title: A Randomised, Parallel-group, Open-label, Multinational Trial Comparing the Safety and Efficacy of Insulin Aspart (NovoRapid®) Versus Human Insulin (Actrapid®), Used in a Multiple Injection Regimen, in the Treatment of Pregnant Women With Type 1 Diabetes, Focusing on Maternal Hypoglycaemia and Pregnancy Outcomes

summary:
This trial was conducted in Europe, Middle East, North America and South America.

The aim of this trial was to compare the use of an intensified insulin treatment with insulin aspart (NovoRapid®) versus human insulin (Actrapid®) in pregnancy.

ReferenceCitation: Mathiesen ER, Kinsley B, Amiel SA, Heller S, McCance D, Duran S, Bellaire S, Raben A; Insulin Aspart Pregnancy Study Group. Maternal glycemic control and hypoglycemia in type 1 diabetic pregnancy: a randomized trial of insulin aspart versus human insulin in 322 pregnant women. Diabetes Care. 2007 Apr;30(4):771-6.

ReferenceCitation: Hod M, Jovanovic L. Improving outcomes in pregnant women with type 1 diabetes. Diabetes Care. 2007 Jul;30(7):e62.

ReferenceCitation: Hod M, Damm P, Kaaja R, Visser GH, Dunne F, Demidova I, Hansen AS, Mersebach H; Insulin Aspart Pregnancy Study Group. Fetal and perinatal outcomes in type 1 diabetes pregnancy: a randomized study comparing insulin aspart with human insulin in 322 subjects. Am J Obstet Gynecol. 2008 Feb;198(2):186.e1-7. Epub 2007 Oct 1.

ReferenceCitation: McCance DR, Damm P, Mathiesen ER, Hod M, Kaaja R, Dunne F, Jensen LE, Mersebach H. Evaluation of insulin antibodies and placental transfer of insulin aspart in pregnant women with type 1 diabetes mellitus. Diabetologia. 2008 Nov;51(11):2141-3. doi: 10.1007/s00125-008-1120-y. Epub 2008 Aug 23.

family: McCance

full_name: D. R. McCance

given: D. R.

family: Damm

full_name: P. Damm

given: P.

family: Mathiesen

full_name: E. R. Mathiesen

given: E. R.

family: Hod

full_name: M. Hod

given: M.

family: Kaaja

full_name: R. Kaaja

given: R.

family: Dunne

full_name: F. Dunne

given: F.

family: Jensen

full_name: L. E. Jensen

given: L. E.

family: Mersebach

full_name: H. Mersebach

given: H.

journal_name: Diabetologia

oa_host_type: publisher

evidence: open (via free pdf)

publisher_dissemination: Springer

publisher_group: Springer

ReferenceCitation: Heller S, Damm P, Mersebach H, Skjøth TV, Kaaja R, Hod M, Durán-García S, McCance D, Mathiesen ER. Hypoglycemia in type 1 diabetic pregnancy: role of preconception insulin aspart treatment in a randomized study. Diabetes Care. 2010 Mar;33(3):473-7. doi: 10.2337/dc09-1605. Epub 2009 Dec 10.

family: Heller

full_name: S. Heller

given: S.

family: Skjoth

full_name: T. V. Skjoth

given: T. V.

family: Duran-Garcia

full_name: S. Duran-Garcia

full_name: D. McCance

given: D.

journal_name: Diabetes Care

title: Hypoglycemia in Type 1 Diabetic Pregnancy: Role of preconception insulin aspart treatment in a randomized study

ReferenceCitation: Damm P, Mersebach H, Råstam J, Kaaja R, Hod M, McCance DR, Mathiesen ER. Poor pregnancy outcome in women with type 1 diabetes is predicted by elevated HbA1c and spikes of high glucose values in the third trimester. J Matern Fetal Neonatal Med. 2014 Jan;27(2):149-54. doi: 10.3109/14767058.2013.806896. Epub 2013 Jun 20.

journal_name: The Journal of Maternal-Fetal & Neonatal Medicine

repository_institution: University of Copenhagen - Research at the University of Copenhagen

title: Poor pregnancy outcome in women with type 1 diabetes is predicted by elevated HbA1cand spikes of high glucose values in the third trimester

ReferenceCitation: Altschuler JA, Casella SJ, MacKenzie TA, Curtis KM. The effect of cinnamon on A1C among adolescents with type 1 diabetes. Diabetes Care. 2007 Apr;30(4):813-6.

ReferenceCitation: Williams MM, Clouse RE, Nix BD, Rubin EH, Sayuk GS, McGill JB, Gelenberg AJ, Ciechanowski PS, Hirsch IB, Lustman PJ. Efficacy of sertraline in prevention of depression recurrence in older versus younger adults with diabetes. Diabetes Care. 2007 Apr;30(4):801-6.

location_country:
Austria
Netherlands
Germany
Finland
Croatia
Bulgaria
France
Greece
Israel
Norway
Ireland
Argentina
Poland
Russian Federation
Spain
Denmark
Canada
United Kingdom


title: RECORD 3 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE; a Controlled., Double-blind, Randomized Study of BAY 59-7939 in the Prevention of VTE in Subjects Undergoing Elective Total Knee Replacement.

acronym: RECORD 3

summary: The purpose of this study is to assess if 10 mg Bay 59-7939, taken once daily as a tablet, is safe and prevents blood clot which may form after a knee replacement operation.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Lassen MR, Ageno W, Borris LC, Lieberman JR, Rosencher N, Bandel TJ, Misselwitz F, Turpie AG; RECORD3 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med. 2008 Jun 26;358(26):2776-86. doi: 10.1056/NEJMoa076016.

family: Lassen

full_name: Michael R. Lassen

given: Michael R.

sequence: first

family: Ageno

full_name: Walter Ageno

given: Walter

sequence: additional

family: Borris

full_name: Lars C. Borris

given: Lars C.

family: Lieberman

full_name: Jay R. Lieberman

given: Jay R.

family: Rosencher

full_name: Nadia Rosencher

given: Nadia

family: Bandel

full_name: Tiemo J. Bandel

given: Tiemo J.

family: Misselwitz

full_name: Frank Misselwitz

given: Frank

family: Turpie

full_name: Alexander G.G. Turpie

given: Alexander G.G.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: New England Journal of Medicine

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Rivaroxaban versus Enoxaparin for Thromboprophylaxis after Total Knee Arthroplasty

lead_sponsor: Bayer

location_country:
Italy
Austria
Peru
South Africa
Sweden
Mexico
Netherlands
Germany
Spain
France
Poland
Israel
Norway
Belgium
China
Denmark
Canada
Czech Republic
Colombia

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Identifier

title: An Open-label Trial With TMC125 as Part of an ART Including TMC114/Rtv and an Investigator-selected OBR in HIV-1 Infected Subjects Who Participated in a DUET Phase III Trial (TMC125-C206 or TMC125-C216).

summary: The purpose of this trial is to evaluate the long-term safety and tolerability of TMC125 200 mg twice daily as part of an antiretroviral therapy including TMC114/rtv and an investigator selected optimized background in HIV-1 infected patients who have participated in a DUET trial (TMC125-C206 or TMC125 C216) and have met the definition of virologic failure at Week 24 or later in these trials.

design_allocation: Non-Randomized

primary_purpose: Treatment

lead_sponsor: Tibotec Pharmaceuticals, Ireland

location_country:
Brazil
Chile
Mexico
Spain
Germany
France
Panama
Thailand
Belgium
Argentina
Australia
Puerto Rico
United States
Canada


type: EudraCT Number

title: ACCESS: A Controlled Comparison of Eritoran Tetrasodium and Placebo in Patients With Severe Sepsis

summary: The purpose of this study is to compare eritoran tetrasodium and placebo in patients with severe sepsis and to demonstrate a reduction of mortality from all causes.

