title: A Phase Ib Study of Cobimetinib Administered in Combination With Niraparib, With or Without Atezolizumab, To Patients With Advanced Platinum-sensitive Ovarian Cancer

summary:
The study will include a safety run-in phase (Stage 1) and a randomization phase (Stage 2).

The purpose of Stage 1 is to evaluate the safety of cobimetinib when administered in combination with niraparib (Cohort 1) and cobimetinib with niraparib plus atezolizumab (Cohort 2).

Stage 1 will enable patient enrollment in the randomized phase of the study (Stage 2) with both regimens at the recommended dose levels from Stage 1.

Stage 2 is a randomized, dose-expansion phase, evaluating clinical outcomes in patients with advanced platinum-sensitive ovarian cancer.

All patients will continue to receive study treatment until disease progression (according to "Response Evaluation Criteria in Solid Tumors" (RECIST), Version 1.1, unacceptable toxicity, death, or patient or investigator decision to withdraw, whichever occurs first.

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
United States
France
Spain

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: Fondazione Policlinico Universitario "A. Gemelli"; Unità di Fase 1: Unità di Farmacologia Clinica

location_facility: Moores Cancer Center at UC San Diego Health

location_facility: Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica

location_facility: Clinica Universidad de Navarra Madrid; Servicio de Oncología

location_facility: Hospital Clínico Universitario de Valencia; Servicio de Oncología

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Istituto Europeo di Oncologia; Svil. Nuovi Farmaci per Terapie Innovative

location_facility: Tennessee Oncology; Sarah Cannon Research Institute

location_facility: Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale

location_facility: VCU Massey Cancer Center, Dalton Oncology Clinic

location_facility: Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia

location_facility: Centro Oncologico de Galicia COG; Medical Oncology

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

location_facility: Medical College of Wisconsin; Department of Obstetrics and Gynecology

location_facility: Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: Florida Hospital Cancer Institute; Clinical Research Department

location_facility: University of Arizona Cancer Center, North

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Stephenson Cancer Center Investigational Pharmacy

location_facility: Medical College of Georgia; Obstetrics & Gynecolog

location_facility: Hospital Universitari Vall dHebron; Oncology


title: A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Efficacy and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered Via the PARI Investigational eFlow® Device Plus Standard of Care Versus Standard of Care Alone in the Treatment of Chronic Lung Allograft Dysfunction / Bronchiolitis Obliterans Syndrome in Patients Post Double Lung Transplantation

summary: This is a Phase III randomized, controlled clinical trial of L-CsA for the treatment of bronchiolitis obliterans syndrome in adults diagnosed with BOS following double lung transplant. Patients will receive either L-CsA (10 mg) via the PARI Investigational eFlow® Device twice daily plus Standard of Care (SoC) treatment, or SoC alone, for a period of 48 weeks. All patients will be eligible to continue in an open-label extension trial of L-CsA following completion of BOSTON-2.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: Zambon SpA

location_country:
Austria
Germany
France
Israel
Belgium
Spain
United States
United Kingdom

location_facility: University of Kentucky Albert B. Chandler Hospital

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


intervention_type: Biological

status: Active, not recruiting

lead_sponsor: Hookipa Biotech GmbH

enrollment_type: Actual

primary_purpose: Prevention

location_country:
Germany
France
Norway
Denmark
United States
United Kingdom

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

location_facility: Thomas E. Starzl Transplantation Institute

location_facility: University of Cincinnati (UC) - College of Medicine

location_facility: Centre Hospitalier Universitaire de Bordeaux Hôpital Pellegrin

location_facility: University Hospitals Cleveland Medical Center

ipd_sharing: No

type: EudraCT Number

source: euctr

title: A Randomized, Placebo-Controlled, Phase 2 Study of HB-101, a Bivalent Cytomegalovirus (CMV) Vaccine, in CMV-Seronegative Recipient (R-) Patients Awaiting Kidney Transplantation From Living CMV-Seropositive Donors (D+).

summary: HB-101 is a bivalent recombinant vaccine against human CMV infection. This is a randomized, placebo-controlled, phase 2 study to assess the safety, reactogenicity, immunogenicity, and efficacy of HB-101 in CMV-Seronegative patients receiving a kidney transplant from a CMV-Seropositive living donor and CMV-Seropositive patients.Patients enrolled should have a living donor kidney transplantation ideally planned between two to four months after the first injection of study drug (HB-101 or placebo).


ReferenceType: derived

ReferenceCitation: Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9:CD013365. doi: 10.1002/14651858.CD013365.pub2. Review.

name: Cochrane Haematology, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf; Faculty of Medicine and University Hospital Cologne, University of Cologne; Cologne Germany

family: Ernst

full_name: Moritz Ernst

given: Moritz

sequence: additional

family: Oeser

full_name: Annika Oeser

given: Annika

family: Besiroglu

full_name: Burcu Besiroglu

given: Burcu

family: Caro-Valenzuela

full_name: Julia Caro-Valenzuela

given: Julia

name: Department of Surgery; Mayo Clinic; Rochester Minnesota USA

family: Abd El Aziz

full_name: Mohamed Abd El Aziz

given: Mohamed

family: Monsef

full_name: Ina Monsef

given: Ina

name: Department I of Internal Medicine; University Hospital of Cologne; Cologne Germany

family: Borchmann

full_name: Peter Borchmann

given: Peter

name: Haematology/Transfusion Medicine; NHS Blood and Transplant; Oxford UK

family: Estcourt

full_name: Lise J Estcourt

given: Lise J

name: Cochrane Cancer, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf; Faculty of Medicine and University Hospital Cologne, University of Cologne; Cologne Germany

family: Skoetz

full_name: Nicole Skoetz

given: Nicole

family: Goldkuhle

full_name: Marius Goldkuhle

given: Marius

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
Austria
United States
Netherlands
Germany
Finland
France
Japan
Norway
Australia
Spain
Denmark
Canada
United Kingdom

acronym: BIANCA

location_facility: Childrens Healthcare of Atlanta At Scottish Rite

location_facility: Monroe Carell Jr Childrens Hospital at Vanderbilt

location_facility: Prinses Maxima Centrum voor Kinderoncologie

location_facility: The Childrens Hospital of Philadelphia Drug Shipment

location_facility: Memorial Sloan Kettering Cancer Center MSKCC (8)

location_facility: University of Wisconsin Hospital and Clinics

location_facility: University of Texas Southwestern Medical Center

location_facility: Cincinnati Children s Hospital Medical Center

location_facility: Dana Farber Cancer Institute Dept.of DFCI

ipd_sharing: Yes

title: A Phase II, Single Arm, Multicenter Open Label Trial to Determine the Safety and Efficacy of Tisagenlecleucel in Pediatric Subjects With Relapsed or Refractory Mature B-cell Non-Hodgkin Lymphoma (NHL)

summary: The purpose of the study is to assess the efficacy and safety of tisagenlecleucel in children and adolescents with relapsed/refractory B-cell non-Hodgkin lymphoma (r/r B-NHL). For pediatric patients who have r/r B-NHL, survival rates are dismal, only ~20-50% subjects are alive at 2 years with overall response rate (ORR) of 20-30% after conventional salvage chemotherapy.


title: Establishment of Baseline and Comparative Infection Rates for the Codman BACTISEAL TM External Ventricular Drainage (EVD) System

summary: The purpose of this non-significant risk study is to establish initial baseline infection rates for the Codman BACTISEAL External Ventricular Drainage (B-EVD) System (Antibiotic impregnated catheter) and to compare relative rates of ventriculostomy-related infection between Subjects with BACTISEAL or conventional EVD catheters in a prospective, randomized open label study

status: Completed

study_completion_date_type: Actual

ReferenceType: background

ReferenceCitation: Codman in house testing reports, TR2213 and PVER99-133 Addendum

ReferenceCitation: Bayston R. Hydrocephalus Shunt Infections. Chapman and Hall Medical, London, 1989, p. 23.

ReferenceCitation: Bayston R, Grove N, Siegel J, Lawellin D, Barsham S. Prevention of hydrocephalus shunt catheter colonisation in vitro by impregnation with antimicrobials. J Neurol Neurosurg Psychiatry. 1989 May;52(5):605-9.

ReferenceCitation: Bayston R, Lambert E. Duration of protective activity of cerebrospinal fluid shunt catheters impregnated with antimicrobial agents to prevent bacterial catheter-related infection. J Neurosurg. 1997 Aug;87(2):247-51.

ReferenceCitation: Govender ST, Nathoo N, van Dellen JR. Evaluation of an antibiotic-impregnated shunt system for the treatment of hydrocephalus. J Neurosurg. 2003 Nov;99(5):831-9.

ReferenceCitation: Lozier AP, Sciacca RR, Romagnoli MF, Connolly ES Jr. Ventriculostomy-related infections: a critical review of the literature. Neurosurgery. 2002 Jul;51(1):170-81; discussion 181-2. Review.

ReferenceCitation: Schierholz J, Jansen B, Jaenicke L, Pulverer G. In-vitro efficacy of an antibiotic releasing silicone ventricle catheter to prevent shunt infection. Biomaterials. 1994 Oct;15(12):996-1000.

ReferenceCitation: Zabramski JM, Whiting D, Darouiche RO, Horner TG, Olson J, Robertson C, Hamilton AJ. Efficacy of antimicrobial-impregnated external ventricular drain catheters: a prospective, randomized, controlled trial. J Neurosurg. 2003 Apr;98(4):725-30.

lead_sponsor: Codman & Shurtleff

location_country:
Hong Kong
France
Norway
Singapore
China
United States
United Kingdom
Canada

location_facility:
Tiantan Hospital
National Neuroscience Institute
Queen Mary Hospital
Singapore General Hospital
Xuan Wu Hospital
Prince of Wales Hospital

intervention_type: Device

status_simplified: Completed


lead_sponsor: Janssen Research & Development, LLC

location_country:
Italy
Brazil
Netherlands
France
Poland
Israel
Belgium
Spain
United States
Korea, Republic of
Taiwan

acronym: PURSUIT 2

location_facility: Uniwersytecki Szpital Dzieciecy w Krakowie

location_facility: Hospital da Crianca Santo Antonio de Porto Alegre

location_facility: Wojewodzki Specjalistyczny Szpital Dziecięcy im. Prof. Stanislawa Popowskiego

location_facility: Szpital Uniwersytecki NR 1 IM. Dr. Antoniego Jurasza

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Rocky Mountain Pediatric Gastroenterology

location_facility: University of North Carolina at Chapel Hill

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Centrum Zdrowia Matki, Dziecka i Młodzieży

location_facility: Azienda USL di Bologna - Ospedale Maggiore

location_facility: Emma Children's Hospital Academic Medical Center

location_facility: Children's Hospital Colorado and University of Colorado

location_facility: Children's Center for Digestive Health Care

location_facility: Universitair Kinderziekenhuis Koningin Fabiola

type: Other Identifier

title: A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Golimumab Treatment, a Human Anti-TNFα Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

summary: The purpose of this study is to evaluate efficacy of golimumab in inducing clinical remission as assessed by the Mayo score, in pediatric participants with moderately to severely active ulcerative colitis (UC). In addition, the safety profile of golimumab, in pediatric participants with moderately to severely active UC will be assessed.


title: Prospective, Multicenter, Single-Arm, Global IDE Study of the Shockwave Coronary Intravascular Lithotripsy (IVL) System With the Shockwave C2 Coronary IVL Catheter in Calcified Coronary Arteries

summary: The study design is a prospective, multicenter, single-arm, global IDE study to evaluate the safety and effectiveness of the Shockwave Medical Coronary Intravascular Lithotripsy (IVL) System in de novo, calcified, stenotic coronary arteries prior to stenting. Disrupt CAD III is being conducted as a staged pivotal study.

