title: An Open-Label Randomized Phase III Trial of BMS-936558 (Nivolumab) Versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC)

summary: The purpose of the study is to compare the overall survival of BMS-936558 as compared with Docetaxel in subjects with squamous cell non-small cell lung cancer (NSCLC), after failure of prior platinum-based chemotherapy.

ReferenceCitation: Borghaei H, Gettinger S, Vokes EE, Chow LQM, Burgio MA, de Castro Carpeno J, Pluzanski A, Arrieta O, Frontera OA, Chiari R, Butts C, Wójcik-Tomaszewska J, Coudert B, Garassino MC, Ready N, Felip E, García MA, Waterhouse D, Domine M, Barlesi F, Antonia S, Wohlleber M, Gerber DE, Czyzewicz G, Spigel DR, Crino L, Eberhardt WEE, Li A, Marimuthu S, Brahmer J. Five-Year Outcomes From the Randomized, Phase III Trials CheckMate 017 and 057: Nivolumab Versus Docetaxel in Previously Treated Non-Small-Cell Lung Cancer. J Clin Oncol. 2021 Mar 1;39(7):723-733. doi: 10.1200/JCO.20.01605. Epub 2021 Jan 15. Erratum in: J Clin Oncol. 2021 Apr 1;39(10):1190.

name: Fox Chase Cancer Center, Philadelphia, PA

family: Borghaei

full_name: Hossein Borghaei

given: Hossein

name: Yale Comprehensive Cancer Center, New Haven, CT

family: Gettinger

full_name: Scott Gettinger

given: Scott

name: Univeristy of Chicago Medicine and Biologic Sciences Division, Chicago, IL

family: Vokes

full_name: Everett E. Vokes

given: Everett E.

name: University of Washington, Seattle Cancer Care Alliance, Seattle, WA

family: Chow

full_name: Laura Q. M. Chow

given: Laura Q. M.

name: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy

family: Burgio

full_name: Marco Angelo Burgio

given: Marco Angelo

name: Hospital De Madrid, Norte Sanchinarro, Madrid, Spain

family: de Castro Carpeno

full_name: Javier de Castro Carpeno

given: Javier

name: Maria Sklodowska-Curie Inst of Oncology, Warsaw, Poland

family: Pluzanski

full_name: Adam Pluzanski

given: Adam

name: Instituto Nacional De Cancerología, Mexico City, Mexico

family: Arrieta

full_name: Oscar Arrieta

given: Oscar

name: Centro de Investigación Clínica Bradford Hill and Centro Internacional de Estudios Clinicos, Santiago, Chile

family: Frontera

full_name: Osvaldo Arén Frontera

given: Osvaldo Arén

name: Ospedale S. Maria Della Misericordia, Perugia, Italy

family: Chiari

full_name: Rita Chiari

given: Rita

name: Cross Cancer Institute, Edmonton, AB, Canada

family: Butts

full_name: Charles Butts

given: Charles

name: Provincial Center of Oncology in Gdańsk, Gdańsk, Poland

family: Wójcik-Tomaszewska

full_name: Joanna Wójcik-Tomaszewska

given: Joanna

name: Centre Georges-François Leclerc, Dijon, France

family: Coudert

full_name: Bruno Coudert

given: Bruno

name: Instituto Nazionale per Lo Studio e La Cura, Milano, Italy

family: Garassino

full_name: Marina Chiara Garassino

given: Marina Chiara

family: Ready

full_name: Neal Ready

given: Neal

name: Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona, Spain

family: Felip

full_name: Enriqueta Felip

given: Enriqueta

name: Hospital Universitario Virgen Del Rocio, Sevilla, Spain

family: García

full_name: Miriam Alonso García

given: Miriam Alonso

name: Oncology Hematology Care, Inc, Cincinnati, OH

family: Waterhouse

full_name: David Waterhouse

given: David

name: Fundacion Jimenez Diaz, IIS-FJD Madrid, Spain

family: Domine

full_name: Manuel Domine

given: Manuel

name: Aix Marseille University, CNRS, INSERM, CRCM, APHM, Marseille, France

family: Barlesi

full_name: Fabrice Barlesi

given: Fabrice

family: Antonia

full_name: Scott Antonia

name: Robert Bosch Cancer Center, Gerlingen, Germany

family: Wohlleber

full_name: Markus Wohlleber

given: Markus

name: UT Southwestern Medical Center, Dallas, TX

family: Gerber

full_name: David E. Gerber

given: David E.

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

name: Universitaetsmedizin Essen und Ruhrlandklinik, Essen, Germany

name: Johns Hopkins Kimmel Cancer Center, Baltimore, MD

publisher: American Society of Clinical Oncology (ASCO)

title: Five-Year Outcomes From the Randomized, Phase III Trials CheckMate 017 and 057: Nivolumab Versus Docetaxel in Previously Treated Non–Small-Cell Lung Cancer

ReferenceCitation: Dercle L, Fronheiser M, Lu L, Du S, Hayes W, Leung DK, Roy A, Wilkerson J, Guo P, Fojo AT, Schwartz LH, Zhao B. Identification of Non-Small Cell Lung Cancer Sensitive to Systemic Cancer Therapies Using Radiomics. Clin Cancer Res. 2020 May 1;26(9):2151-2162. doi: 10.1158/1078-0432.CCR-19-2942. Epub 2020 Mar 20.

publisher: American Association for Cancer Research (AACR)

title: Identification of Non–Small Cell Lung Cancer Sensitive to Systemic Cancer Therapies Using Radiomics

ReferenceCitation: Long GV, Tykodi SS, Schneider JG, Garbe C, Gravis G, Rashford M, Agrawal S, Grigoryeva E, Bello A, Roy A, Rollin L, Zhao X. Assessment of nivolumab exposure and clinical safety of 480 mg every 4 weeks flat-dosing schedule in patients with cancer. Ann Oncol. 2018 Nov 1;29(11):2208-2213. doi: 10.1093/annonc/mdy408.

ReferenceCitation: Vokes EE, Ready N, Felip E, Horn L, Burgio MA, Antonia SJ, Arén Frontera O, Gettinger S, Holgado E, Spigel D, Waterhouse D, Domine M, Garassino M, Chow LQM, Blumenschein G Jr, Barlesi F, Coudert B, Gainor J, Arrieta O, Brahmer J, Butts C, Steins M, Geese WJ, Li A, Healey D, Crinò L. Nivolumab versus docetaxel in previously treated advanced non-small-cell lung cancer (CheckMate 017 and CheckMate 057): 3-year update and outcomes in patients with liver metastases. Ann Oncol. 2018 Apr 1;29(4):959-965. doi: 10.1093/annonc/mdy041.

ReferenceCitation: Horn L, Spigel DR, Vokes EE, Holgado E, Ready N, Steins M, Poddubskaya E, Borghaei H, Felip E, Paz-Ares L, Pluzanski A, Reckamp KL, Burgio MA, Kohlhäeufl M, Waterhouse D, Barlesi F, Antonia S, Arrieta O, Fayette J, Crinò L, Rizvi N, Reck M, Hellmann MD, Geese WJ, Li A, Blackwood-Chirchir A, Healey D, Brahmer J, Eberhardt WEE. Nivolumab Versus Docetaxel in Previously Treated Patients With Advanced Non-Small-Cell Lung Cancer: Two-Year Outcomes From Two Randomized, Open-Label, Phase III Trials (CheckMate 017 and CheckMate 057). J Clin Oncol. 2017 Dec 10;35(35):3924-3933. doi: 10.1200/JCO.2017.74.3062. Epub 2017 Oct 12.

name: Leora Horn, Vanderbilt-Ingram Cancer Center; David R. Spigel, Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN; Everett E. Vokes, University of Chicago, Chicago, IL; Esther Holgado, Hospital De Madrid, Norte Sanchinarro, Madrid; Enriqueta Felip, Hospital Universitari Vall d’Hebron, Barcelona; Luis Paz-Ares, Hospital Universitario Virgen Del Rocio, Seville, Spain; Neal Ready, Duke University Medical Center, Durham, NC; Martin Steins, Thoraxklinik-Heidelberg gGmbH, Heidelberg; Martin...

title: Nivolumab Versus Docetaxel in Previously Treated Patients With Advanced Non–Small-Cell Lung Cancer: Two-Year Outcomes From Two Randomized, Open-Label, Phase III Trials (CheckMate 017 and CheckMate 057)

ReferenceCitation: Brahmer J, Reckamp KL, Baas P, Crinò L, Eberhardt WE, Poddubskaya E, Antonia S, Pluzanski A, Vokes EE, Holgado E, Waterhouse D, Ready N, Gainor J, Arén Frontera O, Havel L, Steins M, Garassino MC, Aerts JG, Domine M, Paz-Ares L, Reck M, Baudelet C, Harbison CT, Lestini B, Spigel DR. Nivolumab versus Docetaxel in Advanced Squamous-Cell Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Jul 9;373(2):123-35. doi: 10.1056/NEJMoa1504627. Epub 2015 May 31.

title: Nivolumab versus Docetaxel in Advanced Squamous-Cell Non–Small-Cell Lung Cancer

location_country:
Italy
Austria
United States
Chile
Peru
Mexico
Netherlands
Germany
Spain
France
Czechia
Poland
Romania
Hungary
Argentina
Australia
Ireland
Russian Federation
Canada
United Kingdom

location_facility: University Of Texas Southwestern Medical Center

location_facility: CISSS du Bas-Saint-Laurent Hopital Regional de Rimouski

location_facility: U of Washington / Seattle Cancer Care Alliance

location_facility: The University Of Texas MD Anderson Cancer Center

location_facility: Chattanooga Oncology Hematology Associates


type: EudraCT Number

title: A Randomized, Double-blind, Placebo Controlled, Phase II/III Study of BKM120 Plus Paclitaxel in Patients With HER2 Negative Inoperable Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Pathway Activation.

summary: This study evaluated whether the addition of daily BKM120 to weekly paclitaxel was effective and safe in treating patients with HER2- locally advanced or metastatic breast cancer.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Novartis Pharmaceuticals

location_country:
Australia
Belgium
Russian Federation
Czech Republic
Taiwan
France
Japan
Canada
Korea, Republic of
South Africa
Hong Kong
Netherlands
Singapore
Hungary
Germany
United States
United Kingdom
Italy
Austria
Brazil
Israel
Spain

location_facility: Arizona Oncology Associates Dept of Oncology

location_facility: University of Oklahoma Health Sciences Center OUHSC 2

location_facility: University of Kansas Cancer Center Univ Kansas 2

location_facility: University of Texas Southwestern Medical Center Harry Hines

location_facility: Northwest Georgia Oncology Center NW Georgia Onc

location_facility: California Cancer Care Marian Speciality

location_facility: Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio

location_facility: Rocky Mountain Cancer Centers RMCC Hale Pkwy

location_facility: H. Lee Moffitt Cancer Center & Research Institute SC

location_facility: Medical Oncology & Hematology Associates of Northern VA Med Onc Hem Northern VA

location_facility: Baylor Health Care System/Sammons Cancer Center Baylor Texas Oncology

location_facility: Ohio State Comprehensive Cancer Center/James Cancer Hospital SC-1

location_facility: Emory University School of Medicine/Winship Cancer Institute Dept.of WinshipCancerInst. (2)

location_facility: Washington University School of Medicine Regulatory

location_facility: University of New Mexico Cancer Research Center Dept of Univ New Mexico

location_facility: Highlands Oncology Group Dept of Highlands Oncology Grp

location_facility: University of Nebraska Medical Center Unv Nebraska Med Ctr (2)

location_facility: Northwest Cancer Specialists Vancouver Loc

location_facility: New York Oncology Hematology, P.C. Dept. of New York Oncology. PC

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase 3, Multicenter, Randomized, Double-blind Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Subjects With Red Blood Cell Transfusion-dependent Anemia and Thrombocytopenia Due to IPSS Lower-risk Myelodysplastic Syndromes.

summary: Evaluation of the Efficacy and Safety of Oral Azacitidine plus Best Supportive care versus Placebo and Best Supportive care in subjects with red blood cell (RBC) transfusion-dependent anemia and thrombocytopenia due to International Prognostic Scoring System (IPSS) lower risk myelodysplastic syndromes (MDS).