ReferenceCitation: Opal SM, Laterre PF, Francois B, LaRosa SP, Angus DC, Mira JP, Wittebole X, Dugernier T, Perrotin D, Tidswell M, Jauregui L, Krell K, Pachl J, Takahashi T, Peckelsen C, Cordasco E, Chang CS, Oeyen S, Aikawa N, Maruyama T, Schein R, Kalil AC, Van Nuffelen M, Lynn M, Rossignol DP, Gogate J, Roberts MB, Wheeler JL, Vincent JL; ACCESS Study Group. Effect of eritoran, an antagonist of MD2-TLR4, on mortality in patients with severe sepsis: the ACCESS randomized trial. JAMA. 2013 Mar 20;309(11):1154-62. doi: 10.1001/jama.2013.2194.

family: Opal

full_name: Steven M. Opal

given: Steven M.

family: Laterre

full_name: Pierre-Francois Laterre

given: Pierre-Francois

family: Francois

full_name: Bruno Francois

given: Bruno

family: LaRosa

full_name: Steven P. LaRosa

given: Steven P.

family: Angus

full_name: Derek C. Angus

given: Derek C.

family: Mira

full_name: Jean-Paul Mira

given: Jean-Paul

family: Wittebole

full_name: Xavier Wittebole

given: Xavier

family: Dugernier

full_name: Thierry Dugernier

given: Thierry

family: Perrotin

full_name: Dominique Perrotin

given: Dominique

family: Tidswell

full_name: Mark Tidswell

given: Mark

family: Jauregui

full_name: Luis Jauregui

given: Luis

family: Krell

full_name: Kenneth Krell

given: Kenneth

family: Pachl

full_name: Jan Pachl

given: Jan

family: Takahashi

full_name: Takeshi Takahashi

given: Takeshi

family: Peckelsen

full_name: Claus Peckelsen

given: Claus

family: Cordasco

full_name: Edward Cordasco

given: Edward

family: Chang

full_name: Chia-Sheng Chang

given: Chia-Sheng

family: Oeyen

full_name: Sandra Oeyen

given: Sandra

family: Aikawa

full_name: Naoki Aikawa

given: Naoki

family: Maruyama

full_name: Tatsuya Maruyama

given: Tatsuya

family: Schein

full_name: Roland Schein

given: Roland

family: Kalil

full_name: Andre C. Kalil

given: Andre C.

family: Van Nuffelen

full_name: Marc Van Nuffelen

given: Marc

family: Lynn

repository_institution: Ghent University - Ghent University Academic Bibliography

title: Effect of Eritoran, an Antagonist of MD2-TLR4, on Mortality in Patients With Severe Sepsis

location_country:
Australia
Belgium
Taiwan
France
Japan
Poland
Argentina
Canada
Korea, Republic of
South Africa
Chile
Hong Kong
Netherlands
Switzerland
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Czechia
Israel
Spain


title: A Phase III, Randomised, Multicenter, Double-blind, Parallel-group, Active Controlled Study to Evaluate the Efficacy and Safety of Oral Dabigatran Etexilate (150 mg Bid) Compared to Warfarin (INR 2.0-3.0) for the Secondary Prevention of Venous Thromboembolism.

acronym: RE-MEDY

summary: The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate administered orally and warfarin (International Normalized Ratio (INR) of 2.0-3.0) for the long-term treatment and secondary prevention of symptomatic venous thromboembolism in patients who have been successfully treated with standard doses of an approved anticoagulant for three to twelve months for confirmed acute symptomatic Venous Thrombo-embolism.

ReferenceCitation: Goldhaber SZ, Eriksson H, Kakkar A, Schellong S, Feuring M, Fraessdorf M, Kreuzer J, Schueler E, Schulman S. Efficacy of dabigatran versus warfarin in patients with acute venous thromboembolism in the presence of thrombophilia: Findings from RE-COVER®, RE-COVER™ II, and RE-MEDY™. Vasc Med. 2016 Dec;21(6):506-514. Epub 2016 Nov 1.

ReferenceCitation: Majeed A, Hwang HG, Connolly SJ, Eikelboom JW, Ezekowitz MD, Wallentin L, Brueckmann M, Fraessdorf M, Yusuf S, Schulman S. Management and outcomes of major bleeding during treatment with dabigatran or warfarin. Circulation. 2013 Nov 19;128(21):2325-32. doi: 10.1161/CIRCULATIONAHA.113.002332. Epub 2013 Sep 30.

name: From the Coagulation Unit, Hematology Center, Karolinska University Hospital and Karolinska Institute, Stockholm, Sweden (A.M., S.S.); the Department of Medicine, Soonchunhyang University Gumi’s Hospital, North Kyungsang Province, South Korea (H.-G-H.); McMaster University, Population Health Research Institute, Hamilton, ON, Canada (S.J.C., J.W.E., S.Y.); Lankenau Medical Center, Thomas Jefferson Medical College, Wynnewood, PA (M.D.E.); Uppsala Clinical Research Center and Department of Medical...

family: Majeed

full_name: Ammar Majeed

given: Ammar

family: Hwang

full_name: Hun-Gyu Hwang

given: Hun-Gyu

family: Connolly

full_name: Stuart J. Connolly

given: Stuart J.

family: Eikelboom

full_name: John W. Eikelboom

given: John W.

family: Ezekowitz

full_name: Michael D. Ezekowitz

given: Michael D.

family: Wallentin

full_name: Lars Wallentin

given: Lars

family: Brueckmann

full_name: Martina Brueckmann

given: Martina

family: Fraessdorf

full_name: Mandy Fraessdorf

given: Mandy

family: Yusuf

full_name: Salim Yusuf

given: Salim

family: Schulman

full_name: Sam Schulman

given: Sam

journal_name: Circulation

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Management and Outcomes of Major Bleeding During Treatment With Dabigatran or Warfarin

ReferenceCitation: Schulman S, Kearon C, Kakkar AK, Schellong S, Eriksson H, Baanstra D, Kvamme AM, Friedman J, Mismetti P, Goldhaber SZ; RE-MEDY Trial Investigators; RE-SONATE Trial Investigators. Extended use of dabigatran, warfarin, or placebo in venous thromboembolism. N Engl J Med. 2013 Feb 21;368(8):709-18. doi: 10.1056/NEJMoa1113697.

family: Kearon

full_name: Clive Kearon

given: Clive

family: Kakkar

full_name: Ajay K. Kakkar

given: Ajay K.

family: Schellong

full_name: Sebastian Schellong

given: Sebastian

family: Eriksson

full_name: Henry Eriksson

given: Henry

family: Baanstra

full_name: David Baanstra

given: David

family: Kvamme

full_name: Anne Mathilde Kvamme

given: Anne Mathilde

family: Friedman

full_name: Jeffrey Friedman

given: Jeffrey

family: Mismetti

full_name: Patrick Mismetti

given: Patrick

family: Goldhaber

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

repository_institution: Nova Science Publishers, Inc. - Nova Science Publishers

title: Extended Use of Dabigatran, Warfarin, or Placebo in Venous Thromboembolism

location_country:
Finland
Greece
Australia
Belgium
Russian Federation
Denmark
Czech Republic
Ukraine
India
France
Poland
Slovakia
Norway
Argentina
Canada
South Africa
Sweden
Netherlands
Bulgaria
Hungary
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
New Zealand
Spain
Turkey

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title: Treat-to-Target Study of Olmesartan Medoxomil and an Add-on Treatment Algorithm Consisting of Hydrochlorothiazide and Amlodipine Besylate in Patients With Mild to Moderate Hypertension

acronym: OLMETREAT

summary: This study is to assess the safety and efficacy of an add-on treatment algorithm with olmesartan, hydrochlorothiazide and amlodipine in patients with mild to moderate hypertension.

lead_sponsor: Sankyo Pharma Gmbh

location_country:
Italy
Austria
Switzerland
Netherlands
France
Belgium
Portugal
Germany
United Kingdom

location_facility: Azienda Policlinico Universitario a Gestione Diret

location_facility: Azienda Ospedaliera "Madonna delle Grazie"

location_facility: Ev. Krankenhaus Bielefeld, Medizinische Klinik in Bethel - Gilead I

location_facility: Division of Cardiovascular and Endocrine Sciences

location_facility: Centre Hospitalier du Bois de l'Abbaye et de Hesba, Department of Intensive Care

location_facility: Allgemeen Ziekenhuis Maria-Middelares, Cardiologie, Campus de Pelikaan


title: Assess Lot-to-lot Consistency of 3 Lots (Double Blind Design) of GlaxoSmithKline Biologicals' 10-valent Pneumococcal Vaccine and Evaluate Non-inferiority to Prevenar™ (Single Blind Design) When Administered as 3-dose Primary Immunization Course Before 6 Months of Age

summary: Evaluate lot-to-lot consistency, safety and reactogenicity of 3 doses of GSK Biologicals' 10-valent pneumococcal conjugate vaccine and non-inferiority with respect to Prevenar.

ReferenceType: background

ReferenceCitation: Chevallier B, Vesikari T, Brzostek J, Knuf M, Bermal N, Aristegui J, Borys D, Cleerbout J, Lommel P, Schuerman L. Safety and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) when coadministered with routine childhood vaccines. Pediatr Infect Dis J. 2009 Apr;28(4 Suppl):S109-18. doi: 10.1097/INF.0b013e318199f62d. Review.