ReferenceType: result

ReferenceCitation: Hill JM, Kereiakes DJ, Shlofmitz RA, Klein AJ, Riley RF, Price MJ, Herrmann HC, Bachinsky W, Waksman R, Stone GW; Disrupt CAD III Investigators. Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Artery Disease. J Am Coll Cardiol. 2020 Dec 1;76(22):2635-2646. doi: 10.1016/j.jacc.2020.09.603. Epub 2020 Oct 15.

family: Hill

full_name: Jonathan M. Hill

given: Jonathan M.

sequence: first

family: Kereiakes

full_name: Dean J. Kereiakes

given: Dean J.

family: Shlofmitz

full_name: Richard A. Shlofmitz

given: Richard A.

family: Klein

full_name: Andrew J. Klein

given: Andrew J.

family: Riley

full_name: Robert F. Riley

given: Robert F.

family: Price

full_name: Matthew J. Price

given: Matthew J.

family: Herrmann

full_name: Howard C. Herrmann

given: Howard C.

family: Bachinsky

full_name: William Bachinsky

given: William

family: Waksman

full_name: Ron Waksman

given: Ron

family: Stone

full_name: Gregg W. Stone

given: Gregg W.

journal_name: Journal of the American College of Cardiology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Kereiakes DJ, Hill JM, Ben-Yehuda O, Maehara A, Alexander B, Stone GW. Evaluation of safety and efficacy of coronary intravascular lithotripsy for treatment of severely calcified coronary stenoses: Design and rationale for the Disrupt CAD III trial. Am Heart J. 2020 Jul;225:10-18. doi: 10.1016/j.ahj.2020.04.005. Epub 2020 Apr 18.

family: Ben-Yehuda

full_name: Ori Ben-Yehuda

given: Ori

family: Maehara

full_name: Akiko Maehara

given: Akiko

family: Alexander

full_name: Beaux Alexander

given: Beaux

journal_name: American Heart Journal

ReferenceCitation: Kereiakes DJ, Di Mario C, Riley RF, Fajadet J, Shlofmitz RA, Saito S, Ali ZA, Klein AJ, Price MJ, Hill JM, Stone GW. Intravascular Lithotripsy for Treatment of Calcified Coronary Lesions: Patient-Level Pooled Analysis of the Disrupt CAD Studies. JACC Cardiovasc Interv. 2021 Jun 28;14(12):1337-1348. doi: 10.1016/j.jcin.2021.04.015. Epub 2021 May 3.

family: Di Mario

full_name: Carlo Di Mario

given: Carlo

location_country:
Germany
United States
United Kingdom
France

location_facility: Pinnacle Health Cardiovascular Institute Inc.

location_facility: Hospital of the University of Pennsylvania

location_facility: Advocate Health and Hospitals Corporation - Edward Hospital

location_facility: University of California, San Diego (UCSD) - Medical Center

location_facility: Clinique des Domes - Pole Sante Republique

location_facility: Columbia University Medical Center/ New York Presbyterian

location_facility: Rheinland Klinikum Neuss GmbH - Lukaskrankenhaus Neuss

location_facility: St. Vincent Heart Center of Indiana, LLC

location_facility: Universitaetsklinikum Giessen and Marburg GmbH

location_facility: New York University (NYU) Langone Medical Center

location_facility: Charleston Area Medical Center (CAMC) - Health Education & Research Institute


title: A Study of the Safety and Efficacy of Teduglutide in Subjects With Parenteral Nutrition-Dependent Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)

summary: The purpose of this clinical study is to evaluate the long-term safety and efficacy of daily administration of teduglutide.

ReferenceCitation: Jeppesen PB, Gilroy R, Pertkiewicz M, Allard JP, Messing B, O'Keefe SJ. Randomised placebo-controlled trial of teduglutide in reducing parenteral nutrition and/or intravenous fluid requirements in patients with short bowel syndrome. Gut. 2011 Jul;60(7):902-14. doi: 10.1136/gut.2010.218271. Epub 2011 Feb 11.

family: Jeppesen

full_name: P. B. Jeppesen

given: P. B.

family: Gilroy

full_name: R. Gilroy

given: R.

family: Pertkiewicz

full_name: M. Pertkiewicz

given: M.

family: Allard

full_name: J. P. Allard

given: J. P.

family: Messing

full_name: B. Messing

given: B.

family: O'Keefe

full_name: S. J. O'Keefe

given: S. J.

journal_name: Gut

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_institution: University of Oxford - Oxford Academic Notes & Queries

version: submittedVersion

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: O'Keefe SJ, Jeppesen PB, Gilroy R, Pertkiewicz M, Allard JP, Messing B. Safety and efficacy of teduglutide after 52 weeks of treatment in patients with short bowel intestinal failure. Clin Gastroenterol Hepatol. 2013 Jul;11(7):815-23.e1-3. doi: 10.1016/j.cgh.2012.12.029. Epub 2013 Jan 17.

full_name: Stephen J.D. O'Keefe

given: Stephen J.D.

full_name: Palle B. Jeppesen

given: Palle B.

full_name: Richard Gilroy

given: Richard

full_name: Marek Pertkiewicz

given: Marek

full_name: Johane P. Allard

given: Johane P.

full_name: Bernard Messing

given: Bernard

journal_name: Clinical Gastroenterology and Hepatology

title: Safety and Efficacy of Teduglutide After 52 Weeks of Treatment in Patients With Short Bowel Intestinal Failure

ReferenceCitation: Vipperla K, O'Keefe SJ. Study of teduglutide effectiveness in parenteral nutrition-dependent short-bowel syndrome subjects. Expert Rev Gastroenterol Hepatol. 2013 Nov;7(8):683-7. doi: 10.1586/17474124.2013.842894. Epub 2013 Oct 17. Review.

journal_name: Expert Review of Gastroenterology & Hepatology

location_country:
United States
Netherlands
France
Poland
Belgium
Denmark
Canada
United Kingdom

location_facility: University of Pennsylvania - Penn Nursing

location_facility: Samodzielny Publiczny Szpital Kliniczny-Im.prof W.Orłowskiego CMKP

location_facility: Academic Medical Center, Department of Endocrinology & Metabolism


title: An Extension to a Phase II Study to Determine the Efficacy and Safety of STI571 in Patients With Chronic Myeloid Leukemia Who Are Refractory to or Intolerant of Interferon-Alpha

summary: During the Core Phase of the study, participants received STI571 at a dose of 400 milligrams (mg) daily for up to 12 months. Participants completing 12 months of therapy were eligible to continue treatment in the Extension Phase of the study provided that, in the opinion of the investigator, they had benefited from treatment with STI571 and there were no safety concerns.

location_country:
Italy
United States
Switzerland
France
Germany
United Kingdom

location_facility: Wayne State University/Kamanos Cancer Center

location_facility: H. Lee Moffet Cancer Center & Research Institute/Univ of South Florida

location_facility: MD Anderson Cancer Center, University of Texas

location_facility: C/O V. Ward - Washington Univ. school of Medicine

location_facility: Northwestern Univ meical School/Robert H. Lurie Comprehensive Cancer Center


title: A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Clinical Efficacy of Two Different Doses of BMS-188667 Administered Intravenously to Subjects With Active Rheumatoid Arthritis While Receiving Methotrexate

summary: This study was conducted to assess the safety and tolerability of Abatacept combined with Methotrexate in participants with active rheumatoid arthritis (RA). The secondary objectives were to assess efficacy, pharmacodynamic marker activity, and immunogenicity of Abatacept combined with Methotrexate.

ReferenceCitation: Westhovens R, Kremer JM, Emery P, Russell AS, Alten R, Barré E, Dougados M. Long-term safety and efficacy of abatacept in patients with rheumatoid arthritis and an inadequate response to methotrexate: a 7-year extended study. Clin Exp Rheumatol. 2014 Jul-Aug;32(4):553-62. Epub 2014 Jul 8.

lead_sponsor: Bristol-Myers Squibb

location_country:
United States
South Africa
Netherlands
Germany
France
Ireland
Belgium
Argentina
Australia
Canada
United Kingdom


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.

family: Simonneau

full_name: Gérald Simonneau

given: Gérald

family: Rubin

full_name: Lewis J. Rubin

given: Lewis J.

family: Galiè

full_name: Nazzareno Galiè

given: Nazzareno

family: Barst

full_name: Robyn J. Barst

given: Robyn J.

family: Fleming

full_name: Thomas R. Fleming

given: Thomas R.

family: Frost

full_name: Adaani Frost

given: Adaani

family: Engel

full_name: Peter Engel

given: Peter

family: Kramer

full_name: Mordechai R. Kramer

given: Mordechai R.

family: Serdarevic-Pehar

full_name: Marjana Serdarevic-Pehar

given: Marjana

family: Layton

full_name: Gary R. Layton

given: Gary R.

family: Sitbon

full_name: Olivier Sitbon

given: Olivier

family: Badesch

full_name: David B. Badesch

given: David B.

journal_name: The Journal of Heart and Lung Transplantation

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

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


title: A Multi-Center, Open-Label, Long-Term, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures.

summary: To allow pediatric patients with partial onset seizures an opportunity to receive (as follow-up to studies N01009(NCT00105040)/N01103(NCT00175890) or by direct enrollment) open-label levetiracetam treatment, continue studying cognition and behavior in children, and continue collection of safety/efficacy data.

design_allocation: Non-Randomized

ReferenceCitation: Piña-Garza JE, Schiemann-Delgado J, Yang H, Duncan B, Hadac J, Hunter SJ. Adjunctive levetiracetam in patients aged 1 month to <4 years with partial-onset seizures: subpopulation analysis of a prospective, open-label extension study of up to 48 weeks. Clin Ther. 2010 Oct;32(11):1935-50. doi: 10.1016/j.clinthera.2010.09.017.

family: Piña-Garza

full_name: Jesus Eric Piña-Garza

given: Jesus Eric

family: Schiemann-Delgado

full_name: Jimmy Schiemann-Delgado

given: Jimmy

family: Yang

full_name: Haichen Yang

given: Haichen

family: Duncan

full_name: Benjamin Duncan

given: Benjamin

family: Hadac

full_name: Jan Hadac

given: Jan

family: Hunter

full_name: Scott J. Hunter

given: Scott J.

