title: A SU011248 Expanded Access Protocol For Systemic Therapy Of Patients With Metastatic Renal Cell Carcinoma Who Are Ineligible For Participation In Other SU011248 Protocols But May Derive Benefit From Treatment With SU011248

summary: The primary objective of this protocol is to provide access to SU011248 treatment for patients with metastatic RCC who are ineligible for participation in ongoing SU011248 clinical studies and have the potential to derive clinical benefit from treatment with SU011248 based on the judgment of the investigator.

status: Approved for marketing

ReferenceCitation: Barrios CH, Herchenhorn D, Chacon M, Cabrera-Galeana P, Sajben P, Zhang K. Safety and efficacy of sunitinib in patients from Latin America: subanalysis of an expanded access trial in metastatic renal cell carcinoma. Onco Targets Ther. 2016 Sep 23;9:5839-5845. doi: 10.2147/OTT.S109445. eCollection 2016.

ReferenceCitation: Lee SH, Bang YJ, Mainwaring P, Ng C, Chang JW, Kwong P, Li RK, Sriuranpong V, Toh CK, Yuan J, Pitman Lowenthal S, Chung HC. Sunitinib in metastatic renal cell carcinoma: an ethnic Asian subpopulation analysis for safety and efficacy. Asia Pac J Clin Oncol. 2014 Sep;10(3):237-45. doi: 10.1111/ajco.12163. Epub 2014 Feb 27.

ReferenceCitation: Gore ME, Hariharan S, Porta C, Bracarda S, Hawkins R, Bjarnason GA, Oudard S, Lee SH, Carteni G, Nieto A, Yuan J, Szczylik C. Sunitinib in metastatic renal cell carcinoma patients with brain metastases. Cancer. 2011 Feb 1;117(3):501-9. doi: 10.1002/cncr.25452. Epub 2010 Sep 22.

ReferenceCitation: Gore ME, Szczylik C, Porta C, Bracarda S, Bjarnason GA, Oudard S, Hariharan S, Lee SH, Haanen J, Castellano D, Vrdoljak E, Schoffski P, Mainwaring P, Nieto A, Yuan J, Bukowski R. Safety and efficacy of sunitinib for metastatic renal-cell carcinoma: an expanded-access trial. Lancet Oncol. 2009 Aug;10(8):757-63. doi: 10.1016/S1470-2045(09)70162-7. Epub 2009 Jul 15.

location_country:
Finland
Germany
Ireland
Poland
Argentina
Australia
Brazil
Bosnia and Herzegovina
Thailand
Turkey
Croatia
Chile
Canada
Serbia
France
Czech Republic
Slovenia
Colombia
Portugal
Slovakia
Hungary
Hong Kong
Switzerland
United States
India
Romania
Lebanon
Belgium
Malaysia
Peru
Egypt
Philippines
Italy
Ecuador
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Mexico
Venezuela
Korea, Republic of
Spain
Greece
Panama
Taiwan
Bulgaria
Russian Federation
Israel


title: An Open Label, Randomized, Parallel-group Pharmacokinetics Trial of Tipranavir / Ritonavir (TPV/RTV), Alone or in Combination With RTV-boosted Saquinavir (SQV), Amprenavir (APV), or Lopinavir (LPV), Plus an Optimized Background Regimen, in Multiple Antiretroviral (ARV) Experienced Patients.

summary:
This is an open-label, randomized, parallel group pharmacokinetics trial of tipranavir/ritonavir (TPV/RTV), alone or in combination with RTV-boosted saquinavir (SQV), amprenavir (APV) or lopinavir (LPV), plus an optimized background regimen, in multiple antiretroviral (ARV) experienced HIV-1 patients.

The primary objective is to determine the safety and pharmacokinetics of:

TPV/RTV given with an optimized background regimen (OBR) and TPV/RTV given in combination with saquinavir, amprenavir, or Kaletra® and an optimized background regimen (OBR).

study_start_date_type: Actual

status: Completed

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

lead_sponsor: Boehringer Ingelheim

location_country:
Germany
Italy
Portugal
United Kingdom
Denmark
Australia
Netherlands
Switzerland
Belgium
United States
Greece
Canada
France

location_facility: ifi Institut für interdisziplinäre Infektiologie

location_facility: Centre Hospitalier Universitaire St. Pierre

location_facility: Boehringer Ingelheim Investigational Site

location_facility: McGill University Health Centre, Suite A5-140

location_facility: Klinikum der Johann Wolfgang Goethe-Universität

location_facility: Canadian Immunodeficiency Research Collaborative Inc.

location_facility: Montreal Chest Institute - McGill University Health Centre

location_facility: Korgialenio-Benakio-Hellenic Red Cross General Hospital

location_facility: 1st Social Insurance Foundation (IKA) Pentelis

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Adjuvant Ganglioside GM2-KLH/QS-21 Vaccination: Post-Operative Adjuvant Ganglioside GM2-KLH/QS-21 (BMS-248479) Vaccination Treatment After Resection of Primary Cutaneous Melanoma Thicker Than 1.5mm (AJCC/UICC Stage II, T3-T4N0M0), a 2-Arm Multicenter Randomized Phase III Trial vs. Observation

summary:
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether vaccine therapy is more effective than observation alone for melanoma.

PURPOSE: This randomized phase III trial is studying vaccine therapy to see how well it works compared to observation alone in treating patients with primary stage II melanoma.

status: Unknown status

design_allocation: Randomized

ReferenceType: result

ReferenceCitation: Eggermont AM, Suciu S, Ruka W, et al.: EORTC 18961: Post-operative adjuvant ganglioside GM2-KLH21 vaccination treatment vs observation in stage II (T3-T4N0M0) melanoma: 2nd interim analysis led to an early disclosure of the results. [Abstract] J Clin Oncol 26 (Suppl 15): A-9004, 2008.

ReferenceType: derived

ReferenceCitation: Patel PM, Suciu S, Mortier L, Kruit WH, Robert C, Schadendorf D, Trefzer U, Punt CJ, Dummer R, Davidson N, Becker J, Conry R, Thompson JA, Hwu WJ, Engelen K, Agarwala SS, Keilholz U, Eggermont AM, Spatz A; EORTC Melanoma Group. Extended schedule, escalated dose temozolomide versus dacarbazine in stage IV melanoma: final results of a randomised phase III study (EORTC 18032). Eur J Cancer. 2011 Jul;47(10):1476-83. doi: 10.1016/j.ejca.2011.04.030. Epub 2011 May 18.

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

location_country:
Finland
Germany
Italy
Poland
Portugal
Israel
Norway
Denmark
Australia
United Kingdom
Netherlands
Switzerland
Belgium
Spain
Estonia
Serbia
Russian Federation
France

location_facility: Nijmegen Cancer Center at Radboud University Medical Center

location_facility: Aarhus University Hospital - Aarhus Sygehus - Norrebrogade

location_facility: Clatterbridge Centre for Oncology NHS Trust

location_facility: North-Estonian Regional Hospital Surgical Oncology Centre

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori

location_facility: Mount Vernon Cancer Centre at Mount Vernon Hospital

location_facility: Centre Hospitalier Regional Metz Thionville

location_facility: Institute of Oncology and Radiology of Serbia

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Instituto Portugues de Oncologia Centro do Porto, S. A.

location_facility: Cancer Research Centre at Weston Park Hospital

location_facility: Daniel Den Hoed Cancer Center at Erasmus Medical Center

location_facility: Russian Academy of Medical Sciences Cancer Research Center

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

location_facility: St. Luke's Cancer Centre at Royal Surrey County Hospital

location_facility: Royal Marsden NHS Foundation Trust - London

location_facility: Istituto Nazionale per la Ricerca sul Cancro

location_facility: Herlev Hospital - University Hospital of Copenhagen

location_facility: Rigshospitalet - Copenhagen University Hospital

location_facility: Centre Hospitalier Regional et Universitaire de Lille

location_facility: Ospendale S.M. Annunziata-A.S.DI Florence

location_facility: Leeds Cancer Centre at St. James's University Hospital

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

location_facility: Centro di Riferimento Oncologico - Aviano

location_facility: Royal Free and University College Medical School

location_facility: Northern Centre for Cancer Treatment at Newcastle General Hospital

location_facility: Selly Oak Hospital at University Hospital NHS Trust

location_facility: Velindre Cancer Center at Velinde Hospital

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

intervention_type: Procedure

status_simplified: Unknown


title: First Line Infusional 5-Fluorouracil, Folinic Acid and Oxaliplatin for Metastatic Colorectal Cancer or Loco-Regional Recurrency - Role of Chronomodulated Delivery Upon Survival - A Multicenter Randomized Phase III Trial

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more effective in treating patients with recurrent or metastatic colorectal cancer.

PURPOSE: Randomized phase III trial to study the effectiveness of combining fluorouracil, leucovorin, and oxaliplatin in different ways in treating patients with recurrent or metastatic colorectal cancer.

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Efficace F, Innominato PF, Bjarnason G, Coens C, Humblet Y, Tumolo S, Genet D, Tampellini M, Bottomley A, Garufi C, Focan C, Giacchetti S, Levi F; Chronotherapy Group of the European Organisation for Research and Treatment of Cancer. Validation of patient's self-reported social functioning as an independent prognostic factor for survival in metastatic colorectal cancer patients: results of an international study by the Chronotherapy Group of the European Organisation for Research and Treatment of Cancer. J Clin Oncol. 2008 Apr 20;26(12):2020-6. doi: 10.1200/JCO.2007.12.3117.

ReferenceCitation: Giacchetti S, Zidani R, Perpoint B, et al.: Phase III trial of 5-fluorouracil (5-FU), folinic acid (FA), with or without oxaliplatin (OXA) in previously untreated patients (pts) with metastatic colorectal cancer (MCC). [Abstract] Proceedings of the American Society of Clinical Oncology 16: A805, 229a, 1997.

ReferenceCitation: Levi F, Zidani R, Misset JL. Randomised multicentre trial of chronotherapy with oxaliplatin, fluorouracil, and folinic acid in metastatic colorectal cancer. International Organization for Cancer Chronotherapy. Lancet. 1997 Sep 6;350(9079):681-6. doi: 10.1016/s0140-6736(97)03358-8.

ReferenceCitation: Mormont MC, Bleuzen P, Lellouch J, et al.: Prognostic value of circadian rhythm assessment for survival of patients with metastatic colorectal cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 16: A-956, 269a, 1997.

