title: An Open Label Randomized Phase 2 Trial of Amcenestrant (SAR439859), Versus Endocrine Monotherapy as Per Physician's Choice in Patients With Estrogen Receptor-positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer With Prior Exposure to Hormonal Therapies

summary:
Primary Objective:

To determine whether amcenestrant per os improves progression free survival (PFS) when compared with a endocrine monotherapy of the choice of the physician, in participants with metastatic or locally advanced breast cancer

Secondary Objectives:

To compare the overall survival in the 2 treatment arms
To assess the objective response rate in the 2 treatment arms
To evaluate the disease control rate in the 2 treatment arms
To evaluate the clinical benefit rate in the 2 treatment arms
To evaluate the duration of response in the 2 treatment arms
To evaluate the PFS according to the estrogen receptor 1 gene (ESR1) mutation status in the 2 treatment arms
To evaluate the pharmacokinetics of amcenestrant as single agent
To evaluate health related quality of life in the 2 treatment arms
To compare the overall safety profile in the 2 treatment arms

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

lead_sponsor: Sanofi

location_country:
Spain
Italy
Ukraine
United States
Belgium
Japan
Czechia
Poland
Russian Federation
Australia
Argentina
Puerto Rico
Israel
Turkey
Mexico
Brazil
Canada
China
Taiwan
Greece
Latvia
Korea, Republic of
France

location_facility:
Investigational Site Number :2030003
Investigational Site Number :2030004
Investigational Site Number :3800001
Investigational Site Number :2500006
Investigational Site Number :7240003
Investigational Site Number :1560004
Investigational Site Number :1560021
Investigational Site Number :1240004
Investigational Site Number :3760003
Investigational Site Number :0320008
Investigational Site Number :0320002
Investigational Site Number :3760002
Investigational Site Number :0320004
Investigational Site Number :2500002
Investigational Site Number :8400016
Investigational Site Number :1580004
Investigational Site Number :0360003
Investigational Site Number :1560033
Investigational Site Number :8400026
Investigational Site Number :1240003
Investigational Site Number :4840006
Investigational Site Number :3920002
Investigational Site Number :1560019
Investigational Site Number :2500007
Investigational Site Number :1560030
Investigational Site Number :6430002
Investigational Site Number :1560014
Investigational Site Number :4280001
Investigational Site Number :4100004
Investigational Site Number :7920004
Investigational Site Number :4100003
Investigational Site Number :0760005
Investigational Site Number :8400014
Investigational Site Number :2500005
Investigational Site Number :8400027
Investigational Site Number :3920005
Investigational Site Number :1560003
Investigational Site Number :1560032
Investigational Site Number :0360002
Investigational Site Number :8400032
Investigational Site Number :1580005
Investigational Site Number :8400018
Investigational Site Number :1240006
Investigational Site Number :1560031
Investigational Site Number :3000002
Investigational Site Number :8040001
Investigational Site Number :0760002
Investigational Site Number :8400015
Investigational Site Number :1560008
Investigational Site Number :0320005
Investigational Site Number :6430003
Investigational Site Number :8400028
Investigational Site Number :0760001
Investigational Site Number :0760006
Investigational Site Number :1560027
Investigational Site Number :1560023
Investigational Site Number :2030002
Investigational Site Number :1580003
Investigational Site Number :4280002
Investigational Site Number :8400009
Investigational Site Number :8400025
Investigational Site Number :1560024
Investigational Site Number :3000004
Investigational Site Number :1560005
Investigational Site Number :8400024
Investigational Site Number :8400030
Investigational Site Number :3920003
Investigational Site Number :8400038
Investigational Site Number :0760003
Investigational Site Number :1580002
Investigational Site Number :6160001
Investigational Site Number :3920009
Investigational Site Number :8400034
Investigational Site Number :1560002
Investigational Site Number :1580001
Investigational Site Number :0560001
Investigational Site Number :3800002
Investigational Site Number :7240006
Investigational Site Number :4840005
Investigational Site Number :7240001
Investigational Site Number :8040004
Investigational Site Number :6160003
Investigational Site Number :1560001
Investigational Site Number :8040005
Investigational Site Number :1560016
Investigational Site Number :3920006
Investigational Site Number :8400022
Investigational Site Number :6430005
Investigational Site Number :7920003
Investigational Site Number :3760001
Investigational Site Number :1560010
Investigational Site Number :3000003
Investigational Site Number :7240008
Investigational Site Number :0560002
Investigational Site Number :3800003
Investigational Site Number :1560015
Investigational Site Number :2500008
Investigational Site Number :8400006
Investigational Site Number :0320007
Investigational Site Number :3920008
Investigational Site Number :0360001
Investigational Site Number :1560011
Investigational Site Number :7920001
Investigational Site Number :1560013
Investigational Site Number :0320006
Investigational Site Number :7920002
Investigational Site Number :3920001
Investigational Site Number :4100002
Investigational Site Number :3920004
Investigational Site Number :0560003
Investigational Site Number :3000001
Investigational Site Number :4100001
Investigational Site Number :1560018
Investigational Site Number :2500001
Investigational Site Number :8400013
Investigational Site Number :8400008
Investigational Site Number :4840002
Investigational Site Number :1560025
Investigational Site Number :0320001
Investigational Site Number :1560026
Investigational Site Number :3760004
Investigational Site Number :8400020


type: EudraCT Number

title: International, Multicentre, Observational, Prospective, Longitudinal Study to Assess the Effectiveness of AboBoNT-A Injections for Adult Lower Limb Spasticity in a Real Life Cohort (AboLiSh)

acronym: AboLiSh

summary: The purpose of the protocol is to assess the longitudinal attainment of person-centered and function related goals of patients who receive AbobotulinumtoxinA (aboBoNT-A) injections for adult lower limb spasticity over a period of 16 months.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Ipsen

location_country:
Poland
Brazil
Italy
Russian Federation
Australia
Canada
United States
France
Germany

location_facility: SAHI Interregional Clinical Diagnostic Center

location_facility: Wake Forest University Baptist Medical Center

location_facility: Wojewódzki Szpital Specjalistyczny we Wrocławiu

location_facility: Centre Hospitalier Universitaire De Reims - Hopital Maison B

location_facility: Dayton Center for Neurological Disorders

location_facility: Centre Hospitalier Regional Universitaire (CHRU) de Lille - Hopital Pierre Swynghedauw - Neurology

location_facility: Rancho Los Amigos National Rehabilitation Center (RLANRC) - Neurology

location_facility: Regional state budget health institution "City Hospital № 5"

location_facility: Beaumont Hospital, Grosse Pointe - Neurology

location_facility: Istituto Scientifico di Riabilitazione di Veruno, Fondazione

location_facility: Kansas City Bone and Joint Clinic, P.A. (KCBJ) - Overland Pa

location_facility: Federal State Budgetary Institution "All-Russian Center for Emergency Medicine and Medical Radiology named after A.M. Nikiforov" of the EMERCOM of Russia

location_facility: MedStar National Rehabilitation Hospital

location_facility: PO Villa Sofia, AO Ospedali Riuniti Villa Sofia-Cervello

location_facility: Yeshiva University - Albert Einstein College of Medicine - Montefiore Medical Center (MMC) - Neurology

location_facility: Good Shepherd Rehabilitation Hospital - Neurology

location_facility: The University of Utah School of Medicine

location_facility: Mazowiecki Szpital Brodnowski w Warszawie Sp. z o.o. Brodnowskie Centrum Kliniczne Poliklinika Brodnowskiego Centrum Klinicznego

location_facility: Neurologie und Psychosomatik am Wittenbergplatz

location_facility: Hospital de Base de São José do Rio Preto at Centro Integrado de Pesquisa (CIP) - Neurology

location_facility: Medizinische Hochschule Hannover - Neurology Neurologische Poliklinik

location_facility: Medical College of Wisconsin - Froedtert Hospital

location_facility: National Medical Research Treatment and Rehabilitation Center of the Ministry of Health of Russia

location_facility: Pavlov First Saint-Petersburg State Medical University - Neurology

location_facility: Wojew. Wielospecjalistyczne Centrum Onkologii i Traumatologii im.M.Kopernika w Lodzi

location_facility: Bekhterev National Research Medical Center for Psychiatry

location_facility: Università Degli studi della Campania - Luigi Vanvitelli - Neurologica

location_facility: Universita degli Studi di Verona - Centro di Ricerca in Riabilitazione Neuromotoria e Cognitiva (CRRNC) - Neurology

location_facility: River Valley Health - Stan Cassidy Foundation - Stan Cassidy

location_facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto (HCFMRP) - Neurology

location_facility: FGBOU VO "Ural state medical university"

lead_sponsor_type: industriel

status_simplified: Completed


title: Performance Evaluation of the VIDAS TB-IGRA Assay.

summary: This study will evaluate the performance of the VIDAS® Interferon Gamma (IFN-γ) Release Assay (TB-IGRA) assay, which is intended for use as an aid in the diagnosis of tuberculosis infection. This study is designed to assess (1) the sensitivity of this assay, (2) its percent agreement with other diagnostic tests, (3) its measurement precision , and (4) any potential interference of the presence of other non-tuberculosis mycobacterial bacterial infections with this assay.

