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.

lead_sponsor: AbbVie

location_country:
United States
Serbia
Netherlands
France
Czechia
Poland
Slovakia
Romania
Hungary
Belgium
New Zealand
Spain
Canada
United Kingdom

location_facility: Universitair Medisch Centrum Utrecht /ID# 212935

location_facility: Cardinal Glennon Children's Hospital /ID# 212349

location_facility: Duplicate_Cardiff & Vale University Health Board /ID# 212504

location_facility: CHUM - Centre hospitalier de l'Universite de Montréal /ID# 227815

location_facility: CHU de Reims - Hôpital Maison Blanche /ID# 212910

location_facility: Orszagos Koranyi Pulmonologiai Intezet /ID# 213494

location_facility: Vanderbilt University Medical Center /ID# 212353

location_facility: Unity Health Toronto - St. Michael's Hospital /ID# 212552

location_facility: Washington University-School of Medicine /ID# 212352

location_facility: University Hospital Southampton NHS Foundation Trust /ID# 212493

location_facility: Royal Brompton and Harefield Hospitals /ID# 212490

location_facility: Manchester University NHS Foundation Trust /ID# 213058

location_facility: QEII - Health Sciences Centre /ID# 212656

location_facility: Hospital Universitario Vall d'Hebron /ID# 213014

location_facility: Royal Devon and Exeter NHS Trust Hospital /ID# 212289

location_facility: Universitair Ziekenhuis Leuven /ID# 213050

location_facility: University of Iowa Hospitals and Clinics /ID# 212351

location_facility: Belfast Health and Social Care Trust /ID# 212502

location_facility: Chu de Nice-Hopital L'Archet Ii /Id# 212862

location_facility: Nationwide Childrens Hospital /ID# 213158

location_facility: Liverpool Heart and Chest Hospital NHS Foundation Trust /ID# 212291

location_facility: Institut za zdravstvenu zaštitu majke i deteta Srbije "Dr Vukan Čupić" /ID# 212820

location_facility: McGill University Health Center Research Institute /ID# 212553

location_facility: CHU Nantes - Hopital Laennec /ID# 212897

location_facility: Medical University of South Carolina /ID# 212187

location_facility: CHU Bordeaux - Hopital Haut Lévêque /ID# 212898

location_facility: CHU Montpellier - Hôpital Saint Eloi /ID# 212856

location_facility: Nottingham University Hospitals NHS Trust /ID# 212531

location_facility: Leeds Teaching Hospitals NHS Trust /ID# 212491

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 212665

location_facility: Heritage Medical Research Clinic (University of Calgary) /ID# 212555

location_facility: Institut universitaire de cardiologie et de pneumologie de Québec - Université L /ID# 212655

location_facility: Univerzitna nemocnica Bratislava Nemocnica Ruzinov /ID# 213146

location_facility: Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 213413

location_facility: Univerzitna nemocnica Bratislava - Specializovana nemocnica v odboroch geriatria /ID# 213596

location_facility: Hospital Universitario La Paz /ID# 213513

location_facility: Royal University Hospital - CTSU /ID# 228188

location_facility: University of Alberta Hospital - Division of Hematology /ID# 213874

location_facility: Royal Papworth Hospital NHS Foundation Trust /ID# 212507

title: A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del Mutation

summary: This study will evaluate the safety, tolerability, and efficacy of ABBV-3067 given alone and in combination with various doses of ABBV-2222 in adults with Cystic Fibrosis who are homozygous for the F508del mutation.


title: A Phase 2/3 Randomized, Double-blind, Palivizumab-controlled Study to Evaluate the Safety of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in High-risk Children (MEDLEY)

summary: The purpose of this study is to evaluate the safety and tolerability of MEDI8897 compared to palivizumab when administered to preterm infants entering their first RSV season and children with chronic lung disease (CLD) and congenital heart disease (CHD) entering their first and second RSV season.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Actual

ipd_sharing: Yes

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: MedImmune LLC

location_country:
Finland
Belgium
Russian Federation
Ukraine
France
Japan
Lithuania
Poland
Canada
Korea, Republic of
Turkey
South Africa
Sweden
Bulgaria
Hungary
United States
Germany
United Kingdom
Italy
Austria
Mexico
Czechia
Israel
New Zealand
Spain
Estonia
Latvia

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


type: EudraCT Number

title: A Phase II, Two-arm Study to Investigate Tepotinib Combined With Osimertinib in MET Amplified, Advanced or Metastatic NSCLC Harboring Activating EGFR Mutations and Having Acquired Resistance to Prior Osimertinib Therapy (INSIGHT 2)

summary: This study will assess the antitumor activity, safety, tolerability, and pharmacokinetics (PK) of the Mesenchymal-epithelial Transition Factor (MET) inhibitor tepotinib combined with the 3rd generation EGFR inhibitor osimertinib in participants with advanced or metastatic non-small cell lung cancer (NSCLC).

status: Recruiting

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing_description: Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html

lead_sponsor: EMD Serono Research & Development Institute, Inc.

location_country:
Italy
United States
Hong Kong
Netherlands
Spain
Vietnam
France
Japan
Malaysia
Thailand
Singapore
Belgium
Russian Federation
China
Germany
Korea, Republic of
Taiwan

location_facility: Asklepios Fachkliniken Muenchen-Gauting - Abteilung internistische Onkologie

location_facility: University of Texas MD Anderson Cancer Center - Unit 432 Thoracic Head and Neck Medical Oncology

location_facility: SBHI "Krasnoyarsk Regional Oncology Dispensary n.a. A.I. Kryzhanovsky"

location_facility: Hospital Universitario Materno-Infantil de Canarias - Servicio de Oncologia

location_facility: Kanagawa Cancer Center - Dept of Respiratory Medicine

location_facility: IOV - Istituto Oncologico Veneto IRCCS - Oncologia Medica 2

location_facility: Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

location_facility: Hopital Albert Calmette - CHU Lille - service de pneumologie et immuno allergologie

location_facility: Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma) - U.O.C. Oncologia

location_facility: Hospital Universitari Quiron Dexeus - Servicio de Oncologia Medica

location_facility: The Affiliated Cancer Hospital of Xinjiang Medical university

location_facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Maison du Ha

location_facility: Hospital Regional Universitario de Malaga

location_facility: Hospital Universitario Virgen Macarena - Servicio de Oncologia

location_facility: Affiliated Tumor Hospital of Harbin Medical University

location_facility: Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen

location_facility: CHU Limoges - Hôpital Dupuytren - Unite d'Oncologie Thoracique et Cutanée

location_facility: The Chinese University of Hong Kong - Emergency Medicine

location_facility: Hospital Pulau Pinang - Clinic Respiratory

location_facility: Hyogo College of Medicine Hospital - Dept of Respiratory Medicine

location_facility: Maastricht University Medical Center - Dept of Medical Oncology

location_facility: Medstar Franklin Square Clinical Research Center

location_facility: Beacon International Specialist Centre Sdn Bhd

location_facility: National Cancer Centre - Medical Oncology Pharmacy

location_facility: Frederick Health- James M Stockman Cancer Institute

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: Eastern Connecticut Hematology & Oncology Associates

location_facility: Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo) - U.O Oncologia Medica

location_facility: Ventura County Hematology Oncology Specialists

location_facility: Hamamatsu University School of Medicine, University Hospital - Dept of Respiratory Medicine

location_facility: Nagoya University Hospital - Dept of Respiratory Medicine

location_facility: Chonnam National University Hwasun Hospital

location_facility: FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"

location_facility: Hospital Universitario Quiron Madrid - Unidad Integral de Oncologia

location_facility: Hematology Oncology Associates of Fredericksburg

location_facility: Oklahoma Cancer Specialists and Research Institute

location_facility: Universitair Medisch Centrum Groningen - Department of Internal Medicine

location_facility: Pavlov First Saint Petersburg State Medical University - Research Institute of Pulmunology

location_facility: New Jersey Cancer Care and Blood Disorders

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

location_facility: Seoul National University Bundang Hospital

location_facility: NYU Langone Clinical Cancer Center - NYU Langone Medical Center

location_facility: Fort Wayne Medical Oncology and Hematology

location_facility: Centre Francois Baclesse - Service d'Oncologie Medicale

location_facility: AO Ospedali Riuniti Cervello - Presidio Villa Sofia - U.O.S. di Neuroimmunologia

location_facility: Chao Family Clinical Research Center - RC for Dr. Kenneth Chang

location_facility: Hospital Cochin Service, Service de Pneumologie et Mucoviscidose

location_facility: The Center for Cancer & Blood Disorders - Maryland

location_facility: Hospital Universitari Vall d'Hebron - Dept of Oncology

location_facility: Weill Cornell Medical College - Gastroenterology

location_facility: Centre Hospitalier Intercommunal de Créteil - Service de Pneumologie

location_facility: Hospital del Mar - Servicio de Oncologia

location_facility: CHU de Toulouse - Hôpital Larrey - Service de Pneumologie et Oncologie Pneumologique

location_facility: Hospital Universitario HM Madrid Sanchinarro - Servicio de Oncologia

location_facility: Pius-Hospital Oldenburg - Klinik f. Haematologie und Onkologie

location_facility: Okayama University Hospital - Dept of Respiratory Medicine/Allergy

location_facility: BHI of Omsk region "Clinical Oncology Dispensary"

location_facility: Queen Elizabeth Hospital - Department of Medicine

location_facility: Shanghai Cancer Hospital, Fudan University

location_facility: Medical College of Wisconsin - Froedtert Hospital

location_facility: University of Miami Miller School of Medicine

location_facility: Sparrow Hospital Herbert - Herman Cancer Center

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: ICO Badalona - Hospital Germans Trias i Pujol - Servicio de Oncologia Medica

location_facility: Boston Medical Center - Dept. Hematology/Oncology

location_facility: Azienda Ospedaliero Universitaria Pisana - U.O. Pneumologia II

location_facility: ICO l´Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia

location_facility: Niigata Cancer Center Hospital - Dept of Internal Medicine

location_facility: Tan Tock Seng Hospital - CTRU/OCS, Research

location_facility: Compassionate Care Research Group Inc - Edinger Medical Group, Inc.