ReferenceCitation: Innominato PF, Giacchetti S, Moreau T, Smaaland R, Focan C, Bjarnason GA, Garufi C, Iacobelli S, Tampellini M, Tumolo S, Carvalho C, Karaboue A, Levi F; ARTBC International Chronotherapy Group. Prediction of survival by neutropenia according to delivery schedule of oxaliplatin-5-Fluorouracil-leucovorin for metastatic colorectal cancer in a randomized international trial (EORTC 05963). Chronobiol Int. 2011 Aug;28(7):586-600. doi: 10.3109/07420528.2011.597532.

ReferenceCitation: Giacchetti S, Bjarnason G, Garufi C, Genet D, Iacobelli S, Tampellini M, Smaaland R, Focan C, Coudert B, Humblet Y, Canon JL, Adenis A, Lo Re G, Carvalho C, Schueller J, Anciaux N, Lentz MA, Baron B, Gorlia T, Levi F; European Organisation for Research and Treatment of Cancer Chronotherapy Group. Phase III trial comparing 4-day chronomodulated therapy versus 2-day conventional delivery of fluorouracil, leucovorin, and oxaliplatin as first-line chemotherapy of metastatic colorectal cancer: the European Organisation for Research and Treatment of Cancer Chronotherapy Group. J Clin Oncol. 2006 Aug 1;24(22):3562-9. doi: 10.1200/JCO.2006.06.1440.

ReferenceCitation: Garufi C, Bjarnason GA, Giacchetti S, et al.: Independent prognostic value of the rest/activity circadian rhythm on overall survival (OS) in patients (pts) with metastatic colorectal cancer (MCC) receiving first line chemotherapy with 5-fluorouracil, leucovorin and oxaliplatin: a companion study to EORTC 05963. [Abstract] J Clin Oncol 23 (Suppl 16): A-3553, 259s, 2005.

ReferenceCitation: Innominato PF, Focan C, Bjarnason GA, et al.: Quality of life (QoL) correlates with the rest/activity circadian rhythm (RAR) in patients (pts) with metastatic colorectal cancer (MCC) on first line chemotherapy with 5-fluorouracil, leucovorin and oxaliplatin : an international multicenter study (EORTC 05963). [Abstract] J Clin Oncol 23 (Suppl 16): A-8029, 736s, 2005.

ReferenceCitation: Lévi F, Gorlia T, Tubiana N, et al.: Gender as a predictor for optimal dynamic scheduling of oxaliplatin, 5-fluorouracil and leucovorin in patients with metastatic colorectal cancer. Results from EORTC randomized phase III trial 05963. [Abstract] J Clin Oncol 23 (Suppl 16): A-3587, 267s, 2005.

ReferenceCitation: Giacchetti S, Bjarnason GA, Garufi C, et al.: First line infusion of 5-fluorouracil, leucovorin, oxaliplatin for metastatic colorectal cancer chronomodulated versus conventional delivery. A multicenter randomized trial of the EORTC chronotherapy group. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-2231, 2002.

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

location_country: Germany Italy Portugal Norway Austria Belgium Greece Canada France

location_facility: Azienda Ospedaliera "Santa Maria Degli Angeli"

location_facility: Centre de Lute Contre le Cancer,Georges-Francois Leclerc

location_facility: Azienda Ospedale S. Luigi - Universita Di Torino

location_facility: Istituti Fisioterapici Ospitalieri - Roma

location_facility: Centre Hospitalier Notre Dame - Reine Fabiola

location_facility: Klinikum der Friedrich-Schiller Universitaet Jena

location_facility: Haukeland Hospital - University of Bergen

location_facility: Centre Hospital Regional Universitaire de Limoges

location_facility: Sunnybrook and Women's College Health Sciences Centre


title: Phase I Study to Determine the Safety of MEN-10755 (BMS-195615) in Patients With a Solid Tumor on a Short I.V. Infusion Given Once Every 3 Weeks

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of MEN-10755 in treating adults who have recurrent or refractory solid tumors.

location_country:
Germany
Italy
Portugal
Israel
Norway
Denmark
United Kingdom
Netherlands
Austria
Belgium
Switzerland
Spain
Greece
France

location_facility: Schneider Children's Medical Center of Israel

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori

location_facility: Herlev Hospital - University Hospital of Copenhagen

location_facility: Ludwig Boltzmann - Institute for Applied Cancer Research

location_facility: Academisch Ziekenhuis der Vrije Universiteit

location_facility: Instituto Portugues de Oncologia de Francisco Gentil


title: PHASE I CLINICAL AND PHARMACOKINETIC STUDY TO DETERMINE THE SAFETY OF ECTEINASCIDIN-743 (ET-743) ADMINISTERED AS A SINGLE INTRAVENOUS INFUSION OVER 60 MINUTES EVERY 21 DAYS IN PATIENTS WITH SOLID TUMORS

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of ecteinascidin 743 in treating adults with advanced solid tumors.

location_facility: Centro di Riferimento Oncologico - Aviano


title: PHASE II TRIAL WITH DOCETAXEL IN PATIENTS WITH RELAPSING GERM CELL CANCER

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients with recurrent or refractory germ cell cancer.


type: Other Identifier

title: Randomized, Double-Masked, Active-Controlled, Phase 3 Study of the Efficacy and Safety of Aflibercept 8 mg in Macular Edema Secondary to Retinal Vein Occlusion

acronym: QUASAR

summary:
Researchers are looking for a better way to treat people who have macular edema secondary to retinal vein occlusion (RVO).

In people with RVO, a blood vessel that carries blood away from the retina (vein) becomes blocked. The retina is the very back part of the eye. The blocked vein causes fluid and blood to leak into the retina and thereby causes a swelling of the macula (the center of the retina responsible for fine vision). This swelling is called macular edema.

When a vein in the retina is blocked, the levels of a protein called vascular endothelial growth factor (VEGF) rises. VEGF helps the growth of new blood vessels. This can lead to macular edema and may cause the vision to become blurry.

The study treatment intravitreal (IVT) aflibercept is given as an injection into the eye. It works by blocking VEGF and this can help repair vision problems related to RVO. IVT aflibercept is already available and is prescribed by doctors as the standard of care treatment for macula edema secondary to RVO. Standard of care is a treatment that medical experts consider most appropriate for a disease.

Standard of care is given every 4 weeks in people with macula edema secondary to RVO. While repeated injections of aflibercept may prevent worsening of vision, it may place a burden on the patient. However, a higher amount (8 mg) compared to the standard of care (2 mg) of IVT aflibercept is being tested in studies. This higher amount could be given less often. The amount of IVT aflibercept given is measured in milligrams, also known as mg.

The main purpose of this study is to learn how well a higher amount of the study treatment aflibercept works in people with macular edema secondary to RVO. To answer this, researchers will measure changes in vision called best corrected visual acuity (BCVA) in the study participants between study start and after 36 weeks of treatment. Changes will then be compared between those participants who received the higher amount of IVT aflibercept and those that received standard of care.

To learn how safe the study treatment is in the participants, the researchers will count the number of participants from study start and up to 64 weeks later that have:

adverse events
serious adverse events

"Adverse events" are any medical problems that the participants have during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think they might be related to the study treatments. An adverse event is considered "serious" when it leads to death, puts the participants' lives at risk, requires hospitalization, causes disability, causes a baby being born with medical problems or is otherwise medically important.

Dependent on the treatment group, the participants will either receive the higher amount of aflibercept or standard of care as an intravitreal injection for up to 60 weeks. The study will consist of a test (screening) phase, a treatment phase and an end of study phase. Each participant will be in the study for up to 64 weeks.

One visit to the study site is planned during the screening phase, followed by visits approximately every 4 weeks (16 in total) during treatment and one visit at the end of the study.

During the study, the study doctors and their team will:

check patients' eye health using various eye examination techniques
measure patients' eye vision (BCVA)
take blood and urine samples
do physical examinations
check vital signs
examine heart health using electrocardiogram (ECG)
do pregnancy tests in women of childbearing age

In addition, participants will be asked to fill a questionnaire on vision-related quality of life.

status: Recruiting

study_completion_date_type: Anticipated

ipd_sharing: No

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

lead_sponsor: Bayer

sponsor_collaborators:
Bayer
Regeneron Pharmaceuticals

location_country:
Germany
Poland
Australia
Japan
Thailand
Turkey
Czechia
Serbia
France
Lithuania
Portugal
Slovakia
Hungary
Switzerland
United States
Latvia
China
Malaysia
Estonia
Italy
United Kingdom
Austria
Mexico
Korea, Republic of
Spain
Bulgaria
Georgia
Israel

location_facility: Zhejiang University School of Medicine - The First Affiliated Hospital - Kidney Disease Center

location_facility: Tianjin Medical University General Hospital

location_facility: Centre Ophthalmologie d'Imagerie et de Laser

location_facility: The People's Hospital of Ningxia Hui Autonomous Region

location_facility: Centre Ophtalmologique Transparence - Tours

location_facility: Specjalistyczny Osrodek Okulistyczny Oculomedica

location_facility: Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.

location_facility: Instituto Oftalmológico Francisco Gomez Ulla

location_facility: University of NC at Chapel Hill (UNC) Ophthalmology

location_facility: International University of Health & Welfare Narita Hospital

location_facility: Universitätsklinikum Düsseldorf / Ophthalmology

location_facility: National Defense Medical College Hospital

location_facility: Japanese Red Cross Nagasaki Genbaku Hospital

location_facility: Medizinische Hochschule Hannover (MHH) - University Clinic for Ophthalmology

location_facility: Northern California Retina-Vitreous Associates

location_facility: Fakultna Nemocnica s poliklinikou F.D.Roosevelta

location_facility: University Hospitals Coventry and Warwickshire NHS Trust

location_facility: The Second Hospital of Anhui medical university

location_facility: Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice

location_facility: The Affiliated Eye Hospital of Wenzhou Medical College

location_facility: Capital Medical University (CMU) - Beijing Tongren Hospital

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: Centrum Diagnostyki i Mikrochirurgii Oka Lens

location_facility: Beyoglu Eye Training and Research Hospital

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: Tokyo Women's Medical University Hospital

location_facility: The Retina Group of Washington | Fairfax

location_facility: Hull and East Yorkshire Eye Hospital Hull and East Yorkshire

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: Hospital de la Santa Creu i Sant Pau | Gynecology Department

location_facility: Osrodek Chirurgii Oka prof. Zagorskiego Sp. z o.o.