journal_name: Clinical Therapeutics

title: Adjunctive levetiracetam in patients aged 1 month to <4 years with partial-onset seizures: Subpopulation analysis of a prospective, open-label extension study of up to 48 weeks

lead_sponsor: UCB Pharma

location_country:
Italy
Brazil
United States
South Africa
India
United Kingdom
Mexico
Germany
France
Poland
Romania
Hungary
Belgium
Russian Federation
Canada
Czech Republic


title: A Phase III, Randomized Multi-centre, Double-blind, Parallel Group, Active Comparator Study to Compare the Efficacy and Safety of SPD476 (Mesalazine)2.4g/Day Once Daily With Asacol 1.6g/Day Twice Daily in the Maintenance of Remission in Patients With Ulcerative Colitis

summary: Ulcerative colitis is a disease of the large bowel (colon) and rectum in which the lining of the bowel becomes red and swollen. Over time, patients with this disease may experience acute episodes of diarrhea, rectal bleeding and abdominal pain followed by periods of time without disease symptoms. 5-ASA drugs are a standard treatment for ulcerative colitis. Mesalazine is an experimental drug designed to gradually release 5-ASA into the areas of large bowel associated with ulcerative colitis. This study will test the safety and efficacy of mesalazine in keeping ulcerative colitis in remission.

lead_sponsor: Shire

location_country:
Peru
Romania
Belgium
Australia
Russian Federation
Denmark
Taiwan
India
France
Poland
Argentina
Canada
Korea, Republic of
South Africa
Chile
Sweden
Netherlands
Singapore
Hungary
Portugal
Germany
United States
United Kingdom
Brazil
Mexico
Czechia
New Zealand
Spain

location_facility: Hospital Italiano de Mendoza, FINAMED SA

location_facility: Institute of Gastronenterology & Hepatology

location_facility: Universidade Federal da Bahia - Hospital

location_facility: Instituto Nacional de Ciencias médicas y Nutrición Salvador Zubirán

location_facility: Sanjay Gandhi Post Graduate Institute of Medical Sciences

location_facility: Hospital Nacional Guillermo Alemnara Irigoyen

location_facility: Hospital Nacional Edgardo Rebagliati Martins

location_facility: Sree Gokulam Medical Centre & Research Foundation

location_facility: S.R. Kalla Memorial Gastro & General Hospital

location_facility: Octavian Fodor Clinical Emergency Hospital

location_facility: Markhot Ferenc Korhaz-Rendelointeze II. Belgyogyaszat - Gasztroenterologia

location_facility: Unidad Medica de Endoscopia y Cirugia (UNIMEDEC)

location_facility: Center for Digestive and Liver Diseases, Inc

location_facility: Hospital Universitario Germans Trias I Pujol

location_facility: Central de Especialidades Medicas (FIDEPAZ)

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

location_facility: Addenbrookes Hospital Department of Gastroenterology

location_facility: Hallyam University, Sacred Heart Hospital

location_facility: Gastroenterologische Praxis Prof. Hackelsberger

location_facility: Heilig Hart ziekenhuis vzw Roeselare-Menen

location_facility: Toronto Digestive Disease Associates, Inc.


title: A Multicenter Study to Describe the Immunogenic Epitope(s) of Factor VIII in Previously Treated Patients With Congenital Hemophilia A Who Develop De Novo Factor VIII Inhibitors While Receiving Factor VIII Infusion Therapy.

summary: This investigation will utilize a systematic determination of anti-FVIII antibody specificity in PTPs (> 50 ED) with hemophilia A who have developed inhibitors in response to treatment with any FVIII product(s). A group of patients with hemophilia A, who have no evidence of current or prior FVIII inhibitor will be included for comparison. The objective of this study is to describe the patterns of antibodies and associated epitopes in the study population.

status: Withdrawn

primary_purpose: Diagnostic

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

location_country:
Italy
United States
France
Belgium
Spain
Germany
United Kingdom

intervention_type: Procedure

status_simplified: Unknown


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.

name: From the VA Medical Center, Minneapolis, Minn (K.E.); University of Minnesota, Minneapolis (K.E.); Fred Hutchinson Cancer Research Center, Seattle, Wash (A.L.); Pfizer Global Research and Development, New London, Conn (J.R.T., D.D.T., R.A.); University of Sheffield, Sheffield, UK (R.E.); University of Aberdeen, Aberdeen, UK (D.M.R.); University of Zagreb, Zagreb, Croatia (S.V.); University of Pittsburgh, Pittsburgh, Pa (J.E.); University of California-San Diego, La Jolla (E.B.-C.); Harvard...

family: Ensrud

full_name: Kristine Ensrud

given: Kristine

family: LaCroix

full_name: Andrea LaCroix

given: Andrea

family: Thompson

full_name: John R. Thompson

given: John R.

full_name: David D. Thompson

given: David D.

family: Eastell

full_name: Richard Eastell

given: Richard

family: Reid

full_name: David M. Reid

given: David M.

family: Vukicevic

full_name: Slobodan Vukicevic

given: Slobodan

family: Cauley

full_name: Jane Cauley

given: Jane

family: Barrett-Connor

full_name: Elizabeth Barrett-Connor

given: Elizabeth

family: Armstrong

full_name: Roisin Armstrong

given: Roisin

family: Welty

full_name: Francine Welty

given: Francine

family: Cummings

full_name: Steven Cummings

given: Steven

journal_name: Circulation

oa_host_type: publisher

evidence: open (via free pdf)

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Lasofoxifene and Cardiovascular Events in Postmenopausal Women With Osteoporosis

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].

full_name: Steven R. Cummings

given: Steven R.

family: Delmas

full_name: Pierre D. Delmas

given: Pierre D.

full_name: Andrea Z. LaCroix

given: Andrea Z.

family: Goldstein

full_name: Steven Goldstein

family: Sriram

full_name: Usha Sriram

title: Lasofoxifene in Postmenopausal Women with Osteoporosis

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


title: Comparison of the Efficacy and Safety of Hylastan to Methylprednisolone Acetate in Patients With Symptomatic Osteoarthritis of the Knee

summary: This is a clinical study to investigate the safety and efficacy of hylastan in treating patients with symptomatic osteoarthritis (OA) of the knee.

lead_sponsor: Genzyme, a Sanofi Company

location_country:
United States
France
Germany
United Kingdom
Canada

location_facility: Centre Hospitalier Lyon-Sud, Service de Rhumatologie

location_facility: Maidstone General Hospital & Tunbridge Wells NHS Trust

location_facility: Bluegrass Orthopaedics/Bluegrass Musculoskeletal Research

location_facility: Arthritis & Osteoporosis Center of Maryland

location_facility: St-Elisabeth Klinik, Orthopädisch Gemeinschaftspraxis

location_facility: Whipps Cross University Hospital NHS Trust, Arthritis Assessment, Physiotherapy Department

location_facility: Orthopedic Center for Joint Replacement and Sports

location_facility: Southampton General Hospital, MRC Environmental Epidemiology Unit

location_facility: Northwestern Center for Clinical Research

location_facility: Midwest Orthopedics at Rush University Medical Center

location_facility: CHU Hôpital Trousseau Service de Rhumatologie


title: A Phase I/II, Open-label, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-Drug Conjugate GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed / Refractory Multiple Myeloma - DREAMM-6

acronym: DREAMM 6

summary:
This study will evaluate the safety and tolerability profile of belantamab mafodotin when administered in combination with approved regimens of either Lenalidomide Plus Dexamethasone [Len/Dex (Arm A)] or Bortezomib Plus Dexamethasone [Bor/Dex (Arm B)] in participants with RRMM, i.e., those who have relapsed or who are refractory to at least 1 line of approved therapy. Part 1 of the study will be a dose escalation phase to evaluate the safety and tolerability of up to 3 dose levels and up to 2 dosing schedules of belantamab mafodotin in combination with the two standard of care (SoC) regimens. Part 2 will further evaluate the safety and preliminary clinical activity of belantamab mafodotin at selected dose levels and dosing schedules in combination with Len/Dex or Bor/Dex.

A total of 152 evaluable participants will be enrolled in the study with up to 27 in Part 1 and up to 125 in Part 2. Participants receiving treatment Arm A, may continue combination treatment until the occurrence of progressive disease (PD), intolerable adverse events (AEs ), consent withdrawal, death or end of study. The participants receiving treatment Arm B, may continue combination treatment for a total of up to 8 cycles. After 8 cycles of combination therapy, the participants will continue treatment with belantamab mafodotin, as a monotherapy until the occurrence of PD, intolerable AEs, consent withdrawal, death or end of study.

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

lead_sponsor: GlaxoSmithKline

location_country:
United States
France
Australia
Spain
Canada
United Kingdom


title: A Phase 2, Open-Label Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia

summary: The purpose of this study is to evaluate the safety and efficacy of parsaclisib administered orally to participants with autoimmune hemolytic anemia (AIHA) who have decreased hemoglobin and evidence of ongoing hemolysis that requires treatment intervention.

lead_sponsor: Incyte Corporation

location_country:
Italy
Austria
United States
France

location_facility: Centre Hospitalier Regional Universitaire (Chru) de Lille

location_facility: Washington University School of Medicine

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Weill Medical College of Cornell University

location_facility: Fondazione Irccs Ca Granda Ospedale Maggiore

location_facility: AZIENDA OSPEDALIERO UNIVERSITARIA MAGGIORE DELLA CARITï¿½ DI NOVARA

location_facility: University Health System Inc., Dba the University of Tn Medical Center


title: A Phase 1, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability Pharmacokinetics Immunogenicity, and Antitumor Activity of MEDI5752 in Subjects With Advanced Solid Tumors.

summary: The purpose of this study is to evaluate MEDI5752 in adult subjects with advanced solid tumors, when administered as a single agent or combined with chemotherapy.

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

lead_sponsor: MedImmune LLC

location_country:
Italy
Netherlands
Spain
France
Australia
Portugal
United States
Korea, Republic of
Taiwan


title: A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept vs Placebo on a Background of Oral Glucocorticosteroids in the Treatment of Subjects With Systemic Lupus Erythematosus and the Prevention of Subsequent Lupus Flares

summary: The purpose of this clinical research study is to learn whether Abatacept can treat and prevent lupus flares; specifically, in patients with active lupus flares in at least one of three organ systems: skin (discoid lesions); inflammation of the lining of the heart (pericarditis), or inflammation of the lining of the lung (pleuritis/pleurisy); or inflammation of more than 4 joints (arthritis). All participants will receive prednisone or prednisone-equivalent treatment in combination with study medication. The safety of this treatment will also be studied.

ReferenceCitation: Hu Y, Carman JA, Holloway D, Kansal S, Fan L, Goldstine C, Lee D, Somerville JE, Latek R, Townsend R, Johnsen A, Connolly S, Bandyopadhyay S, Shadick N, Weinblatt ME, Furie R, Nadler SG. Development of a Molecular Signature to Monitor Pharmacodynamic Responses Mediated by In Vivo Administration of Glucocorticoids. Arthritis Rheumatol. 2018 Aug;70(8):1331-1342. doi: 10.1002/art.40476. Epub 2018 Jul 12.

name: Bristol-Myers Squibb; Princeton New Jersey

family: Hu

full_name: Yanhua Hu

given: Yanhua

family: Carman

full_name: Julie A. Carman

given: Julie A.

family: Holloway

full_name: Deborah Holloway

given: Deborah

family: Kansal

full_name: Selena Kansal

given: Selena

family: Fan

full_name: Li Fan

given: Li

family: Goldstine

full_name: Christine Goldstine

given: Christine

family: Lee

full_name: Deborah Lee

family: Somerville

full_name: John E. Somerville

given: John E.

family: Latek

full_name: Robert Latek

given: Robert

family: Townsend

full_name: Robert Townsend

family: Johnsen

full_name: Alyssa Johnsen

given: Alyssa

family: Connolly

full_name: Sean Connolly

given: Sean

family: Bandyopadhyay

full_name: Somnath Bandyopadhyay

given: Somnath

name: Brigham and Women's Hospital; Boston Massachusetts

family: Shadick

full_name: Nancy Shadick

given: Nancy

family: Weinblatt

full_name: Michael E. Weinblatt

given: Michael E.

family: Furie

full_name: Richard Furie

family: Nadler

full_name: Steven G. Nadler

given: Steven G.

journal_name: Arthritis & Rheumatology

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

ReferenceCitation: Bandyopadhyay S, Connolly SE, Jabado O, Ye J, Kelly S, Maldonado MA, Westhovens R, Nash P, Merrill JT, Townsend RM. Identification of biomarkers of response to abatacept in patients with SLE using deconvolution of whole blood transcriptomic data from a phase IIb clinical trial. Lupus Sci Med. 2017 Jul 28;4(1):e000206. doi: 10.1136/lupus-2017-000206. eCollection 2017.

