title: A Phase 1 / 2 Open Label, Multi-Arm, Multicenter Study of MK-1308 in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

summary: This study will assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of escalating doses of quavonlimab when used in combination with pembrolizumab in participants with advanced solid tumors.

ReferenceType: result

ReferenceCitation: Perets R, Bar J, Rasco DW, Ahn MJ, Yoh K, Kim DW, Nagrial A, Satouchi M, Lee DH, Spigel DR, Kotasek D, Gutierrez M, Niu J, Siddiqi S, Li X, Cyrus J, Chackerian A, Chain A, Altura RA, Cho BC. Safety and efficacy of quavonlimab, a novel anti-CTLA-4 antibody (MK-1308), in combination with pembrolizumab in first-line advanced non-small-cell lung cancer. Ann Oncol. 2021 Mar;32(3):395-403. doi: 10.1016/j.annonc.2020.11.020. Epub 2020 Dec 2.

family: Perets

full_name: R. Perets

given: R.

family: Bar

full_name: J. Bar

given: J.

family: Rasco

full_name: D.W. Rasco

family: Ahn

full_name: M.-J. Ahn

family: Yoh

full_name: K. Yoh

given: K.

family: Kim

full_name: D.-W. Kim

family: Nagrial

full_name: A. Nagrial

given: A.

family: Satouchi

full_name: M. Satouchi

given: M.

family: Lee

full_name: D.H. Lee

family: Spigel

full_name: D.R. Spigel

family: Kotasek

full_name: D. Kotasek

given: D.

family: Gutierrez

full_name: M. Gutierrez

family: Niu

full_name: J. Niu

family: Siddiqi

full_name: S. Siddiqi

given: S.

family: Li

full_name: X. Li

given: X.

family: Cyrus

full_name: J. Cyrus

family: Chackerian

full_name: A. Chackerian

family: Chain

full_name: A. Chain

family: Altura

full_name: R.A. Altura

family: Cho

full_name: B.C. Cho

journal_name: Annals of Oncology

ReferenceCitation: Cho BC, Yoh K, Perets R, Nagrial A, Spigel DR, Gutierrez M, Kim DW, Kotasek D, Rasco D, Niu J, Satouchi M, Ahn MJ, Lee DH, Maurice-Dror C, Siddiqi S, Ren Y, Altura RA, Bar J. Anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody quavonlimab in combination with pembrolizumab: Safety and efficacy from a phase I study in previously treated extensive-stage small cell lung cancer. Lung Cancer. 2021 Sep;159:162-170. doi: 10.1016/j.lungcan.2021.07.009. Epub 2021 Jul 18.

title: Anti–cytotoxic T-lymphocyte–associated antigen-4 monoclonal antibody quavonlimab in combination with pembrolizumab: Safety and efficacy from a phase I study in previously treated extensive-stage small cell lung cancer

location_country:
Italy
United States
Chile
South Africa
Sweden
Spain
France
Japan
Greece
Israel
Poland
Australia
New Zealand
China
Canada
Korea, Republic of

location_facility: Fundacion Arturo Lopez Perez ( Site 5601)

location_facility: Seoul National University Hospital ( Site 0007)

location_facility: Melanoma Institute Australia ( Site 0017)

location_facility: Hospital General Universitario de Valencia ( Site 3404)

location_facility: CH Lyon Sud Hospices Civils de Lyon ( Site 3307)

location_facility: Princess Margaret Cancer Centre ( Site 1104)

location_facility: Severance Hospital Yonsei University Health System ( Site 0008)

location_facility: Beijing Cancer hospital-Digestive Oncology ( Site 5001)

location_facility: National Cancer Center Hospital East ( Site 0014)

location_facility: Banner MD Anderson Cancer Center ( Site 0013)

location_facility: John Theurer Cancer Center at Hackensack University Medical Center ( Site 0005)

location_facility: Blacktown Hospital. Western Sydney local health district ( Site 0009)

location_facility: Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 3403)

location_facility: Hospital Clinic i Provincial de Barcelona ( Site 3401)

location_facility: Ashford Cancer Centre Research ( Site 0012)

location_facility: Policlinico Le Scotte - A.O. Senese ( Site 3907)

location_facility: Cape Town Oncology Trials Pty Ltd ( Site 2704)

location_facility: Canterbury District Health Board ( Site 0023)

location_facility: Sir Run Run Shaw Hospital-Medical Oncology ( Site 5003)

location_facility: Cancercare Rondebosch Oncology ( Site 2706)

location_facility: IRCCS Istituto Oncologico Veneto ( Site 3905)

location_facility: Istituto Nazionale Tumori Fondazione Pascale ( Site 3903)

location_facility: Hadassah Ein Karem Hebrew University Medical Center ( Site 0021)

location_facility: Szpital Kliniczny im. Heliodora Swiecickiego Uniwers Medyczn ( Site 4803)

location_facility: Hospital Universitario Virgen de la Macarena ( Site 3402)

location_facility: McGill University Health Centre ( Site 1101)

location_facility: South Texas Accelerated Research Therapeutics, LLC (START) ( Site 0001)

location_facility: Onkologikoa - Instituto Oncologico de San Sebastian ( Site 3405)

location_facility: Regional General Hospital of Athens "Laiko" ( Site 3001)

location_facility: Inova Schar Cancer Institute ( Site 1001)

location_facility: Chongqing Cancer Hospital-Phase 1 Unite ( Site 5004)

location_facility: CHRU Lille - Hopital Claude Huriez ( Site 3302)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 4801

location_facility: Sheba Medical Center - Cancer Center ( Site 0002)

location_facility: Tennessee Oncology Nashville ( Site 0004)

location_facility: Cairns and Hinterland Hospital and Health Service ( Site 0020)

location_facility: Sunnybrook Research Institute ( Site 1103)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 1102)

location_facility: Gallipoli Medical Research Foundation-GMRF CTU ( Site 0019)

location_facility: Sandton Oncology Medical Group PTY LTD ( Site 2701)

location_facility: Skanes Universitetssjukhus Lund. ( Site 4601)


intervention_type: Drug

status: Recruiting

study_start_date_type: Actual

study_type: Interventional

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://www.clinicalstudydatarequest.com/

lead_sponsor: Bioverativ, a Sanofi company

enrollment_type: Anticipated

primary_purpose: Treatment

location_country:
United States
Sweden
Switzerland
Netherlands
Germany
France
Ireland
Belgium
Australia
Spain
Turkey
Canada
United Kingdom
Taiwan

acronym: XTEND-Kids

location_facility:
Investigational Site Number 8400012
Investigational Site Number 8400003
Investigational Site Number 1240001
Investigational Site Number 8400008
Investigational Site Number 2500002
Investigational Site Number 8400001
Investigational Site Number 7240002
Investigational Site Number 1240002
Investigational Site Number 2500003
Investigational Site Number 7520001
Investigational Site Number 7560001
Investigational Site Number 1580004
Investigational Site Number 7920001
Investigational Site Number 1240004
Investigational Site Number 2760001
Investigational Site Number 1580003
Investigational Site Number 2500001
Investigational Site Number 0360001
Investigational Site Number 2500004
Investigational Site Number 2760002
Investigational Site Number 3720001
Investigational Site Number 0560001
Investigational Site Number 5280002
Investigational Site Number 8400002
Investigational Site Number 1240003
Investigational Site Number 0560002
Investigational Site Number 7240001
Investigational Site Number 8260001
Investigational Site Number 8400015
Investigational Site Number 1580001
Investigational Site Number 0360002

ipd_sharing: Yes

study_completion_date_type: Anticipated

type: EudraCT Number

type: Other Identifier

source: euctr

title: A Phase 3 Open-label, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein (rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Pediatric Patients <12 Years of Age With Severe Hemophilia A

summary:
Primary Objective:

- To evaluate the safety of BIVV001 in previously treated pediatric subjects with hemophilia A

Secondary Objectives:

To evaluate the efficacy of BIVV001 as a prophylaxis treatment
To evaluate the efficacy of BIVV001 in the treatment of bleeding episodes
To evaluate BIVV001 consumption for prevention and treatment of bleeding episodes
To evaluate the effect of BIVV001 prophylaxis on joint health outcomes
To evaluate the effect of BIVV001 prophylaxis on Quality of Life (QoL) outcomes
To evaluate the efficacy of BIVV001 for perioperative management
To evaluate the safety and tolerability of BIVV001 treatment
To assess the pharmacokinetics (PK) of BIVV001

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Two-cohort, Phase 2 Study of FL-101 as Neoadjuvant Therapy in Patients With Surgically Resectable Non-Small Cell Lung Cancer

summary: Phase 2 trial to study FL-101 alone or in combination with nivolumab in patients who have surgically resectable Non-Small Cell Lung Cancer.

design_allocation: Randomized

lead_sponsor: Flame Biosciences

location_country:
United States
Canada
France
Netherlands

location_facility: Centre Hospitalier de l'Universite de Montreal

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


title: A Phase 1/2, Open-Label, Multicenter Study to Investigate the Safety and Preliminary Efficacy of Combined Bempegaldesleukin (NKTR-214) and Pembrolizumab With or Without Chemotherapy in Patients With Locally Advanced or Metastatic Solid Tumors

acronym: PROPEL

summary:
This study is to assess the safety and tolerability, and to assess the preliminary clinical benefit of NKTR-214 when combined with pembrolizumab (KEYTRUDA®) with or without chemotherapy.

The study is comprised of two groups; dose optimization and dose expansion cohorts.

Dose Optimization included first-line and second-line advanced or metastatic solid tumors including non-small cell lung cancer (NSCLC)

The dose expansion cohort will include first-line NSCLC patients.

design_allocation: Non-Randomized

ipd_sharing: Undecided

lead_sponsor: Nektar Therapeutics

location_country:
Italy
United States
France
Australia
Spain
Germany

location_facility: University of Colorado Anschutz Medical Campus

location_facility: Washington University School of Medicine in St. Louis

location_facility: Froedtert & the Medical College of Wisconsin Froedtert Hospital

location_facility: Hospital Universitario Insular de Gran Canaria

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Sarah Cannon Research Institute (SCRI) (The SCRI Oncology Research Consortium)

location_facility: Park Nicollet - Frauenshuh Cancer Center

location_facility: Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: New York University Langone Medical Center

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Highlands Oncology Group, PA - North Hills

location_facility: Southern Illinois University (SIU) School of Medicine

location_facility: University of Kansas Medical Center (KUMC)

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Augusta University - Augusta University Medical Center


title: A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion

acronym: COMINO

summary: This is a Phase III, multicenter, randomized, double-masked, active comparator-controlled, parallel-group study evaluating the efficacy, safety, and pharmacokinetics of faricimab administered by intravitreal (IVT) injection at 4-week intervals until Week 24, followed by a double-masked period of study without active control to evaluate faricimab administered according to a personalized treatment interval (PTI) dosing regimen in patients with macular edema due to central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO).