location_facility: Hospital Al-Sultan Abdullah, UiTM | Opthalmology

location_facility: Specialized hospital for ophthalmology OPHTAL

location_facility: Henan Provincial Ophthalmology Hospital (Henan Eye Institute

location_facility: Cukurova Universitesi Tip Fakultesi Hastanesi

location_facility: Riga East Clinical University Hospital "Gailezers"

location_facility: Japanese Red Cross Wakayama Medical center

location_facility: Cumberland Valley Retina Consultants, PC

location_facility: IRCCS Fondazione G.B. Bietti Studio e Ricerca in Otalmologia

location_facility: Lanzhou University - The Second Hospital (The Second Clinical Medical College of Lanzhou University)

location_facility: Eye Center of the second Bethune Hospital, jinlin University

location_facility: University of Semmelweis/ Semmelweis Egyetem

location_facility: Ankara Numune Egitim ve Arastirma Hastanesi

location_facility: Fundacion Hospital Nuestra Señora de la Luz

location_facility: Shiga University of Medical Science Hospital

location_facility: Centre Hospitalier National d'Ophthalmologie Quinze-Vingt

location_facility: Hospital Universitario Clinica Puerta de Hierro

location_facility: Centre d'Ophtalmologie - Paradis-Monticelli

location_facility: Baskent Universitesi Tip Fakultesi Hastanesi

location_facility: Ophthalmic Consultants of the Capital Region

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: LTD Israeli-Georgian Medical Research Clinic "Helsicore"

location_facility: Centro Hospitalar Vila Nova de Gaia/Espinho | Unit 1 - Clinical Research Office

location_facility: Universitätsklinik Gießen und Marburg GmbH (UKGM) - Ophthalmology

location_facility: National Hospital Organization Tokyo Medical Center

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: Beijing Aier Intech Eye Hospital Co. LTD - Ophthalmology

location_facility: Southern California Desert Retina Consultants

location_facility: Hospital of LT University of Health Sciences Kaunas Clinics

location_facility: St. Franziskus-Hospital Münster - Eye Center

location_facility: Hospital Vall d'Hebron - Servei d'Oftalmologia

location_facility: Adnan Menderes Universitesi Tip fakultesi

location_facility: CHU Bordeaux - Hopital Pellegrin - Ophtalmologie

location_facility: Centro Hospitalar Universitario do Porto

location_facility: Multiprofile Hospital for Active Treatment Sveta Sofia

location_facility: Retinal Consultants of Texas - San Antonio

location_facility: Ankara Universitesi Tip Fakultesi Hastanesi

location_facility: Klinikum d. Stadt Ludwigshafen - Ophthalmology

location_facility: Shenyang Fourth People's Hospital - Ophthalmology

location_facility: Southern California Permanente Medical Group

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Clalit Health Services Rabin Medical Center-Beilinson Campus

location_facility: Hadassah Hebrew University Hospital Ein Kerem

location_facility: Specialized Hospital For Active Treatment of Eye Diseases Zora

location_facility: China Medical University (CMU) - First Affiliated Hospital

location_facility: CHLC - Hospital dos Capuchos - Servico de Oftalmologia

location_facility: The First Affiliated Hospital of Chongqing Medical Universit

location_facility: Universitätsmedizin Göttingen - Ophthalmology

location_facility: SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont

location_facility: Budapesti Jahn Ferenc Del-pesti Korhaz es Rendelointezet

location_facility: Ludwig-Maximilians-Universitaet Muenchen (LMU) Klinikum - Eye Clinic and Polyclinic

location_facility: Univerzitna nemocnica Bratislava, Petrzalka

location_facility: Universitaetsklinikum Tuebingen - Ophthalmology

location_facility: Second Hospital Affiliated of Chongqing Medical University

location_facility: A.O.U. Ospedali Riuniti "Umberto I - G.M.Lancisi - G.Salesi"

location_facility: Hospital General Universitario de Valencia

location_facility: Peking Union Medical College Hospital CAMS

location_facility: Universitaetsklinikum Jena - Ophthalmology

location_facility: Retina Vitreous Associates of Florida - Saint Petersburg

location_facility: Gabinet Okulistyczny Prof. Edward Wylegala

location_facility: Hospital Clínic i Provincial de Barcelona

location_facility: Seoul National University Bundang Hospital

location_facility: FAP Conde de Valenciana, IAP | Oftalmología

location_facility: Hyogo Prefectural Amagasaki General Medical Center

location_facility: SBU Gulhane Egitim ve Arastirma Hastanesi

location_facility: Medical corporation Eiwakai Dannoue Ophthalmology clinic

location_facility: Univerzitna nemocnica Bratislava, Nemocnica Ruzinov

location_facility: Retina Consultants of Southern Colorado, PC

location_facility: Tokyo Metropolitan Institute for Geriatrics and Gerontology

location_facility: Vilnius University Hospital Santaros Klinikos

location_facility: Spec. Hosp. of Ophthalm. Disease for Active Treatment Varna

location_facility: Ankara Etlik City Hospital | Ophthalmology

status_simplified: Ongoing


title: A Multicenter, Phase 3b, Open-Label, Single-Arm Study to Investigate Bowel Urgency and Its Relationship With Other Outcome Measures in Adults With Moderately to Severely Active Ulcerative Colitis Treated With Mirikizumab

acronym: LUCENT-URGE

summary: A study to investigate bowel urgency in adults with moderately to severely active ulcerative colitis (UC) treated with mirikizumab. The study will have 4 periods and will last for 36 weeks.

ipd_sharing: Yes

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

lead_sponsor: Eli Lilly and Company

location_country:
Germany
Italy
Poland
Slovakia
Hungary
United Kingdom
Austria
Belgium
United States
Czechia
Canada
France

location_facility: Nowe Zdrowie-Ck, Kiełtucki I Wspólnicy Sp. J.

location_facility: Universitätsklinikum Leipzig, Med. Klinik II

location_facility: UZ Leuven - E507 Studies IBD tav Tine Hermans

location_facility: Twoja Przychodnia Opolskie Centrum Medyczne

location_facility: Clinical Applications Laboratories, Inc.

location_facility: Fakultná nemocnica s poliklinikou F. D. Roosevelta Banská Bystrica gastroenterologická ambulancia, II. Interná klinika SZU

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: Landeskrankenhaus Salzburg, Innere Medizin I, Labor im Erdgeschoss

location_facility: Topolowa Medicenter Ryszawa & Wspólnicy Sp.j.

location_facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne

location_facility: Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico

location_facility: A.O.Ordine Mauriziano, SC Gastroenterologia, ambulatorio endoscopia digestiva

location_facility: Washington Gastroenterology dba GI Alliance

location_facility: Gastroenterology Associates of Texas - Denise Rodriguez

location_facility: Care Access Research LLC - Salt Lake City

location_facility: Digestive Health Partners - Research Department

location_facility: Bonifraterskie Centrum Medyczne sp. z o.o

location_facility: IRCCS Saverio de Bellis, National Institute of Gastroenterology

location_facility: Vojenska nemocnice Brno, Interni oddeleni

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Citrine Institute for Research and Wellness

location_facility: University Hospital - London Health Sciences Centre

location_facility: Atlanta Center for Gastroenterology, P.C.

location_facility: BMKK-Dr Rethy Pal Tagkórház, Gasztroenterológia

location_facility: AKH Wien- Universitätsklinik für Innere Medizin III Klinische Abteilung für Gastroenterologie & Hepatologie

location_facility: Irccs Ospedale San Raffaele, Gastroenterologia/Ibd Unit, Settore G Piano -1

location_facility: Fondazione Policlinico Agostino Gemelli IRCCS_ CEMAD

location_facility: Centrum Medyczne Kuba Med 2 Sp. z o.o. ETG Zamosc

location_facility: Hospices Civils de Lyon - Hôpital Lyon Sud - ARC HGE bâtiment 3I

location_facility: Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Innere Medizin I

location_facility: Fakultna nemocnica Nitra, Interna klinika

location_facility: Houston Endoscopy And Research Center, LLC

location_facility: Semmelweis Egyetem, Belgyógyászati es Hematológiai Klinika

location_facility: IRCCS Istituto Clinico Humanitas- Centro Malattie Infiammatorie Intestinali

location_facility: MNGI Digestive Health, ATTN: Clinical Research

location_facility: Debreceni Egyetem Klinikai Központ Gasztroenterológia Klinika

location_facility: Encore Borland-Groover Clinical Research

location_facility: GASTRO AMBULANCIA, poliklinika Ťahanovce

location_facility: Azienda Ospedaliero Universitaria Mater Domini - U.O. Fisiopatologia Digestiva

location_facility: Allmedica Badania Kliniczne Sp. z o.o. Sp. k.

location_facility: Universitair Ziekenhuis Gent - Gastro IBD

location_facility: Cotton-O'Neil Clinical Research Center, Digestive Health

location_facility: Uoc Gastroenterologia - Policlinico Tor Vergata

location_facility: DRK Kliniken Berlin Westend, Gastroenterologie, Studienbüro


type: EudraCT Number

title: A Phase 3 Open-label, Randomised Study of Datopotamab Deruxtecan (DatoDXd) With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Who Have Residual Invasive Disease in the Breast and/or Axillary Lymph Nodes at Surgical Resection Following Neoadjuvant Systemic Therapy (TROPION-Breast03)

summary: This is a Phase III, randomized, open-label, 3-arm, multicenter, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with ICT in participants with stage I to III TNBC with residual invasive disease in the breast and/or axillary lymph nodes at surgical resection following neoadjuvant systemic therapy.

