acronym: AD Up

lead_sponsor: AbbVie

summary: The objective of this study is to assess the efficacy and safety of upadacitinib combined with topical corticosteroids (TCS) for the treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

ReferenceCitation: Silverberg JI, Simpson EL, Calimlim BM, Litcher-Kelly L, Li X, Sun X, Leshem YA. Determining Severity Strata for Three Atopic Dermatitis Patient-Reported Outcome Questionnaires: Defining Severity Score Ranges for the Worst Pruritus Numerical Rating Scale and the Atopic Dermatitis Symptom and Impact Scales (ADerm-SS and ADerm-IS). Dermatol Ther (Heidelb). 2022 Dec;12(12):2817-2827. doi: 10.1007/s13555-022-00836-5. Epub 2022 Nov 4.

ReferenceCitation: Mendes-Bastos P, Ladizinski B, Guttman-Yassky E, Jiang P, Liu J, Prajapati VH, Simpson EL, Vigna N, Teixeira HD, Barbarot S. Characterization of acne associated with upadacitinib treatment in patients with moderate-to-severe atopic dermatitis: A post hoc integrated analysis of 3 phase 3 randomized, double-blind, placebo-controlled trials. J Am Acad Dermatol. 2022 Oct;87(4):784-791. doi: 10.1016/j.jaad.2022.06.012. Epub 2022 Jun 15.

repository_institution: CCSD (Centre pour la Communication Scientifique Directe) - HAL - Nantes Université

repository_normalized: HAL

repositories_concat: HAL

ReferenceCitation: Reich K, Teixeira HD, de Bruin-Weller M, Bieber T, Soong W, Kabashima K, Werfel T, Zeng J, Huang X, Hu X, Hendrickson BA, Ladizinski B, Chu AD, Silverberg JI. Safety and efficacy of upadacitinib in combination with topical corticosteroids in adolescents and adults with moderate-to-severe atopic dermatitis (AD Up): results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2021 Jun 5;397(10290):2169-2181. doi: 10.1016/S0140-6736(21)00589-4. Epub 2021 May 21. Erratum In: Lancet. 2021 Jun 19;397(10292):2336. Lancet. 2021 Aug 28;398(10302):746.

location_facility: Hospital Universitario 12 de Octubre /ID# 201135

location_facility: Clinical Research of West Florida, Inc /ID# 203643

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 201765

location_facility: Hiroshima University Hospital /ID# 201914

location_facility: Eastern Canada Cutaneous Resea /ID# 200335

location_facility: Universitaetsklinikum Muenster /ID# 202094

location_facility: Guy's and St Thomas' NHS Foundation Trust /ID# 204642

location_facility: Center for Clinical Studies - Webster TX /ID# 203186

location_facility: Universitaetsklinikum Frankfurt /ID# 202095

location_facility: Michigan Center for Research Company /ID# 200560

location_facility: Dartmouth-Hitchcock Medical Center /ID# 200918

location_facility: University of Wisconsin - Madison /ID# 204933

location_facility: Duplicate_University of Colorado Anchutz Medical Campus /ID# 202822

location_facility: Xiangya Hospital Central South University /ID# 207510

location_facility: Northwestern University Feinberg School of Medicine /ID# 201646

location_facility: Hospital Universitario La Paz /ID# 205438

location_facility: University of California Irvine /ID# 200902

location_facility: Advanced Clinical Research - Woseth Dermatology /ID# 213745

location_facility: Progressive Clinical Research /ID# 201582

location_facility: The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 207132

location_facility: Fakultna nemocnica s poliklinikou J.A. Reimana Presov /ID# 204373

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 204144

location_facility: South Infirmary Victoria University Hospital /ID# 201079

location_facility: Arizona Research Center, Inc. /ID# 200546

location_facility: Colorado Center for Dermatology, PLLC /ID# 203626

location_facility: Epiphany Dermatology of Kansas LLC /ID# 203026

location_facility: Vseobecna fakultni nemocnice v Praze /ID# 202045

location_facility: Psoriasis Treatment Center of Central New Jersey /ID# 200714

location_facility: Queens Square Medical Center dermatology allergology /ID# 203850

location_facility: Bakersfield Derma & Skin Cance /ID# 200892

location_facility: Dre Angelique Gagne-Henley M.D. inc. /ID# 200330

location_facility: Soroka University Medical Center /ID# 206652

location_facility: CMS3 Company for Medical Study /ID# 205195

location_facility: Duplicate_Vseobecna Fakultni Nemocnice /ID# 205248

location_facility: Duplicate_Western States Clinical Research, Inc. /ID# 201702

location_facility: Universitetssykehuset N-Norge, Tromso /ID# 201270

location_facility: Dermatology Research Institute Inc. /ID# 200341

location_facility: Universitair Medisch Centrum Groningen /ID# 202195

location_facility: University General Hospital Attikon /ID# 201126

location_facility: Kepler Universitaetsklinikum GmbH /ID# 201075

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 200744

location_facility: Haukeland University Hospital /ID# 201152

location_facility: Tokai University Hachioji Hospital /ID# 201711

location_facility: Guy's and St Thomas' NHS Foundation Trust /ID# 201193

location_facility: Hospital General Universitario Alicante /ID# 200873

location_facility: Oregon Dermatology and Research Center /ID# 200601

location_facility: National Hospital Organization Sagamihara National Hospital /ID# 201658

location_facility: Leeds Teaching Hospitals NHS Trust /ID# 201106

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 205194

location_facility: Beth Israel Deaconess Medical Center /ID# 200545

location_facility: CHRU Tours - Hopital Gatien de Clocheville /ID# 218209

location_facility: Thessaloniki Hospital of Skin and Venereal Diseases /ID# 201124

location_facility: IMTR - Grand Hopital de Charleroi /ID# 202029

location_facility: General Hospital Andreas Syggros /ID# 201123

location_facility: Ordensklinikum Linz GmbH Elisabethinen /ID# 209567

location_facility: Chu de Nice-Hopital L'Archet Ii /Id# 205780

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 200690

location_facility: Chinese PLA General Hospital /ID# 206786

location_facility: Clin Res Inst of Michigan, LLC /ID# 208020

location_facility: Tel Aviv Sourasky Medical Center /ID# 201608

location_facility: Advanced Dermatology and Skin Care Centre /ID# 213550

location_facility: Juntendo University Hospital /ID# 202888

location_facility: AP-HM - Hopital de la Timone /ID# 206128

location_facility: Univerzitna nemocnica Martin /ID# 203851

location_facility: Vital Prospects Clinical Research Institute, PC /ID# 200901

location_facility: Medical Corporation Matsuo Clinic /ID# 202312

location_facility: Universitair Medisch Centrum Utrecht /ID# 202194

location_facility: Fakultna nemocnica s poliklinikou Nove Zamky /ID# 204240

location_facility: Dermatology Physicians of Connecticut /ID# 201004

location_facility: Advanced Clinical Research at Treasure Valley Dermatology & Skin Cancer Center /ID# 203628

location_facility: The Chaim Sheba Medical Center /ID# 201611

location_facility: Medizinische Universitaet Wien /ID# 201080

location_facility: Hospital Universitario de la Princesa /ID# 201517

location_facility: 401 GSNA - 401 Army General Hospital /ID# 211963

location_facility: University Hospital Waterford /ID# 201253

location_facility: Huashan Hospital of Fudan University /ID# 207437

location_facility: Karolinska University Hospital /ID# 201243

location_facility: Clear Dermatology & Aesthetics Center /ID# 201257

location_facility: Dermatology Associates of Seattle /ID# 200717

location_facility: Skane University Hospital Lund /ID# 201244

location_facility: The second Affiliated hospital of Zhejiang University school of Medicine /ID# 207442

location_facility: A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 200742

location_facility: Northshore University Health System Dermatology Clinical Trials Unit /ID# 200556

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 204372

location_facility: The Centre for Clinical Trials /ID# 205404

location_facility: Medizinische Universitaet Innsbruck /ID# 210897

location_facility: GCM Medical Group PSC - Hato Rey /ID# 202003

location_facility: Total Skin and Beauty Derm Ctr /ID# 200548

location_facility: Centre de recheche dermatologique du Quebec Metropolitain /ID# 205403

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 202256

location_facility: Universitaetsklinik Heidelberg /ID# 202097

location_facility: Azienda Ospedaliera Universitaria Federico II /ID# 200751

location_facility: Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 206728

location_facility: Arlington Research Center, Inc /ID# 200559

location_facility: NHS Greater Glasgow and Clyde /ID# 201374

location_facility: Sahlgrenska University Hospital /ID# 201274

location_facility: Medizinische Hochschule Hannover /ID# 202098

location_facility: Osaka Habikino Medical Center /ID# 204243

location_facility: Oxford University Hospitals NHS Foundation Trust /ID# 202052

location_facility: Clinical Research Puerto Rico /ID# 203644

location_facility: Children's Hosp P. A. Kyriakou /ID# 217573

location_facility: Jichi Medical University Hospital /ID# 201913

location_facility: Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 202093

location_facility: Rivergate Dermatology & Skin Care Center /ID# 201698

location_facility: Hospital Universitario de Puerto Real /ID# 200875

location_facility: Yamate Dermatological Clinic /ID# 202130

location_facility: Angela Montgomery Medicine Professional Corporation /ID# 212653

location_facility: Sanatorium profesora Arenbergera /ID# 202082

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 203014

location_facility: St George Dermatology & Skin Cancer Centre /ID# 204788

location_facility: Derma-B Egeszsegugyi es Szolgaltato Kft. /ID# 217866

location_facility: Florida Academic Centers Research and Education /ID# 200544

location_facility: Papageorgiou General Hospital Thessaloniki /ID# 202392

location_facility: Hospital Santa Creu i Sant Pau /ID# 201325

location_facility: The First Hospital of China Medical University /ID# 209840

location_facility: Universitetssykehuset N-Norge, Harstad /ID# 201269

location_facility: Therapeutics Clinical Research /ID# 200593

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 206669

title: A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis

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:
Germany
Ireland
New Zealand
Australia
Japan
Czechia
Canada
France
Slovakia
Hungary
Hong Kong
United States
Belgium
China
Puerto Rico
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Spain
Greece
Israel


type: EudraCT Number

title: A Phase 1/2 Study of REGN4018 (A MUC16xCD3 Bispecific Antibody) Administered Alone or in Combination With Cemiplimab in Patients With Recurrent Ovarian Cancer or Other Recurrent MUC16+ Cancers

summary:
The main purpose of this study is to:

Learn about the safety of REGN4018 and to find out what dose of REGN4018 can be given alone or with cemiplimab to patients with ovarian cancer or cancer of the uterus
The study will also look at the levels of REGN4018 and/or cemiplimab in your body and measure how well your body can remove the study drug(s). This is called pharmacokinetics
The study will also look at any signs that REGN4018 alone or with cemiplimab can treat recurrent advanced ovarian cancer or cancer of the uterus
To find out how safe and tolerable the sarilumab pretreatment is, in combination with REGN4018 and cemiplimab

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: Regeneron Pharmaceuticals

location_country:
France
Italy
United Kingdom
Australia
Netherlands
Belgium
United States
Korea, Republic of
Spain
Israel

location_facility: James Care Gynecologic Oncology at Mill Run

location_facility: Fondazione Policlinico Agostino Gemelli IRCCS di Roma

location_facility: Radboudumc, dept Medical Oncology hp 452

location_facility: Hospital Clinico Universitatio Santiago de Compostela

location_facility: Seoul National University College of Medicine

location_facility: UNICANCER - Centre Francois Baclesse (CFB)

location_facility: Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

location_facility: The General Hospital Corporation d/b/a Massachusetts General Hospital

location_facility: Rambam Health Care Campus RHCC - Rambam Medical Center

location_facility: Columbia University Irving Medical Center

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


lead_sponsor: Genentech, Inc.

summary: This study will evaluate the safety and efficacy of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in chemotherapy-naive patients with locally advanced unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC), excluding patients with a sensitizing EGFR mutation or ALK translocation.