ReferenceCitation: Merrill JT, Burgos-Vargas R, Westhovens R, Chalmers A, D'Cruz D, Wallace DJ, Bae SC, Sigal L, Becker JC, Kelly S, Raghupathi K, Li T, Peng Y, Kinaszczuk M, Nash P. The efficacy and safety of abatacept in patients with non-life-threatening manifestations of systemic lupus erythematosus: results of a twelve-month, multicenter, exploratory, phase IIb, randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2010 Oct;62(10):3077-87. doi: 10.1002/art.27601.

title: The efficacy and safety of abatacept in patients with non-life-threatening manifestations of systemic lupus erythematosus: Results of a twelve-month, multicenter, exploratory, phase IIb, randomized, double-blind, placebo-controlled trial

location_country:
Italy
Austria
Brazil
South Africa
Mexico
Germany
France
Korea, Republic of
Australia
Belgium
Puerto Rico
United States
United Kingdom
Canada
Taiwan

location_facility: Kentuckiana Center For Better Bone And Joint Health


ReferenceCitation: Pedrosa M, Seyedkazemi S, Francque S, Sanyal A, Rinella M, Charlton M, Loomba R, Ratziu V, Kochuparampil J, Fischer L, Vaidyanathan S, Anstee QM. A randomized, double-blind, multicenter, phase 2b study to evaluate the safety and efficacy of a combination of tropifexor and cenicriviroc in patients with nonalcoholic steatohepatitis and liver fibrosis: Study design of the TANDEM trial. Contemp Clin Trials. 2020 Jan;88:105889. doi: 10.1016/j.cct.2019.105889. Epub 2019 Nov 13.

family: Pedrosa

full_name: Marcos Pedrosa

given: Marcos

family: Seyedkazemi

full_name: Star Seyedkazemi

given: Star

family: Francque

full_name: Sven Francque

given: Sven

family: Sanyal

full_name: Arun Sanyal

given: Arun

family: Rinella

full_name: Mary Rinella

given: Mary

family: Charlton

full_name: Michael Charlton

given: Michael

family: Loomba

full_name: Rohit Loomba

given: Rohit

family: Ratziu

full_name: Vlad Ratziu

given: Vlad

family: Kochuparampil

full_name: Jossy Kochuparampil

given: Jossy

family: Fischer

full_name: Laurent Fischer

given: Laurent

family: Vaidyanathan

full_name: Sujata Vaidyanathan

given: Sujata

family: Anstee

full_name: Quentin M. Anstee

given: Quentin M.

journal_name: Contemporary Clinical Trials

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

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

location_country:
Italy
United States
India
United Kingdom
Spain
Germany
France
Czechia
Israel
Singapore
Belgium
Argentina
Egypt
Russian Federation
Turkey
Canada
Latvia

acronym: TANDEM

ipd_sharing: Undecided

title: A Randomized, Double-blind, Multicenter Study to Assess the Safety, Tolerability, and Efficacy of a Combination Treatment of Tropifexor (LJN452) and Cenicriviroc (CVC) in Adult Patients With Nonalcoholic Steatohepatitis (NASH) and Liver Fibrosis

summary: The purpose of this study was to assess the safety, tolerability, and efficacy of a combination treatment of tropifexor (LJN452) and cenicriviroc (CVC) in adult patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis.


title: An Open-Label Multicenter Randomized Phase 3 Study Comparing the Combination of DOXIL/CAELYX and YONDELIS With DOXIL/CAELYX Alone in Subjects With Advanced Relapsed Ovarian Cancer

summary: The purpose of the study is to compare the progression-free survival (PFS) of the combination of trabectedin + DOXIL with DOXIL monotherapy in patients with ovarian cancer.

ReferenceCitation: Jones RL, Herzog TJ, Patel SR, von Mehren M, Schuetze SM, Van Tine BA, Coleman RL, Knoblauch R, Triantos S, Hu P, Shalaby W, McGowan T, Monk BJ, Demetri GD. Cardiac safety of trabectedin monotherapy or in combination with pegylated liposomal doxorubicin in patients with sarcomas and ovarian cancer. Cancer Med. 2021 Jun;10(11):3565-3574. doi: 10.1002/cam4.3903. Epub 2021 May 7.

name: Sarcoma Unit Royal Marsden Hospital/Institute of Cancer Research London UK

family: Jones

full_name: Robin L. Jones

given: Robin L.

name: University of Cincinnati Cancer CenterUniversity of Cincinnati Cincinnati OH USA

family: Herzog

full_name: Thomas J. Herzog

given: Thomas J.

name: Department of Sarcoma Medical Oncology University of Texas MD Anderson Cancer Center Houston TX USA

family: Patel

full_name: Shreyaskumar R. Patel

given: Shreyaskumar R.

name: Fox Chase Cancer Center Philadelphia PA USA

family: von Mehren

full_name: Margaret von Mehren

given: Margaret

name: Department of Internal Medicine University of Michigan Ann Arbor MI USA

family: Schuetze

full_name: Scott M. Schuetze

given: Scott M.

name: Washington University in St. Louis St. Louis MO USA

family: Van Tine

full_name: Brian A. Van Tine

given: Brian A.

name: US Oncology Research The Woodlands TX USA

family: Coleman

full_name: Robert L. Coleman

given: Robert L.

name: Janssen Research & Development, LLC Raritan NJ USA

family: Knoblauch

full_name: Roland Knoblauch

given: Roland

family: Triantos

full_name: Spyros Triantos

given: Spyros

family: Hu

full_name: Peter Hu

given: Peter

name: Medical Group Oncology Janssen Scientific Affairs, LLC Horsham PA USA

family: Shalaby

full_name: Waleed Shalaby

given: Waleed

family: McGowan

full_name: Tracy McGowan

given: Tracy

name: Arizona Oncology (US Oncology Network) University of Arizona College of Medicine, and Creighton University School of Medicine at St. Joseph's Hospital and Medical Center Phoenix AZ USA

family: Monk

full_name: Bradley J. Monk

given: Bradley J.

name: Sarcoma Center Department of Medical Oncology Dana‐Farber Cancer Institute (DFCI) Harvard Medical School and Ludwig Center at Harvard Boston MA USA

family: Demetri

full_name: George D. Demetri

given: George D.

journal_name: Cancer Medicine

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

repository_institution: Washington University School of Medicine - Digital Commons@Becker

ReferenceCitation: Krasner CN, Poveda A, Herzog TJ, Vermorken JB, Kaye SB, Nieto A, Claret PL, Park YC, Parekh T, Monk BJ. Patient-reported outcomes in relapsed ovarian cancer: results from a randomized Phase III study of trabectedin with pegylated liposomal doxorubicin (PLD) versus PLD alone. Gynecol Oncol. 2012 Oct;127(1):161-7. doi: 10.1016/j.ygyno.2012.06.034. Epub 2012 Jul 2.

family: Krasner

full_name: Carolyn N. Krasner

given: Carolyn N.

family: Poveda

full_name: Andres Poveda

given: Andres

title: Patient-reported outcomes in relapsed ovarian cancer: Results from a randomized Phase III study of trabectedin with pegylated liposomal doxorubicin (PLD) versus PLD Alone

ReferenceCitation: Monk BJ, Herzog TJ, Kaye SB, Krasner CN, Vermorken JB, Muggia FM, Pujade-Lauraine E, Park YC, Parekh TV, Poveda AM. Trabectedin plus pegylated liposomal doxorubicin (PLD) versus PLD in recurrent ovarian cancer: overall survival analysis. Eur J Cancer. 2012 Oct;48(15):2361-8. doi: 10.1016/j.ejca.2012.04.001. Epub 2012 Apr 26.

title: Trabectedin plus pegylated liposomal doxorubicin (PLD) versus PLD in recurrent ovarian cancer: Overall survival analysis

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

location_country:
Brazil
Chile
Sweden
Hong Kong
Netherlands
Spain
Germany
France
Korea, Republic of
Poland
Singapore
Belgium
Argentina
Australia
China
Russian Federation
United States
United Kingdom
Canada
Taiwan


title: A Phase II Study to Evaluate the Efficacy, Safety, and Pharmacodynamics of Lapatinib in Combination With Paclitaxel as Neoadjuvant Therapy in Patients With Newly Diagnosed Inflammatory Breast Cancer

summary: This Study was designed to determine how effective and safe a new investigational drug, lapatinib, is in combination with paclitaxel in treating patients with newly diagnosed inflammatory breast cancer. Tumor tissue collected pre-treatment, following 14 days of treatment and at the time of surgical resection will be examined for pathologic response and biologic activity by IHC (immunohistochemistry) within the tumor. Treatment will consist of 14 days of lapatinib monotherapy followed by 12 weeks of combination therapy with lapatinib and paclitaxel. Blood samples for hematology and chemistry panels, MUGA/ECHO exams and physical exams will be performed throughout the study to monitor safety.

ReferenceCitation: Boussen H, Cristofanilli M, Zaks T, DeSilvio M, Salazar V, Spector N. Phase II study to evaluate the efficacy and safety of neoadjuvant lapatinib plus paclitaxel in patients with inflammatory breast cancer. J Clin Oncol. 2010 Jul 10;28(20):3248-55. doi: 10.1200/JCO.2009.21.8594. Epub 2010 Jun 7.

location_country:
United States
France
Israel
Tunisia
Australia
New Zealand
Spain
Canada
United Kingdom


title: Exploratory, Multi-centre, Randomised, Double-blind, Uncontrolled Trial Evaluating the Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Secondary Bleeding Prophylaxis in Congenital Haemophilia A or B Patients With Inhibitors

summary:
This trial is conducted in Africa, Asia, Europe, South America, and the United States of America (USA).

The purpose of this study is to evaluate the effectiveness of secondary prophylactic treatment with NovoSeven® in haemophilia A and B patients with inhibitors.

