing these specific proteins from functioning. By specifically targeting these proteins, roniciclib in combination with chemotherapy may stop cancer growth.

The primary endpoint (the most meaningful result to be tracked) of this study is based on the progression free survival, i.e. the time the disease is not worsening. The aim is to show that the therapy with roniciclib in combination with chemotherapy prolongs the time the disease is not worsening in this patient population compared to patients receiving placebo in combination with chemotherapy.

ReferenceCitation: Reck M, Horn L, Novello S, Barlesi F, Albert I, Juhász E, Kowalski D, Robinet G, Cadranel J, Bidoli P, Chung J, Fritsch A, Drews U, Wagner A, Govindan R. Phase II Study of Roniciclib in Combination with Cisplatin/Etoposide or Carboplatin/Etoposide as First-Line Therapy in Patients with Extensive-Disease Small Cell Lung Cancer. J Thorac Oncol. 2019 Apr;14(4):701-711. doi: 10.1016/j.jtho.2019.01.010. Epub 2019 Jan 21. Erratum in: J Thorac Oncol. 2019 Aug;14(8):1484.

lead_sponsor: Bayer

location_country:
Poland
Italy
Hungary
Korea, Republic of
United States
France
Belgium
Japan
Germany


title: A Phase 1/2, First in Human, Dose Escalation Study of MGD006, a CD123 x CD3 DART® Bi-Specific Antibody Based Molecule, in Patients With Relapsed or Refractory AML or Intermediate-2/High Risk Myelodysplastic Syndrome (MDS)

acronym: VOYAGE

summary:
Open-label, multi-dose, single-arm, multi-center, Phase 1/2 study conducted in three segments: the Single Patient Dose Escalation Segment (complete), followed by the Multi-Patient Dose Escalation Segment (complete) and the Maximum Tolerated Dose and Schedule (MTDS) Expansion Cohort Segment (closed). Having characterized safety and determined the maximum tolerated dose and schedule, the primary objective of this study now is to assess the anti-neoplastic activity of flotetuzumab in patients with PIF/ER AML, as determined by the proportion of patients who achieve CR or CRh. Starting with Cycle 2, patients who are benefiting from flotetuzumab may receive up to a maximum of 8 cycles of treatment.

Patients will receive daily increasing doses of flotetuzumab for the first week of Cycle 1 (Lead-In Dosing) followed by 3 weeks of continuous intravenous infusion at a specifiedthe assigned dose. Subsequent cycles are each 4 weeks of continuous infusion at the assigned dose. Dosing may continue for up to 8 cycles. Follow up visits may continue for 6 months after treatment is discontinued.

ReferenceCitation: Uy GL, Aldoss I, Foster MC, Sayre PH, Wieduwilt MJ, Advani AS, Godwin JE, Arellano ML, Sweet KL, Emadi A, Ravandi F, Erba HP, Byrne M, Michaelis L, Topp MS, Vey N, Ciceri F, Carrabba MG, Paolini S, Huls GA, Jongen-Lavrencic M, Wermke M, Chevallier P, Gyan E, Récher C, Stiff PJ, Pettit KM, Löwenberg B, Church SE, Anderson E, Vadakekolathu J, Santaguida M, Rettig MP, Muth J, Curtis T, Fehr E, Guo K, Zhao J, Bakkacha O, Jacobs K, Tran K, Kaminker P, Kostova M, Bonvini E, Walter RB, Davidson-Moncada JK, Rutella S, DiPersio JF. Flotetuzumab as salvage immunotherapy for refractory acute myeloid leukemia. Blood. 2021 Feb 11;137(6):751-762. doi: 10.1182/blood.2020007732.

lead_sponsor: MacroGenics

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

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

location_facility: Washington University School of Medicine

location_facility: Loyola University Chicago - Cardinal Bernadin Cancer Center

location_facility: University of North Carolina Lineberger Comprehensive Cancer Center

location_facility: Institut Universitaire du Cancer de Toulouse-Oncopole

location_facility: III. Med. Klinik-Klinikum rechts der Isar-Technische Universität München

location_facility: Georgetown University - Lombardi Cancer Center

location_facility: Medizinische Klinik und II, Universitätsklinikum Würzburg

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Unità Operativa di Ematologia Ospedale Santa Maria delle Croci