location_facility: Hospital Universitari i Politecnic La Fe - Servicio de Oncologia Medica

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


intervention_type: Radiation

lead_sponsor: Merck Sharp & Dohme Corp.

location_country:
Australia
Russian Federation
Ukraine
France
Japan
Poland
Norway
Argentina
Canada
Korea, Republic of
Switzerland
Hungary
Germany
United States
United Kingdom
Italy
Austria
Brazil
New Zealand
Spain
Turkey

location_facility: Oslo Universitetssykehus HF Ulleval Sykehus ( Site 1500)

location_facility: Universitaetsklinikum Heidelberg. ( Site 1204)

location_facility: Hiroshima University Hospital ( Site 2810)

location_facility: William E. Kahlert Regional Cancer Center ( Site 3031)

location_facility: Hospital General Universitari Vall d Hebron ( Site 1602)

location_facility: Rutgers Cancer Institute of New Jersey ( Site 0043)

location_facility: Universitaetsklinikum Essen ( Site 1201)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 2816)

location_facility: Kyiv City Clinical Oncology Centre ( Site 2200)

location_facility: Chelyabinsk Regional Clinical Oncology Dispensary ( Site 2014)

location_facility: Royal Brisbane and Women s Hospital ( Site 2502)

location_facility: Chungbuk National University Hospital ( Site 2605)

location_facility: University of Yamanashi Hospital ( Site 2807)

location_facility: Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital ( Site 2101)

location_facility: Centrum Onkologii im. prof. Franciszka ukaszczyka-Ambulatorium Chemioterapii ( Site 2407)

location_facility: University Hospitals Bristol NHS Foundation Trust ( Site 1802)

location_facility: Port Macquarie Base Hospital ( Site 2500)

location_facility: Hospital Universitario La Fe ( Site 1603)

location_facility: Universitatsklinik LKH Innsbruck ( Site 0802)

location_facility: Clatterbridge Cancer Center NHS FT ( Site 1800)

location_facility: Lehigh Valley Hospital- Cedar Crest ( Site 3005)

location_facility: Hospital Italiano de Buenos Aires ( Site 0206)

location_facility: IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0208)

location_facility: Hospital e Maternidade Celso Pierro ( Site 0313)

location_facility: GUZ Lipetsk Regional Oncology Dispensary ( Site 2010)

location_facility: Medical center Medikal Plaza of Ecodnipro LLC ( Site 2207)

location_facility: University of Massachusetts ( Site 0029)

location_facility: Ospedale Santissima Annunziata ( Site 1303)

location_facility: Orszagos Koranyi Pulmonologiai Intezet ( Site 2304)

location_facility: University of Tennessee Medical Center Knoxville ( Site 3010)

location_facility: Jasz - Nagykun Szolnok megyei Hetenyi Geza Korhaz - Rendelointezet ( Site 2310)

location_facility: A.P.H. Paris. Hopital Bichat Claude Bernard ( Site 1114)

location_facility: Penn State University Milton S. Hershey Medical Center ( Site 0064)

location_facility: USC Norris Comprehensive Cancer Center ( Site 0007)

location_facility: Sanford Cancer Center Oncology Clinic ( Site 0053)

location_facility: Policlinico Agostino Gemelli ( Site 1302)

location_facility: Hospital Paulistano - Amil Clinical Research ( Site 0316)

location_facility: Hacettepe University Medical Faculty ( Site 2100)

location_facility: McGill University Health Center - Research Institute ( Site 0113)

location_facility: Tokyo Metropolitan Komagome Hospital ( Site 2802)

location_facility: Kobe Minimally Invasive Cancer Center ( Site 2811)

location_facility: H. Lee Moffitt Cancer Center and Research Institute ( Site 0016)

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 2307)

location_facility: Oxford University Hospitals NHS Foundation Trust ( Site 1812)

location_facility: Niigata Cancer Center Hospital ( Site 2801)

location_facility: Darlington Memorial Hospital NHS Trust ( Site 1810)

location_facility: Helse Bergen HF Haukeland Universitetssykehus ( Site 1502)

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0300)

location_facility: Russian Scientific Center of Roentgenoradiology ( Site 2011)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 1604)

location_facility: Evangelisches Krankenhaus Hamm gGmbH ( Site 1205)

location_facility: Kartal Training and Research Hospital ( Site 2102)

location_facility: Lancashire Teaching Hospitals NHS Foundation Trust ( Site 1809)

location_facility: Social Medical Center - Otto Wagner Hospital ( Site 0801)

location_facility: Goshen Center for Cancer Care ( Site 0022)

location_facility: Tudogyogyintezet Torokbalint ( Site 2302)

location_facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2403)

location_facility: Charite Universitaetsmedizin Berlin ( Site 1207)

location_facility: Baskent Adana Dr Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 2105)

location_facility: Ukrainian Center of Tomotherapy ( Site 2206)

location_facility: Banner MD Anderson Cancer Center ( Site 3029)

location_facility: National Cancer Center Hospital East ( Site 2800)

location_facility: Mid Florida Hematology and Oncology Center ( Site 0067)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 2301)

location_facility: Moncton Hospital - Horizon Health Network ( Site 0105)

location_facility: Sinai Hospital of Baltimore ( Site 3011)

location_facility: Veszprem Megyei Tudogyogyintezet ( Site 2313)

location_facility: Medical Center Asklepion LLC ( Site 2208)

location_facility: Norfolk and Norwich University Foundation NHS Trust ( Site 1805)

location_facility: Guy s and St Thomas Hospital NHS Foundation Trust ( Site 1808)

location_facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0301)

location_facility: CHU de Brest -Site Hopital Morvan ( Site 1100)

location_facility: Regional Centre of Oncology-Thoracic organs ( Site 2202)

location_facility: Medical institute named after Berezin Sergey ( Site 2009)

location_facility: Kansai Medical University Hospital ( Site 2808)

location_facility: Orszagos Koranyi Pulmonologiai Intezet ( Site 2306)

location_facility: Massachusetts General Hospital-Cancer Center Protocol Office ( Site 3007)

location_facility: Klinikum Esslingen-Klinik für Kardiologie und Pneumologie ( Site 1208)

location_facility: Seoul National University Hospital ( Site 2600)

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii ( Site 2402)

location_facility: Petz Aladar Megyei Oktato Korhaz ( Site 2305)

location_facility: Orszagos Onkologiai Intezet ( Site 2308)

location_facility: University College London Hospital NHS Foundation Trust ( Site 1806)

location_facility: Aichi Cancer Center Hospital ( Site 2804)

location_facility: Kingston Health Sciences Centre ( Site 0100)

location_facility: Hospital Universitario Quiron Madrid ( Site 1601)

location_facility: Pécsi Tudományegyetem Klinikai Központ-Onkoterápiás Intézet ( Site 2314)

location_facility: Vanderbilt University Medical Center ( Site 0075)

location_facility: SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 2404)

location_facility: Hospital Provincial del Centenario ( Site 0205)

location_facility: Erciyes University Medical Faculty ( Site 2109)

location_facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2116)

location_facility: Trillium Health Partners - Credit Valley Hospital ( Site 0102)

location_facility: Instituto Nacional Do Cancer Jose Alencar Gomes Da Silva ( Site 0305)

location_facility: Hospital Britanico de Buenos Aires ( Site 0204)

location_facility: Institut Regional du Cancer de Montpellier - ICM ( Site 1108)

location_facility: N.N.Blokhin Russian Cancer Research center ( Site 2013)

location_facility: Universitaetsspital Zuerich ( Site 1700)

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 0318)

location_facility: The Cancer Institute Hospital of JFCR ( Site 2803)

location_facility: Medical Park Izmir Hastanesi ( Site 2115)

location_facility: Health Sciences North Research Institute ( Site 0107)

location_facility: Franciscan Health Indianapolis ( Site 0024)

location_facility: St. Vincent Healthcare Frontier Cancer Center ( Site 3012)

location_facility: Osaka Medical and Pharmaceutical University Hospital ( Site 2813)

location_facility: Sverdlovsk Regional Oncology Hospital ( Site 2012)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (

location_facility: University of Tsukuba Hospital ( Site 2809)

location_facility: University of Kentucky School of Medicine & Hospitals ( Site 0026)

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2001)

location_facility: Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 2205)

location_facility: Landeskrankenhaus - Universitatsklinikum Graz ( Site 0804)

location_facility: Osaka International Cancer Institute ( Site 2812)

location_facility: Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2203)

location_facility: Sanford Health Roger Maris Cancer Center ( Site 0079)

location_facility: Hopitaux Universitaires de Geneve HUG ( Site 1706)

location_facility: Instituto Medico Especializado Alexander Fleming ( Site 0203)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 2000)

location_facility: The Catholic University of Korea St. Vincent s Hospital ( Site 2606)

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 2312)

location_facility: Keppler Universitatsklinikum ( Site 0806)

location_facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 2400)

location_facility: CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0110)

location_facility: St. Luke's University Health Network ( Site 3006)

location_facility: Sakarya Universitesi Tip Fakultesi Hastanesi ( Site 2114)

type: Other Identifier

type: Registry Identifier

source: euctr

title: A Phase 3, Randomized, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Participants With Unresected Stages I or II Non Small Cell Lung Cancer (NSCLC) (KEYNOTE-867)

summary:
The purpose of this study is to assess the efficacy and safety of stereotactic body radiotherapy (SBRT) plus pembrolizumab (MK-3475) in the treatment of adult participants with unresected stage I or II (Stage IIB N0, M0) non-small cell lung cancer (NSCLC).