ReferenceCitation: Konkle BA, Ebbesen LS, Erhardtsen E, Bianco RP, Lissitchkov T, Rusen L, Serban MA. Randomized, prospective clinical trial of recombinant factor VIIa for secondary prophylaxis in hemophilia patients with inhibitors. J Thromb Haemost. 2007 Sep;5(9):1904-13.

lead_sponsor: Novo Nordisk A/S

location_country:
Brazil
South Africa
Philippines
France
Bulgaria
Poland
Romania
Argentina
Russian Federation
Spain
Turkey
United States


lead_sponsor: BeiGene

location_country:
Italy
United States
Hong Kong
France
China
Germany
Canada
Taiwan

location_facility: Ospedale Policlinico San Martino - IRCCS per l'Oncologia

location_facility: The affiliated hospital of Xuzhou medical university

location_facility: Azienda Ospedaliero-Universitaria di Bologna, Policlinico Sant'Orsola-Malpighi

location_facility: Azienda Ospedaliera Santa Maria di Terni

location_facility: Affiliated Tumor Hospital of Harbin Medical University

location_facility: A.O.U. Pisana, Stabilimento di Santa Chiara

location_facility: Institut d'hématologie de Basse Normandie

location_facility: West China Hospital of Sichuan University

location_facility: Fujian Medical University Union Hospital

location_facility: Froedtert & Medical College of Wisconsin - Froedtert Hospital - Clinical Cancer Center

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

location_facility: The First Affiliated Hospital of Soochow University

location_facility: UBC - British Columbia Cancer Agency - The Vancouver Centre

location_facility: Centre hospitalier Universitaire de Limoges

type: Registry Identifier

title: A Phase 2, Open-Label Study of BGB-A317 in Patients With Relapsed or Refractory Mature T- and NK- Neoplasms

summary:
This is a multi-center, prospective, non-randomized, open-label, Phase 2 clinical study to evaluate the safety and efficacy of BGB-A317 in participants with relapsed or refractory mature T- and natural killer (NK)-cell neoplasms. There will be two cohorts of participants:

Cohort 1: Participants with relapsed or refractory extranodal NK/T cell lymphoma (nasal or non-nasal type)
Cohort 2: other mature T-cell neoplasms (limited to the following histologies: peripheral T-cell lymphoma-not otherwise specified, angioimmunoblastic T-cell lymphoma, or anaplastic large-cell lymphoma)
Cohort 3: cutaneous T-cell lymphoma (limited to mycosis fungoides and Sèzary syndrome)

Up to 70 participants will be enrolled into cohort 1, up to 50 participants into cohort 2, and up to 10 participants into cohort 3 for a total sample size of up to 130 participants.

The primary efficacy endpoint is overall response rate (ORR) determined by investigator assessment. Disease response for the primary endpoint for cohorts 1 and 2 will be assessed per the Lugano criteria with LYRIC modification for immunomodulatory therapy Disease response for the primary endpoint for cohort 3 will be assessed per the International Society for Cutaneous Lymphoma (ISCL)/European Organization for Research and Treatment of Cancer (EORTC) guidelines for immunomodulatory therapy BGB-A317 will be administered intravenously as a 200 mg infusion every 3 weeks (Each cycle consists of 21 days). Study procedures will occur over a Screening phase (up to 35 days); Treatment phase (until disease progression, intolerable toxicity, or withdrawal of informed consent, whichever occurs first); Safety Follow-up phase (up to 90 days following last study treatment for all adverse events (AEs) and serious adverse events (SAEs)); Survival follow-up phase (duration varying by participant).


title: A Randomized, Placebo-controlled, Double-blind Study of the Effect of Bondronat Compared With Zoledronic Acid on Pain in Patients With Malignant Bone Disease Experiencing Moderate to Severe Pain

summary: This 2 arm study will compare the efficacy of intravenous Bondronat with that of zoledronic acid in patients with malignant bone disease experiencing moderate to severe pain. Patients will be randomized to receive either Bondronat (6mg iv on days 1, 2 and 3 and then every 3-4 weeks) or zoledronic acid (4mg iv on day 1 and then every 3-4 weeks). The anticipated time of study treatment is 6-12 months, and the target sample size is 100-500 individuals.

status: Terminated

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
United States
Chile
Guatemala
Switzerland
Mexico
Germany
France
Panama
Poland
Hungary
Belgium
Argentina
Australia
Puerto Rico
Russian Federation
Canada
United Kingdom


lead_sponsor: Actelion

location_country:
United States
Serbia
Germany
France
Malaysia
Poland
Israel
Belarus
Belgium
Hungary
Russian Federation
China
Canada
United Kingdom
Taiwan
Ukraine

location_facility: Institut Za Zdravstvenu Zaštitu Majke I Deteta Srbije ''Dr Vukan Čupić''

location_facility: Samara Regional Clinical Cardiological Dispensary

location_facility: State Institution Republican Scientific And Practical Center For Pediatric Surgery

location_facility: Uniwersytecki Szpital Dzieciecy w Krakowie

location_facility: Saint Petersburg State Pediatric Medical University

location_facility: Municipal Institution Of The Zaporizhzhya Regional Council

location_facility: Municipal Enterprise Of The Dnipropetrovsk Regional Council

location_facility: Moscow Scientific Research Institute For Pediatrics And Childrens Surgery Of Rosmedtechnologies

location_facility: State Institution Of The Ministry Of Health Of Ukraine

location_facility: Gottsegen György Országos Kardiológiai Intézet, Felnőtt kardiológiai osztály

location_facility: Institut Jantung Negara (National Heart Institute)

location_facility: Children'S Hospital Cardiac Care Center University Of Colorado

location_facility: Wojewódzki Szpital Specjalistyczny We Wrocławiu

location_facility: Health Institution 4Th City Children'S Clinical Hospital

location_facility: Cardiovascular institute & Fuwai Hospital- Thrombus Center

location_facility: Federal State Budget Scientific Institution

title: A Prospective, Multicenter, Open Label, Single Arm, Phase 2 Study to Investigate the Safety, Tolerability and Pharmacokinetics of Selexipag in Children With Pulmonary Arterial Hypertension

summary: The purpose of this study to confirm the selexipag starting dose(s), selected based on pharmacokinetic (PK) extrapolation from adults, that leads to similar exposure as adults doses in children from greater than or equal to (>=) 2 to less than (˂) 18 years of age with Pulmonary Arterial Hypertension (PAH), by investigating the PK of selexipag and its active metabolite ACT-333679 in this population.


title: A Treatment Protocol For Patients With Gastrointestinal Stromal Tumor Who Are Ineligible For Participation In Other SU011248 Protocols And Are Refractory To Or Intolerant Of Imatinib Mesylate

summary: The purpose of this study is to permit access to SU011248 for treatment use by patients with GIST given the following conditions: a) patients undergo screening, but are not eligible for participation in ongoing clinical studies such as A6181004; AND b) patients have GIST which standard treatments have not been able to control with acceptable toxicity AND c) patients have the potential to derive clinical benefit from treatment with SU011248.

status: Approved for marketing

study_type: Expanded Access

ReferenceCitation: Reichardt P, Kang YK, Rutkowski P, Schuette J, Rosen LS, Seddon B, Yalcin S, Gelderblom H, Williams CC Jr, Fumagalli E, Biasco G, Hurwitz HI, Kaiser PE, Fly K, Matczak E, Chen L, Lechuga MJ, Demetri GD. Clinical outcomes of patients with advanced gastrointestinal stromal tumors: safety and efficacy in a worldwide treatment-use trial of sunitinib. Cancer. 2015 May 1;121(9):1405-13. doi: 10.1002/cncr.29220. Epub 2015 Jan 13. Erratum in: Cancer. 2019 Mar 1;125(5):821.

name: Department of Interdisciplinary Oncology; HELIOS Clinic Berlin-Buch; Berlin Germany

family: Reichardt

full_name: Peter Reichardt

name: Department of Oncology; Asan Medical Center, University of Ulsan, College of Medicine; Seoul Republic of Korea

family: Kang

full_name: Yoon-Koo Kang

given: Yoon-Koo

name: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology; Warsaw Poland

family: Rutkowski

full_name: Piotr Rutkowski

given: Piotr

name: Hematology/Oncology Practice; Dusseldorf Germany

family: Schuette

full_name: Jochen Schuette

given: Jochen

name: Division of Hematology-Oncology; University of California-Los Angeles; Santa Monica California

family: Rosen

full_name: Lee S. Rosen

given: Lee S.

name: Department of Oncology; University College Hospital; London United Kingdom

family: Seddon

full_name: Beatrice Seddon

given: Beatrice

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

family: Yalcin

full_name: Suayib Yalcin

given: Suayib

name: Department of Clinical Oncology; Leiden University Medical Center; Leiden the Netherlands

family: Gelderblom

full_name: Hans Gelderblom

given: Hans

name: H. Lee Moffitt Cancer Center and Research Institute; Tampa Florida

family: Williams

full_name: Charles C. Williams

given: Charles C.

suffix: Jr

name: Cancer Medicine Department; Milan Cancer Institute, Institute for Research and Treatment of Cancer; Milan Italy

family: Fumagalli

full_name: Elena Fumagalli

given: Elena

name: Department of Hematology and Oncological Sciences; University of Bologna; Bologna Italy

family: Biasco

full_name: Guido Biasco

given: Guido

name: Division of Medical Oncology; Duke University Medical Center; Durham North Carolina

family: Hurwitz

full_name: Herbert I. Hurwitz

given: Herbert I.

name: Oncology Specialists S.C., Lutheran General Cancer Care Center; Park Ridge Illinois

family: Kaiser

full_name: Pamela E. Kaiser

given: Pamela E.

family: Fly

full_name: Kolette Fly

given: Kolette

family: Matczak

full_name: Ewa Matczak

given: Ewa

family: Chen

full_name: Liang Chen

given: Liang

family: Lechuga

full_name: Maria José Lechuga

given: Maria José

name: Ludwig Center at Harvard and Department of Medical Oncology; Center for Sarcoma and Bone Oncology, Dana-Farber Cancer Institute; Boston Massachusetts

journal_name: Cancer

repository_institution: hacettepe.edu.tr - Hacettepe University Institutional Repository

version: acceptedVersion

title: Clinical outcomes of patients with advanced gastrointestinal stromal tumors: Safety and efficacy in a worldwide treatment-use trial of sunitinib

ReferenceCitation: Dudeck O, Zeile M, Reichardt P, Pink D. Comparison of RECIST and Choi criteria for computed tomographic response evaluation in patients with advanced gastrointestinal stromal tumor treated with sunitinib. Ann Oncol. 2011 Aug;22(8):1828-33. doi: 10.1093/annonc/mdq696. Epub 2011 Feb 2.

location_country:
Finland
Greece
Australia
Belgium
Denmark
Czech Republic
Taiwan
India
France
Poland
Thailand
Slovakia
Norway
Argentina
Canada
Korea, Republic of
Colombia
Chile
Sweden
Hong Kong
Netherlands
Switzerland
Singapore
Hungary
Germany
United States
United Kingdom
Italy
Austria
Mexico
Venezuela
Israel
Spain
Turkey


title: Open-Label Extension Study of Omalizumab in Patients With Chronic Rhinosinusitis With Nasal Polyps

summary: The overall purpose of this study is to evaluate the safety, efficacy, and durability of response of omalizumab in an open-label setting in adult participants with chronic rhinosinusitis with nasal polyps who completed the double-blind, placebo-controlled, Phase III studies GA39688 (NCT03280550) or GA39855 (NCT03280537). Participants will be eligible for enrollment in the study at, or within 28 days after, the Week 24 visit of Studies GA39688/GA39855. After enrollment into this open-label extension (OLE) study, participants will receive 28 weeks of dosing of omalizumab before entering a 24-week off-treatment observation phase of the study. Baseline in this OLE study is defined as the last pre-treatment measurement prior to randomization in Studies GA39688/GA39855 (i.e., baseline of Studies GA39688/GA39855). The data that will be reported from baseline to Week 24 inclusive will come from Studies GA39688/GA39855.