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 requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

lead_sponsor: AstraZeneca

sponsor_collaborators:
AstraZeneca
Daiichi Sankyo, Inc.
SWOG Clinical Trials Partnerships

location_country:
Germany
Italy
United Kingdom
Argentina
Denmark
Japan
Brazil
Sweden
Belgium
United States
China
Korea, Republic of
Spain
Greece
Taiwan
Canada
Puerto Rico
France


title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

acronym: ASTRO

summary: The purpose of this study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo in participants with moderately to severely active ulcerative colitis (UC).

status: Active, not recruiting

enrollment_type: Actual

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

lead_sponsor: Janssen Research & Development, LLC

location_country:
Germany
Poland
Taiwan
New Zealand
Argentina
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
Slovakia
Hungary
United States
India
Belgium
China
Malaysia
Mexico
Korea, Republic of
Spain
Jordan
Bulgaria
Israel

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Tokyo Medical and Dental University Hospital

location_facility: The First Affiliated Hospital Zhejiang University College of Medicine

location_facility: Gastroenterology Associates of Central GA

location_facility: National Hospital Organization Kure Medical Center and Chugoku Cancer Center

location_facility: Hospital General de Agudos José Maria Ramos Mejía

location_facility: Shaare Zedek Medical Center - Jerusalem, ISRAEL

location_facility: Sai Clinic, Gastrointestinal and Protology Divisions

location_facility: The Second Affiliated Hospital of Guangzhou Medical University

location_facility: Centro de Investigaciones Medicas Mar Del Plata

location_facility: Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)

location_facility: General Hospital of Ningxia Medical Hospital

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne

location_facility: Hospital Privado Universitario de Córdoba

location_facility: P.D. Hinduja National Hospital and - Medical Research Center

location_facility: National Hospital Organization Shizuoka Medical Center

location_facility: Centro Regiomontano de Estudios Clínicos Roma S.C.

location_facility: Centrum Medyczne Clw-Med Aneta Cichomska i Joanna Luka-Wendrowska sp.j.

location_facility: Shengjing Hospital of China Medical University

location_facility: The Catholic university of Korea, ST Vincent Hospital

location_facility: Ruijin Hospital, Shanghai Jiao Tong University

location_facility: The Second Hospital of Hebei Medical University

location_facility: Sociedade Campineira de Educacao e Instrucao - Hospital e Maternidade Celso Pierro

location_facility: BR TRIALS-Ensaios Clinicos e Consultoria Ltda

location_facility: Gastroenterology Associates of Tidewater

location_facility: The Second Affiliated Hospital of Zhengzhou University

location_facility: National Hospital Organization Mito Medical Center

location_facility: The first affiliated hospital of Henan University of science and technology

location_facility: The 1st affiliated hospital of Anhui Medical University

location_facility: National Hospital Organization Matsumoto Medical Center

location_facility: Shenzhen Hospital of Southern Medical University

location_facility: Ishida Clinic of IBD and Gastroenterology

location_facility: First Affiliated Hospital of Gannan Medical University

location_facility: Centro de Investigacion Clinica Acelerada S.C

location_facility: NPCRS - Nucleo de Pesquisa Clinica do Rio Grande do Sul

location_facility: Clinica de Investigacion en Reumatologia y Obesidad

location_facility: Gastroenterologie, s.r.o., Hradec Kralove

location_facility: Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy

location_facility: Clinical Research Institute Saltillo S.A. de C.V.

location_facility: The Speciality Hospital (TSH) / Advanced Clinical Center

location_facility: CLIAGEN - Clinica de Atencao em Gastroenterologia Especializada e Nutricao

location_facility: Northshore Gastroenterology Research, LLC

location_facility: Medizinisches Versorgungszentrum (MVZ) Dachau

location_facility: Vasutegeszsegugyi Nonprofit Kozhasznu Kft Debreceni Kozpont

location_facility: Gastroenterology Associates of Orangeburg, SC

location_facility: National Center for Global Health and Medicine

location_facility: ZhuJiang Hospital of Southern Medical University

location_facility: National Hospital Organization Kanazawa Medical Center

location_facility: Zespol Poradni Specjalistycznych REUMED Filia nr 2

location_facility: GASTROMED Kopon, Zmudzinski i wspolnicy SP.j., Specjalistyczne Centrum Gastrologii i Endoskopii

location_facility: SIDS (Surat Institute of Digestive Sciences) Hospital and Research Centre

location_facility: The Second Affiliated Hospital of Zhejiang University College of Medicine

location_facility: Instituto D'Or de Pesquisa e Ensino (IDOR)

location_facility: Gastromed Kralisz Romatowski Stachurska Sp. j.

location_facility: CECIP Jau - Centro de Estudos Clínicos do Interior Paulista Ltda


title: A Phase IIIb, Multi-center, Open-label, Randomized Study of Tolerability and Efficacy of Oral Asciminib Versus Nilotinib in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase.

summary: The study is designed to compare the tolerability of asciminib versus nilotinib for the treatment of newly diagnosed, previously untreated patients with Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP).

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:
Germany
Argentina
Turkey
Czechia
Canada
France
Slovakia
Hungary
Switzerland
United States
India
Romania
Malaysia
Oman
Italy
United Kingdom
Singapore
Netherlands
Korea, Republic of
Greece
South Africa
Jordan
Bulgaria

location_facility: Minnesota Oncology Hematology P A Minnesota Oncology Hematology

location_facility: Sarah Cannon Research Institute HCA Healthcare Research Inst

location_facility: Virginia Oncology Associates VOA - Princess Anne

location_facility: Regions Hospital Oncology Research Consortium

location_facility: Florida Cancer Specialists Dept of Oncology (2)


title: ROSY-D: Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Durvalumab and Are Judged by the Investigator to Clinically Benefit From Continued Treatment

acronym: ROSY-D

summary: The rationale of the ROSY-D study is to continue to provide study treatment for patients who have participated in a parent study with Durvalumab and who are continuing to derive clinical benefit from treatment at the end of such studies, as judged by the Investigator.

status: Enrolling by invitation

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Thailand
Vietnam
Turkey
Czechia
Canada
France
Hungary
Switzerland
United States
Ukraine
India
Romania
China
Malaysia
Italy
United Kingdom
Korea, Republic of
Spain
Taiwan
Bulgaria


type: Registry Identifier

title: A Phase III, Double-blind, Placebo-controlled, Randomised, Multicentre, International Study of Durvalumab Plus Oleclumab and Durvalumab Plus Monalizumab in Patients With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Definitive, Platinum-Based Concurrent Chemoradiation Therapy

summary: This is a Phase III, randomised, double-blind, multicentre, international study assessing the efficacy and safety of durvalumab (MEDI4736) in combination with oleclumab (MEDI9447) or durvalumab (MEDI4736) with monalizumab (IPH2201) in adults with locally advanced (Stage III), unresectable NSCLC, who have not progressed following platinum-based cCRT.

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 requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

location_country:
Germany
Poland
Australia
Brazil
Japan
Thailand
Vietnam
Turkey
Canada
France
Colombia
Portugal
United States
Ukraine
China
Peru
Italy
United Kingdom
Korea, Republic of
Spain
Taiwan
Russian Federation


acronym: IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma

lead_sponsor: IO Biotech

summary:
Phase 3, multicenter, international, open-label, randomized, 2-arm trial investigating the safety and efficacy of IO102-IO103 in combination with pembrolizumab as first-line treatment for patients with previously untreated unresectable or metastatic (advanced) melanoma.

Patients will be stratified on the basis of the following factors; Disease stage: Stage III (unresectable) and IV M1a-b versus stage IV M1c-d and BRAFV600 mutation status: mutated vs wild type.

All patients will receive pembrolizumab 200 mg intravenously every 3 weeks for a maximum of 35 cycles (up to 2 years treatment). Patients randomized to IO102-IO103 dual-antigen, immunotherapeutic arm will also be given IO102-IO103 Q3W with an additional dose given during the induction period on Day 8 of cycles 1 and 2. IO102 IO103 will thereafter be administered subcutaneous every 3 weeks during the maintenance period. Each patient can be treated for a maximum of 37 administrations in total (up to 2 years of treatment).

The primary objective is to investigate the efficacy of IO102-IO103 in combination with pembrolizumab (compared with pembrolizumab alone) in terms of progression free survival.

sponsor_collaborators:
IO Biotech
Syneos Health
Merck Sharp & Dohme LLC

location_facility: Universitatsklinikum Augsburg Medizincampus Sued

location_facility: Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: University of Kentucky Markey Cancer Center

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale

location_facility: St. Josef Hospital - Ruhr-Universitt Bochum

location_facility: Hospital Universitario Central de Asturias (HUCA)

location_facility: University Hospital Frankfurt Theodor-Stern-Kai

location_facility: Mid Florida Hematology and Oncology Center

location_facility: Nationales Centrum fr Tumorerkrankungen NCT

location_facility: Maria Sklodowska-Curie National Research Institute of Oncology

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte

location_facility: Bor, -Nemikortani es Onkodermatologiai Klinika

location_facility: The Chaim Sheba Medical Center - The Ella Lemelbaum Institute for Immuno-Oncology

location_facility: Istituto Romagnolo per lo Studio dei Tumori " DINO AMADORI"

location_facility: Department of Dermatology University of Mainz

location_facility: Centre Hospitalier Universitaire de Lille

location_facility: Hospital General Universitario de Valencia

location_facility: Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

location_facility: Centre Hospitalier Universitaire de Bordeaux Hospital Saint Andre

location_facility: Hospital Universitari Germans Trias i Pujol HUGTP, ICO-Badalona

location_facility: Ben-Gurion University of the Negev - Soroka University Medical Center - Soroka Clinical Research Center

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Hospital Regional Universitario de Malaga

location_facility: Adana City Education and Research Hospital

location_facility: AZ Sint-Jan Brugge - Oostende AV - Campus Sint-Jan

location_facility: Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu

location_facility: Centre Hospitalier Universitaire de Besançon Jean Minjoz

location_facility: Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty

location_facility: Hospital General Universitario Gregorio MaraÃ±on

location_facility: Peter MacCallum Cancer Centre PMCC - East Melbourne

location_facility: Instituto Oncologico Dr. Rosell IOR - Hospital Universitari Quiron Dexeus

location_facility: Ege university Faculty of Medicine, T. Aktas Oncology Hospital, Bornova

location_facility: Mühlenkreiskliniken AöR, University Hospital Ruhr University Bochum Campus Minden

title: An Open-label, Randomized, Phase 3 Clinical Trial of IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Patients With Previously Untreated, Unresectable, or Metastatic (Advanced) Melanoma (IO102-IO103-013 / MK3475-D18)

source: euctr

location_country:
Germany
Ireland
Italy
Poland
Hungary
Israel
Denmark
Australia
United Kingdom
Netherlands
Belgium
United States
Spain
South Africa
Turkey
Czechia
France

collaborators:
Syneos Health
Merck Sharp & Dohme LLC


title: A Randomized, Multicenter, Open-label, Phase III Study of Lurbinectedin Single-Agent or Lurbinectedin in Combination With Irinotecan Versus Investigator's Choice (Topotecan or Irinotecan) in Relapsed Small Cell Lung Cancer Patients (LAGOON Trial)

summary: Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate and compare the activity and safety of two experimental arms consisting of lurbinectedin as single agent (Group A) or the combination of lurbinectedin with irinotecan (Group B) versus Investigator's Choice (topotecan or irinotecan) as control arm (Group C), in Small-cell Lung Cancer (SCLC) patients who failed one prior platinum-containing line.