The primary study hypotheses are:

SBRT plus pembrolizumab prolongs Event-free Survival (EFS) compared to SBRT plus placebo (normal saline solution), and
SBRT plus pembrolizumab prolongs Overall Survival (OS) compared to SBRT plus placebo.


status: Terminated

ipd_sharing_description: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.

lead_sponsor: Theravance Biopharma

location_country:
Greece
Romania
Australia
Taiwan
Ukraine
France
Japan
Poland
Slovakia
Canada
Korea, Republic of
South Africa
Bulgaria
Hungary
Portugal
United States
Germany
Italy
Serbia
Israel
Georgia
Spain

acronym: TD-1473 LTS UC Study

location_facility: Theravance Biopharma Investigational Site #2

ipd_sharing: No

study_completion_date_type: Actual

title: A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects With Ulcerative Colitis (UC)

summary: A 3-Year Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis who have participated in the Maintenance Study of Protocol 0157

status_simplified: Unknown


intervention_type: Other

lead_sponsor: AstraZeneca

location_country:
Italy
United States
Netherlands
Spain
Germany
France
Japan
Poland
Israel
Belgium
Puerto Rico
Russian Federation
China
Turkey
Canada
United Kingdom
Korea, Republic of

title: A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab With Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients With Unresected Stage I/II, Lymph-node Negative Non-small Cell Lung Cancer (PACIFIC-4/RTOG-3515)

summary: This is a Phase III, randomized, placebo-controlled, double-blind, multi-center study assessing the efficacy and safety of durvalumab with SoC SBRT versus placebo with SoC SBRT in patients with unresected clinical Stage I/II lymph node-negative (T1 to T3N0M0) NSCLC.


location_country:
United States
Chile
Spain
Germany
France
Japan
Poland
Israel
Argentina
Australia
New Zealand
China
Russian Federation
Turkey
Canada
United Kingdom
Korea, Republic of

location_facility: Hamato-Onkologie Hamburg Prof. Laack und Partner ( Site 0161)

location_facility: Shanghai Pulmonary Hospital ( Site 0101)

location_facility: FSAI Treatment and Rehabilitation Centre of the MoH and SD of RF ( Site 0264)

location_facility: Instituto de Investigaciones Clinicas Mar del Plata ( Site 0371)

location_facility: Bradford Hill Centro de Investigaciones Clinicas ( Site 0387)

location_facility: The Cancer Institute Hospital of JFCR ( Site 0021)

location_facility: Osaka Habikino Medical Center ( Site 0020)

location_facility: Moncton Hospital - Horizon Health Network ( Site 0410)

location_facility: Blacktown Hospital Western Sydney Local Health District ( Site 0008)

location_facility: Universitaetsklinikum des Saarlandes ( Site 0165)

location_facility: Tokyo Metropolitan Komagome Hospital ( Site 0015)

location_facility: National Cancer Center Hospital ( Site 0026)

location_facility: Hospital Universitario Insular de Gran Canaria ( Site 0244)

location_facility: L'hopital Nord-Ouest - Centre Hospitalier de Villefranche sur Saone ( Site 0149)

location_facility: The Second Hospital Affiliated to AMU ( Site 0119)

location_facility: Ankara Universitesi Tip Fakultesi. ( Site 0317)

location_facility: The Catholic University of Korea St. Vincent s Hospital ( Site 0064)

location_facility: Moscow Regional Oncological Dispensary ( Site 0274)

location_facility: Cancer Hospital Chinese Academy of Medical Science ( Site 0117)

location_facility: Parkland Health & Hospital System ( Site 0576)

location_facility: Krankenhaus Martha Maria Halle-Doelau ( Site 0166)

location_facility: Ege Universitesi Tip Fakultesi ( Site 0313)

location_facility: Complejo Hospitalario de Malaga ( Site 0238)

location_facility: Centro de Investigacion y desarrollo Oncologico SpA - CIDO SpA ( Site 0380)

location_facility: First Pavlov State Medical University of Saint Petersburg-Department of Oncology ( Site 0273)

location_facility: Wakayama Medical University Hospital ( Site 0025)

location_facility: Central Clinical Hospital with outpatient Clinic ( Site 0262)

location_facility: Mercy Health-Paducah Medical Oncology and Hematology ( Site 0570)

location_facility: Kansai Medical University Hospital ( Site 0022)

location_facility: CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0412)

location_facility: Christie NHS Foundation Trust ( Site 0275)

location_facility: UT Southwestern Medical Center ( Site 0558)

location_facility: Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0367)

location_facility: Kingston Health Sciences Centre ( Site 0414)

location_facility: Centre de Cancerologie du Grand Montpellier ( Site 0142)

location_facility: North Middlesex University Hospital NHS Trust ( Site 0291)

location_facility: Complejo Hospitalario Universitario A Coruna ( Site 0239)

location_facility: City Clinical Hospital 1 na. NI. Pirogov ( Site 0270)

location_facility: Hopital Cite de la Sante de Laval ( Site 0400)

location_facility: Cancer Hospital Affiliated to Xinjiang Medical University ( Site 0110)

location_facility: Omsk Clinical Oncology Dispensary ( Site 0267)

location_facility: Hacettepe Universitesi Tıp Fakultesi ( Site 0316)

location_facility: Fujita Health University Hospital ( Site 0016)

location_facility: Good Samaritan Hospital Corvallis ( Site 0521)

location_facility: Cambridge University Hospitals NHS Trust ( Site 0293)

location_facility: CHU de Quebec-Universite Laval-Hotel Dieu de Quebec ( Site 0403)

location_facility: National Medical Research Radiology Centre ( Site 0260)

location_facility: CIUSSS de la Mauricie et du Centre du Quebec ( Site 0408)

location_facility: Szpital Wojewodzki im. Mikolaja Kopernika ( Site 0602)

location_facility: Fujian Provincial Cancer Hospital ( Site 0102)

location_facility: Thomas Jefferson University Hospital ( Site 0548)

location_facility: Hospital Universitario La Fe ( Site 0233)

location_facility: Hospital General Universitario de Valencia ( Site 0231)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 0383)

location_facility: Nottingham City Hospital Campus ( Site 0287)

location_facility: Clinica Universidad Catolica del Maule ( Site 0385)

location_facility: The Third Affiliated Hospital of Harbin Medical University ( Site 0100)

location_facility: Wuhan Union Hospital Cancer Center-Cancer Center ( Site 0123)

location_facility: National Hospital Organization Nagoya Medical Center ( Site 0017)

location_facility: Peking Union Medical College Hospital ( Site 0108)

location_facility: Inonu Universitesi Medical Fakultesi ( Site 0318)

location_facility: Centro Oncologico Antofagasta ( Site 0386)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 0237)

location_facility: Pontificia Universidad Catolica de Chile ( Site 0382)

location_facility: Niigata Cancer Center Hospital ( Site 0019)

location_facility: Instituto Medico Especializado Alexander Fleming ( Site 0369)

location_facility: Tianjin Medical University Cancer Institute & Hospital ( Site 0111)

location_facility: Leeds Teaching Hospital NHS Trust. St. James University Hospital ( Site 0276)

location_facility: SAHI Republican Clinical Oncological Dispensary of the MoH of RT ( Site 0261)

location_facility: Hospital Universitario La Paz ( Site 0236)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0269)

location_facility: Shamir Medical Center-Assaf Harofeh ( Site 0227)

location_facility: Cukurova Universitesi Tıp Fakultesi Balcalı Hastanesi ( Site 0314)

location_facility: CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica ( Site 0372)

location_facility: Sanford Health Roger Maris Cancer Center ( Site 0533)

location_facility: West Cancer Center - East Campus ( Site 0544)

location_facility: Hospital General Universitario de Alicante ( Site 0240)

location_facility: Severance Hospital Yonsei University Health System ( Site 0063)

location_facility: El Camino Hospital Cancer Center ( Site 0529)

location_facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0310)

location_facility: Hospital Santa Creu i Sant Pau ( Site 0241)

location_facility: First Affiliated Hospital of The Third Military Medical University ( Site 0118)

location_facility: The First Affiliated Hospital of Wenzhou Medical University ( Site 0124)

location_facility: National Cancer Center Hospital East ( Site 0024)

location_facility: Southern Medical University Nanfang Hospital ( Site 0121)

location_facility: Shaare Zedek Medical Center-Oncology ( Site 0229)

location_facility: Saint Lukes Cancer Institute ( Site 0541)

location_facility: The Prince Charles Hospital ( Site 0010)

location_facility: Hopital Cardiologique Louis Pradel ( Site 0141)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0312)

location_facility: The First Affiliated Hospital Zhejiang University ( Site 0109)

location_facility: Zhongshan Hospital Fudan University ( Site 0103)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0603)

location_facility: St Georges University Hospitals NHS Foundation Trust. ( Site 0292)

location_facility: Abington Hospital - Asplundh Cancer Center ( Site 0575)

location_facility: Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 0601)

location_facility: LungenClinic Grosshansdorf GmbH ( Site 0171)

location_facility: Guys and St Thomas NHS Foundation Trust ( Site 0280)

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0286)

location_facility: Hospital Clinico San Carlos ( Site 0235)

location_facility: Kanazawa University Hospital ( Site 0018)

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii ( Site 0613)

location_facility: Hospital Universitario Miguel Servet ( Site 0242)

location_facility: Chungbuk National University Hospital ( Site 0062)

location_facility: Port Macquarie Base Hospital ( Site 0001)

location_facility: Nizhniy Novgorod Region Oncology Dispensary ( Site 0272)

location_facility: Pleszewskie Centrum Medyczne w Pleszewie Sp. z o.o. ( Site 0615)

location_facility: Leningrad Regional Oncology Center ( Site 0271)

title: A Phase 3 Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First-line Intervention in Participants With Metastatic Nonsquamous Non-small Cell Lung Cancer (LEAP-006)

summary:
The purpose of this study is to assess the safety and efficacy of pemetrexed + platinum chemotherapy + pembrolizumab (MK-3475) with or without lenvatinib (MK-7902/E7080) as first-line intervention in adults with metastatic nonsquamous non-small cell lung cancer.