ReferenceCitation: Hausdorff WP, Dagan R, Beckers F, Schuerman L. Estimating the direct impact of new conjugate vaccines against invasive pneumococcal disease. Vaccine. 2009 Dec 9;27(52):7257-69. doi: 10.1016/j.vaccine.2009.09.111. Epub 2009 Oct 13. Review.

ReferenceCitation: Knuf M, Szenborn L, Moro M, Petit C, Bermal N, Bernard L, Dieussaert I, Schuerman L. Immunogenicity of routinely used childhood vaccines when coadministered with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Pediatr Infect Dis J. 2009 Apr;28(4 Suppl):S97-S108. doi: 10.1097/INF.0b013e318199f61b. Review.

ReferenceCitation: Poolman J, Frasch C, Nurkka A, Käyhty H, Biemans R, Schuerman L. Impact of the conjugation method on the immunogenicity of Streptococcus pneumoniae serotype 19F polysaccharide in conjugate vaccines. Clin Vaccine Immunol. 2011 Feb;18(2):327-36. doi: 10.1128/CVI.00402-10. Epub 2010 Dec 1.

ReferenceCitation: Schuerman L, Borys D, Hoet B, Forsgren A, Prymula R. Prevention of otitis media: now a reality? Vaccine. 2009 Sep 25;27(42):5748-54. doi: 10.1016/j.vaccine.2009.07.070. Epub 2009 Aug 8. Review.

ReferenceCitation: Schuerman L, Wysocki J, Tejedor JC, Knuf M, Kim KH, Poolman J. Prediction of pneumococcal conjugate vaccine effectiveness against invasive pneumococcal disease using opsonophagocytic activity and antibody concentrations determined by enzyme-linked immunosorbent assay with 22F adsorption. Clin Vaccine Immunol. 2011 Dec;18(12):2161-7. doi: 10.1128/CVI.05313-11. Epub 2011 Oct 12.

ReferenceCitation: Vesikari T, Wysocki J, Chevallier B, Karvonen A, Czajka H, Arsène JP, Lommel P, Dieussaert I, Schuerman L. Immunogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) compared to the licensed 7vCRM vaccine. Pediatr Infect Dis J. 2009 Apr;28(4 Suppl):S66-76. doi: 10.1097/INF.0b013e318199f8ef.

ipd_sharing: Yes

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

lead_sponsor: GlaxoSmithKline

location_country: Finland France Poland

intervention_type: Biological


title: An Open-Label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801, C-1802, C-1803, or C-1808 and a Dosing Suspension Safety Evaluation

acronym: STRATA

summary: The primary objectives for the initial treatment period of this study are to further evaluate the safety of natalizumab monotherapy by evaluating the risk of hypersensitivity reactions and immunogenicity following re-exposure to natalizumab and confirming the safety of switching from interferon (IFN), glatiramer acetate, or other multiple sclerosis (MS) therapies to natalizumab. The primary objective for the long-term treatment period of this study is to evaluate the long-term impact of natalizumab monotherapy on the progression of disability measured by Expanded Disability Status Scale (EDSS) changes over time.

status: Terminated

ReferenceType: result

ReferenceCitation: Gorelik L, Lerner M, Bixler S, Crossman M, Schlain B, Simon K, Pace A, Cheung A, Chen LL, Berman M, Zein F, Wilson E, Yednock T, Sandrock A, Goelz SE, Subramanyam M. Anti-JC virus antibodies: implications for PML risk stratification. Ann Neurol. 2010 Sep;68(3):295-303. doi: 10.1002/ana.22128.

family: Gorelik

full_name: Leonid Gorelik

given: Leonid

family: Lerner

full_name: Michaela Lerner

given: Michaela

family: Bixler

full_name: Sarah Bixler

given: Sarah

family: Crossman

full_name: Mary Crossman

given: Mary

family: Schlain

full_name: Brian Schlain

given: Brian

family: Simon

full_name: Kenneth Simon

given: Kenneth

family: Pace

full_name: Amy Pace

given: Amy

family: Cheung

full_name: Anne Cheung

given: Anne

family: Chen

full_name: Ling Ling Chen

given: Ling Ling

family: Berman

full_name: Melissa Berman

given: Melissa

family: Zein

full_name: Fairuz Zein

given: Fairuz

family: Wilson

full_name: Ewa Wilson

given: Ewa

family: Yednock

full_name: Ted Yednock

given: Ted

family: Sandrock

full_name: Alfred Sandrock

given: Alfred

family: Goelz

full_name: Susan E. Goelz

given: Susan E.

family: Subramanyam

full_name: Meena Subramanyam

given: Meena

journal_name: Annals of Neurology

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Anti-JC virus antibodies: Implications for PML Risk Stratification

ReferenceCitation: Rudick RA, O'Connor PW, Polman CH, Goodman AD, Ray SS, Griffith NM, Jurgensen SA, Gorelik L, Forrestal F, Sandrock AW, Goelz SE. Assessment of JC virus DNA in blood and urine from natalizumab-treated patients. Ann Neurol. 2010 Sep;68(3):304-10. doi: 10.1002/ana.22107.

family: Rudick

full_name: Richard A. Rudick

given: Richard A.

family: O'Connor

full_name: Paul W. O'Connor

given: Paul W.

family: Polman

full_name: Chris H. Polman

given: Chris H.

family: Goodman

full_name: Andrew D. Goodman

given: Andrew D.

family: Ray

full_name: Soma S. Ray

given: Soma S.

ReferenceCitation: O'Connor P, Goodman A, Kappos L, Lublin F, Polman C, Rudick RA, Hauswirth K, Cristiano LM, Forrestal F, Duda P. Long-term safety and effectiveness of natalizumab redosing and treatment in the STRATA MS Study. Neurology. 2014 Jul 1;83(1):78-86. doi: 10.1212/WNL.0000000000000541. Epub 2014 Jun 4. Erratum in: Neurology. 2014 Aug 19;83(8):773.

location_country:
Finland
Greece
Belgium
Australia
Denmark
Czech Republic
France
Poland
Canada
Sweden
Switzerland
Netherlands
Hungary
Ireland
Germany
United Kingdom
Italy
Israel
New Zealand
Spain
Turkey


ReferenceCitation: de Azevedo SJ, de Melo AC, Roberts L, Caro I, Xue C, Wainstein A. First-line atezolizumab monotherapy in patients with advanced BRAF(V600) wild-type melanoma. Pigment Cell Melanoma Res. 2021 Sep;34(5):973-977. doi: 10.1111/pcmr.12960. Epub 2021 Feb 15.

name: Hospital de Clínicas de Porto Alegre Unidade de Pesquisa Clinica em Oncologia Porto Alegre Brazil

family: Azevedo

full_name: Sergio Jobim Azevedo

given: Sergio Jobim

name: Instituto Nacional de Câncer Rio de Janeiro Brazil

family: Melo

full_name: Andreia Cristina Melo

given: Andreia Cristina

name: Genentech/Roche South San Francisco CA USA

family: Roberts

full_name: Louise Roberts

given: Louise

family: Caro

full_name: Ivor Caro

given: Ivor

name: Hoffmann‐La Roche Limited Mississauga ON Canada

family: Xue

full_name: Cloris Xue

given: Cloris

name: Cenantron Centro Avançado de Tratamento Oncológico, Ltda. Belo Horizonte Brazil

family: Wainstein

full_name: Alberto Wainstein

given: Alberto

journal_name: Pigment Cell & Melanoma Research

title: First‐line atezolizumab monotherapy in patients with advanced BRAF V600 wild‐type melanoma

study_start_date_type: Actual

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Brazil
Netherlands
Germany
France
Poland
Greece
Hungary
Belgium
Australia
Russian Federation
Spain
United States
United Kingdom
Korea, Republic of

location_facility: City of Hope Comprehensive Cancer Center

location_facility: Thomas Jefferson University Hospital;Medical Oncology

location_facility: IFO - Istituto Regina Elena; Oncologia Medica

location_facility: Copernicus Podmiot Medyczny Sp. z o.o. Wojewodzkie Centrum Onkologii

location_facility: Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia

location_facility: Zentrum für Dermatoonkologie, Universitäts-Hautklinik Tübingen

location_facility: Orszagos Onkologiai Intezet; Borgyogyaszati Osztaly

location_facility: USC Norris Cancer Center; USC Oncology Hematology Newport Beach

location_facility: Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

location_facility: Massachusetts General Hospital;Hematology/ Oncology

location_facility: A.O. Universitaria Policlinico Di Modena; Ematologia

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

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Klinikum der Ludwigs-Maximilians-Universität München; Dermatologie

location_facility: Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu.