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

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

lead_sponsor: Hoffmann-La Roche

location_country:
Australia
Russian Federation
Taiwan
France
Japan
Poland
Argentina
Korea, Republic of
Hong Kong
Singapore
Hungary
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Czechia
Israel
Spain

location_facility: Belfast Health and Social Care Trust, ROYAL VICTORIA HOSPITAL

location_facility: Gloucestershire Hospitals NHS Foundation Trust

location_facility: Mid Atlantic Retina - Wills Eye Hospital

location_facility: Hospital Universitario Rio Hortega; Servicio de Oftalmologia

location_facility: The 2nd Affiliated Hospital of Harbin Medical University

location_facility: Kansai Medical University Medical Center

location_facility: Northwestern Medical Group/Northwestern University

location_facility: Queen Mary Hospital; Department of Ophthalmology

location_facility: Hospital Universitario de Bellvitge; Servicio de oftalmologia

location_facility: Northern California Retina Vitreous Associates

location_facility: Hospital de Santa Creu I Sant Pau; Servicio de Oftalmologia

location_facility: Irccs Ospedale San Raffaele;U.O. Oculistica

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

location_facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik

location_facility: Tan Tock Seng Hospital; Ophthalmology Department

location_facility: Szegedi Tudományegyetem ÁOK; Department of Ophtalmology

location_facility: Universitätsklinikum Freiburg, Klinik für Augenheilkunde

location_facility: Centro de Oftalmologia Barraquer; Servicio Oftalmologia

location_facility: California Eye Specialists Medical group Inc.

location_facility: Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT

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

location_facility: Complejo Hospitalario de Navarra; Servicio de oftalmologia

location_facility: Eye Hospital, Wenzhou Medical University

location_facility: Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC)

location_facility: Ośrodek Chirurgii Oka Prof. Zagórskiego Nałęczów

location_facility: Specjalistyczny Ośrodek Okulistyczny Oculomedica

location_facility: Szpital Specjalistyczny nr 1; Oddzial Okulistyki

location_facility: Chang Gung Medical Foundation - Linkou; Ophthalmology

location_facility: Hospital Universitario Puerta de Hierro; Servicio de oftalmologia

location_facility: Centre Ophtalmologique; Imagerie et laser

location_facility: Internationale Innovative Ophthalmochirurgie GbR; c/o Makula-Netzhaut-Zentrum Breyer Kaymak Klabe

location_facility: Hospital Clinic Barcelona; Servicio Oftalmologia

location_facility: General Teaching Hospital Prague; Ophthalmology clinic

location_facility: Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika

location_facility: Retina-Vitreous Associates Medical Group

location_facility: National University Hospital; Ophthalmology Department

location_facility: Seoul National University Bundang Hospital

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: Centres Ophtalmologique St Exupéry; Ophtalmologie

location_facility: Hospital de Santa Maria; Servico de Oftalmologia

location_facility: Complejo Hospitalario Universitario Albacete; Servicio de oftalmologia

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

location_facility: Retina Consultants of Southern Colorado PC

location_facility: Faculty Hospital Brno; Ophthalmology clinic

location_facility: Taipei Veterans General Hospital; Ophthalmology

location_facility: Bristol Eye Hospital;Retinal Treatment and Research Unit

location_facility: Gabinet Okulistyczny Prof Edward Wylegala

location_facility: Changhua Christian Hospital; Department of Ophthalmology

location_facility: Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie

location_facility: Shiga University Of Medical Science Hospital

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

location_facility: FSBI "Scientific Research Institute of Eye Diseases" of Russian Academy of medical Sciences

location_facility: Zhongshan Ophthalmic Center, Sun Yat-sen University

location_facility: Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre

location_facility: University Retina and Macula Associates, PC

location_facility: Tokyo Women's Medical University Hospital

location_facility: Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico

intervention_type: Procedure


title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy of Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) Plus Anti-TIGIT Monoclonal Antibody BGB-A1217 Versus Tislelizumab Plus Placebo as Second-Line Treatment in Patients With PD-L1 vCPS ≥ 10% Unresectable, Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

summary: A study of tislelizumab (BGB-A317) plus ociperlimab versus tislelizumab plus placebo as second-line treatment in participants with programmed cell death protein-ligand 1 (PD-L1) visually estimated combined positive score (vCPS) ≥ 10% unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma.

lead_sponsor: BeiGene

location_country:
Taiwan
Korea, Republic of
France
China

location_facility: Meizhou Hospital Affiliated to Sun Yat-sen University

location_facility: The Second Affiliated Hospital of Nanchang University

location_facility: The Second Hospital of Anhui Medical University

location_facility: Nanfang Hospital of Southern Medical University

location_facility: The First Affiliated Hospital of Guangzhou University of Chinese Medicine

location_facility: First Affiliated Hospital of Xiamen University

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hopital Europeen Georges Pompidou - Digestive Oncology

location_facility: The First Affiliated Hospital of Xinjiang Medical University

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

location_facility: Affiliated Hospital of Jiangnan University

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

location_facility: First Affiliated Hospital of Kunming Medical University

location_facility: Centre Hospitalier Universitaire d'Amiens - Hopital Sud

location_facility: The First Affiliated Hospital of Fujian Medical University

location_facility: Heping Hospital Affiliated to Changzhi Medical College

location_facility: Cancer Hospital of Shantou University Medical College

location_facility: The First Affiliated Hospital of Zhengzhou University

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: The First People's Hospital of Changzhou

location_facility: The Affiliated Hospital of Xuzhou Medical University

location_facility: Hwa Mei Hospital, University of Chinese Academy of Sciences

location_facility: Quanzhou First Hospital of Fujian Province

location_facility: Guangxi Medical University Affiliated Tumor Hospital

location_facility: Chonnam National University Hwasun Hospital

location_facility: The First Affiliated Hospital of Xinxiang Medical University

location_facility: Beijing Friendship Hospital, Capital Medical University

location_facility: General Hospital of Ningxia Medical University

location_facility: Harbin Medical University Cancer Hospital

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: Guangdong Provincial Hospital of Chinese Medicine


title: A Phase 3, Multi-center, Open-label, Randomized Study of Oral ABL001 Versus Bosutinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase (CML-CP), Previously Treated With 2 or More Tyrosine Kinase Inhibitors

summary:
The purpose of this pivotal study was to compare the efficacy of ABL001 with that of bosutinib in the treatment of patients with CML-CP having previously been treated with a minimum of two prior ATP-binding site TKIs.

Patients intolerant to the most recent TKI therapy must have had BCR-ABL1 ratio > 0.1% IS at screening and patients failing their most recent TKI therapy must have met the definition of treatment failure as per the 2013 ELN guidelines.

Patients with documented treatment failure while on bosutinib treatment had the option to switch to asciminib treatment within 96 weeks after the last patient has been randomized on study.

status: Active, not recruiting

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Réa D, Mauro MJ, Boquimpani C, Minami Y, Lomaia E, Voloshin S, Turkina A, Kim DW, Apperley JF, Abdo A, Fogliatto LM, Kim DDH, le Coutre P, Saussele S, Annunziata M, Hughes TP, Chaudhri N, Sasaki K, Chee L, García-Gutiérrez V, Cortes JE, Aimone P, Allepuz A, Quenet S, Bédoucha V, Hochhaus A. A phase 3, open-label, randomized study of asciminib, a STAMP inhibitor, vs bosutinib in CML after 2 or more prior TKIs. Blood. 2021 Nov 25;138(21):2031-2041. doi: 10.1182/blood.2020009984.

family: Rea

full_name: Delphine Rea

given: Delphine

sequence: first

name: Memorial Sloan Kettering Cancer Center, New York, New York, United States

family: Mauro

full_name: Michael J Mauro

given: Michael J

sequence: additional

suffix: MD

name: Hemorio, Institute of Hematology, Rio de Janeiro, Brazil

family: Boquimpani

full_name: Carla Boquimpani

given: Carla

name: National Cancer Center Hospital East, Kashiwa, Japan

family: Minami

full_name: Yosuke Minami

given: Yosuke

name: Almazov National Medical Research Centre, St. Petersburg, Russian Federation

family: Lomaia

full_name: Elza Lomaia

given: Elza

name: Federal State Budgetary Institution "Russian Scientific and Research Institute of Hematology and Transfusiology of Federal Medico-Biological Agency", St. Petersburg, Russian Federation

family: Voloshin

full_name: Sergey Voloshin

given: Sergey

name: Hematology Research Center, Moscow, Russian Federation

family: Turkina

full_name: Anna Grigorievna Turkina

given: Anna Grigorievna

name: Seoul St. Mary's Hospital, Leukemia Research Institute, The Catholic University of Korea, Seoul, Korea, Republic of

full_name: Dong-Wook Kim

given: Dong-Wook

name: Imperial College London, London, United Kingdom

family: Apperley

full_name: Jane F Apperley

given: Jane F

name: São Paulo State Cancer Institute (ICESP), University of São Paulo, and Oncology Center at Hospital Alemão Oswaldo Cruz, São Paulo, Brazil., Sao Paulo, Brazil

family: Abdo

full_name: Andre Abdo

given: Andre

name: Hospital de Clínicas de Porto Alegre (HCPA), Porto ALegre, Brazil

family: Fogliatto

full_name: Laura M Fogliatto

given: Laura M

name: Princess Margaret Hospital, Toronto, Canada

full_name: Dennis Dong Hwan Kim

given: Dennis Dong Hwan

name: Campus Virchow Klinikum, Charité, Berlin, Germany

family: le Coutre

full_name: Philipp le Coutre

given: Philipp

name: Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany

family: Saussele

full_name: Susanne Saussele

given: Susanne

family: Annunziata

full_name: Mario Annunziata

given: Mario

name: South Australian Health and Medical Research Institute, Adelaide, Australia

family: Hughes

full_name: Timothy P Hughes

given: Timothy P

name: King Faisal Specialist Hospital & Research Centre, Riyadh, Saudi Arabia

family: Chaudhri

full_name: Naeem Chaudhri

given: Naeem

name: The University of Texas MD Anderson Cancer Center, Houston, Texas, United States

family: Sasaki

full_name: Koji Sasaki

given: Koji

name: The Royal Melbourne Hospital/ Peter MacCallum Cancer Centre, Melbourne, Australia

family: Chee

full_name: Lynette Chee

given: Lynette

family: Garcia-Gutierrez

full_name: Valentin Garcia-Gutierrez

given: Valentin

name: Georgia Cancer Center, Augusta, Georgia, United States

family: Cortes

full_name: Jorge Cortes

given: Jorge

family: Aimone

full_name: Paola Aimone

given: Paola

family: Allepuz

full_name: Alex Allepuz

given: Alex

name: Universitätsklinikum Jena, Jena, Germany

title: A Phase 3, Open-Label, Randomized Study of Asciminib, a STAMP Inhibitor, vs Bosutinib in CML After ≥2 Prior TKIs