The primary study hypotheses state that: 1) the combination of lenvatinib + platinum doublet chemotherapy + pembrolizumab prolongs Progression-free Survival (PFS) as assessed by blinded independent central review (BICR) per modified Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST 1.1) compared to matching placebo + platinum doublet chemotherapy + pembrolizumab, and 2) the combination of lenvatinib + platinum doublet chemotherapy + pembrolizumab prolongs Overall Survival (OS) compared to matching placebo + platinum doublet chemotherapy + pembrolizumab.


title: A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Neovascular Age-Related Macular Degeneration (LUCERNE)

summary: This study will evaluate the efficacy, safety, durability, and pharmacokinetics of faricimab administered at intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with neovascular age-related macular degeneration (nAMD).

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

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

lead_sponsor: Hoffmann-La Roche

location_country:
Australia
Russian Federation
Denmark
Taiwan
France
Poland
Argentina
Korea, Republic of
Hong Kong
Bulgaria
Singapore
Hungary
China
Portugal
Germany
United States
Italy
Austria
Brazil
Spain
Turkey

location_facility: Hospital de Braga; Servico de Oftalmologia

location_facility: Mid Atlantic Retina - Wills Eye Hospital

location_facility: Hospital Universitario Rio Hortega; Servicio de Oftalmologia

location_facility: Hospital de Sao Joao; Servico de Oftalmologia

location_facility: Queen Mary Hospital; Department of Ophthalmology

location_facility: "Intersec Research and Technology Complex Eye Microsurgery n a Fyodorov Novosibirsk Branch

location_facility: Hospital Universitario de Bellvitge; Servicio de oftalmologia

location_facility: Northern California Retina Vitreous Associates

location_facility: Nuovo Ospedale S. Chiara - A.O.U.P Presidio Ospedaliero di Cisanello; U.O. Oculistica Universitaria

location_facility: Hacettepe University Medical Faculty; Department of Ophthalmology

location_facility: The Second Hospital of Jilin University; ophthalmology department

location_facility: SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej

location_facility: Instituto Oftalmologico Fernandez Vega; Servicio de oftalmologia

location_facility: Szegedi Tudományegyetem ÁOK; Department of Ophtalmology

location_facility: Southwest Hospital , Third Military Medical University; Ophthalmology

location_facility: Gazi University Faculty of Medicine; Department Of Ophthalmology

location_facility: The First Hospital of China Medical University; ophthalmology department

location_facility: Centro Hospitalar E Universitário de Coimbra EPE - Serviço Oftalmologia; Serviço Oftalmologia

location_facility: Eye Hospital, Wenzhou Medical University

location_facility: The Affiliated Eye Hospital of Nanjing Medical University

location_facility: Rigshospitalet Glostrup; Afdeling for Øjensygdomme, Center for Forskning

location_facility: Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica

location_facility: Universitätkslinikum Düsseldorf, Augenklinik; Klinik fürAugenheilkunde

location_facility: The Second Affiliated Hospital of Harbin Medical University; ophthalmology department

location_facility: Chang Gung Medical Foundation - Linkou; Ophthalmology

location_facility: A.O.U. Policlinico - V. Emanuele - P.O. Gaspare Rodolico; Clinica Oculistica

location_facility: Centre Ophtalmologique; Imagerie et laser

location_facility: ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)

location_facility: Hopital de la croix rousse; Ophtalmologie

location_facility: Augenabteilung am St. Franziskus-Hospital

location_facility: Ankara University Medical Faculty; Department of Ophthalmology

location_facility: National University Hospital; Ophthalmology Department

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont; Szemészeti Osztály

location_facility: Seoul National University Bundang Hospital

location_facility: 1 Saint-Petersburg St. Med. University named after academician I.P.Pavlov; Chair of ophathalmology

location_facility: Centres Ophtalmologique St Exupéry; Ophtalmologie

location_facility: Pentagram Eye Hospital (Medical Center "Pentagram")

location_facility: Specialized Hospital for Active Treatment of Eye Diseases Zora

location_facility: Centre Odeon; Exploration Ophtalmologique

location_facility: Intersec Research and Technology Complex "Eye Microsurgery" n.a. S.N. Fyodorov; Cheboksary Branch

location_facility: A.O. Universitaria S. Maria Della Misericordia Di Udine; Clinica Oculistica

location_facility: "Intersec. Research and Technology Complex "Eye Microsurgery" n a Fyodorov Irkutsk branch

location_facility: Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche

location_facility: Taipei Veterans General Hospital; Ophthalmology

location_facility: Sjællands Universitetshospital, Roskilde; Øjenafdelingen

location_facility: The Ohio State University Havener Eye Institute

location_facility: UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.;CLINICA OCULISTICA

location_facility: Hospital Clinic de Barcelona; Consultas Externas Oftalmologia

location_facility: Changhua Christian Hospital; Department of Ophthalmology

location_facility: Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie

location_facility: Ege University Medical Faculty; Department of Ophthalmology

location_facility: Hospital Universitario Miguel Servet; Servicio de Oftalmologia

location_facility: Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia

location_facility: Zhongshan Ophthalmic Center, Sun Yat-sen University

location_facility: University Retina and Macula Associates, PC

location_facility: Daping Hospital of Third Military Medical University

location_facility: Southeastern Retina Associates Chattanooga

location_facility: Centre Paradis Monticelli; Ophtalmologie

intervention_type: Procedure


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 expert 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 is currently available according to the process described on www.clinicalstudydatarequest.com.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Peru
Jordan
Finland
Belgium
Russian Federation
India
Costa Rica
France
Thailand
Lithuania
Argentina
Canada
Colombia
South Africa
Sweden
Bulgaria
Hungary
Portugal
Germany
United States
Austria
Brazil
Czechia

acronym: AMALEE

location_facility: Comprehensive Cancer Centers of Nevada CCC of Nevada Henderson (4)

location_facility: Weinberg Cancer Institute at Franklin Square Hospital

location_facility: Mount Sinai School of Medicine CFTY720D2306

location_facility: Nebraska Cancer Specialists Oncology Hematology West

location_facility: Northwest Medical Specialties Dept.ofNW Med. Specialties

location_facility: Rocky Mountain Cancer Centers Rocky Mountain Cancer Ctr (50)

location_facility: Emory University School of Medicine/Winship Cancer Institute

title: A Phase II, Multicenter, Randomized, Open-label Study to Evaluate the Safety and Efficacy of 400 mg of Ribociclib in Combination With Non-steroidal Aromatase Inhibitors for the Treatment of Pre- and Postmenopausal Women With Hormone Receptor-positive, HER2-negative Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease

summary:
QT interval prolongation and neutropenia are considered to be important identified risks for ribociclib. The approved dosing regimen of ribociclib is 600 mg daily (QD) on a 3 weeks on/1 week off schedule.

The purpose of the study is to explore whether a reduced dosing regimen of 400 mg ribociclib orally QD 3 weeks on/1 week off may decrease the risk of QTc prolongation without compromising the efficacy of ribociclib in combination with an NSAI in pre- and postmenopausal women with HR-positive, HER2-negative aBC who have received no prior therapy for advanced disease. The risks of other AEs of special interest, such as neutropenia and hepatobiliary toxicity will be evaluated in this study as well.

Approximately 350 patients will be randomly assigned to one of the below treatment arms in a 1:1 ratio: Experimental arm (Arm 1) - Ribociclib 400 mg QD 3 weeks on/1 week off + NSAI (+ goserelin in premenopausal women): 175 patients Control arm (Arm 2) - Ribociclib 600 mg QD 3 weeks on/1 week off + NSAI (+ goserelin in premenopausal women): 175 patients Randomization will be stratified by the presence of lung and/or liver metastases (yes versus no).


location_country:
Australia
Russian Federation
Taiwan
Ukraine
India
France
Poland
Slovakia
Canada
Korea, Republic of
South Africa
Bulgaria
Hungary
Puerto Rico
China
United States
Germany
United Kingdom
Italy
Austria
Czechia
Israel
Spain

acronym: INTREPID

title: A 52-Week, Multicenter, Randomized, Double-blind, Placebo and Active-Controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease (INTREPID Lead-In)

summary: This study seeks to evaluate the safety and efficacy of brazikumab versus placebo (Stage I) and versus an active comparator (Stage 2) in participants with moderately to severely active CD and will include assessments of clinical response as demonstrated by improvement of symptoms and colonic mucosal appearance as observed on endoscopy


acronym: RHEA

location_facility: Theravance Biopharma Investigational Site (2)

location_facility: Theravance Biopharma Investigational Site #2

title: A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy With TD-1473 in Subjects With Moderately-to-Severely Active Ulcerative Colitis

summary: A Phase 2b/3 set of studies to evaluate the efficacy and safety of induction and maintenance therapy with TD-1473 in subjects with moderately-to-severely active ulcerative colitis with up to 60 weeks of treatment.


