acronym: BRIGHT AML1019

title: A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA

lead_sponsor: Pfizer

ReferenceCitation: Cortes JE, Dombret H, Merchant A, Tauchi T, DiRienzo CG, Sleight B, Zhang X, Leip EP, Shaik N, Bell T, Chan G, Sekeres MA. Glasdegib plus intensive/nonintensive chemotherapy in untreated acute myeloid leukemia: BRIGHT AML 1019 Phase III trials. Future Oncol. 2019 Nov;15(31):3531-3545. doi: 10.2217/fon-2019-0373. Epub 2019 Sep 13.

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

location_country:
Spain
Italy
United Kingdom
United States
Romania
Belgium
Japan
Czechia
Poland
Austria
Australia
Russian Federation
Israel
Mexico
Sweden
Canada
Hungary
China
Germany
Taiwan
Korea, Republic of
France

location_facility: UCLA Hematology/Oncology - Westlake Village

location_facility: Petz Aladár Megyei Oktató Kórház, II. Belgyógyászat- Hematológiai Osztály

location_facility: Chang Gung Memorial Hospital-Linkou Branch

location_facility: Universitaire Ziekenhuizen Brussel (UZ Brussel)

location_facility: The First Affiliated Hospital of USTC, Anhui Provincial Hospital

location_facility: AO Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore di Pesaro -

location_facility: Blood Cancer and Stem Cell Transplant Clinic

location_facility: Landeskrankenhaus Salzburg, Universitatsklinik fur Innere Medizin III der PMU

location_facility: UC Irvine Health - Chao Family Comprehensive Cancer Center

location_facility: Uniklinikum Salzburg, Landeskrankenhaus Salzburg

location_facility: Rabin Medical Center, Beilinson Hospital

location_facility: Sp. Clinic de Urgenta Militar Central Dr. Carol Davila

location_facility: Klinika Hematologii i Transplantologii Uniwersyteckie Centrum Kliniczne

location_facility: Interní hematologická klinika, Fakultni nemocnice Královské Vinohrady

location_facility: The First Affiliated Hospital College of Medicine, Zhejiang University

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

location_facility: A.O.U. di Ferrara- Arcispedale Sant'Anna,

location_facility: Spitalul Clinic Coltea, Clinica de Hematologie

location_facility: Szabolcs-Szatmar Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Korhaz, Hematologia

location_facility: State Budgetary Institution of Ryazan Region 'Regional Clinical Hospital' (SBI RR RCH)

location_facility: Fujian Medical University Union Hospital

location_facility: Hospital General Universitario Gregorio Maranon

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

location_facility: Methodist Healthcare System of San Antonio

location_facility: UCLA Drug Information/Investigational Drugs

location_facility: Georgia Cancer Center at Augusta University

location_facility: Japanese Red Cross Nagoya Daini Hospital

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

location_facility: Koo Foundation Sun Yat-Sen Cancer Center

location_facility: University Hospitals Cleveland Medical Center

location_facility: CIUSSS de l'Est-de-l'Ile-de- Montréal - Hôpital Maisonneuve-Rosemont

location_facility: Institutul Oncologic 'Prof. Dr. Ion Chiricuta'

location_facility: Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhugel

location_facility: Interni hematologicka a onkologicka klinika, Fakultni nemocnice Brno

location_facility: AOU Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia

location_facility: MidAmerica Division, Inc., c/o Research Medical Center

location_facility: Guangdong Second Provincial General Hospital

location_facility: Centre Hospitalier Lyon Sud - Service d'Hematologie

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Hospital Universitario Arnau de Vilanova

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center

location_facility: SOD Farmacia-Dipt dei servizi -AOU Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi

location_facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology/Cancer Center

location_facility: Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek

location_facility: Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

location_facility: Azienda Ospedaliera Universitaria Senese.

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

location_facility: National Hospital Organization Disaster Medical Center

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie

location_facility: State Budgetary Healthcare Institution of Moscow

location_facility: Tufts Medical Center Investigational Drug Pharmacy

location_facility: Henan Provincial People's Hospital/Hematology Department

location_facility: Clinical Trial Center, Severance Hospital, Yonsei University Health System

location_facility: National Hospital Organization Kumamoto Medical Center

summary:
Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).

Glasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).


ipd_sharing: Yes

status: Recruiting

primary_purpose: Treatment

intervention_type: Biological

title: An Open-label, Uncontrolled, Multicenter Phase II Trial of MK-3475 (Pembrolizumab) in Children and Young Adults With Newly Diagnosed Classical Hodgkin Lymphoma With Inadequate (Slow Early) Response to Frontline Chemotherapy (KEYNOTE 667)

study_completion_date_type: Anticipated

lead_sponsor: Merck Sharp & Dohme LLC

type: Other Identifier

type: EudraCT Number

source: euctr

design_allocation: Non-Randomized

study_start_date_type: Actual

study_type: Interventional

enrollment_type: Anticipated

location_country:
Brazil
Spain
Greece
Italy
Mexico
Netherlands
United Kingdom
Guatemala
Korea, Republic of
France
United States
South Africa
Colombia
Germany
Czechia

location_facility: Universita degli Studi di Roma La Sapienza ( Site 0403)

location_facility: Kaiser Permanente - Roseville ( Site 0080)

location_facility: Memorial Regional Hospital/Joe DiMaggio Children's Hospital ( Site 0048)

location_facility: Kaiser Permanente Downey Medical Center ( Site 0024)

location_facility: Children's Healthcare of Atlanta at Egleston ( Site 0033)

location_facility: Universitätsklinikum Münster - Albert Schweitzer Campus-Pädiatrische Hämatologie und Onkologie ( Sit

location_facility: Hopital Universitaire Robert Debre ( Site 0446)

location_facility: Kaiser Permanente - Santa Clara ( Site 0079)

location_facility: Centro di Riferimento Oncologico CRO ( Site 0404)

location_facility: Hackensack University Medical Center ( Site 0026)

location_facility: Alliance for Childhood Diseases ( Site 0064)

location_facility: Athens Childrens Hospital Aglaia Kyriakou ( Site 0361)

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0531)

location_facility: CHU de Bordeaux. Hopital Pellegrin ( Site 0447)

location_facility: Ospedale Infantile Regina Margherita ( Site 0401)

location_facility: Albert Alberts Stem Cell Transplant Centre ( Site 0324)

location_facility: Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 0507)

location_facility: Children's Hospital of Michigan ( Site 0056)

location_facility: Fakultni nemocnice v Motole ( Site 0356)

location_facility: Columbia University/Herbert Irving Cancer Center ( Site 0063)

location_facility: MemorialCare Health System - Long Beach Medical Center-Cherese Mari Laulhere Children's Village ( Si

location_facility: Instituto Nacional De Cancerologia ( Site 0566)

location_facility: Hospital Universitari Vall d Hebron ( Site 0432)

location_facility: Dell Children's Medical Center Of Central Texas ( Site 0058)

location_facility: Rutgers Cancer Institute of New Jersey ( Site 0027)

location_facility: Hematologica Alta Especialidad ( Site 0532)

location_facility: Connecticut Children's Medical Center ( Site 0045)

location_facility: University of Louisville-Norton Children's Hospital ( Site 0059)

location_facility: Arkansas Children's Hospital ( Site 0046)

location_facility: Methodist HealthCare System of San Antonio Clinical Trials Office, Texas Transplant Institute ( Site

location_facility: CHU de Marseille Hopital de la Timone Enfants ( Site 0449)

location_facility: University of Athens - Aghia Sophia Childrens Hospital ( Site 0362)

location_facility: Hospital Pablo Tobon Uribe-Hematology ( Site 0565)

location_facility: Children's Hospital of Alabama ( Site 0023)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 0060)

location_facility: UMAE Hospital de Especialidades - CMN La Raza ( Site 0536)

location_facility: Charite-Universitaetsmedizin Berlin Campus Virchow-Klinikum ( Site 0413)

location_facility: University of Kentucky Markey Cancer Center ( Site 0057)

location_facility: Institut d'Hematologie-Oncologie Pediatrique (IHOP) ( Site 0448)

location_facility: Vanderbilt University Medical Center-Ingram Cancer Center ( Site 0054)

location_facility: Universitaetsklinikum Essen ( Site 0415)

location_facility: Cohen Children's Medical Center of New York ( Site 0052)

location_facility: Children's Hospitals and Clinics of Minnesota ( Site 0036)

location_facility: UNC Lineberger Comprehensive Cancer ( Site 0044)

location_facility: Universitaetsklinikum Giessen und Marburg GmbH ( Site 0411)

location_facility: Nationwide Children's Hospital ( Site 0037)

location_facility: Severance Hospital Yonsei University Health System ( Site 0221)

location_facility: St. Louis Children's Hospital ( Site 0038)

location_facility: Kaiser Permanente - Oakland ( Site 0047)

location_facility: University College London Hospitals NHS Foundation Trust ( Site 0454)

location_facility: Hopital d'Enfants Armand Trousseau ( Site 0443)

location_facility: Roswell Park Cancer Institute ( Site 0040)

location_facility: University General Hospital of Thessaloniki "AHEPA" ( Site 0363)

location_facility: Organizacion Clinica Bonnadona-Prevenir S.A.S. ( Site 0529)

location_facility: Azienda Ospedaliera Santobono - Pausilipon ( Site 0402)

location_facility: Hospital Infantil Universitario Nino Jesus ( Site 0433)

location_facility: Cincinnati Children's Hospital Medical Center ( Site 0035)

location_facility: Children's Hospital - Colorado ( Site 0028)

location_facility: Instituto de Oncologia Pediatrica - GRAACC - Unifesp ( Site 0500)

location_facility: Unidad Nacional de Oncologia Pediatrica ( Site 0542)

location_facility: Klinikum der Universitaet Muenchen-Campus Innenstadt ( Site 0414)

location_facility: Hospital Infantil de Mexico Federico Gomez ( Site 0535)

location_facility: Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0510)

location_facility: Riley Hospital for Children ( Site 0091)

location_facility: Hospital Universitario La Paz ( Site 0434)

location_facility: Children's National Medical Center ( Site 0090)

location_facility: IRCCS Ospedale Pediatrico Bambino Gesu ( Site 0400)

location_facility: St. Francis Hospital Cancer Center ( Site 0001)

summary: This study will examine the safety and efficacy of pembrolizumab (MK-3475) in combination with chemotherapy in children and young adults with newly diagnosed classical Hodgkin Lymphoma (cHL) who are slow early responders (SERs) to frontline chemotherapy.