location_country:
United States
Mexico
Spain
Germany
France
Czechia
Poland
Hungary
Belgium
Russian Federation
Portugal
Canada
United Kingdom
Ukraine

location_facility: Fakultni nemocnice Hradec Kralove, Chirurgicka klinika

location_facility: Synexus Affiliate - Clinic Med s.j. Bialystok

location_facility: Nouvel Hopital Civil; Pole de Pathologie Thoracique

location_facility: Clinical Research Center of Alabama, LLC

location_facility: Central Clinical Hospital With Polyclinic of President Administration of RF

location_facility: Charie Campus Mitte; Hals, Nasen, Ohrenheilkunde

location_facility: Banner University of Arizona Medical Center

location_facility: Instituto Jalisciense de Investigacion Clinica S.A. de C.V.

location_facility: Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna

location_facility: Poltava Regional Clinical Hospital n.a. M.V. Skliphosovskyi

location_facility: Municipal Institution "City Clinical Hospital #3"

location_facility: Medical University of South Carolina Hospital

location_facility: Centre Hospitalier Universitaire de Bordeaux Hopital Pellegrin

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Municipal Health Care Institution Regional clinical specialized dispensary of radiation protection

location_facility: Centro Hospitalar do Algarve - Hospital de Portimao

location_facility: Allergy Associates Research Center LLC - CRN

location_facility: Stredomoravska nemocnicni a.s. - odstepny zavod Nemocnice Prostejov

location_facility: Universitatsklinikum Schleswig-Holstein; Klinik fuer Innere Medizin I

location_facility: Centro Hospitalar do Baixo Vouga E.P.E. - Hospital de Aveiro; Servicos Farmaceuticos

location_facility: Ivano-Frankivsk Central City Clinical Hospital

location_facility: University of Missouri Health Care System

location_facility: Szent Janos Korhaz es Eszak-Budai Egyesitett Korhazak

location_facility: State Institution Institute of Otolaryngology n.a. Prof. O.S.

location_facility: Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar

location_facility: Hospital Senhora da Oliveira - Guimarses, E.P.E

location_facility: Hospital Universitario Fundacion Jimenez Diaz.

location_facility: CHUS - H. Clinico U. de Santiago; Servicio de Farmacia

location_facility: Vital Prospects Clinical Research Institute PC - CRN


ReferenceCitation: Grünewald S, Politz O, Bender S, Héroult M, Lustig K, Thuss U, Kneip C, Kopitz C, Zopf D, Collin MP, Boemer U, Ince S, Ellinghaus P, Mumberg D, Hess-Stumpp H, Ziegelbauer K. Rogaratinib: A potent and selective pan-FGFR inhibitor with broad antitumor activity in FGFR-overexpressing preclinical cancer models. Int J Cancer. 2019 Sep 1;145(5):1346-1357. doi: 10.1002/ijc.32224. Epub 2019 Mar 13.

family: Grünewald

full_name: Sylvia Grünewald

given: Sylvia

family: Politz

full_name: Oliver Politz

given: Oliver

family: Bender

full_name: Sebastian Bender

given: Sebastian

family: Héroult

full_name: Mélanie Héroult

given: Mélanie

family: Lustig

full_name: Klemens Lustig

given: Klemens

family: Thuss

full_name: Uwe Thuss

given: Uwe

family: Kneip

full_name: Christoph Kneip

given: Christoph

family: Kopitz

full_name: Charlotte Kopitz

given: Charlotte

family: Zopf

full_name: Dieter Zopf

given: Dieter

family: Collin

full_name: Marie‐Pierre Collin

given: Marie‐Pierre

family: Boemer

full_name: Ulf Boemer

given: Ulf

family: Ince

full_name: Stuart Ince

given: Stuart

family: Ellinghaus

full_name: Peter Ellinghaus

given: Peter

family: Mumberg

full_name: Dominik Mumberg

given: Dominik

family: Hess‐Stumpp

full_name: Holger Hess‐Stumpp

given: Holger

family: Ziegelbauer

full_name: Karl Ziegelbauer

given: Karl

journal_name: International Journal of Cancer

title: Rogaratinib: A potent and selective pan‐FGFR inhibitor with broad antitumor activity in FGFR‐overexpressing preclinical cancer models

ipd_sharing_description: Availability of this study's data will 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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.

lead_sponsor: Bayer

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

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Institut Bergonié - Unicancer Nouvelle Aquitaine

location_facility: Institut de Cancérologie de l'Ouest - Saint Herblain

location_facility: Hospital General Universitario de Valencia

location_facility: Severance Hospital, Yonsei University Health System

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

location_facility: Uniklinikum Salzburg - Landeskrankenhaus

location_facility: Universitätsmedizin der Johannes Gutenberg Universität Mainz

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: IRCCS Istituto Europeo di Oncologia s.r.l. (IEO)

location_facility: Hospital Clínic i Provincial de Barcelona

title: An International, Multicenter, Phase 1b/2 Study of Rogaratinib (BAY1163877) in Combination With Atezolizumab as First-line Treatment in Cisplatin-ineligible Patients With FGFR-positive Locally Advanced or Metastatic Urothelial Carcinoma

summary:
FORT-2 is designed to evaluate safety, efficacy, RP2D and PK of rogaratinib in combination with atezolizumab in patients with untreated FGFR-positive urothelial carcinoma. The study comprises two separate parts: Phase 1b (Part A) and Phase 2 (Part B).The study parts differ in design, objectives and treatment.

The primary objectives of this Phase 1b study (Part A) are to determine the safety, tolerability,RP2D and pharmacokinetics of rogaratinib in combination with atezolizumab in these patients.

The primary objective of the Part B is to compare progression-free survival (PFS) according to RECIST v1.1 of rogaratinib in combination with atezolizumab over placebo in combination with atezolizumab in untreated patients with FGFR-positive locally advanced or metastatic urothelial carcinoma.

Of note, patients who participate in Part A are not allowed to participate in Part B.

Part B will be initiated once the data from Part A supports continuation of the study, even if this occurs prior to primary completion of Part A. The sponsor may decide not to continue the study as a whole after completion of Part A if the data do not support further development.


title: An Open-label Study to Evaluate the Long-term Safety of Daily Oral BCX7353 in Subjects With Type I and II Hereditary Angioedema

acronym: APeX-S

summary: This is an open-label study to evaluate the long term safety and effectiveness of oral treatment with BCX7353 in preventing acute angioedema attacks in patients with Type I and Type II HAE.

ReferenceCitation: Farkas H, Stobiecki M, Peter J, Kinaciyan T, Maurer M, Aygören-Pürsün E, Kiani-Alikhan S, Wu A, Reshef A, Bygum A, Fain O, Hagin D, Huissoon A, Jeseňák M, Lindsay K, Panovska VG, Steiner UC, Zubrinich C, Best JM, Cornpropst M, Dix D, Dobo SM, Iocca HA, Desai B, Murray SC, Nagy E, Sheridan WP. Long-term safety and effectiveness of berotralstat for hereditary angioedema: The open-label APeX-S study. Clin Transl Allergy. 2021 Jun;11(4):e12035. doi: 10.1002/clt2.12035.

name: Hungarian Angioedema Center of Reference and Excellence Department of Internal Medicine and Hematology Semmelweis University  Budapest Hungary

family: Farkas

full_name: Henriette Farkas

given: Henriette

name: Department of Clinical and Environmental Allergology Jagiellonian University Medical College  Krakow Poland

family: Stobiecki

full_name: Marcin Stobiecki

given: Marcin

name: Allergy and Immunology Unit University of Cape Town Lung Institute  Cape Town South Africa

name: Division of Allergy and Clinical Immunology Department of Medicine University of Cape Town  Cape Town South Africa

family: Peter

full_name: Jonny Peter

given: Jonny

name: Department of Dermatology Medical University of Vienna  Vienna Austria

family: Kinaciyan

full_name: Tamar Kinaciyan

given: Tamar

name: Dermatological Allergology Department of Dermatology and Allergy Charité ‐ Universitätsmedizin Berlin  Berlin Germany

family: Maurer

full_name: Marcus Maurer

given: Marcus

name: Department for Children and Adolescents University Hospital Frankfurt Goethe University Frankfurt  Frankfurt Germany

family: Aygören‐Pürsün

full_name: Emel Aygören‐Pürsün

given: Emel

name: Department of Immunology Barts Health NHS Trust Royal London Hospital  London UK

family: Kiani‐Alikhan

full_name: Sorena Kiani‐Alikhan

given: Sorena

name: Center for Allergy and Asthma Care Central  Hong Kong China

family: Wu

full_name: Adrian Wu

given: Adrian

name: Angioderma Center Barzilai University Medical Center  Ashkelon Israel

family: Reshef

full_name: Avner Reshef

given: Avner

name: Department of Dermatology and Allergy Centre Odense University Hospital  Odense Denmark

name: Department of Clinical Genetics Odense University Hospital  Odense Denmark

name: Clinical Institute University of Southern Denmark  Odense Denmark

family: Bygum

full_name: Anette Bygum

given: Anette

name: Sorbonne Université Service de Médecine Interne AP‐HP, Hôpital Saint‐Antoine  Paris France

family: Fain

full_name: Olivier Fain

given: Olivier

name: Allergy and Clinical Immunology Unit Department of Medicine Tel Aviv Sourasky Medical Center and Sackler Faculty of Medicine University of Tel Aviv  Tel Aviv Israel

family: Hagin

full_name: David Hagin

given: David

name: Department of Immunology Birmingham Heartlands Hospital University Hospitals Birmingham  UK

family: Huissoon

full_name: Aarnoud Huissoon

given: Aarnoud

name: National Center for Hereditary Angioedema Department of Pediatrics Department of Pulmonology and Allergology Comenius University in Bratislava Jessenius Faculty of Medicine  Martin Slovakia

family: Jeseňák

full_name: Miloš Jeseňák

given: Miloš

name: Auckland DHB Clinical Immunology and Allergy  Auckland New Zealand

family: Lindsay

full_name: Karen Lindsay

given: Karen

name: University Clinic of Dermatology Ss Cyril and Methodius University  Skopje Macedonia

family: Panovska

full_name: Vesna Grivcheva Panovska

given: Vesna Grivcheva

name: Department of Immunology University Hospital Zurich  Zurich Switzerland

family: Steiner

full_name: Urs C. Steiner

given: Urs C.

name: Allergy, Asthma and Clinical Immunology Alfred Health  Melbourne Victoria Australia

family: Zubrinich

full_name: Celia Zubrinich

given: Celia

name: BioCryst Pharmaceuticals  Durham North Carolina USA

family: Best

full_name: Jessica M. Best

given: Jessica M.

family: Cornpropst

full_name: Melanie Cornpropst

given: Melanie

family: Dix

full_name: Daniel Dix

given: Daniel

family: Dobo

full_name: Sylvia M. Dobo

given: Sylvia M.

family: Iocca

full_name: Heather A. Iocca

given: Heather A.