title: A Randomized, Multicenter, Parallel-group, Phase III Study to Compare the Efficacy of Arfolitixorin Versus Leucovorin in Combination With 5 Fluorouracil, Oxaliplatin, and Bevacizumab in Patients With Advanced Colorectal Cancer

acronym: AGENT

summary: This is a multicenter, randomized, parallel-group, Phase III study in at least 440 patients with advanced colorectal cancer to compare the efficacy of treatment with arfolitixorin versus Leucovorin in combination with 5-fluorouracil, oxaliplatin, and bevacizumab according to modified FOLFOX-6 until PD according to RECIST 1.1 criteria.

lead_sponsor: Isofol Medical AB

location_country:
Austria
United States
Sweden
Germany
France
Japan
Greece
Australia
Spain
Canada

location_facility: 724-06 - Hospital Universitario Reina Sofia

location_facility: 276-04 - MVZ Mitte - Onkologische Schwerpunktpraxis

location_facility: 124-05 - Ottawa Hospital Research Institute

location_facility: 840-30 - Joliet Oncology-Hematology Associates

location_facility: 124-04 - CISSS de l'Outaouais - Hôpital de Gatineau

location_facility: 840-01 - University of Southern California

location_facility: 036-10 - Border Medical Oncology Research Unit

location_facility: 040-06 - Ordensklinikum Linz GmbH - Barmherzige Schwestern

location_facility: 840-04 - St. Vincent Frontier Cancer Center

location_facility: 040-02 - Klinikum Klagenfurt am Wörthersee

location_facility: 036-07 - Northern Health - Epping Hospital

location_facility: 392-06 - National Cancer Center Hospital

location_facility: 840-10 - Oregon Health and Science University-Knight Cancer Institute

location_facility: 036-04 - Peninsula Health - Frankston Hospital

location_facility: 840-34 - Banner MD Anderson Cancer Center

location_facility: 392-12 - Saitama Medical University International Medical Center

location_facility: 276-12 - Charité - Universitätsmedizin Berlin

location_facility: 124-10 - Thunder Bay Regional Health Research Institute

location_facility: 724-05 - Hospital Universitario Virgen del Rocío

location_facility: 276-02 - Universitätsklinikum Carl Gustav Carus

location_facility: 392-14 - Kansai Medical University Hospital

location_facility: 840-29 - Ashland-Bellefonte Cancer Center

location_facility: 724-01 - Vall d'Hebron Institute of Oncology

location_facility: 300-06 - University General Hospital of Larissa

location_facility: 250-01 - Institute Hospitalier Franco-Britannique

location_facility: 840-12 - Rutgers Cancer Institute of New Jersey

location_facility: 392-01 - National Cancer Center Hospital East

location_facility: 840-02 - The University of Texas Health Science Center

location_facility: 392-11 - National Hospital Organization Osaka National Hospital

location_facility: 124-01 - Montreal University Health Center

location_facility: 724-09 - Hospital Universitario HM Sanchinarro

location_facility: 840-27 - Charleston Hematology Oncology Associates

location_facility: 036-01 - Western Health - Sunshine Hospital

location_facility: 840-22 - University of Oklahoma Stephenson Cancer Center

location_facility: 840-13 - UCH-MHS d/b/a Memorial Health System

location_facility: 840-14 - University of Michigan Cancer Center

location_facility: 300-02 - University General Hospital Attikon

location_facility: 724-03 - Instituto Oncologico Baselga - Hospital Quiron

location_facility: 036-09 - Southern Medical Day Care Center

location_facility: 040-01 - Allgemeines Krankenhaus der Stadt Wien

location_facility: 276-10 - Universitärers Cancer Center Hamburg (UCCH)

location_facility: 250-06 - Centre Georges Francois Leclerc

location_facility: 276-08 - Carl von Basedow Klinikum Saalekrei GmbH

location_facility: 392-08 - St.Marianna University School of Medicine Hospital

location_facility: 724-04 - Hospital Unviersitario 12 de Octubre

location_facility: 276-13 - Universitäres Krebszentrum Leipzig (UCCL)

location_facility: 392-09 - National Hospital Organization Shikoku Cancer Center

location_facility: 724-02 - Hospital Regional Universitario Carlos Haya

location_facility: 840-19 - University of Louisville Research Foundation Inc. (ULRF)

location_facility: 724-07 - Hospital del la Santa Creu i Sant Pau

location_facility: 276-01 - Klinikum der Universität München - Campus Grosshadern

location_facility: 124-03 - William Osler Health System - Brampton Civi Hospital


title: A Prospective, Multi-national, Non-interventional Study in Haemophilia A and B Patients With or Without Inhibitors Treated According to Routine Clinical Treatment Practice (Explorer™6)

summary: This study will collect data on bleeds and data related to quality of life in people with severe congenital (a disease existing from birth) haemophilia A and B, with or without inhibitors. The aim for the study is to look at the number of bleeds when on usual treatment for haemophilia. Participants will be asked to keep an electronic diary to track the number of bleeds and the treatment of their bleeds. Participants will be asked to wear an activity tracker on their wrist to capture their level of activity every day for up to 12 weeks. While taking part in this study, participants will keep getting their usual treatment as given to them by their doctor. All study visits at the clinic are done in the same way as the participants are used to. In the time between the participants' visits to the clinic, the study staff at the clinic may call or email the participant. The study will last for about 2½ years.

status: Completed

study_type: Observational

time_perspective: Prospective

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

lead_sponsor: Novo Nordisk A/S

location_country:
Finland
Malaysia
Greece
Australia
Russian Federation
Ukraine
India
Croatia
France
Japan
Lithuania
Poland
Norway
Slovakia
Canada
Korea, Republic of
Turkey
South Africa
Sweden
Switzerland
Netherlands
Bulgaria
Hungary
Algeria
Portugal
Germany
United States
United Kingdom
Italy
Austria
Bosnia and Herzegovina
Serbia
Mexico
Israel
Spain
Estonia

status_simplified: Completed


title: A Randomized Phase 3, Double-Blind Study of Chemotherapy With or Without Pembrolizumab Followed by Maintenance With Olaparib or Placebo for the First-Line Treatment of BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (KEYLYNK-001 / ENGOT-ov43 / GOG-3036)

summary:
The purpose of this study is to assess the efficacy and safety of treatment with carboplatin/paclitaxel* PLUS pembrolizumab (MK-3475) and maintenance olaparib (MK-7339) in women with epithelial ovarian cancer (EOC), fallopian tube cancer, or primary peritoneal cancer.

The primary study hypotheses are that the combination of pembrolizumab plus carboplatin/paclitaxel* followed by continued pembrolizumab and maintenance olaparib is superior to carboplatin/paclitaxel alone with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in participants with programmed death-ligand 1 (PD-L1)-positive tumors (Combined Positive Score [CPS]≥10) and in all participants, and that the combination of pembrolizumab plus carboplatin/paclitaxel followed by continued pembrolizumab is superior to carboplatin/paclitaxel alone with respect to PFS per RECIST 1.1 in participants with PD-L1-positive tumors (CPS≥10) and in all participants.

location_country:
Belgium
Australia
Russian Federation
Taiwan
Ukraine
France
Japan
Poland
Canada
Korea, Republic of
Colombia
South Africa
Chile
Hungary
United States
Germany
Italy
Brazil
Czechia
Israel
Spain
Turkey

location_facility: Hospital Araujo Jorge Associacao de Combate ao Cancer de Goias ( Site 2708)

location_facility: National Cancer Center Hospital ( Site 2605)

location_facility: Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1507)

location_facility: A.O.U. Federico II di Napoli ( Site 1107)

location_facility: Hospital Universitario Lucus Augusti ( Site 1609)

location_facility: UZ Leuven Campus Gasthuisberg ( Site 0306)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0208)

location_facility: Hospital Provincial San Pedro de Alcantara ( Site 1607)

location_facility: Linkou Chang Gung Memorial Hospital ( Site 2501)

location_facility: Caritas Klinikum Saarbruecken St. Theresia ( Site 0702)

location_facility: Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 2912)

location_facility: Hokkaido University Hospital ( Site 2607)

location_facility: MEDICAL COLLEGE OF WISCONSIN ( Site 0064)

location_facility: Texas Oncology, P.A. Texas Oncology-Tyler ( Site 8006)

location_facility: Kaiser Permanente Oncology Clinical Trial - San Francisco ( Site 0078)

location_facility: Marienhospital Stuttgart Vincenz von Paul Kliniken gGmbH ( Site 0707)

location_facility: Miami Valley Hospital [Dayton, OH] ( Site 0073)

location_facility: Texas Oncology-Dallas Presbyterian Hospital ( Site 8004)

location_facility: Swietokrzyskie Centrum Onkologii SPZOZ ( Site 1410)

location_facility: UT Southwestern Medical Center ( Site 0046)

location_facility: Saint Vincent Hospital and Health Center ( Site 0012)

location_facility: ASST Lecco. Ospedale A. Manzoni ( Site 1101)

location_facility: Sanford Gynecology Oncology ( Site 0004)

location_facility: Centro Medico Imbanaco de Cali S.A ( Site 2909)

location_facility: Centre D Oncologie de Gentilly ( Site 0609)

location_facility: Smilow Cancer Center at Yale-New Haven ( Site 0057)

location_facility: Staedtisches Krankenhaus Kiel GmbH ( Site 0709)

location_facility: National Hospital Organization Shikoku Cancer Center ( Site 2601)

location_facility: Gunma Prefectural Cancer Center ( Site 2609)

location_facility: Medical Rehabilitation Center ( Site 1502)

location_facility: Medipol Universite Hastanesi ( Site 1909)

location_facility: Charite Campus Virchow-Klinikum - CVK ( Site 0700)

location_facility: Cairns and Hinterland Hospital and Health Service ( Site 2201)

location_facility: Seoul National University Bundang Hospital ( Site 2404)

location_facility: Princess Margaret Hospital.. ( Site 0202)

location_facility: Centre Hospitalier de l'Ardenne ( Site 0303)