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Pilot Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Explore the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ-53718678 at Two Dose Levels in Non-Hospitalized Adult Subjects Infected With Respiratory Syncytial Virus

summary: The purpose of this study is to explore the antiviral effect of JNJ-53718678 at 2 dose levels (80 milligrams [mg] and 500 mg) once daily for 7 days in adults with Respiratory Syncytial Virus (RSV) infection, as measured by RSV viral load in nasal secretions by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay.

status: Completed

study_completion_date_type: Actual

design_allocation: Randomized

enrollment_type: Actual

lead_sponsor: Janssen Research & Development, LLC

location_country:
Poland
Taiwan
Brazil
Spain
Russian Federation
Australia
Mexico
Argentina
Canada
Ukraine
Sweden
Korea, Republic of
United States
France
South Africa
Belgium
Japan
Germany
Bulgaria

location_facility: Dr Anil K Gupta Medicine Professional Corporation

location_facility: Private Small Enterprise Medical Center Pulse

location_facility: Medical Center of LL Company 'Scientific Medical Center-Your Doctor'

location_facility: Centro de Estudos e Pesquisas em Moléstias Infecciosas

location_facility: Mi 'Kherson City Clinical Hospital Of E.E. Karabelesh'

location_facility: Beata Asankowicz-Bargiel i Partnerzy, Lekarze-sp. Spec. Poradnia Pulmonologiczna

location_facility: Seoul Metropolitan Government Seoul National University Boramae Medical Center

location_facility: Diagnostic Consultation Centre 'Alexandrovska' EOOD

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: Instituto Médico de la Fundación de Estudios Clínicos (ECLIN)

location_facility: SHAT of Pneumo-phthisiatric Diseases Dr Dimitar Gramatikov - Ruse, EOOD

location_facility: Hospital Universitario de Nuevo Leon 'Dr Jose Eleuterio Gonzalez'

location_facility: Medical Center Ltd 'Health Clinic', Department Of General Therapy

location_facility: Soonchunhyang University Bucheon Hospital

location_facility: Barwon Health - University Hospital Geelong

location_facility: Medical Unit Of Company 'Kharkiv Tractor Plant', Kharkiv Medical Academy Of Postgraduate Education

location_facility: Centro de Investigacion Medico Biologica y Terapia Avanzada CIMBYTA

location_facility: IKF Pneumologie GmbH & Co. KG Am Standort IFS - Interdisziplinäres Facharztzentrum

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

location_facility: Vinnytsia City Clinical Hospital #1, Vinnytsia National Medical University

location_facility: AllinaHealth - Abbott Northwestern Hospital (13520)

location_facility: Specialized Hospital for Active Treatment of Pulmonary Diseases - Troyan EOOD

location_facility: Specialized Hospital for Active Treatment of Pulmonary Diseases - Pernik

location_facility: Santa Casa de Misericordia de Belo Horizonte

location_facility: Policlinic of State Joint Stock Holding Company 'Artem'

location_facility: Hospital Universitario Prof Edgard Santos

location_facility: Universidade Federal de Santa Catarina/Clínica Médica

location_facility: SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im.Barlickiego Uniwersytetu Med. w Lodzi Zespol Poradni

location_facility: Hospital Interzonal General de Agudos Dr. Jose Penna

location_facility: Centrum Badan Klinicznych, Osrodek Badan Wczesnej Fazy

location_facility: Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska Lek. Krzysztof Lis

location_facility: Hospital Privado - Centro Medico de Cordoba

location_facility: City Polyclinic #25 of the Nevsky District of SPB

location_facility: Taipei Medical University Shuang Ho Hospital

intervention_type: Drug

status_simplified: Completed


status: Terminated

title: An Open-Label, Multicenter, Extension Study to Evaluate the Safety and Efficacy of Padsevonil as Adjunctive Treatment of Focal-Onset Seizures in Adult Subjects With Drug-Resistant Epilepsy

lead_sponsor: UCB Biopharma SRL

ipd_sharing_description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Lithuania
United States
Belgium
Japan
Romania
Czechia
Poland
Australia
Turkey
Mexico
Slovakia
Bosnia and Herzegovina
Canada
Hungary
Germany
Bulgaria
Denmark
Greece
Ireland
Estonia
Finland
France

summary: The purpose of the study is to evaluate the long-term safety and tolerability of Padsevonil administered at individualized doses as adjunctive treatment for subjects with drug-resistant epilepsy.

status_simplified: Unknown


title: A Phase III Trial of Marizomib in Combination With Standard Temozolomide-based Radiochemotherapy Versus Standard Temozolomide-based Radiochemotherapy Alone in Patients With Newly Diagnosed Glioblastoma

acronym: MIRAGE

summary: The standard of care for newly diagnosed glioblastoma includes surgery, involved-field radiotherapy, and concomitant and six cycles of maintenance temozolomide chemotherapy, however the prognosis remains dismal. Marizomib has been tested in patients with newly diagnosed and recurrent glioblastoma in phase I and phase II studies. In patients with recurrent glioblastoma, marizomib was administered as a single agent or in combination with bevacizumab (NCT02330562). Based on encouraging observations, a phase I/II trial of marizomib in combination with TMZ/RT -->TMZ in newly diagnosed glioblastoma has been launched (NCT02903069) which explores safety and tolerability of this triple combination and which shall help to determine the dose for further clinical trials in glioblastoma. In this context, given that marizomib has been established as a safe addition to the standard TMZ/RT -->TMZ, a phase III study is considered essential to establishing its impact on overall survival.

status: Active, not recruiting

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

location_country:
Denmark
Spain
United Kingdom
Austria
Netherlands
Canada
Switzerland
United States
France
Belgium
Norway
Germany

location_facility: Technische Universitaet Muenchen - Klinikum Rechts Der Isar

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

location_facility: Grand Hopital de Charleroi - Grand Hôpital de Charleroi - Site Notre Dame

location_facility: Ohio State University Comprehensive Cancer Center

location_facility: Odette Cancer Centre - Sunnybrook Health Sciences Centre

location_facility: The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis

location_facility: Universitair Medisch Centrum - Academisch Ziekenhuis

location_facility: University Health Network - Oci / Princess Margaret Hospital

location_facility: Spaarne Gasthuis - Vrije Universiteit Medisch Centrum

location_facility: Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Medical University Vienna - General Hospital AKH

location_facility: Clinica Universidad de Navarra - Clinica Universitaria De Navarra

location_facility: Guy's and St Thomas' NHS - Guy s and St Thomas' NHS - Guy's Hospital

location_facility: Johannes Gutenberg Universitaetskliniken - Mainz University Medical Center

location_facility: UniversitaetsKlinikum Heidelberg - Head Hospital

location_facility: QEII Health Sciences Centre-Capital District Health Authority

location_facility: Universitaetsklinikum Tuebingen- Crona Kliniken

location_facility: CHU de Quebec-Hopital l'Enfant-Jesus (HEJ)

location_facility: University Hospitals Copenhagen - Rigshospitalet

location_facility: Universitaetsklinik Erlangen-Neurologische Klinik (3031)

location_facility: Penn State College of Medicine, Hershey Medical Center-Penn State Neuroscience Institute

location_facility: Montreal Neurological Institute and Hospital McGill University

location_facility: Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere

location_facility: CHUM - Centre Hospitalier de l'Université de Montreal - Hopital Notre-Dame

location_facility: Universitaetsklinikum Leipzig-Klinik für Strahlentherapie und Radioonkologie

location_facility: Radboud University Medical Center Nijmegen

location_facility: Oslo University Hospital - Radiumhospitalet

location_facility: CHU de Lyon - CHU Lyon - Hopital neurologique Pierre Wertheimer

location_facility: Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme

location_facility: Regional Cancer Program of Hopital Reg. de Sudbury Reg. Hospital

location_facility: GasthuisZusters Antwerpen - Sint-Augustinus

location_facility: Hamilton Health Sciences, Juravinski Cancer Centre

location_facility: Aarhus University Hospitals - Aarhus University Hospital (440)

location_facility: Klinikum Der J.W. Goethe Universitaet-Klinik und Poliklinik fur Neurochirurgie

location_facility: Centre hospitalier regional de Trois-Rivieres

location_facility: Hospital Clinic Universitari de Barcelona

location_facility: Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)

intervention_type: Radiation


title: A Dose-Ranging Study of Intravitreal OPT-302 in Combination With Ranibizumab, Compared With Ranibizumab Alone, in Participants With Neovascular Age-Related Macular Degeneration (Wet AMD)

summary: A multicentre, randomised, parallel group, sham-controlled, double-masked, dose-ranging study, investigating two doses of OPT-302 in combination with ranibizumab compared with ranibizumab with sham, over six consecutive monthly dosing cycles in participants with neovascular (wet) AMD.

lead_sponsor: Opthea Limited

location_country:
Poland
Spain
Italy
Latvia
United Kingdom
Hungary
United States
France
Israel
Czechia

location_facility:
Opthea Investigational Site
Opthea Study Site
Opthea Investigationa Site


acronym: Morpheus Lung

intervention_type: Other

title: A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating The Efficacy And Safety Of Multiple Immunotherapy-Based Treatment Combinations In Patients With Metastatic Non-Small Cell Lung Cancer (Morpheus-Lung)

lead_sponsor: Hoffmann-La Roche

location_country:
Taiwan
Spain
United Kingdom
Australia
Korea, Republic of
United States
Israel
France

location_facility: Smilow Cancer Hospital at Yale New Haven

location_facility: Hospital Regional Universitario de Malaga

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

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Chonnam National University Hwasun Hospital

location_facility: Columbia University Medical Center; Research Pharmacy, Irving Pavillion, Ip 7-749

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

location_facility: Hospital Universitario HM Sanchinarro-CIOCC

location_facility: Chaim Sheba Medical Center; Oncology Dept

location_facility: University of Ulsan College of Medicine - Asan Medical Center (AMC) - Asan Cancer Center (ACC)

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Institut Universitaire du Cancer de Toulouse-Oncopole; PHARMACIE

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: Institut Régional du Cancer de Montpellier

location_facility: National Cheng Kung University Hospital; Gasterointestinal

location_facility: University Hospitals Case Medical Center; Seidman Cancer Center

location_facility: Royal Marsden Hospital; Institute of Cancer Research

summary:
This study will evaluate the efficacy, safety, and pharmacokinetics of immunotherapy-based treatment combinations in patients with metastatic non-small cell lung cancer (NSCLC).

Two cohorts will be enrolled in parallel in this study: the first-line (1L) cohort will consist of patients who have not received any systemic therapy for their disease and the second-line (2L) cohort will consist of patients who progressed during or after receiving a platinum-containing regimen and a PD-L1/PD-1 checkpoint inhibitor treatment. In each cohort, eligible patients will be assigned to one of several treatment arms.


title: A Phase 1/2, Multicenter, Dose-Escalation and Expansion Study of Combination Therapy With Venetoclax, Daratumumab and Dexamethasone (With and Without Bortezomib) in Subjects With Relapsed or Refractory Multiple Myeloma

summary:
This is a study of venetoclax, daratumumab, and dexamethasone with and without bortezomib combination therapy to evaluate safety, tolerability, and efficacy of these combinations in participants with relapsed or refractory multiple myeloma. The study will consist of 3 distinct parts: Part 1 includes participants with t(11;14) positive relapsed/refractory (R/R) multiple myeloma who will receive venetoclax in combination with daratumumab and dexamethasone (VenDd); Part 2 includes participants with R/R multiple myeloma who will receive venetoclax in combination with daratumumab, bortezomib, and dexamethasone (VenDVd); Part 3 includes participants with t(11;14) positive R/R multiple myeloma who will receive venetoclax in combination with daratumumab and dexamethasone (VenDd) or daratumumab, bortezomib, and dexamethasone (DVd).

Part 1 and Part 2 are non-randomized and will be initiated with a dose-escalation phase in which increasing doses of venetoclax will be given with fixed doses of daratumumab and dexamethasone (Part 1a) or with fixed doses of daratumumab, bortezomib, and dexamethasone (Part 2a). Each dose escalation phase will be followed by a single-arm, open-label expansion phase. Part 3 will include a randomized, open-label expansion phase with participants receiving venetoclax in combination with daratumumab and dexamethasone (VenDd) or daratumumab, bortezomib, and dexamethasone (DVd).

ReferenceType: derived

ReferenceCitation: Bahlis NJ, Baz R, Harrison SJ, Quach H, Ho SJ, Vangsted AJ, Plesner T, Moreau P, Gibbs SD, Coppola S, Yang X, Al Masud A, Ross JA, Bueno O, Kaufman JL. Phase I Study of Venetoclax Plus Daratumumab and Dexamethasone, With or Without Bortezomib, in Patients With Relapsed or Refractory Multiple Myeloma With and Without t(11;14). J Clin Oncol. 2021 Nov 10;39(32):3602-3612. doi: 10.1200/JCO.21.00443. Epub 2021 Aug 13.