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceType: background

ReferenceCitation: Garcia-Manero G, Almeida A, Giagounidis A, Platzbecker U, Garcia R, Voso MT, Larsen SR, Valcarcel D, Silverman LR, Skikne B, Santini V. Design and rationale of the QUAZAR Lower-Risk MDS (AZA-MDS-003) trial: a randomized phase 3 study of CC-486 (oral azacitidine) plus best supportive care vs placebo plus best supportive care in patients with IPSS lower-risk myelodysplastic syndromes and poor prognosis due to red blood cell transfusion-dependent anemia and thrombocytopenia. BMC Hematol. 2016 May 3;16:12. doi: 10.1186/s12878-016-0049-5. eCollection 2016.

ReferenceType: derived

ReferenceCitation: Garcia-Manero G, Santini V, Almeida A, Platzbecker U, Jonasova A, Silverman LR, Falantes J, Reda G, Buccisano F, Fenaux P, Buckstein R, Diez Campelo M, Larsen S, Valcarcel D, Vyas P, Giai V, Olíva EN, Shortt J, Niederwieser D, Mittelman M, Fianchi L, La Torre I, Zhong J, Laille E, Lopes de Menezes D, Skikne B, Beach CL, Giagounidis A. Phase III, Randomized, Placebo-Controlled Trial of CC-486 (Oral Azacitidine) in Patients With Lower-Risk Myelodysplastic Syndromes. J Clin Oncol. 2021 May 1;39(13):1426-1436. doi: 10.1200/JCO.20.02619. Epub 2021 Mar 25.

name: Department of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX

family: Garcia-Manero

full_name: Guillermo Garcia-Manero

given: Guillermo

sequence: first

name: MDS Unit, Hematology, AOU Careggi, University of Florence, Florence, Italy

family: Santini

full_name: Valeria Santini

given: Valeria

sequence: additional

name: Hospital da Luz Lisboa, Lisbon, Portugal

family: Almeida

full_name: Antonio Almeida

given: Antonio

name: Leipzig University Hospital, Leipzig, Germany

family: Platzbecker

full_name: Uwe Platzbecker

given: Uwe

name: Medical Department Hematology, Charles University General University Hospital, Prague, Czech Republic

family: Jonasova

full_name: Anna Jonasova

given: Anna

name: Icahn School of Medicine at Mount Sinai, New York, NY

family: Silverman

full_name: Lewis R. Silverman

given: Lewis R.

name: Hospital Universitario Virgen del Rocio, Seville, Spain

family: Falantes

full_name: Jose Falantes

given: Jose

name: Hematology Unit, Fondazione IRCCS Ca Granda, Ospedale Maggiore Policlinico, Milan, Italy

family: Reda

full_name: Gianluigi Reda

given: Gianluigi

name: Hematology, Fondazione PTV Policlinico Tor Vergata, Rome, Italy

family: Buccisano

full_name: Francesco Buccisano

given: Francesco

name: Hôpital St Louis, Assistance Publique—Hôpitaux de Paris, and Université de Paris, Paris, France

family: Fenaux

full_name: Pierre Fenaux

given: Pierre

name: Sunnybrook Health Sciences Centre, Toronto, Canada

family: Buckstein

full_name: Rena Buckstein

given: Rena

name: Hospital Universitario de Salamanca, Salamanca, Spain

family: Diez Campelo

full_name: Maria Diez Campelo

given: Maria

name: Royal Prince Alfred Hospital, Sydney, Australia

family: Larsen

full_name: Stephen Larsen

given: Stephen

name: Hospital Universitari Vall d’Hebron, Barcelona, Spain

family: Valcarcel

full_name: David Valcarcel

name: MRC Molecular Haematology Unit and Oxford Biomedical Research Centre, University of Oxford and Oxford University Hospitals, Oxford, United Kingdom

family: Vyas

full_name: Paresh Vyas

given: Paresh

name: Antonio e Biagio e Cesare Arrigo Hospital, Alessandria, Italy

family: Giai

full_name: Valentina Giai

given: Valentina

name: Grande Ospedale Metropolitano Bianchi Melacrino Morelli, Reggio Calabria, Italy

family: Olíva

full_name: Esther Natalie Olíva

given: Esther Natalie

name: Monash University and Monash Health, Melbourne, Australia

family: Shortt

full_name: Jake Shortt

given: Jake

family: Niederwieser

full_name: Dietger Niederwieser

given: Dietger

name: Tel Aviv Sourasky Medical Center, Tel Aviv, Israel

name: Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel

family: Mittelman

full_name: Moshe Mittelman

given: Moshe

name: Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome, Italy

family: Fianchi

full_name: Luana Fianchi

given: Luana

name: Celgene, a Bristol-Myers Squibb Company, Boudry, Switzerland

family: La Torre

full_name: Ignazia La Torre

given: Ignazia

name: Bristol Myers Squibb, Princeton, New Jersey

family: Zhong

full_name: Jianhua Zhong

name: University of Kansas Medical Center, Kansas City, KS

name: Marienhospital Düsseldorf, Düsseldorf, Germany

publisher_dissemination: American Society of Clinical Oncology (ASCO)

publisher_group: American Society of Clinical Oncology (ASCO)

publisher_normalized: American Society of Clinical Oncology (ASCO)

location_country:
Finland
Greece
Belgium
Australia
Denmark
France
Poland
Norway
Canada
Korea, Republic of
Sweden
Netherlands
Portugal
United States
Germany
United Kingdom
Italy
Brazil
Mexico
Czechia
Israel
Spain
Turkey

location_facility: Hematology and Oncology Specialists, LLC

location_facility: University of Florida Health Cancer Center at Orlando Health

location_facility: IRCCS - Istituo Clinico Humanitas - Humanitas Cancer Center

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: Royal Prince Alfred Hospital, Sydney Cancer Centre

location_facility: ULSBA (Unidade Local de Saúde do Baixo Alentejo, EPE) - Hospital de Beja

location_facility: Universitatsklinkikum DusseldorfKlinik fur Hamatologie, Onkologie und klin. Immunoligie

location_facility: Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi

location_facility: Oslo University Hospital, Rikshospitalet HF

location_facility: McGill University, Dept. Oncology Clinical Research Program

location_facility: University of Alberta Hospital Adult Hematology Research

location_facility: Nottingham City Hospital - Dept of Haematology

location_facility: University of Louisville, J.G. Brown Cancer Center

location_facility: Brooke Army Medical Center Francis Street Medical Center

location_facility: Hospital Angeles Lomas - Consultorio 830

location_facility: Icahn School of Medicine at Mount Sinai Medical Center

location_facility: Phoebe Cancer Center of Phoebe Putney Memorial Hospital

location_facility: SU/Sahlgrenska, Section of Haematology and Coagulation

location_facility: Hospital Txagorritxu - Hospital Universitario de Álava

location_facility: Severance Hospital, Yonsei University Health System

location_facility: California Cancer Associates for Research and Excellence cCARE

location_facility: AUSL LE1 - Vito Fazzii Hospital Medical Oncology Department

location_facility: Hospital Albert Einstein Sociedade Beneficente Israelita Brasileira

location_facility: U.O. Ematologia. Ospedale Oncologico di Riferimento Regionale Armando Businco

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello

location_facility: Baskent University Medical Faculty Adana Practice and Research Center

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: University Hospitals of Cleveland Case Medical Center

location_facility: Seoul St Marys Hospital College of Medicine The Catholic University of Korea

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

location_facility: Az. Osp. SS.Antonio e Biagio - SC Ematologia

location_facility: VA Commonwealth University Massey Cancer Center

location_facility: University of Southern California Norris Cancer Center

location_facility: Complejo Hospitalario Universitario de Granada

location_facility: Tower Hematology/Oncology Medical Group and Tower Cancer Research Found

location_facility: Queens Centre for Oncology & Haematology

location_facility: Instituto Portugues de Oncologia do Porto

location_facility: Robert H Lurie Comprehensive Cancer Center NW Univ

location_facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

location_facility: IRCCS Centro di Riferimento Oncologico di Basilicata

location_facility: Kaiser Permanente Northwest Oncology Hematology

location_facility: Haematoloy and Oncology Clinics of Australia

location_facility: MD Anderson Cancer Center The University of Texas

location_facility: Kansas City VA Medical Center University of Kansas Medical Center

location_facility: Attikon General University Hospital of Athens

location_facility: Azienda Ospedaliera San Giovanni Battista

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

location_facility: Centro Hospitalar de Lisboa Central - Hospital de Santo António dos Capuchos

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Hospital Universitario "Dr. Jose E. Gonzalez"

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi

location_facility: Princess Margaret Hospital University Health Network

location_facility: CHRU de Lille-Hopital Claude Huriez Service des Maladies du Sang

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Szpital Uniwersytecki nr 2 im dr. Jana Biziela

location_facility: Royal Liverpool University Hospital, Prescot Street

location_facility: Specjalistyczny Szpital Miejski im. M. Kopernika w Toruniu

location_facility: Opsedale Maggiore Policlinico and University

location_facility: Instytut Hematologii i Transfuzjologii, Klinika Hematologii

location_facility: Instituto Portugues de Oncologia de Lisboa

location_facility: University General Hospital of Heraklion

location_facility: Uniwersytet Jagiellonski Collegium Medicum

location_facility: Karolinska Universitetssjukhuset - Huddinge

location_facility: Institute Paoli-Calmettes Service Haematology


title: AN OPEN-LABEL, RANDOMIZED PHASE 3 STUDY OF INOTUZUMAB OZOGAMICIN COMPARED TO A DEFINED INVESTIGATOR'S CHOICE IN ADULT PATIENTS WITH RELAPSED OR REFRACTORY CD22-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (ALL)

summary: This study will compare the efficacy, in terms of complete responses and overall survival, of inotuzumab ozogamicin versus investigator's choice of chemotherapy.