ReferenceType: derived

ReferenceCitation: Cho BC, Abreu DR, Hussein M, Cobo M, Patel AJ, Secen N, Lee KH, Massuti B, Hiret S, Yang JCH, Barlesi F, Lee DH, Ares LP, Hsieh RW, Patil NS, Twomey P, Yang X, Meng R, Johnson ML. Tiragolumab plus atezolizumab versus placebo plus atezolizumab as a first-line treatment for PD-L1-selected non-small-cell lung cancer (CITYSCAPE): primary and follow-up analyses of a randomised, double-blind, phase 2 study. Lancet Oncol. 2022 Jun;23(6):781-792. doi: 10.1016/S1470-2045(22)00226-1. Epub 2022 May 13.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: Hopital Nord AP-HM; Service Clinique des bronches allergies et sommeil

location_facility: Hospital Universitari Vall d'Hebron; Oncology

location_facility: Centro Medico Quironsalud Sagrado Corazon

location_facility: Clinical Hospital Center Bezanijska Kosa; Physical Medicine and Rehabilitation

location_facility: Northwest Cancer Specialists - Vancouver

location_facility: Hospital General Universitario de Alicante

location_facility: Hospital Regional Universitario de Malaga ? Hospital General; Servicio de Neurologia

location_facility: Institut Bergonié Centre Régional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest

location_facility: National Cheng Kung University Hospital; Internal Medicine

location_facility: SCRI Florida Cancer Specialists North; Research Office North Region.

location_facility: Seoul National University Bundang Hospital

location_facility: Centre Georges François Leclerc; Service Pharmacie, Bp 77980

location_facility: Complejo Hospitalario Universitario Insular?Materno Infantil

location_facility: Taipei Medical University ?Shuang Ho Hospital

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Institut De Cancerologie De L'Ouest; Medical Oncology

status: Active, not recruiting

title: A Phase II, Randomized, Blinded, Placebo-Controlled Study of Tiragolumab, An Anti-TIGIT Antibody, In Combination With Atezolizumab In Chemotherapy-Naïve Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer

source: euctr

enrollment_type: Actual

design_allocation: Randomized

location_country:
United States
Spain
Korea, Republic of
Taiwan
Serbia
France


lead_sponsor: Agios Pharmaceuticals, Inc.

summary: Study AG348-C-006 evaluated the efficacy and safety of orally administered AG-348 as compared with placebo in participants with pyruvate kinase (PK) deficiency, who were not regularly receiving blood transfusions. Participants were randomized 1:1 to receive either AG-348 or a matching placebo.

ReferenceCitation: Al-Samkari H, Galacteros F, Glenthoj A, Rothman JA, Andres O, Grace RF, Morado-Arias M, Layton DM, Onodera K, Verhovsek M, Barcellini W, Chonat S, Judge MP, Zagadailov E, Xu R, Hawkins P, Beynon V, Gheuens S, van Beers EJ; ACTIVATE Investigators. Mitapivat versus Placebo for Pyruvate Kinase Deficiency. N Engl J Med. 2022 Apr 14;386(15):1432-1442. doi: 10.1056/NEJMoa2116634.

oa_host_type: publisher

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Rab MAE, Van Oirschot BA, Kosinski PA, Hixon J, Johnson K, Chubukov V, Dang L, Pasterkamp G, Van Straaten S, Van Solinge WW, Van Beers EJ, Kung C, Van Wijk R. AG-348 (Mitapivat), an allosteric activator of red blood cell pyruvate kinase, increases enzymatic activity, protein stability, and ATP levels over a broad range of PKLR genotypes. Haematologica. 2021 Jan 1;106(1):238-249. doi: 10.3324/haematol.2019.238865.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

location_facility: Toronto General Hospital, University Health Network

location_facility: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

location_facility: Indiana Hemophilia and Thrombosis Center

location_facility: Hospital Central da Faculdade de Medicina USP Cidade Universitaria

location_facility: Department of Paediatrics and Thalassaemia Center, Faculty of Medicine Siriraj

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Wayne State University School of Medicine, Children's Hospital of Michigan

location_facility: Kansai Medical University, Department of Pediatrics, Hirakata Hospital

location_facility: Imperial College Healthcare NHS Trust, Hammersmith Hospital

location_facility: Primary Children's Hospital Univ. of Utah

location_facility: The Children's Hospital Corporation d/b/a Boston's Children Hospital

location_facility: McMaster University - Health Sciences Centre

location_facility: The Royal Liverpool and Broadgreen University

location_facility: AOU Policlinico, Università della Campania "Luigi Vanvitelli"

location_facility: University of Arkansas for Medical Sciences

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: University of Copenhagen, Herlev Hospital

location_facility: Institute of Hematology and Blood Transfusion

location_facility: Hospital U. Vall d'Hebron Servicio de Hematología Clínica

location_facility: Hospital Clinico Universitario Virgen de la Arricaxa

status: Completed

title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AG-348 in Not Regularly Transfused Adult Subjects With Pyruvate Kinase Deficiency

study_completion_date_type: Actual

location_country:
Germany
Italy
United Kingdom
Denmark
Japan
Brazil
Netherlands
Switzerland
United States
Korea, Republic of
Spain
Thailand
Turkey
Czechia
Canada
France

ipd_sharing: No

status_simplified: Completed


lead_sponsor: Jazz Pharmaceuticals

summary: This is a study of the efficacy and safety of JZP-258, an oxybate mixed-salts oral solution being developed as a low sodium alternative product for Xyrem.

ReferenceCitation: Dauvilliers Y, Arnulf I, Foldvary-Schaefer N, Morse AM, Sonka K, Thorpy MJ, Mignot E, Chandler P, Parvataneni R, Black J, Sterkel A, Chen D, Skobieranda F, Bogan RK. Safety and efficacy of lower-sodium oxybate in adults with idiopathic hypersomnia: a phase 3, placebo-controlled, double-blind, randomised withdrawal study. Lancet Neurol. 2022 Jan;21(1):53-65. doi: 10.1016/S1474-4422(21)00368-9.

location_facility: SleepCare Research Institute d/b/a Clinical Research

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Montefiore Medical Center/Sleep-Wake Disorders Center

location_facility: Ohio Sleep Medicine and Neuroscience Institute

location_facility: Hospital Vithas Nuestra Señora de America

location_facility: lnstytut Psychiatrii i Neurologii, Zaklad Neurofizjologii Klinicznej

location_facility: Southern California Institute for Respiratory Diseases, Inc.

location_facility: Hospital Universitario Clinico San Carlos

title: A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension

location_country:
Finland
Poland
United Kingdom
Belgium
United States
Spain
Czechia
France


lead_sponsor: LEO Pharma

summary:
Primary objective:

To evaluate the efficacy of subcutaneous (SC) administration of tralokinumab compared with placebo in treating adolescent subjects (age 12 to <18 years) with moderate-to-severe AD.

Secondary objectives:

To evaluate the efficacy of tralokinumab on severity and extent of AD, itch, and health-related quality of life compared with placebo.

To investigate the safety, immunogenicity, and tolerability of SC administration of tralokinumab compared with placebo when used to treat adolescent subjects (age 12 to <18 years) with moderate-to-severe AD.

ReferenceType: result

ReferenceCitation: Paller AS, Flohr C, Cork M, Bewley A, Blauvelt A, Hong HC, Imafuku S, Schuttelaar MLA, Simpson EL, Soong W, Arlert P, Lophaven KW, Kurbasic A, Soldbro L, Vest NS, Wollenberg A. Efficacy and Safety of Tralokinumab in Adolescents With Moderate to Severe Atopic Dermatitis: The Phase 3 ECZTRA 6 Randomized Clinical Trial. JAMA Dermatol. 2023 Jun 1;159(6):596-605. doi: 10.1001/jamadermatol.2023.0627. Erratum In: JAMA Dermatol. 2023 Jun 1;159(6):673.

oa_colors: green hybrid

evidence: open (via free pdf)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

repositories_concat: PubMed Central;pure.rug.nl

unpaywall_oa_status: hybrid

publisher_dissemination: American Medical Association

ReferenceCitation: Soehoel A, Larsen MS, Timmermann S. Population Pharmacokinetics of Tralokinumab in Adult Subjects With Moderate to Severe Atopic Dermatitis. Clin Pharmacol Drug Dev. 2022 Aug;11(8):910-921. doi: 10.1002/cpdd.1113. Epub 2022 Jun 7.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: Wiley

location_facility:
Leo Pharma Investigational Site
Leo Pharma Investigationel Site
LEO Pharma Investigational Site

title: A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Trial to Evaluate the Efficacy, Safety, and Tolerability of Tralokinumab Monotherapy in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) Who Are Candidates for Systemic Therapy

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

location_country:
Germany
Poland
United Kingdom
Australia
Japan
Netherlands
Belgium
United States
Canada
France

ipd_sharing: Yes


acronym: CheckMate 9UT

lead_sponsor: Bristol-Myers Squibb

summary: A study to evaluate the safety and tolerability of nivolumab or nivolumab Plus BMS-986205 with or without BCG in BCG-Unresponsive non-muscle invasive Bladder Cancer.

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Instituto Nazionale Tumori Fondazione G. Pascale

status: Terminated

title: A Phase 2, Randomized, Open-label Study of Nivolumab or Nivolumab/BMS-986205 Alone or Combined With Intravesical BCG in Participants With BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer

location_country:
Italy
United Kingdom
Argentina
Hong Kong
Australia
Brazil
Netherlands
Mexico
United States
China
Spain
Chile
Canada
Russian Federation
France

status_simplified: Unknown


acronym: innovaTV 207

lead_sponsor: Seagen Inc.

summary:
This trial will study tisotumab vedotin to find out whether it is an effective treatment for certain solid tumors and what side effects (unwanted effects) may occur. There are seven parts to this study.

In Part A, the treatment will be given to participants every 3 weeks (3-week cycles).
In Part B, participants will receive tisotumab vedotin on Days 1, 8, and 15 every 4-week cycle.
In Part C, participants will receive tisotumab vedotin on Days 1 and 15 of every 4-week cycle.