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

lead_sponsor: AbbVie

location_country:
Denmark
Australia
Canada
United States
France
Japan
Germany

location_facility: Atrium Health Carolinas Medical Center /ID# 164948

location_facility: Oregon Health & Science University /ID# 166822

location_facility: Roswell Park Comprehensive Cancer Center /ID# 169615

location_facility: Emory University, Winship Cancer Institute /ID# 165427

location_facility: The University of Chicago Medical Center /ID# 165429

location_facility: Royal Victoria Hospital / McGill University Health Centre /ID# 167824

location_facility: Universitaetsklinikum Freiburg /ID# 166036

location_facility: CHRU Tours - Hopital Bretonneau /ID# 164795

location_facility: Nagoya City University Hospital /ID# 225273

location_facility: Dana-Farber Cancer Institute /ID# 166886

location_facility: Univ of Colorado Cancer Center /ID# 167331

location_facility: Matsuyama Red Cross Hospital /ID# 225196

location_facility: Beth Israel Deaconess Medical Center /ID# 210904

location_facility: St Vincent's Hospital Melbourne /ID# 165853

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 164767


title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE)

summary: The purpose of this study is to assess whether co-administration of belimumab and a single cycle of rituximab will optimize treatment with belimumab, which will result in improvements of clinical status with a favorable safety profile, by comparing subjects randomized to belimumab plus rituximab versus belimumab plus rituximab-placebo. Approximately 292 subjects will be randomized in a 1:2:1 ratio to 1 of 3 treatment arms; belimumab plus rituximab-placebo (Arm A, control), belimumab plus rituximab (Arm B, combination), or belimumab plus standard therapy (Arm C, reference). Belimumab will be administered as subcutaneous (SC) and rituximab-placebo or rituximab will be administered by intravenous (IV) infusions. The total duration of the study is for 104 weeks.

ReferenceType: background

ReferenceCitation: Teng YKO, Bruce IN, Diamond B, Furie RA, van Vollenhoven RF, Gordon D, Groark J, Henderson RB, Oldham M, Tak PP. Phase III, multicentre, randomised, double-blind, placebo-controlled, 104-week study of subcutaneous belimumab administered in combination with rituximab in adults with systemic lupus erythematosus (SLE): BLISS-BELIEVE study protocol. BMJ Open. 2019 Mar 20;9(3):e025687. doi: 10.1136/bmjopen-2018-025687.

ReferenceCitation: Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3:CD007478. doi: 10.1002/14651858.CD007478.pub2.

ReferenceCitation: Parodis I, Lopez Benavides AH, Zickert A, Pettersson S, Möller S, Welin Henriksson E, Voss A, Gunnarsson I. The Impact of Belimumab and Rituximab on Health-Related Quality of Life in Patients With Systemic Lupus Erythematosus. Arthritis Care Res (Hoboken). 2019 Jun;71(6):811-821. doi: 10.1002/acr.23718.

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

lead_sponsor: GlaxoSmithKline

location_country:
Brazil
Spain
Russian Federation
Netherlands
Argentina
Canada
Korea, Republic of
United States
France
Mexico
Germany


title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study With an Open-Label Period to Evaluate the Efficacy and Safety of Fremanezumab for the Prophylactic Treatment of Migraine in Patients With Inadequate Response to Prior Preventive Treatments

acronym: FOCUS

summary:
The purpose of this study is to evaluate the efficacy, safety, and tolerability of monthly and quarterly subcutaneous (sc) injections of fremanezumab compared with sc injections of placebo in participants with chronic migraine (CM) or episodic migraine (EM) who have responded inadequately to 2 to 4 classes of prior preventive treatments.

Approximately equal numbers of participants from each subgroup (CM and EM) are randomized in blinded-fashion 1:1:1 into one of 3 treatments for the subgroup - 2 active treatments and 1 placebo treatment- consisting of monthly injections for 3 months (up to Week 12). Then all participants continue into an open-label extension of 3 months (up to Week 24) during which everyone is administered sc injections of fremanezumab.

ReferenceCitation: McAllister P, Cohen JM, Campos VR, Ning X, Janka L, Barash S. Impact of fremanezumab on disability outcomes in patients with episodic and chronic migraine: a pooled analysis of phase 3 studies. J Headache Pain. 2022 Aug 29;23(1):112. doi: 10.1186/s10194-022-01438-4.

ReferenceCitation: Diener HC, McAllister P, Jürgens TP, Kessler Y, Ning X, Cohen JM, Campos VR, Barash S, Silberstein SD. Safety and tolerability of fremanezumab in patients with episodic and chronic migraine: a pooled analysis of phase 3 studies. Cephalalgia. 2022 Jul;42(8):769-780. doi: 10.1177/03331024221076485. Epub 2022 Mar 25.

ReferenceCitation: Lampl C, Rapoport AM, Cohen JM, Barash S, Ramirez Campos V, Seminerio MJ, Ning X, Silberstein SD. Efficacy and quality-of-life improvements with fremanezumab treatment in patients with difficult-to-treat migraine with associated neurological dysfunction. Eur J Neurol. 2022 Jul;29(7):2129-2137. doi: 10.1111/ene.15328. Epub 2022 Mar 29.

ReferenceCitation: MaassenVanDenBrink A, Terwindt GM, Cohen JM, Barash S, Campos VR, Galic M, Ning X, Kärppä M. Impact of age and sex on the efficacy of fremanezumab in patients with difficult-to-treat migraine: results of the randomized, placebo-controlled, phase 3b FOCUS study. J Headache Pain. 2021 Dec 18;22(1):152. doi: 10.1186/s10194-021-01336-1.

ReferenceCitation: Nahas SJ, Naegel S, Cohen JM, Ning X, Janka L, Campos VR, Krasenbaum LJ, Holle-Lee D, Kudrow D, Lampl C. Efficacy and safety of fremanezumab in clinical trial participants aged ≥60 years with episodic or chronic migraine: pooled results from 3 randomized, double-blind, placebo-controlled phase 3 studies. J Headache Pain. 2021 Nov 24;22(1):141. doi: 10.1186/s10194-021-01351-2. Erratum in: J Headache Pain. 2022 May 17;23(1):57.

ReferenceCitation: Ashina M, Cohen JM, Galic M, Campos VR, Barash S, Ning X, Kessler Y, Janka L, Diener HC. Efficacy and safety of fremanezumab in patients with episodic and chronic migraine with documented inadequate response to 2 to 4 classes of migraine preventive medications over 6 months of treatment in the phase 3b FOCUS study. J Headache Pain. 2021 Jul 10;22(1):68. doi: 10.1186/s10194-021-01279-7.

ReferenceCitation: Pazdera L, Cohen JM, Ning X, Campos VR, Yang R, Pozo-Rosich P. Fremanezumab for the Preventive Treatment of Migraine: Subgroup Analysis by Number of Prior Preventive Treatments with Inadequate Response. Cephalalgia. 2021 Sep;41(10):1075-1088. doi: 10.1177/03331024211008401. Epub 2021 May 14.

ReferenceCitation: Spierings ELH, Kärppä M, Ning X, Cohen JM, Campos VR, Yang R, Reuter U. Efficacy and safety of fremanezumab in patients with migraine and inadequate response to prior preventive treatment: subgroup analyses by country of a randomized, placebo-controlled trial. J Headache Pain. 2021 Apr 16;22(1):26. doi: 10.1186/s10194-021-01232-8.

ReferenceCitation: Ferrari MD, Diener HC, Ning X, Galic M, Cohen JM, Yang R, Mueller M, Ahn AH, Schwartz YC, Grozinski-Wolff M, Janka L, Ashina M. Fremanezumab versus placebo for migraine prevention in patients with documented failure to up to four migraine preventive medication classes (FOCUS): a randomised, double-blind, placebo-controlled, phase 3b trial. Lancet. 2019 Sep 21;394(10203):1030-1040. doi: 10.1016/S0140-6736(19)31946-4. Epub 2019 Aug 16. Erratum in: Lancet. 2019 Oct 29;:.

lead_sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

location_country:
Denmark
Poland
Spain
Italy
United Kingdom
Netherlands
Finland
Switzerland
Sweden
United States
France
Belgium
Germany
Czechia

location_facility:
Teva Investigational Site 37089
Teva Investigational Site 54163
Teva Investigational Site 32690
Teva Investigational Site 40034
Teva Investigational Site 14756
Teva Investigational Site 39049
Teva Investigational Site 14743
Teva Investigational Site 31225
Teva Investigational Site 40033
Teva Investigational Site 53417
Teva Investigational Site 31231
Teva Investigational Site 14732
Teva Investigational Site 14740
Teva Investigational Site 35240
Teva Investigational Site 54162
Teva Investigational Site 53416
Teva Investigational Site 32697
Teva Investigational Site 53425
Teva Investigational Site 14731
Teva Investigational Site 14761
Teva Investigational Site 39048
Teva Investigational Site 40032
Teva Investigational Site 31234
Teva Investigational Site 45018
Teva Investigational Site 14753
Teva Investigational Site 53422
Teva Investigational Site 14738
Teva Investigational Site 42054
Teva Investigational Site 54160
Teva Investigational Site 54164
Teva Investigational Site 14729
Teva Investigational Site 54159
Teva Investigational Site 39052
Teva Investigational Site 35238
Teva Investigational Site 40036
Teva Investigational Site 30199
Teva Investigational Site 14745
Teva Investigational Site 32695
Teva Investigational Site 45017
Teva Investigational Site 14735
Teva Investigational Site 14754
Teva Investigational Site 39051
Teva Investigational Site 42051
Teva Investigational Site 37092
Teva Investigational Site 31230
Teva Investigational Site 42050
Teva Investigational Site 14734
Teva Investigational Site 34233
Teva Investigational Site 14736
Teva Investigational Site 14749
Teva Investigational Site 31227
Teva Investigational Site 32701
Teva Investigational Site 31226
Teva Investigational Site 34231
Teva Investigational Site 32698
Teva Investigational Site 14742
Teva Investigational Site 14750
Teva Investigational Site 34232
Teva Investigational Site 53424
Teva Investigational Site 54157
Teva Investigational Site 54165
Teva Investigational Site 39050
Teva Investigational Site 53420
Teva Investigational Site 14758
Teva Investigational Site 37091
Teva Investigational Site 32689
Teva Investigational Site 35239
Teva Investigational Site 31236
Teva Investigational Site 14737
Teva Investigational Site 34236
Teva Investigational Site 14739
Teva Investigational Site 14746
Teva Investigational Site 14733
Teva Investigational Site 37090
Teva Investigational Site 54161
Teva Investigational Site 35236
Teva Investigational Site 42049
Teva Investigational Site 14751
Teva Investigational Site 40037
Teva Investigational Site 31228
Teva Investigational Site 32692
Teva Investigational Site 54166
Teva Investigational Site 14747
Teva Investigational Site 31233
Teva Investigational Site 38124
Teva Investigational Site 32699
Teva Investigational Site 14748
Teva Investigational Site 42052
Teva Investigational Site 32700
Teva Investigational Site 40035
Teva Investigational Site 32691
Teva Investigational Site 14843
Teva Investigational Site 14730
Teva Investigational Site 34235
Teva Investigational Site 32693
Teva Investigational Site 35235
Teva Investigational Site 35237
Teva Investigational Site 14741
Teva Investigational Site 53418
Teva Investigational Site 45016
Teva Investigational Site 53423
Teva Investigational Site 34230
Teva Investigational Site 54158
Teva Investigational Site 38127
Teva Investigational Site 38126
Teva Investigational Site 14752
Teva Investigational Site 53419
Teva Investigational Site 14760
Teva Investigational Site 31235
Teva Investigational Site 31229
Teva Investigational Site 32694
Teva Investigational Site 38125
Teva Investigational Site 30204


title: A Multinational, Multi-Center, Randomised, Double-Bind, Placebo-Controlled, Parallel Group Study to Assess the Safety and Efficacy of a Subject Optimised Dose of Sildenafil Citrate (20, 40, or 80 mg. Sildenafil Citrate TID) Based on the Toleration, When Used in Combination With Intravenous Prostacyclin( Epoprostenol) in the Treatment of Pulmonary Arterial Hypertension.

summary: Determination of the effects of sildenafil citrate and epoprostenol when used in combination in patients with pulmonary arterial hypertension

ReferenceCitation: Simonneau G, Rubin LJ, Galiè N, Barst RJ, Fleming TR, Frost A, Engel P, Kramer MR, Serdarevic-Pehar M, Layton GR, Sitbon O, Badesch DB; PACES Study Group. Long-term sildenafil added to intravenous epoprostenol in patients with pulmonary arterial hypertension. J Heart Lung Transplant. 2014 Jul;33(7):689-97. doi: 10.1016/j.healun.2014.02.019. Epub 2014 Feb 22.

lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

location_country:
Denmark
Spain
Italy
United Kingdom
Canada
United States
France
Israel
Belgium
Netherlands
Czechia


title: A Phase 2, Dose-Finding, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study, Evaluating the Safety and Efficacy of Pridopidine 45, 67.5, 90, and 112.5 mg Twice-Daily vs Placebo for Symptomatic Treatment in Patients With Huntington's Disease

summary: This is a multicenter, multinational, randomized, parallel-group, double-blind, placebo-controlled, dose range finding study to compare the efficacy and safety of different doses of pridopidine versus placebo in the treatment of motor impairment in Huntington's Disease (HD).