ReferenceCitation: Kantarjian HM, Stock W, Cassaday RD, DeAngelo DJ, Jabbour E, O'Brien SM, Stelljes M, Wang T, Paccagnella ML, Nguyen K, Sleight B, Vandendries E, Neuhof A, Laird AD, Advani AS. Inotuzumab Ozogamicin for Relapsed/Refractory Acute Lymphoblastic Leukemia in the INO-VATE Trial: CD22 Pharmacodynamics, Efficacy, and Safety by Baseline CD22. Clin Cancer Res. 2021 May 15;27(10):2742-2754. doi: 10.1158/1078-0432.CCR-20-2399. Epub 2021 Feb 18.

family: Kantarjian

full_name: Hagop M. Kantarjian

given: Hagop M.

family: Stock

full_name: Wendy Stock

given: Wendy

family: Cassaday

full_name: Ryan D. Cassaday

given: Ryan D.

family: DeAngelo

full_name: Daniel J. DeAngelo

given: Daniel J.

family: Jabbour

full_name: Elias Jabbour

given: Elias

family: O'Brien

full_name: Susan M. O'Brien

given: Susan M.

family: Stelljes

full_name: Matthias Stelljes

given: Matthias

family: Wang

full_name: Tao Wang

given: Tao

family: Paccagnella

full_name: M. Luisa Paccagnella

given: M. Luisa

family: Nguyen

full_name: Kevin Nguyen

given: Kevin

family: Sleight

full_name: Barbara Sleight

given: Barbara

family: Vandendries

full_name: Erik Vandendries

given: Erik

family: Neuhof

full_name: Alexander Neuhof

given: Alexander

family: Laird

full_name: A. Douglas Laird

given: A. Douglas

family: Advani

full_name: Anjali S. Advani

given: Anjali S.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Clinical Cancer Research

publisher_dissemination: American Association for Cancer Research

publisher_group: American Association for Cancer Research

publisher_normalized: American Association for Cancer Research

ReferenceCitation: Stock W, Martinelli G, Stelljes M, DeAngelo DJ, Gökbuget N, Advani AS, O'Brien S, Liedtke M, Merchant AA, Cassaday RD, Wang T, Zhang H, Vandendries E, Jabbour E, Marks DI, Kantarjian HM. Efficacy of inotuzumab ozogamicin in patients with Philadelphia chromosome-positive relapsed/refractory acute lymphoblastic leukemia. Cancer. 2021 Mar 15;127(6):905-913. doi: 10.1002/cncr.33321. Epub 2020 Nov 24.

name: Section of Hematology/Oncology Department of Medicine, and University of Chicago Comprehensive Cancer Center University of Chicago Chicago Illinois

name: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRCCS Meldola Italy

family: Martinelli

full_name: Giovanni Martinelli

given: Giovanni

name: Universitätsklinikum Münster Münster Germany

name: Dana‐Farber Cancer Institute Boston Massachusetts

family: Gökbuget

full_name: Nicola Gökbuget

given: Nicola

name: Cleveland Clinic Taussig Cancer Institute Cleveland Ohio

name: Chao Family Comprehensive Cancer Center University of California Irvine Orange California

family: O’Brien

name: Stanford Cancer Institute Stanford California

name: Cedars Sinai Medical Center Los Angeles California

name: University of Washington School of Medicine and Fred Hutchinson Cancer Research Center Seattle Washington

title: Efficacy of inotuzumab ozogamicin in patients with Philadelphia chromosome–positive relapsed/refractory acute lymphoblastic leukemia

ReferenceCitation: DeAngelo DJ, Advani AS, Marks DI, Stelljes M, Liedtke M, Stock W, Gökbuget N, Jabbour E, Merchant A, Wang T, Vandendries E, Neuhof A, Kantarjian H, O'Brien S. Inotuzumab ozogamicin for relapsed/refractory acute lymphoblastic leukemia: outcomes by disease burden. Blood Cancer J. 2020 Aug 7;10(8):81. doi: 10.1038/s41408-020-00345-8.

ReferenceCitation: Jabbour E, Gökbuget N, Advani A, Stelljes M, Stock W, Liedtke M, Martinelli G, O'Brien S, Wang T, Laird AD, Vandendries E, Neuhof A, Nguyen K, Dakappagari N, DeAngelo DJ, Kantarjian H. Impact of minimal residual disease status in patients with relapsed/refractory acute lymphoblastic leukemia treated with inotuzumab ozogamicin in the phase III INO-VATE trial. Leuk Res. 2020 Jan;88:106283. doi: 10.1016/j.leukres.2019.106283. Epub 2019 Nov 25.

ReferenceCitation: Fujishima N, Uchida T, Onishi Y, Jung CW, Goh YT, Ando K, Wang MC, Ono C, Matsumizu M, Paccagnella ML, Sleight B, Vandendries E, Fujii Y, Hino M. Inotuzumab ozogamicin versus standard of care in Asian patients with relapsed/refractory acute lymphoblastic leukemia. Int J Hematol. 2019 Dec;110(6):709-722. doi: 10.1007/s12185-019-02749-0. Epub 2019 Nov 13.

ReferenceCitation: Kantarjian HM, DeAngelo DJ, Stelljes M, Liedtke M, Stock W, Gökbuget N, O'Brien SM, Jabbour E, Wang T, Liang White J, Sleight B, Vandendries E, Advani AS. Inotuzumab ozogamicin versus standard of care in relapsed or refractory acute lymphoblastic leukemia: Final report and long-term survival follow-up from the randomized, phase 3 INO-VATE study. Cancer. 2019 Jul 15;125(14):2474-2487. doi: 10.1002/cncr.32116. Epub 2019 Mar 28.

name: The University of Texas MD Anderson Cancer Center Houston Texas

name: University Hospital Münster Münster Germany

name: Irvine Medical Center University of California Orange California

name: Taussig Cancer Institute, Cleveland Clinic Cleveland Ohio

title: Inotuzumab ozogamicin versus standard of care in relapsed or refractory acute lymphoblastic leukemia: Final report and long‐term survival follow‐up from the randomized, phase 3 INO‐VATE study

ReferenceCitation: Jabbour EJ, DeAngelo DJ, Stelljes M, Stock W, Liedtke M, Gökbuget N, O'Brien S, Wang T, Paccagnella ML, Sleight B, Vandendries E, Advani AS, Kantarjian HM. Efficacy and safety analysis by age cohort of inotuzumab ozogamicin in patients with relapsed or refractory acute lymphoblastic leukemia enrolled in INO-VATE. Cancer. 2018 Apr 15;124(8):1722-1732. doi: 10.1002/cncr.31249. Epub 2018 Jan 30.

name: Department of Leukemia; The University of Texas MD Anderson Cancer Center; Houston Texas

name: Department of Medical Oncology/Hematologic Malignancies; Dana-Farber Cancer Institute; Boston Massachusetts

name: Department of Internal Medicine; University of Münster; Münster Germany

name: Department of Hematology/Oncology; University of Chicago; Chicago Illinois

name: Divisions of Hematology and Oncology; Stanford Cancer Institute; Stanford California

name: Department of Medicine; Goethe University; Frankfurt Germany

name: Division of Hematology/Oncology; University of California Irvine; Orange California

ReferenceCitation: Kebriaei P, Cutler C, de Lima M, Giralt S, Lee SJ, Marks D, Merchant A, Stock W, van Besien K, Stelljes M. Management of important adverse events associated with inotuzumab ozogamicin: expert panel review. Bone Marrow Transplant. 2018 Apr;53(4):449-456. doi: 10.1038/s41409-017-0019-y. Epub 2018 Jan 12.

ReferenceCitation: Kantarjian HM, DeAngelo DJ, Advani AS, Stelljes M, Kebriaei P, Cassaday RD, Merchant AA, Fujishima N, Uchida T, Calbacho M, Ejduk AA, O'Brien SM, Jabbour EJ, Zhang H, Sleight BJ, Vandendries ER, Marks DI. Hepatic adverse event profile of inotuzumab ozogamicin in adult patients with relapsed or refractory acute lymphoblastic leukaemia: results from the open-label, randomised, phase 3 INO-VATE study. Lancet Haematol. 2017 Aug;4(8):e387-e398. doi: 10.1016/S2352-3026(17)30103-5. Epub 2017 Jul 4.

ReferenceCitation: Kantarjian HM, DeAngelo DJ, Stelljes M, Martinelli G, Liedtke M, Stock W, Gökbuget N, O'Brien S, Wang K, Wang T, Paccagnella ML, Sleight B, Vandendries E, Advani AS. Inotuzumab Ozogamicin versus Standard Therapy for Acute Lymphoblastic Leukemia. N Engl J Med. 2016 Aug 25;375(8):740-53. doi: 10.1056/NEJMoa1509277. Epub 2016 Jun 12.

repository_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

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

location_country:
Italy
United States
Sweden
Netherlands
Spain
Germany
Finland
France
Czechia
Japan
Poland
Singapore
Hungary
Argentina
Australia
China
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: Oddzial Hematologii, Klinika Hematologii, Regionalny Osrodek Onkologiczny Wojewodzki Szpital

location_facility: Freidenrich Center for Translational Research (CTRU), Stanford University

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: UT Southwestern University Hospital- Zale Lipshy

location_facility: Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku

location_facility: U.O. di Ematologia Dip. Medicine Specialistiche A.O.U. Arcispedale Sant'Anna

location_facility: Penn State Milton S. Hershey Medical Center,

location_facility: Children's Center for Cancer and Blood Diseases, Childrens Hospital Los Angeles

location_facility: Interni Hematologicka a Onkologicka Klinika

location_facility: University of Colorado Hospital, Cancer Center Infusion Center

location_facility: University of New Mexico Comprehensive Cancer Center

location_facility: National University Hospital/National University Cancer Institute Singapore (NCIS)

location_facility: University of Iowa Hospitals and Clinics

location_facility: USC/Norris Comprehensive Cancer Center / Investigational Drug Services

location_facility: IDS-investigational drug pharmacy Penn State Milton S. Hershey Medical Center

location_facility: Eastern Clinical Research Unit, Box Hill Hospital

location_facility: Universitätsklinikum Köln, Klinik I für Innere Medizin

location_facility: Hospital General Universitario Jose Maria Morales Meseguer

location_facility: UCLA Drug Information/Investigation Drug

location_facility: Hospital de la Santa Creu i Sant Pau(Nuevo Hospital)

location_facility: Hospital Clinico Universitario de Valencia

location_facility: CHU de Dijon-Hopital d'Enfants-Service d'hematologie Clinique

location_facility: University of Texas Southwestern Universtiy Hospital - William P Clements Jr.