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: UCSF - Helen Diller Family Comprehensive Cancer Center

location_facility: Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

location_facility: Universitat Autonomaa de Barcelona (UAB) - Hospital de la Santa Creu i de Sant Pau


title: A Double-Blind, Randomised, Placebo-Controlled, Multi-Centre Field Study to Assess the Efficacy and Safety of HDM-SPIRE in Subjects With a History of House Dust Mite-Induced Rhinoconjunctivitis

summary: The purpose of this study is to compare the treatment effect of three treatment regimens of HDM-SPIRE vs placebo and to evaluates the treatment effect of HDM-SPIRE on symptoms, rescue medication usage, Quality of Life and Sleep Quality

lead_sponsor: Circassia Limited

location_country:
Spain
Italy
Netherlands
Canada
United States
France
South Africa
Germany


acronym: LUME-Colon 1

title: A Double-blind, Randomised, Placebo Controlled Phase III Study of Nintedanib Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Patients With Metastatic Colorectal Cancer Refractory to Standard Therapies.

lead_sponsor: Boehringer Ingelheim

ReferenceCitation: Van Cutsem E, Yoshino T, Lenz HJ, Lonardi S, Falcone A, Limón ML, Saunders M, Sobrero A, Park YS, Ferreiro R, Hong YS, Tomasek J, Taniguchi H, Ciardiello F, Stoehr J, Oum'Hamed Z, Vlassak S, Studeny M, Argiles G. Nintedanib for the treatment of patients with refractory metastatic colorectal cancer (LUME-Colon 1): a phase III, international, randomized, placebo-controlled study. Ann Oncol. 2018 Sep 1;29(9):1955-1963. doi: 10.1093/annonc/mdy241.

ReferenceCitation: Van Cutsem E, Yoshino T, Hocke J, Oum'Hamed Z, Studeny M, Tabernero J. Rationale and Design for the LUME-Colon 1 Study: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Nintedanib Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Patients With Advanced Colorectal Cancer Refractory to Standard Treatment. Clin Colorectal Cancer. 2016 Mar;15(1):91-94.e1. doi: 10.1016/j.clcc.2015.09.005. Epub 2015 Oct 9.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Mexico
Sweden
Canada
Germany
Denmark
Taiwan
Korea, Republic of
France
Netherlands

location_facility: 1199.52.4204 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3307 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.9005 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3103 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3901 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3102 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.0115 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4502 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3906 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.9703 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3502 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.5401 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3207 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4504 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8201 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3905 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8203 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.0114 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8107 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3406 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.6103 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.0121 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8108 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8503 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3401 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4801 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4401 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.9004 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3407 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3404 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4303 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8114 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.0120 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4904 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8502 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8802 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4202 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4403 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4404 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8109 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8102 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.0703 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3907 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8110 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8116 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4803 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.9704 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.6104 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4302 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.9001 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.6105 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3402 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.5404 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4804 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.0104 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.5201 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.0105 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8105 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8111 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4901 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4905 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.0125 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8801 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8104 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4503 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3208 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8112 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8803 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.9002 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.0701 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.0101 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4601 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3903 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8501 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8204 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8115 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4602 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.1001 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.5403 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8805 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.6106 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3204 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.0702 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4903 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3501 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3505 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3206 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8106 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3403 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.0113 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4906 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3904 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3301 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8202 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.1004 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.0119 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3521 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3504 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.1003 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4501 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.9706 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.9003 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3405 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.5406 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.1002 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.5405 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4402 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4405 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3203 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8101 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3201 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3305 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.0707 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.0108 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8113 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3202 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4201 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.0106 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.6101 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3205 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8504 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3506 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4304 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8103 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3101 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.0123 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.0102 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3304 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.6102 Boehringer Ingelheim Investigational Site

summary: The objective of this Phase III study is to evaluate the efficacy of nintedanib in patients with metastatic colorectal cancer (mCRC) after failure of previous treatment with standard chemotherapy and biological agents.


title: A Phase 3 Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AMG0001 in Subjects With Critical Limb Ischemia

acronym: AGILITY

summary: Study to Evaluate the Efficacy and Safety of AMG0001 in Subjects with Critical Limb Ischemia.

lead_sponsor: AnGes USA, Inc.