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

title: Long‐term safety and effectiveness of berotralstat for hereditary angioedema: The open‐label APeX‐S study

location_country:
Italy
Austria
South Africa
Serbia
Hong Kong
Switzerland
North Macedonia
Germany
France
Poland
Israel
Slovakia
Hungary
Australia
New Zealand
Spain
Denmark
United States
United Kingdom
Korea, Republic of


title: A Phase 1B Study Evaluating Glofitamab (RO7082859) in Combination With Rituximab (R) or Obinutuzumab (G) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Participants With Relapsed or Refractory Non-Hodgkin Lymphoma (R/R NHL) or in Participants With Untreated Diffuse Large B-Cell Lymphoma (DLBCL)

summary:
This is a phase 1B, multi-center, dose-finding study of glofitamab administered in combination with obinutuzumab (Gazyva; [G]), rituximab (R) and standard doses of CHOP (G/R-CHOP or R-CHOP) in participants with r/r NHL and untreated diffuse large B-cell lymphoma (DLBCL). Evaluating the safety, preliminary activity, pharmacokinetic (PK), and pharmacodynamic effects of this combination will be the main objectives of this study. The study is divided in two parts:

Part I: Dose finding in participants with r/r NHL; test use of G vs R in Cycle 1
Part II: Dose Expansion. The maximum tolerated dose or optimal biological dose (MTD or OBD) will be further assessed in participants with r/r NHL and those with untreated DLBCL (>60 years of age with an age-adjusted International Prognostic Index (IPI) of 2-3). Particularly, the impact of using glofitamab plus G/R-CHOP (i.e., add-on arm) versus glofitamab plus CHOP (i.e., replacement arm) will be assessed in untreated DLBCL participants.

location_country:
Italy
United States
Germany
France
Australia
Spain
Denmark
Canada
United Kingdom

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

location_facility: West Virginia University; Health Sciences Center

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

location_facility: University College London Hospitals NHS Foundation Trust; NIHR UCLH Clinical Research Facility

location_facility: Universitätsklinikum Würzburg; Studienzentrale Hämatologie/Onkologie

location_facility: Nottingham University Hospitals NHS Trust - City Hospital

location_facility: START Madrid-FJD, Hospital Fundacion Jimenez Diaz

location_facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología

location_facility: Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo.

location_facility: UO Ematologia, Ospedale S.Maria delle Croci

location_facility: Hopital Hotel Dieu Et Hme; Clinique Hematologie

location_facility: Universitätsklinikum Freiburg; Klinik für Innere Medizin I; Hämatologie/Onkologie

location_facility: Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica

location_facility: Universitätsklinikum Erlangen, Translational Research Center (TRC), Medizin 5


title: A Phase 1/2 Study of Relatlimab (Anti-LAG-3 Monoclonal Antibody) Administered in Combination With Both Nivolumab (Anti-PD-1 Monoclonal Antibody) and BMS-986205 (IDO1 Inhibitor) or in Combination With Both Nivolumab and Ipilimumab (Anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors

summary: The purpose of this study is to investigate safety and anti-tumor activity of relatlimab combination therapy in solid cancers that are advanced or have spread

location_country:
Italy
Switzerland
France
Australia
Spain
United States
United Kingdom

location_facility: Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

location_facility: H.R.U Málaga - Hospital General-Oncology

location_facility: Washington University School OF Medicine-Siteman Cancer Center

location_facility: Istituto Nazionale Tumori Fondazione Pascale


title: A PHASE 2, 12 WEEK, ADAPTIVE, OPEN LABEL, SEQUENTIAL COHORT TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF 06730512 FOLLOWING MULTIPLE DOSES IN ADULT SUBJECTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS)

acronym: PODO

summary: The purpose of this Phase 2 adaptive study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06730512 following multiple intravenous infusion in adult subjects with FSGS.

ReferenceCitation: Beck LH Jr, Berasi SP, Copley JB, Gorman D, Levy DI, Lim CN, Henderson JM, Salant DJ, Lu W. PODO: Trial Design: Phase 2 Study of PF-06730512 in Focal Segmental Glomerulosclerosis. Kidney Int Rep. 2021 Apr 3;6(6):1629-1633. doi: 10.1016/j.ekir.2021.03.892. eCollection 2021 Jun.

family: Beck

full_name: Laurence H. Beck

given: Laurence H.

suffix: Jr.

family: Berasi

full_name: Stephen P. Berasi

given: Stephen P.

family: Copley

full_name: J. Brian Copley

given: J. Brian

family: Gorman

full_name: Donal Gorman

given: Donal

family: Levy

full_name: Daniel I. Levy

given: Daniel I.

family: Lim

full_name: Chay Ngee Lim

given: Chay Ngee

family: Henderson

full_name: Joel M. Henderson

given: Joel M.

family: Salant

full_name: David J. Salant

given: David J.

family: Lu

full_name: Weining Lu

given: Weining

currency_apc_doaj: USD

journal_name: Kidney International Reports

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.

lead_sponsor: Pfizer

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

location_facility: UNC Clinical and Translational Research Center

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Miedzyleski Szpital Specjalistyczny w Warszawie

location_facility: UAB Nephrology Research Clinic at Paula Building

location_facility: UCLA Clinical and Translational Research Center

location_facility: Yale Center for Clinical Investigation - Church Street Research Unit

location_facility: New York University Grossman School of Medicine - CTSI

location_facility: The Ohio State University Investigational Drug Services

location_facility: University of Alberta - Pharmacy Research Office

location_facility: University of Iowa Hospitals and Clinics

location_facility: Boston Medical Center - Interventional Radiology

location_facility: University of Miami Katz Family Division of Nephrology

location_facility: University of Cincinnati Gardner Neuroscience Institute

location_facility: The Ohio State University Clinical Research Center

location_facility: Centre for Innovative Medicine, Research Institute of the McGill University Health Centre

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej

location_facility: CIUSSS de l'Est-de-l'Ile-de-Montreal - installation Hopital Maisonneuve-Rosemont

location_facility: Stanford Health Care Investigational Pharmacy

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: St. George's University Hospitals NHS Foundation Trust

location_facility: University of Cincinnati at DCI McMillan Research Unit

location_facility: Yale Nephrology Clinical Research Clinic

location_facility: Washington University School of Medicine

location_facility: The Ohio State University Wexner Medical Center- Nephrology Clinical Trials Unit

location_facility: The Kirklin Clinic of University Alabama Birmingham Hospital

location_facility: Niigata University Medical & Dental Hospital

location_facility: Cedars-Sinai Comprehensive Transplant Center

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica

location_facility: CarePoint East at The Ohio State University

location_facility: University of Miami Hospital and Clinics

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Yale University School of Medicine - Yale-New Haven Hospital

location_facility: Sunnybrook Health Sciences Centre - Kidney Care Centre at the CNIB

location_facility: Investigational Drug Service Pharmacy UAB Hosptial

location_facility: Baylor Scott & White Clinic - Temple South Loop


lead_sponsor: Regeneron Pharmaceuticals

location_country:
United States
France
Poland
Belgium
Spain
Germany
United Kingdom
Korea, Republic of
Taiwan

title: A Randomized, Open-Label Study of Combinations of Standard and High Dose REGN2810 (Cemiplimab; Anti-PD-1 Antibody) and Ipilimumab (Anti-CTLA-4 Antibody) in the Second-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer

summary: The primary objective of the study is to compare the objective response rate (ORR) of high dose cemiplimab (HDREGN2810) and standard dose cemiplimab plus ipilimumab combination therapy (SDREGN2810/ipi) to the ORR of standard dose cemiplimab (SDREGN2810) in the second-line treatment of patients with advanced squamous or non-squamous non-small cell lung cancer (NSCLC), in patients whose tumors express programmed cell death ligand 1 (PD-L1) in <50% of tumor cells.


ReferenceCitation: Ratziu V, Rinella ME, Neuschwander-Tetri BA, Lawitz E, Denham D, Kayali Z, Sheikh A, Kowdley KV, Desta T, Elkhashab M, DeGrauw J, Goodwin B, Ahmad A, Adda N. EDP-305 in patients with NASH: A phase II double-blind placebo-controlled dose-ranging study. J Hepatol. 2021 Nov 2. pii: S0168-8278(21)02155-3. doi: 10.1016/j.jhep.2021.10.018. [Epub ahead of print]

family: Ratziu

full_name: Vlad Ratziu

given: Vlad

family: Rinella

full_name: Mary E. Rinella

given: Mary E.

family: Neuschwander-Tetri

full_name: Brent A. Neuschwander-Tetri

given: Brent A.

family: Lawitz

full_name: Eric Lawitz

given: Eric

family: Denham

full_name: Douglas Denham

given: Douglas

family: Kayali

full_name: Zeid Kayali

given: Zeid

family: Sheikh

full_name: Aasim Sheikh

given: Aasim

family: Kowdley

full_name: Kris V. Kowdley

given: Kris V.

family: Desta

full_name: Taddese Desta

given: Taddese

family: Elkhashab

full_name: Magdy Elkhashab

given: Magdy

family: DeGrauw

full_name: Jeffery DeGrauw

given: Jeffery

family: Goodwin

full_name: Bryan Goodwin

given: Bryan

family: Ahmad

full_name: Alaa Ahmad

given: Alaa

family: Adda

full_name: Nathalie Adda

given: Nathalie

journal_name: Journal of Hepatology

lead_sponsor: Enanta Pharmaceuticals

location_country:
France
Puerto Rico
New Zealand
United States
United Kingdom
Canada

location_facility: CHU de Strasbourg - Nouvel Hôspital Civil

location_facility: University Of Tennessee Health Science Center

location_facility: Addenbrookes Hospital (AH)-Cambridge University Hospitals NHS Foundation Trust

location_facility: Fleming Island Center for Clinical Research

location_facility: Carolinas Medical Center Transplant Center/Center for Liver Disease

location_facility: University of Washington / Harborview Medical Center

location_facility: Southern California Transplantation Institute Research Foundation

location_facility: University of Pittsburgh Medical Center - Center for Liver Diseases

location_facility: Mayo Clinic Health System - Franciscan Healthcare

location_facility: Jacksonville Center for Clinical Research

location_facility: Research Associates of South Florida, LLC

location_facility: Baylor College of Medicine - Advanced Liver Therapies

location_facility: Clinical Research Advantage, Inc. / Colorado Springs Family Practice

location_facility: Wasatch Peak Family Practice/Radiant Research, Inc

location_facility: Jacksonville Center for Endoscopy - Southside ; Borland Groover Clinic

location_facility: Advanced Gastroenterology Associates, LLC

location_facility: Carolinas Center for Liver Disease / Carolinas Health Care System

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

location_facility: WestGlen Gastrointestinal Consultants, PA

location_facility: Chronic Viral Illness Service McGill University Health Center/Royal Victoria

location_facility: NYU Langone Medical Center - The Center for Musculoskeletal Care (CMC)

location_facility: Swedish Medical Center-Swedish Organ Transplant and Liver Center

location_facility: CHU de Bordeaux - GH Sud - Hoital Haut Leveque

location_facility: Feinberg School of Medicine Northwestern University

location_facility: UCSD Altman Clinical and Translational Research Institute

title: A Phase 2 Dose Ranging, Randomized, Double Blind, and Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Non-Alcoholic Steatohepatitis (NASH)

summary: A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of EDP-305 in subjects with Non-Alcoholic Steatohepatitis


title: Pixantrone (BBR 2778) Versus Other Chemotherapeutic Agents for Third-line Single Agent Treatment of Patients With Relapsed Aggressive Non-Hodgkin's Lymphoma: A Randomized, Controlled, Phase III Comparative Trial

summary: BBR 2778 is a novel aza-anthracenedione that has activity in experimental tumors and shows reduced potential for cardiotoxicity in animal models. This cytotoxic agent has structural similarities with mitoxantrone as well as general similarities with anthracyclines (such as the tricyclic central quinoid chromophore).