location_facility: Georgia Regents Medical Center Pharmacy, Georgia Regents University Cancer Center

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: UT Southwestern Medical Center at Dallas

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Azienda Ospedaliera Brotzu CTMO P.O. Businco

location_facility: Chonnam National University, Hwasun Hospital

location_facility: Karmanos Cancer Institute Weisberg Cancer Treatment Center

location_facility: The Hospital of Hyogo College of Medicine

location_facility: Stanford University Hospital and Clinics

location_facility: MD Anderson Cancer Center Orlando - 5th Floor Investigational Pharmacy

location_facility: Winship Cancer Institute, Emory University

location_facility: Investigational Drug Services - UC San Diego Moores Cancer Center

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: University of Chicago Medical Center, Dept. of Pharmacy

location_facility: Yale-New Haven Hospital & Smilow Cancer Center

location_facility: Zentralapotheke des Universitaetsklinikums Muenster

location_facility: New York Presbyterian Hospital-Weill Cornell Medical College

location_facility: Martha Hamilton, Investigational Drug Services, Dept of Pharmacy

location_facility: UNC Hospitals - The University of North Carolina at Chapel Hill

location_facility: Egyesitett Szent Istvan és Szent Laszlo Korhaz-Rendelointezet;

location_facility: Blood and Marrow Transplant Group of Georgia

location_facility: C.H.U. de Grenoble, Hopital Albert Michallon

location_facility: Division of Hematology/Oncology, Stony Brook University Hospital

location_facility: Chang Gung Medical Foundation, Kaohsiung Branch

location_facility: Stony Brook University Medical Center, The Cancer Center

location_facility: West Virginia University Hospitals Pharmaceutical Services

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: U.O. Ematologia, Ospedale S. Maria delle Croci

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

location_facility: Northwestern Medicine Developmental Therapeutics Institute

location_facility: Investigational Drug Service, Emory University Clinic

location_facility: Nottingham University Hospitals NHS Trust

location_facility: A.O.U. Vittorio Emanuele di Catania-Ospedale Ferrarotto

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

location_facility: Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum II. Belgyogyaszati Klinika

location_facility: The Sidney Kimmel Comprehensive Cancer Center


type: Other Identifier

title: POST-AUTHORISATION SAFETY COHORT OBSERVATION OF RETACRIT (EPOETIN ZETA) ADMINISTERED SUBCUTANEOUSLY FOR THE TREATMENT OF RENAL ANAEMIA (PASCO II)

acronym: PASCO II

summary: The purpose of this study is to estimate the incidence of Pure Red Cell Aplasia (PRCA), neutralising antibodies, lack of efficacy, and thromboembolic events under treatment with Retacrit™ (epoetin zeta) administered subcutaneously in patients with renal anaemia. The other key objective of this study is to obtain information on adverse drug reactions (ADR) associated with Retacrit™ (epoetin zeta), use of epoetin zeta during pregnancy and lactation and data on long term use.

study_type: Observational

time_perspective: Prospective

ipd_sharing: No

lead_sponsor: Pfizer

location_country:
Italy
Sweden
Finland
Croatia
Bulgaria
France
Greece
Ireland
Spain
Denmark
Germany
United Kingdom

location_facility: Praxisklinik-Dialysezentrum Herne DOKUSAN Gesellschaft für medizinische Studien mbH & Co. KG

location_facility: Department of Renal Medicine Medicinerhuset 3 sal Aalborg University Hospital

location_facility: Dutchmed Dialysis Clinic (in the building of 5 DCC)

location_facility: Fondazione S. Maugeri - IRCCS Clinica del Lavoro e della Riabilitazione,

location_facility: Azienda Ospedaliera di Rilievo Nazionale "Antonio Cardarelli" - U.O. S. C. Nefrologia ed Emodialisi

location_facility: Dipartimento di Nefrologia Ospedale Versilia-Viareggio (Lucca)

location_facility: Nephrologisches- und Dialysezentrum Niebüll

location_facility: Office of Eleni Stefanopoulou/Private Physician

location_facility: 35 Nephrologie Centre Medico Chirurgical de l'Europe

location_facility: OSPEDALE MAGGIORE DI CHIERI - ASL TO 5 - S.C. Nefrologia e Dialisi

location_facility: Dipartimento di Nefrologia- Ospedale Mazzoni

location_facility: Medizinisches Versorgungszentrum MVZ Diaverum Kleve GmbH

location_facility: Acibadem City Clinic Tokuda Hospital EAD MHAT "Tokuda Hospital Sofia"

location_facility: Polyclinique de la Louvière, Service Hemodialyse Nephrologie CHSA Maubeuge

location_facility: General Hospital of Komotini Sismanogleio

location_facility: A.O.U. San Giovanni Battista di Torino - S.C. di Nefrologia, Dialisi e Trapianto

location_facility: U.O.C. Nefrologia e Dialisi Azienda Ospedaliera

location_facility: Städtisches Klinikum Solingen Abt. Nephrologie - Innere Medizin

location_facility: Div. of Nephrology, Helsinki University HospitalHUS Kirurginen sairaala

location_facility: CHU Amiens-Picardie Site Sud,, service de Nefrologie

location_facility: Hospital Universitario Central de Asturias

location_facility: UO Nefrologia, trapianti e dialisi SSN EDIFICIO 30A Azienda Ospedaliera Universitaria Pisa

location_facility: ASL SA 1 P.O. Umberto I - U.O.C. di NEFROLOGIA E DIALISI

location_facility: Ospedale SANTA MARIA DELLA PIETA - U.O.C. di NEFROLOGIA E DIALISI

location_facility: U.O.C. Nefrologia, Dialisi e Trapianto - Azienda Ospedaliera Universitaria Senese

location_facility: Njurmedicinska kliniken, Danderyds sjukhus

location_facility: Hospital Gabriel Montpied, Centre de Dialyse

location_facility: Dipartimento di Medicina -DIMED- Policlinico Padova

location_facility: Universita degli Studi di Napoli Federico II - Dipartimento di Patologia Sistematica

location_facility: ze:ro Dialysezentren und Gemeinschaftspraxis

location_facility: Presidio Ospedaliero S. GIUSEPPE e MELORIO AUSL CE/2 S. - U.O. Nefrologia e Dialisi

location_facility: Märkische Kliniken GmbH Klinikum Lüdenscheid

location_facility: University General Hospital of Alexandroupoli

location_facility: U.O.C. Nefrologia e Dialisi - Ospedale "Del Ceppo"

location_facility: U.O.C. Nefrologia e Dialisi Ospedale degli Infermi-S.Miniato-USL 11 Empoli

location_facility: "Presidio Ospedaliero" di Soverato - Servizio Dialisi

location_facility: Policlinico S. Marco di Istituti Ospedalieri Bergamaschi, U.O. Nefrologia e Dialisi

location_facility: Deutsche Klinik fuer Diagnostik Department of Nephrology

location_facility: Centro Dialisi Nefrologia - Ospedale S. Donato Arezzo

location_facility: Gemeinschaftspraxis Dr. Gööck & Dr. Anger

location_facility: Ospedale Niguarda Cà Granda - U.O. Nefrologia e Dialisi e Terapia Medica del Trapianto Renale

location_facility: Hopital de Rangueil, service de nephrologie

location_facility: Gemeinschaftspraxis Schuerfeld Moeller Henrich

location_facility: Presidio ospesdaliero G.CRISCUOLI - UO DIALISI

location_facility: Ospedali Riuniti Anzio-Nettuno, Nefrologia e Dialisi ASL RMH

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

location_facility: Nephrologische Gemeinschaftspraxis und Dialysezentrum

location_facility: A.O. MONALDI- Dept nephrology and Dialysis

location_facility: Ospedale Martini - S.C. Nefrologia E Dialisi

location_facility: U.O. Nefrologia e Dialisi, Azienda Ospedaliero-Universitaria Ospedali Riuniti

location_facility: Ospedale San Giovanni Bosco - Struttura Complessa Nefrologia e Dialisi


ReferenceCitation: Rimawi M, Ferrero JM, de la Haba-Rodriguez J, Poole C, De Placido S, Osborne CK, Hegg R, Easton V, Wohlfarth C, Arpino G; PERTAIN Study Group. First-Line Trastuzumab Plus an Aromatase Inhibitor, With or Without Pertuzumab, in Human Epidermal Growth Factor Receptor 2-Positive and Hormone Receptor-Positive Metastatic or Locally Advanced Breast Cancer (PERTAIN): A Randomized, Open-Label Phase II Trial. J Clin Oncol. 2018 Oct 1;36(28):2826-2835. doi: 10.1200/JCO.2017.76.7863. Epub 2018 Aug 14.

name: Mothaffar Rimawi and C. Kent Osborne, Baylor College of Medicine, Houston, TX; Jean-Marc Ferrero, Centre Antoine Lacassagne, Nice, France; Juan de la Haba-Rodriguez, Reina Sofía Hospital, University of Córdoba, Córdoba, Spain; Christopher Poole, University Hospitals Coventry; Christopher Poole, Warwickshire National Health Service Trust, Coventry, United Kingdom; Sabino De Placido and Grazia Arpino, University Federico II, Naples, Italy; Roberto Hegg, Hospital Pérola Byington; Roberto Hegg, Faculdade de...

family: Rimawi

full_name: Mothaffar Rimawi

given: Mothaffar

family: Ferrero

full_name: Jean-Marc Ferrero

given: Jean-Marc

family: de la Haba-Rodriguez

full_name: Juan de la Haba-Rodriguez

given: Juan

family: Poole

full_name: Christopher Poole

given: Christopher

family: De Placido

full_name: Sabino De Placido

given: Sabino

family: Osborne

full_name: C. Kent Osborne

given: C. Kent

family: Hegg

full_name: Roberto Hegg

given: Roberto

family: Easton

full_name: Valerie Easton

given: Valerie

family: Wohlfarth

full_name: Christine Wohlfarth

given: Christine

family: Arpino

full_name: Grazia Arpino

given: Grazia

journal_name: Journal of Clinical Oncology

title: First-Line Trastuzumab Plus an Aromatase Inhibitor, With or Without Pertuzumab, in Human Epidermal Growth Factor Receptor 2–Positive and Hormone Receptor–Positive Metastatic or Locally Advanced Breast Cancer (PERTAIN): A Randomized, Open-Label Phase II Trial