ReferenceCitation: McGarry A, Leinonen M, Kieburtz K, Geva M, Olanow CW, Hayden M. Effects of Pridopidine on Functional Capacity in Early-Stage Participants from the PRIDE-HD Study. J Huntingtons Dis. 2020;9(4):371-380. doi: 10.3233/JHD-200440.

ReferenceCitation: Rodrigues FB, Quinn L, Wild EJ. Huntington's Disease Clinical Trials Corner: January 2019. J Huntingtons Dis. 2019;8(1):115-125. doi: 10.3233/JHD-190001. Review.

ReferenceCitation: Reilmann R, McGarry A, Grachev ID, Savola JM, Borowsky B, Eyal E, Gross N, Langbehn D, Schubert R, Wickenberg AT, Papapetropoulos S, Hayden M, Squitieri F, Kieburtz K, Landwehrmeyer GB; European Huntington's Disease Network; Huntington Study Group investigators. Safety and efficacy of pridopidine in patients with Huntington's disease (PRIDE-HD): a phase 2, randomised, placebo-controlled, multicentre, dose-ranging study. Lancet Neurol. 2019 Feb;18(2):165-176. doi: 10.1016/S1474-4422(18)30391-0. Epub 2018 Dec 15.

lead_sponsor: Prilenia

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

location_facility:
Investigational Site 35122
Investigational Site 35165
Investigational Site 32409
Investigational Site 34060
Investigational Site 39027
Investigational Site 35123
Investigational Site 78057
Investigational Site 30081
Investigational Site 34061
Investigational Site 12204
Investigational Site 32408
Investigational Site 53149
Investigational Site 30082
Investigational Site 35121
Investigational Site 30083
Investigational Site 50214
Investigational Site 39028
Investigational Site 12209
Investigational Site 50213
Investigational Site 78058
Investigational Site 12199
Investigational Site 34058
Investigational Site 50215
Investigational Site 12207
Investigational Site 12205
Investigational Site 30080
Investigational Site 35124
Investigational Site 53150
Investigational Site 53151
Investigational Site 12201
Investigational Site 12203
Investigational Site 34057
Investigational Site 32407
Investigational Site 35125
Investigational Site 11035
Investigational Site 33027
Investigational Site 78055
Investigational Site 34055
Investigational Site 12202
Investigational Site 12210
Investigational Site 34056
Investigational Site 11036
Investigational Site 12208
Investigational Site 78056
Investigational Site 12200
Investigational Site 38059
Investigational Site 32410
Investigational Site 12198
Investigational Site 33021
Investigational Site 12196
Investigational Site 34054
Investigational Site 12211
Investigational Site 12197
Investigational Site 12206
Investigational Site 11037
Investigational Site 34059
Investigational Site 53148
Investigational Site 30084


title: An Open-Label, Multicenter, Phase 1b Study of JNJ-54767414 (HuMax CD38) (Anti-CD38 Monoclonal Antibody) in Combination With Backbone Regimens for the Treatment of Subjects With Multiple Myeloma

summary: The purpose of this study is to evaluate the safety, tolerability, and dose regimen of daratumumab when administered in combination with various treatment regimens for the treatment of multiple myeloma.

ReferenceCitation: He J, Berringer H, Heeg B, Ruan H, Kampfenkel T, Dwarakanathan HR, Johnston S, Mendes J, Lam A, Bathija S, Mackay E. Indirect Treatment Comparison of Daratumumab, Pomalidomide, and Dexamethasone Versus Standard of Care in Patients with Difficult-to-Treat Relapsed/Refractory Multiple Myeloma. Adv Ther. 2022 Sep;39(9):4230-4249. doi: 10.1007/s12325-022-02226-x. Epub 2022 Jul 22.

ReferenceCitation: Leleu X, Beksac M, Chou T, Dimopoulos M, Yoon SS, Prince HM, Pour L, Shelekhova T, Chari A, Khurana M, Zhang J, Obreja M, Qi M, Oriol A, Siegel D. Efficacy and safety of weekly carfilzomib (70 mg/m(2)), dexamethasone, and daratumumab (KdD70) is comparable to twice-weekly KdD56 while being a more convenient dosing option: a cross-study comparison of the CANDOR and EQUULEUS studies. Leuk Lymphoma. 2021 Feb;62(2):358-367. doi: 10.1080/10428194.2020.1832672. Epub 2020 Oct 28.

ReferenceCitation: Xu XS, Moreau P, Usmani SZ, Lonial S, Jakubowiak A, Oriol A, Krishnan A, Bladé J, Luo M, Sun YN, Zhou H, Nnane I, Deraedt W, Qi M, Ukropec J, Clemens PL. Split First Dose Administration of Intravenous Daratumumab for the Treatment of Multiple Myeloma (MM): Clinical and Population Pharmacokinetic Analyses. Adv Ther. 2020 Apr;37(4):1464-1478. doi: 10.1007/s12325-020-01247-8. Epub 2020 Feb 20.

ReferenceCitation: Chari A, Martinez-Lopez J, Mateos MV, Bladé J, Benboubker L, Oriol A, Arnulf B, Rodriguez-Otero P, Pineiro L, Jakubowiak A, de Boer C, Wang J, Clemens PL, Ukropec J, Schecter J, Lonial S, Moreau P. Daratumumab plus carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma. Blood. 2019 Aug 1;134(5):421-431. doi: 10.1182/blood.2019000722. Epub 2019 May 21.

ReferenceCitation: Chari A, Suvannasankha A, Fay JW, Arnulf B, Kaufman JL, Ifthikharuddin JJ, Weiss BM, Krishnan A, Lentzsch S, Comenzo R, Wang J, Nottage K, Chiu C, Khokhar NZ, Ahmadi T, Lonial S. Daratumumab plus pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma. Blood. 2017 Aug 24;130(8):974-981. doi: 10.1182/blood-2017-05-785246. Epub 2017 Jun 21.

location_country:
United States
Spain
France


status: Withdrawn

title: Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of CR8020 and CR6261 in Hospitalized Patients With Influenza A Infection

lead_sponsor: Crucell Holland BV

location_country:
Brazil
Spain
Australia
Netherlands
Canada
Sweden
United States
France
South Africa
Belgium
Germany
Bulgaria

summary: The purpose of this study is to evaluate the rate of decline in quantitative viral load measured in hospitalized patients with Influenza A infection


title: A Multi-center, Randomized, Double-blind Study to Compare the Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea (CDAD)

summary: This clinical study is conducted to assess the efficacy of cadazolid compared to vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).

ReferenceCitation: Gerding DN, Cornely OA, Grill S, Kracker H, Marrast AC, Nord CE, Talbot GH, Buitrago M, Gheorghe Diaconescu I, Murta de Oliveira C, Preotescu L, Pullman J, Louie TJ, Wilcox MH. Cadazolid for the treatment of Clostridium difficile infection: results of two double-blind, placebo-controlled, non-inferiority, randomised phase 3 trials. Lancet Infect Dis. 2019 Mar;19(3):265-274. doi: 10.1016/S1473-3099(18)30614-5. Epub 2019 Jan 29.

ReferenceCitation: Kleinman L, Talbot GH, Hunsche E, Schüler R, Nord CE. The CDI-DaySyms: Content Development of a New Patient-Reported Outcome Questionnaire for Symptoms of Clostridium difficile Infection. Value Health. 2018 Apr;21(4):441-448. doi: 10.1016/j.jval.2017.08.3017. Epub 2017 Nov 7. Review.

lead_sponsor: Actelion

location_country:
Poland
Brazil
Spain
Italy
Australia
Netherlands
Canada
United States
France
Peru
Romania
Germany


title: A Phase 3 Evaluation of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination in Non-cirrhotic Subjects With Genotype 1 Chronic Hepatitis C

lead_sponsor: Bristol-Myers Squibb

ReferenceCitation: Poordad F, Sievert W, Mollison L, Bennett M, Tse E, Bräu N, Levin J, Sepe T, Lee SS, Angus P, Conway B, Pol S, Boyer N, Bronowicki JP, Jacobson I, Muir AJ, Reddy KR, Tam E, Ortiz-Lasanta G, de Lédinghen V, Sulkowski M, Boparai N, McPhee F, Hughes E, Swenson ES, Yin PD; UNITY-1 Study Group. Fixed-dose combination therapy with daclatasvir, asunaprevir, and beclabuvir for noncirrhotic patients with HCV genotype 1 infection. JAMA. 2015 May 5;313(17):1728-35. doi: 10.1001/jama.2015.3860.

location_country:
Australia
Canada
Puerto Rico
United States
France

location_facility: University Of Pittsburgh Medical Center, Ctr For Liver Diseases

location_facility: Hospital Of The University Of Pennsylvania

location_facility: Asheville Gastroenterology Associates, Pa

location_facility: Washington University School Of Medicine

location_facility: Premier Medical Group Of The Hudson Valley, Pc

location_facility: The Gastroenterology Group Of South Jersey

location_facility: University Of Colorado Denver & Hospital

location_facility: Bon Secours St. Mary'S Hospital Of Richmond, Inc.

location_facility: University Hospitals Case Medical Center

summary: To demonstrate the effectiveness of DCV 3DAA fixed dose regimen in treatment naive and treatment experienced non-cirrhotic subjects


title: A Multi-center, Multinational, Randomized, Double-blind, Controlled, Dose Comparison Study to Evaluate Safety and Efficacy of MP4OX Plus Standard Treatment, in Severely Injured Trauma Subjects With Lactic Acidosis Due to Hemorrhagic Shock

summary: MP4OX is being developed as an ischemic rescue therapy to perfuse and oxygenate tissues at risk during hemorrhagic shock. MP4OX is a pegylated hemoglobin-based colloid designed to improve perfusion and target delivery of oxygen to ischemic tissues. This study will evaluate safety and efficacy of MP4OX treatment, in addition to standard therapy, in trauma patients suffering from lactic acidosis due to severe hemorrhagic shock.

ReferenceCitation: Cole RH, Vandegriff KD. MP4, a vasodilatory PEGylated hemoglobin. Adv Exp Med Biol. 2011;701:85-90. doi: 10.1007/978-1-4419-7756-4_12.

ReferenceCitation: Young MA, Lohman J, Malavalli A, Vandegriff KD, Winslow RM. Hemospan improves outcome in a model of perioperative hemodilution and blood loss in the rat: comparison with hydroxyethyl starch. J Cardiothorac Vasc Anesth. 2009 Jun;23(3):339-47. doi: 10.1053/j.jvca.2008.08.006. Epub 2008 Oct 22.