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:
Romania
Australia
Russian Federation
France
Japan
Argentina
Canada
Korea, Republic of
Saudi Arabia
Switzerland
Netherlands
Bulgaria
Hungary
Germany
United States
United Kingdom
Italy
Brazil
Serbia
Lebanon
Mexico
Czechia
Israel
Spain
Turkey

location_facility: Weill Cornell Medicine NewYork Presbyterian Hospital

location_facility: Indiana Blood and Marrow Institute Regulatory - 2

location_facility: University of Michigan Clinical Trials Office Main Site

location_facility: Sidney Kimmel Comprehensive Cancer Center


intervention_type: Biological

status: Completed

location_country:
Italy
United States
Germany
France
Bulgaria
Japan
Belgium
Spain
Canada
United Kingdom

location_facility: Azienda Ospedaliera Pediatrica Santobono Pausillipon

location_facility: Hemostase Clinique - Institut Cœur-Poumons (4eme étage aile est)

location_facility: University of Colorado Hemophilia & Thrombosis Center

location_facility: Children's & Women's Health Centre of British Columbia

location_facility: Gulf States Hemophilia and Thrombophilia Center

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Indiana Hemophilia and Thrombosis Center

study_completion_date_type: Actual

title: A Non-controlled, Open-Label, Multicenter, Study of Efficacy of rFVIIIFc for Immune Tolerance Induction (ITI) in Severe Hemophilia A Subjects With Inhibitors Undergoing the First ITI Treatment

summary: The primary purpose of this study was to describe the time to tolerization (i.e., ITI success) with rFVIIIFc in participants within a maximum of 48 weeks (12 months) of ITI treatment.

status_simplified: Completed


title: A Randomized Phase 3 Study of MRTX849 Versus Docetaxel in Patients With Previously Treated Non-Small Cell Lung Cancer With KRAS G12C Mutation

summary: This Phase 3 study will evaluate the efficacy of the investigational agent MRTX849 (adagrasib) versus docetaxel in patients who have been previously treated for metastatic NSCLC with a KRAS G12C mutation.

ipd_sharing: No

lead_sponsor: Mirati Therapeutics Inc.

location_country:
Italy
Austria
Hong Kong
Switzerland
France
Poland
Greece
Hungary
Russian Federation
United States
United Kingdom
Korea, Republic of


lead_sponsor: Ipsen

location_country:
Italy
Brazil
Serbia
Spain
Germany
France
Poland
Romania
Hungary
Belgium
Australia
Russian Federation
China
Turkey
United States
Korea, Republic of
Taiwan
Ukraine

acronym: RESILIENT

location_facility: Communal Non-profit Enterprise Regional Center of Oncology

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

location_facility: Cancer & Hematology Centers of Western Michigan

location_facility: CCCH City Oncological Center SHEI Uzhgorod NU

location_facility: Hospital Regional Universitario de Malaga

location_facility: Tri County Hematology & Oncology Associates, Inc

location_facility: Azienda Sanitaria Universitaria Integrata di Udine

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

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

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: SP Zespol Gruzlicy i Chorob Pluc w Olsztynie

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

location_facility: North Shore Hematology Oncology Associates, PC

location_facility: RCI Sumy Regional Clinical Oncological Dispensary

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

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: The First Affiliated Hospital of Bengbu Medical College

location_facility: SBIH of Stavropol territory "Pyatigorsk Oncological Dispensary"

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: Istanbul Medeniyet Uni Goztepe Training&Res Hosp

location_facility: Winship Cancer Institute of Emory University

location_facility: Charleston Hematology Oncology Associates, PA

location_facility: Treatment and Diagnostic Center of LLC Specialized clinic Dobryi Prognoz

location_facility: Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

location_facility: SBHI of Kaluga Region "Kaluga regional clinical oncology dispensary"

location_facility: HGB - Hospital Giovanni Battista - Mãe de Deus Center

location_facility: Greenville Hospital System University Medical Center

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

location_facility: Szpitale Pomorskie spółka z ograniczoną odpowiedzialnością

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

location_facility: Azienda Socio Sanitaria Territoriale Bergamo Ovest (Ospedale Treviglio Caravaggio di Treviglio)

location_facility: Hospital General Universitario de Alicante

location_facility: Cancer Treatment Centers of America-Georgia

location_facility: Treatment-Prevention Institution Volyn Regional Oncological Dispensary

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza

location_facility: Baskent University Adana Application and Research Center

location_facility: Florida Cancer Specialists (South Region)

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet

location_facility: BHI of Omsk region "Clinical Oncology Dispensary"

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

location_facility: SPb SBIH "City Clinical Oncological Dispensary"

location_facility: CI Kryvyi Rih Oncological Dispensary of DRC

location_facility: Institute for Pulmonary Diseases of Vojvodina

location_facility: Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca

location_facility: MultiCare Health System Institute for Research and Innovation

location_facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto

location_facility: Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"

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

location_facility: SBIH "Samara Regional Clinical Oncological Dispensary"

title: RESILIENT: A Randomized, Open Label Phase 3 Study of Irinotecan Liposome Injection (ONIVYDE®) Versus Topotecan in Patients With Small Cell Lung Cancer Who Have Progressed on or After Platinum-based First-Line Therapy

summary:
A Randomized, Open Label Phase 3 Study of Irinotecan Liposome Injection (ONIVYDE®) versus Topotecan in Patients with Small Cell Lung Cancer Who Have Progressed on or after Platinum-based First-Line Therapy

The study will be conducted in two parts:

Dose determination of irinotecan liposome injection
A randomized, efficacy study of irinotecan liposome injection versus topotecan


title: A Multicenter, Open-Label, Phase I/II Study to Evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of Escalating Doses of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab Administered After a Fixed, Single Dose Pre-Treatment of Obinutuzumab (Gazyva®/Gazyvaro™) in Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

summary: This is a Phase I/II, multicenter, open-label, dose-escalation study designed to evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of a novel T-Cell bispecific (TCB), glofitamab, administered by intravenous (IV) infusion as a single agent and in combination with obinutuzumab, following pre-treatment with a one-time, fixed dose of obinutuzumab. This entry-to-human study is divided in 3 parts: dose escalation (Parts I and II) and dose expansion (Part III). Single-participant dose-escalation cohorts will be used in Part I, followed by conversion to multiple participant dose-escalation cohorts (Part II), in order to define a tentative maximum tolerated dose (MTD) or optimal biological dose (OBD). The expansion cohorts (Part III) will be initiated when the tentative MTD/OBD is defined, to further evaluate the safety, PK and therapeutic activity of glofitamab.

ReferenceCitation: Hutchings M, Morschhauser F, Iacoboni G, Carlo-Stella C, Offner FC, Sureda A, Salles G, Martínez-Lopez J, Crump M, Thomas DN, Morcos PN, Ferlini C, Bröske AE, Belousov A, Bacac M, Dimier N, Carlile DJ, Lundberg L, Perez-Callejo D, Umaña P, Moore T, Weisser M, Dickinson MJ. Glofitamab, a Novel, Bivalent CD20-Targeting T-Cell-Engaging Bispecific Antibody, Induces Durable Complete Remissions in Relapsed or Refractory B-Cell Lymphoma: A Phase I Trial. J Clin Oncol. 2021 Jun 20;39(18):1959-1970. doi: 10.1200/JCO.20.03175. Epub 2021 Mar 19.

name: Department of Hematology and Phase 1 Unit, Rigshospitalet, Copenhagen, Denmark

family: Hutchings

full_name: Martin Hutchings

given: Martin

name: Université de Lille, CHU Lille, ULR 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées, Lille, France

family: Morschhauser

full_name: Franck Morschhauser

given: Franck

name: Department of Hematology, Vall d'Hebron University Hospital, Experimental Hematology, Vall d'Hebron Institute of Oncology (VHIO), Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain

name: Department of Medicine, Universitat Autònoma of Barcelona, Barcelona, Spain

family: Iacoboni

full_name: Gloria Iacoboni

given: Gloria

name: Humanitas Clinical and Research Center—IRCCS and Humanitas University, Rozzano, Italy

family: Carlo-Stella

full_name: Carmelo Carlo-Stella

given: Carmelo

family: Offner

full_name: Fritz C. Offner

given: Fritz C.

name: Institut Català d'Oncologia-Hospitalet, Institut d'Investigació Biomedica de Bellvitge, Universitat de Barcelona, Barcelona, Spain

family: Sureda

full_name: Anna Sureda

given: Anna

name: Hôpital Lyon Sud, Université Claude Bernard Lyon 1, Pierre-Bénite, France

family: Salles

full_name: Gilles Salles

given: Gilles

name: Hospital 12 de Octubre, i+12, Complutense University, Centro Nacional de Investigaciones Oncológicas, CRIS Unit, Madrid, Spain

family: Martínez-Lopez

full_name: Joaquín Martínez-Lopez

given: Joaquín

name: Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, Canada

family: Crump

full_name: Michael Crump

given: Michael

name: Roche Innovation Center New York, Roche Pharma Research and Early Development, New York, NY

family: Thomas

full_name: Denise N. Thomas

given: Denise N.

family: Morcos

full_name: Peter N. Morcos

given: Peter N.

family: Ferlini

full_name: Cristiano Ferlini

given: Cristiano

name: Roche Innovation Center Munich, Roche Pharma Research and Early Development, Penzberg, Germany

family: Bröske

full_name: Ann-Marie E. Bröske

given: Ann-Marie E.

name: Roche Innovation Center Zurich, Roche Pharma Research and Early Development, Zurich, Switzerland

family: Belousov

full_name: Anton Belousov

given: Anton

family: Bacac

full_name: Marina Bacac

given: Marina

name: Roche Innovation Center Welwyn, Roche Pharma Research and Early Development, Welwyn Garden City, United Kingdom

family: Dimier

full_name: Natalie Dimier

given: Natalie

family: Carlile

full_name: David J. Carlile

given: David J.

name: Roche Innovation Center Basel, Roche Pharma Research and Early Development, Basel, Switzerland

family: Lundberg

full_name: Linda Lundberg

given: Linda

family: Perez-Callejo

full_name: David Perez-Callejo

given: David

family: Umaña

full_name: Pablo Umaña

given: Pablo

family: Moore

full_name: Tom Moore

given: Tom

family: Weisser

full_name: Martin Weisser

name: Peter MacCallum Cancer Centre, Royal Melbourne Hospital, The University of Melbourne, Melbourne, Australia

family: Dickinson

full_name: Michael J. Dickinson

given: Michael J.