In Part D, participants will be given treatment on Day 1 of every 3-week cycle. Participants in Part D will get tisotumab vedotin with either:

Pembrolizumab or,
Pembrolizumab and carboplatin, or
Pembrolizumab and cisplatin
In Part E, participants will receive tisotumab vedotin on Days 1 and 15 of every 4-week cycle.
In Part F, participants will receive tisotumab vedotin on Days 1, 15, and 29 of every 6-week cycle. Participants in Part F will get tisotumab vedotin with pembrolizumab.
In Part G, participants will receive tisotumab vedotin on Days 1, 15, and 29 of every 6-week cycle. Participants in Part G will get tisotumab vedotin with pembrolizumab and carboplatin.

sponsor_collaborators:
Seagen Inc.
Genmab
Merck Sharp & Dohme LLC

location_facility: Northwestern Medicine Cancer Center Warrenville

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Karmanos Cancer Institute / Wayne State University

location_facility: Stanford Cancer Center / Blood and Marrow Transplant Program

location_facility: University of Alberta / Cross Cancer Institute

location_facility: Northwestern Medicine Cancer Center Kishwaukee / Kishwaukee Cancer Center

location_facility: Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington

location_facility: Universitätsklinikum Halle-Universitätsklinik und Poliklinik

location_facility: Hospital Quironsalud Barcelona Instituto Oncologico Baselga

location_facility: Northwestern Medicine Cancer Center Delnor

location_facility: Oncologia Medica, Ospedale Civile S. Maria delle Croci

location_facility: Winship Cancer Institute / Emory University School of Medicine

location_facility: University of Pennsylvania / Perelman Center for Advanced Medicine

location_facility: Wake Forest Baptist Medical Center / Wake Forest University

location_facility: HM Centro Integral Oncologico Clara Campal

location_facility: MD Anderson Cancer Center / University of Texas

location_facility: Joe Arrington Cancer Research and Treatment Center

location_facility: UNC Lineberger Comprehensive Cancer Center / University of North Carolina

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Seconda Università degli Studi di Napoli, AOU

location_facility: Ingalls Cancer Care / Ingalls Memorial Hospital

location_facility: Shands Cancer Center / University of Florida

title: Open Label Phase 2 Study of Tisotumab Vedotin for Locally Advanced or Metastatic Disease in Solid Tumors

type: Other Identifier

location_country:
Germany
Italy
United Kingdom
United States
Spain
Canada
France

collaborators:
Genmab
Merck Sharp & Dohme LLC


title: An Open-Label Phase 1/2a Study of the Safety and Efficacy of Melflufen and Dexamethasone in Combination With Either Bortezomib or Daratumumab in Patients With Relapsed or Relapsed-Refractory Multiple Myeloma

acronym: ANCHOR

summary: This is an open-label Phase 1/2a study which will enroll patients that have relapsed or relapsed-refractory multiple myeloma to combination regimens of melflufen with currently approved agents. Patients will receive either melflufen+dexamethasone+bortezomib or melflufen+dexamethasone+daratumumab.

lead_sponsor: Oncopeptides AB

location_country:
United States
Czechia
Spain
France

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Centre Jean Bernard - Clinique Victor Hugo

location_facility: Centre Hospitalier Universitaire Institut Gustave Roussy

location_facility: Hospital Universitai Germans Trias i Pujol


title: Prevention of Mortality With Long-Term Administration of Human Albumin in Subjects With Decompensated Cirrhosis and Ascites

acronym: PRECIOSA

summary: This is a phase 3, multicenter, randomized, controlled, parallel-group, and open-label clinical study to evaluate the efficacy of standard medical treatment (SMT) + Albutein 20% administration versus SMT alone in subjects with decompensated cirrhosis and ascites. The study population will consist of subjects being discharged after hospitalization for acute decompensation of liver cirrhosis with ascites (or with prior history of ascites requiring diuretic therapy) with or without acute-on-chronic liver failure (ACLF) at admission or during hospitalization but without ACLF at discharge.

ReferenceCitation: Fernandez J, Claria J, Amoros A, Aguilar F, Castro M, Casulleras M, Acevedo J, Duran-Guell M, Nunez L, Costa M, Torres M, Horrillo R, Ruiz-Del-Arbol L, Villanueva C, Prado V, Arteaga M, Trebicka J, Angeli P, Merli M, Alessandria C, Aagaard NK, Soriano G, Durand F, Gerbes A, Gustot T, Welzel TM, Salerno F, Banares R, Vargas V, Albillos A, Silva A, Morales-Ruiz M, Carlos Garcia-Pagan J, Pavesi M, Jalan R, Bernardi M, Moreau R, Paez A, Arroyo V. Effects of Albumin Treatment on Systemic and Portal Hemodynamics and Systemic Inflammation in Patients With Decompensated Cirrhosis. Gastroenterology. 2019 Jul;157(1):149-162. doi: 10.1053/j.gastro.2019.03.021. Epub 2019 Mar 22.

evidence: open (via crossref license)

repository_institution: Elsevier - Scopus

repository_normalized: Pure (Denmark)

repository_institution: Consorci de Serveis Universitaris de Catalunya - RECERCAT

version: acceptedVersion

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repository_institution: Goethe University Frankfurt - Publication Server of Goethe University Frankfurt am Main

version: submittedVersion

lead_sponsor: Grifols Therapeutics LLC

sponsor_collaborators:
Grifols Therapeutics LLC
Instituto Grifols, S.A.

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Denmark
Belgium
United States
Bosnia and Herzegovina
Spain
Bulgaria
Canada
Serbia
France

location_facility: Klinika Gastroenterologii i Hepatologii z Pododdziałem Chorób Wewnętrznych Kliniczny Szpital Wojewodzki nr 1

location_facility: Dr. Abdulah Nakas General Hospital, Department of Internal Medicine, Department of Gastroenterohepatology

location_facility: University Clinical Centre of the Republic Srpska, Clinic for Internal Diseases, Department of gastroenterology, hepatology and toxicology with internal medicine

location_facility: Oddział Gastroenterologii i Hepatologii Uniwersyteckie Centrum Kliniczne im. prof.K.Gibińskiego SUM w Katowicach

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: SP ZOZ Szpital Uniwersytecki w Krakowie, Zakład Endoskopii SIV 31Aug22

location_facility: Magyar Honvédség Egészségügyi Központ Gasztroenterológiai Osztály

location_facility: Clinical Hospital Center "Bezanijska Kosa", Clinic for Internal Medicine, Department for Gastroenterology and Hepatology

location_facility: University Clinical Center Kragujevac, Clinic for Internal Medicine, Gastroenterohepatology Center

location_facility: Hospital Universitario Politecnico La Fe

location_facility: Markhot Ferenc Oktatókórház és Rendelőintézet

location_facility: Klinika Chorób Wewnętrznych, Diabetologii i Farmakologii Klinicznej, Centralny Szpital Kliniczny

location_facility: Clinical Hospital Center Zvezdara, Clinic for Internal Diseases, Clinical Department for Gastroenterology and Hepatology

location_facility: CHRU de Strasbourg - Hôpital Hautepierre

location_facility: Oddział Kliniczny Gastroenterologii Ogólnej i Onkologicznej, Uniwersytecki Szpital Kliniczny im. Barlickiego

location_facility: Semmelweis Egyetem I. sz. Sebészeti és Intervenciós Gasztroenterológiai Klinika

location_facility: 'University Clinical Center Nis, Clinic for Gastroenterology and Hepatology

location_facility: Institution: General Hospital Pančevo, Internal Diseases Department, Gastroenterology Section

location_facility: Samodzielny Publiczny Szpital im.Papieza Jana Pawla II

location_facility: Clinical Hospital Center "Dr Dragisa Misovic-Dedinje", Clinic for Internal Medicine, Gastroenterology Department

location_facility: Zenica Cantonal Hospital, Department of Internal Medicine with hemodialysis, Department of Gastroenterology and hepatology

location_facility: University Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology

location_facility: Centre Hépato-Biliaire - Hôpital Universitaire Paul Brousse

location_facility: Debreceni Egyetem Klinikai Központ Gasztroenterológiai Klinika

location_facility: Military Medical Academy, Clinic for Gastroenterology and Hepatology

location_facility: Royal Free NHS Foundation Trust Hospital

location_facility: University Health Network - Toronto General Hospital

location_facility: 'Health Center Uzice, Internal Diseases Department, Gastroenterology Section

location_facility: Azienda Ospedaliero-Universitaria di Bologna Policlinico - S.Orsola


lead_sponsor: Merck Sharp & Dohme LLC

summary: The main objectives of this study will be to evaluate the efficacy of gefapixant in reducing cough frequency as measured over a 24-hour period at Week 12, and to evaluate the safety and tolerability of gefapixant. The primary hypothesis is that at least one gefapixant dose is superior to placebo in reducing coughs per hour (over 24 hours) at Week 12.

ReferenceCitation: Dicpinigaitis PV, Birring SS, Blaiss M, McGarvey LP, Morice AH, Pavord ID, Satia I, Smith JA, La Rosa C, Li Q, Nguyen AM, Schelfhout J, Tzontcheva A, Muccino D. Demographic, clinical, and patient-reported outcome data from 2 global, phase 3 trials of chronic cough. Ann Allergy Asthma Immunol. 2023 Jan;130(1):60-66. doi: 10.1016/j.anai.2022.05.003. Epub 2022 May 13.

ReferenceCitation: McGarvey LP, Birring SS, Morice AH, Dicpinigaitis PV, Pavord ID, Schelfhout J, Nguyen AM, Li Q, Tzontcheva A, Iskold B, Green SA, Rosa C, Muccino DR, Smith JA; COUGH-1 and COUGH-2 Investigators. Efficacy and safety of gefapixant, a P2X3 receptor antagonist, in refractory chronic cough and unexplained chronic cough (COUGH-1 and COUGH-2): results from two double-blind, randomised, parallel-group, placebo-controlled, phase 3 trials. Lancet. 2022 Mar 5;399(10328):909-923. doi: 10.1016/S0140-6736(21)02348-5.

repository_institution: Queen's University Belfast - Research Portal

repositories_institution: Queen's University Belfast - Research Portal

location_facility: Private Small-Scale Enterprise Medical Centre "Pulse" ( Site 2815)

location_facility: Ishikawa Prefectural Central Hospital ( Site 1554)

location_facility: Prywatny Gabinet Specjalistyczny ( Site 1927)

location_facility: Clinical Research Institute LLC ( Site 0004)

location_facility: The Center for Pharmaceutical Research PC ( Site 0016)

location_facility: Q & T Research Sherbrooke Inc. ( Site 0512)

location_facility: Specjalistyczny osrodek .All-Med. Grazyna Pulka ( Site 1919)

location_facility: Kawaguchi Respiratory Clinic ( Site 1504)

location_facility: JA Niigatakoseiren Niigata Medical Center ( Site 1522)

location_facility: Petz Aladar Megyei Oktato Korhaz ( Site 1206)

location_facility: Centrum Medyczne Pratia Gdynia ( Site 1910)

location_facility: Cotton-O'Neil Clinical Research Center ( Site 0052)

location_facility: Centrum Medyczne Pratia Bydgoszcz ( Site 1418)

location_facility: Dr Kenessey Albert Korhaz-Rendelointezet ( Site 1200)

location_facility: Centrum Medyczne Pratia Czestochowa ( Site 1926)

location_facility: Kamei Internal Medicine and Respiratory Clinic ( Site 1509)

location_facility: Osaka Habikino Medical Center ( Site 1546)