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Brazil
India
France
Spain
Turkey
United States
United Kingdom

acronym: PERTAIN

location_facility: Centre Antoine Lacassagne; Hopital De Jour A2

location_facility: Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica

location_facility: Jaslok Hospital & Research Centre; Medical Oncology

location_facility: Inst. Brasileiro de Controle Ao Cancer; Oncologia Clinica / Quimioterapia

location_facility: Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia

location_facility: Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital

location_facility: Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: Hopital Morvan; Oncologie - Radiotherapie

location_facility: Centre Catherine de Sienne; Chimiotherapie

location_facility: A.O. Santa Maria Degli Angeli; U.O Di Oncologia Medica

location_facility: Hospital de Donostia; Servicio de Oncologia Medica

location_facility: Ege Uni Medical Faculty Hospital; Oncology Dept

location_facility: Az Ospedaliera Nuovo Garibaldi Quartiere Nesima; Oncologia Medica

location_facility: Ospedale S.S. Trinità Nuovo; Divisione Oncologia

location_facility: IRCCS Fondazione Maugeri; Oncologia Medica I

location_facility: Baylor College of Medicine; Lester & Sue Smith Breast Ctr

location_facility: Weston Park Hospital; Cancer Clinical Trials Centre

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1

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

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Hospital Universitario Virgen Macarena; Servicio de Oncologia

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología

location_facility: University Hospital coventry; Oncology Department

location_facility: Centre Alexis Vautrin; Oncologie Medicale

location_facility: Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia

location_facility: Hematology Oncology Associates; Carol G. Simon Ctr

location_facility: Hospital Provincial de Castellon; Servicio de Oncologia

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

location_facility: Ospedale Antonio Perrino; Oncologia Medica

location_facility: Clinique De La Sauvegarde; Chimiotherapie

location_facility: Centro Oncológico Gallego José Antonio Quiroga y Piñeiro, Servicio de Oncologia

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Ospedale Misericordia E Dolce; Oncologia Medica

location_facility: IInstituto Oncologico de San Sebastian, Oncologikoa; Servicio de Oncologia

location_facility: Washington University School of Medicine; Internal Medicine - Renal

location_facility: Università degli Studi Federico II; Clinica di Oncologia Medica

location_facility: Ospedale Vito Fazzi; Div. Oncoematologia

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Ospedale Regionale Di Parma; Divisione Di Oncologia Medica

location_facility: Casa di Cura MultiMedica Ospedale di Castellanza; UO Senologia Medica

source: euctr

title: A Randomized, Two-Arm, Open-Label, Multicenter Phase II Trial Assessing the Efficacy and Safety of Pertuzumab Given in Combination With Trastuzumab Plus an Aromatase Inhibitor in First Line Patients With HER2-Positive and Hormone Receptor-Positive Advanced (Metastatic or Locally Advanced) Breast Cancer

summary: This randomized, open-label, two-arm, multi-center, Phase II study will evaluate the efficacy and safety of pertuzumab in combination with trastuzumab plus an aromatase inhibitor (AI) in first-line participants with HER2-positive and hormone receptor-positive advanced breast cancer. Participants will be randomized to one of two treatment arms; Arm A (pertuzumab in combination with trastuzumab plus an AI) or Arm B (trastuzumab plus an AI). Participants may also receive induction chemotherapy (a taxane, either docetaxel or paclitaxel) at the investigator's discretion in combination with the assigned treatment arm. The anticipated time on study treatment is until disease progression, unacceptable toxicity, withdrawal of consent, or death whichever occurs first.


title: A Phase 3b Randomized, Open-Label Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI + RTV) Plus Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (EVG/COBI/FTC/TDF) in Virologically-Suppressed, HIV-1 Infected Patients

summary: This study will evaluate the non-inferiority of Stribild® (elvitegravir/cobicistat/ emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) single-tablet regimen (STR) relative to regimens consisting of a protease inhibitor (PI) boosted with ritonavir (RTV) plus Truvada® (FTC/TDF) fixed-dose combination in maintaining HIV-1 RNA < 50 copies/mL at Week 48 in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety, tolerability, and efficacy of the two regimens through 96 weeks of treatment.

ReferenceType: result

ReferenceCitation: Arribas JR, Pialoux G, Gathe J, Di Perri G, Reynes J, Tebas P, Nguyen T, Ebrahimi R, White K, Piontkowsky D. Simplification to coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir versus continuation of ritonavir-boosted protease inhibitor with emtricitabine and tenofovir in adults with virologically suppressed HIV (STRATEGY-PI): 48 week results of a randomised, open-label, phase 3b, non-inferiority trial. Lancet Infect Dis. 2014 Jul;14(7):581-9. doi: 10.1016/S1473-3099(14)70782-0. Epub 2014 Jun 5.

family: Arribas

full_name: Jose R Arribas

given: Jose R

family: Pialoux

full_name: Gilles Pialoux

given: Gilles

family: Gathe

full_name: Joseph Gathe

given: Joseph

family: Di Perri

full_name: Giovanni Di Perri

family: Reynes

full_name: Jacques Reynes

given: Jacques

family: Tebas

full_name: Pablo Tebas

given: Pablo

family: Nguyen

full_name: Thai Nguyen

given: Thai

family: Ebrahimi

full_name: Ramin Ebrahimi

given: Ramin

family: White

full_name: Kirsten White

given: Kirsten

family: Piontkowsky

full_name: David Piontkowsky

given: David

journal_name: The Lancet Infectious Diseases

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Pozniak A, Markowitz M, Mills A, Stellbrink HJ, Antela A, Domingo P, Girard PM, Henry K, Nguyen T, Piontkowsky D, Garner W, White K, Guyer B. Switching to coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir versus continuation of non-nucleoside reverse transcriptase inhibitor with emtricitabine and tenofovir in virologically suppressed adults with HIV (STRATEGY-NNRTI): 48 week results of a randomised, open-label, phase 3b non-inferiority trial. Lancet Infect Dis. 2014 Jul;14(7):590-9. doi: 10.1016/S1473-3099(14)70796-0. Epub 2014 Jun 5.

family: Pozniak

full_name: Anton Pozniak

given: Anton

family: Markowitz

full_name: Martin Markowitz

given: Martin

family: Mills

full_name: Anthony Mills

given: Anthony

family: Stellbrink

full_name: Hans-Juergen Stellbrink

given: Hans-Juergen

family: Antela

full_name: Antonio Antela

given: Antonio

family: Domingo

full_name: Pere Domingo

given: Pere

family: Girard

full_name: Pierre-Marie Girard

given: Pierre-Marie

family: Henry

full_name: Keith Henry

given: Keith

family: Garner

full_name: Will Garner

ReferenceCitation: Arribas JR, DeJesus E, van Lunzen J, Zurawski C, Doroana M, Towner W, Lazzarin A, Nelson M, McColl D, Andreatta K, Swamy R, Szwarcberg J, Nguyen T. Simplification to single-tablet regimen of elvitegravir, cobicistat, emtricitabine, tenofovir DF from multi-tablet ritonavir-boosted protease inhibitor plus coformulated emtricitabine and tenofovir DF regimens: week 96 results of STRATEGY-PI. HIV Clin Trials. 2017 May;18(3):118-125. doi: 10.1080/15284336.2017.1330440. Epub 2017 May 30. Erratum in: HIV Clin Trials. 2018 Aug;19(4):163.

name: Hospital Universitario La Paz, IdiPAZ, Madrid, Spain

name: Orlando Immunology Center, Orlando FL, USA

name: Universitaetsklinikum Hamburg-Eppendorf, Hamburg, Germany

name: Hospital de Santa Maria, Lisbon, Portugal

name: Southern California Kaiser Permanente Medical Group, Los Angeles CA, USA

name: Fondazione IRCCS San Raffaele del Monte Tabor, Milan, Italy

name: Chelsea and Westminster Hospital, London, UK

name: Gilead Sciences, Inc., Foster City, CA, USA

ReferenceCitation: Gathe J, Arribas JR, Van Lunzen J, Garner W, Speck RM, Bender R, Shreay S, Nguyen T. Patient-Reported Symptoms over 48 Weeks in a Randomized, Open-Label, Phase 3b Non-inferiority Trial of Adults with HIV Switching to Coformulated Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir DF Versus Continuation of Ritonavir-Boosted Protease Inhibitor with Emtricitabine and Tenofovir DF. Patient. 2015 Oct;8(5):445-54. doi: 10.1007/s40271-015-0137-9.

journal_name: The Patient - Patient-Centered Outcomes Research

repository_institution: RePEc: Research Papers in Economics - RePEc

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

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

location_country:
Italy
Austria
United States
Switzerland
Spain
Germany
France
Belgium
Puerto Rico
Portugal
Canada
United Kingdom

location_facility: University Hospital of Zurich; Division of Infectious Diseases and Hospital Epidemiology

location_facility: Infektionsambulanz, Med Poliklink, Klinikum der Universitat Munchnen

location_facility: Johann Wolfgang Goethe-University Hospital / Infectious Diseases Hs 68

location_facility: Midway Immunology & Research Center, LLC

location_facility: National Institute for Infectious Diseases "L. Spallanzani"

location_facility: Hospital Santo Antonio Dos Capuchos, Centro Hospitalar de Lisboa

location_facility: Infectious Diseases Department, Hospital Carlos III

location_facility: Universitätsklinikum Essen, Dermatologie, HIV Ambulanz

location_facility: Brighton and Sussex University Hospitals NHS Trust

location_facility: Archet 1 Chu Nice Department of Infectology

location_facility: Northwestern University Division of Infectious Diseases

location_facility: Hospital Universitari Bellvitge HIV Unit. Infectious Disease Service.

location_facility: John H. Stroger, Jr. Hospital of Cook County/Ruth M. Rothstein CORE Center

location_facility: Tarrant County Infectious Disease Associates

location_facility: La Playa Medical Group and Clinical Research

location_facility: Infectious Diseases Associates of NW FL, P.A.

location_facility: University of Puerto Rico School of Medicine

location_facility: University of Torino, Dept of Infectious Disease

location_facility: Universitätsklinikum Hamburg-Eppendorf, Ambulanzzentrum des UKE GmbH, Bereich Infektiologie

location_facility: Clinic of Infectious Diseases, University of Milan-San Paolo Hospital

location_facility: Southwest Infectious Disease Clinical Research, Inc

location_facility: St. Joseph's Comprehensive Research Institute


title: A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

acronym: OCTAVE

summary: This study is an open label, long-term extension study for subjects with moderate to severe ulcerative colitis designed to evaluate long term therapy of CP-690,550.

design_allocation: Non-Randomized

ReferenceCitation: Feagan BG, Khanna R, Sandborn WJ, Vermeire S, Reinisch W, Su C, Salese L, Fan H, Paulissen J, Woodworth DA, Niezychowski W, Sands BE. Agreement between local and central reading of endoscopic disease activity in ulcerative colitis: results from the tofacitinib OCTAVE trials. Aliment Pharmacol Ther. 2021 Dec;54(11-12):1442-1453. doi: 10.1111/apt.16626. Epub 2021 Oct 6.

name: Robarts Research Institute Western University London Ontario Canada

family: Feagan

full_name: Brian G. Feagan

given: Brian G.

name: Department of Medicine Division of Gastroenterology Western University London Ontario Canada

family: Khanna

full_name: Reena Khanna

given: Reena

name: Division of Gastroenterology University of California San Diego La Jolla CA USA

family: Sandborn

full_name: William J. Sandborn

given: William J.