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: A.O.U. Cons. Policlinico Bari - Consorzlale Policlinico; Scienze Biomediche e Oncologia Umana

location_facility: Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie

location_facility: Western General Hospital; Edinburgh Cancer Center

location_facility: Hopital l Archet 2; Ginestriere, Service de; Dermatologie

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2

location_facility: Medizinische Hochschule Hannover; Klinik für Dermatologie, Allergologie und Venerologie

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Erasmus Mc - Daniel Den Hoed Kliniek; Interne Oncologie

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: University of Szeged Szent-Györgyi Albert Clinical Center; Department of Dermatology and Allergology

location_facility: Hospital Universitario Virgen Macarena; Servicio de Oncologia

location_facility: Metropolitan Hospital; Dept. of Oncology

location_facility: TriHealth Hatton Institute; Surgical Education

location_facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

location_facility: Clinica Universitaria de Navarra; Servicio de oncología

location_facility: IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A

location_facility: FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"

location_facility: Universitatsklinikum Essen; Klinik für Dermatologie

location_facility: Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico

location_facility: Guys & St Thomas Hospital; Department of Oncology

location_facility: Klinikum Mannheim Klinik fuer Dermatologie, Venerologie und Allergologie

location_facility: Hospital General Universitario de Valencia; Servicio de oncologia

location_facility: UF Health Cancer Center at Orlando Health

location_facility: HELIOS Klinikum Erfurt; Klinik für Dermatologie & Allergologie

location_facility: Azienda Osp Uni Seconda Università Degli Studi Di Napoli; Unità Operativa Oncologia Medica

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

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

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: University of Michigan; Michigan Institute for Clinical and Health Research (MICHR)

location_facility: IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica B

location_facility: Amphia Ziekenhuis, locatie Langendijk;Oncology

location_facility: Centre Eugene Marquis; Service d'oncologie

location_facility: Centre Hospitalier Le Mans; Dermatologie

location_facility: Hospital Clínic i Provincial; Servicio de Oncología

location_facility: Universitatsklinikum Mainz; Klinik und Poliklinik fur Dermatologie

location_facility: Leicester Royal Infirmary; Dept. of Medical Oncology

location_facility: SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie

location_facility: Antoni Van Leeuwenhoek Ziekenhuis; Inwendige Geneeskunde

location_facility: Hopital Charles Nicolle; Dermatologie Serv.

location_facility: Azienda Ospedaliero - Universitaria Pisana U.O. Oncologia Medica 2 Universitaria - Polo Oncologico

location_facility: COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej

location_facility: Hospital Universitario Son Espases; Servicio de Oncologia

location_facility: BRISTOL ONCOLOGY CENTRE; CLINICAL TRIALS UNIT; R & D department

location_facility: Groupe Hospitalier Bichat Claude Bernard

location_facility: Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych

location_facility: Hopital Saint Andre CHU De Bordeaux; Dermatologie

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Forsythe Memorial Hospital Inc., dba Novant Health Oncology Specialists

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: M.D Anderson Cancer Center; Uni of Texas At Houston

location_facility: Pecsi Tudomanyegyetem AOK; Borgyogyaszati Klinika

location_facility: UKSH Kiel; Klinik für Dermatologie, Venerologie und Allergologie

location_facility: University of California at Irvine Medical Center; Department of Oncology

location_facility: Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Dermatologie

location_facility: University Hospitals of North Midlands NHS Trust-Royal Stoke University Hospital

location_facility: Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica

location_facility: Dartmouth-Hitchcock Medical Center; Hematology/Oncology

location_facility: Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine

source: euctr

title: A Phase III, Open-Label, Multicenter, Two Arm, Randomized Study to Investigate the Efficacy and Safety of Cobimetinib Plus Atezolizumab Versus Pembrolizumab in Patients With Previously Untreated Advanced BRAF V600 Wild-Type Melanoma

summary: This is a Phase III, multicenter, open-label, randomized study designed to evaluate the efficacy, safety, and pharmacokinetics of cobimetinib plus atezolizumab compared with pembrolizumab in treatment-naive participants with advanced BRAFV600 wild-type melanoma.


title: A Phase 2, Open-Label, 2-Cohort, Multicenter Study of INCB050465, a PI3Kδ Inhibitor, in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a BTK Inhibitor (CITADEL-205)

summary: This is a Phase 2, open-label, 2-cohort study designed to evaluate the efficacy and safety of 2 parsaclisib treatment regimens in subjects with relapsed or refractory mantle cell lymphoma (MCL) previously treated either with or without a Bruton's tyrosine kinase (BTK) inhibitor.

status: Active, not recruiting

study_completion_date_type: Anticipated

ipd_sharing_description: Individual participant data (IPD) will be made available to interested researchers after the end of study, a thorough analysis, and the publication of the data in the clinical study report (CSR). As required, results of the data will be posted to ClinicalTrials.gov. Upon request, individual investigators may obtain IPD from the sponsor. The format for data delivery will be determined between sponsor and investigator.

lead_sponsor: Incyte Corporation

location_country:
Italy
Germany
France
Czechia
Poland
Israel
Belgium
Spain
Denmark
United States
United Kingdom

location_facility: Nu-Med Centrum Diagnostykii I Terapii Onkologicznej

location_facility: Universitaire Ziekenhuis Leuven - Gasthuisberg

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie

location_facility: University of Alabama At Birmingham Comprehensive Cancer Center

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Fundacion Jimenez Diaz University Hospital

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: University College London Hospitals (Uclh)

location_facility: Hospital Universitario Y Politecnic La Fe

location_facility: Hospices Civils de Lyon Centre Hospitalier Lyon Sud

location_facility: Fakultni Nemocnice Kralovske Vinohadry, Interni Hematologicka Klinika

location_facility: Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

location_facility: Fondazione Irccs Istituto Nazionale Dei Tumori

location_facility: Centre Hospitalier Departemental - La-Roche-Sur-Yon - Les Oudairies

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte

location_facility: Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza

location_facility: Hospital General Universitari Vall D Hebron

location_facility: Yakima Valley Memorial Hospital/North Star

location_facility: Beskidzkie Centrum Onkologii Im.Jana Pawla Ii

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Chu de Clermont - Ferrand- Hospital Estaing

location_facility: Chru Hopitaux de Tours, Hospital Bretonneau

location_facility: Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza

location_facility: Odense Universitetshospital (Ouh) (Odense University Hospital)

location_facility: Hadassah Hebrew University Medical Center Ein Karem Hadassah

status_simplified: Ongoing


title: A Multicenter, Double-blind, Randomized, Placebo-controlled, 3 Parallel Groups, Dose-ranging Trial Evaluating the Efficacy and Safety of Ucb 34714 Used as Adjunctive Treatment at Doses of 50 and 150 mg/Day in b.i.d. Administration (Oral Capsules of 25 mg) for a Maximum of 12 Weeks in Subjects From 16 to 65 Years With Refractory Epilepsy Suffering From Partial Onset Seizures Whether or Not Secondarily Generalized

summary: This trial will evaluate the efficacy and safety of brivaracetam (at doses of 50 and 150 mg/day in twice a day administration) as add on therapy in subjects with focal epilepsy

ReferenceCitation: Ben-Menachem E, Baulac M, Hong SB, Cleveland JM, Reichel C, Schulz AL, Wagener G, Brandt C. Safety, tolerability, and efficacy of brivaracetam as adjunctive therapy in patients with focal seizures, generalized onset seizures, or Unverricht-Lundborg disease: An open-label, long-term follow-up trial. Epilepsy Res. 2021 Feb;170:106526. doi: 10.1016/j.eplepsyres.2020.106526. Epub 2020 Dec 4.

family: Ben-Menachem

full_name: Elinor Ben-Menachem

given: Elinor

family: Baulac

full_name: Michel Baulac

given: Michel

family: Hong

full_name: Seung Bong Hong

given: Seung Bong

family: Cleveland

full_name: Jody M. Cleveland

given: Jody M.

family: Reichel

full_name: Christoph Reichel

given: Christoph

family: Schulz

full_name: Anne-Liv Schulz

given: Anne-Liv

family: Wagener

full_name: Gilbert Wagener

given: Gilbert

family: Brandt

full_name: Christian Brandt

given: Christian

journal_name: Epilepsy Research

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

host_type: repository

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repository_normalized: HAL

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

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Safety, tolerability, and efficacy of brivaracetam as adjunctive therapy in patients with focal seizures, generalized onset seizures, or Unverricht–Lundborg disease: An open-label, long-term follow-up trial