location_facility: Centro de Investigacion y desarrollo Oncologico SpA - CIDO SpA ( Site 2808)

location_facility: Bialostockie Centrum Onkologii ( Site 1412)

location_facility: China Medical University Hospital ( Site 2506)

location_facility: Imelda Ziekenhuis Bonheiden ( Site 0301)

location_facility: Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2170)

location_facility: FSBI National Medical Oncology Research Center n.a. N.N. Blokhina ( Site 1500)

location_facility: Washington University - School of Medicine ( Site 0062)

location_facility: Hospital General Universitario de Valencia ( Site 1610)

location_facility: Etlik Zubeyde Hanim Kadin Hastaliklari Egitim ve Arastirma Hastanesi ( Site 1903)

location_facility: Disney Family Cancer Center ( Site 0042)

location_facility: A. Tsyb Medical Radiological Research Center ( Site 1513)

location_facility: Municipal non-profit Enterprise Khmelnytskyi Regional Antitu-Gynecological Oncology department, Poli

location_facility: Oncology/Hematology Care Clinical Trials, LLC ( Site 8001)

location_facility: Complejo Hospitalario Universitario A Coruna. CHUAC ( Site 1608)

location_facility: Kaiser Permanente Oncology Clinical Trial - Walnut Creek ( Site 0080)

location_facility: IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 1108)

location_facility: Institut de Cancerologie Lucien Neuwirth ( Site 0613)

location_facility: RMI - Sumy Regional Clinical Oncology Dispensary ( Site 2191)

location_facility: Central City Clinical Hospital ( Site 2150)

location_facility: Sanford Roger Maris Cancer Center ( Site 0082)

location_facility: Sandton Oncology Medical Group PTY LTD ( Site 1712)

location_facility: Hillel Yaffe Medical Center ( Site 1011)

location_facility: Department of Medical Oncology ( Site 1703)

location_facility: Osaka International Cancer Institute ( Site 2617)

location_facility: Universitaetsklinikum Muenster ( Site 0720)

location_facility: Bakirkoy Sadi Konuk Egitim ve Arastirma Hastanesi ( Site 1907)

location_facility: Saitama Medical University International Medical Center ( Site 2604)

location_facility: CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0219)

location_facility: Instituto Nacional de Cancerologia E.S.E ( Site 2910)

location_facility: National Cancer Center Hospital East ( Site 2602)

location_facility: Kaiser Permanente Oncology Clinical Trials-Roseville ( Site 0084)

location_facility: Clinica de Pesquisas e Ctro de Estudos Onc. Ginecol. e Mamaria Ltda ( Site 2706)

location_facility: National Cheng Kung University Hospital ( Site 2508)

location_facility: Istituto Europeo di Oncologia ( Site 1100)

location_facility: Sakarya Universitesi Tip Fakultesi Hastanesi ( Site 1906)

location_facility: Royal Victoria Hospital McGill University Health Centre ( Site 0211)

location_facility: Instituto Nacional de Cancer Hospital do Cancer II ( Site 2700)

location_facility: Vseobecna fakultni nemocnice v Praze ( Site 0400)

location_facility: Little Company of Mary Hospital ( Site 1700)

location_facility: City Clinical Oncology Center ( Site 1505)

location_facility: Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2180)

location_facility: Hospital de Caridade de Ijui ( Site 2712)

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1509)

location_facility: University of Arizona Cancer Center ( Site 0074)

location_facility: Kaiser Permanente Oncology Clinical Trial - Santa Clara ( Site 0079)

location_facility: Pontificia Universidad Catolica de Chile ( Site 2805)

location_facility: University of the Ryukyus Hospital ( Site 2616)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1115)

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi ( Site 1900)

location_facility: Northeast Georgia Medical Center ( Site 0029)

location_facility: Universitaetsklinikum Duesseldorf ( Site 0704)

location_facility: National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 1504)

location_facility: Northwell Health- Monter Cancer Center ( Site 0075)

location_facility: Taipei Veterans General Hospital ( Site 2503)

location_facility: Seoul National University Hospital ( Site 2403)

location_facility: Hospital Universitario de Donostia ( Site 1602)

location_facility: Instituto do Cancer do Ceara ( Site 2707)

location_facility: Rush University Medical Center ( Site 0019)

location_facility: Orszagos Onkologiai Intezet ( Site 0800)

location_facility: Arkhangelsk Clinical Oncological Dispensary ( Site 1508)

location_facility: Virginia Cancer Specialists, PC ( Site 8003)

location_facility: Szpital Kliniczny im. Przemienienia Panskiego Uniwersytetu Medycznego im. K. Marcinkowskiego w Pozna

location_facility: Presidio Ospedaliero Santa Chiara ( Site 1109)

location_facility: Severance Hospital Yonsei University Health System ( Site 2400)

location_facility: Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 2913)

location_facility: Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 0805)

location_facility: A.O.U. Citta della Salute e della Scienza di Torino ( Site 1104)

location_facility: Kaiser Permanente N. CA Regional Oncology Clinical Trials ( Site 0008)

location_facility: Ankara UTF Cebeci Arastırma ve Uygulama Hastanesi ( Site 1905)

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz ( Site 0802)

location_facility: Cliniques Universitaires Saint-Luc ( Site 0312)

location_facility: Edith Wolfson Medical Center ( Site 1003)

location_facility: Azienda Ospedaliera Policlinico Umberto I ( Site 1111)

location_facility: Shaare Zedek Medical Center ( Site 1005)

location_facility: Iwate Medical University Hospital ( Site 2606)

location_facility: Uludag Universitesi Tip Fakultesi ( Site 1904)

location_facility: Akdeniz Universitesi Tıp Fakultesi ( Site 1901)

location_facility: Institut de Cancerologie du Gard - CHU Caremeau ( Site 0610)

location_facility: Hospital Universitario Virgen del Rocio ( Site 1604)

location_facility: Taichung Veterans General Hospital ( Site 2510)

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 2714)

location_facility: Hospital Nossa Senhora Da Conceicao ( Site 2703)

location_facility: Weinberg Cancer Institute at Franklin Square ( Site 0035)

location_facility: Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 2710)

location_facility: Memorial Health University Medical Center ( Site 0011)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 0801)

location_facility: St. Marianna University School of Medicine Hospital ( Site 2613)

location_facility: Cancer Care Langenhoven Drive Oncology Centre ( Site 1701)

location_facility: Women and Infants Hospital [Providence, RI] ( Site 0039)

location_facility: Dr. Sudarshan K. Sharma, LTD ( Site 0061)

location_facility: Outeniqua Cancercare Oncology Unit ( Site 1708)

location_facility: University of Iowa Hospital and Clinics ( Site 0005)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (

location_facility: Szpitale Pomorskie Sp. z o.o. ( Site 1407)

location_facility: Cape Town Oncology Trials Pty Ltd ( Site 1707)

location_facility: Nebraska Methodist Hospital ( Site 0063)

location_facility: National Taiwan University Hospital ( Site 2502)

location_facility: Istanbul Acibadem University Atakent Hospital ( Site 1902)

location_facility: Istituto Oncologico Veneto IRCCS ( Site 1113)

location_facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1406)

location_facility: A.O. Univ. S. M. della Misericordia ( Site 1114)

location_facility: Xarxa Assistencial Universitaria Manresa ( Site 1605)

location_facility: Klinikum Rechts der Isar. Technischen Universitaet Muenchen ( Site 0710)

location_facility: University of Alabama at Birmingham (UAB) ( Site 0036)

location_facility: Kaiser Permanente Oncology Clinical Trial -Oakland ( Site 0077)

location_facility: Dartmouth Hitchcock Medical Center ( Site 0024)

location_facility: CHU de Brest -Site Hopital Morvan ( Site 0616)

location_facility: National Defense Medical College Hospital ( Site 2608)

location_facility: FSCC of Special Types of Med. Care and Technologies ( Site 1503)

location_facility: Instituto Valenciano de Oncologia ( Site 1601)

location_facility: Texas Oncology, P.A. - Bedford ( Site 8005)

location_facility: Changhua Christian Hospital ( Site 2507)

location_facility: Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 1603)

location_facility: Kyiv City Clinical Oncological Center ( Site 2140)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 2800)

location_facility: MI Odessa Regional Oncological Centre ( Site 2121)

location_facility: Centro Oncologico Antofagasta ( Site 2804)

location_facility: Sacro Cuore di Gesu Fatebenefratelli ( Site 1112)

location_facility: MI Precarpathian Clinical Oncology Center ( Site 2181)

location_facility: MD Anderson Cancer Center at Cooper ( Site 0067)

location_facility: CIUSSS du Saguenay-Lac-St-Jean ( Site 0218)

location_facility: Kaiser Permanente Oncology Clinical Trials-Sacramento ( Site 0083)

location_facility: Saint Dominic - Jackson Memorial Hospital ( Site 0072)

location_facility: Centro Investigación del Cáncer James Lind ( Site 2810)

location_facility: Clinica Universitaria de Navarra ( Site 1600)

location_facility: Niigata Cancer Center Hospital ( Site 2618)

location_facility: Policlinico Universitario Gemelli ( Site 1105)

location_facility: Kingston Health Sciences Centre ( Site 0207)


title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Tolerability of GRF6021 Infusions in Subjects With Parkinson's Disease and Cognitive Impairment

summary: This study will evaluate the safety, tolerability, and potential effects on cognition of GRF6021, a plasma-derived product, administered as an intravenous (IV) infusion, to subjects with Parkinson's disease and cognitive impairment.

lead_sponsor: Alkahest, Inc.

location_country:
United States
Australia
France

location_facility: Rocky Mountain Movement Disorders Center


title: A Randomized, Double-blind, Multicenter Study Assessing Short (16 Weeks) and Long-term Efficacy (up to 1 Year), Safety, and Tolerability of 2 Subcutaneous Secukinumab Dose Regimens in Adult Patients With Moderate to Severe Hidradenitis Suppurativa (SUNRISE)

acronym: SUNRISE

summary: The purpose of this study is to demonstrate superiority of secukinumab at Week 16, based on Hidradenitis Suppurativa Clinical Response (HiSCR) rates versus placebo, along with the maintenance of efficacy of secukinumab at Week 52 in subjects with moderate to severe HS. Moreover, this study will also assess the safety and tolerability of secukinumab.