location_country:
Denmark
Poland
Italy
Finland
Canada
Sweden
Hungary
United States
France
Belgium
Netherlands

location_facility: CHU Amiens - Groupe Hospitalier Hopital Sud

location_facility: University of California, San Diego (UCSD)

location_facility: Central Arkansas Veteran's Healthcare System

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinika Központ

location_facility: Karlkirurgiska Kliniken, Karolinska Universitetssjukhuset

location_facility: Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Northwestern Medicine Central DuPage Hospital

location_facility: The Methodist Hospital Research Institute

location_facility: Bekes Megyei Pandy Kalman Korhaz Ersebeszet

location_facility: SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: University of Oklahoma - Physicians Surgical Specialists

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz Altalanos- Mellkas es Ersebeszeti Osztaly

location_facility: Szpital Uniwersytecki nr 1 im. Dr A. Jurasza w Bydgoszczy

location_facility: Universita Cattolica Policlinico Gemelli

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

location_facility: Sarasota Memorial Hospital Clinical Research Center

location_facility: New York Presbyterian Hospital - Columbia University Medical Center

location_facility: San Francisco Veterans Affairs Medical Center


title: A Randomized, Double-blind, Placebo-controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat (0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg TID) in Patients With Symptomatic Pulmonary Hypertension Associated With Idiopathic Interstitial Pneumonias (IIP).

acronym: RISE-IIP

summary: To evaluate the efficacy and safety of 26-weeks of treatment with riociguat vs. placebo in patients with symptomatic PH (pulmonary hypertension) associated with IIP (idiopathic interstitial pneumonias).

ReferenceCitation: Nathan SD, Behr J, Collard HR, Cottin V, Hoeper MM, Martinez FJ, Corte TJ, Keogh AM, Leuchte H, Mogulkoc N, Ulrich S, Wuyts WA, Yao Z, Boateng F, Wells AU. Riociguat for idiopathic interstitial pneumonia-associated pulmonary hypertension (RISE-IIP): a randomised, placebo-controlled phase 2b study. Lancet Respir Med. 2019 Sep;7(9):780-790. doi: 10.1016/S2213-2600(19)30250-4. Epub 2019 Aug 12.

location_country:
Saudi Arabia
Italy
Spain
United Kingdom
United States
Belgium
Japan
Portugal
Russian Federation
Australia
Argentina
Israel
Turkey
Canada
Switzerland
Germany
Denmark
Greece
New Zealand
France
Colombia

location_facility:
University of California, Los Angeles
Columbia University Medical Center
Via Christi Clinic


title: Substrate Targeted Ablation Using the FlexAbility™ Ablation Catheter System for the Reduction of Ventricular Tachycardia (STAR-VT) - G130132

acronym: STAR-VT

summary: To demonstrate that scar-based ventricular tachycardia (VT) ablation using the FlexAbility™ ablation catheter system results in a superior clinical outcome compared to routine drug therapy in subjects with documented Monomorphic Ventricular Tachycardia [MMVT] (both ischemic and non-ischemic) while maintaining an acceptable safety profile.

lead_sponsor: Abbott Medical Devices

location_country:
United Kingdom
Italy
Australia
United States
France

location_facility: Washington University School of Medicine - Barnes Jewish Hospital

location_facility: Staten Island University Hospital - North

location_facility: University of California at San Francisco

location_facility: Hospital of the University of Pennsylvania

location_facility: New York University Langone Medical Center

location_facility: Texas Cardiac Arrhythmia Research Foundation

location_facility: University of California at San Diego (UCSD) Medical Center


title: A Single Arm, Open-label, Phase 2 Study to Assess the Efficacy and Safety of Lucitanib Given Orally as a Single Agent to Patients With Advanced/Metastatic Lung Cancer and FGF, VEGF, or PDGF Related Genetic Alterations

summary: The purpose of this study is to determine whether lucitanib is safe and effective in the treatment of patients with advanced/metastatic lung cancer and fibroblast growth factor (FGF), vascular endothelial growth factor receptor (VEGF), or platelet derived growth factor (PDGF) related genetic alterations.