ReferenceCitation: Vandegriff KD, Winslow RM. Hemospan: design principles for a new class of oxygen therapeutic. Artif Organs. 2009 Feb;33(2):133-8. doi: 10.1111/j.1525-1594.2008.00697.x.

ReferenceCitation: Vandegriff KD, Malavalli A, Mkrtchyan GM, Spann SN, Baker DA, Winslow RM. Sites of modification of hemospan, a poly(ethylene glycol)-modified human hemoglobin for use as an oxygen therapeutic. Bioconjug Chem. 2008 Nov 19;19(11):2163-70. doi: 10.1021/bc8002666.

ReferenceCitation: Svergun DI, Ekström F, Vandegriff KD, Malavalli A, Baker DA, Nilsson C, Winslow RM. Solution structure of poly(ethylene) glycol-conjugated hemoglobin revealed by small-angle X-ray scattering: implications for a new oxygen therapeutic. Biophys J. 2008 Jan 1;94(1):173-81. Epub 2007 Sep 7.

ReferenceCitation: Cole RH, Vandegriff KD, Szeri AJ, Savaş O, Baker DA, Winslow RM. A quantitative framework for the design of acellular hemoglobins as blood substitutes: implications of dynamic flow conditions. Biophys Chem. 2007 Jun;128(1):63-74. Epub 2007 Mar 13.

ReferenceCitation: Young MA, Riddez L, Kjellström BT, Bursell J, Winslow F, Lohman J, Winslow RM. MalPEG-hemoglobin (MP4) improves hemodynamics, acid-base status, and survival after uncontrolled hemorrhage in anesthetized swine. Crit Care Med. 2005 Aug;33(8):1794-804.

ReferenceCitation: Drobin D, Kjellstrom BT, Malm E, Malavalli A, Lohman J, Vandegriff KD, Young MA, Winslow RM. Hemodynamic response and oxygen transport in pigs resuscitated with maleimide-polyethylene glycol-modified hemoglobin (MP4). J Appl Physiol (1985). 2004 May;96(5):1843-53. Epub 2004 Jan 16.

ReferenceCitation: Winslow RM, Lohman J, Malavalli A, Vandegriff KD. Comparison of PEG-modified albumin and hemoglobin in extreme hemodilution in the rat. J Appl Physiol (1985). 2004 Oct;97(4):1527-34. Epub 2004 Jun 18.

ReferenceCitation: Vandegriff KD, Bellelli A, Samaja M, Malavalli A, Brunori M, Winslow RM. Kinetics of NO and O2 binding to a maleimide poly(ethylene glycol)-conjugated human haemoglobin. Biochem J. 2004 Aug 15;382(Pt 1):183-9.

ReferenceCitation: Tsai AG, Vandegriff KD, Intaglietta M, Winslow RM. Targeted O2 delivery by low-P50 hemoglobin: a new basis for O2 therapeutics. Am J Physiol Heart Circ Physiol. 2003 Oct;285(4):H1411-9. Epub 2003 Jun 12.

ReferenceCitation: Vandegriff KD, Malavalli A, Wooldridge J, Lohman J, Winslow RM. MP4, a new nonvasoactive PEG-Hb conjugate. Transfusion. 2003 Apr;43(4):509-16.

ReferenceCitation: McCarthy MR, Vandegriff KD, Winslow RM. The role of facilitated diffusion in oxygen transport by cell-free hemoglobins: implications for the design of hemoglobin-based oxygen carriers. Biophys Chem. 2001 Aug 30;92(1-2):103-17.

ReferenceCitation: Young MA, Riddez L, Kjellström BT, Winslow RM. Effect of maleimide-polyethylene glycol hemoglobin (MP4) on hemodynamics and acid-base status after uncontrolled hemorrhage in anesthetized swine: comparison with crystalloid and blood. J Trauma. 2007 Dec;63(6):1234-44. doi: 10.1097/TA.0b013e31815bd7b0.

ReferenceCitation: Wettstein R, Tsai AG, Erni D, Winslow RM, Intaglietta M. Resuscitation with polyethylene glycol-modified human hemoglobin improves microcirculatory blood flow and tissue oxygenation after hemorrhagic shock in awake hamsters. Crit Care Med. 2003 Jun;31(6):1824-30.

ReferenceCitation: Husain FA, Martin MJ, Mullenix PS, Steele SR, Elliott DC. Serum lactate and base deficit as predictors of mortality and morbidity. Am J Surg. 2003 May;185(5):485-91.

ReferenceCitation: Régnier MA, Raux M, Le Manach Y, Asencio Y, Gaillard J, Devilliers C, Langeron O, Riou B. Prognostic significance of blood lactate and lactate clearance in trauma patients. Anesthesiology. 2012 Dec;117(6):1276-88. doi: 10.1097/ALN.0b013e318273349d.

ReferenceCitation: McNelis J, Marini CP, Jurkiewicz A, Szomstein S, Simms HH, Ritter G, Nathan IM. Prolonged lactate clearance is associated with increased mortality in the surgical intensive care unit. Am J Surg. 2001 Nov;182(5):481-5.

ReferenceCitation: Abramson D, Scalea TM, Hitchcock R, Trooskin SZ, Henry SM, Greenspan J. Lactate clearance and survival following injury. J Trauma. 1993 Oct;35(4):584-8; discussion 588-9.

ReferenceCitation: Tsai AG, Cabrales P, Manjula BN, Acharya SA, Winslow RM, Intaglietta M. Dissociation of local nitric oxide concentration and vasoconstriction in the presence of cell-free hemoglobin oxygen carriers. Blood. 2006 Nov 15;108(10):3603-10. Epub 2006 Jul 20.

lead_sponsor: Sangart

location_country:
Brazil
United Kingdom
Australia
New Zealand
Switzerland
France
Israel
South Africa
Belgium
Norway
Germany

location_facility: Faculdade de Medicina de S. J. Do Rio Preto

location_facility: Hopital Universitário, Centro de Estudos em Emergências em Saúde, USP Ribeirão Preto

location_facility: Klinikum der J.-W.-Goethe-Universität Frankfurt a.M.

location_facility: Charlotte Maxeke Johannesburg Academic Hospita

location_facility: Universitätsklinikum der Rheinisch-Westfälische Technische Hochschule Aachen

location_facility: Vincent Palotti Dr Christiaan Barnard Memorial Hospital

location_facility: Hadassah Medical Organization, Hadassah University Hospital, Ein-Karem

location_facility: Kliniken der Stadt Köln gGmbH Krankenhaus Merheim

location_facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo - FMUSP


title: A Phase 3 Evaluation of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination in Subjects With Genotype 1 Chronic Hepatitis C and Compensated Cirrhosis

ReferenceCitation: Muir AJ, Poordad F, Lalezari J, Everson G, Dore GJ, Herring R, Sheikh A, Kwo P, Hézode C, Pockros PJ, Tran A, Yozviak J, Reau N, Ramji A, Stuart K, Thompson AJ, Vierling J, Freilich B, Cooper J, Ghesquiere W, Yang R, McPhee F, Hughes EA, Swenson ES, Yin PD. Daclatasvir in combination with asunaprevir and beclabuvir for hepatitis C virus genotype 1 infection with compensated cirrhosis. JAMA. 2015 May 5;313(17):1736-44. doi: 10.1001/jama.2015.3868.

location_country:
Australia
United States
Canada
France

summary: To demonstrate the effectiveness of DCV 3DAA fixed dose combination with or without Ribavirin in treatment naive cirrhotic subjects.


title: A Randomized, Global, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Once-daily Oral Avatrombopag for the Treatment of Adults With Thrombocytopenia Associated With Liver Disease Prior to an Elective Procedure

summary: This is a global, multicenter, randomized, double-blind, placebo-controlled, parallel group study using avatrombopag to treat adults with thrombocytopenia associated with liver disease. The study will evaluate avatrombopag in the treatment of thrombocytopenia associated with liver disease prior to an elective procedure to reduce the need for platelet transfusions or any rescue procedure for bleeding due to procedural and post-procedural bleeding complications. Participants will be enrolled into 2 cohorts according to mean baseline platelet count and, within each baseline platelet count cohort will be further stratified by risk of bleeding associated with the elective procedure (low, moderate, or high) and hepatocellular carcinoma (HCC) status (Yes or No).

ReferenceCitation: Poordad F, Terrault NA, Alkhouri N, Tian W, Allen LF, Rabinovitz M. Avatrombopag, an Alternate Treatment Option to Reduce Platelet Transfusions in Patients with Thrombocytopenia and Chronic Liver Disease-Integrated Analyses of 2 Phase 3 Studies. Int J Hepatol. 2020 Jan 25;2020:5421632. doi: 10.1155/2020/5421632. eCollection 2020.

ReferenceCitation: Terrault N, Chen YC, Izumi N, Kayali Z, Mitrut P, Tak WY, Allen LF, Hassanein T. Avatrombopag Before Procedures Reduces Need for Platelet Transfusion in Patients With Chronic Liver Disease and Thrombocytopenia. Gastroenterology. 2018 Sep;155(3):705-718. doi: 10.1053/j.gastro.2018.05.025. Epub 2018 May 17.

lead_sponsor: Eisai Inc.

location_country:
Poland
Taiwan
Brazil
Portugal
Spain
Italy
Austria
Australia
United Kingdom
Argentina
Canada
Thailand
Hungary
Korea, Republic of
United States
Chile
China
France
Belgium
Germany


title: PEARL: Postmenopausal Evaluation And Risk-Reduction With Lasofoxifene

acronym: PEARL

summary: The purpose of the study is to determine the safety and effectiveness of 2 doses of the investigational drug, lasofoxifene, compared to placebo (an inactive substance) in reducing new spinal fractures in women with osteoporosis.

ReferenceCitation: Ensrud K, LaCroix A, Thompson JR, Thompson DD, Eastell R, Reid DM, Vukicevic S, Cauley J, Barrett-Connor E, Armstrong R, Welty F, Cummings S. Lasofoxifene and cardiovascular events in postmenopausal women with osteoporosis: Five-year results from the Postmenopausal Evaluation and Risk Reduction with Lasofoxifene (PEARL) trial. Circulation. 2010 Oct 26;122(17):1716-24. doi: 10.1161/CIRCULATIONAHA.109.924571. Epub 2010 Oct 11.

ReferenceCitation: Cummings SR, Ensrud K, Delmas PD, LaCroix AZ, Vukicevic S, Reid DM, Goldstein S, Sriram U, Lee A, Thompson J, Armstrong RA, Thompson DD, Powles T, Zanchetta J, Kendler D, Neven P, Eastell R; PEARL Study Investigators. Lasofoxifene in postmenopausal women with osteoporosis. N Engl J Med. 2010 Feb 25;362(8):686-96. doi: 10.1056/NEJMoa0808692. Erratum in: N Engl J Med. 2011 Jan 20;364(3):290. Kucu kdeveci A [corrected to Kucukdeveci, A].

lead_sponsor: Ligand Pharmaceuticals

location_country:
Croatia
Spain
Italy
United Kingdom
Lithuania
United States
Costa Rica
Belgium
Japan
Romania
South Africa
Poland
Hong Kong
Russian Federation
Australia
Argentina
India
Turkey
Mexico
Norway
Sweden
Egypt
Brazil
Canada
Hungary
Germany
Denmark
Ireland
Estonia
Finland
Korea, Republic of
France


title: Open-label Follow-up Study of the VIPES Study to Evaluate Long-term Efficacy and Safety of the Viaskin Peanut

acronym: OLFUS-VIPES

summary:
The objectives of this open-label follow-up study for subjects who previously were randomized and have completed the VIPES study for the treatment of peanut allergy, are:

To assess the efficacy of Viaskin Peanut after up to 36 months of treatment.
To evaluate the safety of long-term treatment with Viaskin Peanut.
To evaluate sustained unresponsiveness to peanut after a period of 2 months without treatment in subjects showing desensitization to peanut after treatment with Viaskin Peanut.