ReferenceCitation: Brandt C, Klein P, Badalamenti V, Gasalla T, Whitesides J. Safety and tolerability of adjunctive brivaracetam in epilepsy: In-depth pooled analysis. Epilepsy Behav. 2020 Feb;103(Pt A):106864. doi: 10.1016/j.yebeh.2019.106864. Epub 2020 Jan 12. Review.

family: Klein

full_name: Pavel Klein

given: Pavel

family: Badalamenti

full_name: Vincent Badalamenti

given: Vincent

family: Gasalla

full_name: Teresa Gasalla

given: Teresa

family: Whitesides

full_name: John Whitesides

given: John

journal_name: Epilepsy & Behavior

ReferenceCitation: Van Paesschen W, Hirsch E, Johnson M, Falter U, von Rosenstiel P. Efficacy and tolerability of adjunctive brivaracetam in adults with uncontrolled partial-onset seizures: a phase IIb, randomized, controlled trial. Epilepsia. 2013 Jan;54(1):89-97. doi: 10.1111/j.1528-1167.2012.03598.x. Epub 2012 Jul 19.

title: Efficacy and tolerability of adjunctive brivaracetam in adults with uncontrolled partial-onset seizures: A phase IIb, randomized, controlled trial

location_country:
United Kingdom
Netherlands
Finland
France
Poland
Belgium
Spain
Germany
Czech Republic


ReferenceCitation: Johnston SRD, Harbeck N, Hegg R, Toi M, Martin M, Shao ZM, Zhang QY, Martinez Rodriguez JL, Campone M, Hamilton E, Sohn J, Guarneri V, Okada M, Boyle F, Neven P, Cortés J, Huober J, Wardley A, Tolaney SM, Cicin I, Smith IC, Frenzel M, Headley D, Wei R, San Antonio B, Hulstijn M, Cox J, O'Shaughnessy J, Rastogi P; monarchE Committee Members and Investigators. Abemaciclib Combined With Endocrine Therapy for the Adjuvant Treatment of HR+, HER2-, Node-Positive, High-Risk, Early Breast Cancer (monarchE). J Clin Oncol. 2020 Dec 1;38(34):3987-3998. doi: 10.1200/JCO.20.02514. Epub 2020 Sep 20.

name: Royal Marsden NHS Foundation Trust, London, United Kingdom

family: Johnston

full_name: Stephen R. D. Johnston

given: Stephen R. D.

name: Department of Obstetrics and Gynecology, Breast Center, LMU University Hospital, Munich, Germany

family: Harbeck

full_name: Nadia Harbeck

given: Nadia

name: Clinica Pesquisas e Centro São Paulo, São Paulo, Brazil

family: Hegg

full_name: Roberto Hegg

given: Roberto

family: Toi

full_name: Masakazu Toi

given: Masakazu

name: Hospital General Universitario Gregorio Marañon, Universidad Complutense, Ciberonc, GEICAM, Madrid, Spain

family: Martin

full_name: Miguel Martin

given: Miguel

name: Fudan University Shanghai Cancer Center, Shanghai, China

family: Shao

full_name: Zhi Min Shao

given: Zhi Min

name: Harbin Medical University Cancer Hospital, Harbin, China

family: Zhang

full_name: Qing Yuan Zhang

given: Qing Yuan

name: Alivia Clinica de Alta Especialidad, Nuevo Leon, Mexico

family: Martinez Rodriguez

full_name: Jorge Luis Martinez Rodriguez

given: Jorge Luis

name: Institut de Cancérologie de l’Ouest Pays de la Loire, Saint Herblain-Angers, France

family: Campone

full_name: Mario Campone

given: Mario

name: Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN

family: Hamilton

full_name: Erika Hamilton

given: Erika

family: Sohn

full_name: Joohyuk Sohn

given: Joohyuk

name: Department of Surgery, Oncology, and Gastroenterology, University of Padova, Istituto Oncologico Veneto IOV IRCCS, Padova, Italy

family: Guarneri

full_name: Valentina Guarneri

given: Valentina

name: Hiroshima University Hospital, Hiroshima, Japan

family: Okada

full_name: Morihito Okada

given: Morihito

name: Mater Hospital Sydney, Patricia Ritchie Centre for Cancer Care and Research, North Sydney, New South Wales, Australia

family: Boyle

full_name: Frances Boyle

given: Frances

name: Universitaire Ziekenhuizen Leuven–Campus Gasthuisberg, Leuven, Belgium

family: Neven

full_name: Patrick Neven

given: Patrick

name: IOB Institute of Oncology, Quiron Group, Madrid, Barcelona, and Vall d'Hebron Institute of Oncology, Barcelona, Spain

family: Cortés

full_name: Javier Cortés

given: Javier

name: Breast Center, University of Ulm, Ulm, Germany

family: Huober

full_name: Jens Huober

given: Jens

name: NIHR Manchester Clinical Research Facility at The Christie, and Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology Medicine and Health, University of Manchester, Manchester, United Kingdom

family: Wardley

full_name: Andrew Wardley

given: Andrew

name: Dana-Farber Cancer Institute, Boston, MA

family: Tolaney

full_name: Sara M. Tolaney

given: Sara M.

name: Trakya University Faculty of Medicine, Edirne, Turkey

family: Cicin

full_name: Irfan Cicin

given: Irfan

name: Artios Pharma, Cambridge, United Kingdom

family: Smith

full_name: Ian C. Smith

given: Ian C.

family: Frenzel

full_name: Martin Frenzel

given: Martin

family: Headley

full_name: Desirée Headley

given: Desirée

family: Wei

full_name: Ran Wei

given: Ran

family: San Antonio

full_name: Belen San Antonio

given: Belen

name: Baylor University Medical Center, Texas Oncology, US Oncology, Dallas, TX

name: University of Pittsburgh, NSABP Foundation, Pittsburgh, PA

name: on behalf of the monarchE Committee Members and Investigators

publisher: American Society of Clinical Oncology (ASCO)

publisher_dissemination: American Society of Clinical Oncology (ASCO)

publisher_group: American Society of Clinical Oncology (ASCO)

publisher_normalized: American Society of Clinical Oncology (ASCO)

title: Abemaciclib Combined With Endocrine Therapy for the Adjuvant Treatment of HR+, HER2−, Node-Positive, High-Risk, Early Breast Cancer (monarchE)

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

location_country:
Finland
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Taiwan
Ukraine
India
France
Japan
Poland
Argentina
Canada
Korea, Republic of
South Africa
Sweden
Saudi Arabia
Hong Kong
Netherlands
Singapore
Hungary
Puerto Rico
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
New Zealand
Spain
Turkey

location_facility: CHU de Quebec-Hopital de Saint-Sacrement

location_facility: Communal Enterprise "Volyn Regional Medical Oncology Center"

location_facility: Instituto de Assistência Médica ao Servidor Público Estadual

location_facility: Poltava Regional Clinical Oncological Dispensary

location_facility: Severance Hospital Yonsei University Health System

location_facility: Spitalul Clinic Judetean de Urgenta Sf.Apostol Andrei Constanta

location_facility: University of Texas Southwestern Medical Center at Dallas

location_facility: Centro de Estudios y Prevencion del Cancer A.C.

location_facility: National Center for Global Health and Medicine

location_facility: General Hospital of Thessaloniki Papageorgiou

location_facility: Centrum Onkologii Ziemii Lubelskiej im. sw. Jana z Dukli

location_facility: Dnipropetrovsk City Multifunctional Clinical Hospital #4 of Dnipropetrovsk Regional Council

location_facility: KH Hietzing mit neurologischem Zentrum Rosenhügel

location_facility: Pamela Youde Nethersole Eastern Hospital

location_facility: GOU VPO St-Petersburg SMA n/a Mechnikov Fed. Agen of Health

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: National Hospital Organization Osaka National Hospital

location_facility: King Abdulaziz Medical City - National Guard Hospital

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: Oncology and Hematology Associates of Southwest Virginia Inc

location_facility: University Hospitals Case Medical Center

location_facility: St Marianna University School of Medicine Toyoko Hospital

location_facility: COI Centro Oncológico Internacional S.A.P.I de C.V.

location_facility: Joaquin Gabriel Reinoso Toledo (Consultorios de Medicina Especializada)