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 2613)

location_facility: Hospital Chancay y Servicios Basicos de Salud ( Site 1810)

location_facility: National Clinical Research-Richmond, Inc. ( Site 0073)

location_facility: Pneumologie Varnsdorf S.R.O. ( Site 0706)

location_facility: Medinova Lakeside Dedicated Research Centre ( Site 2710)

location_facility: Biosolutions Clinical Research Center ( Site 0070)

location_facility: National Hospital Organization Ehime Medical Center ( Site 1556)

location_facility: Investigaciones en Patologias Respiratorias ( Site 0325)

location_facility: Centro Medico Privado de Reumatologia ( Site 0309)

location_facility: Chang Gung Medical Foundation - Keelung Branch ( Site 2404)

location_facility: Hillel Yaffe Medical Center ( Site 1303)

location_facility: 167877 Canada Inc. Dr. Jaime Del Carpio ( Site 0506)

location_facility: Yedikule Gogus Hast. ve Gogus Cer. Egitim ve Arastirma Hastanesi ( Site 2601)

location_facility: National Hospital Organization Minami-Okayama Medical Center ( Site 1553)

location_facility: Kanazawa University Hospital ( Site 1536)

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi ( Site 2606)

location_facility: Research Solutions of Arizona PC ( Site 0036)

location_facility: NZOZCentrum Medyczne Kermed ( Site 1905)

location_facility: Kanagawa Cardiovascular and Respiratory Center ( Site 1503)

location_facility: National Hospital Organization Nagoya Medical Center ( Site 1539)

location_facility: Prywatny Gabinet Internistyczno ( Site 1928)

location_facility: Hospital Clinico Universitario de Santiago ( Site 2303)

location_facility: The Catholic University of Korea Eunpyeong St Mary s Hospital ( Site 2209)

location_facility: Terada Clinic Respiratory Medicine & General Practice ( Site 1565)

location_facility: Idaimae Minamiyojo Int Clinic ( Site 1521)

location_facility: Sirius Clinical Research, LLC ( Site 0102)

location_facility: Florida Pulmonary Research Institute, LLC ( Site 0019)

location_facility: MeDiNova Yorkshire Dedicated Research Centre ( Site 2708)

location_facility: Vital Prospects Clinical Research Institute, PC ( Site 0037)

location_facility: Well Pharma Medical Research, Corp. ( Site 0093)

location_facility: Center for Clinical Trials, LLC ( Site 0059)

location_facility: CEMEDIC - Centro de Especialidades Medicas ( Site 0304)

location_facility: Konkuk University Medical Center ( Site 2205)

location_facility: MUDr. I. Cierna Peterova s.r.o. ( Site 0707)

location_facility: CCBR AS Vejle, Center for Clinical & Basic Research ( Site 0801)

location_facility: Nagoya City University Hospital ( Site 1528)

location_facility: Center Hospital of the National Center for Global Health and Medicine ( Site 1574)

location_facility: CCBR AS Aalborg, Center for Clinical & Basic Research ( Site 0802)

location_facility: Hopital Arnaud de Villeneuve ( Site 0905)

location_facility: I.U. Cerrahpasa Tip Fakultesi Gogus Hastaliklari Anabilim Dali ( Site 2600)

location_facility: National Hospital Organization Kinki-chuo Chest Medical Center ( Site 1519)

location_facility: Sher Allergy Specialists/Center For Cough ( Site 0078)

location_facility: Wonju Severance Christian Hospital ( Site 2214)

location_facility: National Hospital Organization Disaster Medical Center ( Site 1558)

location_facility: Asthma Nasal Disease & Allergy Research Center of New England ( Site 0075)

location_facility: Mainland Medical Research Institute ( Site 0003)

location_facility: Hallym University Sacred Heart Hospital ( Site 2208)

location_facility: Far Eastern Memorial Hospital ( Site 2402)

location_facility: Intermountain Clinical Research ( Site 0033)

location_facility: Pharmaceutical Research & Consulting, Inc. ( Site 0029)

location_facility: Taichung Veterans General Hospital ( Site 2401)

location_facility: Chaim Sheba Medical Center. ( Site 1304)

location_facility: Korea University Guro Hospital ( Site 2213)

location_facility: National Hospital Organization Ibarakihigashi National Hospital ( Site 1526)

location_facility: Seoul National University Hospital ( Site 2210)

location_facility: Asociacion Civil por la Salud ( Site 1805)

location_facility: Tokyo Metropolitan Geriatric Hospital ( Site 1577)

location_facility: Centrum Medycyny Oddechowej Mroz Spolka Jawna ( Site 1918)

location_facility: Juntendo University Hospital ( Site 1578)

location_facility: National Hospital Organization Tokyo National Hospital ( Site 1557)

location_facility: Shizuoka Prefectural Hospital Organization Shizuoka General Hospital ( Site 1524)

location_facility: National Taiwan University Hospital ( Site 2400)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 2309)

location_facility: National Hospital Organization Fukuoka Hospital ( Site 1552)

location_facility: Medical Corporation Shintokai Yokohama Minoru Clinic ( Site 1568)

location_facility: Clinical Research of Gastonia ( Site 0043)

location_facility: Hospital Privado Universitario de Cordoba ( Site 0313)

location_facility: Recep Tayyip Erdogan Universitesi Tip Fakultesi Egitim ve Aras. Has ( Site 2620)

location_facility: F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2830)

location_facility: Hiroshima Allergy & Respiratory Clinic ( Site 1529)

location_facility: Hospital Nacional Adolfo Guevara Velasco ( Site 1808)

location_facility: Yokohama City Minato Red Cross Hospital ( Site 1506)

location_facility: InAER Investigaciones en Alergia y Enfermedades Respiratorias ( Site 0324)

location_facility: Tokyo Medical University Hachioji Medical Center ( Site 1569)

location_facility: Charlottesville Medical Research Center, LLC ( Site 0006)

location_facility: Bernstein Clinical Research Center, LLC ( Site 0005)

location_facility: Saiseikai Yokohamashi Nanbu Hospital ( Site 1533)

location_facility: Incheon St. Mary s Hospital ( Site 2200)

location_facility: Kocaeli Universitesi Tip Fakultesi ( Site 2611)

location_facility: Plicni stredisko Teplice s. r. o ( Site 0700)

location_facility: Pulmonary Associates of Richmond Inc. ( Site 0101)

location_facility: Changhua Christian Hospital ( Site 2403)

location_facility: Midwest Allergy Sinus Asthma, SC ( Site 0081)

location_facility: CHU de Toulouse - Hopital Larrey ( Site 0900)

location_facility: The Catholic University of Korea St. Mary s Hospital ( Site 2215)

title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Month Study to Evaluate the Efficacy and Safety of MK-7264 in Adult Participants With Chronic Cough (PN027)

type: Registry Identifier

location_country:
Poland
Hungary
Argentina
Denmark
Israel
Japan
United Kingdom
United States
Korea, Republic of
Spain
Turkey
Taiwan
Czechia
Ukraine
Canada
Peru
France


title: A Phase 1/2, Open-Label, Study to Evaluate the Safety and Anti-Tumor Activity of FS118, a LAG-3/PD-L1 Bispecific Antibody, as a Monotherapy and in Combination With Paclitaxel, in Patients With Advanced Malignancies

summary: This study will be conducted in adult participants diagnosed with advanced tumors to characterize the safety, tolerability, pharmacokinetics (PK), and activity of FS118. This is a Phase 1/2, multi-center, open-label, multiple-dose, first-in-human study, designed to systematically assess safety and tolerability, to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) for FS118 in participants with advanced tumors and to determine the efficacy of FS118 in participants with squamous cell carcinoma of the head and neck (SCCHN) as monotherapy and in combination with paclitaxel. In addition to safety, pharmacokinetics, pharmacodynamics, immunogenicity and efficacy will also be assessed.

ipd_sharing: Undecided

lead_sponsor: invoX Pharma Limited

location_country:
United States
France

location_facility: University of California Los Angeles (UCLA)

location_facility: South Texas Accelerated Research Therapeutics


intervention_type: Biological

acronym: MENACWY CONJ-069 (V59_78)

lead_sponsor: GlaxoSmithKline

summary:
MenACWY (Menveo) is a GSK vaccine intended for protection against disease caused by meningococcal bacteria groups A, C, W and Y in infants, children and adults, licensed in more than 60 countries.

The purpose of this study is to compare the immunogenicity of the currently licensed MenACWY vaccine with the investigational MenACWY liquid vaccine aged for different lengths of time by storage at 2-8ºC.

ReferenceCitation: Vir Singh P, Tiberi P, Di Domenico GF, Romolini V, Mzolo T, Costantini M, Akhund T, Basile V, Lattanzi M, Pellegrini M. Fully Liquid MenACWY-CRM Vaccine: Results from an Integrated Safety Analysis. Drug Saf. 2023 Jan;46(1):99-108. doi: 10.1007/s40264-022-01242-8. Epub 2022 Nov 11.

publisher_dissemination: Springer-Nature

title: Immunogenicity, Reactogenicity and Safety Study of Different Formulations of GSK Biologicals' Meningococcal ACWY Conjugate Vaccine (GSK3536820A and Menveo) When Administered to Healthy Adolescents and Young Adults 10 to 40 Years of Age

primary_purpose: Prevention

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

location_country:
Finland
Brazil
Mexico
Spain
South Africa
Turkey
Estonia
Russian Federation
France


title: A Multicenter Phase 2 Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens

summary: The purpose of this study is to evaluate the clinical benefit of subcutaneous (SC) daratumumab administered in combination with standard multiple myeloma (MM) regimens in participants with MM as measured by overall response rate (ORR) or very good partial response (VGPR) or better rate.

lead_sponsor: Janssen Research & Development, LLC

location_country:
Germany
Israel
United Kingdom
Japan
Brazil
United States
Spain
Czechia
France

location_facility: Avera Medical Group - Oncology & Hematology

location_facility: SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo

location_facility: UF Health Cancer Center at Orlando Health

location_facility: Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie

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

location_facility: Ministerio da Saude - Instituto Nacional do Cancer

location_facility: Cancer Center of Central Connecticut - Southington

location_facility: University of Virginia Cancer Center - Emily Couric Clinical Cancer Center - Women's Oncology Clinic

location_facility: Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center

location_facility: Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo

location_facility: Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,


title: A Phase 1/2 Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers

summary: The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.

location_country:
Germany
Italy
Poland
United Kingdom
Argentina
Australia
Switzerland
Belgium
United States
Spain
Chile
Canada
France

location_facility: The Alfred Hospital-Medical Oncology Alfred Cancer Trials

location_facility: Gustave Roussy-Medicine department - Dermatology

location_facility: Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone

location_facility: Fort Wayne Medical Oncology and Hematology

location_facility: Atlantic Health System Morristown Medical Center

location_facility: Istituto Nazionale Tumori Fondazione Pascale

location_facility: Sir Charles Gairdner Hospital-Medical Oncology Clinical Trials Unit


summary: This Phase 3 study in hemodialysis-dependent subjects with anemia will evaluate the efficacy and safety of daprodustat administered three-times weekly compared to epoetin alfa, the current standard of care. This study includes a 4 week Screening Period, a 52 week Treatment Period and a 4 to 6 week follow-up period. Each subject will remain in the study for up to 62 weeks. Approximately 402 subjects will be randomized to receive either daprodustat three times weekly or epoetin alfa three-times weekly or once weekly, depending on dose level.

ReferenceCitation: Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.