ReferenceCitation: Liao M, Zhou J, Wride K, Lepley D, Cameron T, Sale M, Xiao J. Population Pharmacokinetic Modeling of Lucitanib in Patients with Advanced Cancer. Eur J Drug Metab Pharmacokinet. 2022 Sep;47(5):711-723. doi: 10.1007/s13318-022-00773-w. Epub 2022 Jul 18.

lead_sponsor: Clovis Oncology, Inc.

location_country:
Spain
Italy
United States
France
Germany

location_facility: Fondazione IRCCS Istituto Nazionale Tumori


acronym: MONARCH 2

title: MONARCH 2: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Fulvestrant With or Without Abemaciclib, a CDK4/6 Inhibitor, for Women With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer

lead_sponsor: Eli Lilly and Company

ReferenceCitation: Neven P, Rugo HS, Tolaney SM, Iwata H, Toi M, Goetz MP, Kaufman PA, Lu Y, Haddad N, Hurt KC, Sledge GW Jr. Abemaciclib plus fulvestrant in hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in premenopausal women: subgroup analysis from the MONARCH 2 trial. Breast Cancer Res. 2021 Aug 23;23(1):87. doi: 10.1186/s13058-021-01463-2.

ReferenceCitation: Inoue K, Masuda N, Iwata H, Takahashi M, Ito Y, Miyoshi Y, Nakayama T, Mukai H, van der Walt JS, Mori J, Sakaguchi S, Kawaguchi T, Tanizawa Y, Llombart-Cussac A, Sledge GW Jr, Toi M. Japanese subpopulation analysis of MONARCH 2: phase 3 study of abemaciclib plus fulvestrant for treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer that progressed on endocrine therapy. Breast Cancer. 2021 Sep;28(5):1038-1050. doi: 10.1007/s12282-021-01239-8. Epub 2021 Apr 1.

ReferenceCitation: Goetz MP, Okera M, Wildiers H, Campone M, Grischke EM, Manso L, André VAM, Chouaki N, San Antonio B, Toi M, Sledge GW Jr. Safety and efficacy of abemaciclib plus endocrine therapy in older patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: an age-specific subgroup analysis of MONARCH 2 and 3 trials. Breast Cancer Res Treat. 2021 Apr;186(2):417-428. doi: 10.1007/s10549-020-06029-y. Epub 2021 Jan 3.

ReferenceCitation: Sledge GW Jr, Toi M, Neven P, Sohn J, Inoue K, Pivot X, Burdaeva O, Okera M, Masuda N, Kaufman PA, Koh H, Grischke EM, Conte P, Lu Y, Barriga S, Hurt K, Frenzel M, Johnston S, Llombart-Cussac A. The Effect of Abemaciclib Plus Fulvestrant on Overall Survival in Hormone Receptor-Positive, ERBB2-Negative Breast Cancer That Progressed on Endocrine Therapy-MONARCH 2: A Randomized Clinical Trial. JAMA Oncol. 2020 Jan 1;6(1):116-124. doi: 10.1001/jamaoncol.2019.4782.

ReferenceCitation: Sledge GW Jr, Toi M, Neven P, Sohn J, Inoue K, Pivot X, Burdaeva O, Okera M, Masuda N, Kaufman PA, Koh H, Grischke EM, Frenzel M, Lin Y, Barriga S, Smith IC, Bourayou N, Llombart-Cussac A. MONARCH 2: Abemaciclib in Combination With Fulvestrant in Women With HR+/HER2- Advanced Breast Cancer Who Had Progressed While Receiving Endocrine Therapy. J Clin Oncol. 2017 Sep 1;35(25):2875-2884. doi: 10.1200/JCO.2017.73.7585. Epub 2017 Jun 3.

ipd_sharing_description: Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

location_country:
Denmark
Poland
Taiwan
Romania
Spain
Greece
Italy
Australia
Mexico
Canada
Finland
Russian Federation
Switzerland
Korea, Republic of
United States
France
Puerto Rico
Belgium
Japan
Germany

location_facility: Columbia University College of Phys & Surgeons

location_facility: Novant Health, Oncology Research Institute

location_facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

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.

location_facility: Southern California Permanente Medical Group

location_facility: Oncology and Hematology Associates of Southwest Virginia Inc

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

location_facility: Mount Sinai School of Medicine Dermatology Clinical Trials

summary:
The main purpose of this study is to compare progression-free survival for women with hormone receptor positive (HR+), human epidermal growth factor receptor (HER2) negative advanced breast cancer receiving either abemaciclib + fulvestrant or fulvestrant alone. Participants will be randomized to abemaciclib or placebo in a 2:1 ratio. The study will last about 9 months for each participant.

For the endocrine naïve cohort, all participants will received abemaciclib + fulvestrant.