lead_sponsor: PharmaMar

location_country:
Germany
Poland
Australia
Brazil
Turkey
Chile
Canada
France
Hungary
Denmark
Switzerland
United States
Romania
Belgium
Italy
United Kingdom
Austria
Korea, Republic of
Spain
Bulgaria
Georgia
Israel

location_facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola Malpighi Oncologia medica

location_facility: Spital Thurgau - Kantonspital Frauenfeld

location_facility: Wojewódzkie Wielospecjalistyczne Centrum Onkologii

location_facility: Staedtisches Klinikum München - Bogenhausen

location_facility: Centre Hospitalier Intercommunal de Creteil (CHIC)

location_facility: Box Hill Hospital Eastern Health Clinical School

location_facility: Algemeen Ziekenhuis AZ Klina - Borstkliniek

location_facility: Oncology Hematology West, PC (Grand Island)

location_facility: ASST Valtellina e Alto Lario Ospedale di Sondrio

location_facility: IRCCS Istituto Clinico Humanitas - Cancer Center

location_facility: Hospital Universitario Fundación Jimenez Díaz

location_facility: Azienda Ospedaliera Univ. Senese Policlinico Le Scotte

location_facility: Azienda Ospedaliero Universitaria delle Marche

location_facility: MultiCare Regional Cancer Center - Tacoma

location_facility: ASL 3 Genovese Oncologia Medica Villa Scassi

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Hospital Clínico Universitario Lozano Bleza

location_facility: Centre Hospitalier Universitaire CHU De Limoges

location_facility: Hospital Regional Universitario Málaga Hospital Civil

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Centre Hospitalier Chretien CHC - MontLegia

location_facility: Complex Oncology Center - Plovdiv EOOD, First Department of Medical Oncology and Oncological Diseases in Gastroenterology

location_facility: UPCO - Hospital de Clinicas de Porto Alegre

location_facility: Spital Thurgau - Kantonsspital Muensterlingen

location_facility: Specialized hospital for active treatment of oncological diseases

location_facility: Azienda Ospedaliera Univ. Policlinico G Rodolico San Marco

location_facility: Universita degli Studi della Campania Luigi Vanvitelli

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

location_facility: Specjalistyczny Szpital Onkologiczny NU-MED sp. Z

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Centre Hospitalier Universitaire (CHU) Ambroise Pare

location_facility: Oncocentro-Centro de Oncologia do Parana

location_facility: Klinikum Kassel - Medizinische Klinik IV

location_facility: Azienda Ospedaliero-Universitaria San Luigi Gonzaga

location_facility: Oncologia Medica II Istituto Oncologico Veneto IRCCS

location_facility: Fondazione Policlinico Universitario Campus Bio-Medico

location_facility: Institut Català d Oncologia (ICO) - Hospital Germans Trias i Pujol

location_facility: Complexo Hospitalario Universitario De Vigo (CHUVI) - Hospital Xeral

location_facility: Multiprofile Hospital for Active Treatment Serdika EOOD Second Department of Medical Oncology

location_facility: Mrukmed. Lekarz Beata Madej-Mruk i Partner. Sp.p

location_facility: ONCOSITE - Centro de Pesquisa Clinica em Oncologia Ltda

location_facility: A.O. Santa Croce e Carle, Ospedale Carle

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Gosford Hospital GH - Central Coast Cancer Centre

location_facility: Seoul Metropolitan Government-Seoul National University Boramae Medical Center

location_facility: Istituto Oncologico della Svizzera Italiana

location_facility: Bagcilar Medipol Mega University Hospital

location_facility: University Health Network - Princess Margaret Hospital

location_facility: Specjalistyczna Praktyka Lekarska Slawomir Mandziuka

location_facility: Grand Hopital de Charleroi GHdC - Hopital Saint Joseph

location_facility: Multiprofile Hospital for Active Treatment - Uni Hospital OOD Department of Medical Oncology

location_facility: Instituto Nacional de Cancer - Ministrio da Sade

location_facility: Froedtert Hospital/Medical College of Wisconsin

location_facility: Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals

location_facility: The Catholic University of Korea, St.Vincents Hospital

location_facility: Szpital Specjalistyczny w Prabutach Sp. z o.o

location_facility: Irmandade daSanta Casa de Misericordia de Porto Alegre

location_facility: CHA Bundang Medical Center, CHA University

location_facility: Goztepe Prof. Dr. Suleyman Yalcin City Hospital

location_facility: Veszprem Megyei Tudogyogyintezet Farkasgyepu

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos - Hospital de Amor

location_facility: Szpitale Pomorskie Sp. z o.o., Oddzial Onkologii K

location_facility: Complejo Hospitalario Materno-Insular de Gran Canaria

location_facility: A.O. SS. Antonio e Biagio e Cesare Arrigo di Alessandria

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Oncology Hematology West, PC dba Nebraska Cancer Specialists


title: A Randomized, Multi-center, Double-blind, Placebo-controlled Phase 3 Study of Bemarituzumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer With FGFR2b Overexpression

summary: The main objective of this study is to compare efficacy of bemarituzumab combined with oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS) in participants with FGFR2b ≥10% 2+/3+ tumor cell staining (FGFR2b ≥10% 2+/3+TC)

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

lead_sponsor: Amgen

sponsor_collaborators:
Amgen
Zai Lab (China only)

location_country:
Ireland
Poland
Argentina
Australia
Brazil
Japan
Thailand
Turkey
Chile
Czechia
Canada
France
Lithuania
Colombia
Portugal
Hungary
Denmark
United States
Latvia
Romania
Belgium
China
Malaysia
Estonia
Italy
Norway
Singapore
Sweden
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Israel

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: University Multiprofile Hospital for Active Treatment Dr Georgi Stranski EAD

location_facility: Azienda Unita Sanitaria Locale LE Presidio Ospedaliero Vito Fazzi Polo Oncologico Giovanni Paolo II

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz

location_facility: The Second Affiliated Hospital Zhejiang University School of Medicine

location_facility: Azienda Ospedaliera Ordine Mauriziano di Torino

location_facility: Institucion Prestadora de Servicios de Salud Sociedad Médica Rionegro S.A. Somer S.A.

location_facility: Vilnius University Hospital Santaros Clinic Public Institution

location_facility: Lietuvos sveikatos mokslu universiteto ligonine viesoji istaiga Kauno klinikos

location_facility: The First Affiliated Hospital of Anhui Medical University

location_facility: The First Affiliated Hospital of Jinzhou Medical University

location_facility: Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz

location_facility: Cancer Hospital of Shantou University Medical College

location_facility: Azienda Ospedaliero Universitaria di Cagliari Policlinico Duilio Casula

location_facility: Severance Hospital Yonsei University Health System

location_facility: Centro de Estudios Clinicos e Investigaciones Medicas CeCim

location_facility: The First Hospital of China Medical University

location_facility: Azienda Ospedaliera Cardinale Giovanni Panico

location_facility: Centro Hospitalar Universitario de Sao Joao, EPE - Hospital Sao Joao

location_facility: Oncosite Centro de Pesquisa Clinica Em Oncologia Ltda

location_facility: Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria

location_facility: Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD

location_facility: Centre Hospitalier Universitaire Amiens Picardie - Hopital Sud

location_facility: Specialized Hospital for Active Treatment of Oncology - Haskovo EOOD

location_facility: Kobe City Medical Center General Hospital

location_facility: Affiliated Hospital of Jiangnan University

location_facility: James Lind Centro de Investigacion del Cancer

location_facility: Centre Hospitalier Universitaire de Brest

location_facility: Fujian Medical University Union Hospital

location_facility: Taihe Hospital Affiliated Hospital of Hubei University of Medicine

location_facility: The Affiliated Cancer Hospital of Shandong First Medical University

location_facility: Wojewodzki Szpital im Sw Ojca Pio w Przemyslu

location_facility: Centre Hospitalier Universitaire de Reims - Hôpital Robert Debré

location_facility: Centre Hospitalier Universitaire de Liege - Sart Tilman

location_facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg

location_facility: Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez

location_facility: Van Yuzuncu Yil Universitesi Dursun Odabas Tip Merkezi

location_facility: Azienda Ospedaliera Universitaria Integrata di Verona Ospedale Civile Maggiore Borgo Trento

location_facility: Azienda Ospedaliero Universitaria Integrata Santa Maria della Misericordia

location_facility: Instituto de Ensino e Pesquisa Sao Lucas Iep Sao Lucas

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Centrum Onkologii im prof Franciszka Lukaszczyka

location_facility: Centre Hospitalier Régional Universitaire de Besançon, Hôpital Jean Minjoz

location_facility: Hospital Privado Universitario de Cordoba

location_facility: The Catholic University of Korea Incheon St Marys Hospital

location_facility: The Catholic University of Korea Seoul St Marys Hospital

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Hospital Universitario Fundacion Favaloro

location_facility: Chongqing University Three Gorges Hospital

location_facility: Doktor Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

location_facility: The First Affiliated Hospital of Zhengzhou University

location_facility: Investigación Biomédica para el Desarrollo de Fármacos SA de CV

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

location_facility: Centro Hospitalar Universitario do Porto, EPE - Hospital de Santo Antonio

location_facility: The First Affiliate Hospital of Ningbo University

location_facility: Multiprofile Hospital for Active Treatment Serdika EOOD

location_facility: Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz

location_facility: Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of ScienceandTechnology

location_facility: Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi

location_facility: Kocaeli Universitesi Tip Fakultesi Hastanesi

location_facility: Szpital Wojewodzki imienia Mikolaja Kopernika w Koszalinie

location_facility: Multiprofile Hospital for Active Treatment Park Hospital EOOD

location_facility: SPZOZ Opolskie Centrum Onkologii imienia prof Tadeusza Koszarowskiego w Opolu

location_facility: Baskent Universitesi Adana Doktor Turgut Noyan Uygulama ve Arastirma Merkezi

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Centro de Pesquisa e Ensino em Oncologia de Santa Catarina