time_perspective: Cross-Sectional

ipd_sharing: No

lead_sponsor: BioMérieux

location_country:
Brazil
United Kingdom
Italy
Georgia
India
United States
France
South Africa
Mexico

location_facility: Universidade Federal Da Grande Dourados (UFGD)

location_facility: Autonomous University of Baja California

location_facility: University of Cape Town Centre for Lung Infection and Immunity

location_facility: Universidade Federal de Mato Grosso do Sul (UFMS)

location_facility: National Center for Tuberculosis and Lung Disease

location_facility: TASK Applied Science, Delft Day Hospital Premises

intervention_type: Diagnostic Test


title: An Open-label Multi-cohort Phase 1b/2 Study of Derazantinib and Atezolizumab in Patients With Urothelial Cancer Expressing Activating Molecular FGFR Aberrations

summary: The purpose of this study is to evaluate efficacy of derazantinib monotherapy or derazantinib-atezolizumab in combination in patients with advanced urothelial cancer harboring fibroblast growth factor receptor (FGFR) genetic aberrations (GA) of various clinical stages of disease progression and prior treatments.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: Basilea Pharmaceutica

location_country:
Poland
Spain
Italy
Austria
Australia
United Kingdom
Canada
Switzerland
Hungary
Korea, Republic of
United States
France
Germany
Czechia

location_facility: ASST Valtellina e Alto Lario - UOC Oncologia Medica Ospedale di Sondrio

location_facility: IRCCS - Istituto Europeo di Oncologia IEO

location_facility: Seoul St. Marys Hospital Catholic University of Korea

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte

location_facility: Seoul National University Bundang Hospital

location_facility: Medical Oncology Associates PS (dba Summit Cancer Centers)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Marques de Valdecilla University Hospital

location_facility: Barts and The London School of Medicine and Dentistry - Barts Cancer Institute (BCI)

location_facility: Medical Oncology - Pitié-Salpêtrière Hopital

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Hospital Universitario HM Sanchinarro CIOCC

location_facility: Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o., 04-073, Warszawa, Poland

location_facility: Ballarat Oncology & Haematology Services

location_facility: Medizinische Universitaet Wien - Allgemeines Krankenhaus der Stadt Wien (AKH) - Universitaetsklinik fuer Urologie

location_facility: University of Texas Southwestern Medical Center (UTSWMC)

location_facility: Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego

location_facility: Englander Institute Weill Cornell Medicine

intervention_type: Drug


ipd_sharing: Yes

status: Recruiting

acronym: RECLAIIM

title: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults With Dermatomyositis (DM) - The RECLAIIM Study

study_completion_date_type: Anticipated

lead_sponsor: CSL Behring

source: euctr

ipd_sharing_description:
CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.

Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.

If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.

enrollment_type: Anticipated

location_country:
Poland
Spain
Italy
Russian Federation
Mexico
Netherlands
United Kingdom
Switzerland
Ukraine
France
United States
Belgium
Japan
Germany
Czechia

location_facility: 7560033 - University Hospital Bern Inselspital

location_facility: 2500146 - CHU De Dijon Hopital Du Bocage

location_facility: 8040057 - Khmelnitskiy Regional Hospital

location_facility: 8040058 - State Institution National Scientific Center Strazhesko

location_facility: 3920125 - Tokyo Medical And Dental University Medical Hospital

location_facility: 3920097 - Tokyo Women's Medical University Hospital

location_facility: 6160106 - Specjalistyczne Gabinety Sp. z o.o

location_facility: 8401117 - Arizona Arthritis & Rheumatology Research

location_facility: 3800134 - Azienda Ospedaliero Universitaria Pisana

location_facility: 0560048 - Universitair Ziekenhuis (UZ) Leuven

location_facility: 2500188 - Centre Hospitalier Regional Universitaire de Lille

location_facility: 8401131 - Paramount Medical Research & Consulting

location_facility: 3800139 - Universita degli Studi Firenze

location_facility: 2760211 - Charité - Universitätsmedizin Berlin

location_facility: 4840082 - CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C.

location_facility: 7240011 - Hospital Universitario Valle de Hebron

location_facility: 2760201 - Medizinische Hochschule Hannover (MHH)

location_facility: 8401115 - The University of Texas Medical School at Houston

location_facility: 8401486 - Oregon Health and Science University

location_facility: 2760212 - University Hospital Of Tuebingen

location_facility: 8040051 - Kyiv Railway Clinical Hospital No.2

location_facility: 7240086 - Complejo Hospitalario Universitario A Coruña

location_facility: 8401107 - Morsani Center for Advanced Health Care (CAHC)

location_facility: 0560050 - Ghent Universit Hospital (UZ Gent)

location_facility: 6430124 - ORIS Firm Limited Liability Company

location_facility: 8040055 - Mechnikov Institute of Microbiology and Immunology

location_facility: 4840081 - Centro Integral en Reumatologia, SA de CV

location_facility: 6160104 - Zespol Poradni Specjalistycznych REUMED, ONYKSOWA Filia nr 2

location_facility: 6430123 - Yaroslavl Oblast Clinical Hospital

location_facility: 8401129 - UCLA - Rheumatology Los Angeles

location_facility: 3920086 - St. Marianna University Hospital

location_facility: 5280065 - Amsterdam Universitair Medische Centra (UMC)

location_facility: 3920087 - Wakayama Medical University Hospital

location_facility: 8401474 - West Tennessee Research Institute, LLC

location_facility: 4840084 - Centro de Alta Especialidad en Reumatologia e Investigacion del Potosí, S.C.

location_facility: 6430120 - St. Petersburg City Rheumatological Hospital 25

location_facility: 3800133 - Universita degli Studi Di Brescia - Azienda Ospedaliera Spedali Civili di Brescia

location_facility: 2500144 - Hopitaux Universitaire de Strasbourg

location_facility: 3920091 - Nippon Medical School Hospital

location_facility: 8401473 - RecioMed Clinical Research Network, Inc.

location_facility: 8401152 - The University of Kansas Medical Center

location_facility: 3800132 - Universitaria Vittorio Emanuele

summary: This is a phase 3, multicenter, randomized, placebo-controlled, double-blind study of IgPro20 (subcutaneous Ig) treatment in adult subjects with dermatomyositis (DM). The primary objective of this study is to assess the efficacy of IgPro20 subcutaneous (SC) doses in comparison to placebo in adult subjects with DM, as measured by responder status based on Total Improvement Score (TIS) assessments.

status_simplified: Ongoing


type: Other Identifier

title: A Phase 1b, Multicenter, Two-Part, Open-Label Study of Trastuzumab Deruxtecan (DS-8201a), An Anti-Human Epidermal Growth Factor Receptor-2 (HER2)-Antibody Drug Conjugate (ADC), In Combination With Pembrolizumab, An Anti-PD-1 Antibody, For Subjects With Locally Advanced/Metastatic Breast Or Non-Small Cell Lung Cancer (NSCLC)

summary: This two-part study will include a dose escalation part to determine the recommended dose for expansion of DS8201a and pembrolizumab and a dose expansion part to evaluate efficacy, safety, and tolerability of the combination.

design_allocation: Non-Randomized

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

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
United Kingdom
United States
Spain
France

location_facility: Siteman Cancer Center-Washington University

location_facility: University of California San Francisco Medical Center

location_facility: Institute Oncologico Baselga Hospital Quiron

location_facility: Massachusetts General Hospital Cancer Center

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Hospital General Universitario Gregorio Marañon


title: A Phase 1, Multicenter, Open-label, Dose Finding Study of CC-99712, a BCMA Antibody-Drug Conjugate, in Subjects With Relapsed and Refractory Multiple Myeloma

summary: Study CC-99712-MM-001 is an open-label, Phase 1, dose escalation (Part A) and expansion (Part B), First-in-Human (FIH) clinical study of CC-99712 in monotherapy or combination with BMS-986405 in participants with relapsed and refractory multiple myeloma (MM). The dose escalation part (Part A) of the study will evaluate the safety and tolerability of escalating doses of CC-99712, administered intravenously (IV) in monotherapy (Arm 1) or combination with BMS-986405 (Arm 2), to determine the maximum tolerated dose (MTD) of CC-99712 guided by a Bayesian logistic regression model (BLRM). A modified accelerated titration design will also be used for Arm 1 and Arm 2. The MTD may be established separately for CC-99712 administered at Q3W and/ or Q4W schedules. The expansion part (Part B) will further evaluate the safety and efficacy of CC-99712 in monotherapy (Arm 1) or combination (Arm 2) administered at or below the MTD in selected expansion cohorts in order to determine the RP2D. One or more doses or dosing regimens may be selected for cohort expansion. All participants will be treated until confirmed disease progression per IMWG criteria, unacceptable toxicity, or participants//Investigator decision to withdraw.

ipd_sharing_description:
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

lead_sponsor: Celgene

location_country:
Spain
Italy
Canada
United States
France

location_facility: University Of California San Diego Moores Cancer Center

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Hopital Maisonneuve Rosemont dba CIUSSS de lEst de lIle de Montreal

location_facility: Istituto Nazionale dei Tumori | Fondazione IRCCS

location_facility: University of California San Diego Moores Cancer Center

location_facility: Complejo Asistencial Universitario de Salamanca - H. Clinico

location_facility: Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele" - Ospedale Vittorio Emanuele


title: An Open-Label Study With Extension Phase to Evaluate the Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Subjects (Age 1 Month to Less Than 18 Years) With Childhood Epilepsy

lead_sponsor: Eisai Inc.

ipd_sharing_description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

location_country:
Denmark
Spain
United States
France
Belgium
Germany
Czechia

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Wake Forest Baptist Medical Center - PPDS

location_facility: Nemours Foundation Alfred Dupont Children's Hospital

location_facility: Pediatric Epilepsy and Neurology Specialists

location_facility: Centro Medico Teknon - Grupo Quironsalud

location_facility: University Hospitals Cleveland Medical Center

location_facility: Hopitaux de Paris CHU Hopital Robert Debre - Inserm U676

location_facility: Meridian Clinical Research-(Savannah Georgia)

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Hôpital Universitaire des Enfants Reine Fabiola

location_facility: Children's Hospital of Richmond at VCU - CHoR-PIN

summary: The purpose of the study is to evaluate the efficacy of perampanel as measured by the 50 percent (%) responder rate during the maintenance period of the core study for seizure frequency in participants with pediatric epileptic syndrome (Cohort 1) and partial-onset seizures (POS) (Cohort 2).


title: A Phase 3b, Multicenter, Open-Label, Single-Arm Study of Acalabrutinib (ACP-196) in Subjects With Chronic Lymphocytic Leukemia.

acronym: ASSURE

summary: This is a global, Phase 3b, multicenter, open-label, single-arm study to evaluate the safety and efficacy of acalabrutinib 100 mg twice daily (bid) in approximately 540 participants with chronic lymphocytic leukemia (CLL). Participants will be enrolled into 3 cohorts: treatment-naive (TN), relapsed/refractory (R/R), and prior Bruton tyrosine kinase inhibitor (BTKi) therapy. Participants will remain on study treatment until completion of 48 cycles (28 days per cycle), disease progression, toxicity requiring discontinuation, withdrawal of consent, lost to Follow-up, death, or study termination by the sponsor whichever occurs first. The duration of the study will be approximately 72 months from the first participant enrolled. This duration includes an estimated 24-month recruitment time and an assumed 48 cycles of study treatment (28 days per cycle); additional study time will be accrued during the disease Follow up period for those participants remaining on study treatment after completion of 48 cycles prior to the final data cutoff (DCO) (the amount of time will vary by participant).

status: Active, not recruiting

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

lead_sponsor: AstraZeneca

location_country:
Denmark
Taiwan
Brazil
Spain
Italy
Russian Federation
Australia
Netherlands
Canada
Finland
United Kingdom
Sweden
Korea, Republic of
United States
France
Norway
Germany


type: Registry Identifier

title: A Phase 3 Randomized, Double Blind Study of Pembrolizumab Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin as First-Line Therapy in Participants With Advanced and/or Unresectable Biliary Tract Carcinoma

summary: This is a study of pembrolizumab plus gemcitabine/cisplatin versus placebo plus gemcitabine/cisplatin as first-line therapy in participants with advanced and/or unresectable biliary tract carcinoma. The primary hypothesis is pembrolizumab plus gemcitabine/cisplatin is superior to placebo plus gemcitabine/cisplatin with respect to overall survival (OS).