ReferenceCitation: Pettengell R, Coiffier B, Narayanan G, de Mendoza FH, Digumarti R, Gomez H, Zinzani PL, Schiller G, Rizzieri D, Boland G, Cernohous P, Wang L, Kuepfer C, Gorbatchevsky I, Singer JW. Pixantrone dimaleate versus other chemotherapeutic agents as a single-agent salvage treatment in patients with relapsed or refractory aggressive non-Hodgkin lymphoma: a phase 3, multicentre, open-label, randomised trial. Lancet Oncol. 2012 Jul;13(7):696-706. doi: 10.1016/S1470-2045(12)70212-7. Epub 2012 May 30. Erratum in: Lancet Oncol. 2012 Jul;13(7):e285.

family: Pettengell

full_name: Ruth Pettengell

given: Ruth

family: Coiffier

full_name: Bertrand Coiffier

given: Bertrand

family: Narayanan

full_name: Geetha Narayanan

given: Geetha

family: de Mendoza

full_name: Fernando Hurtado de Mendoza

given: Fernando Hurtado

family: Digumarti

full_name: Raghunadharao Digumarti

given: Raghunadharao

family: Gomez

full_name: Henry Gomez

given: Henry

family: Zinzani

full_name: Pier Luigi Zinzani

given: Pier Luigi

family: Schiller

full_name: Gary Schiller

given: Gary

family: Rizzieri

full_name: David Rizzieri

given: David

family: Boland

full_name: Giles Boland

given: Giles

family: Cernohous

full_name: Paul Cernohous

given: Paul

family: Wang

full_name: Lixia Wang

given: Lixia

family: Kuepfer

full_name: Christine Kuepfer

given: Christine

family: Gorbatchevsky

full_name: Igor Gorbatchevsky

given: Igor

family: Singer

full_name: Jack W Singer

given: Jack W

journal_name: The Lancet Oncology

lead_sponsor: CTI BioPharma

location_country:
Ecuador
Italy
Peru
India
Costa Rica
Mexico
Germany
Uruguay
France
Bulgaria
Panama
Poland
Romania
Hungary
Argentina
Russian Federation
Estonia
United States
United Kingdom
Ukraine

location_facility: St. Petersburg State Medical Institution: Municipal Hospital #31

location_facility: Research Insitute of Hematology and Blood Transfusion

location_facility: Policlinico S. Orsola, Instituto di Ematologia

location_facility: Institutul Oncologic "Ion Chiricuta" Oncologie Medicala

location_facility: Bhagwan Mahaveer Cancer Hospital & Research Center

location_facility: Universita degli Studi Perugia Policlinico Monteluce

location_facility: FUNDALEU - fundacion para combatir le Leucernia

location_facility: Shirdi Sai Baba Cancer Hospital, K.M.C. Manipal

location_facility: State Therapeutical & Prophlatic Institution: Cheylabinsk Regional Oncological Center

location_facility: Azienda Ospedaliera Pisanan "Santana Chiara"

location_facility: Tartu University Clinics, Hematology Oncology Clinic

location_facility: Prof. Dr. Ian Chiricuta, Institute of Oncology, Radiotheraphy

location_facility: Medical Radiological Research Center under the Russian academey of Medical Sciences

location_facility: State Research Institution: Research Institute of Oncology

location_facility: Hospital Privado Centro Medico de Cordoba S.A.

location_facility: Hopitaux Universitaires de Strabourg - Hopital de Hautepierre

location_facility: Central Research Rontgenological and Radiological Institute

location_facility: Beatson Oncology Centre, Western Infirmary

location_facility: State Institution: Moscow Regional Research Clinical institute n.a. M.F.

location_facility: St. Petersburg Pavlov State Medical Clinic of Intensive Care & Bone Marrow Transplantation

location_facility: University Gernal Hospital for Active Treatment "Alexandrovska" - Clinic of Hematology

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Orvos-es Gyogy II

location_facility: Institute of Clinical Radiology of the Research Center for Radiation Medicine under the UAMS

location_facility: State Medical Institution Altai Territorial Oncological Center

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

location_facility: State Institution: Hematological Research Center under the Russian Academy of Medical Sciences

location_facility: Indo-American Cancer Institute & Research Center

location_facility: Institute of Blood Pathology & Transfusion Medicine under the UAMS

location_facility: Centre Hospitalier Lyo Sud, Service d'Hematologie et d'Oncologie

location_facility: Russian Oncological Research Center n.a. N.N. Blokhin

location_facility: State Medical Institution: Clinical Oncological Center

location_facility: State Medical Institution Replubican Oncological Center

location_facility: Zhtomyr O.F. Gerbachevsky Regional Hospital

location_facility: Ospedale Oncolgoico Regionale della Basilicata

location_facility: Klinika Hematologii, Onkologii i Chorob Wewnetrznych

location_facility: Complejo Hospitalario "Arnulfo Arias Madrid

location_facility: University General Hospital for Active Treatment "St. Marina" Clinic of Hematology

location_facility: Watson Clinic for Cancer Care and Research

location_facility: Azienda ospedaliera Pisana "Santa Chiara"

location_facility: Universitatklinik des Saarlandes, Innere Medzin I


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

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

The study is enrolling a pivotal cohort of frontline BPDCN patients and a cohort of relapsed/refractory BPDCN patients.

lead_sponsor: ImmunoGen, Inc.

location_country:
Italy
United States
France
Spain

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

location_facility: Baylor Scott & White University Medical Center

location_facility: Hospital Universitari I Politècnic La Fe

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


title: A Phase 2b Randomized, Double-masked, Controlled Trial to Establish the Safety and Efficacy of Zimura™ (Complement C5 Inhibitor) Compared to Sham in Subjects With Autosomal Recessive Stargardt Disease

summary: To evaluate the safety and efficacy of Zimura™ (complement factor C5 inhibitor) compared to Sham in subjects with autosomal recessive Stargardt disease 1 (STGD1).

lead_sponsor: IVERIC bio, Inc.

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

location_facility: Szegedi Tudomanyegyetem, Szent-Gyorgyi Albert Klinikai Kozpont, Szemeszeti Klinika

location_facility: University of Utah John A. Moran Eye Center

location_facility: Debreceni Egyetem Klinikai Kozpont Szemklinika

location_facility: Tel-Aviv Sourasky Medical Center, Ichilov Hospital

location_facility: Semmelweis University, Ophthalmology Clinics

location_facility: Augenklinik und Poliklinik des Klinikums der Universitat München

location_facility: AOU Policlinico Sant'Orsola Malpighi, U.O. Oftalmologia,

location_facility: Jules Stein Eye Institute/ David Geffen School of Medicine

location_facility: Centre ophtalmologique des Quinzes Vingts

location_facility: Foundation Policlinico Tor Vergata, UOSD Patologie Retiniche

location_facility: Hopital Intercommunal de Verdun, University Paris Est

location_facility: AOU Universita degli studi della Campania Luigi Vanvitelli - UOC Oculistica

intervention_type: Other


ReferenceCitation: Bourque JM, Hanson CA, Agostini D, Bateman TM, Bax JJ, Beanlands RSB, Berman DS, Garcia EV, Heller GV, Knuuti J, Tamaki N, Udelson JE, Maddahi J. Assessing myocardial perfusion in suspected coronary artery disease: rationale and design of the second phase 3, open-label multi-center study of flurpiridaz (F-18) injection for positron emission tomography (PET) imaging. J Nucl Cardiol. 2021 Jun;28(3):1105-1116. doi: 10.1007/s12350-021-02527-8. Epub 2021 Jan 31.

family: Bourque

full_name: Jamieson M. Bourque

given: Jamieson M.

family: Hanson

full_name: Christopher A. Hanson

given: Christopher A.

family: Agostini

full_name: Denis Agostini

given: Denis

family: Bateman

full_name: Timothy M. Bateman

given: Timothy M.

family: Bax

full_name: Jeroen J. Bax

given: Jeroen J.

family: Beanlands

full_name: Rob S. B. Beanlands

given: Rob S. B.

family: Berman

full_name: Daniel S. Berman

given: Daniel S.

family: Garcia

full_name: Ernest V. Garcia

given: Ernest V.

family: Heller

full_name: Gary V. Heller

given: Gary V.

family: Knuuti

full_name: Juhani Knuuti

given: Juhani

family: Tamaki

full_name: Nagara Tamaki

given: Nagara

family: Udelson

full_name: James E. Udelson

given: James E.

family: Maddahi

full_name: Jamshid Maddahi

given: Jamshid

journal_name: Journal of Nuclear Cardiology

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: GE Healthcare

location_country:
United States
Switzerland
Netherlands
Finland
France
Germany
Canada

location_facility: Cardiology Physicians PA/Red Clay Research LLC

location_facility: Groupe Hospitalier Bichat Claude Bernard

location_facility: Washington University School of Medicine

location_facility: Vascular Biology and Hypertension Program, University of Alabama at Birmingham

location_facility: The Methodist Hospital Research Institute

location_facility: VA Greater Los Angeles Health Care System

location_facility: Columbia University Medical Center/New York Presbyterian Hospital - Milstein Hospital Building

location_facility: Memorial City and Katy Cardiology Associates

location_facility: Center Hospitalier Universitaire de Sherbrooke CHUS

location_facility: University of Texas Southwestern Medical Center

location_facility: VA North Texas Health Care System - NAVREF - PPDS

location_facility: University Of Iowa Hospitals And Clinics

title: A Phase 3, Open-Label, Multicentre Study of Flurpiridaz (18F) Injection for Positron Emission Tomography (PET) Imaging for Assessment of Myocardial Perfusion in Patients Referred for Invasive Coronary Angiography Because of Suspected Coronary Artery Disease

summary: This is a Phase 3, prospective, open-label, international, multicentre study of Flurpiridaz (18F) Injection for PET MPI in patients referred for ICA because of suspected CAD.


title: A Randomized, Partially Blinded, Phase II Study to Assess the Safety, Tolerability and Efficacy of ZD6474 Alone or in Combination With Paclitaxel and Carboplatin in Subjects With Previously Untreated Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

summary:
The purpose of the run-in phase of this study is to determine the appropriate and tolerable dose of ZD6474 (200mg or 300mg) to be administered in combination with paclitaxel and carboplatin in subjects with previously untreated locally advanced or metastatic NSCLC. This phase of the trial is closed to enrollment.

The purpose of the randomized phase of this study is to determine the efficacy of ZD6474 alone versus that of ZD6474 in combination with paclitaxel and carboplatin versus that of paclitaxel and carboplatin alone in subjects with previously untreated locally advanced or metastatic NSCLC. This phase of the trial is closed to enrollment.

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Italy
United States
South Africa
India
Finland
France
Thailand
Spain
Germany