name: Department of Gastroenterology University Hospitals Leuven Leuven Belgium

family: Vermeire

full_name: Séverine Vermeire

given: Séverine

name: Department of Internal Medicine III Medical University of Vienna Vienna Austria

family: Reinisch

full_name: Walter Reinisch

given: Walter

family: Su

full_name: Chinyu Su

given: Chinyu

family: Salese

full_name: Leonardo Salese

given: Leonardo

family: Fan

full_name: Haiyun Fan

given: Haiyun

family: Paulissen

full_name: Jerome Paulissen

given: Jerome

family: Woodworth

full_name: Deborah A. Woodworth

given: Deborah A.

family: Niezychowski

full_name: Wojciech Niezychowski

given: Wojciech

name: Dr. Henry D. Janowitz Division of Gastroenterology Icahn School of Medicine at Mount Sinai New York NY USA

family: Sands

full_name: Bruce E. Sands

given: Bruce E.

journal_name: Alimentary Pharmacology & Therapeutics

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Panés J, Vermeire S, Dubinsky MC, Loftus EV, Lawendy N, Wang W, Salese L, Su C, Modesto I, Guo X, Colombel JF. Efficacy and Safety of Tofacitinib Re-treatment for Ulcerative Colitis After Treatment Interruption: Results from the OCTAVE Clinical Trials. J Crohns Colitis. 2021 Nov 8;15(11):1852-1863. doi: 10.1093/ecco-jcc/jjab065.

name: Inflammatory Bowel Disease Unit, Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain

family: Panés

full_name: Julian Panés

given: Julian

name: Department of Gastroenterology, University Hospitals Leuven, Leuven, Belgium

name: Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY, USA

family: Dubinsky

full_name: Marla C Dubinsky

given: Marla C

name: Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine, Rochester, MN, USA

family: Loftus

full_name: Edward V Loftus

given: Edward V

suffix: Jr

family: Lawendy

full_name: Nervin Lawendy

given: Nervin

family: Wang

full_name: Wenjin Wang

given: Wenjin

name: Division of Gastroenterology, Icahn School of Medicine at Mount Sinai Hospital, New York, NY, USA

ReferenceCitation: Sandborn WJ, Peyrin-Biroulet L, Sharara AI, Su C, Modesto I, Mundayat R, Gunay LM, Salese L, Sands BE. Efficacy and Safety of Tofacitinib in Ulcerative Colitis Based on Prior Tumor Necrosis Factor Inhibitor Failure Status. Clin Gastroenterol Hepatol. 2021 Mar 6. pii: S1542-3565(21)00222-6. doi: 10.1016/j.cgh.2021.02.043. [Epub ahead of print]

journal_name: Clinical Gastroenterology and Hepatology

ReferenceCitation: Curtis JR, Regueiro M, Yun H, Su C, DiBonaventura M, Lawendy N, Nduaka CI, Koram N, Cappelleri JC, Chan G, Modesto I, Lichtenstein GR. Tofacitinib Treatment Safety in Moderate to Severe Ulcerative Colitis: Comparison of Observational Population Cohort Data From the IBM MarketScan® Administrative Claims Database With Tofacitinib Trial Data. Inflamm Bowel Dis. 2021 Aug 19;27(9):1394-1408. doi: 10.1093/ibd/izaa289.

name: Division of Clinical Immunology and Rheumatology, Department of Medicine, Department of Epidemiology, University of Alabama at Birmingham, Birmingham, AL, USA

name: Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland, OH, USA

name: Perelman School of Medicine of the University of Pennsylvania, Philadelphia, PA, USA

ReferenceCitation: Sandborn WJ, Peyrin-Biroulet L, Quirk D, Wang W, Nduaka CI, Mukherjee A, Su C, Sands BE. Efficacy and Safety of Extended Induction With Tofacitinib for the Treatment of Ulcerative Colitis. Clin Gastroenterol Hepatol. 2020 Oct 27. pii: S1542-3565(20)31496-8. doi: 10.1016/j.cgh.2020.10.038. [Epub ahead of print]

ReferenceCitation: Colombel JF, Osterman MT, Thorpe AJ, Salese L, Nduaka CI, Zhang H, Lawendy N, Friedman GS, Quirk D, Su C, Reinisch W. Maintenance of Remission With Tofacitinib Therapy in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2020 Oct 9. pii: S1542-3565(20)31389-6. doi: 10.1016/j.cgh.2020.10.004. [Epub ahead of print]

title: Maintenance of Remission With Tofacitinib Therapy in Patients With Ulcerative Colitis

ReferenceCitation: Sands BE, Colombel JF, Ha C, Farnier M, Armuzzi A, Quirk D, Friedman GS, Kwok K, Salese L, Su C, Taub PR. Lipid Profiles in Patients With Ulcerative Colitis Receiving Tofacitinib-Implications for Cardiovascular Risk and Patient Management. Inflamm Bowel Dis. 2021 May 17;27(6):797-808. doi: 10.1093/ibd/izaa227.

name: Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York, USA

name: Inflammatory Bowel Disease Center, Cedars-Sinai Medical Center, Los Angeles, California, USA

name: PEC2, EA 7460, University of Bourgogne—Franche Comté and Department of Cardiology, CHU Dijon-Bourgogne, Dijon, France

name: IBD Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy

name: Inflammation & Immunology, Pfizer Inc, Collegeville, Pennsylvania, USA

name: Inflammation & Immunology, Pfizer Inc, New York, New York, USA

name: Division of Cardiovascular Medicine, University of California, San Diego, California, USA

repository_institution: University of California - eScholarship University of California

repository_normalized: California Digital Library - eScholarship

repositories: California Digital Library - eScholarship

repositories_institution: University of California - eScholarship University of California

title: Lipid Profiles in Patients With Ulcerative Colitis Receiving Tofacitinib—Implications for Cardiovascular Risk and Patient Management

ReferenceCitation: Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum in: Dig Dis Sci. 2020 Oct 10;:.

repository_institution: Newcastle Univesity - Newcastle University ePrints

repositories_institution: Newcastle Univesity - Newcastle University ePrints

ReferenceCitation: Lichtenstein GR, Rogler G, Ciorba MA, Su C, Chan G, Pedersen RD, Lawendy N, Quirk D, Nduaka CI, Thorpe AJ, Panés J. Tofacitinib, an Oral Janus Kinase Inhibitor: Analysis of Malignancy (Excluding Nonmelanoma Skin Cancer) Events Across the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2021 May 17;27(6):816-825. doi: 10.1093/ibd/izaa199.

name: Division of Gastroenterology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA

name: Department of Gastroenterology and Hepatology, University of Zürich, Zürich, Switzerland

name: Division of Gastroenterology, Washington University in Saint Louis, Saint Louis, Missouri, USA

name: Pfizer Inc, Collegeville, Pennsylvania, USA

name: Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain

ReferenceCitation: Sands BE, Armuzzi A, Marshall JK, Lindsay JO, Sandborn WJ, Danese S, Panés J, Bressler B, Colombel JF, Lawendy N, Maller E, Zhang H, Chan G, Salese L, Tsilkos K, Marren A, Su C. Efficacy and safety of tofacitinib dose de-escalation and dose escalation for patients with ulcerative colitis: results from OCTAVE Open. Aliment Pharmacol Ther. 2020 Jan;51(2):271-280. doi: 10.1111/apt.15555. Epub 2019 Oct 29.

name: Icahn School of Medicine at Mount Sinai; New York NY USA

name: Fondazione Policlinico Universitario A. Gemelli IRCCS; Università Cattolica del Sacro Cuore; Rome Italy

name: Farncombe Family Digestive Health Research Institute; McMaster University; Hamilton ON Canada

name: The Royal London Hospital; Barts Health NHS Trust; London UK

name: University of California, San Diego; La Jolla CA USA

name: Humanitas Research Hospital; Rozzano Italy

name: Hospital Clínic de Barcelona; Barcelona Spain

name: University of British Columbia; Vancouver BC Canada

ReferenceCitation: Sandborn WJ, Panés J, Sands BE, Reinisch W, Su C, Lawendy N, Koram N, Fan H, Jones TV, Modesto I, Quirk D, Danese S. Venous thromboembolic events in the tofacitinib ulcerative colitis clinical development programme. Aliment Pharmacol Ther. 2019 Nov;50(10):1068-1076. doi: 10.1111/apt.15514. Epub 2019 Oct 9.

name: Division of Gastroenterology; University of California, San Diego; La Jolla California

name: Hospital Clínic de Barcelona; IDIBAPS, CIBERehd; Barcelona Spain

name: Dr. Henry D. Janowitz Division of Gastroenterology; Icahn School of Medicine at Mount Sinai; New York New York

name: Medical University of Vienna; Vienna Austria

name: Division of Gastroenterology; IBD Center; Humanitas University; Rozzano Milan Italy

ReferenceCitation: Sands BE, Taub PR, Armuzzi A, Friedman GS, Moscariello M, Lawendy N, Pedersen RD, Chan G, Nduaka CI, Quirk D, Salese L, Su C, Feagan BG. Tofacitinib Treatment Is Associated With Modest and Reversible Increases in Serum Lipids in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2020 Jan;18(1):123-132.e3. doi: 10.1016/j.cgh.2019.04.059. Epub 2019 May 8.

ReferenceCitation: Sandborn WJ, Panés J, D'Haens GR, Sands BE, Su C, Moscariello M, Jones T, Pedersen R, Friedman GS, Lawendy N, Chan G. Safety of Tofacitinib for Treatment of Ulcerative Colitis, Based on 4.4 Years of Data From Global Clinical Trials. Clin Gastroenterol Hepatol. 2019 Jul;17(8):1541-1550. doi: 10.1016/j.cgh.2018.11.035. Epub 2018 Nov 23.