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Hong Kong
Australia
Argentina
Israel
Turkey
Malaysia
Brazil
Canada
China
Germany
Taiwan
Ireland
New Zealand
Thailand
Korea, Republic of
France
Chile
Netherlands

location_facility: Universitaetsklinikum Aachen AOER ( Site 0275)

location_facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0495)

location_facility: CHA Bundang Medical Center CHA University ( Site 0835)

location_facility: Hospital General Universitari Vall d Hebron ( Site 0432)

location_facility: Kyungpook National University Chilgok Hospital ( Site 0834)

location_facility: Royal Free London NHS Foundation Trust ( Site 0520)

location_facility: Western Health-Sunshine Hospital ( Site 0709)

location_facility: Pontificia Universidad Catolica de Chile ( Site 0620)

location_facility: Hunan Provincial People Hospital ( Site 0142)

location_facility: The First Affiliated Hospital Zhejiang University ( Site 0136)

location_facility: University Hospital Coventry and Warwickshire NHS Trust ( Site 0518)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0506)

location_facility: Hospital de Caridade de Ijui ( Site 0602)

location_facility: University of Colorado Hospital ( Site 0011)

location_facility: Inonu Universitesi Medical Fakultesi ( Site 0501)

location_facility: Aichi Cancer Center Hospital ( Site 0080)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 0433)

location_facility: Severance Hospital Yonsei University Health System ( Site 0836)

location_facility: ASST Grande Ospedale Metropolitano Niguarda ( Site 0332)

location_facility: A.O. di Rilievo Nazionale e di alta Specializzazione Garibaldi ( Site 0330)

location_facility: A.P.H. Paris, Hopital Beaujon ( Site 0247)

location_facility: Royal Marsden NHS Foundation Trust ( Site 0535)

location_facility: Policlinico Universitario Campus Biomedico ( Site 0328)

location_facility: OHSU Center for Health & Healing ( Site 0044)

location_facility: Columbia University/Herbert Irving Cancer Center ( Site 0009)

location_facility: CHU de Montpellier - Hopital Saint-Eloi ( Site 0248)

location_facility: University of Oklahoma- Stephenson Oklahoma Cancer Center ( Site 0055)

location_facility: The Third Xiangya Hospital of Central South University ( Site 0157)

location_facility: University of California San Diego Moores Cancer Center ( Site 0008)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0180)

location_facility: National Cancer Center Hospital East ( Site 0081)

location_facility: Kobe City Medical Center General Hospital ( Site 0087)

location_facility: Hospital Universitario General de Asturias ( Site 0434)

location_facility: Harbin Medical University Cancer Hospital ( Site 0133)

location_facility: Izmir Medical Park Hospital Department of Medical Oncology ( Site 0502)

location_facility: Hospital Paulistano - Amil Clinical Research ( Site 0603)

location_facility: Medizinische Hochschule Hannover ( Site 0265)

location_facility: Chang Gung Medical Foundation. Linkou ( Site 0853)

location_facility: Charite - Universtitatsmedizin Berlin CCM ( Site 0269)

location_facility: CHU Bordeaux Haut-Leveque Centre Francois Magendie ( Site 0245)

location_facility: Universitaetsklinikum Essen ( Site 0273)

location_facility: First Affiliated Hospital of The Third Military Medical University ( Site 0130)

location_facility: CHU Clermont-Ferrand - Site Estaing ( Site 0249)

location_facility: Tallaght University Hospital ( Site 0522)

location_facility: Oncobio Servicos de Saude SA ( Site 0604)

location_facility: Chungnam National University Hospital ( Site 0840)

location_facility: Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0580)

location_facility: Klinikum der Ludwig - Maximilian Universitat Munchen ( Site 0264)

location_facility: China Medical University Hospital ( Site 0862)

location_facility: Institut Kanser Negara - National Cancer Institute ( Site 0767)

location_facility: University of California - San Francisco ( Site 0030)

location_facility: Northwest Georgia Oncology Centers PC ( Site 0045)

location_facility: Universitaetsklinikum Hamburg-Eppendorf ( Site 0268)

location_facility: National Taiwan University Hospital ( Site 0860)

location_facility: Fudan University Shanghai Cancer Center ( Site 0160)

location_facility: Saint Francis Health System ( Site 0051)

location_facility: Chonnam National University Hwasun Hospital ( Site 0837)

location_facility: The First Affiliated Hospital of Xi an Jiaotong University ( Site 0145)

location_facility: The First Hospital of Jilin University ( Site 0131)

location_facility: Hospital Regional Universitario Carlos Haya ( Site 0431)

location_facility: The Christie NHS Foundation Trust ( Site 0537)

location_facility: Hadassah Ein Karem - Sharett Institute of Oncology ( Site 0309)

location_facility: Azienda Ospedaliera Universitaria di Verona ( Site 0334)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 0078)

location_facility: King Chulalongkorn Memorial Hospital ( Site 0884)

location_facility: Erasmus University Medical Center ( Site 0352)

location_facility: Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0609)

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0038)

location_facility: Centro Investigación del Cáncer James Lind ( Site 0622)

location_facility: Guangdong Provincial People s Hospital ( Site 0161)

location_facility: Policlinico S. Orsola-Malpighi ( Site 0333)

location_facility: Universita Cattolica del Sacro Cuore - Policlinico Gemelli ( Site 0329)

location_facility: Korea University Guro Hospital ( Site 0832)

location_facility: Staedtisches Klinikum Dresden ( Site 0272)

location_facility: Hospital Universitario HM Sanchinarro ( Site 0435)

location_facility: University Malaya Medical Centre ( Site 0770)

location_facility: Taipei Veterans General Hospital ( Site 0861)

location_facility: Osaka International Cancer Institute ( Site 0084)

location_facility: Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0865)

location_facility: Centro Oncologico Riojano Integral ( Site 0584)

location_facility: Mid North Coast Cancer Institute ( Site 0708)

location_facility: McGill University Health Centre ( Site 0179)

location_facility: UZA University Hospital Antwerp ( Site 0202)

location_facility: St Vincents University Hospital ( Site 0521)

location_facility: Tianjin Medical University Cancer Institute & Hospital ( Site 0155)

location_facility: Instituto COI de Pesquisa Educacao e Gestao ( Site 0606)

location_facility: Azienda Ospedaliero Universitaria Pisana ( Site 0326)

location_facility: Gazi Universitesi Tip Fakultesi ( Site 0496)

location_facility: The Cancer Institute Hospital of JFCR ( Site 0082)

location_facility: The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 0839)

location_facility: Winship Cancer Institute of Emory University ( Site 0013)

location_facility: Hacettepe University Faculty of Medicine ( Site 0498)

location_facility: Erciyes Universitesi Tip Fakultesi ( Site 0500)

location_facility: Koo Foundation Sun Yat-Sen Cancer Center ( Site 0863)

location_facility: Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0158)

location_facility: West China Hospital of Sichuan University ( Site 0147)

location_facility: Universitaetsklinikum Magdeburg A.o.R. ( Site 0271)

location_facility: Pamela Youde Nethersole Eastern Hospital ( Site 0857)

location_facility: Baskent University Adana Training Hospital ( Site 0499)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 0623)

location_facility: Maharaj Nakorn Chiang Mai Hospital ( Site 0887)

location_facility: Pantai Hospital Kuala Lumpur ( Site 0771)

location_facility: Ajou University Hospital, Clinical Research Center ( Site 0838)

location_facility: National Cheng Kung University Hospital ( Site 0864)

location_facility: University of Alabama at Birmingham Comprehensive Cancer Ctr ( Site 0016)

location_facility: Associacao Hospitalar Moinhos de Vento ( Site 0599)

location_facility: UCLA Hematology/Oncology - Santa Monica ( Site 0014)

location_facility: Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0182)

location_facility: Winthrop University Hospital ( Site 0059)

location_facility: Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 0525)

location_facility: Seoul National University Bundang Hospital ( Site 0833)

location_facility: Universitaetsklinikum Koeln ( Site 0274)

location_facility: Hospital de Clinicas de Porto Alegre ( Site 0610)

location_facility: Zhongshan Hospital Fudan University ( Site 0129)

location_facility: Princess Margaret Hospital. ( Site 0856)

location_facility: Gallipoli Medical Research Foundation ( Site 0705)

location_facility: Abdurrahman Yurtaslan Onkoloji Hastanesi ( Site 0494)

location_facility: Peking Union Medical College Hospital ( Site 0150)

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0607)

location_facility: Universitair Medisch Centrum Utrecht ( Site 0351)

location_facility: Hospital Nossa Senhora da Conceicao ( Site 0601)

location_facility: Fujian Provincial Cancer Hospital ( Site 0154)

location_facility: Maastricht University Medical Centre ( Site 0347)

intervention_type: Biological


title: An Open Label, Multi-center Roll-over Study to Assess Long-term Effect in Pediatric Patients Treated With Tafinlar (Dabrafenib) and/or Mekinist (Trametinib)

lead_sponsor: Novartis Pharmaceuticals

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

This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

location_country:
United Kingdom
Spain
Canada
United States
France

location_facility: Childrens National Hospital CQTI571A2306

location_facility: Cincinnati Children s Hospital Medical Center

summary: A roll-over study to assess long-term effect in pediatric patients treated with dabrafenib and/or trametinib.