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

location_facility: Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan

location_facility: Clin. Pesq.e Centro Estudos Oncologia Ginecológica e Mamária

location_facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

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

location_facility: Cancer Specialists of North Florida -St Augustine

location_facility: Hospital de Base Fac de Medicina de Sao Jose do Rio Preto

location_facility: The Fifth Medical Center of PLA General Hospital

location_facility: Hospital Araujo Jorge da Assoc. Combate ao Cancer em Goias

location_facility: Yaroslavl region regional clinical oncology hospital

location_facility: Texas Oncology Cancer Care and Research Center

location_facility: Istituto Scientifico Romagnolo - Studio e la Cura dei Tumori

location_facility: Soonchunhyang University Hospital Cheonan

location_facility: Texas Oncology - Methodist Dallas Cancer Center

location_facility: St. Petersburg City Clinical Oncological Dispensary

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

location_facility: Instituto de Investigaciones Clinicas Mar del Plata

location_facility: Volgograd regional clinical oncology dispensary

location_facility: I.F.O. Istituto Nazionale Tumori Regina Elena

location_facility: Aarhus Universitetshospital, Aarhus Sygehus

location_facility: University of Southern Florida School of Medicine

location_facility: Instituto COI de Pesquisa Educação e Gestão

location_facility: Centre Hospitalier Universitaire de Sherbrooke - CHUS

location_facility: Commu Instit "Krivorizhskiy oncology dispensary" Dnip reg Co

location_facility: King Faisal Specialist Hospital & Research Center

location_facility: Kliniken Essen-Mitte Ev. Huyssens-Stiftung

location_facility: Hospital Clinico Universitario San Cecilio

location_facility: Ruby Hall Clinic and Grant Medical Foundation

location_facility: Mammazentrum Hamburg Brustklinik am Krankenhaus Jerusalem

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Instituto de Investigaciones Metabolicas

location_facility: New England Cancer Specialists - Scarborough

location_facility: Wake Forest University School of Medicine

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Ankara Gulhane Training ve Research Hospital

location_facility: Loma Linda University School of Medicine

location_facility: Centre Hospitalier de Vendee Les Oudairies

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

location_facility: Deenanth Mangeshkar Hospital and Research Centre

location_facility: Centre de Lutte Contre le Cancer Leon Berard

location_facility: Fujian Medical University Union Hospital

location_facility: WellSpan Health/York Cancer Center Oncology Research

location_facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center

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

location_facility: Evangelisches Krankenhaus Bethesda Mönchengladbach gGmbH

location_facility: Centro de Atención e Investigación Clínica en Oncología

location_facility: Hospital Quirón Salud Barcelona-Instituto Oncológico Baselga

location_facility: Hospital Clínico Universitario de Valencia

location_facility: St. Elisabeth Gruppe - Marien Hospital Witten

location_facility: Texas Oncology-El Paso Cancer Treatment Center

location_facility: Soc. Beneficente de Senhoras Hospital Sirio Libanes-Oncology

location_facility: Azienda Ospedaliera Universitaria Policlinico de Modena

location_facility: Euromedica - General Clinic of Thessaloniki

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Fundacion CENIT para la Investigacion en Neurociencias

location_facility: Centros de Investigaciones Cli-nicas. Clinica Viedma

location_facility: Centre Hospitalier Universitaire Sart Tilman

location_facility: California Cancer Associates Research and Excellence (cCARE)

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: Azienda Ospedaliero Universitaria di Ferrara

location_facility: Azienda Ospedaliero-Universitaria S.Giovanni Battista

location_facility: Saitama Medical University International Medical Center

location_facility: Dongnam Institute of Radiological and Medical Sciences

location_facility: Willamette Valley Cancer Institute & research Ctr.

location_facility: Instituto Português de Oncologia Dr. Francisco Gentil

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

location_facility: Principal Military Clinical Hospital n.a. N. N. Burdenko

location_facility: Gemeinschaftspraxis für Hämatologie und Onkologie

location_facility: Seoul National University Bundang Hospital

location_facility: Centro para la Atencion Integral del Paciente Oncologico

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: University of Texas Health Science Center - San Antonio

location_facility: Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.

location_facility: Harbin Medical University Cancer Hospital

location_facility: Taipei Medical University- Shuang Ho Hospital

location_facility: Miami Cancer Institute at Baptist Health, Inc.

location_facility: Fovarosi Onkormanyzat Uzsoki utcai Korhaz

location_facility: Gynäkologisch-onkologische Schwerpunktpraxis am Pelikanplatz

location_facility: Chelyabinsk Regional Oncology Dispensary

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Istanbul Medeniyet University Medical Faculty

location_facility: California Cancer Associates in Research and Excellence

location_facility: Hospital Universitario Nuestra Señora de Valme

location_facility: University General Hospital of Heraklion

location_facility: CIONC - Centro Integrado de Oncologia de Curitiba

location_facility: Orenburg Regional Clinical Oncology Dispensary

location_facility: University of California, Davis - Health Systems

location_facility: Texas Oncology - San Antonio Medical Center

location_facility: Unidad de Investigacion en Salud de Chihuahua S.C.

location_facility: Centro Hospitalar Lisboa Norte - Hospital de Santa Maria

location_facility: Centro de Oncologia e Investigacion Buenos Aires

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

location_facility: Semmelweis Egyetem III. sz Belgyogyaszati Klinika

location_facility: CRI Centro Regiomontano de Investigacion S.C.

location_facility: Centre de Cancérologie du Grand Montpellier

location_facility: Samara Regional Clinical Oncology Dispensary

location_facility: S.C. R.T.C. Radiology Therapeutic Center S.R.L.

location_facility: Texas Oncology-Deke Slayton Cancer Center

location_facility: The Hospital of Hyogo College of Medecine

location_facility: Hospital Civil De Guadalajara Fray Antonio Alcalde

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz

location_facility: Ibcc-Instituto Brasileiro de Controle Do Câncer

location_facility: Hospital Universitario Central de Asturias

location_facility: Istituto Tumori Fondazione G. Pascale IRCCS

location_facility: Sírio-Libanês Brasilia-Centro de Oncologia-Asa Sul

location_facility: Fovarosi Onkormanyzat Szent Margit Korhaza

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Medizinisches Versorgungszentrum Onkologischer Schwerpunkt am Oskar-Helene-Heim

location_facility: Kocaeli University Medical Faculty Hospital

location_facility: Azienda Ospedaliera Universitaria Ospedale San Martino di Genova

location_facility: Providence Cancer Center Oncology Hematology Care

location_facility: Hematology Oncology Associates of Fredericksburg Inc.

location_facility: Texas Oncology - Dallas Presbyterian Hospital

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

location_facility: Kyungpook National University Medical Center Chilgok Hospital

location_facility: MVZ Onkologie Barmbek - Asklepios Klinik Barmbek

location_facility: Centre Hospitalier de l'Universite de Montreal

location_facility: Ruijin Hospital Affiliated to Shanghai Jiao Tong University

location_facility: Chang Gung Memorial Hospital - Kaohsiung

location_facility: ASST Monza - Presidio Ospedaliero di Monza

location_facility: St-Petersburg scientifical practical cente spec medical care

location_facility: Columbus Community Clinical Oncology Program

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Instituto Médico Especializado Alexander Fleming

location_facility: Institutul Oncologic Dr Trestioreanu Bucuresti

location_facility: Brig Center For Cancer Care and Survivorship

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: Consultorio Centro Hemato Oncologico Privado

location_facility: Hacettepe University Faculty of Medicine

location_facility: Ordination Dr. Hubalek - Brustzentrum Schwaz

location_facility: Post Graduate Institute of Medical Education & Research

title: A Randomized, Open-Label, Phase 3 Study of Abemaciclib Combined With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone in Patients With High Risk, Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer

summary: The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.


ReferenceCitation: Miles D, Gligorov J, André F, Cameron D, Schneeweiss A, Barrios C, Xu B, Wardley A, Kaen D, Andrade L, Semiglazov V, Reinisch M, Patel S, Patre M, Morales L, Patel SL, Kaul M, Barata T, O'Shaughnessy J; IMpassion131 investigators. Primary results from IMpassion131, a double-blind, placebo-controlled, randomised phase III trial of first-line paclitaxel with or without atezolizumab for unresectable locally advanced/metastatic triple-negative breast cancer. Ann Oncol. 2021 Aug;32(8):994-1004. doi: 10.1016/j.annonc.2021.05.801. Epub 2021 Jul 1.

family: Miles

full_name: D. Miles

given: D.

family: Gligorov

full_name: J. Gligorov

given: J.

family: André

full_name: F. André

given: F.

family: Cameron

full_name: D. Cameron

family: Schneeweiss

full_name: A. Schneeweiss

given: A.

family: Barrios

full_name: C. Barrios

given: C.

family: Xu

full_name: B. Xu

given: B.

full_name: A. Wardley

family: Kaen

full_name: D. Kaen

family: Andrade

full_name: L. Andrade

given: L.

family: Semiglazov

full_name: V. Semiglazov

given: V.

family: Reinisch

full_name: M. Reinisch

given: M.

family: Patel

full_name: S. Patel

given: S.