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi

location_facility: The First Affiliated Hospital of Hainan Medical University

location_facility: Istituto Ospedaliero Fondazione Poliambulanza

location_facility: Centro Hospitalar de Entre o Douro e Vouga, EPE - Hospital Sao Sebastiao

location_facility: The Second Affiliated Hospital of Soochow University

location_facility: Hospital Regional Universitario de Malaga

location_facility: Sunnybrook Research Institute Sunnybrook Health Sciences Centre

location_facility: Anticancer Hospital of Thessaloniki Theageneio

location_facility: Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji

location_facility: Fourth Hospital of Hebei Medical University

location_facility: Azienda Ospedaliera San Giovanni Addolorata

location_facility: Sociedad de Beneficencia Hospital Italiano

location_facility: Investigacion Biomedica para el Desarrollo de Farmacos SA de CV

location_facility: The First Affiliated Hospital Zhejiang University School of Medicine

location_facility: Sainte Catherine - Institut du Cancer d Avignon

location_facility: Instituto Brasileiro de Controle do Cancer Ibcc

location_facility: Cancer Hospital of Chinese Academy of Medical Sciences

location_facility: Institutul Oncologic Prof Dr Alexandru Trestioreanu Bucuresti

location_facility: Seoul National University Bundang Hospital

location_facility: The First Affiliated Hospital of Xiamen University

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi

location_facility: Inonu Universitesi Turgut Ozal Tip Merkezi

location_facility: Azienda Ospedaliera Rilievo Nazionale e Alta Specializzazione Garibaldi Nesima

location_facility: Hospital General Universitario Jose Maria Morales Meseguer

location_facility: Institut de cancerologie Strasbourg Europe

location_facility: Complexo Hospitalario Universitario de Ourense

location_facility: The Cancer Center Union Hospital Tongji Medical College Huazhong University of Science and Tech

location_facility: The Affiliated Hospital of Qingdao University

location_facility: Università Cattolica del Sacro Cuore Policlinico Universitario Agostino Gemelli

location_facility: Xiangya Hospital of Central South University

location_facility: Viesoji istaiga Klaipedos universitetine ligonine

location_facility: Harbin Medical University Cancer Hospital

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: China-Japan Union Hospital of Jilin University

location_facility: Pauls Stradins Clinical University Hospital

location_facility: The First Affiliated Hospital of Xi an Jiaotong University

location_facility: Azienda Unita Saniataria Locale IRCCS di Reggio Emilia

location_facility: The Affiliated Hospital of Xuzhou Medical University

location_facility: The Oncology Institute Clinical Research

location_facility: Instituto Argentino de Diagnostico y Tratamiento IADT

location_facility: Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center

location_facility: Centro Hospitalar e Universitario de Coimbra EPE

location_facility: Centre Hospitalier Universitaire de Clermont Ferrand, Hôpital Estaing

location_facility: The First Affiliated Hospital of Henan University of science and Technology

location_facility: Sociedad de Oncologia y Hematologia del Cesar

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

location_facility: Tianjin Medical University Cancer institute and hospital

location_facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

location_facility: Ruijin Hospital Shanghai Jiao Tong University School of Medicine

location_facility: Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation

location_facility: Sir Run Run Shaw Hospital Zhejiang University School of Medicine

location_facility: Hospital da Senhora da Oliveira Guimaraes, EPE

location_facility: Spitalul Judeţean de Urgenţă Dr.Constantin Opriş Baia Mare

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

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

location_facility: Izmir Ataturk Egitim ve Arastirma Hastanesi

location_facility: Healthier Hematology and Oncology Excelsior Integrated Medical Group

location_facility: Centre Hospitalier Universitaire Nord de Saint Etienne - Hôpital Nord

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: The First Affiliated Hospital of Bengbu Medical College

location_facility: University Multiprofile Hospital for Active Treatment Pulmed OOD

location_facility: Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Wielkopolskie Centrum Onkologii imienia Marii Sklodowskiej-Curie

location_facility: Kliniki Neuroradiochirurgii Spzoo Radom Centr Onkolo im Bohater Radomsk Czerwca -76 Szpital Specjal


title: A Phase 3, Open-Label, Randomized Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer After Osimertinib Failure

summary: The purpose of this study is to assess the efficacy of adding lazertinib to amivantamab, carboplatin, and pemetrexed (LACP/ACP-L dosing strategies) and amivantamab, carboplatin and pemetrexed (ACP) compared with carboplatin and pemetrexed (CP) in participants with locally advanced or metastatic epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R substitution non-small cell lung cancer (NSCLC) after osimertinib failure. The purpose of the extension cohort is to further describe the safety and efficacy for the ACP-L dosing schedule versus ACP with additional data.

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

location_country:
Germany
Poland
Argentina
Japan
Brazil
Turkey
Czechia
Canada
France
Portugal
Hong Kong
Denmark
United States
India
Belgium
China
Malaysia
Puerto Rico
Italy
United Kingdom
Sweden
Netherlands
Mexico
Korea, Republic of
Spain
Taiwan
Bulgaria
Russian Federation
Israel

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Tianjin Medical University General Hospital

location_facility: Private Specialist Hospitals - MedPolonia

location_facility: Fakultni nemocnice Olomouc - I.P.Pavlova 6

location_facility: COT - Centro Oncologico do Triangulo S.A

location_facility: CHU de Grenoble - Hopital Albert Michallon

location_facility: Taipei Medical University Shuang Ho Hospital

location_facility: Affiliated Hospital of North Sichuan Medical College

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

location_facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

location_facility: Rajiv Gandhi Cancer Institute and Research Centre

location_facility: Kobe City Medical Center General Hospital

location_facility: Grand Hopital de Charleroi, site Notre Dame

location_facility: Hospital Privado Universitario de Córdoba

location_facility: IADT Instituto Argentino de Diagnostico y Tratamiento

location_facility: Fundacao Antonio Prudente - A.C. Camargo Cancer Center

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)

location_facility: Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

location_facility: Ruijin Hospital, Shanghai Jiao Tong University

location_facility: National Hospital Organization Shibukawa Medical Center

location_facility: Centro Hospitalar Universitario do Porto, EPE

location_facility: Multiprofile Hospital for Active Treatment 'Tokuda Hospital Sofia'

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

location_facility: UPCO Unidade de Pesquisa Clinica em Oncologia

location_facility: CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia

location_facility: Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

location_facility: National Hospital Organization Iwakuni Clinical Center

location_facility: Daping Hospital Army Characteristic Medical Center

location_facility: Real e Benemérita Associação Portuguesa de Beneficência

location_facility: CINME - Centro de Investigaciones Metabolicas

location_facility: Azienda Ospedaliero-Universitaria Di Parma

location_facility: National Hospital Organization Yamaguchi Ube Medical Center

location_facility: Seoul National University Bundang Hospital

location_facility: Centrum Onkologii im. Prof. F. Lukaszczyka

location_facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

location_facility: Centro Hospitalar Lisboa Norte EPE - Hospital Pulido Valente

location_facility: The First Affiliated Hospital, Sun Yat-sen University

location_facility: Thoraxklinik am Universitätsklinikum Heidelberg

location_facility: IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado

location_facility: Bhaktivedanta Hospital & Research Institute

location_facility: CIONC - Centro Integrado de Oncologia de Curitiba

location_facility: CHU de Montpellier - Arnaud de Villeneuve

location_facility: Pan American Center for Oncology Trials LLC

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

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

location_facility: Specialized Hospital for Active Treatment in Oncology

location_facility: Second Affiliated Hospital, School of Medicine, Zhejiang University

location_facility: Guy's and St Thomas' NHS Foundation Trust

location_facility: CEMIC (Centro de Educación Médica e Investigaciones Clínicas)

location_facility: Multifunctional Hospital for Active Treatment 'Serdika'

location_facility: Sun Yat-Sen Memorial Hospital Sun Yat-sen University

location_facility: Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

location_facility: Cancer Hospital, Chinese Academy of Medical Sciences

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

location_facility: Harbin medical university cancer hospital

location_facility: Beijing Chest hospital, Capital medical university

location_facility: CHA Bundang Medical Center, CHA University

location_facility: University of Mississippi Medical Center

location_facility: The Second Affiliated Hospital of Zhejiang University College of Medicine

location_facility: CIMOVA, Morals Vargas Centro de Investigación SC

location_facility: Instituto D'Or de Pesquisa e Ensino (IDOR)

location_facility: Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie


title: Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Self-administered Subcutaneous Selatogrel for Prevention of All-cause Death and Treatment of Acute Myocardial Infarction in Subjects With a Recent History of Acute Myocardial Infarction

acronym: SOS-AMI

summary: This study will randomize patients recently discharged from the hospital with a confirmed diagnosis of type 1 acute myocardial infarction (Thygesen et al. 2018) and having additional cardiovascular risk factors.

ReferenceCitation: Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). J Am Coll Cardiol. 2018 Oct 30;72(18):2231-2264. doi: 10.1016/j.jacc.2018.08.1038. Epub 2018 Aug 25. No abstract available.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: publisher-specific-oa

license_normalized: publisher-specific

version: publishedVersion

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

host_type: repository

license_normalized: no license

repository_institution: Imperial College London - Spiral

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ReferenceCitation: Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.

lead_sponsor: Idorsia Pharmaceuticals Ltd.

location_country:
Finland
Germany
Ireland
Poland
Czechia
Canada
Serbia
France
Lithuania
Slovakia
Hungary
Denmark
Switzerland
United States
Romania
Belgium
Estonia
Italy
Norway
United Kingdom
Netherlands
Austria
Spain
Bulgaria
Israel

location_facility: Szegedi Tudományegyetem ÁOK Szent-Györgyi Albert Klinikai Központ II.sz. Belgyógyászati Klinika és Kardiológiai Központ

location_facility: Centre Intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec

location_facility: Spital Clinic Judetean de Urgentia Cluj Napoca

location_facility: Covenant Medical Group d/b/a Parkway Cardiology Associates

location_facility: Unity Health Toronto - Saint Michaels Site

location_facility: Carol Davila University of Medicine and Pharmacy - Spitalul Universitar de Urgenta Elias

location_facility: Shaare Zedek Medical Center, Cardiology Department

location_facility: Debreceni Egyetem Klinikai Központ Kardiológiai és Szívsebészeti Klinika

location_facility: CHU Caen · Unité Cardiologie et Pathologie Vasculaire

location_facility: Wojewódzki Szpital Specjalistyczny w Olsztynie, Oddział Kardiologii

location_facility: University Hospital of Ferrara, Cardiology Unit

location_facility: Central Slovak Institute of Cardiovascular Diseases

location_facility: Dignity Health Mercy Gilbert Medical Center

location_facility: Northern Light Eastern Maine Medical Center

location_facility: Kliničko Bolnički Centar Bežanijska Kosa

location_facility: Cardiology Department - Santa Chiara Hospital

location_facility: Studienzentrum Innere Med. II Kardiologie, Universitätsklinikum Regensburg

location_facility: Invasive Cardiology Department, University Teaching Hospital in Białystok

location_facility: Penn State Health Medical Group - Berks Cardiology

location_facility: Hillel Yaffee Medical Center, Cardiology Department

location_facility: Hospital of Lithuanian University of Health Sciences Kauno Klinikos

location_facility: Adventist Healthcare White Oak Medical Center

location_facility: Lister Hospital East and North Hertfordshire NHS Trust

location_facility: County Clinical Emergency Hospital Tirgu Mures

location_facility: Betegápoló Irgalmasrend Budai Irgalmasrendi Kórház, Kardiológia