title: An Open-label, Dose-escalation, Phase I/II Study to Assess the Safety, the Tolerability, the Immunogenicity and the Preliminary Clinical Activity of the Therapeutic Cancer Vaccine, PDC*lung01, Associated or Not With Anti-PD-1 Treatment in Patients With Non-small-cell Lung Cancer (NSCLC)

lead_sponsor: PDC*line Pharma SAS

location_country: Poland Netherlands France Belgium Germany

location_facility: Institut régional du Cancer de Montpellier

location_facility: Centre Léon Bérard, Centre de lutte contre le cancer

location_facility: Jeroen Bosch Ziekenhuis - 's hertogenbosch

location_facility: Antoni Van Leeuwenhoek (Nederlands Kanker Instituut)

location_facility: Assistance Publique Hôpitaux de Marseille, Centre d'essais précoces en cancérologie de Marseille (CEPCM)

summary: PDC-LUNG-101 trial is an open-label, dose-escalation, phase I/II study to assess the safety, the tolerability, the immunogenicity and the preliminary clinical activity of the therapeutic cancer vaccine, PDC*lung01, associated or not with anti-PD-1 treatment in patients with non-small-cell lung cancer.


title: An Open-label, Long-term Extension Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease (INTREPID OLE)

acronym: INTREPID OLE

summary: The purpose of Study D5271C00002 (Legacy #3150-303-008) is to permit participants in D5271C00001 (Legacy #3150-301-008) to receive open-label brazikumab in Study D5271C00002 (Legacy #3150-303-008). This will permit long-term observation of safety in these participants with brazikumab.

status: Enrolling by invitation

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

status_simplified: Unknown


title: An Open-Label, Randomized, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 in Pediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension

lead_sponsor: Biogen

ipd_sharing_description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/

location_country:
Croatia
Serbia
Saudi Arabia
Italy
Spain
United States
Belgium
Czechia
Portugal
Russian Federation
Australia
Argentina
Tunisia
Israel
Turkey
Slovakia
Kuwait
Hungary
Germany
Bulgaria
Greece
France

location_facility: Hopital Bicetre, Groupement Hospitalier Universita

summary: This study will evaluate the safety, tolerability, and descriptive efficacy of BIIB017 in pediatric participants with relapsing-remitting multiple sclerosis (RRMS) and to assess the pharmacokinetics (PK) of BIIB017 in pediatric participants with RRMS in Part 1. In Part 2, the study will evaluate the long-term safety of BIIB017 and further describe safety and the long-term multiple sclerosis (MS) outcomes after BIIB017 treatment in participants who completed the study treatment at Week 96 in Part 1 of the study.


title: A Multicenter, Double-Blind, Multidose, Placebo-Controlled, Randomized, Parallel-Group, Phase 2 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 for Patients With Brain Contusion

summary:
The primary objective is to determine if BIIB093 reduces brain contusion expansion by Hour 96 when compared to placebo.

The secondary objectives are to evaluate the effects of BIIB093 on acute neurologic status, functional outcomes, and treatment requirements, to further differentiate the mechanism of action of BIIB093 on contusion expansion by examining differential effects on hematoma and edema expansion, and to determine if BIIB093 improves survival at Day 90 when compared to placebo.

location_country:
Spain
Italy
United States
Israel
France
Japan
Germany

location_facility:
Research Facility
Research site
Research Site


title: An Open-Label Extension Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis

acronym: ELEVATE UC OLE

summary: The purpose of this open-label extension (OLE) study is to evaluate the safety and efficacy of etrasimod in participants with moderately to severely active ulcerative colitis (UC) who previously received double-blind treatment (either etrasimod 2 mg per day or placebo) during participation in one of the qualified Phase 3 or Phase 2 double-blind, placebo-controlled parent studies including but not limited to: (APD334-301 [NCT03945188] or APD334-302 [NCT03996369] or APD334-210 [NCT04607837]).

lead_sponsor: Arena Pharmaceuticals

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Belgium
Japan
Romania
South Africa
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
India
Israel
Turkey
Mexico
Slovakia
Lebanon
Canada
Hungary
Germany
Bulgaria
Moldova, Republic of
Denmark
Belarus
Latvia
Georgia
Estonia
Thailand
Korea, Republic of
France
Chile
Netherlands

location_facility: Washington University School of Medicine

location_facility: Acibadem City Clinic Tokuda Hospital Ead

location_facility: Medical College of Wisconsin Clinical Trials Office

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Communal Non-Commercial Enterprise Lviv Clinical Hospital of Emergency Medical Care

location_facility: Stavropol Regional Clinical Diagnostic Centre

location_facility: JSC Infectious Diseases, AIDS and Clinical Immunology Research Center

location_facility: Azienda Ospedaliero Universitaria Mater Domini

location_facility: Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E

location_facility: Centrum Dentystyczno-Lekarskie Promedica Joanna Markiewicz

location_facility: Gastroenterology Associates of Tidewater

location_facility: LLC "Gastroenterological centre Expert",

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - CEMAD

location_facility: Clinical Center " Dr Dragisa Misovic Dedinje"

location_facility: Centro de Investigacion Medico Biologica y Terapia Avanzada s.c.

location_facility: Government Medical College and Super Speciality Hospital

location_facility: I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital

location_facility: P. Stradins Clinical University Hospital

location_facility: Great Lakes Medical Research, LLC - Harrisburg

location_facility: Health Care Institution "10th City Clinical Hospital"

location_facility: Spitalul Clinic Judetean de Urgenta Cluj Napoca

location_facility: Communal Noncommercial Enterprise Ye.Ye. Karabelesh Kherson City Clinical Hospital of Kherson City

location_facility: Endoscopy Center of the North Shore - Gen1 Research

location_facility: Iwate Medical University Uchimaru Medical Center

location_facility: Zuyderland Medisch Centrum - Sittard-Geleen

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta

location_facility: Timofei Mosneaga Republican Clinical Hospital, Department of Gastroenterology

location_facility: Great Lakes Medical Research, LLC - Beachwood

location_facility: UCI Institute for Clinical Translational Services

location_facility: Children's Center for Digestive Health Care, LLC

location_facility: Clinic of Plastic and Laser Surgery "Anturium" LLC

location_facility: Charité Universitätsmedizin Berlin - Campus Charité Mitte

location_facility: Malkhaz Katsiashvili Multiprofile Emergency Medicine Center

location_facility: Topolowa Medicenter Mrozek & Wspolnicy Spolka Jawna

location_facility: Federal state Budgetary Educational Institution of Higher Education "North-Western Medical University"

location_facility: SPb SBIH "City Hospital # 40 of Kurortnyi region"

location_facility: Semmelweis Egyetem Belgyógyászati és Hematológiai Klinika

location_facility: SBIH of Nizhniy Novgorod region "Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko"

location_facility: Centralny Szpital Kliniczny MSW w Warszawie

location_facility: Medical Clinical Investigational Center Medical Center LLC Health Clinic

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

location_facility: Hospital General Universitario de Alicante

location_facility: Severance Hospital, Yonsei University Health System

location_facility: CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC

location_facility: Odesa regional clinical hospital, regional center of gastroenterology, surgical department

location_facility: Diagnostic-Consultative Center I - Sliven, EOOD

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

location_facility: UAB "Inlita", Santaros Clinical Trials Centre

location_facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne

location_facility: State Budgetary Healthcare Institution "Penza Region Clinical Hospital n.a. N.N. Burdenko"

location_facility: Great Lakes Medical Research, LLC - Mentor

location_facility: Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital

location_facility: SUBARU Health Insurance Society Ota Memorial Hospital

location_facility: A. Novak Transcarpathian Regional Clinical Hospital

location_facility: Vitebsk Regional Clinical Specialized Center

location_facility: Dr. Peter Bossuyt - GI Clinical Research Center

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

location_facility: SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU

location_facility: CI City Clinical Hospital #6 Dept of Gastroenterology

location_facility: San Diego Gastroenterology Medical Associates

location_facility: National Military Medical Clinical Center Main Military Clinical Hospital

location_facility: Diagnostic Consultation Center CONVEX EOOD

location_facility: Municipal non-profit enterprise Regional Clinical Hospital of Ivano-Frankivsk Regional Council

location_facility: Aalborg University Hospital, department of medical gastroenterology

location_facility: Hospital da Senhora da Oliveira Guimarães

location_facility: Biopharma Informatic, Inc. Research Center

location_facility: General Hospital "Dr.Tomislav Bardek" Koprivnica

location_facility: LTD Acad. F. Todua Medical Center - LTD Research Institute of Clinical Medicine

location_facility: Guy's and St Thomas NHS Foundation Trust

location_facility: Gastromed Kralisz, Romatowski, Stachurska sp.j

location_facility: EMC INSTYTUT MEDYCZNY SA, EuroMediCare Szpital Specjalistyczny z Przychodnia

location_facility: Duke University Medical Center GI Clinical Research Unit

location_facility: Texas Digestive Disease Consultants - Dallas

location_facility: Republican Panevezys Hospital, Department of Gastroenterology

location_facility: LTD Central University Clinic After Academic N. Kipshidze

location_facility: Marshall University Department of Clinical Research

location_facility: American University of Beirut Medical Center

location_facility: Private Educational Institution of Higher Education "Medical University "REAVIZ"

location_facility: Japan Community Health care Organization Osaka Hospital

location_facility: SAIH "Kemerovo Regional Clinical Hospital

location_facility: Clinical Hospital of the Ministry of Health, Labor and Social Protection

location_facility: M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU

location_facility: Kocaeli University Research and Training Hospital

location_facility: Karkonoskie Centrum Badan Klinicznych - Lexmedica

location_facility: Postgraduate department of Medicine, GSVM Medical college

location_facility: Acibadem City Clinic University Hospital EOOD

location_facility: Irkutsk State Medical Academy of Continuing Education

location_facility: Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz

location_facility: Great Lakes Medical Research, LLC - Warren

location_facility: Barts Health NHS Trust - Whipps Cross University Hospital

location_facility: FSBI of higher Education "First Saint Petersburg State Medical University n.a. I.P.Pavlov

location_facility: Digestive Health Specialists of the Southeast

location_facility: Department of Propaedeutics of Internal Medicine Ivano-Frankivsk National Medical University

location_facility: Osaka Medical and Pharmaceutical University Hospital

location_facility: Communal Non-Commercial Enterprise City Clinical Hospital #13 of Kharkiv City Council

location_facility: University of California San Diego Medical Center

location_facility: DiGiovanna Institute for Medical Education & Research

location_facility: Kitasato University Kitasato Institute Hospital

location_facility: Institution "Gomel Regional Clinical Hospital"

location_facility: Kyungpook National University Chilgok Hospital

location_facility: LTD Israeli-Georgian Medical Research clinic Helsicore

location_facility: Atlanta Center for Gastroenterology, P.C.