ReferenceCitation: Lewis MO, Brown-Whitehorn TF, Cianferoni A, Rooney C, Spergel JM. Peanut-allergic patient experiences after epicutaneous immunotherapy: peanut consumption and impact on QoL. Ann Allergy Asthma Immunol. 2019 Jul;123(1):101-103. doi: 10.1016/j.anai.2019.04.006. Epub 2019 Apr 10.

lead_sponsor: DBV Technologies

location_country:
Netherlands
United States
Canada
France

location_facility: Centre de Recherche Appliquée en Asthme et Allergie de Québec

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: University of California, Rady Childrens Hospital

location_facility: Ottawa Allergy Asthma Research Institute

location_facility: Centre Hospitalier Universitaire de Bordeaux, Hôpital Pellegrin


title: A Randomised, Placebo-controlled, Parallel Group Single Dose Study of SB681323 in Patients With Active RA to Investigate the CRP Dose Response Relationship

summary: This study is designed to compare a range of doses of SB-681323 with prednisolone, which has known effects on rheumatoid arthritis patients. By comparing the two drugs and their effects on blood proteins that indicate for rheumatoid arthritis, we hope to ascertain information on the most effective dose of SB-681323 to use in future.

location_country:
United Kingdom
Russian Federation
Australia
France
Germany


title: A Long-Term Continuation Study of Patients With Infantile-Onset Pompe Disease Who Were Previously Enrolled in Protocol AGLU01602

summary: Pompe disease (also known as glycogen storage disease type II) is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates and is stored in various tissues, especially heart and skeletal muscle, which prevents their normal function. The overall objective of this study is to evaluate the long-term safety and efficacy of Myozyme treatment in patients with infantile-onset Pompe disease.

ReferenceCitation: Kishnani PS, Goldenberg PC, DeArmey SL, Heller J, Benjamin D, Young S, Bali D, Smith SA, Li JS, Mandel H, Koeberl D, Rosenberg A, Chen YT. Cross-reactive immunologic material status affects treatment outcomes in Pompe disease infants. Mol Genet Metab. 2010 Jan;99(1):26-33. doi: 10.1016/j.ymgme.2009.08.003.

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Taiwan
Italy
Netherlands
United States
Israel
France
Germany

location_facility: Shands Hospital at the University of Florida

location_facility: Chi-Mei Medical Center Dept of Pediatrics


title: A Phase II Study of Abatacept Versus Placebo to Assess the Prevention of Rheumatoid Arthritis (RA) in Adult Patients With Undifferentiated Arthritis Who Are at High Risk for the Development of RA

summary: The purpose of this study is to assess if Abatacept given for six months will prevent rheumatoid arthritis (RA) in patients who are at risk for the development of RA in comparison to placebo. High risk patients are defined as those having a positive laboratory test for anti-cyclic citrullinated peptide (anti-CCP2).

ReferenceCitation: Emery P, Durez P, Dougados M, Legerton CW, Becker JC, Vratsanos G, Genant HK, Peterfy C, Mitra P, Overfield S, Qi K, Westhovens R. Impact of T-cell costimulation modulation in patients with undifferentiated inflammatory arthritis or very early rheumatoid arthritis: a clinical and imaging study of abatacept (the ADJUST trial). Ann Rheum Dis. 2010 Mar;69(3):510-6. doi: 10.1136/ard.2009.119016. Epub 2009 Nov 23. Erratum in: Ann Rheum Dis. 2011 Aug;70(8):1519.

location_country:
Spain
Italy
United Kingdom
Australia
Mexico
Puerto Rico
United States
France
Belgium
Germany


title: Randomized, Double-Blind, and Placebo-Controlled Study Using Eculizumab in Transfusion Dependent PNH Patients

summary: The primary objective is to evaluate the safety and efficacy of eculizumab in transfusion dependent patients with hemolytic PNH.

primary_purpose: Educational/Counseling/Training

ReferenceType: result

ReferenceCitation: Hillmen P, Young NS, Schubert J, Brodsky RA, Socié G, Muus P, Röth A, Szer J, Elebute MO, Nakamura R, Browne P, Risitano AM, Hill A, Schrezenmeier H, Fu CL, Maciejewski J, Rollins SA, Mojcik CF, Rother RP, Luzzatto L. The complement inhibitor eculizumab in paroxysmal nocturnal hemoglobinuria. N Engl J Med. 2006 Sep 21;355(12):1233-43.

ReferenceCitation: Hill A, Rother RP, Wang X, Morris SM Jr, Quinn-Senger K, Kelly R, Richards SJ, Bessler M, Bell L, Hillmen P, Gladwin MT. Effect of eculizumab on haemolysis-associated nitric oxide depletion, dyspnoea, and measures of pulmonary hypertension in patients with paroxysmal nocturnal haemoglobinuria. Br J Haematol. 2010 May;149(3):414-25. doi: 10.1111/j.1365-2141.2010.08096.x. Epub 2010 Mar 8.

lead_sponsor: Alexion Pharmaceuticals

location_country:
United Kingdom
Ireland
Italy
Australia
Netherlands
Canada
Switzerland
Sweden
United States
France
Belgium
Germany

location_facility: Medizinische Hochschule Hannover, Abt. Hamatologie/Onkologie, Zentrum fur Innere Medizin

location_facility: Washington University School of Medicine, Dept. of Internal Medicine/Division of Hematology

location_facility: Azienda Ospedaliera Universitaria Careggi, Dipartimento di area critica medico-chirurgica

location_facility: Belfast City Hospital, Dept. of Haematology C Floor

location_facility: Hopital Saint-Louis, Centre G. Hayem-Secteur Bleu Porte 7, Laboratoire De Pathologie/Greffe de Moelle

location_facility: Leeds General Infirmary, D Floor Brotherton Wing

location_facility: Lund University Hospital, Department of Internal Medicine, Section of Hematology

location_facility: The Royal Perth Hosptial, Department of Haematology/Level 2

location_facility: Duke University Health System, Division of Cell Therapy, Heme Malignancies Program

location_facility: Universitar degli Studi di Napoli, Divisione di Ematologia, Azienda Universitar Policlinico

location_facility: Queen Elizabeth Hospital, Dept. of Haematology

location_facility: Hospital De L'Hotel Dieu, Hematologie et Oncologie Medicale

location_facility: Stanford University Medical Center, Division of Hematology

location_facility: Princess Alexandra Hospital, Oncology Haematology Radiation Department

location_facility: Royal Cornwall Hospital, Haematology Dept.

location_facility: National Heart, Blood, and Lung Institute, National Institutes of Health

location_facility: Royal Melbourne Hospital, Dept. of Clinical Haematology & Medical Oncology

location_facility: Cleveland Clinic, Dept. of Clinical Research

location_facility: Universitatsklinikum Essen, Zentrum fur Innere Medizin

location_facility: Institut fur Klinische Transfusionmedizin und Immungenetik, Abtlg. Transfusionsmedizin des Universitatskinikums Ulm

location_facility: Presbyterian Medical Center, PENN Comprehensive Hemophilia & Thrombosis Program

location_facility: Universitatsklinik Greifswald, Innere Medizin C - Hamato-Onkologie

location_facility: Ospedale San Bortolo, Divisione di Ematologia

location_facility: Indiana University Cancer Pavilion, Div. of Hematology-Oncology, Hematological Malignancy Program/Immunology

location_facility: University of Alberta, Cross Cancer Institute

location_facility: Saarland University Medical School, Internal Medicine 1

location_facility: Ospedale Maggiore di Milano, Divisione di Ematologia

location_facility: Hartford Hospital, Cancer Clinical Research Office

location_facility: Universitatsklinik Basel, Division of Hematology

location_facility: St. George's Hospital, Department of Haematology

location_facility: Umea University Hospital, Dept. of Internal Medicine 3, Section for Hematology

location_facility: City of Hope National Medical Center, Div. of Hematology & Bone Marrow Transplant

location_facility: St. James Hospital, Haematology Department

location_facility: Ospedale San Martino, Dept. of Hematology


title: An Open-label Multi-center, Randomized Parallel Group Comparison of Efficacy and Safety of Degarelix Three-Month Depot in Three Different Dosing Regimens in Patients With Prostate Cancer

summary: The rationale of the study was to evaluate different degarelix dosing regimens for a three-month interval that was to produce and maintain castration in prostate cancer patients through immediate and prolonged testosterone suppression, and to provide confirmatory evidence of the safety of degarelix.

lead_sponsor: Ferring Pharmaceuticals

location_country:
Romania
United Kingdom
Russian Federation
Netherlands
Finland
Canada
Former Serbia and Montenegro
United States
France
Belgium
Germany

location_facility: Clinical Center Novi Sad, Clinic of Urology Hajduk

location_facility: Mount Vernon Cancer Centre, Marie Curie Research Wing

location_facility: The Male/Female Health Centres and Research

location_facility: Pavlov State Medical University, Urology Department

location_facility: University CF Hospital No.2, Urology Clinic

location_facility: Clinical Center of Serbia Institute of Urology and Nephrology

location_facility: Gemeinschaftspraxis Dres Effert und Benedic

location_facility: Oulu University Hospital, Department of Surgery Division of Urology

location_facility: Tampere University Hospital, Dept. of Urology

location_facility: Centre Hospitalier Départemental des Oudairies, Chirurgie Urologie

location_facility: Klinik fuer Urologie, Vivantes Klinikum Am Urban

location_facility: Central Hospital, North Karelian, Dept. of Urology

location_facility: Level 7, Urology Research Unit, Derriford Hospital

location_facility: South Orange County Medical Research Center

location_facility: Pavlov State Medical University, Outpatient Diagnostic Center affiliated with the Urology Department

location_facility: University of Missouri, Urology, Deptof Surgery

location_facility: Clinical Hospital "Prof. Dr. Theodor Burghele", Urology Department

location_facility: Ward 10, NHS Forth Valley Acute Operating Division, Falkirk and District Royal Infirmary

location_facility: Helsinki University Hospital, Maria Hospital, Dept Urology


title: Phase 2 Study Of SU011248 As Consolidation Therapy In Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer

summary: The purpose of this study is to find out if SU011248 (sunitinib) provides additional benefit when it is given after treatment with two chemotherapy drugs carboplatin and paclitaxel and also if sunitinib is safe for patients with locally advanced and metastatic Non Small Cell Lung Cancer (NSCLC).

lead_sponsor: Pfizer

location_country:
United States
Canada
France


ipd_sharing: Undecided

title: A Phase 1 Study of the TRK Inhibitor Selitrectinib (BAY 2731954) in Adult and Pediatric Subjects With Previously Treated NTRK Fusion Cancers

lead_sponsor: Bayer

ReferenceCitation: O'Reilly EM, Hechtman JF. Tumour response to TRK inhibition in a patient with pancreatic adenocarcinoma harbouring an NTRK gene fusion. Ann Oncol. 2019 Nov 1;30(Suppl_8):viii36-viii40. doi: 10.1093/annonc/mdz385. Epub 2019 Dec 24.