repository_normalized: University of Melbourne - Minerva Access

publisher: American Society of Clinical Oncology (ASCO)

title: Glofitamab, a Novel, Bivalent CD20-Targeting T-Cell–Engaging Bispecific Antibody, Induces Durable Complete Remissions in Relapsed or Refractory B-Cell Lymphoma: A Phase I Trial

location_country:
Italy
United States
Finland
France
Czechia
Poland
Belgium
Australia
New Zealand
Spain
Denmark
Canada
Taiwan

location_facility: Hopital Henri Mondor; Hematologie Clinique

location_facility: Uniwersyteckie Centrum Kliniczne; Osrodek Badan Wczesnych Faz

location_facility: Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK

location_facility: Hospital Univ. 12 de Octubre; Servicio de Hematologia

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia

location_facility: Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Hematologia

location_facility: National Taiwan Universtiy Hospital; Division of Hematology

location_facility: AUSL della Romagna; Dipartimento Oncoematologico - U.O.C. Oncologia

location_facility: Ch Lyon Sud; Hemato Secteur Jules Courmont

location_facility: Uniwersytecki Szpital Kliniczny; Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku

location_facility: Hospital Duran i Reynals L'Hospitalet; Hematology Department

location_facility: Helsinki University Central Hospital; Dept of Oncology

location_facility: China Medical University Hospital; Oncology and Hematology

location_facility: Washington University; Wash Uni. Sch. Of Med

location_facility: Virginia Commonwealth University Medical Center

location_facility: CHU DE RENNES - CHU Pontchaillou; Service d'Hématologie Clinique Adulte

location_facility: Auckland Cancer Trial Centre; Ward 64, Auckland City Hospital,

location_facility: Szpital Kliniczny; Oddzial Hematologii i Transplantacji Szpiku

location_facility: CHU Saint Eloi; Service d'Hématologie Clinique

location_facility: A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia

location_facility: Hospital del Mar; Servicio de Hematologia

location_facility: Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie; Oddzial Badan Wczesnych Faz

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Hematologia

location_facility: Fond. IRCCS Istituto Nazionale Tumori; S. C. Ematologia


ReferenceType: background

ReferenceCitation: Wei AH, Montesinos P, Ivanov V, DiNardo CD, Novak J, Laribi K, Kim I, Stevens DA, Fiedler W, Pagoni M, Samoilova O, Hu Y, Anagnostopoulos A, Bergeron J, Hou JZ, Murthy V, Yamauchi T, McDonald A, Chyla B, Gopalakrishnan S, Jiang Q, Mendes W, Hayslip J, Panayiotidis P. Venetoclax plus LDAC for newly diagnosed AML ineligible for intensive chemotherapy: a phase 3 randomized placebo-controlled trial. Blood. 2020 Jun 11;135(24):2137-2145. doi: 10.1182/blood.2020004856.

ReferenceCitation: Wei AH, Panayiotidis P, Montesinos P, Laribi K, Ivanov V, Kim I, Novak J, Stevens DA, Fiedler W, Pagoni M, Bergeron J, Ting SB, Hou JZ, Anagnostopoulos A, McDonald A, Murthy V, Yamauchi T, Wang J, Chyla B, Sun Y, Jiang Q, Mendes W, Hayslip J, DiNardo CD. 6-month follow-up of VIALE-C demonstrates improved and durable efficacy in patients with untreated AML ineligible for intensive chemotherapy (141/150). Blood Cancer J. 2021 Oct 1;11(10):163. doi: 10.1038/s41408-021-00555-8. Erratum in: Blood Cancer J. 2021 Oct 26;11(10):171.

family: Wei

full_name: Andrew H. Wei

given: Andrew H.

family: Panayiotidis

full_name: Panayiotis Panayiotidis

given: Panayiotis

family: Montesinos

full_name: Pau Montesinos

given: Pau

family: Laribi

full_name: Kamel Laribi

given: Kamel

family: Ivanov

full_name: Vladimir Ivanov

given: Vladimir

family: Kim

full_name: Inho Kim

given: Inho

family: Novak

full_name: Jan Novak

given: Jan

family: Stevens

full_name: Don A. Stevens

given: Don A.

family: Fiedler

full_name: Walter Fiedler

given: Walter

family: Pagoni

full_name: Maria Pagoni

given: Maria

family: Bergeron

full_name: Julie Bergeron

given: Julie

family: Ting

full_name: Stephen B. Ting

given: Stephen B.

family: Hou

full_name: Jing-Zhou Hou

given: Jing-Zhou

family: Anagnostopoulos

full_name: Achilles Anagnostopoulos

given: Achilles

family: McDonald

full_name: Andrew McDonald

given: Andrew

family: Murthy

full_name: Vidhya Murthy

given: Vidhya

family: Yamauchi

full_name: Takahiro Yamauchi

given: Takahiro

family: Wang

full_name: Jianxiang Wang

given: Jianxiang

family: Chyla

full_name: Brenda Chyla

given: Brenda

family: Sun

full_name: Yan Sun

given: Yan

family: Jiang

full_name: Qi Jiang

given: Qi

family: Mendes

full_name: Wellington Mendes

given: Wellington

family: Hayslip

full_name: John Hayslip

given: John

family: DiNardo

full_name: Courtney D. DiNardo

given: Courtney D.

bso_classification: Medical research

currency_apc_doaj: GBP

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

location_country:
Greece
Belgium
Australia
Russian Federation
Taiwan
France
Japan
Norway
Argentina
Canada
Korea, Republic of
South Africa
Hungary
Ireland
Puerto Rico
China
Germany
United States
United Kingdom
Brazil
Mexico
Czechia
New Zealand
Spain

location_facility: Kinki University -Osakasayama Campus /ID# 160777

location_facility: VA Caribbean Healthcare System /ID# 158999

location_facility: University of Alberta Hospital /ID# 159646

location_facility: Blood disease hosp of Chinese Academy of Med Sciences(Institute of Hematology) /ID# 167509

location_facility: Hospital do Cancer Mae de Deus /ID# 163416

location_facility: Yaroslavl Regional Clinic Hosp /ID# 162172

location_facility: Centro de Pesquisas Oncologicas /ID# 163567

location_facility: Hospital Maisonneuve-Rosemont /ID# 159780

location_facility: Pusan National University Hosp /ID# 158725

location_facility: Fakult Nem Kralovske Vinohrady /ID# 159248

location_facility: Chungnam National University Hospital /ID# 158726

location_facility: University Hospital Limerick /ID# 162735

location_facility: Netcare Pretoria East Hospital /ID# 157373

location_facility: Semmelweis Egyetem I. Belklini /ID# 158180

location_facility: Gunmaken Saiseikai Maebashi Hospital /ID# 160597

location_facility: Nagasaki University Hospital /ID# 160233

location_facility: Gen Univ Hosp Alexandroupolis /ID# 157868

location_facility: Nizhniy Novgorod regional clinical hospital named N. A. Semashko /ID# 163186

location_facility: Cliniques Universitaires Saint Luc /ID# 159567

location_facility: Haukeland University Hospital /ID# 165630

location_facility: Almazov North-West Federal Med /ID# 162170

location_facility: City Clinical Hospital Botkina /ID# 164086

location_facility: Petz Aladar Megyei Oktato Korh /ID# 161739

location_facility: Tokyo Metropolitan Komagome Hospital /ID# 160759

location_facility: Nanfang Hospital of Southern Medical University /ID# 170147

location_facility: Centre Hospitalier de la Cote /ID# 159697

location_facility: The First Hosp of Jilin Univ /ID# 167512

location_facility: Saitama Med Univ Int Med Ctr /ID# 161308

location_facility: Seoul National University Hospital /ID# 162253

location_facility: University Hospital of Wales /ID# 162726

location_facility: Hosp. Univ. Dr. Jose E. Gonz /ID# 159268

location_facility: Jiangsu Province People's Hospital /ID# 167511

location_facility: Hospital Universitario y Politecnico La Fe /ID# 161181

location_facility: Universitair Ziekenhuis Antwerpen /ID# 159566

location_facility: National Hospital Organization Mito Medical Center /ID# 162988

location_facility: Samara State Medical Universit /ID# 164173

location_facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 157869

location_facility: Instituto Nacional de Cancerol /ID# 159269

location_facility: Casa de Saúde Santa Marcelina /ID# 163413

location_facility: General Hospital of Athens Laiko /ID# 157870

location_facility: Tri-Service General Hospital /ID# 161683

location_facility: Juntendo University Hospital /ID# 159781

location_facility: Kaohsiung Medical University /ID# 161693

location_facility: Osaka City University Hospital /ID# 159722

location_facility: Cath Univ Seoul St Mary's Hosp /ID# 158724

location_facility: Dokkyo Medical University Hosp /ID# 159650

location_facility: Hospital de Cancer de Barretos /ID# 163568

location_facility: The First Affiliated Hospital,College of Medicine, Zhejiang University /ID# 167324

location_facility: Yamagata University Hospital /ID# 161223

location_facility: Universitaetsklinikum Hamburg /ID# 161760

location_facility: State Institution of Health of the Ryazan Regional Clinical Hospital /ID# 163126

location_facility: Hopital Sacre Coeur Montreal /ID# 160982

location_facility: Qilu Hospital of Shandong Univ /ID# 167507

location_facility: Ruijin Hospital, Shanghai Jiaotong /ID# 167325

location_facility: Fujian Medical Univ Union Hosp /ID# 167321

location_facility: Centro de Invest Clin Chapulte /ID# 162625

location_facility: General Hospital of Thessaloniki George Papanikolaou /ID# 157867

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 167515

location_facility: University Gen Hosp of Patra /ID# 157871

location_facility: Debreceni Egyetem Klinikai Koz /ID# 158178

location_facility: Saint Petersburg State Institu /ID# 162171

location_facility: Dél-pesti Centrumkórház- Országos Hematológiai és Infektológiai Intézet /ID# 159127

location_facility: University of Fukui Hospital /ID# 159770

location_facility: Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev /ID# 162991

title: A Randomized, Double-Blind, Placebo Controlled Phase 3 Study of Venetoclax Co-Administered With Low Dose Cytarabine Versus Low Dose Cytarabine in Treatment Naïve Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy

summary: The primary objective of this study is to evaluate if venetoclax when co administered with low-dose cytarabine (LDAC) improves overall survival (OS) versus LDAC and placebo, in treatment-naïve patients with acute myeloid leukemia (AML).


type: Registry Identifier

type: U.S. NIH Grant/Contract

title: MOUNTAINEER: A Phase II, Open Label Study of Tucatinib Combined With Trastuzumab in Patients With HER2+ Metastatic Colorectal Cancer

summary:
This trial studies how well the drug tucatinib works when given with trastuzumab and when given by itself. The participants in this trial have HER2-positive (HER2+) metastatic colorectal cancer (mCRC). 'Metastatic' means that the cancer has spread to other parts of the body.