location_facility: Texas Digestive Disease Consultants - San Marcos

location_facility: Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika -Gasztroenterologia

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: UMHAT "Sv. Ivan Rilski", EAD,Clinic of gastroenterology

location_facility: UF Health Jacksonville Gastroenterology-Emerson

location_facility: Dept of Gastroenterology, Szent Gyorgy Hospital

location_facility: Vilnius University Hospital Santaros Clinics, Center of Hepatology, Gastroenterology and Dietology

location_facility: IRCCS Ospedale San Raffaele Unità di Gastroenterologia

location_facility: Premier Medical Group of the Hudson Valley, PC

location_facility: Kremenchuk first city hospital n.a. O.T. Bohaievskyi

location_facility: Lake Success Gastroenterology, a Division of Pro Healthcare

location_facility: Naugatuck Valley Gastroenterology Consultants

location_facility: University Hospital Antwerp Gastroenterology and Hepatology Department

location_facility: Centro Hospitalar e Universitário de Coimbra E.P.E


title: An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy for Seizures in Patients With Rare Seizure Disorders Such as Epileptic Encephalopathies Including Dravet Syndrome and Lennox-Gastaut Syndrome

summary: This is an international, multicenter, open-label, long-term safety study of ZX008 in subjects with Dravet syndrome, Lennox-Gastaut syndrome or epileptic encephalopathy

lead_sponsor: Zogenix, Inc.

location_country:
Denmark
Poland
Spain
Italy
United Kingdom
Australia
Mexico
Canada
Netherlands
Sweden
United States
France
Belgium
Germany

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej VITAMED

location_facility: CHU Amiens - Hopital Sud - Service pédiatrique

location_facility: Comitato Etico per la Sperimentazione Clinica (CESC) delle Provincie di Verona e Rovigo

location_facility: Epilepsie-zentrum Bethel im Krankenhaus Mara

location_facility: A.O.U Anna Meyer - Clinica di Neurologia Pediatrica

location_facility: Secretaria del CEIC Hospital Ruber Internacional

location_facility: UT Southwestern Medical Center / Children's Medical Center Dallas

location_facility: University Hospitals Cleveland Medical Center Rainbow Clinical Research Center

location_facility: Istituto Gianna Gaslini, Istituto Pediatrico di Ricovero e Cura a Carattere Scientifico

location_facility: Pediatric Epilepsy & Research Center of Central Florida

location_facility: Hopital Robert Debre - Paris - Neuropediatrie Et Maladies Met

location_facility: Universitätsklinikum Jena Kinder - und Jugendklinik

location_facility: CHRU - HÃ´pital Roger Salengro - Neurophysiologie

location_facility: MultiCare Institute for Research & Innovation

location_facility: AOU S.Martino, IRCCS, IST-Istituto Nazionale Ricerca Sul Cancro Di Genova

location_facility: Ann & Robert H Laurie Children's Hospital of Chicago

location_facility: Comitato Etico Val Padana Istituti Ospitalieri Riuniti di Cremona

location_facility: Hôpital Universitaire Des Enfants Reine Fabiola

location_facility: Ospedale Civile Maggiore di Borgo Trento - Ospedale della Donna e del Bambino - UOC Neuropsichiatria Infantile

location_facility: Alder Hey Children's NHS Foundation Trust

location_facility: Policlinico Universitario Agostino Gemelli, Università Cattolica del Sacro Cuore - Neuropsichiatria Infantile

location_facility: Ospedale ASST Grande Ospedale Metropolitano Niguarda

location_facility: Fondazione Irccs Istituto Neurologico Carlo Besta Di Milano

location_facility: Queen Elizabeth University Hospital Glasgow

location_facility: Kleinwachau - Sachsisches Epilepsiezentrum Radeberg

location_facility: Sahlgrenska Universitetssjukhuset - Neurologkliniken

location_facility: Institute of Neurology and Neurosurgery at St. Barnabas

location_facility: Massachusetts General Hospital for Children

location_facility: Great Ormond Street Hospital for Children-Neurology

location_facility: COMITATO ETICO della Fondazione Policlinico Universitario A. Gemelli IRCCS Università Cattolica Sacro Cuore

location_facility: Hospital Civil De Guadalajara Fray Antonio Alcalde

location_facility: IRCCS Ospedale Pediatrico Bambino Gesù, - Dipartimento di Neuroscienze e Neuroriabilitazione

location_facility: HÃ´pital Necker - Enfants Malades - Service de Neurologie Pediatri

location_facility: Borgo Trento, Ospedale Civile Maggiore, AOU Integrata di Ver

location_facility: Skejby Sygehus or Aarhus University Hospital

location_facility: Universitätsklinikum Freiburg Zentrum für Kinder- und Jugendmedizin

location_facility: Universitätsklinikum Schleswig-Holstein Campus Kiel

location_facility: Istituto Neurologica Carlo Besta - UOC Neuropsichiatria Infantile

location_facility: U.O Malattie Neuromuscolari e Neurodegenerative - IRCCS Ospedale Pediatrico Bambino Gesu

location_facility: Clinical Integrative Research Center of Atlanta, Panda Neurology


primary_purpose: Prevention

title: A Phase 3 Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of Letermovir (LET) Prophylaxis When Extended From 100 Days to 200 Days Post-transplant in Cytomegalovirus (CMV) Seropositive Recipients (R+) of an Allogenic Hematopoietic Stem Cell Transplant (HSCT)

location_country:
United Kingdom
Italy
United States
France
Japan
Germany

location_facility: Duke University Medical Center ( Site 0169)

location_facility: ASST Spedali Civili di Brescia ( Site 0052)

location_facility: Freeman Hospital Newcastle upon Tyne Foundation NHS Trust ( Site 0092)

location_facility: Fondazione PTV Policlinico Tor Vergata ( Site 0054)

location_facility: University of Miami, Sylvester Comprehensive Cancer Center ( Site 0160)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 0164)

location_facility: Centre Hospitalier Universitaire Dupuytren ( Site 0182)

location_facility: Queen Elizabeth University Hospital [Glasgow, UK] ( Site 0096)

location_facility: National Hospital Organization Kumamoto Medical Center ( Site 0122)

location_facility: Jichi Medical University Hospital ( Site 0123)

location_facility: The University of Texas MD Anderson Cancer Center ( Site 0154)

location_facility: Universitaetsklinikum Heidelberg-Medizinische Klinik V ( Site 0042)

location_facility: Universitaetsklinikum Muenster ( Site 0043)

location_facility: John Theurer Cancer Center at Hackensack University Med Ctr ( Site 0174)

location_facility: IRCCS Ospedale San Raffaele ( Site 0051)

location_facility: Indiana Blood and Marrow Transplantation ( Site 0175)

location_facility: Policlinico Universitario Agostino Gemelli ( Site 0055)

location_facility: City of Hope National Medical Center ( Site 0158)

location_facility: Fred Hutchinson Cancer Research Center ( Site 0152)

location_facility: Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital ( Site 0121)

location_facility: University of California Davis Medical Center ( Site 0156)

summary: The purpose of this study was to evaluate the safety and efficacy of letermovir (LET) versus placebo when cytomegalovirus (CMV) prophylaxis was extended from 100 days to 200 days post-transplant in CMV seropositive participants who received an allogenic hematopoietic stem cell transplant (HSCT). It was hypothesized that LET is superior to placebo in the prevention of clinically-significant CMV infection when LET prophylaxis is extended from 100 to 200 days.


title: Phase 1b Study of LY3295668 Erbumine Monotherapy in Patients With Platinum-Sensitive, Extensive-Stage Small-Cell Lung Cancer

summary: The purpose of this study is to determine the recommended phase 2 dose of LY3295668 erbumine in participants with platinum-sensitive, extensive-stage small-cell lung cancer.

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:
Spain
United Kingdom
Korea, Republic of
United States
France
Turkey
Belgium
Japan

location_facility: Institut de Cancérologie de l'Ouest Centre René Gauducheau

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Severance Hospital Yonsei University Health System

location_facility: Levine Cancer Institute- Carolinas Medical Center

location_facility: Grand Hopital de Charleroi-Site Notre-Dame

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: Hospital Universitario La Fe de Valencia

location_facility: Dr.Abdurrahman Yurtaslan Ankara Oncology Training & Res Hosp

location_facility: Centre de Lutte Contre le Cancer Leon Berard


title: PROCADE: A Multinational Phase 3, Randomized, Double-Blind, Non-inferiority, Efficacy and Safety Study of Oral HC-1119 Versus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

summary:
This study is a multinational Phase 3, randomized, double-blind, non-inferiority, efficacy and safety study of oral HC-1119 (80 mg/day) versus enzalutamide (160 mg/day) in asymptomatic or mildly symptomatic patients with progressive metastatic castration-resistant prostate cancer (mCRPC).

The following assessment of prostate cancer status will be collected during the course of the trial: soft tissue disease on computed tomography (CT) scan or on magnetic resonance imaging (MRI), bone disease on radionuclide bone scans, FACT-P and EQ-5D, Brief Fatigue Inventory, and PSA.