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

location_country:
Guatemala
Malaysia
Greece
Belgium
Russian Federation
Denmark
India
Croatia
France
Lithuania
Poland
Slovakia
Argentina
Canada
Colombia
South Africa
Switzerland
Netherlands
Philippines
Vietnam
Bulgaria
Singapore
Hungary
United States
Germany
United Kingdom
Italy
Lebanon
Czechia
Israel
Spain
Turkey


title: A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib in First-line Therapy of Participants With Advanced Hepatocellular Carcinoma (LEAP-002)

summary:
The purpose of this study is to evaluate the safety and efficacy of lenvatinib (E7080/MK-7902) in combination with pembrolizumab (MK-3745) versus lenvatinib in combination with placebo as first-line therapy for the treatment of advanced hepatocellular carcinoma in adult participants.

The primary hypotheses of this study are that lenvatinib plus pembrolizumab is superior to lenvatinib plus placebo with respect to progression-free survival (PFS) and overall survival (OS).

location_country:
Australia
Russian Federation
Taiwan
France
Japan
Poland
Thailand
Canada
Korea, Republic of
Colombia
Chile
Ireland
China
United States
Germany
United Kingdom
Italy
Mexico
New Zealand
Spain
Turkey

location_facility: Affiliated Tumor Hospital of Xinjiang Medical University ( Site 0109)

location_facility: Instituto Nacional de Cancerologia E.S.E ( Site 0142)

location_facility: Musashino Red Cross Hospital ( Site 0310)

location_facility: University of Oklahoma Health Science Center ( Site 0625)

location_facility: Policlinico S. Orsola-Malpighi ( Site 0286)

location_facility: The First Affiliated Hospital of Zhejiang University ( Site 0097)

location_facility: Tampa General Medical Group ( Site 0629)

location_facility: Massachusetts General Hospital ( Site 0603)

location_facility: Toranomon Hospital Kajigaya ( Site 0312)

location_facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 0550)

location_facility: University of Kansas Cancer Center ( Site 0600)

location_facility: Icahn School of Medicine at Mount Sinai ( Site 0611)

location_facility: City Clinical Oncology Center ( Site 0446)

location_facility: First Moscow State Medical University n.a. I.M.Sechenov ( Site 0453)

location_facility: Hospital Universitario Ramon y Cajal ( Site 0514)

location_facility: Chang Gung Medical Foundation. Linkou ( Site 0525)

location_facility: National Cancer Center Hospital ( Site 0307)

location_facility: Centre Hospitalier Regional du Orleans ( Site 0169)

location_facility: Fudan University Shanghai Cancer Center ( Site 0086)

location_facility: Chiang Mai University Maharaj Nakorn Chiang Mai Hospital ( Site 0211)

location_facility: National Cheng Kung University Hospital ( Site 0528)

location_facility: Administradora Country SA - Clinica del Country ( Site 0146)

location_facility: Universitaetsklinikum Hamburg-Eppendorf ( Site 0184)

location_facility: Monash Health-Monash Medical Centre ( Site 0004)

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 0529)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 0504)

location_facility: Hospital Universitari Vall d Hebron ( Site 0508)

location_facility: Royal Prince Alfred Hospital ( Site 0001)

location_facility: McGill University Health Centre ( Site 0052)

location_facility: Yonsei University Severance Hospital ( Site 0463)

location_facility: Ospedale Sacro Cuore - Don Calabria ( Site 0289)

location_facility: Clinica Universidad Catolica del Maule ( Site 0065)

location_facility: Beth Israel Deaconess Medical Center ( Site 0716)

location_facility: Sunnybrook Research Institute ( Site 0055)

location_facility: Pyatigorsk Oncology Dispensary ( Site 0441)

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0363)

location_facility: Universitaetsklinikum Wuerzburg ( Site 0186)

location_facility: Abdurrahman Yurtaslan Onkoloji Hastanesi ( Site 0551)

location_facility: China Medical University Hospital ( Site 0527)

location_facility: Princess Margaret Cancer Centre ( Site 0050)

location_facility: Taichung Veterans General Hospital ( Site 0526)

location_facility: Universitaetsklinikum Essen ( Site 0188)

location_facility: The University of Tokyo Hospital ( Site 0308)

location_facility: National Taiwan University Hospital ( Site 0523)

location_facility: Hospital Universitario y Politecnico La Fe de Valencia ( Site 0505)

location_facility: National Cancer Center Hospital East ( Site 0306)

location_facility: Medical Care and Research S.A. de C.V. ( Site 0359)

location_facility: The Christie NHS Foundation Trust ( Site 0575)

location_facility: Princess Alexandra Hospital ( Site 0007)

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0573)

location_facility: First Affiliated Hospital of Anhui Medical University ( Site 0095)

location_facility: Pacific Hematology Oncology Associates ( Site 0588)

location_facility: Inonu Universitesi Medical Fakultesi ( Site 0545)

location_facility: Szpital Wojewodzki w Koszalinie im. Mikolaja Kopernika ( Site 0421)

location_facility: Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital ( Site 0304)

location_facility: Fundacion Arturo Lopez Perez ( Site 0064)

location_facility: Cancer Hospital Chinese Academy of Medical Sciences ( Site 0100)

location_facility: Yokohama City University Medical Center ( Site 0313)

location_facility: Kagawa Prefectural Central Hospital ( Site 0325)

location_facility: The First Affiliated Hospital of Xi an Jiaotong University ( Site 0090)

location_facility: London Health Sciences Centre ( Site 0053)

location_facility: Taipei Veterans General Hospital ( Site 0524)

location_facility: Oaxaca Site Management Organization S.C. ( Site 0366)

location_facility: National Hospital Organization Kyushu Medical Center ( Site 0321)

location_facility: Akdeniz Universitesi Tip Fakultesi ( Site 0548)

location_facility: CHRU de Lille - Hopital Claude Huriez ( Site 0159)

location_facility: Klinikum der Universitaet Aachen - RWTH ( Site 0185)

location_facility: Aichi Cancer Center Hospital ( Site 0316)

location_facility: Trakya Universitesi Tip Fakultesi ( Site 0544)

location_facility: Mater Misericordiae University Hospital ( Site 0241)

location_facility: Hospital Universitario La Paz ( Site 0510)

location_facility: Otto-Von-Guericke-Universitaet Magdeburg ( Site 0182)

location_facility: MTZ Clinical Research Sp. z o. o. ( Site 0427)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0418)

location_facility: The Beatson West of Scotland Cancer Centre ( Site 0566)

location_facility: Wakayama Medical University Hospital ( Site 0318)

location_facility: Saga-Ken Medical Centre Koseikan ( Site 0323)

location_facility: Az Osp Univ Policlin Paolo Giaccone ( Site 0284)

location_facility: The University of Arizona Cancer Center - North Campus ( Site 0621)

location_facility: Emory University Winship Cancer Institute ( Site 0639)

location_facility: Hiroshima University Hospital ( Site 0320)

location_facility: Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu ( Site 0419)

location_facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0450)

location_facility: St Vincents Hospital Melbourne ( Site 0003)

location_facility: The Third Xiangya Hospital of Central South University ( Site 0093)

location_facility: CRYPTEX Investigacion Clinica S.A. de C.V. ( Site 0362)

location_facility: Universitaetsklinikum Carl Gustav Carus der TU Dresden ( Site 0178)

location_facility: University of Miami, Sylvester Comprehensive Cancer Center ( Site 0596)

location_facility: Royal Free London NHS Foundation Trust ( Site 0567)

location_facility: Eastern Regional Medical Center, Inc. ( Site 0626)

location_facility: Harbin Medical University Cancer Hospital ( Site 0089)

location_facility: Hospital Universitario Virgen del Rocio ( Site 0509)

location_facility: Centro di Riferimento Oncologico de Aviano Istituto Nazionale Tumori ( Site 0292)

location_facility: Nottingham University Hospitals NHS Trust ( Site 0569)

location_facility: Centro de Investigacion Medica Aguascalientes ( Site 0355)

location_facility: Universitaetsklinikum Leipzig ( Site 0187)

location_facility: Kanazawa University Hospital ( Site 0315)

location_facility: Azienda Ospedaliero-Univers. Pisana Ospedale S. Chiara ( Site 0291)

location_facility: Central Texas Veterans Healthcare System ( Site 0617)

location_facility: Instituto Clinico Oncologico del Sur ( Site 0067)

location_facility: West China Hospital of Sichuan University ( Site 0087)

location_facility: Zhongshan Hospital Fudan University ( Site 0096)

location_facility: Erzurum Ataturk University Faculty of Medicine ( Site 0546)

location_facility: Universitaetsklinikum Tuebingen ( Site 0179)

location_facility: Complejo Hospitalario Universitario de Santiago ( Site 0506)

location_facility: Pontificia Universidad Catolica de Chile ( Site 0070)

location_facility: Southern Medical University Nanfang Hospital ( Site 0102)

location_facility: Wuhan Union hospital Cancer Center ( Site 0105)

location_facility: St Vincents University Hospital ( Site 0242)

location_facility: Kings College Hospital NHS Foundation Trust ( Site 0565)

location_facility: Hospital Universitario Puerta de Hierro ( Site 0513)

location_facility: CHU de Nancy Hopital Brabois Adultes ( Site 0164)

location_facility: Fundacion Centro de Investigacion Clinica CIC ( Site 0141)

location_facility: Stony Brook University Medical Center - Cancer Center ( Site 0612)

location_facility: Policlinico Universitario Campus Biomedico ( Site 0288)

location_facility: Seoul National University Hospital ( Site 0462)