In the first part of this study, participants enrolled into Cohort A and received both tucatinib and trastuzumab. In the second part of this study, participants are randomly assigned to either Cohort B or Cohort C. Participants in Cohort B will receive tucatinib and trastuzumab. Participants in Cohort C will receive tucatinib. Participants in Cohort C who do not respond to therapy may have an option to receive tucatinib plus trastuzumab.

lead_sponsor: Seagen Inc.

location_country:
Italy
France
Belgium
Spain
United States

location_facility: Case Western Reserve University / University Hospitals Cleveland Medical Center

location_facility: Cedars Sinai Medical Center / Samuel Oschin Comprehensive Cancer Institute

location_facility: Texas Oncology - San Antonio Medical Center

location_facility: Huntsman Cancer Institute/University of Utah

location_facility: Texas Oncology - Baylor Sammons Cancer Center

location_facility: Florida Cancer Specialists - South Region

location_facility: Winship Cancer Institute / Emory University School of Medicine

location_facility: Lombardi Cancer Center / Georgetown University Medical Center

location_facility: Hôpital Franco-Britannique - Fondation Cognacq-Jay

location_facility: Karmanos Cancer Institute / Wayne State University

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Azienda Ospedaliero-Universitaria Pisana - Ospedale S. Chiara

location_facility: Joe Arrington Cancer Research and Treatment Center

location_facility: Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes

location_facility: Florida Cancer Specialists - North Region

location_facility: University of Iowa Hospitals and Clinics

location_facility: Hospital General Universitario Gregorio Marañon

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

location_facility: Tennessee Oncology-Nashville/Sarah Cannon Research Institute

location_facility: Seattle Cancer Care Alliance / University of Washington

location_facility: Keck Medical Center / University of Southern California

location_facility: Providence Regional Medical Center Everett


ReferenceCitation: Machiels JP, Tao Y, Burtness B, Tahara M, Licitra L, Rischin D, Waldron J, Simon C, Gregoire V, Harrington K, Alves GV, Figueiredo Lima IP, Pointreau Y, M Hughes BG, Aksoy S, Hetnal M, Ge JY, Brown H, Cheng J, Bidadi B, Siu LL. Pembrolizumab given concomitantly with chemoradiation and as maintenance therapy for locally advanced head and neck squamous cell carcinoma: KEYNOTE-412. Future Oncol. 2020 Jun;16(18):1235-1243. doi: 10.2217/fon-2020-0184. Epub 2020 Jun 3.

name: Department of Medical Oncology, Institut Roi Albert II, Cliniques Universitaires Saint-Luc & Institut de Recherche Clinique et Expérimentale, Université Catholique de Louvain (UCLouvain), Avenue Hippocrate 10, Brussels, Belgium

family: Machiels

full_name: Jean-Pascal Machiels

given: Jean-Pascal

name: Department of Radiation Oncology, Gustave Roussy Cancer Campus, 114 Rue Edouard Vaillant, 94800, Villejuif, France

family: Tao

full_name: Yungan Tao

given: Yungan

name: Department of Medicine, Yale University School of Medicine & Yale Cancer Center, 333 Cedar Street, New Haven, CT 06510, USA

family: Burtness

full_name: Barbara Burtness

given: Barbara

name: Department of Head & Neck Medical Oncology, National Cancer Center Hospital East, 6-Chome-5-1 Kashiwanoha, Kashiwa, Chiba, 27-8577, Japan

family: Tahara

full_name: Makoto Tahara

given: Makoto

name: Department of Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori and University of Milan, Via Giacomo Venezian 1, 20133, Milan, Italy

family: Licitra

full_name: Lisa Licitra

given: Lisa

name: Department of Medical Oncology, Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne, VIC, 3000, Australia

family: Rischin

full_name: Danny Rischin

given: Danny

name: Department of Radiation Oncology University of Toronto, Princess Margaret Cancer Centre, 610 University Avenue, Toronto, ON, M5G 2M9, Canada

family: Waldron

full_name: John Waldron

name: Department of Otorhinolaryngology, University Hospital CHUV, Rue du Bugnon 21, 1011, Lausanne, Switzerland

family: Simon

full_name: Christian Simon

given: Christian

name: Department of Radiation Oncology, Centre Leon Berard, 28 Prom. Lea et Napoleon Bullukian, 69008, Lyon, France

family: Gregoire

full_name: Vincent Gregoire

given: Vincent

name: Division of Radiotherapy & Imaging, The Institute of Cancer Research, London, SW3 6JB, UK

family: Harrington

full_name: Kevin Harrington

given: Kevin

name: Centro Integardo de Pesquisa em Oncologia, Hospital Nossa Senhora da Conceição, Avenida Francisco Trein, 596 – Cristo Redentor Porto Alegre – RS, 91350-200, Brazil

family: Alves

full_name: Gustavo Vasconcelos Alves

given: Gustavo Vasconcelos

name: Crio Centro Regional Integrado de Oncologia, R. Francisco Calaca, 1300 – Alvaro Weyne, Fortaleza – CE, 60335-480, Brazil

family: Figueiredo Lima

full_name: Iane Pinto Figueiredo Lima

given: Iane Pinto

name: Department of Radiation Oncology, Institut Inter-Regional de Cancerologie-Centre Jean Bernard/Clinique Victor Hugo, 72000, Le Mans, France

family: Pointreau

full_name: Yoann Pointreau

given: Yoann

name: Cancer Care Services, Royal Brisbane & Women's Hospital, Butterfield Street, Herston QLD 4029, Australia & School of Medicine, University of Queensland, 20 Weightman Street, Herston, QLD, 4006, Australia

family: M Hughes

full_name: Brett G M Hughes

given: Brett G

name: Hacettepe University, Cancer Institute, Department of Medical Oncology, 06100, Ankara, Turkey

family: Aksoy

full_name: Sercan Aksoy

given: Sercan

name: Faculty of Medicine & Health Sciences, Andrzej Frycz Modrzewski Krakow University, Amethyst Radiotherapy Centre, Rydygier Hospital, Krakow, Poland, Złotej Jesieni 1, Krakow, Poland

family: Hetnal

full_name: Marcin Hetnal

given: Marcin

name: Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA

family: Ge

full_name: Joy Y Ge

given: Joy Y

family: Brown

full_name: Holly Brown

given: Holly

family: Cheng

full_name: Jonathan Cheng

given: Jonathan

family: Bidadi

full_name: Behzad Bidadi

given: Behzad

name: Division of Medical Oncology & Hematology, Princess Margaret Cancer Centre, University Health Network, 610 University Avenue, Toronto, ON, M5G 2M9, Canada

family: Siu

full_name: Lillian L Siu

given: Lillian L

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Future Oncology

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

repository_institution: University of Melbourne - Minerva Access

repositories: University of Melbourne - Minerva Access

repositories_institution: University of Melbourne - Minerva Access

location_country:
Australia
Belgium
Taiwan
France
Japan
Poland
Canada
Korea, Republic of
Colombia
Netherlands
Germany
United States
United Kingdom
Italy
Austria
Brazil
Czechia
Israel
New Zealand
Spain
Turkey

acronym: Pembrolizumab or placebo in combination with chemoradiation in subjects with locally advanced HNSCC

location_facility: Zachodniopomorskie Centrum Onkologii ( Site 1013)

location_facility: Osaka International Cancer Institute ( Site 0355)

location_facility: Smilow Cancer Hospital at Yale New Haven ( Site 0256)

location_facility: Hospital Clinico San Carlos ( Site 1051)

location_facility: Norfolk & Norwich University Hospital NHS Foundation Trust ( Site 1206)

location_facility: Peter MacCallum Cancer Centre ( Site 0300)

location_facility: Cliniques Universitaires Saint Luc - Bruxelles ( Site 0651)

location_facility: Dolnoslaskie Centrum Onkologii. ( Site 1001)

location_facility: Capital & Coast District Health Board - Wellington Hospital ( Site 0400)

location_facility: St. Vincent Healthcare Frontier Cancer Center ( Site 0286)

location_facility: Clinique et Maternite Sainte-Elisabeth ( Site 0653)

location_facility: Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 0269)

location_facility: National Cancer Center Hospital East ( Site 0350)

location_facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 1008)

location_facility: Inonu Universitesi Tip Fakultesi ( Site 1101)

location_facility: Chang Gung Medical Foundation - Kaohsiung ( Site 0501)

location_facility: University Hospital of North Staffordshire ( Site 1202)

location_facility: C.H.U. Sart Tilman-Service d'Oncologie Medicale ( Site 0654)

location_facility: Instituto do Cancer de Sao Paulo - ICESP ( Site 0004)

location_facility: Universitares Cancer Center Hamburg - UCCH ( Site 0811)

location_facility: Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 1007)

location_facility: Rush University Medical Center ( Site 0260)

location_facility: Tel Aviv Sourasky Medical Center ( Site 0900)

location_facility: Hadassah Ein Karem Jerusalem ( Site 0902)

location_facility: Universitätsklinikum Erlangen ( Site 0801)

location_facility: University of Rochester - James P. Wilmot Cancer Center ( Site 0255)

location_facility: St. Joseph Heritage Healthcare ( Site 0254)

location_facility: Liga Norte Riograndense Contra o Cancer ( Site 0005)

location_facility: Kocaeli Universitesi Tip Fakultesi ( Site 1106)

location_facility: Erasmus University Medical Center ( Site 1354)

location_facility: Barbara Ann Karmanos Cancer Institute ( Site 0272)

location_facility: Klinikum der Universitaet Munchen ( Site 0810)

location_facility: London Health Sciences Centre ( Site 0055)

location_facility: CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0057)

location_facility: Hiroshima University Hospital ( Site 0352)

location_facility: Texas Oncology-Arlington North ( Site 8005)

location_facility: Fakultni Nemocnice Hradec Kralove ( Site 0705)

location_facility: Azienda Ospedaliero Universitaria Careggi ( Site 0955)

location_facility: Chungbuk National University Hospital ( Site 0454)

location_facility: Seoul National University Bundang Hospital ( Site 0453)

location_facility: Royal Marsden NHS Foundation Trust ( Site 1201)

location_facility: Centro Regional Integrado de Oncologia ( Site 0002)

location_facility: Hospital Gral Universitario de Valencia ( Site 1050)

location_facility: McGill University Health Centre ( Site 0061)

location_facility: Medical Hospital, Tokyo Medical And Dental University ( Site 0356)

location_facility: Royal Brisbane and Women s Hospital ( Site 0302)

location_facility: Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1005)

location_facility: Texas Oncology-Austin Central ( Site 8002)

location_facility: Hospital das Clinicas da FMUSP de Ribeirao Preto ( Site 0008)

location_facility: Blacktown Hospital Western Sydney Local Health District ( Site 0304)

location_facility: Istituto Europeo di Oncologia ( Site 0953)

location_facility: Krankenhaus der Barmherzigen Schwestern Linz ( Site 0603)