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Inselspital, Universitäatspital Bern, Universitäatklinik für Kardiologie

location_facility: Uniwersytecki Szpital Kliniczny we Wroclawiu

location_facility: Heart and Lung Center, Helsinki University Hospital

location_facility: CHI Institute for Research and Innovation

location_facility: Hospital Alvaro Cunqueiro, Cardiovascular Unit

location_facility: University of California San Diego Medical Center

location_facility: "SOD Cardiologia Interventistica Strutturale, AOU Careggi

location_facility: Royal Papworth Hospital NHS Foundation Trust

location_facility: Northeast Arkansas Charitable Foundation, Inc.- NEA Baptist Clinic

location_facility: Oddzial Kardiologii i intensywnej Terapii Kardiologicznej

location_facility: County Clinical Emergency Hospital Brasov

location_facility: Universitätsklinikum Tübingen, Medizinische Klinik Innere Medizin III Kardiologie und Angiologie

location_facility: TAYS Tutkimusvastaanotto / TAYS Research Center

location_facility: Ospedale Maggiore Bologna - Dept. Cardiology

location_facility: University of Florida Health Science Center at Jacksonville

location_facility: Krankenhaus der Augustinerinnen Köln gGmbH

location_facility: Institute of Cardiovascular Diseases, Vojvodina

location_facility: SCCS Zabrze I i II Oddział Kardiologii i Angiologii

location_facility: Klinicko bolnicki centar, Bežanijska kosa

location_facility: Moses H. Cone Memorial Hospital Operation Corporation d/b/a Cone Health

location_facility: Onze Lieve Vrouwe Gasthuis, locatie Oost

location_facility: Universitätsklinikum Freiburg; Universitäts-Herzzentrum Freiburg-Bad Krozingen

location_facility: University Hospital Centre Dr Dragiša Mišovic - Dedinje

location_facility: Nemocnice Pardubickeho kraje, a.s. - Pardubicka nemocnice

location_facility: CHUM - Centre hospitalier de l'Universite de Montreal"

location_facility: Department of Cardiology, Clinical Hospital Center Zemun

location_facility: Monument Health Clinical Research, Monument Health Rapid City Hospital Inc.

location_facility: Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika Kardiológia

location_facility: Leviev Heart Center, Sheba Medical Center

location_facility: Bon Secours St. Mary's Hospital of Richmond, LLC

location_facility: Gottsegen György Országos Kardiovaszkuláris Intézet

location_facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kardiologii oraz Interwencji Sercowo-Naczyniowych

location_facility: Amarillo Heart Clinical Research Institute Inc.

location_facility: University Hospitals Cleveland Medical Center

location_facility: Herzzentrum Dresden GmbH; Universitätsklinik an der Technischen Universität Dresden

location_facility: Gesellschaft für Klinische Forschung mbH Ludwigshafen

location_facility: North Tyneside General Hospital, Northumbria Healthcare

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Spitalul Judetean de Urgenta ""Dr. Constantin Opris" Baia Mare

location_facility: Karl Landsteiner Institut für Kardiovaskuläre und Intensivmedizinische Forschung

location_facility: Miedziowe Centrum Zdrowia Regionalny, Ośrodek Kardiologiczny, Pracownia Angiografii i Hemodynamiki

location_facility: Kaplan Medical Center, Intensive Cardiac Care Unit

location_facility: University Clinical Center of Serbia (Department for Cardiovascular Disease Cardiology Clinic)

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

location_facility: Indiana University Health Ball Memorial Hospital

location_facility: Východoslovenský ústav srdcových a cievnych chorôb

location_facility: University Clinical Center of Serbia (Diagnostic and Catheterization Lab)

location_facility: Columbia University Irving Medical Center

location_facility: Jorvi Hospital, Helsinki University Hospital

location_facility: University Clinical Center of Serbia (Emergency Cardiology Services)

location_facility: University of Calgary Foothills Medical Centre

location_facility: Górnośląskie Centrum Medyczne w Katowicach, III Oddział Kardiologii

location_facility: MHAT South-West Hospital, Cardiology Department

location_facility: Grandview Medical Center and Affinity Cardiovascular Specialists, LCC

location_facility: University of Oklahoma Health Sciences Center

location_facility: University of Michigan (also known as Michigan Medicine and University of Michigan Health Systems)

location_facility: Azienda Ospedaliero-Universitaria Policlinico ""G. Rodolico - San Marco

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Pracownia Kardiologii Inwazyjnej I Katedry i Kliniki Kardiologii Uniwersyteckiego Centrum Klinicznego Warszawskiego Uniwersytetu Medycznego

location_facility: Sinai Hospital Baltimore, LifeBridge Health

location_facility: Institutu Klinicke a Experimentalni Mediciny (IKEM) (Institute for Clinical and Experimental Medicine)

location_facility: Penn State Health Milton S. Hershey Medical Center

location_facility: Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center

location_facility: Oslo University Hospital, Ullevål hospital

location_facility: Institute of Cardiovascular Diseases Timisoara

location_facility: Universitätsspital Basel; Universitäres Herzzentrum

location_facility: Vilnius University Hospital Santaros Klinikos

intervention_type: Combination Product


title: A Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) + Lenvatinib (E7080/MK-7902) + Chemotherapy Compared With Standard of Care as First-line Intervention in Participants With Metastatic Esophageal Carcinoma

summary:
The purpose of this study is to assess the efficacy and safety of pembrolizumab plus lenvatinib plus chemotherapy compared with pembrolizumab plus chemotherapy as first-line intervention in participants with metastatic esophageal carcinoma

The primary hypotheses are that pembrolizumab plus lenvatinib plus chemotherapy is superior to pembrolizumab plus chemotherapy with respect to overall survival (OS) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).

lead_sponsor: Merck Sharp & Dohme LLC

sponsor_collaborators:
Merck Sharp & Dohme LLC
Eisai Inc.

location_country:
Argentina
Japan
Costa Rica
Thailand
Turkey
Chile
Canada
France
Hungary
Hong Kong
Denmark
United States
Ukraine
Romania
China
Malaysia
Italy
Guatemala
United Kingdom
Singapore
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation

location_facility: Niigata Cancer Center Hospital ( Site 9022)

location_facility: Universita Cattolica del Sacro Cuore - Policlinico Gemelli ( Site 1310)

location_facility: Okayama University Hospital ( Site 9024)

location_facility: A.O.U. Universita degli Studi della Campania-Luigi Vanvitelli ( Site 1305)

location_facility: Istanbul Okmeydanı Egitim ve Arastirma Hastanesi ( Site 1711)

location_facility: National Taiwan University Hospital ( Site 6001)

location_facility: Centro Regional de Sub Especialidades Medicas SA ( Site 0604)

location_facility: Institut de cancérologie Strasbourg Europe (ICANS) ( Site 1014)

location_facility: St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1915)

location_facility: Medeniyet Universitesi Tip Fakultesi ( Site 1703)

location_facility: Osaka General Medical Center ( Site 9018)

location_facility: Communal nonprofit enterprise "Kherson Regional Oncology Dispensary" of Kherson Regional Council (

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 9010)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 0403)

location_facility: Humanitas Research Hospital ( Site 1309)

location_facility: National Cheng Kung University Hospital ( Site 6004)

location_facility: CHRU de Tours - Hopital Bretonneau ( Site 1018)

location_facility: Centre Hospitalier Régional Universitaire de Brest - Hôpital-Institut de cancérologie et hématologi

location_facility: Institut De Cancerologie De Lorraine ( Site 1010)

location_facility: National Cancer Centre Singapore ( Site 9201)

location_facility: Instituto de Investigaciones Clinicas Mar del Plata ( Site 0205)

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

location_facility: Centro de Investigacion y desarrollo Oncologico SpA - CIDO SpA ( Site 0401)

location_facility: Academician I.P. Pavlov First St. Petersburg State Medical University ( Site 1519)

location_facility: Hospital Provincial del Centenario ( Site 0217)

location_facility: The First Affiliated Hospital of Henan University of Science &Technology-Tumor ( Site 8036)

location_facility: Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0203)

location_facility: The Cancer Institute Hospital of JFCR ( Site 9005)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1503)

location_facility: Faculty of Medicine Siriraj Hospital ( Site 7002)

location_facility: Kharkiv Regional Clinical Oncology Center ( Site 1812)

location_facility: China Medical University Hospital ( Site 6003)

location_facility: Centre Georges Francois Leclerc ( Site 1008)

location_facility: Acibadem Universitesi Atakent Hastanesi-Medical Oncology ( Site 1716)

location_facility: Ibaraki Prefectural Central Hospital ( Site 9007)

location_facility: CIMCA Centro de Investigacion y Manejo del Cancer ( Site 0902)

location_facility: Chernihiv Medical Center of Modern Oncology ( Site 1811)

location_facility: Taipei Veterans General Hospital ( Site 6006)

location_facility: Aichi Cancer Center Hospital ( Site 9006)

location_facility: University Malaya Medical Centre ( Site 9101)

location_facility: West China Hospital of Sichuan University ( Site 8048)

location_facility: A.O. Universitaria di Modena ( Site 1307)

location_facility: Southern Medical University Nanfang Hospital ( Site 8031)

location_facility: The Christie NHS Foundation Trust ( Site 1909)

location_facility: Chang Gung Med Foundation. Kaohsiung Branch ( Site 6005)

location_facility: IRCCS Ospedale San Raffaele di Milano ( Site 1304)

location_facility: University Hospital,Kyoto Prefectural University of Medicine ( Site 9027)

location_facility: Complexo Hospitalario Universitario de Ourense-MEDICAL ONCOLOGY ( Site 1609)

location_facility: MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council ( Site 1804)

location_facility: Soluciones Gastrointestinales S.A. ( Site 0607)