family: Patre

full_name: M. Patre

family: Morales

full_name: L. Morales

full_name: S.L. Patel

family: Kaul

full_name: M. Kaul

family: Barata

full_name: T. Barata

given: T.

family: O’Shaughnessy

full_name: J. O’Shaughnessy

family: Zhang

full_name: Q. Zhang

given: Q.

family: Shao

full_name: Z. Shao

given: Z.

family: Wang

full_name: X. Wang

given: X.

family: Geng

full_name: C. Geng

family: Yan

full_name: X. Yan

location_country:
Greece
Romania
Russian Federation
India
Morocco
Croatia
France
Japan
Slovakia
Argentina
Canada
South Africa
Saudi Arabia
Vietnam
China
United States
Germany
United Kingdom
Italy
Brazil
Czechia
Israel
Spain
Turkey

location_facility: Dr. B L Kapur Memorial Hospital; BLK Cancer Centre

location_facility: Rambam Health Corporation; Oncology Institute

location_facility: Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum

location_facility: IRCCS Istituto Regina Elena (IFO); Oncologia Medica B

location_facility: Manipal Hospital; Department of Oncology

location_facility: Narodny Onkologicky Ustav; Oddelenie klinickej onkologie A

location_facility: IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia

location_facility: Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology

location_facility: Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)

location_facility: Hadassah Ein Karem Hospital; Oncology Dept

location_facility: Klinikum Ernst von Bergmann; Frauenklinik

location_facility: Presidio Ospedaliero S. Giovanni Di Dio; U.O. Di Oncologia

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Hospital Universitario de Fuenlabrada; Servicio de Oncologia

location_facility: Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)

location_facility: Prof. Dr. I. Chiricuta Institute of Oncology

location_facility: King Fahad Medical City; Gastroentrology

location_facility: Fondazione Università G. D'Annunzio; Clinical Research Center (CRC); Centro Studi (CESI)

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: IRCCS Istituto Clinico Humanitas; Oncologia

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg

location_facility: Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia

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

location_facility: Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont

location_facility: Clinique Sainte Catherine; Hopital De Semaine

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

location_facility: Hopital Saint Louis, Service D Oncologie Medicale

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Hospital Universitario Virgen Macarena; Servicio de Oncologia

location_facility: Azienda Ospedaliero - Universitaria di Modena Policlinico

location_facility: Centre Hospitalier Universitaire Mohamed VI; Oncologie-Hématologie

location_facility: Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt

location_facility: Florida Cancer Specialists; Department of Oncology

location_facility: Universita Campus Bio-Medico di Roma (UCBM)

location_facility: Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.

location_facility: St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe

location_facility: Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology

location_facility: Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology

location_facility: Hospital Araujo Jorge; Departamento de Ginecologia E Mama

location_facility: Izmir Ataturk Training and Research Hospital

location_facility: Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)

location_facility: ARETAIEION UNIVERSITY HOSPITAL; oncology unit

location_facility: Ospedale Civile; Unita Operativa Di Oncologia Medica

location_facility: Gemeinschaftspraxis für Hämatologie und Onkologie

location_facility: Fondazione Del Piemonte Per L'oncologia IRCC Di Candiolo

location_facility: Cancer Hospital Chinese Academy of Medical Sciences.

location_facility: Centro de Pesquisas Clinicas em Oncologia - CPCO

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: Dicle Uni Medical Faculty; Internal Medicine

location_facility: Centre Eugene Marquis; Service d'oncologie

location_facility: Adana Baskent University Medical Faculty; Oncology

location_facility: HOPA im Struensee-Haus, Dres. Erik Engel, Wiebke Hollburg

location_facility: Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika

location_facility: Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters

location_facility: First Affiliated Hospital of Medical College of Xi'an Jiaotong University

location_facility: Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde

location_facility: Harbin Medical University Cancer Hospital

location_facility: King Fahad Specialist Hospital; Oncology

location_facility: West China Hospital, Sichuan University; Department of Breast

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Fakultni nemocnice Ostrava; Klinika onkologicka FNO a LF OU

location_facility: Rabin MC; Davidof Center - Oncology Institute

location_facility: Kocaeli University Faculty of Medicine; Medical oncology

location_facility: Papageorgiou General Hospital; Medical Oncology

location_facility: The Second Affiliated Hospital of Xi'an Jiao Tong University

location_facility: Institut National D'oncologie Sidi Mohammed Ben Abdellah; Anatomopathologie

location_facility: Northwest Georgia Oncology Centers PC - Marietta

location_facility: Tennessee Oncology; Sarah Cannon Research Institute

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: IEO Istituto Europeo di Oncologia;Divisione Oncologia Medica

location_facility: Uludag University Medical Faculty; Internal Medicine

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

location_facility: Tata Memorial Hospital; Dept of Medical Oncology

location_facility: Guys and St Thomas NHS Foundation Trust, Guys Hospital

location_facility: Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Centre D'Oncologie de Gentilly; Oncology

location_facility: Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis

location_facility: Ch Pitie Salpetriere; Oncologie Medicale

location_facility: Max Super Speciality Hospital; Medical Oncology

title: A Phase III, Multicenter, Randomised, Double-Blind, Placebo-Controlled Study of Atezolizumab (Anti-Pd-L1 Antibody) in Combination With Paclitaxel Compared With Placebo With Paclitaxel for Patients With Previously Untreated Inoperable Locally Advanced or Metastatic Triple Negative Breast Cancer

summary: This Phase 3, multicenter, randomized, double-blind, placebo controlled study is designed to evaluate the efficacy and safety of atezolizumab (MPDL3280A, an anti-programmed death-ligand 1 [PD-L1] antibody) administered in combination with paclitaxel compared with placebo in combination with paclitaxel in participants with previously untreated, inoperable locally advanced or metastatic, centrally confirmed TNBC. Participants will be randomized in a 2:1 ratio to receive atezolizumab or placebo plus paclitaxel until disease progression or unacceptable toxicity or end of study, whichever occurs first (maximum up to approximately 40 months). In addition, the Sponsor may decide to terminate the study at any time.


title: A Phase III Randomized Open-label Multi-center Study of Ruxolitinib vs. Best Available Therapy in Patients With Corticosteroid-refractory Chronic Graft vs Host Disease After Allogeneic Stem Cell Transplantation (REACH3)

summary: The purpose of this study is to assess the efficacy of ruxolitinib against best available therapy in participants with steroid-refractory chronic graft-versus-host disease (SR cGvHD).

ReferenceCitation: Zeiser R, Polverelli N, Ram R, Hashmi SK, Chakraverty R, Middeke JM, Musso M, Giebel S, Uzay A, Langmuir P, Hollaender N, Gowda M, Stefanelli T, Lee SJ, Teshima T, Locatelli F; REACH3 Investigators. Ruxolitinib for Glucocorticoid-Refractory Chronic Graft-versus-Host Disease. N Engl J Med. 2021 Jul 15;385(3):228-238. doi: 10.1056/NEJMoa2033122.

name: From the Department of Medicine I, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg (R.Z.), and Medizinische Klinik und Poliklinik I, Universitätsklinikum Dresden, Dresden (J.M.M.) — both in Germany; the Unit of Blood Diseases and Stem Cell Transplantation, Department of Clinical and Experimental Sciences, ASST Spedali Civili di Brescia, University of Brescia, Brescia (N.P.), UOC di Oncoematologia e TMO, Dipartimento Oncologico “la Maddalena,” Palermo (M.M.), and Dipartimento di...

family: Zeiser

full_name: Robert Zeiser

given: Robert

family: Polverelli

full_name: Nicola Polverelli

given: Nicola

family: Ram

full_name: Ron Ram

given: Ron

family: Hashmi

full_name: Shahrukh K. Hashmi

given: Shahrukh K.

family: Chakraverty

full_name: Ronjon Chakraverty

given: Ronjon

family: Middeke

full_name: Jan Moritz Middeke

given: Jan Moritz

family: Musso

full_name: Maurizio Musso

given: Maurizio

family: Giebel

full_name: Sebastian Giebel

given: Sebastian

family: Uzay

full_name: Ant Uzay

given: Ant

family: Langmuir

full_name: Peter Langmuir

given: Peter

family: Hollaender

full_name: Norbert Hollaender

given: Norbert

family: Gowda

full_name: Maanasa Gowda

given: Maanasa

family: Stefanelli

full_name: Tommaso Stefanelli

given: Tommaso

family: Lee

full_name: Stephanie J. Lee

given: Stephanie J.