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

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

location_country:
Denmark
Spain
Ireland
Italy
Australia
United States
France
Singapore
Belgium
Germany

location_facility: UCLA Jonsson Comprehensive Cancer Center

location_facility: University of Texas MD Anderson Cancer Center

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

location_facility: Fundacion Jimenez Diaz (Clinica de la Concepcion)

location_facility: Univ.of California-San Diego Moores Cancer Center

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

summary: This research study is done to test the safety of the new drug selitrectinib in children and adults with cancer having a change in a particular gene (NTRK1, NTRK2 or NTRK3). The drug may treat cancer by interfering with the effect of the NTRK genes on cancer growth. The study also investigates how the drug is absorbed and processed in the human body, and how well and for how long the cancer responds to the drug. This is the first study to test selitrectinib in humans with cancer, for whom no other effective therapy exists.


title: An Open Label Extension Study to Evaluate Safety and Efficacy of Mepolizumab in Patients With Hypereosinophilic Syndromes

summary: This is an open label study of mepolizumab 750 mg intravenous in those subjects who participated in study 100185 to evaluate the long term safety and efficacy of mepolizumab in subjects with hypereosinophilic syndrome. The study will also evaluate the optimal dosing frequency for clinical use, the effects on corticosteroid reduction, and decrease of signs and symptoms of Hypereosinophilic Syndrome.

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

location_country:
Italy
Australia
Canada
United States
France
Belgium
Germany


title: A Phase III, Multi-Center, Multi-National, Randomized Withdrawal Study to Evaluate the Safety and Efficacy of BMS-188667 in Children and Adolescents With Active Polyarticular Juvenile Rheumatoid Arthritis (JRA)

summary: The primary purpose of the clinical research study is to assess the safety of treating children and juvenile subjects with BMS-188667 (Abatacept). In addition, the study will assess the effectiveness of BMS-188667 in reducing disease activity of Juvenile Rheumatoid Arthritis (JRA) or Juvenile Idiopathic Arthritis (JIA) as measured by the time to occurrence of disease flare.

ReferenceCitation: Ruperto N, Brunner HI, Tzaribachev N, Vega-Cornejo G, Louw I, Cimaz R, Dare J, Espada G, Faugier E, Ferrandiz M, Gerloni V, Quartier P, Silva CA, Wagner-Weiner L, Gandhi Y, Passarell J, Nys M, Wong R, Martini A, Lovell DJ; Pediatric Rheumatology Collaborative Study Group (PRCSG) and the Paediatric Rheumatology International Trials Organisation (PRINTO). Absence of Association Between Abatacept Exposure and Initial Infection in Patients With Juvenile Idiopathic Arthritis. J Rheumatol. 2021 Jul;48(7):1073-1081. doi: 10.3899/jrheum.200154. Epub 2021 Jan 15.

ReferenceCitation: Lovell DJ, Ruperto N, Mouy R, Paz E, Rubio-Pérez N, Silva CA, Abud-Mendoza C, Burgos-Vargas R, Gerloni V, Melo-Gomes JA, Saad-Magalhaes C, Chavez-Corrales J, Huemer C, Kivitz A, Blanco FJ, Foeldvari I, Hofer M, Huppertz HI, Job Deslandre C, Minden K, Punaro M, Block AJ, Giannini EH, Martini A; Pediatric Rheumatology Collaborative Study Group and the Paediatric Rheumatology International Trials Organisation. Long-term safety, efficacy, and quality of life in patients with juvenile idiopathic arthritis treated with intravenous abatacept for up to seven years. Arthritis Rheumatol. 2015 Oct;67(10):2759-70. doi: 10.1002/art.39234.

ReferenceCitation: Ruperto N, Lovell DJ, Li T, Sztajnbok F, Goldenstein-Schainberg C, Scheinberg M, Penades IC, Fischbach M, Alcala JO, Hashkes PJ, Hom C, Jung L, Lepore L, Oliveira S, Wallace C, Alessio M, Quartier P, Cortis E, Eberhard A, Simonini G, Lemelle I, Chalom EC, Sigal LH, Block A, Covucci A, Nys M, Martini A, Giannini EH; Paediatric Rheumatology International Trials Organisation (PRINTO); Pediatric Rheumatology Collaborative Study Group (PRCSG). Abatacept improves health-related quality of life, pain, sleep quality, and daily participation in subjects with juvenile idiopathic arthritis. Arthritis Care Res (Hoboken). 2010 Nov;62(11):1542-51. doi: 10.1002/acr.20283. Epub 2010 Jul 1.

ReferenceCitation: Ruperto N, Lovell DJ, Quartier P, Paz E, Rubio-Pérez N, Silva CA, Abud-Mendoza C, Burgos-Vargas R, Gerloni V, Melo-Gomes JA, Saad-Magalhães C, Chavez-Corrales J, Huemer C, Kivitz A, Blanco FJ, Foeldvari I, Hofer M, Horneff G, Huppertz HI, Job-Deslandre C, Loy A, Minden K, Punaro M, Nunez AF, Sigal LH, Block AJ, Nys M, Martini A, Giannini EH; Paediatric Rheumatology International Trials Organization and the Pediatric Rheumatology Collaborative Study Group. Long-term safety and efficacy of abatacept in children with juvenile idiopathic arthritis. Arthritis Rheum. 2010 Jun;62(6):1792-802. doi: 10.1002/art.27431.

ReferenceCitation: Ruperto N, Lovell DJ, Quartier P, Paz E, Rubio-Pérez N, Silva CA, Abud-Mendoza C, Burgos-Vargas R, Gerloni V, Melo-Gomes JA, Saad-Magalhães C, Sztajnbok F, Goldenstein-Schainberg C, Scheinberg M, Penades IC, Fischbach M, Orozco J, Hashkes PJ, Hom C, Jung L, Lepore L, Oliveira S, Wallace CA, Sigal LH, Block AJ, Covucci A, Martini A, Giannini EH; Paediatric Rheumatology INternational Trials Organization; Pediatric Rheumatology Collaborative Study Group. Abatacept in children with juvenile idiopathic arthritis: a randomised, double-blind, placebo-controlled withdrawal trial. Lancet. 2008 Aug 2;372(9636):383-91. doi: 10.1016/S0140-6736(08)60998-8. Epub 2008 Jul 14.

location_country:
Brazil
Portugal
Spain
Italy
Austria
Switzerland
United States
France
Peru
Mexico
Germany


title: A Randomized Controlled Study of Docetaxel Monotherapy or Docetaxel and DOXIL for the Treatment of Advanced Breast Cancer

summary: The purpose of the study is to evaluate whether the time to progression for the DOXIL and docetaxel combination therapy group was superior to that of the group treated with docetaxel monotherapy in participants with advanced breast cancer.

lead_sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

location_country:
Poland
Portugal
Serbia
Spain
Latvia
Russian Federation
Estonia
United Kingdom
Lithuania
Ukraine
Hungary
United States
France
Israel
South Africa
Romania
Netherlands
Bulgaria


title: Safety and Pharmacokinetics of Valganciclovir Syrup Formulation in Pediatric Solid Organ Transplant Recipients

summary: This study will assess the safety and pharmacokinetics of Valcyte syrup in pediatric solid organ transplant recipients. The anticipated time on study treatment is 3-12 months and the target sample size is less than 100 individuals.

lead_sponsor: Hoffmann-La Roche

location_country:
Spain
Australia
Canada
United States
France
Mexico
Germany


title: A Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- Sparing Effects of Mepolizumab in Subjects With Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of Subjects With HES

summary:
Hypereosinophilic syndrome (HES) is a rare disease with broad clinical signs and symptoms which is diagnosed based on a persistent blood eosinophil count of greater than 1500 cells, various end-organ damages (including skin, heart, lung, nervous system and digestive system etc.), and with exclusion of known secondary causes of hypereosinophilia.

HES has a high morbidity/mortality rate. The major treatment of HES has been systemic corticosteroid and other chemotherapeutic drugs (for example, hydroxyurea and interferon) with the intention to lower eosinophil counts and therefore to slow down the progression of disease. Even though corticosteroid and other therapies can effectively reduce eosinophilia in some patients, some may eventually become nonresponsive and intolerable to the amount of side effects of the long-term therapy with these medications.

Mepolizumab is a humanized monoclonal antibody that binds specifically to human interleukin 5 (hIL-5) and inhibits its activity. Previous human experience has shown it has been effective in reducing blood eosinophilia in atopic and HES patients and has alleviated some HES clinical signs and symptoms. This study intends to further evaluate the corticosteroid-sparing and clinical benefit of mepolizumab in HES.

ReferenceCitation: Roufosse F, de Lavareille A, Schandené L, Cogan E, Georgelas A, Wagner L, Xi L, Raffeld M, Goldman M, Gleich GJ, Klion A. Mepolizumab as a corticosteroid-sparing agent in lymphocytic variant hypereosinophilic syndrome. J Allergy Clin Immunol. 2010 Oct;126(4):828-835.e3. doi: 10.1016/j.jaci.2010.06.049.

ReferenceCitation: Rothenberg ME, Klion AD, Roufosse FE, Kahn JE, Weller PF, Simon HU, Schwartz LB, Rosenwasser LJ, Ring J, Griffin EF, Haig AE, Frewer PI, Parkin JM, Gleich GJ; Mepolizumab HES Study Group. Treatment of patients with the hypereosinophilic syndrome with mepolizumab. N Engl J Med. 2008 Mar 20;358(12):1215-28. doi: 10.1056/NEJMoa070812. Epub 2008 Mar 16. Erratum in: N Engl J Med. 2008 Jun 5;358(23): 2530.

lead_sponsor: GlaxoSmithKline

location_country:
Italy
Australia
Canada
Switzerland
United States
France
Belgium
Germany


title: Phase IV, Multicenter, Open Label, Randomized Study of Rebif® 44 mcg Administered Three Times Per Week by Subcutaneous Injection Compared With Copaxone® 20 mg Administered Daily by Subcutaneous Injection in the Treatment of Relapsing Remitting Multiple Sclerosis

summary: The primary objective of the study is to assess the clinical efficacy of Rebif® 44 microgram (mcg) three times per week compared with Copaxone® 20 milligram (mg) daily in subjects with relapsing Multiple Sclerosis.

ReferenceCitation: Mikol DD, Barkhof F, Chang P, Coyle PK, Jeffery DR, Schwid SR, Stubinski B, Uitdehaag B; REGARD study group. Comparison of subcutaneous interferon beta-1a with glatiramer acetate in patients with relapsing multiple sclerosis (the REbif vs Glatiramer Acetate in Relapsing MS Disease [REGARD] study): a multicentre, randomised, parallel, open-label trial. Lancet Neurol. 2008 Oct;7(10):903-14. doi: 10.1016/S1474-4422(08)70200-X. Epub 2008 Sep 11.

lead_sponsor: EMD Serono

location_country:
Brazil
Spain
Italy
Austria
Netherlands
Russian Federation
Argentina
United Kingdom
Switzerland
United States
France
Germany

location_facility: Associated Neurologists of Southern Connecticut, P.C.

location_facility: Academisch Ziekenhuis Vrije Universiteit

location_facility: Dept of Neurology St Petersburg State Medical University

location_facility: State Instituion Central Clinical Milatary Hospital

location_facility: Div of Clinical Neurology B Floor Medical School Univ Hospital

location_facility: Dept of Neurology Johannes Gutenberg University

location_facility: University of Minnesota Medical School, Dept of Neurology

location_facility: Servicio de Neurologia Hospital Bellvitge

location_facility: Division of Clinical Neurology Medical School Universtity Hopsital

location_facility: Fundacion Rosarina de Neurorehabilitacion

location_facility: The MS Treatment Center at Griffin Hospital

location_facility: Chair of Nuerological Diseases and Medical Genetics

location_facility: Dept of Neurology Medical Clinic of Russian MoH

location_facility: Campus Ribeirao Preto Faculdade de Medicina de Sao Paolo

location_facility: SUNY At Stony Brook U Hospital - Department of Neurology

location_facility: Thomas Jefferson University Physicians Dept of Neurology

location_facility: Albany Medical College Dept of Neurology MC-70

location_facility: Dept of Neurology Universitatsklinikum Munster

location_facility: SUNY Upstate Medical University Dept of Neurology

location_facility: Dept Neurologia Sanatorio Britanico de Rosario

location_facility: Dept of Neurosciences Oftamology and Genetics Univ of Genoa

location_facility: Dept of Neurological and Psychiatric Sciences University of Bari

location_facility: Dept of Neurological Sciences University La Sapienza Rome

location_facility: Unidad de EM Neurologia Hospital Virgen Macarena

location_facility: Scientific Research Center of Neurology Russian MOH

location_facility: Neurology Health Care Service / Fletcher Allen Health Care

location_facility: Department Of Neurology Royal London Hospital

location_facility: Department of Neurology City Hospital #33

location_facility: Dept Of Neurology and Neurosurgery, Russian State Med Univ

location_facility: Dept of MS Institute for Human Brain of R.A.Sci

location_facility: Neuroinmunologia Clinica Hospital Vall d'Hebron

location_facility: Servicio de Neurologia Departmento Enfermedades Desmielinizantes


title: A Multi-center, Open-Label Extension Study of the Safety and Efficacy of Recombinant Human a-Galactosidase A (r-haGAL) Replacement in Patients With Fabry Disease

summary: People with Fabry disease have an alteration in their genetic material (DNA) which causes a deficiency of the a-galactosidase A enzyme. Fabrazyme is a drug that helps to breakdown and remove certain types of fatty substances called "glycolipids." These glycolipids are normally present within the body in most cells. In Fabry disease, glycolipids build up in various tissues such as the liver, kidney, skin, and blood vessels because a-galactosidase A is not present, or is present in small quantities. The build up of glycolipid ("globatriaosylceramide" or "GL-3") levels in these tissues in particular is thought to cause the clinical symptoms that are common to Fabry disease. This study will test the safety and efficacy of Fabrazyme in the treatment of patients with Fabry disease.