ReferenceCitation: Winthrop KL, Melmed GY, Vermeire S, Long MD, Chan G, Pedersen RD, Lawendy N, Thorpe AJ, Nduaka CI, Su C. Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib. Inflamm Bowel Dis. 2018 Sep 15;24(10):2258-2265. doi: 10.1093/ibd/izy131.

name: Oregon Health & Science University, Portland, Oregon

name: Cedars-Sinai Medical Center, Los Angeles, California

name: Center for Gastrointestinal Biology and Disease, University of North Carolina, Chapel Hill, North Carolina

repositories:
LIRIAS (KU Leuven)
PubMed Central
pdfs.semanticscholar.org

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

title: Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib

location_country:
Romania
Australia
Belgium
Russian Federation
Denmark
Taiwan
Ukraine
Croatia
France
Japan
Poland
Slovakia
Canada
Korea, Republic of
Colombia
South Africa
Netherlands
Hungary
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Czechia
Israel
New Zealand
Spain
Estonia
Latvia

location_facility: CI of Uzhgorod Regional Rada Uzhgorod Central Regional Hospital". Therapy Department. SHEI Uzhgorod

location_facility: North Shore Hospital (Waitemata District Health Board)

location_facility: Clinical Centre of Serbia Clinic for Gastroenterology and Hepatology

location_facility: Clinical Trials Unit- Tauranga Hospital-Bay of Plenty (BOP) Clinical School

location_facility: Universitatsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, I. Sz. Belgyogyaszati Klinika

location_facility: Minicipal Institution City Hospital #7, Therapeutic Department,

location_facility: Atlanta Gastroenterology Specialists, PC

location_facility: SI 'Institute of Gastroenterology of the NAMS of Ukraine', Dep.-nt of Stomach and Duodenum diseases

location_facility: McGovern Medical School -The University of Texas Health Science Center at Houston

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Regional Municipal Institution "Chernivtsi Regional Clinical Hospital"

location_facility: Carolina Research, Carolina Digestive Diseases

location_facility: Klinicke Centrum ISCARE I.V.F., Gastroenterologie

location_facility: Szent Margit Kórház, III. Belgyógyászati-Gasztroenterológiai Osztály

location_facility: National Hospital Organization Hirosaki National Hospital

location_facility: Municipal Healthcare Institution Kharkiv City Clinical Hospital #2

location_facility: Limited Liability Company Medical Company "Hepatolog"

location_facility: National Hospital Organization Mito Medical Center

location_facility: Great Lakes Gastroenterology Research, LLC

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza III.sz. Belgyoyaszat Gasztroenterologia

location_facility: Gastroenterology Associates of Central Georgia, LLC

location_facility: London Health Sciences Centre - University Hospital

location_facility: Universitaetsmedizin Berlin, Charite Campus Virchow-Klinikum, Medizinische Klinik mit

location_facility: State Institution "L.T. Malaya Therapy Institute of NAMS of Ukraine"

location_facility: Municipal Institution "Odesa Regional Clinical Hospital", polyclinic department

location_facility: University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre

location_facility: Krankenhaus Barmherzige Brueder St. Veit/Glan

location_facility: Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej, Uniwersytecki Szpital Kliniczny nr

location_facility: Gastroenterology Center of Connecticut, PC

location_facility: The Gastroenterology Group of South Jersey

location_facility: Clinical Centre of Vojvodina, Clinic for Gastroenterology and Hepatology

location_facility: Nemocnice Strakonice, a.s., Interni oddeleni

location_facility: VCU Health System Digestive Health Center

location_facility: MGG Group Co., Inc., Chevy Chase Clinical Research

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Shiga University of Medical Science Hospital

location_facility: Kitasato University Kitasato Institute Hospital

location_facility: Samara Diagnostic center, X-ray Department

location_facility: Clinical Hospital Center Zvezdara - Clinic for Gastroenterology and Hepatology

location_facility: State budget institution of healthcare of Yaroslavl region Regional clinical hospital

location_facility: Universitaesklinikum Halle, Klinik und Poliklinik fuer Innere Medizin I

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

location_facility: Federal State Budgetary Institution Scientific Research Institute of Physiology and Fundamental

location_facility: Cotton O'Neil Clinical Research Center, Digestive Health

location_facility: Medical Research Center of Connecticut, LLC

location_facility: Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust

location_facility: Kyiv Municipal Clinical Hospital #18, Proctology Department

location_facility: Hospital de Clinicas de Porto Alegre - HCPA

location_facility: Clinical Centre of Kragujevac Clinic for Gastroenterology and Hepatology

location_facility: Perlman Medical Offices - UC San Diego Health System

location_facility: "Odesa Clinical Hospital for Railway ""Branch of ""Healthcare center of Private JSC ""Ukrainian

location_facility: Centrum Medyczne Szpital Sw. Rodziny Sp. z o. o.

location_facility: NYU Langone Long Island Clinical Research Associates

location_facility: Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych

location_facility: Hopital Saint Antoine - Service de Gastroenterologie

location_facility: Municipal Budget Institution of Healthcare of Novosibirsk

location_facility: The Hospital of Hyogo College of Medicine

location_facility: Peterfy Sandor utcai Korhaz-Rendelointezet es Manninger Jeno Orszagos Traumatologiai Intezet

location_facility: FSBI "Scientific Research Institute of Physiology and Fundamental Medicine"

location_facility: Medical Science Research Building 1 - UMHS

location_facility: Federal State Budgetary Institution "State Scientific Centre of Coloproctology n.a. A.N. Ryzhikh"

location_facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak I Belgyogyaszati-Gasztroenterologiai Osztaly

location_facility: Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza; III. Belgyogyaszat - Gasztroenterologia'.

location_facility: "KM Management spol. s.r.o.Gastroenterologicke a hepatologicke centrum Nitra

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Chris Hani Baragwanath Academic Hospital

location_facility: Montreal General Hospital - McGill University Health Care Centre

location_facility: Center for Endoscopy- Covenant Surgical Partners

location_facility: State budget Healthcare Institution Moscow regional scientific research clinical institute

location_facility: AKH Wien, Universitaetsklinik fuer Innere Medizin III

location_facility: AOU Mater Domini - U.O. Fisiopatologia Digestiva

location_facility: UZ Leuven (University Hospital Leuven), Campus Gasthuisberg

location_facility: Norfolk and Norwich University Hospitals NHS Foundation Trust

location_facility: Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital

location_facility: Vinnytsia Regional Clinical Hospital for War Veterans, Therapeutics Dept. No. 2

location_facility: Regional Municipal Institution 'Chernivtsi Regional Clinical Hospital'

location_facility: Columbia University Irving Medical Center

location_facility: Tokyo Medical And Dental University Hospital, Faculty of Medicine

location_facility: The North West London Hospitals NHS Trust

location_facility: The Edith Wolfson Medical Center/Gastroenterology Department

location_facility: Oddzial Chorob Wewnetrznych i Gastroenterologii, SP ZOZ Wojewodzki Szpital

location_facility: Klinika Chorob Wewnetrznych i Gastroenterologii z Pododdzialem Leczenia Nieswoistych Chorob

location_facility: Hôpital Saint Louis - Service d'hepato-gastroenterologie

location_facility: University Medical Center Groningen (UMCG)

location_facility: Hopital Haut-Leveque-CMC Magellan- Unite de Recherche Clinique

location_facility: Istituto Clinico Humanitas IRCCS-IBD Center

location_facility: Clinical Centre of Vojvodina Emergency Internal Medicine Division

location_facility: University of Alberta - Zeidler Ledcor Centre

location_facility: Wisconsin Center for Advanced Research - a division of GI Associates, LLC

location_facility: Hopital Beaujon, Gastroenterologie, MICI et Assistance Nutritive

location_facility: Cabinet Particular Policlinic Algomed SRL

location_facility: State budget Institution of Healthcare Nizhniy Novgorod Regional Clinical Hospital named after N. A.

location_facility: CHU de Nantes - Hotel Dieu-Service d'Hepato-Gastroenterologie

location_facility: Atlanta Center for Gastroenterology, P.C.

location_facility: University of Calgary, Heritage Medical Research Clinic, TRW Building

location_facility: North Florida Gastroenterology Research, LLC

location_facility: Baylor College of Medicine- Baylor Medical Center

location_facility: Poliklinika Libris, Synergy group, a.s.,

location_facility: Non-State Healthcare Institution "Road Clinical Hospital at the station Samara"

location_facility: Municipal City Clinical Hospital of the Emergency Medical Care, 1-st Therapy Department of hospital,

location_facility: UCSF Center for Colitis and Crohn's Disease

location_facility: Huron Gastroenterology Associates - Center for Digestive Care

location_facility: Altman Clinical and Translational Research Institute

location_facility: Spitalul Universitar de Urgenta Bucharest, Medicina Interna II Gastroenterologie

location_facility: East Ann Arbor Health and Geriatrics Center -UMHS

location_facility: Clinical Research Institute of Michigan, LLC


title: Lux-Breast 3; Randomised Phase II Study of Afatinib Alone or in Combination With Vinorelbine Versus Investigator's Choice of Treatment in Patients With HER2 Positive Breast Cancer With Progressive Brain Metastases After Trastuzumab and/or Lapatinib Based Therapy

summary: The aim of this study is to investigate the efficacy and safety of afatinib alone or in combination with vinorelbine, as treatment in patients with HER2-overexpressing metastatic breast cancer, who have progressive brain lesions after trastuzumab and/or lapatinib based therapy

ReferenceCitation: Cortés J, Dieras V, Ro J, Barriere J, Bachelot T, Hurvitz S, Le Rhun E, Espié M, Kim SB, Schneeweiss A, Sohn JH, Nabholtz JM, Kellokumpu-Lehtinen PL, Taguchi J, Piacentini F, Ciruelos E, Bono P, Ould-Kaci M, Roux F, Joensuu H. Afatinib alone or afatinib plus vinorelbine versus investigator's choice of treatment for HER2-positive breast cancer with progressive brain metastases after trastuzumab, lapatinib, or both (LUX-Breast 3): a randomised, open-label, multicentre, phase 2 trial. Lancet Oncol. 2015 Dec;16(16):1700-10. doi: 10.1016/S1470-2045(15)00373-3. Epub 2015 Nov 17.

family: Cortés

full_name: Javier Cortés

given: Javier

family: Dieras

full_name: Véronique Dieras

given: Véronique

family: Ro

full_name: Jungsil Ro

given: Jungsil

family: Barriere

full_name: Jérôme Barriere

given: Jérôme

family: Bachelot

full_name: Thomas Bachelot

given: Thomas

family: Hurvitz

full_name: Sara Hurvitz

given: Sara

family: Le Rhun

full_name: Emilie Le Rhun

given: Emilie

family: Espié

full_name: Marc Espié

given: Marc

family: Kim

full_name: Sung-Bae Kim

given: Sung-Bae

family: Schneeweiss

full_name: Andreas Schneeweiss

given: Andreas

family: Sohn

full_name: Joo Hyuk Sohn

given: Joo Hyuk

family: Nabholtz

full_name: Jean-Marc Nabholtz

given: Jean-Marc

family: Kellokumpu-Lehtinen

full_name: Pirkko-Liisa Kellokumpu-Lehtinen

given: Pirkko-Liisa

family: Taguchi

full_name: Julie Taguchi

given: Julie

family: Piacentini

full_name: Federico Piacentini

given: Federico

family: Ciruelos

full_name: Eva Ciruelos

given: Eva

family: Bono

full_name: Petri Bono

given: Petri

family: Ould-Kaci

full_name: Mahmoud Ould-Kaci

given: Mahmoud

family: Roux

full_name: Flavien Roux

given: Flavien

family: Joensuu

full_name: Heikki Joensuu

given: Heikki

journal_name: The Lancet Oncology

lead_sponsor: Boehringer Ingelheim

location_country:
Italy
United States
Finland
France
Korea, Republic of
Spain
Germany
Canada

location_facility: 1200.67.49004 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.33011 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.49008 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.49007 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.10105 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.33004 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.10108 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.10004 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.49005 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.33005 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.10003 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.33001 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.82003 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.82001 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.35802 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.34004 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.49006 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.82004 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.33003 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.39001 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.34005 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.39002 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.35803 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.33002 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.33009 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.11002 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.10106 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.33012 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.33010 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.11003 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.82002 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.33008 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.34002 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.35801 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.11004 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.49003 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.49002 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.34003 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.10001 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.34006 Boehringer Ingelheim Investigational Site


title: A Multicenter, Two Arm, Randomized, Open Label Clinical Study Investigating Renal Function in an Advagraf® Based Immunosuppressive Regimen With or Without Sirolimus in Kidney Transplant Patients

acronym: ADHERE

summary: The purpose of this study is to compare the effect of two anti-rejection therapy regimens on kidney function in kidney transplant recipients.