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0003)

location_facility: Lancashire Teaching Hospitals NHS Foundation Trust ( Site 1208)

location_facility: Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 1204)

location_facility: Chungnam National University Hospital ( Site 0455)

location_facility: The Royal Marsden Foundation Trust ( Site 1200)

location_facility: UZ Leuven Campus Gasthuisberg ( Site 0652)

location_facility: Severance Hospital Yonsei University Health System ( Site 0452)

location_facility: Allgemeines Krankenhaus der Stadt Wien ( Site 0602)

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1102)

location_facility: Princess Margaret Cancer Centre ( Site 0051)

location_facility: Centro de Investigacion Clinica del Country ( Site 0155)

location_facility: Fondazione IRCCS - Policlinico San Matteo ( Site 0960)

location_facility: Taipei Veterans General Hospital ( Site 0504)

location_facility: Hokkaido University Hospital ( Site 0351)

location_facility: Universitaetsklinikum Schleswig-Holstein-Campus Luebeck ( Site 0803)

location_facility: Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0010)

location_facility: Hospital Nossa Senhora da Conceicao ( Site 0001)

location_facility: Medical Park Izmir Hastanesi ( Site 1109)

location_facility: The Cancer Institute Hospital of JFCR ( Site 0357)

location_facility: Taichung Veterans General Hospital ( Site 0506)

location_facility: Hospital Santa Izabel - Santa Casa de Misericordia da Bahia ( Site 0006)

location_facility: Willamette Valley Cancer Institute and Research Center ( Site 8000)

location_facility: Hospital Universitario Ramon y Cajal ( Site 1055)

location_facility: Princess Alexandra Hospital ( Site 0305)

location_facility: St. Francis Hospital Cancer Center ( Site 1461)

location_facility: Azienda Ospedaliera San Paolo ( Site 0952)

location_facility: Hospital Universitario Virgen de la Victoria ( Site 1056)

location_facility: Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center ( Site 0290)

location_facility: Medipol Universite Hastanesi ( Site 1104)

location_facility: St. Luke's Cancer Center - Anderson ( Site 0251)

location_facility: Centre Jean Bernard Laboratoire Mahe Meziani ( Site 0760)

location_facility: Medical Oncology Associates (Summit Cancer Centers) ( Site 0257)

location_facility: University of Massachusetts Memorial Medical Center ( Site 0285)

location_facility: Oncology Hematology Care, Inc. ( Site 8003)

location_facility: University of Virginia Health System ( Site 0261)

location_facility: Basken Adana Dr.Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 1103)

location_facility: National Taiwan University Hospital ( Site 0500)

location_facility: University of Michigan Hospital and Health Systems ( Site 0267)

location_facility: Medizinische Hochschule Hannover ( Site 0807)

location_facility: Noordwest Ziekenhuisgroep NWZ ( Site 1350)

location_facility: University Hospital Southampton NHS Foundation Trust ( Site 1203)

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi ( Site 1100)

location_facility: Landeskrankenhaus - Universitatsklinikum Graz ( Site 0601)

location_facility: Comprehensive Cancer Centers of Nevada ( Site 8004)

location_facility: Mazowiecki Szpital Onkologiczny ( Site 1015)

location_facility: University of California San Francisco ( Site 0274)

location_facility: National Cheng Kung University Hospital ( Site 0503)

location_facility: Centro Medico Imbanaco de Cali S.A ( Site 0156)

location_facility: The Ottawa Hospital - Cancer Care ( Site 0052)

location_facility: Linkou Chang Gung Memorial Hospital ( Site 0502)

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0951)

location_facility: Hospital de Clinicas de Porto Alegre ( Site 0011)

location_facility: Mary Bird Perkins Cancer Center at St. Tammany Parish Hospital ( Site 0281)

location_facility: Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0954)

location_facility: Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie ( Site 1000)

location_facility: Centrum Onkologii. Instytut im. Marii Sklodowskiej-Curie ( Site 1010)

location_facility: Institut De Cancerologie De Lorraine ( Site 0758)

title: A Randomized Phase III Study of Pembrolizumab Given Concomitantly With Chemoradiation and as Maintenance Therapy Versus Chemoradiation Alone in Subjects With Locally Advanced Head and Neck Squamous Cell Carcinoma (KEYNOTE-412)

summary: The purpose of this study is to determine the efficacy and safety of pembrolizumab given concomitantly with chemoradiation (CRT) and as maintenance therapy versus placebo plus CRT in participants with locally advanced head and neck squamous cell carcinoma (LA HNSCC). The primary hypothesis is that pembrolizumab in combination with CRT is superior to placebo in combination with CRT with respect to event-free survival (EFS).


title: Non-Interventional, Exploratory, Phase IV, Single-Blind, Cross-Sectional, Randomised, Cross-over Study Evaluating Patient Palatability and Preference of 3 Potassium Binders in Patients With Chronic Kidney Disease & Hyperkalaemia (APPETIZE).

acronym: APPETIZE

summary: This non-interventional, Phase IV, exploratory, cross-over, randomised, single-blind, active comparator-controlled study has been designed to measure the palatability and preference of Lokelma® versus Veltassa® versus S/CPS in patients with dialysis and non-dialysis chronic kidney disease (CKD) and hyperkalaemia (HK). The sponsor hypothesizes that palatability, in terms of taste, texture, smell, and mouthfeel, will score higher (better) for Lokelma when compared with Veltassa and S/CPS.

study_type: Observational

time_perspective: Cross-Sectional

ReferenceCitation: Thomsen RW, Nicolaisen SK, Hasvold P, Sanchez RG, Pedersen L, Adelborg K, Egstrup K, Egfjord M, Sørensen HT. Elevated potassium levels in patients with chronic kidney disease: occurrence, risk factors and clinical outcomes-a Danish population-based cohort study. Nephrol Dial Transplant. 2018 Sep 1;33(9):1610-1620. doi: 10.1093/ndt/gfx312.

ReferenceCitation: Laureati P, Xu Y, Trevisan M, Schalin L, Mariani I, Bellocco R, Sood MM, Barany P, Sjölander A, Evans M, Carrero JJ. Initiation of sodium polystyrene sulphonate and the risk of gastrointestinal adverse events in advanced chronic kidney disease: a nationwide study. Nephrol Dial Transplant. 2020 Sep 1;35(9):1518-1526. doi: 10.1093/ndt/gfz150.

ReferenceCitation: Noel JA, Bota SE, Petrcich W, Garg AX, Carrero JJ, Harel Z, Tangri N, Clark EG, Komenda P, Sood MM. Risk of Hospitalization for Serious Adverse Gastrointestinal Events Associated With Sodium Polystyrene Sulfonate Use in Patients of Advanced Age. JAMA Intern Med. 2019 Aug 1;179(8):1025-1033. doi: 10.1001/jamainternmed.2019.0631. Erratum in: JAMA Intern Med. 2020 Feb 24;:.

ReferenceCitation: Zann V, McDermott J, Jacobs JW, Davidson JP, Lin F, Korner P, Blanks RC, Rosenbaum DP. Palatability and physical properties of potassium-binding resin RDX7675: comparison with sodium polystyrene sulfonate. Drug Des Devel Ther. 2017 Sep 6;11:2663-2673. doi: 10.2147/DDDT.S143461. eCollection 2017.

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

lead_sponsor: AstraZeneca

location_country:
Italy
United States
Sweden
France
Spain
Germany
Canada


ipd_sharing_description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

lead_sponsor: Astellas Pharma Global Development, Inc.

location_country:
Italy
United States
Germany
France
Japan
Greece
Poland
Belgium
Australia
New Zealand
Spain
Denmark
Canada
United Kingdom
Korea, Republic of
Taiwan

acronym: MORPHO

location_facility: University of Minnesota School of Medicine

location_facility: University of Wisconsin Hospital and Clinics

location_facility: University Hospitals of Cleveland Medical Center

title: A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Trial of the FLT3 Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/ITD AML

summary: The purpose of this study is to compare relapse-free survival between participants with FLT3/ITD AML in first morphologic complete remission (CR1) who undergo hematopoietic stem cell transplant (HCT) and are randomized to receive gilteritinib or placebo beginning after the time of engraftment for a two year period.


title: A Double-Blind, Placebo-Controlled Study to Examine the Safety and Efficacy of Pimavanserin for the Treatment of Agitation and Aggression in Alzheimer's Disease

summary: To evaluate the efficacy of pimavanserin compared with placebo in treatment of agitation and aggression after 12 weeks of treatment

status: Terminated

lead_sponsor: ACADIA Pharmaceuticals Inc.

location_country:
Chile
France
Spain
United States
United Kingdom

intervention_type: Other

status_simplified: Unknown


title: A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver)

summary:
This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants with advanced liver cancers. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, modify the participant population, or introduce additional cohorts of participants with other types of advanced primary liver cancer.

Cohort 1 will enroll participants with locally advanced or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy for their disease. Eligible participants will initially be randomly assigned to one of several treatment arms (Stage 1). Participants who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to receive treatment with a different treatment combination (Stage 2). When a Stage 2 treatment combination is available, this will be introduced by amending the protocol.