ReferenceCitation: Coyne DW, Singh AK, Lopes RD, Bailey CK, DiMino TL, Huang C, Connaire J, Rastogi A, Kim SG, Orias M, Shah S, Patel V, Cobitz AR, Wanner C. Three Times Weekly Dosing of Daprodustat versus Conventional Epoetin for Treatment of Anemia in Hemodialysis Patients: ASCEND-TD: A Phase 3 Randomized, Double-Blind, Noninferiority Trial. Clin J Am Soc Nephrol. 2022 Sep;17(9):1325-1336. doi: 10.2215/CJN.00550122. Epub 2022 Aug 2.

publisher_dissemination: Wolters Kluwer Health

title: A Phase 3 Randomized, Double-blind, Active-controlled, Parallel-group, Multi-center Study in Hemodialysis Participants With Anemia of Chronic Kidney Disease to Evaluate the Efficacy, Safety and Pharmacokinetics of Three-times Weekly Dosing of Daprodustat Compared to Recombinant Human Erythropoietin, Following a Switch From Recombinant Human Erythropoietin or Its Analogs

location_country:
Italy
Poland
United Kingdom
Argentina
Romania
Australia
Brazil
United States
Korea, Republic of
Spain
Canada
Russian Federation
France


acronym: ATLAS

lead_sponsor: pharmaand GmbH

summary: The purpose of the ATLAS study is to determine how patients with locally advanced unresectable or metastatic urothelial carcinoma respond to treatment with rucaparib.

ReferenceCitation: Grivas P, Loriot Y, Morales-Barrera R, Teo MY, Zakharia Y, Feyerabend S, Vogelzang NJ, Grande E, Adra N, Alva A, Necchi A, Rodriguez-Vida A, Gupta S, Josephs DH, Srinivas S, Wride K, Thomas D, Simmons A, Loehr A, Dusek RL, Nepert D, Chowdhury S. Efficacy and safety of rucaparib in previously treated, locally advanced or metastatic urothelial carcinoma from a phase 2, open-label trial (ATLAS). BMC Cancer. 2021 May 24;21(1):593. doi: 10.1186/s12885-021-08085-z.

license: cc-by

license_normalized: cc-by

repository_institution: Universitat Pompeu Fabra - Repositori digital de la UPF

repository_institution: Indiana University - Purdue University Indianapolis - IUPUI ScholarWorks

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

sponsor_collaborators:
pharmaand GmbH
Foundation Medicine

location_facility: New York - Presbyterian Hospital-Weill Cornell Medical Center

location_facility: Saint John's Health Center - John Wayne Cancer Institute (JWCI)

location_facility: University of Texas, UT Health Science Center

location_facility: Guy's & St. Thomas' Hospital (London Oncology Clinic)

location_facility: Miami Cancer Institute, Baptist Health South Florida

location_facility: University of New Mexico UNM Cancer Research and Treatment Center

location_facility: Sarah Cannon Research Institute - United Kingdom - London Office

location_facility: Azienda Ospedaliera Universitaria Federico II Oncologia Medica

location_facility: University of California, Los Angeles (UCLA)

location_facility: Minnesota Oncology Hematology P.A. (USO - US Oncology)

location_facility: Universitatsklinikum Munster / Urologie und Kinderurologie

location_facility: University of Utah, Huntsman Cancer Institute

location_facility: University of California San Diego (UCSD), Moores Cancer Center

location_facility: Eastern Connecticut Hematology & Oncology Associates (ECHO)

location_facility: New York Oncology Hematology, P.C. (USO - US Oncology)

location_facility: Indiana University - Melvin and Bren Simon Cancer Center (IUSCC)

location_facility: Medstar Georgetown University Medical Center

location_facility: The University of Iowa and Holden Comprehensive Cancer Center

location_facility: University of Washington / Seattle Cancer Care Alliance

location_facility: Northwest Cancer Specialists P.C. (USO - US Oncology)

location_facility: Universidad de Navarra - Clinica Universitaria de Navarra

location_facility: University of Virginia, Emily Couric Clinical Center

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Comprehensive Cancer Centers of Nevada (CCCN)

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Centre de Lutte Contre le Cancer - Institut de Cancerologie de l'Ouest - Rene Gauducheau

location_facility: Hospital Universitari Vall d'Hebron de Barcelona

location_facility: Hospital Clínico Universitario de Santiago de Compostela

location_facility: Froedtert & Medical College of Wisconsin

location_facility: Urologische und Kinderurologische Universitätsklinik im Malteser

location_facility: Fondazione IRCCS Istituto Nazionale Tumori

location_facility: Fondazionerca sul Cancro ONLUS - Istituto di Candiolo IRCCS

location_facility: IRCCS Ospedale San Raffaele - Medical Oncology Dept

location_facility: Centre de Lutte Contre le Cancer (CLCC) - Universite de Lyon - Centre Leon-Berard

location_facility: University of Maryland, Marlene and Stewart Greenebaum Cancer Center

title: A Phase 2, Open-label Study of Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma

location_country:
Germany
Italy
United Kingdom
United States
Spain
France


acronym: A phase 3, randomized, controlled study of prophylactic and on-demand treatment of cTTP with BAX 930

lead_sponsor: Baxalta now part of Shire

summary:
Thrombotic thrombocytopenic purpura (or TTP for short) is a condition where blood clots form in small blood vessels throughout the body. The clots can limit or block the flow of oxygen-rich blood to the body's organs, such as the brain, kidneys, and heart. As a result, serious health problems can develop. The increased clotting that occurs in TTP uses up the cells that help the blood to clot, called platelets. With fewer platelets available in the blood, bleeding problems can occur. People who have TTP may bleed underneath the skin forming purple bruises or purpura, or from the surface of the skin. TTP also can cause anemia, a condition in which red blood cells break apart faster than the body can replace them leading to lower than normal number of red blood cells.

A lack of activity in the ADAMTS13 enzyme, a protein in the blood involved in blood clotting, causes TTP. The enzyme breaks up another blood protein called von Willebrand factor that clumps together with platelets to form blood clots. Some people are born with this condition, others get the condition during their life. Many people who born with TTP experience frequent flareups that need to be treated right away. If not treated It can be fatal or cause lasting damage, such as brain damage or a stroke. BAX 930 is a medicine that replaces ADAMTS13 and can prevent or control TTP flareups, called TTP events.

The main aim of this study is to compare the number of TTP events in people born with severe TTP when they treated with BAX 930 versus when they are treated with the standard treatment. Treatment will be given in 2 ways:

BAX 930 or standard treatment given to prevent TTP events from happening.
BAX 930 or standard treatment given to control an acute TTP event when it happens, according to the clinic's standard practice.

Both BAX 930 and standard treatment are given slowly through a vein (infusion).

At the first visit, the study doctor will check if you can participate in the study. If you are eligible and enter the study, you will follow an assigned schedule and either start with BAX 930 (Period 1) and then switch to standard treatment (Period 2) or start with standard treatment (Period 1) and then switch to BAX 930 (Period 2). Everyone will be treated with BAX 930 again for Period 3. Each Period will last approximately 6 months.

If you enter the study to control an acute TTP event, you will follow a schedule receiving either BAX 930 or standard care to treat your acute TTP event. Once the acute TTP event has gotten better, you can decide to continue in the study and be given treatment to prevent TTP events from happening, following the schedule above.

Another study's aim is to assess side effects from treatment with BAX 930 and standard treatment. To do that, the study doctor will ask you questions about your health at each study visit.

The study doctors will also check how long BAX 930 stays in the blood of the participants, over time. They will do this from blood samples taken after participants receive their specific infusions of BAX 930. This will happen at different times during the study.

1 month after all treatment has been completed, participants will visit the clinic for a final check-up.

sponsor_collaborators: Takeda Development Center Americas, Inc.

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)

location_facility: Azienda Ospedaliera Universitaria "Policlinico - Vittorio Emanuele" (Presidio Ferrarotto Alessi)

location_facility: Dipartimento di Medicina Traslazionale e di Precisione - "Sapienza" Universita di Roma

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: Hospital General Universitario de Alicante

location_facility: Alliance for Childhood Diseases, Cure 4 the Kids Foundation

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Samodzielny Publiczny Dzieciecy Szpital Kliniczny

location_facility: Medical Hospital, Tokyo Medical and Dental University

title: A Phase 3, Prospective, Randomized, Controlled, Open-label, Multicenter, 2 Period Crossover Study With a Single Arm Continuation Evaluating the Safety And Efficacy of BAX 930 (rADAMTS13) in the Prophylactic And On-demand Treatment of Subjects With Severe Congenital Thrombotic Thrombocytopenic Purpura (cTTP, Upshaw-Schulman Syndrome [USS], Hereditary Thrombotic Thrombocytopenic Purpura [hTTP])

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.

location_country:
Germany
Italy
Poland
United Kingdom
Japan
Switzerland
Austria
United States
Spain
France


title: A Phase 1/2, Multi-center, Open-label Study of IMGN632 Monotherapy Administered Intravenously in Patients With CD123-positive Acute Myeloid Leukemia and Other CD123-positive Hematologic Malignancies

summary: This is an open-label, multi-center, Phase 1/2 study to determine the MTD and assess the safety, tolerability, PK, immunogenicity, and anti-leukemia activity of IMGN632 when administered as monotherapy to patients with CD123+ disease.

lead_sponsor: ImmunoGen, Inc.

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

location_facility: Hospital Universitari I Politècnic La Fe

location_facility: Novant Health Cancer Institute Hematology - Forsyth

location_facility: Baylor Scott & White University Medical Center

location_facility: Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance

location_facility: Azienda ospedaliera Santa Maria della Misericordia

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


summary: The purpose of this study is to evaluate the efficacy of daratumumab in addition to standard chemotherapy in pediatric participants with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL)/lymphoblastic lymphoma (LL) and T-cell ALL/LL as measured by the complete response (CR) rate.