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0365)

location_facility: Bezmi Alem Universitesi Tıp Fakultesi ( Site 0547)

location_facility: City of Hope Comprehensive Cancer Center ( Site 0587)

location_facility: Seoul National University Bundang Hospital ( Site 0464)

location_facility: Siriraj Hospital. Mahidol Univerisity ( Site 0213)

location_facility: Hospital General de Medellin Luz Castro de Gutierrez ( Site 0137)

location_facility: Hacettepe Uni. Tip Fakultesi ( Site 0553)

location_facility: Oregon Health & Science University ( Site 0645)

location_facility: Fondazione Salvatore Maugeri IRCCS. ( Site 0290)

location_facility: Centro Medico Imbanaco de Cali S.A ( Site 0139)

location_facility: Universitaetsklinikum Frankfurt ( Site 0180)


ReferenceType: derived

ReferenceCitation: Hultin S, Johnson DW, Badve SV. Recent evidence on the effect of treatment of metabolic acid on the progression of kidney disease. Curr Opin Nephrol Hypertens. 2021 Sep 1;30(5):467-473. doi: 10.1097/MNH.0000000000000728.

family: Hultin

full_name: Sebastian Hultin

given: Sebastian

sequence: first

family: Johnson

full_name: David W. Johnson

given: David W.

sequence: additional

family: Badve

full_name: Sunil V. Badve

given: Sunil V.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Current Opinion in Nephrology & Hypertension

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: Tricida, Inc.

location_country:
Armenia
North Macedonia
Malaysia
Romania
Australia
Belgium
Taiwan
Ukraine
Spain
France
Poland
Slovakia
Argentina
Canada
Korea, Republic of
Colombia
Chile
Hong Kong
Netherlands
Bulgaria
Singapore
Hungary
Portugal
United States
United Kingdom
Italy
Brazil
Serbia
Mexico
Czechia
Albania
Israel
Georgia
New Zealand
Belarus

acronym: VALOR-CKD

location_facility:
Investigative Site 3902
Investigative Site 2505
Investigative Site 2312
Investigative Site 2707
Investigative Site 4152
Investigative Site 3108
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title: A Phase 3b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of TRC101 in Delaying Chronic Kidney Disease Progression in Subjects With Metabolic Acidosis

summary: The purpose of this study is to evaluate the effect of TRC101 on the progression of chronic kidney disease (CKD) and to evaluate the safety profile of TRC101 in CKD patients with metabolic acidosis.


title: Phase II, Open-label, Single Arm, Multicenter Study of Encorafenib, Binimetinib Plus Cetuximab in Subjects With Previously Untreated BRAF V600E -Mutant Metastatic Colorectal Cancer

acronym: ANCHOR-CRC

summary: The purpose of this study is to evaluate the efficacy and safety of the combination of study drugs encorafenib, binimetinib and cetuximab in patients who have BRAF V600 mutant metastatic colorectal cancer and have not received any prior treatment for their metastatic disease.

lead_sponsor: Pierre Fabre Medicament

location_country:
Italy
Austria
Netherlands
France
Japan
Belgium
Spain
United States
United Kingdom

location_facility: Fondazione del Piemonte per l'Oncologia IRCC Candiolo

location_facility: Hôpital Morvan CHRU de Brest Institut de cancérologie et d'hematologie

location_facility: Institut Català d'Oncologia (ICO L'Hospitalet)

location_facility: Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Hospital Universitario y Politécnico La FE

location_facility: Hospital Clínic I Provincial de Barcelona

location_facility: Complejo Hospitalario De Navarra S Oncologia Medica

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: GI Research Team, The Christie NHS Foundation Trust


title: A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration (Portal)

acronym: Portal

summary: This study will evaluate the long-term safety and tolerability of the Port Delivery System with ranibizumab (PDS) 100 mg/mL with refill-exchanges administered every 24 weeks (Q24W) or every 36 weeks (Q36W) for approximately 144 weeks in participants with neovascular age-related macular degeneration who have completed either Phase II Study GX28228 (Ladder), Phase III Study GR40548 (Archway) or Phase IIIb Study WR42221 (Velodrome).

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

location_country:
Austria
United States
France

location_facility: Mid Atlantic Retina - Wills Eye Hospital

location_facility: Jacobs Retina center at the Shiley eye Institute UCSD

location_facility: Hopital de la croix rousse; Ophtalmologie

location_facility: Retina-Vitreous Associates Medical Group

location_facility: Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie

location_facility: University Retina and Macula Associates, PC

location_facility: Centre Paradis Monticelli; Ophtalmologie


title: A Phase 3, Interventional, Randomized, Multicenter, Open-Label Study of DCC-2618 vs Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumors After Treatment With Imatinib

acronym: intrigue

summary: This is a 2-arm, randomized, open-label, international, multicenter study comparing the efficacy of DCC-2618 to sunitinib in GIST patients who progressed on or were intolerant to first-line anticancer treatment with imatinib. Approximately 426 patients will be randomized in a 1:1 ratio to DCC-2618 150 mg once daily (QD) (continuous dosing for 6 week cycles) or sunitinib 50 mg QD (6 week cycles, 4 weeks on, 2 weeks off).

ReferenceCitation: Nemunaitis J, Bauer S, Blay JY, Choucair K, Gelderblom H, George S, Schöffski P, Mehren MV, Zalcberg J, Achour H, Ruiz-Soto R, Heinrich MC. Intrigue: Phase III study of ripretinib versus sunitinib in advanced gastrointestinal stromal tumor after imatinib. Future Oncol. 2020 Jan;16(1):4251-4264. doi: 10.2217/fon-2019-0633. Epub 2019 Nov 22.

name: The University of Toledo College of Medicine & Life Sciences, Toledo, OH 43606, USA

name: ProMedica Health System, Toledo, OH 43606, USA

family: Nemunaitis

full_name: John Nemunaitis

given: John

name: West German Cancer Center, Deparment of Medical Oncology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany

family: Bauer

full_name: Sebastian Bauer

name: Centre Léon Bérard, Unicancer, LYRICAN and Université Claude Bernard Lyon 1, Lyon, France

family: Blay

full_name: Jean-Yves Blay

given: Jean-Yves

family: Choucair

full_name: Khalil Choucair

given: Khalil

name: Leiden University Medical Center, Leiden, The Netherlands

family: Gelderblom

full_name: Hans Gelderblom

given: Hans

name: Medical Oncology, Dana-Farber Cancer Institute, Boston, MA 02215, USA

family: George

full_name: Suzanne George

given: Suzanne

name: University Hospitals Leuven, Department of General Medical Oncology, Leuven Cancer Institute, Leuven, Belgium

family: Schöffski

full_name: Patrick Schöffski

given: Patrick

name: Fox Chase Cancer Center, Philadelphia, PA 19111, USA

family: Mehren

full_name: Margaret von Mehren

given: Margaret von

name: Department of Epidemiology & Preventive Medicine, School of Public Health & Preventive Medicine, Monash University & Department of Medical Oncology Alfred Health, Melbourne, Australia

family: Zalcberg

full_name: John Zalcberg

name: Deciphera Pharmaceuticals, LLC, Waltham, MA 02451, USA

family: Achour

full_name: Haroun Achour

given: Haroun

family: Ruiz-Soto

full_name: Rodrigo Ruiz-Soto

given: Rodrigo

name: Portland VA Health Care System & OHSU Knight Cancer Institute, Oregon Health & Science University, Portland, OR 97239, USA

family: Heinrich

full_name: Michael C Heinrich

given: Michael C

journal_name: Future Oncology

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

repository_institution: University of Melbourne - Minerva Access

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

lead_sponsor: Deciphera Pharmaceuticals LLC

location_country:
Belgium
Australia
Taiwan
France
Poland
Norway
Argentina
Canada
Korea, Republic of
Chile
Sweden
Switzerland
Netherlands
Singapore
Hungary
United States
Germany
United Kingdom
Italy
Czechia
Israel
Spain

location_facility: stituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori

location_facility: Hospital Universitario Clinico San Carlos

location_facility: University of Texas MD Anderson Cancer Center

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

location_facility: Washington Cancer Institute at MedStar Washington Hospital Center

location_facility: Universitaetsspital Zuerich, Klinik fuer Onkologie

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: University of California San Diego Medical Center

location_facility: Instituto Medicao Especializado Alexander Fleming

location_facility: Froedtert Hospital-Medical College of Wisconsin

location_facility: Virginia Commonwealth University Massey Cancer Center

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: University of Colorado Hospital - Anschutz Cancer Pavillion

location_facility: Oregon Health & Science University Center for Health and Healing

location_facility: Clinica San Carlos de Apoquindo Red Salud UC Christs

location_facility: Centre Hospitalier Universitaire Vaudois, Fondation du Centre Pluridisciplinaire d'Oncologi

location_facility: Norton Cancer Institute, Audubon Hospital Campus

location_facility: Miami Cancer Institute at Baptist Health, Inc.

location_facility: Hospital Universitario HM Madrid Sanchinarro

location_facility: Montefiore Medical Center-Montefiore Medical Park

location_facility: UCLA Hematology Oncology Center - Main Site

location_facility: Washington University School of Medicine - Siteman Cancer Center

location_facility: The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Solove Research Institute

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

location_facility: Complejo Hospitalario Universitario de Vigo

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

location_facility: University of Minnesota Medical Center-Fairview