Throughout the study, safety and tolerability will be assessed by the recording of adverse events, monitoring of vital signs and physical examinations, safety laboratory evaluations, and 12-lead electrocardiograms (ECGs). Blood samples for population pharmacokinetics for HC-1119 and enzalutamide and related metabolites will be collected.

lead_sponsor: Hinova Pharmaceuticals USA, Inc.

location_country:
Denmark
Poland
Spain
Italy
Austria
Australia
Netherlands
Canada
Finland
Russian Federation
United Kingdom
United States
France
Germany

location_facility: Urologica Praktyka Lekarska Adam Marcheluk

location_facility: Hospital Regional Universitario de Malaga - Hospital Civil

location_facility: Urology San Antonio Stone Oak, 18915 Meisner Drive

location_facility: Hospital Universitario Virgen del Rocio - PPDS

location_facility: First St. Petersburg State Medical University n.a. I.P Pavlov

location_facility: First Urology PSC, 101 Hospital Boulevard

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

location_facility: Hopital d'Instruction des Armées de Begin

location_facility: Helsinki University Hospital Comprehensive Cancer Center - PPDS

location_facility: Federal State Institution Medical Radiology Research Center

location_facility: Urology Center of Colorado, 2777 Mile High Stadium Circle

location_facility: Fundacion Instituto Valenciano de Oncologia

location_facility: Centre Jean Bernard Clinique Victor Hugo

location_facility: Clinical Research Center Spolka z Ograniczona

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

location_facility: Azienda Ospedaliera Universitaria Integrata Di Verona


title: A Phase Ib/II, Open-Label Study of M7824 in Combination With Chemotherapy in Participants With Stage IV Non-small Cell Lung Cancer

summary: The main purpose of the study is to evaluate the safety and tolerability of M7824 in combination with chemotherapy.

ReferenceType: derived

ReferenceCitation: Vugmeyster Y, Grisic AM, Wilkins JJ, Loos AH, Hallwachs R, Osada M, Venkatakrishnan K, Khandelwal A. Model-informed approach for risk management of bleeding toxicities for bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1. Cancer Chemother Pharmacol. 2022 Oct;90(4):369-379. doi: 10.1007/s00280-022-04468-6. Epub 2022 Sep 6.

ipd_sharing_description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

lead_sponsor: EMD Serono Research & Development Institute, Inc.

location_country:
United States
France
Belgium

location_facility: Baptist Health Lexington Oncology Associates

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

location_facility: Universitair Ziekenhuis Brussel - Geriatrie

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

location_facility: Hôpital de la Timone# - CPCEM CIC - Bat F 1er étage

location_facility: CHU Poitiers - Hôpital la Milétrie - service d'oncologie médicale

location_facility: University of Maryland - DUPLICATE/Pediatric Surgery

location_facility: Centre Georges François Leclerc - Unité de Phase I

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

location_facility: Hematology - Oncology Associates of Treasure Coast - Hematology-Oncology Associates of Treasure Coast

location_facility: Universitair Ziekenhuis Gent - Medical Oncology


status: Terminated

acronym: The FUZE Clinical Trial

title: A Phase II Basket Study of the Oral Selective Pan-FGFR Inhibitor Debio 1347 in Subjects With Solid Tumors Harboring a Fusion of FGFR1, FGFR2 or FGFR3

lead_sponsor: Debiopharm International SA

location_country:
Croatia
Spain
United Kingdom
Ukraine
United States
Romania
Philippines
Czechia
Poland
Austria
Australia
Russian Federation
Norway
Singapore
Brazil
Bulgaria
Denmark
Taiwan
Greece
Finland
Korea, Republic of
France
Netherlands

location_facility: LKH - Universitätsklinikum der PMU Salzburg

location_facility: Seoul National University Hospital (SNUH)

location_facility: University of North Carolina at Chapel Hill

location_facility: St. Luke's Medical Center, Human Cancer Biobank Research Center

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

location_facility: Taipei Veterans General Hospital, Medical Science & Technology Building

location_facility: SI V.T. Zaycev Institute of general & urgent surgery of National academy medical sciences of Ukraine, Department of purulent surgery

location_facility: Cebu Doctors' University Hospital (CDUH), Research Office

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Taipei Medical University Hospital (TMUH)

location_facility: Communal Non-profit Enterprise Regional Center of Oncology

location_facility: Ajou University Hospital, CRC room, Clinical Trial Center

location_facility: The Catholic University of Korea, St. Vincent's Hospital, CRC Room, 3F

location_facility: FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"

location_facility: Complex Oncological Center - Plovdiv, EOOD

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

location_facility: Philippine General Hospital, Clinical Trial Unit Room 5, Medical Research Laboratory

location_facility: Seoul National University Bundang Hospital, Department of Oncology Medical office

location_facility: Linear Clinical Research, B Block Sir Charles Gairdner Hospital

location_facility: H. Lee Moffitt Cancer Center and Research Institute, Inc

location_facility: University Hospital Centre, Sestre Milosrdnice

location_facility: Ironwood Cancer & Research Centers - Scottsdale

location_facility: BHI of Omsk region "Clinical Oncology Dispensary"

location_facility: General Hospital of Athens of Chest Diseases "SOTIRIA"

location_facility: ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira, Avenida Doutor Arnaldo

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

location_facility: Taichung Veterans General Hospital, The Radiation Oncology Department

location_facility: CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU

location_facility: TSBHI "Altai Territorial oncological dispensary"

location_facility: SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"

location_facility: Gachon University Gil Medical Center, CRC Room, 18F, Artificial intelligence hospital

location_facility: Tan Tock Seng Hospital, Communicable Disease Centre

location_facility: CHU Bordeaux - Hôpital Saint André, Groupe Hospitalier Sud - Hôpital Haut-Lévêque

location_facility: The Ohio State University Wexner Medical Center - James Cancer Hospital

location_facility: Groupe Hospitalier Sud - Hôpital Haut Lévêque

location_facility: Hospital de Caridade de Ijuí, Avenida David J Martins

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

summary: The primary objective of this study is to assess the efficacy of Debio 1347 in terms of objective response rate (ORR) in participants with solid tumors harboring fibroblast growth factor receptor (FGFR)1-3 gene fusion/rearrangement.


title: A Prospective, Randomized, Double-Blind Comparison of LY900014 to Humalog in Adults With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion

location_country:
Spain
Italy
Austria
Australia
Canada
Hungary
Puerto Rico
United States
France
Israel
Germany

location_facility: Rocky Mountain Diabetes and Osteoporosis Center

location_facility: Southern New Hampshire Diabetes and Endocrinology

location_facility: John Muir Physician Network Clinical Research Center

location_facility: Tacoma Center for Arthritis Research, PS

location_facility: Dip.to Med. Sperimentale -Polic.Umberto I -Univ. La Sapienza

location_facility: Prairie Education and Research Cooperative

location_facility: Texas Diabetes and Endocrinology-Austin South

location_facility: Centro de Endocrinologia Alcantara Gonzalez

location_facility: Soroka Medical Center - Pediatric Outpatient Clinic

location_facility: Diabetologische Schwerpunktpraxis B. Scholz/Dr. B. Paschen

location_facility: Gemeinschaftspraxis für innere Medizin und Diabetologie

location_facility: Center of Excellence in Diabetes & Endocrinology

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Northwestern Feinberg School of Medicine

location_facility: Groupe hospitalier mutualiste Les Portes du sud

location_facility: Barbara Davis Center for Childhood Diabetes

location_facility: Centre hospitalier universitaire Lapeyronie

location_facility: Institut für Diabetesforschung Münster GmbH

summary: The reason for this study is to compare the study drug LY900014 to insulin lispro (Humalog) when both are used in insulin pump therapy in adults with type 1 diabetes (T1D).


title: A Randomized, Subject and Investigator Blinded, Placebo-controlled and Multi-center Platform Study, to Assess Efficacy and Safety of Different Investigational Drugs in Patients With Moderate to Severe Hidradenitis Suppurativa

summary: The main purpose of this study is to assess preliminary efficacy and safety of CFZ533, LYS006, MAS825 and LOU064 in patients with moderate to severe hidradenitis suppurativa and to determine if CFZ533, LYS006, MAS825 and LOU064 have an adequate clinical profile for further clinical development.

ipd_sharing: Undecided

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

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

location_country:
Denmark
Spain
Austria
Netherlands
Hungary
United States
France
Belgium
Iceland
Germany
Czechia


title: GAIN Trial: A Randomized, Double-Blind, Placebo-Controlled Study of COR388 in Subjects With Alzheimer's Disease

summary: This is a randomized, double-blind, placebo-controlled study that will assess the efficacy, safety, and tolerability of 2 dose levels of COR388 in subjects with a clinical diagnosis of mild to moderate AD dementia.

lead_sponsor: Cortexyme Inc.

location_country:
Poland
Spain
United Kingdom
United States
France
Netherlands

location_facility: Northeastern Pennsylvania Memory and Alzheimer's Center

location_facility: Neurology Specialists of Monmouth County

location_facility: Hospital Universitari General de Catalunya

location_facility: Isala Zwolle - Interne geneeskunde Centrum voor ouderengeneeskunde

location_facility: Anil Nair MD, Alzheimer's Disease Center

location_facility: Hôpitaux Universitaires de Strasbourg, Centre d'Investigation Clinique, Hôpital Hautepierre

location_facility: Houston Methodist Department of Neurology

location_facility: Alzheimer's Research and Treatment Center

location_facility: CHRU de Nancy Hôpital de Brabois Service de Gériatrie

location_facility: Cognition Health Ltd. (private) Guildford

location_facility: ANI Neurology, PLLC dba Alzheimer's Memory Center

location_facility: Disease Research & Neurology Center of Neurological Associates of Albany

location_facility: Brain Matters Research at the Kane Center

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska

location_facility: Neuropsychiatric Research Center of Southwest Florida

location_facility: Memory Assessment and Research Centre, Moorgreen Hospital

location_facility: The Cognitive Research Center of New Jersey

location_facility: NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS

location_facility: Cleveland Clinic Lou Ruvo Center for Brain Health

location_facility: RICE - The Research Institute for the Care of Older People

location_facility: University Hospital La Timone, Department of Neurology and Neuropsychology

location_facility: Memory Health Center at Summit Research Network

location_facility: NZOZ Wrocławskie Centrum Alzheimerowskie

location_facility: Hospital Universitario Marqués de Valdecilla


title: A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)

summary: The purpose of this study is to evaluate the efficacy and safety of pemigatinib in participants with previously treated locally advanced/metastatic or surgically unresectable solid tumor malignancies harboring activating FGFR mutations or translocations.