ReferenceCitation: Ruhayel SD, Valvi S. Daratumumab in T-cell acute lymphoblastic leukaemia: A case report and review of the literature. Pediatr Blood Cancer. 2021 May;68(5):e28829. doi: 10.1002/pbc.28829. Epub 2020 Nov 27. No abstract available.

repository_institution: Authorea - Authorea

repository_normalized: Authorea - Authorea

repositories_concat: Authorea - Authorea

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

location_facility: UCSF Benioff Children's Hospital Oakland

location_facility: Children'S Healthcare Of Atlanta/Emory Univ. Dept. Of Pediatrics

location_facility: AOU Città della Salute e della Scienza di Torino, Presidio Ospedale Infantile Regina Margherita

location_facility: Charite-Universitätsmedizin Berlin - Berlin

location_facility: New York University Langone Medical Center

location_facility: Dell Children's Medical Center of Central Texas/Children's Blood and Cancer Center

location_facility: University of Utah Primary Children's Medical Center

location_facility: Washington Univeristy School of Medicine/ Pediatrics

title: An Open-label, Multicenter, Phase 2 Study Evaluating the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Subjects >=1 and <=30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

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


title: A Phase II Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Orally Administered BI 409306 During a 28-week Treatment Period as Adjunctive Therapy to Antipsychotic Treatment for the Prevention of Relapse in Patients With Schizophrenia.

summary: The objective of the study is to investigate the efficacy, safety and tolerability of BI 409306 once daily compared with placebo given for 28 weeks in patients with schizophrenia on antipsychotic treatment. The study is designed to show superiority of BI 409306 over placebo in preventing relapse of schizophrenia symptoms.

lead_sponsor: Boehringer Ingelheim

location_country:
Japan
United States
Korea, Republic of
Spain
Taiwan
Canada
France

location_facility: National Center Neurology and Psychiatry

location_facility: IUSMM Institut Universitaire en Sante Mentale de Montreal

location_facility: National Hospital Organization Hizen Psychiatric Medical Center

location_facility: Okehazama Hospital Fujita Kokoro Care Center

location_facility: Seoul National University Bundang Hospital

location_facility: St. Charles Psychiatric Associates & Midwest Research Group

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Chatham-Kent Clinical Trials Research Centre

location_facility: National Center for Global Health and Medicine Kohnodai Hospital

location_facility: Collaborative Neuroscience Network, LLC (CNS)

location_facility: Centre for Addiction and Mental Health (CAMH)

location_facility: Orange County Neuropsychiatric Research Center LLC


title: A Phase IIb, Randomized (Stratified), Double-Blind (Sponsor Open), Parallel-Group, Placebo-Controlled, Dose-Finding Study of Nemiralisib (GSK2269557) Added to Standard of Care (SoC) Versus SoC Alone in Participants Diagnosed With an Acute Moderate or Severe Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)

summary: Nemiralisib is being developed as an anti-inflammatory drug for the treatment of inflammatory airways disease. This study is designed to assess the dose response, efficacy, safety, and pharmacokinetics of nemiralisib across a range of doses [up to 750 micrograms (µg)] compared with placebo. The study consists of a Screening Period, a 12-Week Treatment Period and a 12-Week Post-Treatment Follow-Up Period. Approximately 1,250 subjects with an acute moderate or severe exacerbation of COPD requiring standard of care (SoC) therapy will be randomized in this double-blind study. Subjects will be randomized to receive different doses of nemiralisib or placebo via ELLIPTA® inhaler. The total duration of study participation is approximately 6 months (170 days). ELLIPTA is the registered trademark of GlaxoSmithKline (GSK) group of companies.

ReferenceType: background

ReferenceCitation: Fahy WA, Homayoun-Valiani F, Cahn A, Robertson J, Templeton A, Meeraus WH, Wilson R, Lowings M, Marotti M, West SL, Tabberer M, Hessel EM. Nemiralisib in Patients with an Acute Exacerbation of COPD: Placebo-Controlled, Dose-Ranging Study. Int J Chron Obstruct Pulmon Dis. 2021 Jun 3;16:1637-1646. doi: 10.2147/COPD.S309320. eCollection 2021.

ipd_sharing_description: IPD for this study is available via the Clinical Study Data Request site

location_country:
Germany
Italy
Poland
United Kingdom
Argentina
Romania
Australia
Sweden
Netherlands
Mexico
United States
Korea, Republic of
Spain
Canada
Russian Federation
France


title: A Double-blind, Randomized, Active-controlled, Parallel-group Study of Paliperidone Palmitate 6-Month Formulation

summary: The purpose of this study is to demonstrate that injection cycles consisting of a single administration of paliperidone palmitate 6-month (PP6M) are not less effective than 2 sequentially administered injections of paliperidone palmitate 3-month PP3M) (350 or 525 mg eq.) for the prevention of relapse in participants with schizophrenia previously stabilized on corresponding doses of paliperidone palmitate 1-month (PP1M) (100 or 150 mg eq.) or PP3M (350 or 525 mg eq.).

ReferenceCitation: Najarian D, Sanga P, Wang S, Lim P, Singh A, Robertson MJ, Cohen K, Schotte A, Milz R, Venkatasubramanian R, T'Jollyn H, Walling DP, Galderisi S, Gopal S. A Randomized, Double-Blind, Multicenter, Noninferiority Study Comparing Paliperidone Palmitate 6-Month Versus the 3-Month Long-Acting Injectable in Patients With Schizophrenia. Int J Neuropsychopharmacol. 2022 Mar 17;25(3):238-251. doi: 10.1093/ijnp/pyab071.

publisher_dissemination: Oxford University Press

location_country:
Poland
Argentina
Australia
Brazil
Turkey
Czechia
France
Hungary
Hong Kong
United States
Ukraine
India
Malaysia
Italy
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Bulgaria
Russian Federation

location_facility: Centro de Atencion e Investigacion Cardiovascular del Potosi, S.C.

location_facility: Psychiatric Clinical hospital 1 named after N.A. Alekseev

location_facility: CNCE of the Lviv Regional Council 'Lviv Regional Clinical Psychiatric Hospital'

location_facility: Mnpe of Kharkiv Regional Council 'Regional Clinical Psychiatric Hospital #3'

location_facility: Deva Institute of Health Care and Research Pvt Ltd

location_facility: Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu

location_facility: Centre for Mental Health Prof.N.Shipkovenski EOOD

location_facility: Clinica Psichiatrica - Università di Cagliari

location_facility: Juan Schrönen - Western Cape South Africa

location_facility: State Psychiatric HospitalDr.Georgi Kissiov

location_facility: Wexner Medical Center at the Ohio State University

location_facility: C.I.A.P. (Centro de investigación y Asistencia en Psiquiatría)

location_facility: Bács-Kiskun Megyei Kórház a Szegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza

location_facility: MNCE of Kyiv RC Regional Psychiatric and Narcological Medical Association

location_facility: Mental Health Center Prof. Dr. Ivan Temkov

location_facility: Universita degli Studi di Roma 'La Sapienza' - Azienda Ospedaliera Sant Andrea

location_facility: Nizny Novgorod clinical psychiatric hospital 1

location_facility: Centrum Badań Klinicznych PI-House sp. z o.o.

location_facility: Abdurrah Yurtarslan Training and Research Hospital

location_facility: University of Pennsylvania Medical Center

location_facility: Mazowieckie Specjalistyczne Centrum Zdrowia im. Prof. Jana Mazurkiewicza w Pruszkowie

location_facility: CNPE'Kherson Regional Institution of Mental Care'of Kherson Regional Council

location_facility: Ruschel Medicina e Pesquisa Clínica Ltda

location_facility: Centro de Estudios Clinicos y Especialidades Medicas, S.C.

location_facility: Jehangir Clinical Development Center Pvt Ltd

location_facility: CNCE Odesa regional psychiatric hospital #2 Odesa regional council

location_facility: Psychoneurological Dispensary of Frunzensky District

location_facility: Ankara Numune Research and Training Hospital

location_facility: Kyiv Territorial Medical Incorporation 'Psychiatry'

location_facility: Trial Tech Tecnologia em Pesquisas com Medicamentos

location_facility: Wlokiennicza MED Specjalistyczna Praktyka Lekarska dr n.med. Tomasz Markowski

location_facility: Saratov Regional Psychiatric hospital named after St. Sofia

location_facility: Sakarya University Medical Faculty Psychiatry Department

location_facility: California Pharmaceutical Research Institute, Inc.

location_facility: St-Petersburg Bekhterev Psychoneurological Research Institute

location_facility: Psychiatricka ambulance, MUDr. Marta Holanova

location_facility: Selcuk University, Medical School, Department of Psychiatry

location_facility: CNCE 'Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council'

location_facility: SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo

location_facility: SHI 'Saratov City Clinical Hospital 2 n.a V.I. Razumovsky

location_facility: Clinica Privada de Salud Mental Santa Teresa de Ávila

location_facility: Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales

location_facility: Szpital Specjalistyczny im. H. Klimontowicza, Oddzial Psychiatryczny

location_facility: Józsefvarosi Szent Kozma Egészségügyi Központ

location_facility: Seconda Universita degli Studi di Napoli - Azienda Ospedaliera Universitaria

location_facility: Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk

location_facility: Psychiatricka ambulance MUDr. Simona Papezova

location_facility: Sverdlovsk Regional Clinical Psychiatric Hospital

location_facility: Clinical Psychiatric Hospital #3 Named After V.A. Gilyarovsky

location_facility: Municipal Institution 'Lviv Regional Clinical Psycho-Neurological Dispensary'

location_facility: Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS

location_facility: CHA Bundang Medical Center, CHA University

location_facility: Poradnia Zdrowia Psychicznego 'Syntonia' w Pruszczu Gdanskim

location_facility: Hospital Das Clinicas Da Faculdade De Medicina Da USP

location_facility: CNCE 'Vinnytsya RC Psychoneurological Hospital n.a. O.I. Yushchenko Vinnytsya RC'


title: Multiorgan Metabolic Imaging Response Assessment of Abemaciclib

acronym: MiMe-A

summary:
Open-label, phase II, basket trial. This trial is a screening program for abemaciclib efficacy in multiple platinum-resistant tumour types by using metabolic imaging (PERCIST) and RECIST v1.1 criteria.

Based on the rate of FDG-avidity and the absence of deactivation of the Rb gene function in more than 95% of cases, we propose to define 5 tumour types of interest in a preliminary stage:

Platinum-refractory esophageal adenocarcinoma (ADC)
Platinum-refractory esophageal squamous cell carcinoma (SCC)
Platinum-refractory cholangiocarcinoma
Platinum-refractory and progressive after immunotherapy urothelial cancer
Platinum-refractory endometrial cancer

lead_sponsor: Jules Bordet Institute

sponsor_collaborators:
Jules Bordet Institute
Eli Lilly and Company

location_country: Belgium France

location_facility: IUCT Oncopole - Institut Claudius Regaud

location_facility: Hôpital universitaire de Strasbourg - ICANS


title: A Phase 2 Study of Nivolumab in Combination With Either Rucaparib, Docetaxel, or Enzalutamide in Men With Castration-resistant Metastatic Prostate Cancer

acronym: CheckMate 9KD

summary: The purpose of this study is to assess the safety and efficacy of nivolumab in combination with rucaparib, docetaxel, or enzalutamide in participants with castration-resistant prostate cancer that has spread.

ReferenceCitation: Fizazi K, Retz M, Petrylak DP, Goh JC, Perez-Gracia J, Lacombe L, Zschabitz S, Burotto M, Mahammedi H, Gravis G, Bastos DA, McCune SL, Vazquez Limon JC, Kwan EM, Castellano D, Flechon A, Saad F, Grimm MO, Shaffer DR, Armstrong AJ, Bhagavatheeswaran P, Amin NP, Unsal-Kacmaz K, Wang X, Li J, Loehr A, Pachynski RK. Nivolumab plus rucaparib for metastatic castration-resistant prostate cancer: results from the phase 2 CheckMate 9KD trial. J Immunother Cancer. 2022 Aug;10(8):e004761. doi: 10.1136/jitc-2022-004761.

repository_institution: Technical University Munich - mediaTUM – the media and publications repository of the Technical University Munich

repository_institution: Der Gemeinsame Bibliotheksverbund - Common Library Network

publisher_dissemination: British Medical Journal

ReferenceCitation: Fizazi K, Gonzalez Mella P, Castellano D, Minatta JN, Rezazadeh Kalebasty A, Shaffer D, Vazquez Limon JC, Sanchez Lopez HM, Armstrong AJ, Horvath L, Bastos DA, Amin NP, Li J, Unsal-Kacmaz K, Retz M, Saad F, Petrylak DP, Pachynski RK. Nivolumab plus docetaxel in patients with chemotherapy-naive metastatic castration-resistant prostate cancer: results from the phase II CheckMate 9KD trial. Eur J Cancer. 2022 Jan;160:61-71. doi: 10.1016/j.ejca.2021.09.043. Epub 2021 Nov 18.

sponsor_collaborators:
Bristol-Myers Squibb
Clovis Oncology, Inc.
Astellas Pharma Inc

location_country:
Germany
Colombia
Argentina
Australia
Brazil
Mexico
United States
Spain
Chile
Canada
France

location_facility: Northwest Georgia Oncology Centers, P.C.


acronym: SPARK

lead_sponsor: Biogen

summary:
The primary objective of the study is to evaluate the clinical efficacy of BIIB054 via dose response using the change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score.