location_facility: Ovidius Clinical Hospital OCH-Oncology and Hematology ( Site 2203)

location_facility: Azienda Ospedaliero Universitaria Careggi ( Site 1301)

location_facility: The First Affiliated Hospital of Hainan Medical University ( Site 8042)

location_facility: Seoul National University Bundang Hospital ( Site 5006)

location_facility: Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 1203)

location_facility: National Hospital Organization Shikoku Cancer Center ( Site 9019)

location_facility: Fujian Provincial Cancer Hospital ( Site 8029)

location_facility: VCU Health Adult Outpatient Pavillion ( Site 0160)

location_facility: Hospital General Universitari Vall d Hebron ( Site 1607)

location_facility: SC Radiotherapy Center Cluj SRL ( Site 2202)

location_facility: MedStar Washington Hospital Center ( Site 0186)

location_facility: A.O.U. Santa Maria della Misericordia di Udine ( Site 1302)

location_facility: IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0202)

location_facility: Shanxi Provincial Cancer Hospital ( Site 8019)

location_facility: Tongji Medical College Huazhong Uinversity Of Science and Technology ( Site 8025)

location_facility: Institute of General and Emergency Surgery n.a Zaitsev NAMS of Ukraine ( Site 1813)

location_facility: National Cancer Center Hospital East ( Site 9002)

location_facility: Azienda Ospedaliera Mater Domini-Translational Oncology Unit ( Site 1314)

location_facility: Osaka International Cancer Institute ( Site 9009)

location_facility: Affiliated hospital of Jiangnan university ( Site 8049)

location_facility: The First Affiliated Hospital of Xinxiang Medical University ( Site 8018)

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1701)

location_facility: Bradford Hill Centro de Investigaciones Clinicas ( Site 0404)

location_facility: SAIH of Tyumen reg "Multifield clinical medical center "Medical city" ( Site 1520)

location_facility: Hematology-Oncology Associates of CNY ( Site 0173)

location_facility: Cambridge University Hospitals NHSFT ( Site 1908)

location_facility: Atatürk Üniversitesi-onkoloji ( Site 1712)

location_facility: UMASS Memorial Medical Center ( Site 0120)

location_facility: The Affiliated Hospital of Xuzhou Medical University ( Site 8015)

location_facility: Royal Marsden NHS Foundation Trust ( Site 1905)

location_facility: Zhongshan Hospital Affiliated to Xiamen University ( Site 8055)

location_facility: James Graham Brown Cancer Center ( Site 0117)

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-Oncologia Medica ( Site 1313)

location_facility: University College London Hospitals NHS Foundation Trust ( Site 1901)

location_facility: The First Affiliated Hospital.Sun Yat-sen University ( Site 8047)

location_facility: Johns Hopkins Bayview Medical Center ( Site 0152)

location_facility: Seattle Cancer Care Alliance ( Site 0145)

location_facility: The Third Xiangya Hospital of Central South University ( Site 8046)

location_facility: Orszagos Onkologiai Intezet ( Site 1207)

location_facility: National Cancer Center Hospital ( Site 9001)

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

location_facility: Korea University Guro Hospital ( Site 5001)

location_facility: Tianjin Medical University Cancer Institute & Hospital ( Site 8035)

location_facility: Weill Cornell Medical College ( Site 0133)

location_facility: The First Affiliated Hospital of Xiamen University ( Site 8003)

location_facility: Clínica San Carlos de Apoquindo Red Salud UC Christus ( Site 0407)

location_facility: Fundacion Estudios Clinicos-Oncology ( Site 0215)

location_facility: Affiliated Hospital of Chengde Medical Univeristy ( Site 8053)

location_facility: Osaka Medical and Pharmaceutical University Hospital ( Site 9008)

location_facility: Princess Margaret Cancer Centre ( Site 0004)

location_facility: Nottingham University Hospital NHS Trust ( Site 1910)

location_facility: Linyi Cancer Hospital- Medical Oncology Department ( Site 8051)

location_facility: Sarawak General Hospital-Radiotherapy Unit ( Site 9100)

location_facility: Podillya Regional Center of Oncology ( Site 1809)

location_facility: Volyn Regional Oncological Dispensary ( Site 1816)

location_facility: S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2204)

location_facility: ICIMED-Oncology Research Unit ( Site 0903)

location_facility: Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 1714)

location_facility: Hospital Italiano de Córdoba ( Site 0218)

location_facility: Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0221)

location_facility: Petz Aladar Egyetemi Oktato Korhaz ( Site 1210)

location_facility: Institut De Cancerologie De L Ouest ( Site 1003)

location_facility: The Second Affiliated Hospital of Anhui Medical University ( Site 8026)

location_facility: Harbin Medical University Cancer Hospital ( Site 8009)

location_facility: Institut du Cancer de Montpellier ( Site 1002)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1306)

location_facility: James Lind Centro de Investigación del Cáncer ( Site 0412)

location_facility: Chi Mei Hospital - Liouying Branch-Clinical Trial Center ( Site 6007)

location_facility: Azienda Ospedaliera Universitaria Pisana ( Site 1312)

location_facility: Ninewells Hospital and Medical School ( Site 1907)

location_facility: Hospital Universitario Marques de Valdecilla ( Site 1602)

location_facility: FSBI National Medical Oncology Research Center n.a. N.N. Blokhina ( Site 1510)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 1604)

location_facility: Kindai University Hospital- Osakasayama Campus ( Site 9017)

location_facility: Affiliated Hospital of Jining Medical University ( Site 8017)

location_facility: Hospital Universitario General de Asturias ( Site 1601)

location_facility: AHN Allegheny General Hospital ( Site 0164)

location_facility: SNPE National Cancer Institute ( Site 1806)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 0132)

location_facility: Cancer Hospital Affiliated to Xinjiang Medical University ( Site 8041)


title: A Phase 3 Clinical Trial to Confirm Efficacy and Evaluate Safety of Twice-daily Delgocitinib Cream 20 mg/g Compared With Cream Vehicle for a 16-week Treatment Period in Adult Subjects With Moderate to Severe Chronic Hand Eczema (DELTA 1)

acronym: DELTA 1

summary:
This is a 16-week study in adult participants with chronic hand eczema (CHE). The participants will visit the clinic regularly to have the study doctor assess their CHE and to answer questions about itch, pain, CHE symptoms, and quality of life.

The purpose is to assess how delgocitinib cream works to treat CHE when compared to a placebo cream with no active substance.

study_completion_date_type: Actual

ipd_sharing_description: De-identified IPD can be made available to researchers in a closed environment for a specified period of time.

lead_sponsor: LEO Pharma

location_country:
Germany
Italy
Poland
United Kingdom
Canada
France


title: PRophylactic Cerebral Irradiation or Active MAgnetic Resonance Imaging Surveillance in Small-cell Lung Cancer Patients (PRIMALung Study)

acronym: PRIMALung

summary: In this phase III study, the primary objective is to test with a one-sided significance of 5% whether for the treatment of small cell lung cancer (SCLC) patients, brain MRI surveillance alone is non-inferior in terms of overall survival compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the entire study population.

location_country:
Germany
Italy
Poland
United Kingdom
Switzerland
Austria
Belgium
Spain
France

location_facility: Centre D'Onco. & Radioth. De Haute Energie Du Pays Basque (UNICANCER)

location_facility: CHU de Lyon - Hopital Lyon Sud (UNICANCER)

location_facility: Universitaetsklinikum Aachen AOR - Medizinische Fakultaet der RWTH

location_facility: Gasthuiszusters van Antwerpen - GasthuisZusters Antwerpen - Sint-Augustinus

location_facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma

location_facility: Fondazione IRCCS - Policlinico San Matteo

location_facility: AZ Groeninge Kortrijk - Campus Kennedylaan

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital

location_facility: Nottingham University Hospitals NHS Trust - City Hospital

location_facility: University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre

location_facility: Reseau Hospitalier Neuchatelois - RHNe - La Chaux de Fonds

location_facility: CHU de Dijon - Centre Georges-Francois-Leclerc (UNICANCER)

location_facility: Institut de Cancerologie Strasbourg Europe (UNICANCER)

location_facility: Centre Hospitalier Departemental Vendee (UNICANCER)

location_facility: Centre Francois Baclesse (CLCC) (UNICANCER)

location_facility: Institut du Cancer de Montpellier (UNICANCER)

location_facility: Maidstone & Tunbridge Wells NHS Trust - Maidstone Hospital

location_facility: Medical University of Graz - Radio-oncology

location_facility: ULSS 9 Scaligera Veneto - Azienda Unita Locale Socio-Sanitaria N. 9-Mater Salutis Hospital

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino "IST" - IRCCS - AUO San Martino - IST

intervention_type: Radiation

appel_a_projets: PHRCK

region: Île-de-France

nom_etablissement: GCS UNICANCER SIEGE

type_etablissement: GCS

acronyme: PRIMALUNG

titre: PRIMALUNG-rradiation prophylactique cérébrale ou surveillance active par IRM pour les patients atteints de cancer bronchique à petites cellules

discipline_principale: cancer

nom_porteur: LE PECHOUX

prenom_porteur: Cécile


title: A Randomised Double-blind Placebo-controlled Clinical Trial Investigating the Effect and Safety of Oral Semaglutide in Subjects With Early Alzheimer´s Disease (EVOKE)

summary:
This study is done to find out whether the medicine, semaglutide, has a positive effect on early Alzheimer's disease.

Participants will either get semaglutide or placebo (a "dummy" medicine which does not contain any study medicine) - which treatment participants get is decided by an equal chance.

The study will last for up to 173 weeks (about 3 years and 4 months). Participants will have 17 clinic visits and 1 phone call with the study doctor. The study includes various tests and scans. At 10 of the clinic visits participants will have blood samples taken.

Participants must have a study partner, who is willing to take part in the study.

Women cannot take part if pregnant, breastfeeding or plan to become pregnant during the study period.

A cerebrospinal fluid (CSF) sub-study will be performed as a part of the study. The sub-study will be performed on a selection of sites based on their experience with CSF sampling and willingness to participate in this sub-study. The endpoints related to this sub-study are exploratory only.

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

lead_sponsor: Novo Nordisk A/S

location_country:
Finland
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Turkey
Czechia
Canada
Serbia
France
Slovenia
Portugal
Slovakia
Hungary
Denmark
Switzerland
United States
Ukraine
Romania
Belgium
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Bulgaria
Russian Federation
Israel