ipd_sharing_description:
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a 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.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

lead_sponsor: Incyte Corporation

location_country:
Denmark
Spain
Italy
United Kingdom
Switzerland
Korea, Republic of
United States
Israel
France
Japan
Germany

location_facility: Virginia Oncology Associates-Lake Wright

location_facility: Centro Integral Oncologico Clara Campal (Ciocc)

location_facility: Centro Ricerche Cliniche Di Verona (Crc)

location_facility: Institut Universitaire Du Cancer de Toulouse Oncopole

location_facility: Chao Family Comprehensive Cancer Center University of California, Irvine

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Hospital Universitario Y Politcnico de La Fe

location_facility: Istituto Nazionale Tumori Irccs Fondazione Pascale

location_facility: L AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA POLICLINICO S. ORSOLA ï¿½ MALPIGHI

location_facility: Cancer Institute of Greenville Health System

location_facility: Imperial College Healthcare Nhs Trust - Hammersmith Hospital

location_facility: Hospital General Universitario Vall D Hebron

location_facility: Fondazione Irccs Istituto Nazionale Dei Tumori

location_facility: Multicare Institute For Research & Innovation

location_facility: University Medical Centre Hamburg-Eppendorf, Centre of Oncology

location_facility: University College London Hospitals (Uclh)

location_facility: Hadassah Hebrew University Medical Center Ein Karem Hadassah

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Fondazione Del Piemonte Per L Oncologia Ircc Candiolo

location_facility: Istituto Nazionale Tumori Regina Elena Irccs

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Seoul National University Bundang Hospital

location_facility: Hospital Regional Universitario de Malaga

location_facility: Florida Cancer Specialists & Research Institute

location_facility: Severance Hospital Yonsei University Health System

location_facility: Indiana University Health - Arnett Cancer Care

location_facility: University of Wisconsin Carbone Cancer Center

location_facility: University of Texas Southwestern Medical Center


title: A Randomized, Observer-blind, First-in-Human Phase 1/2a Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health

summary: The purpose of this study is to assess the safety, reactogenicity, and immunogenicity of 3 different doses of ExPEC10V and to select the optimal dose for further clinical development (Cohort 1). Cohort 2 is aimed to expand the dataset supporting the short- and long-term safety and immunogenicity of the optimal dose of ExPEC10V, selected from the primary analysis results of Cohort 1. Cohort 2 will include participants in stable health with a history of urinary tract infection (UTI) in the past 5 years and will be included in the study to support the plan for late stage development of ExPEC vaccine.

primary_purpose: Other

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:
Spain
United States
France
Belgium
Netherlands

location_facility:
Hosp. Univ. Marques de Valdecilla
Hosp. Del Mar
Chu Rennes - Hopital Pontchaillou
APHP - Hopital Bichat - Claude Bernard
Hosp. Univ. La Paz
Synexus Clinical Research US, Inc
Johnson County Clin-Trials
Hosp. Virgen Macarena
Coastal Carolina Research Center
ATC Pharma
Hosp. Univ. de La Princesa
Rochester Clinical Research, Inc
Anima
Qps-Mra, Llc
Hosp. Reina Sofia
PRA Health Sciences
Optimal Research
CHU Nantes
Hopital Cochin
CHU Lyon Sud
CHRU Tours Hôpital Bretonneau
EB Flevo Research
Clinical Pharmacology Unit


acronym: Pembrolizumab plus lenvatinib as second-line plus intervention for select solid tumors

title: A Multicenter, Open-label Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects With Selected Solid Tumors (LEAP-005)

location_country:
Taiwan
Spain
Italy
Russian Federation
Australia
United Kingdom
Argentina
Canada
Switzerland
Thailand
Korea, Republic of
United States
Chile
France
Israel
Colombia
Germany

location_facility: Pontificia Universidad Catolica de Chile ( Site 1202)

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1603)

location_facility: Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0402)

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0023)

location_facility: Sir Charles Gairdner Hospital ( Site 0903)

location_facility: Fundacion Favaloro para la Docencia e Investigacion Medica ( Site 2106)

location_facility: Rutgers Cancer Institute of New Jersey ( Site 0009)

location_facility: Policlinico Le Scotte - A.O. Senese ( Site 1401)

location_facility: National Taiwan University Hospital ( Site 3000)

location_facility: Clinica Universitaria de Navarra ( Site 0704)

location_facility: City Clinical Oncology Center ( Site 1608)

location_facility: Hopitaux Universitaires de Geneve HUG ( Site 1701)

location_facility: Leningrad Regional Oncology Center ( Site 1609)

location_facility: University of Colorado, Anschutz Cancer Pavilion ( Site 0007)

location_facility: Inselspital Universitaetsspital Bern ( Site 1705)

location_facility: Hadassah Ein Kerem Medical Center ( Site 0604)

location_facility: Instituto de Oncologia de Rosario ( Site 2105)

location_facility: Sanford Fargo Medical Center ( Site 0059)

location_facility: Seoul National University Hospital ( Site 1000)

location_facility: Royal Brisbane and Women s Hospital ( Site 0901)

location_facility: HELIOS Dr. Horst Schmidt Kliniken Wiesbaden ( Site 0301)

location_facility: Istituto Clinico Humanitas Research Hospital ( Site 1402)

location_facility: Hospital Universitario Gregorio Maranon ( Site 0701)

location_facility: Hospital Clinico Universidad de Chile ( Site 1200)

location_facility: Istituto Nazionale Tumori Fondazione Pascale ( Site 1400)

location_facility: West Cancer Center - East Campus ( Site 0018)

location_facility: Severance Hospital Yonsei University Health System ( Site 1001)

location_facility: Christie NHS Foundation Trust ( Site 0805)

location_facility: Fondazione Policlinico Universitario A. Gemelli ( Site 1403)

location_facility: University of Wisconsin Carbone Cancer Center ( Site 0017)

location_facility: Leicester Royal Infirmary. Univ. Hosp. of Leicester NHS Trust ( Site 0804)

location_facility: Oncologos del Occidente S.A. ( Site 1106)

location_facility: Lehigh Valley Hospital- Cedar Crest ( Site 0047)

location_facility: Hospital Britanico de Buenos Aires ( Site 2109)

location_facility: Cedars Sinai Medical Center ( Site 0003)

location_facility: Hospital Clinic i Provincial ( Site 0703)

location_facility: National Cheng Kung University Hospital ( Site 3003)

location_facility: Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0208)

location_facility: Fundacion Arturo Lopez Perez ( Site 1201)

location_facility: Fundacion Colombiana de Cancerologia Clinica Vida ( Site 1105)

location_facility: Sunnybrook Research Institute ( Site 0207)

location_facility: Cambridge University Hospitals NHS Trust ( Site 0803)

location_facility: SRH Wald-Klinikum Gera GmbH ( Site 0309)

location_facility: Mary Crowley Cancer Research Centers - Medical City Hospital ( Site 0049)

location_facility: Princess Margaret Cancer Centre ( Site 0202)

location_facility: CHU de Quebec Universite de Laval ( Site 0206)

location_facility: Centro Investigación del Cáncer James Lind ( Site 1203)

location_facility: Royal Marsden Hospital (Sutton) ( Site 0800)

location_facility: Universitaetsklinikum Regensburg ( Site 0304)

location_facility: University of Florida-Health Cancer Center-Orlando ( Site 0015)

location_facility: Ospedale Regionale di Bellinzona e Valli ( Site 1703)

location_facility: Universitaetsklinikum Frankfurt ( Site 0306)

location_facility: University of California Davis Comprehensive Cancer Center ( Site 0005)

location_facility: Institut Claudius Regaud IUCT Oncopole ( Site 0403)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1610)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0210)

location_facility: Russian Oncological Research Center n.a. N.N. Blokhin ( Site 1604)

location_facility: Instituto Nacional de Cancerologia E.S.E ( Site 1102)

location_facility: IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 2101)

location_facility: Arkhangelsk Clinical Oncological Dispensary ( Site 1600)

summary: The purpose of this study is to determine the safety and efficacy of combination therapy with pembrolizumab (MK-3475) and lenvatinib (E7080/MK-7902) in participants with triple negative breast cancer (TNBC), ovarian cancer, gastric cancer, colorectal cancer (CRC), glioblastoma (GBM), biliary tract cancers (BTC), or pancreatic cancer.


acronym: ZEPHYR

title: A Phase 2b/3 Study to Evaluate the Safety, Tolerability, and Effects of Livoletide (AZP-531), an Unacylated Ghrelin Analogue, on Food-related Behaviors in Patients With Prader-Willi Syndrome

lead_sponsor: Millendo Therapeutics SAS

location_country:
Spain
Italy
United Kingdom
Australia
United States
France
Belgium
Netherlands

location_facility: Corporacio Sanitaria Parc Tauli - Hospital de Sabadell

location_facility: Children's Hospitals and Clinics of Minnesota-Minneapolis

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Hospital General Universitario de Alicante

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: University of California - Irvine Medical Center

location_facility: University of Texas Southwestern Medical Center

location_facility: New York Presbyterian Morgan Stanley Children's Hospital

summary: This Phase 2b/3 double-blind, placebo-controlled study will evaluate the safety, tolerability, and effects of livoletide on food-related behaviors in patients with Prader-Willi Syndrome (PWS).


title: A Phase 1b/2, Open-Label Study Evaluating the Safety and Efficacy of KRT-232 in Patients With p53 Wild-Type (p53WT) Merkel Cell Carcinoma (MCC) Who Have Failed Anti-PD-1 or Anti-PD-L1 Immunotherapy, or in Combination With Avelumab in MCC Patients Who Are Anti-PD-1 or Anti-PD-L1 Treatment Naïve

summary: This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with Merkel Cell Carcinoma (MCC) who have failed treatment with at least one anti-PD-1 or anti-PD-L1 immunotherapy or in combination with avelumab in MCC patients who are anti-PD-1 or anti-PD-L1 treatment naïve. Inhibition of MDM2 is a novel mechanism of action in MCC.

lead_sponsor: Kartos Therapeutics, Inc.