family: Teshima

full_name: Takanori Teshima

given: Takanori

family: Locatelli

full_name: Franco Locatelli

given: Franco

ReferenceCitation: Jagasia M, Zeiser R, Arbushites M, Delaite P, Gadbaw B, Bubnoff NV. Ruxolitinib for the treatment of patients with steroid-refractory GVHD: an introduction to the REACH trials. Immunotherapy. 2018 Apr;10(5):391-402. doi: 10.2217/imt-2017-0156. Epub 2018 Jan 10.

name: Vanderbilt-Ingram Cancer Center, 1301 Medical Center Dr #1710, Nashville, TN, USA 37232

family: Jagasia

full_name: Madan Jagasia

given: Madan

name: Department of Hematology, Oncology & Stem Cell Transplantation, University Hospital Freiburg, Hugstetter Str. 55, 79106 Freiburg im Breisgau, Germany

name: Incyte Corporation, 1801 Augustine Cut-off, Wilmington, DE, USA 19803

family: Arbushites

full_name: Michael Arbushites

given: Michael

family: Delaite

full_name: Patricia Delaite

given: Patricia

name: Novartis Pharmaceuticals Corporation, 1 Health Plaza, East Hanover, NJ, USA 07936

family: Gadbaw

location_country:
Jordan
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
India
France
Japan
Poland
Norway
Canada
Korea, Republic of
Sweden
Saudi Arabia
Switzerland
Netherlands
Bulgaria
Hungary
Puerto Rico
Portugal
Germany
United States
United Kingdom
Italy
Austria
Czechia
Israel
Spain
Turkey

location_facility:
Incyte Investigative Site
Novartis Investigative Site
Novartis Investigational Site


title: A Phase 3, Open-Label, Randomized Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer After Osimertinib Failure

summary: The purpose of this study is to assess the efficacy of lazertinib, amivantamab, carboplatin, and pemetrexed (LACP) compared with carboplatin and pemetrexed (CP), in participants with locally advanced or metastatic epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R substitution non-small cell lung cancer (NSCLC) after osimertinib failure.

status: Recruiting

enrollment_type: Anticipated

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

location_country:
Malaysia
Belgium
Russian Federation
Denmark
Taiwan
India
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Sweden
Hong Kong
Netherlands
Bulgaria
Puerto Rico
China
Portugal
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Czechia
Israel
Spain
Turkey

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: UPCO Unidade de Pesquisa Clinica em Oncologia

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

location_facility: Bhaktivedanta Hospital & Research Institute

location_facility: CINME - Centro de Investigaciones Metabolicas

location_facility: Beijing Chest hospital, Capital medical university

location_facility: The First Affiliated hospital of Anliui Medical University

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

location_facility: Nizhny Novgorod Regional Oncological Dispensary

location_facility: University of Mississippi Medical Center

location_facility: Grand Hôpital de Charleroi, site Notre Dame

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: ViDia Christliche Kliniken Karlsruhe/St. Vincentius-Kliniken

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

location_facility: Tianjin Medical University General Hospital

location_facility: Centro Hospitalar Universitario do Porto, EPE

location_facility: Fundação Antônio Prudente - A.C. Camargo Cancer Center

location_facility: The First People's Hospital Of Changzhou

location_facility: Daping Hospital Army Characteristic Medical Center

location_facility: N.N. Petrov Research Institute Of Oncology

location_facility: Cancer Care Specialists of Central Illinois

location_facility: Multifunctional Hospital for Active Treatment "Serdika"

location_facility: Taipei Medical University Shuang Ho Hospital

location_facility: Sun Yat-Sen Memorial Hospital Sun Yat-sen University

location_facility: CEMIC (Centro de Educación Médica e Investigaciones Clínicas)

location_facility: Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

location_facility: Private Specialist Hospitals - MedPolonia

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Harbin medical university cancer hospital

location_facility: Oncology Medical Clinics AV Medical group

location_facility: Pacific Health Research and Education Institute

location_facility: Multiprofile Hospital for Active Treatment 'Sveta Marina' EAD

location_facility: National Hospital Organization Shibukawa Medical Center

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

location_facility: Multiprofile Hospital for Active Treatment 'Tokuda Hospital Sofia'

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

location_facility: Cancer Hospital, Chinese Academy of Medical Sciences

location_facility: CHA Bundang Medical Center, CHA University

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

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

location_facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc w Olsztynie

location_facility: Specialized Hospital for Active Treatment in Oncology

location_facility: National Hospital Organization Iwakuni Clinical Center

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: Affiliated Hospital of North Sichuan Medical College

location_facility: Centro de Investigaciones Clinicas - CIC-IESR

location_facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

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

location_facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandow

location_facility: Seoul National University Bundang Hospital

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC

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

location_facility: IADT Instituto Argentino de Diagnostico y Tratamiento

location_facility: Pan American Center for Oncology Trials LLC

location_facility: Instituto D'Or de Pesquisa e Ensino (IDOR)

location_facility: CIMOVA, Morals Vargas Centro de Investigación SC

location_facility: Princess Margaret Cancer Centre University Health Network

location_facility: Azienda Ospedaliero-Universitaria Di Parma

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

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

location_facility: Pacific Shores Medical Group in Long Beach

location_facility: IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado

location_facility: Klinikum der Johann Wolfgang Goethe-Universität

location_facility: Thoraxklinik am Universitätsklinikum Heidelberg

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: CHU de Montpellier - Arnaud de Villeneuve

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Centrum Onkologii im. Prof. F. Lukaszczyka

location_facility: Kokilaben Dhirubhai Ambani Hosp. & Med. Research Inst

location_facility: Kobe City Medical Center General Hospital

location_facility: Barts Heart Centre, St. Bartholomew's Hospital

location_facility: Centro Hospitalar Lisboa Norte EPE - Hospital Pulido Valente

location_facility: National Hospital Organization Yamaguchi Ube Medical Center

location_facility: Rajiv Gandhi Cancer Institute and Research Centre

location_facility: University of Miami/Sylvester Cancer Center

location_facility: Krasnoyarsk Regional Oncology Dispensary

location_facility: Hospital Privado Universitario de Córdoba

location_facility: CIONC - Centro Integrado de Oncologia de Curitiba

location_facility: University of Tennessee Health Sciences Center

location_facility: Ruijin Hospital, Shanghai Jiao Tong University

location_facility: Fakultni nemocnice Olomouc - I.P.Pavlova 6

location_facility: Tambov Regional Oncology Clinical Dispansary

location_facility: BP - Beneficencia Portuguesa de São Paulo


title: A Phase 2, Open-Label, Multi-Center, Randomized Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Scheduled for Radical Cystectomy and Are Ineligible for or Refusing Platinum-Based Neoadjuvant Chemotherapy

summary: The purpose of this study is to evaluate the anti-tumor effects of TAR-200 in combination with cetrelimab and cetrelimab alone.

study_start_date_type: Anticipated

status: Not yet recruiting

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

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

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital

location_facility: Ospedale San Giuseppe Moscati di Avellino

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

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

location_facility: Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: University of California Irvine Medical Center

location_facility: Polyclinique de Limoges - Francois Chenieux

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: ASL Napoli 2 Nord-SM delle Grazie Hospital

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale


title: A Phase 3 Open-Label, Randomized Study of LOXO-305 Versus Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in BTK Inhibitor Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-321)

summary: This is a study for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) who have previously received treatment with at least a BTK inhibitor. The main purpose is to compare LOXO-305 to idelalisib plus rituximab or bendamustine plus rituximab. Participation could last up to four years, and possibly longer, if the disease does not progress.

lead_sponsor: Loxo Oncology, Inc.

location_country:
Italy
United States
France
Czechia
Japan
Australia
Spain
Canada
United Kingdom
Korea, Republic of

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

location_facility: The Center for Cancer and Blood Disorders

location_facility: Texas Oncology - San Antonio Medical Center

location_facility: Kobe City Medical Center General Hospital

location_facility: Oncology and Hematology Associates of Southwest Virginia Inc

location_facility: Texas Oncology - Dallas Presbyterian Hospital

location_facility: Oncology-Hematology Associates of West Broward

location_facility: Willamette Valley Cancer Institute and Research Center

location_facility: University of Kentucky Markey Cancer Center

location_facility: Chu Nimes/Institut De Cancerologie Du Gard

location_facility: Arizona Oncology Associates, P.C. - HOPE

location_facility: Pole Regionalde Cancérologie(CHU de Poitiers)

location_facility: Hospital Universitario Infanta Leonor-INTERNAL MED

location_facility: Cancer Center Office of Clinical Research

location_facility: Queen Elizabeth II Health Sciences Center

location_facility: Cancer Specialists of North Florida -St Augustine

location_facility: Mercy Health-Paducah Medical Oncology and Hematology

location_facility: Medical Oncology Hematology Consultants, PA