The secondary objectives of the study are to evaluate the dose-related safety of BIIB054, to evaluate the clinical efficacy of BIIB054 via MDS-UPDRS total score, to assess the pharmacokinetic (PK) profile of BIIB054, to evaluate the clinical efficacy of BIIB054 based on MDS-UPDRS subparts, to evaluate the pharmacodynamic effects of BIIB054 on the integrity of nigrostriatal dopaminergic nerve terminals and to evaluate the immunogenicity of BIIB054.

ReferenceCitation: Lang AE, Siderowf AD, Macklin EA, Poewe W, Brooks DJ, Fernandez HH, Rascol O, Giladi N, Stocchi F, Tanner CM, Postuma RB, Simon DK, Tolosa E, Mollenhauer B, Cedarbaum JM, Fraser K, Xiao J, Evans KC, Graham DL, Sapir I, Inra J, Hutchison RM, Yang M, Fox T, Budd Haeberlein S, Dam T; SPARK Investigators. Trial of Cinpanemab in Early Parkinson's Disease. N Engl J Med. 2022 Aug 4;387(5):408-420. doi: 10.1056/NEJMoa2203395.

ReferenceCitation: Hutchison RM, Evans KC, Fox T, Yang M, Barakos J, Bedell BJ, Cedarbaum JM, Brys M, Siderowf A, Lang AE. Evaluating dopamine transporter imaging as an enrichment biomarker in a phase 2 Parkinson's disease trial. BMC Neurol. 2021 Nov 23;21(1):459. doi: 10.1186/s12883-021-02470-8.

location_facility: Klinikum rechts der Isar der TU Muenchen

location_facility: Seconda Università degli Studi di Napoli

location_facility: Booth Gardner Parkinson's Care Center at Evergreen Health

location_facility: Azienda Ospedaliera Santa Maria di Terni

location_facility: Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico

location_facility: Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona

location_facility: University of Kansas Medical Center Research Institute

location_facility: University of Pittsburgh Medical Center Health System

location_facility: St. Joseph's Hopsital & Medical Center- Barrow Neurological Institute

location_facility: I.R.C.C.S. Neuromed-Istituto Neurologico Mediterraneo

location_facility: University of California San Francisco Medical Center

location_facility: Parkinson's Disease and Movement Disorders Centerf

location_facility: Northwestern University PD and Movement Disorders Center

location_facility: Montreal Neurological Institute Clinical Research Unit

location_facility: Rocky Mountain Movement Disorders Center, PC

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, With an Active-Treatment Dose-Blinded Period, to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects With Parkinson's Disease

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

location_country:
Germany
Italy
Israel
United Kingdom
Austria
United States
Spain
Canada
France


title: A Phase 1/2 Study for the Safety, Efficacy, Pharmacokinetic and Pharmacodynamics Evaluation of Amcenestrant (SAR439859), Administered Orally as Monotherapy, Then in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor-positive Advanced Breast Cancer

summary:
Primary Objectives:

Dose Escalation:

To assess the incidence rate of dose-limiting toxicity (DLT) and to determine the maximum tolerated dose (MTD) as well as the recommended dose (RD) of amcenestrant administered as monotherapy and in combination with palbociclib
To assess the incidence rate of DLT and determine the RD of everolimus or abemaciclib in combination with the selected amcenestrant dose for the combination therapy

Safety Run-In:

- To confirm the RD of amcenestrant in combination with alpelisib

Dose Expansion:

Antitumor activity using objective response rate (ORR)
Overall safety profile of amcenestrant administered in combination with palbociclib, alpelisib, everolimus, and abemaciclib

Secondary Objectives:

Overall safety profile of amcenestrant monotherapy and in combination
Pharmacokinetic (PK) profile of amcenestrant administered as monotherapy or in combination and PK profile of palbociclib, alpelisib, everolimus and abemaciclib
Antitumor activity using ORR, the clinical benefit rate (CBR) and progression free survival (PFS)
Time to first tumor response
Residual ER availability with positron emission tomography (PET) scan [(18)F] fluoroestradiol (18F-FES) uptake with increasing doses of amcenestrant
Food effect on PK of amcenestrant
Potential induction/inhibition effect of amcenestrant on cytochrome P450 (CYP) 3A using 4b-OH cholesterol

ReferenceCitation: Bardia A, Chandarlapaty S, Linden HM, Ulaner GA, Gosselin A, Cartot-Cotton S, Cohen P, Doroumian S, Paux G, Celanovic M, Pelekanou V, Ming JE, Ternes N, Bouaboula M, Lee JS, Bauchet AL, Campone M. AMEERA-1 phase 1/2 study of amcenestrant, SAR439859, in postmenopausal women with ER-positive/HER2-negative advanced breast cancer. Nat Commun. 2022 Jul 15;13(1):4116. doi: 10.1038/s41467-022-31668-8.

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

lead_sponsor: Sanofi

location_country:
Italy
Poland
Portugal
United Kingdom
Belgium
United States
Spain
Czechia
Canada
France

location_facility:
Investigational Site Number :8400002
Investigational Site Number :8260002
Investigational Site Number :6200002
Investigational Site Number :8400102
Investigational Site Number :2500005
Investigational Site Number :2030001
Investigational Site Number :1240002
Investigational Site Number :7240001
Investigational Site Number :1240003
Investigational Site Number :1240004
Investigational Site Number :0560001
Investigational Site Number :8400003
Investigational Site Number :8400001
Investigational Site Number :3800003
Investigational Site Number :6160001
Investigational Site Number :2500002
Investigational Site Number :8400005
Investigational Site Number :2030002
Investigational Site Number :2500001
Investigational Site Number :2500004
Investigational Site Number :2030003
Investigational Site Number :3800002
Investigational Site Number :6160004
Investigational Site Number :7240002
Investigational Site Number :3800001
Investigational Site Number :8260003
Investigational Site Number :6200001
Investigational Site Number :6200003
Investigational Site Number :2500003
Investigational Site Number :7240007
Investigational Site Number :3800004


title: A Prospective, Double-masked, Randomized, Multicenter, Active-controlled, Parallel-group, 6-month Study Assessing the Safety and Ocular Hypotensive Efficacy of PG324 Ophthalmic Solution Compared to GANFORT® (Bimatoprost 0.03% / Timolol 0.5%) Ophthalmic Solution in Subjects With Elevated Intraocular Pressure (MERCURY 3)

summary: The study is intended to test the effectiveness and safety of Netarsudil / Latanoprost 0.02% / 0.005% Ophthalmic Solution, relative to GANFORT® for lowering of intraocular pressure (IOP) in patients with elevated intraocular pressure

lead_sponsor: Aerie Pharmaceuticals

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Austria
Belgium
Latvia
Spain
Czechia
France

location_facility: UZ Leuven, campus Gasthuisberg, Herestraat 49, 3000 Leuven

location_facility: Markusovszky University Teaching Hospital

location_facility: University of Debrecen, Clinical Center, Ophthalmology Department

location_facility: Professor K. Gibinski University Clinical Centre

location_facility: City Hospitals Sunderland NHS Foundation Trust Sunderland Eye Infirmary

location_facility: University Medical Center Freiburg, Eye Center,Killianstr.5, Freiburg i. Breisgau

location_facility: Cambridge University Hospitals NHS Trust

location_facility: Ophthalmology Service Centre Francois Xavier Michelet CHU Pellegrin

location_facility: Queen Mary Hospital, King's College Hospital NHS

location_facility: Department of Ophthalmology Clinical Johannes Gutenberg-University Mainz

location_facility: Institut Catala de retina (ICR) Glaucoma and Investigation Department

location_facility: Universitats-Augenklinik, Studienzentrum/Clinical Trials in Opthalmology (CTO)

location_facility: P.Stradins Clinical University Hospital, Ophthalmology Clinic

location_facility: Military Institute of Medicine Klinika Okulistyki

location_facility: Ophthalmology Department, Queen Alexandra Hospital

location_facility: Ophthalmology Department Hospital Universitario Rio Hortega

location_facility: Department of Ophthalmology Semmelweis University

location_facility: Hospital Universitario Reina Sofía de Córdoba

location_facility: Hospital Clinico Universitario Lozano Blesa Zaragoza Ophthalmology department

location_facility: Department of Medicine and Surgery University of Parma

location_facility: Ophthalmic Clinic DiNOGMI University Hospital San Martino

location_facility: Riga East University hospital, In-patient Department "Biķernieki", Ophthalmology Clinic

location_facility: Hospital General del S.A.S. de Jerez de la Frontera

location_facility: S.C.U Oculistica, Azienda Ospedaliero Universitaria, Città della Salute e della Scienza

location_facility: Hospital Universitario de Torrevieja Ophthalmology Department

location_facility: Mid-Cheshire Hospitals NHS Foundation Trust

location_facility: Ophthalmology department Necker University Hospital-Enfants Malades

location_facility: Politecnico Gianbattista Rossi AOUI Ospedale Borgo Roma

location_facility: Department of Diagnostics and Microsurgery of Glaucoma

location_facility: CHU de Nantes-Hospital Hotel Dieu Ophthalmology Service

location_facility: Ophthalmology Service - Batiment R Hospital de la Croix-Rousse

location_facility: Dept. Ophthalmology, San Raffaele Hospital

location_facility: State Hospital - University Medical Center Academical Department of Ophthalmology

location_facility: Ophthamic Clinic of the University of Pavia, IRCCS Foundation San Matteo Policlinic

location_facility: Centre ophtalmologique Pole vision val d'ouest

location_facility: University of Szeged, Department of Ophthalmology

location_facility: Hospital Universitario Virgen Macarena Ophthalmology Department

location_facility: Hospital General de Catalunya Ophthalmology Department

location_facility: Signes Ozolinas Doctor Practice in Ophthalmology

location_facility: ASST Santi Paolo e Carlo - Ophthalmic Clinic

location_facility: Glaucoma center Oční klinika VFN a 1. LF UK

location_facility: Guy's & St Thomas' NHS Foundation Trust Glaucoma Research Area

location_facility: Hospital Universitario Miguel Servet Ophthalmology Department

location_facility: University Eye Hospital Tuebingen, STC eyetrial at the center for Ophthalmolgy

location_facility: Northwest Anglia NHS Foundation trust Hinchingbrooke Hospital


intervention_type: Other

lead_sponsor: Bayer

summary:
The purpose of this study is to obtain long-term clinical data from patients approximately 15 years after their first clinical event, who participated in the former BENEFIT 304747 study and were treated at least once within that study.