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

location_country:
France
Israel
New Zealand
China
United States
Korea, Republic of
Taiwan

location_facility: University of California San Francisco Cancer Center; Pharmacy

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: Rabin Medical Center-Beilinson Campus; Davidof Institute

location_facility: The University of Texas Southwestern Medical Center at Dallas


title: Open-label, Phase 2 Study of Tusamitamab Ravtansine (SAR408701) Combined With Pembrolizumab and Tusamitamab Ravtansine (SAR408701) Combined With Pembrolizumab and Platinum-based Chemotherapy With or Without Pemetrexed in Patients With CEACAM5 Positive Expression Advanced/Metastatic Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC)

summary:
Primary Objective:

•To assess the tolerability and to determine the recommended doses of tusamitamab ravtansine in combination with pembrolizumab and tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy with or without pemetrexed in the NSQ NSCLC population

Secondary Objectives:

To assess the safety and tolerability of tusamitamab ravtansine in combination with pembrolizumab and tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy with or without pemetrexed
To assess the antitumor activity of tusamitamab ravtansine in combination with pembrolizumab and tusamitamab ravtansine in combination with pembrolizumab, and platinum-based chemotherapy, with or without pemetrexed in the NSQ NSCLC population
To assess the pharmacokinetics (PK) of tusamitamab ravtansine, pembrolizumab, pemetrexed, cisplatin, and carboplatin, each when given in combination as a doublet (tusamitamab ravtansine + pembrolizumab) or triplet (tusamitamab ravtansine + pembrolizumab + platinum-based chemotherapy) or a quadruplet (tusamitamab ravtansine + pembrolizumab + platinum-based chemotherapy + pemetrexed)
To assess the immunogenicity of tusamitamab ravtansine in combination with pembrolizumab and tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy with or without pemetrexed

lead_sponsor: Sanofi

location_country:
Chile
France
Czechia
Israel
Hungary
Spain
United States

location_facility:
Investigational Site Number :2500005
Investigational Site Number :3480004
Investigational Site Number :2500001
Investigational Site Number :7240001
Investigational Site Number :7240004
Investigational Site Number :8400002
Investigational Site Number :2030002
Investigational Site Number :2500004
Investigational Site Number :7240002
Investigational Site Number :3480003
Investigational Site Number :2030001
Investigational Site Number :7240005
Investigational Site Number :3760002
Investigational Site Number :8400004
Investigational Site Number :7240003
Investigational Site Number :2500003
Investigational Site Number :3480002
Investigational Site Number :3760004
Investigational Site Number :1520003
Investigational Site Number :1520002
Investigational Site Number :1520001
Investigational Site Number :3760001
Investigational Site Number :8400001
Investigational Site Number :3480006


ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

lead_sponsor: Takeda

location_country:
Italy
Brazil
Mexico
Netherlands
Spain
France
Czechia
Poland
Argentina
Australia
China
United States
United Kingdom
Korea, Republic of
Portugal

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS

location_facility: Cambridge University Hospitals NHS Foundation Trust

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

location_facility: Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN

location_facility: The Second Hospital of Anhui Medical University

location_facility: Hospital de Clinicas de Porto Alegre (HCPA) - PPDS

location_facility: The Affiliated Hospital of Guizhou Medical University

location_facility: Hospital Universitario Virgen del Rocio - PPDS

location_facility: Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

location_facility: Princess Maxima Center for Pediatric Oncology - PIN

location_facility: Childrens Medical Center Research Institute at UT Southwestern

location_facility: The Affiliated Hospital of Qingdao University

location_facility: SPZOZ Centralny Szpital Kliniczny UM w Lodzi

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

location_facility: Royal Hospital for Children (Glasgow) - PPDS - PIN

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: West China Second University Hospital, Sichuan Univesity

location_facility: Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E.

location_facility: Assistance Publique Hopitaux de Marseille

location_facility: Severance Hospital Yonsei University Health System

location_facility: SPSK Nr 1 im. Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego

location_facility: Hospital Das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP

location_facility: IRCCS Ospedale Pediatrico Bambino Gesu - INCIPIT - PIN

location_facility: Irmandade Da Santa Casa de Misericordia de Porto Alegre

location_facility: Fundacao Pio XII Hospital de Cancer de Barretos

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez

location_facility: Nuevo Hospital Civil de Guadalajara Dr. Juan I. Menchaca

location_facility: Children's Hospital of Chongqing Medical University

location_facility: Graacc Grupo de Apoio Ao Adolescente E A Crianca Com Cancer

location_facility: Ann and Robert H Lurie Childrens Hospital of Chicago

location_facility: Royal Children's Hospital Melbourne - PIN

location_facility: Ospedale Infantile Regina Margherita - INCIPIT - PIN

location_facility: Cincinnati Children's Hospital Medical Center - PIN

location_facility: Children's Hospital of Soochow University

location_facility: Fndazione MBBM (MONZA E BRIANZA PER IL BAMBINO E LA SUA MAMMA) - c/o Centro Maria Letizia Verga

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

location_facility: Hospital Infantil Universitario Nino Jesus - PIN

title: A Pivotal Phase 1/2, Single-Arm, Open-label Study to Evaluate the Safety and Efficacy of Ponatinib With Chemotherapy in Pediatric Patients With Philadelphia Chromosome-Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) Who Have Relapsed or Are Resistant or Intolerant to a Prior Tyrosine Kinase Inhibitor-Containing Therapy, or Who Have the T315I Mutation

summary:
This study is about an anticancer drug called ponatinib which is a tyrasine kinase inhibitor given with chemotherapy to children, teenagers, and young adults up to 21 years of age with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia who have relapsed or are resistant to other treatment.

The main aims of this study are to confirm the highest dose of ponatinib tablets and minitablet capsules that can be given to participants with acceptable side effects, and to evaluate if participant's leukemia achieves remission.

Participants will take ponatinib tablets with chemotherapy. For participants who cannot swallow tablets, a minitablet form of the ponatinib will be provided. Participants will take ponatinib for 10 weeks in combination with chemotherapy (reinduction and consolidation blocks) and will be followed up for at least 3 years.


title: A Randomized, Double-blind, Multi-dose, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of GSK2330672 Administration for the Treatment of Pruritus in Patients With Primary Biliary Cholangitis (GLIMMER: GSK2330672 triaL of IBAT Inhibition With Multidose Measurement for Evaluation of Response)

summary: This study is being conducted to evaluate the efficacy, safety and tolerability of GSK2330672 administration for the treatment of pruritus (itch) in participants with primary biliary cholangitis (PBC). Participants will receive either placebo or one of the 4 dose regimens of GSK2330672 (20 milligram [mg], 90 mg or 180 mg taken once daily or 90 mg twice daily). Participants on GSK2330672 will also receive placebo tablets to maintain blinding. The study has a prospectively defined adaptive design that will utilize interim data to further inform and potentially optimize the doses under investigation. Hence, additional dose regimen may be added during study. The total duration of a participant in the study will be up to 45 days of screening and 24 weeks of study including follow-up.

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

lead_sponsor: GlaxoSmithKline

location_country:
Italy
United States
Germany
France
Japan
Poland
Australia
Spain
Canada
United Kingdom


title: A Phase 2b, Open-label, Single-arm Study of ZW25 Monotherapy in Subjects With Advanced or Metastatic HER2-amplified Biliary Tract Cancers

summary: This multicenter, open-label, single-arm trial will evaluate the anti-tumor activity of ZW25 (zanidatamab) monotherapy in subjects with human epidermal growth factor receptor 2 (HER2)-amplified, inoperable and advanced or metastatic biliary tract cancer (BTC), including intra-hepatic cholangiocarcinoma (ICC), extra-hepatic cholangiocarcinoma (ECC), and gallbladder cancer (GBC).

lead_sponsor: Zymeworks Inc.

location_country:
Italy
Chile
Spain
France
Korea, Republic of
China
United States
United Kingdom
Canada

location_facility: Institut de Cancerologie et d'Hematologie Hopital Morvan - CHRU de Brest

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

location_facility: Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School

location_facility: Hospital Universitari Parc Tauli de Sabadell

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

location_facility: Winship Cancer Institute, Emory University

location_facility: University of Texas Southwestern Medical Center - Hospital

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: Washington University School of Medicine

location_facility: Pontificia Universidad Catolica de Chile

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

location_facility: Seoul National University Bundang Hospital

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Affiliated Tumor Hospital of Harbin Medical University

location_facility: Severance Hospital Yonsei University Health System

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Département Oncologie Gastro-entérologie CHRU de Poitiers La Miletrie

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: The First Affiliated Hospital of Zhengzhou University

location_facility: The Third Affiliated Hospital of the Chinese PLA

location_facility: University College London Hospitals (UCLH)

location_facility: The First Affiliated Hospital of Zhejiang University

location_facility: Affiliated Zhongshan Hospital of Fudan University

location_facility: The Oncology Institute of Hope and Innovation

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

location_facility: Fondazione del Piemonte per l'Oncologia (IRCCS)


title: An Umbrella Study of INCMGA00012 Alone and in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-Based Chemotherapy (POD1UM-204)

summary: This is a multicenter, open-label, nonrandomized, Phase 2 umbrella study of retifanlimab in participants who have advanced or metastatic endometrial cancer that has progressed on or after platinum-based chemotherapy. retifanlimab will be administered as monotherapy or in combination with other immunotherapy or targeted agents.

lead_sponsor: Incyte Corporation

location_country:
Italy
France
Greece
Belgium
United States

location_facility: The Ohio State University Wexner Medical Center Division of Gynecologic Oncology

location_facility: Euromedica General Clinic of Thessaloniki

location_facility: Universitaire Ziekenhuis Leuven - Gasthuisberg

location_facility: Presidio Ospedaliero Di Summa Antonio Perrino

location_facility: University of North Carolina At Chapel Hill

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

location_facility: Istituto Nazionale Tumori Irccs Fondazione Pascale

location_facility: University Hospital of West Attica - Attikon

location_facility: Arizona Oncology Associates - Biltmore Cancer Center

location_facility: Fondazione Policlinico Universitario Agostino Gemelli Irccs

location_facility: Cario - Centre Armoricain de Radiotherapie Imagerie Medicale Et Oncologie


ReferenceCitation: Gaspar N, Campbell-Hewson Q, Gallego Melcon S, Locatelli F, Venkatramani R, Hecker-Nolting S, Gambart M, Bautista F, Thebaud E, Aerts I, Morland B, Rossig C, Canete Nieto A, Longhi A, Lervat C, Entz-Werle N, Strauss SJ, Marec-Berard P, Okpara CE, He C, Dutta L, Casanova M. Phase I/II study of single-agent lenvatinib in children and adolescents with refractory or relapsed solid malignancies and young adults with osteosarcoma (ITCC-050)(☆). ESMO Open. 2021 Oct;6(5):100250. doi: 10.1016/j.esmoop.2021.100250. Epub 2021 Sep 22.

family: Gaspar

full_name: N. Gaspar

given: N.

family: Campbell-Hewson

full_name: Q. Campbell-Hewson

given: Q.

family: Gallego Melcon

full_name: S. Gallego Melcon

given: S.

family: Locatelli

full_name: F. Locatelli

given: F.

family: Venkatramani

full_name: R. Venkatramani

given: R.

family: Hecker-Nolting

full_name: S. Hecker-Nolting

family: Gambart

full_name: M. Gambart

given: M.

family: Bautista

full_name: F. Bautista

family: Thebaud

full_name: E. Thebaud

given: E.

family: Aerts

full_name: I. Aerts

given: I.

family: Morland

full_name: B. Morland

given: B.

family: Rossig

full_name: C. Rossig

given: C.

family: Canete Nieto

full_name: A. Canete Nieto

given: A.

family: Longhi

full_name: A. Longhi

family: Lervat

full_name: C. Lervat

family: Entz-Werle

full_name: N. Entz-Werle

family: Strauss

full_name: S.J. Strauss

family: Marec-Berard

full_name: P. Marec-Berard

given: P.