location_country:
Spain
Italy
Australia
Korea, Republic of
United States
France
Germany

location_facility: University of Colorado Anschutz Medical Campus

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale

location_facility: Vivantes Network for Health Gmb, Neukölln Clinic

location_facility: Hôpital de la Timone. Aix-Marseille Université

location_facility: Fundacio Investigao Hospital General Universitario de Valencia

location_facility: Severance Hospital Yonsei University Health System

location_facility: Nationales Centrum für Tumorerkrankungen NCT

location_facility: Hospital General Universitario Gregorio Marañn (Madrid)


title: A Phase 2, Single-Arm Study of Bempegaldesleukin (NKTR-214) in Combination With Nivolumab in Cisplatin Ineligible, Locally Advanced or Metastatic Urothelial Cancer Patients

lead_sponsor: Nektar Therapeutics

location_country:
Portugal
Spain
Greece
Italy
Australia
Mexico
Argentina
Canada
Finland
Netherlands
Russian Federation
United States
France
Israel
Turkey
Belgium
United Kingdom
Germany

location_facility: Centro Hospitalar E Universitário de Coimbra EPE

location_facility: Ankara University Medical Faculty - PPDS

location_facility: Instituto Médico Especializado Alexander Fleming

location_facility: Hospital Universitario HM Sanchinarro - CIOCC

location_facility: Hospital Universitario Virgen del Rocio - PPDS

location_facility: San Francisco VA Medical Center - NAVREF - PPDS

location_facility: Health Pharma Professional Research S.A de C.V.

location_facility: CAIPO Centro para la atención integral del paciente oncológico

location_facility: Innovative Clinical Research Institute, LLC

location_facility: Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS

location_facility: Helsingin Yliopistollinen Keskussairaala - PPDS

location_facility: Federal State Institution Medical Radiology Research Center

location_facility: Winship Cancer Institute, Emory University

location_facility: Hôpital Privé TOULON/HYERES Sainte Marguerite

location_facility: Laura And Isaac Perlmutter Cancer Center

location_facility: Fundacion Instituto Valenciano de Oncologia

location_facility: Centre Jean Bernard Clinique Victor Hugo

location_facility: Centro de Investigación Clínica - Clínica Viedma

location_facility: Sanatorio Privado Duarte Quirós, de Clínica Colombo S.A.

location_facility: Inonu University Faculty of Medicine Turgut Ozal Medical Center

location_facility: Phylasis Clinicas Research S. de R.L. de C.V.

location_facility: Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

location_facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Southeastern Regional Medical Center - CTCA - PPDS

summary: The main purpose of this study is to evaluate the anti-tumor activity of bempegaldesleukin (NKTR-214) in combination with nivolumab by assessing the objective response rate (ORR) in cisplatin ineligible, locally advanced or metastatic urothelial cancer patients.


title: A Phase II Study Assessing the Efficacy of Osimertinib in Combination With Savolitinib in Patients With EGFRm+ and MET+, Locally Advanced or Metastatic Non Small Cell Lung Cancer Who Have Progressed Following Treatment With Osimertinib.

acronym: SAVANNAH

summary: This study (the SAVANNAH study) will investigate the efficacy of osimertinib in combination with savolitinib in patients with EGFRm+ and MET+, locally advanced or metastatic NSCLC who have progressed following treatment with osimertinib

ReferenceCitation: Schmid S, Früh M, Peters S. Targeting MET in EGFR resistance in non-small-cell lung cancer-ready for daily practice? Lancet Oncol. 2020 Mar;21(3):320-322. doi: 10.1016/S1470-2045(19)30859-9. Epub 2020 Feb 3.

lead_sponsor: AstraZeneca

location_country:
Denmark
Taiwan
Brazil
Spain
Italy
Canada
Vietnam
Korea, Republic of
United States
Chile
France
India
Puerto Rico
Japan


title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Clinical Study Comparing the Efficacy and Safety of Tislelizumab (BGB-A317) Plus Platinum and Fluoropyrimidine Versus Placebo Plus Platinum and Fluoropyrimidine as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

lead_sponsor: BeiGene

location_country:
Poland
Taiwan
Spain
Italy
Russian Federation
United Kingdom
Korea, Republic of
United States
France
China
Puerto Rico
Turkey
Japan

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: The First Affiliated Hospital of Bengbu Medical College

location_facility: Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital

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

location_facility: Chonnam National University Hwasun Hospital

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

location_facility: Hiroshima City Hiroshima Citizens Hospita

location_facility: Tianjin Medical University General Hospital

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

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

location_facility: SBIH of Yaroslavl region "Regional Clinical Oncological Hospital"

location_facility: Hospital Universitario HM Madrid Sanchinarro

location_facility: Hamamatsu University School of Medicine, University Hospital

location_facility: The First Hospital of Lanzhou University

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: The First Affiliated Hospital of Fujian Medical University

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: General Hospital of Shenyang Military Region

location_facility: SBIH " Volgograd Regional Clinical Oncological Dispensary # 1"

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

location_facility: Harbin Medical University Cancer Hospital

location_facility: Thomas Jefferson University Hospital - Central

location_facility: The Second Affiliated Hospital of Nanchang University

location_facility: The Affiliated Drum Tower Hospital of Nanjing University

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Chinese PLA General Hospital Medical School of Chinese PLA

location_facility: Osaka Medical and Pharmaceutical University Hospital

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

location_facility: University of California Davis Health System

location_facility: Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna

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

location_facility: The Second Hospital of Anhui Medical University

location_facility: Private Educational Institution of Higher Education "Medical University "REAVIZ"

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Center Hospital of the National Center for Global Health and Medicine

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: Saitama Medical University International Medical Center

location_facility: BHI of Omsk region "Clinical Oncology Dispensary"

location_facility: FSBI "Clinical Research and Practical Center for specialized medical care (oncology)"

location_facility: The First Hospital of China Medical University

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: The First Affiliated Hospital of Zhengzhou University

location_facility: Ruijin Hospital, Shanghai Jiaotong Uni. School of Med.

location_facility: The Affiliated Hospital of Qingdao University

location_facility: Fourth Hospital of Hebei Medical University

location_facility: SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"

location_facility: Seoul National University Bundang Hospital

location_facility: The First Affiliated Hospital of Guilin Medical University

location_facility: Hospital Regional Universitario de Malaga

location_facility: Osaka International Cancer Institute - Clinical Oncology

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: Daping Hospital of The 3rd Military University

location_facility: RBIH "Ivanovo Regional Oncological Dispensary"

location_facility: Xiangya Hospital Central South University

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

location_facility: Beijing Friendship Hospital, Capital Medical University

summary: This is a randomized (1:1), double-blind, placebo-controlled, Phase 3 study designed to compare the efficacy and safety of tislelizumab or placebo plus chemotherapy as first-line (1L) therapy for locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.


title: A Multicenter, Open Label Single-Arm, Phase 2 Study of Zandelisib (ME-401) in Subjects With Follicular Lymphoma and Marginal Zone Lymphoma After Failure of Two or More Prior Systemic Therapies (The TIDAL Study)

lead_sponsor: MEI Pharma, Inc.

location_country:
Poland
Taiwan
Spain
Italy
Austria
Australia
New Zealand
United Kingdom
Switzerland
Korea, Republic of
United States
France
Belgium
Germany

location_facility: Investigative Clinical Research of Indiana LLC

location_facility: IRCCS Regina Elena National Cancer Institute

location_facility: Centre Hospitalier Universitaire (CHU) de Poitiers - Hôpital de la Miletrie

location_facility: Centro di Riferimento Oncologico di Aviano (CRO) IRCCS

location_facility: Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku

location_facility: C H de la Cote Basque, Service d'Hematologie

location_facility: Norfolk and Norwich University Hospital NHS Foundation Trust

location_facility: The Oncology Institute of Hope and Innovation

location_facility: Lewisham and Greenwich University Hospital Lewisham

location_facility: National Taiwan University Hospital NTUH

location_facility: Peninsula and South Eastern Haematology and Oncology Group

location_facility: Hospital Universitario Quiron Salud Madrid

location_facility: Belfast Health and Social Care Trust - Belfast City Hospital

location_facility: University of Wisconsin Carbone Cancer Center

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

location_facility: Centre for Haematology, Imperial College London

location_facility: North Wales Cancer Treatment Centre, Glan Clwyd Hospital

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori I.R.S.T.

summary: This is the study of the PI3Kδ inhibitor Zandelisib (ME-401) in subjects with relapsed/refractory follicular lymphoma or marginal zone lymphoma after failure of at least 2 prior lines of systemic therapy


title: Open-label, Multicentre, Phase Ib Dose-escalation Study of MEN1611, a PI3K Inhibitor Combined With Trastuzumab With or Without Fulvestrant, in Subjects With PIK3CA Mutated HER2 Positive Locally Recurrent Unresectable (Advanced) or Metastatic (a/m) Breast Cancer Progressed to Anti-HER2 Based Therapy

summary: The main purpose of this open-label, dose-escalation, phase Ib study is to identify the appropriate dose of MEN1611 to be used in combination with Trastuzumab with/without Fulvestrant for the treatment of advanced or metastatic HER2-positive breast cancer

lead_sponsor: Menarini Group

location_country:
Spain
Italy
United Kingdom
United States
France
Belgium

location_facility: Azienda Ospedaliero Universitaria Mater Domini

location_facility: Hospital Clínico Universitario Virgen de la Victoria

location_facility: Hospital Clínic i Provincial de Barcelona

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Institut Régional du Cancer de Montpellier


title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Oral BTK Inhibitor Rilzabrutinib (PRN1008) in Moderate to Severe Pemphigus

lead_sponsor: Principia Biopharma, a Sanofi Company

location_country:
Croatia
Poland
Brazil
Serbia
Spain
Greece
Italy
Australia
Taiwan
Argentina
Canada
United Kingdom
Ukraine
United States
France
Israel
Turkey
Germany
Bulgaria

location_facility: Central Recruiting (Principia Biopharma)

summary: This was a Phase 3 randomized, parallel-group, double-blind, placebo-controlled trial (blinded treatment [BT] period) followed by an open-label extension [OLE] period intended to evaluate the efficacy and safety of oral PRN1008 in moderate to severe pemphigus. After completing the open-label extension period, eligible participants might continue in a long term extension (LTE) Period of 48 weeks.