This study will collect clinical information on the disease course, on disability, relapses, cognitive function over time, quality of life, depression, fatigue, resource use, and employment status. In addition, brain MRI is performed.

location_facility: Universitätsmedizin der Georg-August-Universität Göttingen

location_facility: Städt. Krankenhaus Martha-Maria Halle-Dölau gGmbH

location_facility: A.O.U. Città della Salute e della Scienza di Torino

location_facility: Landeskrankenhaus - Universitätskliniken Innsbruck

location_facility: Universitätsklinik Gießen und Marburg GmbH

location_facility: Helse Bergen HF Haukeland universitetssjukehus

location_facility: Hospital Clínic i Provincial de Barcelona

location_facility: Ciutat Sanitària i Universitaria de la Vall d'Hebron

location_facility: Peterfy Sandor utcai Korhaz - Rendelointezet

location_facility: Klinikum der Universität München Grosshadern

location_facility: 10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4

location_facility: Hospital Universitario Virgen de la Macarena

location_facility: Ciutat Sanitària i Universitària de Bellvitge

location_facility: IRCCS Ist Neurologico Nazionale C.Mondino

location_facility: Tampereen yliopistollinen sairaala, keskussairaala

location_facility: Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego

location_facility: Hadassah Hebrew University Hospital Ein Kerem

location_facility: Szent-Gyorgyi Albert Orvostudomanyi Egyetem

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Instituto Português de Oncologia Francisco Gentil - Coimbra

title: BENEFIT 15 Long-term Follow-up Study of the BENEFIT and BENEFIT Follow-up Studies

location_country:
Finland
Germany
Italy
Poland
Portugal
Hungary
Israel
Denmark
Norway
Sweden
Switzerland
Austria
Belgium
United Kingdom
Spain
Czechia
Canada
France


title: A Phase 3, Randomized, Controlled, Open-label, Clinical Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Patients With Higher-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Low-Blast Acute Myelogenous Leukemia

acronym: PANTHER

summary: The purpose of this study is to determine whether the combination of pevonedistat and azacitidine improves event-free survival (EFS) when compared with single-agent azacitidine. (An event is defined as death or transformation to AML in participants with MDS or CMML, whichever occurs first, and is defined as death in participants with low-blast AML).

ReferenceCitation: Ades L, Girshova L, Doronin VA, Diez-Campelo M, Valcarcel D, Kambhampati S, Viniou NA, Woszczyk D, De Paz Arias R, Symeonidis A, Anagnostopoulos A, Munhoz EC, Platzbecker U, Santini V, Fram RJ, Yuan Y, Friedlander S, Faller DV, Sekeres MA. Pevonedistat plus azacitidine vs azacitidine alone in higher-risk MDS/chronic myelomonocytic leukemia or low-blast-percentage AML. Blood Adv. 2022 Sep 13;6(17):5132-5145. doi: 10.1182/bloodadvances.2022007334.

evidence: open (via page says license)

publisher_dissemination: American Society of Hematology

lead_sponsor: Takeda

collaborators: Takeda Development Center Americas, Inc.

location_country:
Germany
Poland
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
United States
Belgium
China
Italy
United Kingdom
Mexico
Korea, Republic of
Spain
Greece
Russian Federation
Israel

location_facility: New Jersey Hematology Oncology Associates LLC

location_facility: North-West Federal Medical Research Center n.a. V.A. Almazov

location_facility: Oncology and Hematology Associates of Southwest Virginia Inc

location_facility: Complejo Asistencial Universitario de Leon

location_facility: Arizona Oncology Associates (Wilmot HOPE) - USOR

location_facility: Rocky Mountain Cancer Centers (Williams) - USOR

location_facility: Tennessee Oncology - SHELBYVILLE - SCRI - PPDS

location_facility: Tennessee Oncology - DICKSON - SCRI - PPDS

location_facility: Florida Cancer Specialists - NORTH - SCRI - PPDS

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

location_facility: Japan Mutual Aid Association of Public School Teachers Chugoku Central Hospital

location_facility: Presbyterian Saint Lukes Medical Center Laboratory

location_facility: Tennessee Oncology - LEBANON - SCRI - PPDS

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

location_facility: Baptist Health System (N Kendall) - USOR

location_facility: Universitatsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: Tennessee Oncology - FRANKLIN - SCRI - PPDS

location_facility: University of Texas Southwestern Medical Center

location_facility: Arizona Oncology Associates (Rudasill HOPE) - USOR

location_facility: Rocky Mountain Cancer Centers (Lakewood) - USOR

location_facility: Kobe City Medical Center General Hospital

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Tennessee Oncology SKYLINE - SCRI - PPDS

location_facility: Xuanwu Hospital Capital Medical University

location_facility: Tennessee Oncology - SMYRNA - SCRI - PPDS

location_facility: Universidade Federal do Rio de Janeiro - UFRJ

location_facility: ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN

location_facility: Tennessee Oncolgy - BAPTIST - SCRI - PPDS

location_facility: Georgios Papanikolaou General Hospital of Thessaloniki

location_facility: Complejo Asistencial Universitario de Salamanca - H. Clinico

location_facility: Greenville Health System Cancer Institute

location_facility: Sarah Cannon Center for Blood Centers - SCRI - PPDS

location_facility: Tennessee Oncology - SOUTHERN HILLS - SCRI - PPDS

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

location_facility: University of North Carolina at Chapel Hill

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: University of Miami Miller School of Medicine

location_facility: Rocky Mountain Cancer Centers (Pueblo) - USOR

location_facility: Rocky Mountain Cancer Centers (Denver) - USOR

location_facility: Oncology and Hematology Associates of Southwest Virginia (Low Moor) - USOR

location_facility: Chonnam National University Hwasun Hospital

location_facility: Southeastern Regional Medical Center - CTCA - PPDS

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Rocky Mountain Cancer Centers (Colorado Springs) - USOR

location_facility: Gazi University Medical Faculty Gazi Hospital

location_facility: Tennessee Oncology - MURFREESBORO - SCRI - PPDS

location_facility: Compassionate Cancer Care Medical Group Inc

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Arizona Oncology Associates (Orange HOPE) - USOR

location_facility: Oncology Hematology Care, Inc - Fairfield

location_facility: Compassionate Care Research Group Inc. at Compassionate Cancer Care Medical Group, Inc

location_facility: Saint Alphonsus Caldwell Cancer Care Center

location_facility: Rocky Mountain Cancer Centers (Longmont) - USOR

location_facility: Rocky Mountain Cancer Centers (Parker) - USOR

location_facility: Oncology and Hematology Associates of Southwest Virginia (Roanoke) - USOR

location_facility: Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi

location_facility: IRCCS Centro Di Riferimento Oncologico Della Basilicata

location_facility: Capital Humano para Investigacion Clinica SC

location_facility: Tennessee Oncology - SUMMIT - SCRI - PPDS

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

location_facility: Russian Research Institute of Hematology and Blood Transfusion

location_facility: Oncology and Hematology Associates of Southwest Virginia (Blacksburg) - USOR

location_facility: Azienda Ospedaliero Universitaria San Giovanni Battista Di Torino

location_facility: ICO lHospitalet Hospital Duran i Reynals

location_facility: Rocky Mountain Cancer Centers (Thornton) - USOR

location_facility: Tennessee Oncology - GALLATIN - SCRI - PPDS

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

location_facility: Tennessee Oncology - ST THOMAS WEST - SCRI - PPDS

location_facility: Marien Hospital Akademisches Lehrkrankenhaus

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Hematologii I Transplantologii, Budynek Centrum Medycyny N

location_facility: Rocky Mountain Cancer Centers (Littleton) - USOR

location_facility: University Hospital, Kyoto Prefectural University of Medicine

location_facility: Karadeniz Technical University Faculty of Medicine

location_facility: Winship Cancer Institute, Emory University

location_facility: Rocky Mountain Cancer Centers (Lone Tree) - USOR

location_facility: Weill Cornell Medical Center - Monitoring Location

location_facility: Texas Oncology - San Antonio Medical Center - USOR

location_facility: Rocky Mountain Cancer Centers (Aurora) - USOR

location_facility: Rocky Mountain Cancer Centers (Boulder) - USOR


lead_sponsor: AbbVie

summary: An open-label, global, multi-center study to evaluate the safety and pharmacokinetics of venetoclax monotherapy, to determine the dose limiting toxicity (DLT) and the recommended Phase 2 dose (RPTD), and to assess the preliminary efficacy of venetoclax in pediatric and young adult participants with relapsed or refractory malignancies.

ReferenceCitation: Dalton KM, Krytska K, Lochmann TL, Sano R, Casey C, D'Aulerio A, Khan QA, Crowther GS, Coon C, Cai J, Jacob S, Kurupi R, Hu B, Dozmorov M, Greninger P, Souers AJ, Benes CH, Mosse YP, Faber AC. Venetoclax-based Rational Combinations are Effective in Models of MYCN-amplified Neuroblastoma. Mol Cancer Ther. 2021 Aug;20(8):1400-1411. doi: 10.1158/1535-7163.MCT-20-0710. Epub 2021 Jun 4.

oa_colors: green other

repository_institution: University of Illinois at Chicago - INDIGO

repository_institution: La Trobe University - OPAL (Open@LaTrobe)

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Place AE, Goldsmith K, Bourquin JP, Loh ML, Gore L, Morgenstern DA, Sanzgiri Y, Hoffman D, Zhou Y, Ross JA, Prine B, Shebley M, McNamee M, Farazi T, Kim SY, Verdugo M, Lash-Fleming L, Zwaan CM, Vormoor J. Accelerating drug development in pediatric cancer: a novel Phase I study design of venetoclax in relapsed/refractory malignancies. Future Oncol. 2018 Sep;14(21):2115-2129. doi: 10.2217/fon-2018-0121. Epub 2018 Mar 29.

repository_institution: University of Zurich - Zurich Open Repository and Archive

publisher_dissemination: Future Science Ltd

sponsor_collaborators: AbbVie Roche-Genentech

location_facility: St Jude Children's Research Hospital /ID# 163447

location_facility: AP-HP - Hopital Armand-Trousseau /ID# 163728

location_facility: Univ California, San Francisco /ID# 163460

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 162938

location_facility: Women and Childrens Hospital /ID# 163147

location_facility: AP-HM - Hopital de la Timone /ID# 161465

location_facility: CHU Toulouse - Hôpital des enfants /ID# 163727

location_facility: Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 161730

location_facility: Dana-Farber Cancer Institute /ID# 163440

location_facility: Kinderspital Zurich - Eleonorenstiftung /ID# 163037

location_facility: Cincinnati Children's Hospital /ID# 161550

location_facility: Memorial Sloan Kettering Cancer Center-Koch Center /ID# 163444

location_facility: Children's Hospital Colorado /ID# 161551

location_facility: Great Ormond Street Hospital for Children /ID# 169238

location_facility: Universitaetsklinikum Freiburg /ID# 164206

location_facility: Children's Healthcare of Atlan /ID# 161552

location_facility: Children's Hospital of Philadelphia /ID# 163445

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 161729

location_facility: Queensland Children's Hospital /ID# 163146

location_facility: Medical College of Wisconsin /ID# 163461

title: A Phase 1 Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies

location_country:
Germany
United Kingdom
Australia
Netherlands
Switzerland
United States
Canada
France