family: Okpara

full_name: C.E. Okpara

family: He

full_name: C. He

family: Dutta

full_name: L. Dutta

given: L.

family: Casanova

full_name: M. Casanova

currency_apc_doaj: EUR

journal_name: ESMO Open

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

title: Phase I/II study of single-agent lenvatinib in children and adolescents with refractory or relapsed solid malignancies and young adults with osteosarcoma (ITCC-050)☆

location_country:
Italy
South Africa
Peru
Guatemala
Serbia
Sweden
Spain
Croatia
Czechia
France
Israel
Hungary
Belgium
Argentina
Australia
New Zealand
Russian Federation
Turkey
United States
Korea, Republic of

location_facility: Dmitry Rogachev National Research Center ( Site 0550)

location_facility: Hospital Universitario Sant Joan de Deu ( Site 0476)

location_facility: Royal Childrens Hospital Melbourne ( Site 0802)

location_facility: IRCCS Ospedale Pediatrico Bambino Gesu ( Site 0410)

location_facility: Hospital de Niños Ricardo Gutiérrez ( Site 0125)

location_facility: Klinicki bolnicki centar Rijeka ( Site 0726)

location_facility: Seoul National University Hospital ( Site 0875)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0401)

location_facility: Institute for Oncology and Radiology of Serbia ( Site 0780)

location_facility: Skanes Universitetssjukhus Lund. ( Site 0525)

location_facility: Fakultni nemocnice v Motole ( Site 0650)

location_facility: Ege Universitesi Tip Fakultesi ( Site 0601)

location_facility: Hospital Universitario Austral ( Site 0126)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 0677)

location_facility: A.O.Universitaria Meyer-Oncology & Haematology Unit ( Site 0400)

location_facility: Univerzitetska decja klinika ( Site 0782)

location_facility: Monroe Carell Jr. Children's Hospital at Vanderbilt ( Site 0102)

location_facility: Children's Hospital of Colorado ( Site 0110)

location_facility: Unidad Nacional de Oncologia Pediatrica ( Site 0176)

location_facility: Queensland Children s Hospital ( Site 0804)

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi OktatoKorhaz ( Site 0678)

location_facility: Dokuz Eylul Universitesi Arastirma Uygulama Hastanesi ( Site 0602)

location_facility: Mary Crowley Cancer Research Center ( Site 0107)

location_facility: Starship Childrens Hospital ( Site 0826)

location_facility: Klinika za djecje bolesti Zagreb ( Site 0725)

location_facility: Ospedale Infantile Regina Margherita ( Site 0412)

location_facility: St.Petersburg State Medical Univ. n.a. acad. I.P.Pavlov ( Site 0554)

location_facility: Istanbul Universitesi Onkoloji Enstitusu ( Site 0600)

location_facility: Hacettepe Universitesi Tip Fakultesi ( Site 0603)

location_facility: Clinical Research Center of specialized types medical care-Oncology ( Site 0553)

location_facility: Fakultni Nemocnice Brno Bohunice ( Site 0651)

title: An Open-Label, Multicenter Phase 2 Basket Study to Evaluate the Antitumor Activity and Safety of Lenvatinib in Children, Adolescents, and Young Adults With Relapsed or Refractory Solid Malignancies

summary: The main purpose of this study is to evaluate the antitumor activity and safety of Lenvatinib (MK-7902/E7080) in children, adolescents, and young adults with relapsed or refractory solid malignancies after administration. Participants will be enrolled into initial tumor-specific cohorts which will be expanded based on observed response.


ReferenceCitation: Lebwohl MG, Papp KA, Mørch MH, Bernasconi MYJ, Warren RB. Long-Term Proactive Treatment of Plaque Psoriasis with Calcipotriene/Betamethasone Dipropionate Foam Prolongs Remission and Reduces Relapses Irrespective of Patient Baseline Characteristics. Dermatol Ther (Heidelb). 2021 Oct;11(5):1657-1665. doi: 10.1007/s13555-021-00585-x. Epub 2021 Aug 2.

family: Lebwohl

full_name: Mark G. Lebwohl

given: Mark G.

family: Papp

full_name: Kim A. Papp

given: Kim A.

family: Mørch

full_name: Marie Holst Mørch

given: Marie Holst

family: Bernasconi

full_name: Marie Y. Jablonski Bernasconi

given: Marie Y. Jablonski

family: Warren

full_name: Richard B. Warren

given: Richard B.

journal_name: Dermatology and Therapy

license: cc-by-nc

license_normalized: cc-by-nc

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Stein Gold L, Alonso-Llamazares J, Lacour JP, Warren RB, Tyring SK, Kircik L, Yamauchi P, Lebwohl M; PSO-LONG Trial Investigators. PSO-LONG: Design of a Novel, 12-Month Clinical Trial of Topical, Proactive Maintenance with Twice-Weekly Cal/BD Foam in Psoriasis. Adv Ther. 2020 Nov;37(11):4730-4753. doi: 10.1007/s12325-020-01497-6. Epub 2020 Sep 23.

family: Stein Gold

full_name: Linda Stein Gold

given: Linda

family: Alonso-Llamazares

full_name: Javier Alonso-Llamazares

given: Javier

family: Lacour

full_name: Jean-Philippe Lacour

given: Jean-Philippe

family: Tyring

full_name: Stephen K. Tyring

given: Stephen K.

family: Kircik

full_name: Leon Kircik

given: Leon

family: Yamauchi

full_name: Paul Yamauchi

given: Paul

full_name: Mark Lebwohl

given: Mark

journal_name: Advances in Therapy

oa_colors: green hybrid

evidence: open (via crossref license)

location_country:
United States
France
Poland
Germany
United Kingdom
Canada

location_facility: The Guenther Dermatology Research Centre

location_facility: Psoriasis Treatment Center of Central NJ

location_facility: Rivergate Dermatology Clinical Research Center

location_facility: Kliniczny Szpital Wojewódzki, Klinika Dermatologii

location_facility: Universitätsklinikum Essen (AöR), Klinik für Dermatologie

location_facility: C.H.U. de nice, Hôpital de l'Archet II, Service de Dermatologie-Vénérologie

location_facility: Henry Ford Medical Center - New Center One

location_facility: C.H.U. de Saint-Etienne Service de Dermatologie

location_facility: Center for Dermatology Clinical Research

title: LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris

summary:
A phase 3 trial comparing the efficacy and safety of LEO 90100 aerosol foam with the aerosol foam vehicle used twice weekly as long-term maintenance therapy in subjects with psoriasis vulgaris.

A 12-month, international, multi-centre, randomised, vehicle controlled, double-blind, 2-arm, parallel group trial.


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://www.clinicalstudydatarequest.com/.

location_country:
Italy
Austria
United States
Switzerland
France
Czechia
Israel
Hungary
Belgium
Spain
Turkey
Canada
United Kingdom

location_facility:
Investyigator Site 1
Investigator site 1
Investigator Site 2
Investigator Site
Investigator site
Investigator Site 1
Investigator site 2

title: Prospective Follow-up Study for Patients Who Completed Study ALX0681-C301 (HERCULES) to Evaluate Long-term Safety and Efficacy of Caplacizumab (Post-HERCULES)

summary: The objectives of this study were to evaluate long-term safety and efficacy of caplacizumab, to evaluate safety and efficacy of repeated use of caplacizumab and to characterize long-term impact of acquired thrombotic thrombocytopenic purpura (aTTP).


lead_sponsor: Jazz Pharmaceuticals

primary_purpose: Prevention

location_country:
Italy
United States
Germany
France
Japan
Israel
Belgium
Australia
New Zealand
Spain
Turkey
Canada
United Kingdom
Korea, Republic of

location_facility: Schneider Children Medical Center of Israel

location_facility: Medical University of South Carolina - PPDS

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden

location_facility: 11. Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G M Lancisi G Salesi

location_facility: Hospital Infantil Universitario Niño Jesus

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopôle

location_facility: Akdeniz University Medical Faculty Department of Pediatrics

location_facility: Penn State Milton S Hershey Medical Center

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Medical Hospital Tokyo Medical and Dental University

location_facility: Centre Hospitalier Universitaire du Sart Tilman

location_facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: Acibadem Universitesi Tip Fakultesi Atakent Hastanesi

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

location_facility: Hospital Regional Universitario de Malaga Hospital General

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: Severance Hospital at Yonsei University Health System

location_facility: Ann and Robert H Lurie Childrens Hospital of Chicago

location_facility: Japanese Red Cross Nagoya Daiichi Hospital

title: A Phase 3, Randomized, Adaptive Study Comparing the Efficacy and Safety of Defibrotide vs Best Supportive Care in the Prevention of Hepatic Veno-Occlusive Disease in Adult and Pediatric Patients Undergoing Hematopoietic Stem Cell Transplant

summary: This study is to compare the efficacy and safety of defibrotide prophylaxis in addition to best supportive care versus best supportive care alone in the prevention of hepatic veno- occlusive disease (VOD) in adult and pediatric patients undergoing hematopoietic stem cell transplant who are at high risk or very high risk of developing VOD.


title: A Prospective, Non-interventional Study Measuring Quality of Life, Treatment Preference and Treatment Satisfaction of Autosomal Dominant Polycystic Kidney Disease Patients in Europe

acronym: ACQUIRE

summary: This is a prospective, non-interventional study (NIS) measuring health-related quality of life (HRQoL), treatment satisfaction, and other patient-reported outcomes (PROs) of ADPKD patients in Europe.

status: Unknown status

time_perspective: Prospective

ReferenceCitation: Joly D, Quinn J, Mokiou S, O'Reilly K, Sánchez-Covisa J, Wang-Silvanto J, Doll H. Rationale and study protocol of ACQUIRE, a prospective, observational study measuring quality of life, treatment preference and treatment satisfaction of autosomal dominant polycystic kidney disease (ADPKD) patients in Europe. BMC Nephrol. 2020 Jul 24;21(1):298. doi: 10.1186/s12882-020-01927-1.

family: Joly

full_name: Dominique Joly

given: Dominique

family: Quinn

full_name: Jennifer Quinn

given: Jennifer

family: Mokiou

full_name: Stella Mokiou

given: Stella

family: O’Reilly

full_name: Karl O’Reilly

given: Karl

family: Sánchez-Covisa

full_name: Joaquín Sánchez-Covisa

given: Joaquín

family: Wang-Silvanto

full_name: Jing Wang-Silvanto

given: Jing

family: Doll

full_name: Helen Doll

given: Helen

journal_name: BMC Nephrology

lead_sponsor: Otsuka Pharmaceutical Europe Ltd

location_country:
Austria
Switzerland
France
Belgium
Spain
Germany
United Kingdom

location_facility: University Medical Center Schleswig-Holstein

location_facility: CHU Liège - Domaine Universitaire du Sart Tilman