ReferenceCitation: Germain DP, Charrow J, Desnick RJ, Guffon N, Kempf J, Lachmann RH, Lemay R, Linthorst GE, Packman S, Scott CR, Waldek S, Warnock DG, Weinreb NJ, Wilcox WR. Ten-year outcome of enzyme replacement therapy with agalsidase beta in patients with Fabry disease. J Med Genet. 2015 May;52(5):353-8. doi: 10.1136/jmedgenet-2014-102797. Epub 2015 Mar 20.

location_country:
United Kingdom
Puerto Rico
United States
France
Netherlands

location_facility: Northwest Oncology & Hematology Associates

location_facility: National Hospital for Neurology and Neurosurgery

location_facility: University of Rochester School of Medicine

location_facility: University of Washington School of Medicine

location_facility: Hematology/Oncology Associates of South Texas


title: Randomized Phase II Trial With Infliximab (Remicade) in Patients With Myelodysplastic Syndrome and a Relatively Low Risk of Developing Acute Leukemia

summary:
RATIONALE: Monoclonal antibodies, such as infliximab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Randomized phase II trial to study the effectiveness of infliximab in treating patients who have myelodysplastic syndrome.

ReferenceCitation: Baron F, Suciu S, Amadori S, Muus P, Zwierzina H, Denzlinger C, Delforge M, Thyss A, Selleslag D, Indrak K, Ossenkoppele G, de Witte T. Value of infliximab (Remicade®) in patients with low-risk myelodysplastic syndrome: final results of a randomized phase II trial (EORTC trial 06023) of the EORTC Leukemia Group. Haematologica. 2012 Apr;97(4):529-33. doi: 10.3324/haematol.2011.044347. Epub 2011 Nov 18.

ReferenceCitation: Baila L, Suciu S, Muus P, et al.: Assessment of two doses of infliximab in patients with low/intermediate risk IPSS myelodysplastic syndrome (MDS): an EORTC leukemia group (LG) randomized phase II trial (06023). [Abstract] Blood 110 (11): A-1456, 2007.

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

location_country:
Italy
Netherlands
Czech Republic
France
Belgium
Germany

location_facility: Southwest German Cancer Center at Eberhard-Karls-University

location_facility: Universitair Medisch Centrum St. Radboud - Nijmegen

location_facility: Institute of Hematology and Blood Transfusion

location_facility: Ruprecht - Karls - Universitaet Heidelberg


title: A Phase 1 Study Of Cmc-544 Administered As A Single Agent In Subjects With B-cell Non- Hodgkin's Lymphoma

summary: To determine the Maximum Tolerated Dose (MTD), the tolerability, and the initial safety profile of CMC-544 in subjects with B-cell Non-Hodgkin's Lymphoma (NHL).

location_country:
Spain
United Kingdom
Switzerland
United States
France
Belgium
Germany

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Universitaet Muenchen Klinikum Grosshadern

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet

location_facility: Medizinische Klinik und Poliklinik III, Klinikum der Universitat Muenchen-Grosshadern

location_facility: University of Alabama at Birmingham Kirklin Clinic


title: A Phase III, Randomized, Open-Label Study Of IV Edotecarin Vs Temozolomide Or Carmustine (BCNU) Or Lomustine (CCNU) In Patients With Glioblastoma Multiforme At First Relapse After Alkylator-Based (NEO) Adjuvant Chemotherapy

summary: The purpose of this clinical trial is to study Edotecarin in patients with the brain tumor glioblastoma multiforme (GBM) who have progression or first recurrence following initial treatment with surgery, radiation and chemotherapy.

location_country:
Croatia
Spain
Italy
Austria
Australia
Russian Federation
Canada
Czech Republic
United States
France
India
South Africa
Germany


title: A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly

summary: The purpose of the study is to determine if Pegvisomant is more efficacious than Sandostatin LAR Depot in normalizing IGF-I levels in treatment naive patients with acromegaly.

location_country:
Brazil
Spain
Greece
Ireland
Australia
Italy
Canada
United Kingdom
Sweden
United States
France
Norway
Germany


title: A Randomized, Parallel Group, Three-Arm Study To Evaluate Treatment With A Combination Of Pegvisomant Plus Sandostatin Lar, Pegvisomant (Alone), And Sandostatin Lar (Alone) In Patients With Acromegaly

summary: The purpose of this study is to compare the safety and tolerability of combination therapy with Sandostatin LAR plus Pegvisomant to that of Sandostatin LAR alone or Pegvisomant alone.

location_country:
Brazil
Spain
Italy
United Kingdom
Australia
Netherlands
Canada
United States
France
Mexico
Norway
Germany


title: Multi-Center Clinical Evaluation of the ATTUNE® Revision System in Revision Total Knee Arthroplasty

summary: Five-year, Prospective, multi-center, non-randomized, non-controlled study of the ATTUNE® Revision total knee prostheses, utilizing the fixed bearing (FB) and rotating platform (RP) tibial component with the posterior stabilizing (PS) femoral component in revision total knee arthroplasty.

ipd_sharing: No

lead_sponsor: DePuy Orthopaedics

location_country:
United Kingdom
Ireland
Austria
Australia
Italy
Canada
Netherlands
New Zealand
Switzerland
United States
France
Belgium
Germany

location_facility: Kantonsspital Baselland (Bruderholz, Liestal, Laufen), Department of Orthopaedic Surgery and Traumatology

location_facility: Asklepios Orthopädische Klinik Lindenlohe

location_facility: CLINICHE GAVAZZENI SPA aka Humanitas Castelli

location_facility: Klinik und Poliklinik für Orthopädie und Sportorthopädie am Klinikum rechts der Isar der Technischen Universität Münche

location_facility: London Health Sciences Centre University Hospital

location_facility: The Gold Coast Centre for Bone and Joint Surgery

location_facility: The Ohio State University Wexner Medical Center

location_facility: University of Mississippi Medical Center

location_facility: Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H.

location_facility: The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

location_facility: Hampshire Hospitals NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire de Rennes

intervention_type: Device


title: A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of Teclistamab, a Humanized BCMA x CD3 Bispecific Antibody in Subjects With Relapsed or Refractory Multiple Myeloma

summary: The purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule assessed to be safe for Teclistamab and to characterize the safety and tolerability of Teclistamab at the RP2Ds.

ReferenceCitation: Girgis S, Lin SXW, Pillarisetti K, Banerjee A, Stephenson T, Ma X, Shetty S, Yang TY, Hilder BW, Jiao Q, Hanna B, Adams HC 3rd, Sun YN, Sharma A, Smit J, Infante JR, Goldberg JD, Elsayed Y. Translational Modeling Predicts Efficacious Therapeutic Dosing Range of Teclistamab for Multiple Myeloma. Target Oncol. 2022 Jul;17(4):433-439. doi: 10.1007/s11523-022-00893-y. Epub 2022 Jun 24. Erratum In: Target Oncol. 2022 Aug 1;:

ReferenceCitation: Moreau P, Garfall AL, van de Donk NWCJ, Nahi H, San-Miguel JF, Oriol A, Nooka AK, Martin T, Rosinol L, Chari A, Karlin L, Benboubker L, Mateos MV, Bahlis N, Popat R, Besemer B, Martínez-López J, Sidana S, Delforge M, Pei L, Trancucci D, Verona R, Girgis S, Lin SXW, Olyslager Y, Jaffe M, Uhlar C, Stephenson T, Van Rampelbergh R, Banerjee A, Goldberg JD, Kobos R, Krishnan A, Usmani SZ. Teclistamab in Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2022 Aug 11;387(6):495-505. doi: 10.1056/NEJMoa2203478. Epub 2022 Jun 5.

ReferenceCitation: Usmani SZ, Garfall AL, van de Donk NWCJ, Nahi H, San-Miguel JF, Oriol A, Rosinol L, Chari A, Bhutani M, Karlin L, Benboubker L, Pei L, Verona R, Girgis S, Stephenson T, Elsayed Y, Infante J, Goldberg JD, Banerjee A, Mateos MV, Krishnan A. Teclistamab, a B-cell maturation antigen × CD3 bispecific antibody, in patients with relapsed or refractory multiple myeloma (MajesTEC-1): a multicentre, open-label, single-arm, phase 1 study. Lancet. 2021 Aug 21;398(10301):665-674. doi: 10.1016/S0140-6736(21)01338-6. Epub 2021 Aug 10.

ReferenceCitation: Pillarisetti K, Powers G, Luistro L, Babich A, Baldwin E, Li Y, Zhang X, Mendonça M, Majewski N, Nanjunda R, Chin D, Packman K, Elsayed Y, Attar R, Gaudet F. Teclistamab is an active T cell-redirecting bispecific antibody against B-cell maturation antigen for multiple myeloma. Blood Adv. 2020 Sep 22;4(18):4538-4549. doi: 10.1182/bloodadvances.2020002393.

lead_sponsor: Janssen Research & Development, LLC

location_country:
Spain
Sweden
United States
France
Netherlands

location_facility: Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects


title: A Randomized, Multicenter, Open-label Study of Yondelis (ET-743 Ecteinascidin) Administered by 2 Different Schedules (Weekly for 3 of 4 Weeks vs. q3 Weeks) in Subjects With Locally Advanced or Metastatic Liposarcoma or Leiomyosarcoma Following Treatment With an Anthracycline and Ifosfamide

summary: The purpose of this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with types of advanced cancer referred to as liposarcoma or leiomyosarcoma.

location_country:
Spain
Russian Federation
Australia
Canada
United States
France
Belgium
Germany


title: A Phase 1 Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Antitumor Activity of MEDI7247 in Patients With Selected Relapsed/Refractory Hematological Malignancies

summary: To assess safety and tolerability, describe the dose-limiting toxicities, determine the maximum tolerated dose (MTD) or the highest protocol-defined dose (maximum administered dose) in the absence of establishing the MTD, and a recommended dose for further evaluation of MEDI7247 in patients with selected hematological malignancies who have relapsed after, or are refractory to prior standard therapy, and for whom there is no standard salvage regimen available.

lead_sponsor: MedImmune LLC

location_country:
Korea, Republic of
United States
France