primary_purpose: Prevention

ipd_sharing: Yes

ipd_sharing_description: Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

lead_sponsor: Astellas Pharma Inc

location_country:
Italy
Austria
Hong Kong
Netherlands
Spain
France
Czechia
Poland
Hungary
Australia
Belgium
Russian Federation
Belarus
Turkey
Germany
Korea, Republic of
Taiwan


title: A 24-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GSK573719/GW642444 Inhalation Powder and the Individual Components Delivered Once-Daily Via a Novel Dry Powder Inhaler in Subjects With Chronic Obstructive Pulmonary Disease

summary: This is a phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of GSK573719/GW642444 Inhalation Powder, GSK573719 Inhalation Powder, GW642444 Inhalation Powder and Placebo when administered once-daily via a Novel Dry Powder Inhaler over a 24-week treatment period in subjects with COPD. Subjects who meet eligibility criteria at Screening (Visit 1) will complete a 7 to14 day run-in period followed by a randomization visit (Visit 2) then a 24-week treatment period. There will be a total of 9 clinic study visits. A follow-up phone contact for adverse event assessment will be conducted approximately one week after the last study visit (Visit 9 or Early Withdrawal). The total duration of subject participation in the study will be approximately 27 weeks. A subset of subjects at selected sites will also perform 24-hour serial spirometry and Holter monitoring during the study and provide serial blood samples for pharmacokinetic analysis. Sparse pharmacokinetic sampling for population pharmacokinetic analyses will be obtained from non-subset subjects. The primary measure of efficacy is clinic visit trough (pre-bronchodilator and pre-dose) FEV1 on Treatment Day 169. Safety will be assessed by adverse events, 12-lead ECGs, vital signs, clinical laboratory tests, and 24 hour Holter monitoring (subset only).

ReferenceCitation: Celli B, Crater G, Kilbride S, Mehta R, Tabberer M, Kalberg CJ, Church A. Once-daily umeclidinium/vilanterol 125/25 mcg in COPD: a randomized, controlled study. Chest. 2014 May;145(5):981-991. doi: 10.1378/chest.13-1579.

family: Celli

full_name: Bartolome Celli

given: Bartolome

family: Crater

full_name: Glenn Crater

given: Glenn

family: Kilbride

full_name: Sally Kilbride

given: Sally

family: Mehta

full_name: Rashmi Mehta

given: Rashmi

family: Tabberer

full_name: Maggie Tabberer

given: Maggie

family: Kalberg

full_name: Chris J. Kalberg

given: Chris J.

family: Church

full_name: Alison Church

given: Alison

journal_name: Chest

title: Once-Daily Umeclidinium/Vilanterol 125/25 μg Therapy in COPD

lead_sponsor: GlaxoSmithKline

location_country:
Sweden
Netherlands
Philippines
Germany
France
Japan
Slovakia
Norway
Hungary
Belgium
Estonia
Denmark
United States
Ukraine


title: A Phase 3B, Randomized, Open-label Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared With a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

summary:
The purpose of the study was to evaluate the safety and efficacy of the emtricitabine (FTC)/rilpivirine (RPV)/tenofovir disoproxil fumarate (TDF) single-tablet regimen (STR) compared with the efavirenz (EFV)/FTC/TDF STR in HIV-1 infected adults who had not previously received treatment with antiretroviral medications.

Participants were randomized in a 1:1 ratio to receive one of the study treatments. Randomization was stratified by HIV-1 RNA level (≤ 100,000 copies/mL or > 100,000 copies/mL) at screening. A treatment duration of 96 weeks was planned, with the option for subjects in FTC/RPV/TDF STR arm to receive treatment following the Week 96 visit until FTC/RPV/TDF STR is commercially available or until Gilead Sciences elects to terminate development in that country.

lead_sponsor: Gilead Sciences

location_country:
Italy
Austria
United States
Switzerland
Netherlands
Spain
Germany
France
Australia
Belgium
Puerto Rico
Portugal
Canada
United Kingdom

location_facility: IRCCS Ospedale San Raffaele Centro San Luigi, Unità Operativa di Malattie Infettive

location_facility: Department of Dermatology, Allergy, and Infectious Disease University Vienna Medical School

location_facility: Universitätsklinikum Innsbruck Universitätsklinik für Dermatologie und Venerologie

location_facility: Living Hope Education and Research Consultants

location_facility: Medizinische Universitätsklinik I der Friedrich-Wilhelms Universität Bonn

location_facility: I Div Infectious Diseases, Luigi Sacco Hospital

location_facility: Hospital of the University of Pennsylvania

location_facility: Universitätsklinikum Eppendorf Ambulanzzentrum des UKE GmbH, Infekiologie

location_facility: Hopital Saint Antoine- Service Maladies infectieuses

location_facility: North Shore University Hospital--Division of Infectious Diseases

location_facility: Division of Infectious Disease, Department of Medicine, University Hospital Freiburg

location_facility: Clinical Research - Infectious Diseases Unit Alfred Hospital

location_facility: National Institute for Infectious Diseases "L. Spallanzani" IRCCS

location_facility: Jeffrey Goodman Special Care Clinic/Los Angeles Gay and Lesbian Center

location_facility: HOSPITAL SAINT LOUIS - Services des Maladies Infectieuses

location_facility: Clinical and Translational Research Center - UNC Hospitals

location_facility: University Health Network/Toronto General Hospital

location_facility: Division of HIV/AIDS, St. Paul's Hospital

location_facility: Kaiser Permanente Medical Center, San Francisco

location_facility: Foundation "IRCCS Policlinico San Matteo Hospital"

location_facility: San Gerardo Hospital - Uo Malattie Infettive

location_facility: Hopital Tenon Service des Maladies infectieuses et tropicales

location_facility: Vancouver ID Research and Care Centre Society

location_facility: Cliniques Universitaires Saint-Luc - UCL

location_facility: Claudia T Martorell, MD., LLC dba The Research Institute

location_facility: LKH Medical University Graz West, Department of Internal Medicine

location_facility: Wohlfeiler, Piperato and Associates, LLC

location_facility: Infectious Disease Specialists of America

location_facility: Southwest Infectious Disease Associates, Inc.

location_facility: Tarrant County Infectious Disease Associates

location_facility: Hospital Universitario de Elche, Unidad de Enfermedades Infecciosas

location_facility: Serviço de Doenças Infecciosas, Hospital S. Joao

location_facility: St. Joseph's Hospital d/b/a Comprehensive Research Institute

location_facility: Hôpital Pitié Salpêtrière - Service des Maladies Infectieuses

location_facility: La Playa Medical Group and Clinical Research

location_facility: Community Research Initiative of New England

location_facility: Clinical Research, Grahame Hayton Unit Ambrose King Centre, The Royal London Hospital

location_facility: Johns Hopkins Rockland Physicians Practice and Research Group at Greenspring Station

location_facility: McGill University Health Center, Montreal Chest Institute

location_facility: The Brody School of Medicine at East Carolina University

location_facility: Department of Dermatology University Hospital Essen

location_facility: Private Practice Gute & Locher & Lutz, Infektiologikum

location_facility: Maple Leaf Research Maple Leaf Medical Clinic


title: Randomized, Open Label, Multi-Center Study Comparing Cabazitaxel at 25 mg/m^2 and at 20 mg/m^2 in Combination With Prednisone Every 3 Weeks to Docetaxel in Combination With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer Not Pretreated With Chemotherapy

acronym: FIRSTANA

summary:
Primary Objective:

To demonstrate the superiority of cabazitaxel plus prednisone at 25 mg/m^2 (Arm A) or 20 mg/m^2 (Arm B) versus docetaxel plus prednisone (Arm C) in term of overall survival (OS) in participants with metastatic castration resistant prostate cancer (mCRPC) and not previously treated with chemotherapy.

Secondary Objectives:

To evaluate safety in the 3 treatment arms.

To compare efficacy of cabazitaxel at 20 mg/m^2 and 25 mg/m^2 to docetaxel for:

Progression Free Survival (PFS) (RECIST 1.1)
Tumor progression free survival (RECIST 1.1)
Tumor response in participants with measurable disease (RECIST 1.1),
PSA response
PSA-Progression free survival (PSA-PFS).
Pain response in participants with stable pain at baseline
Pain progression free survival
Time to occurrence of any skeletal related events (SRE)
To compare Health-Related Quality of Life (HRQL).
To assess the pharmacokinetics and pharmacogenomics of cabazitaxel.

ReferenceCitation: Thiery-Vuillemin A, Fizazi K, Sartor O, Oudard S, Bury D, Thangavelu K, Ozatilgan A, Poole EM, Eisenberger M, de Bono J. An analysis of health-related quality of life in the phase III PROSELICA and FIRSTANA studies assessing cabazitaxel in patients with metastatic castration-resistant prostate cancer. ESMO Open. 2021 Apr;6(2):100089. doi: 10.1016/j.esmoop.2021.100089. Epub 2021 Mar 16.

family: Thiery-Vuillemin

full_name: A. Thiery-Vuillemin

given: A.

family: Fizazi

full_name: K. Fizazi

given: K.

family: Sartor

full_name: O. Sartor

given: O.

family: Oudard

full_name: S. Oudard

given: S.

family: Bury

full_name: D. Bury

given: D.

family: Thangavelu

full_name: K. Thangavelu

family: Ozatilgan

full_name: A. Ozatilgan

family: Poole

full_name: E.M. Poole

family: Eisenberger

full_name: M. Eisenberger

given: M.

family: de Bono

full_name: J. de Bono

given: J.

currency_apc_doaj: EUR

journal_name: ESMO Open

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

ReferenceCitation: Mehra N, Dolling D, Sumanasuriya S, Christova R, Pope L, Carreira S, Seed G, Yuan W, Goodall J, Hall E, Flohr P, Boysen G, Bianchini D, Sartor O, Eisenberger MA, Fizazi K, Oudard S, Chadjaa M, Macé S, de Bono JS. Plasma Cell-free DNA Concentration and Outcomes from Taxane Therapy in Metastatic Castration-resistant Prostate Cancer from Two Phase III Trials (FIRSTANA and PROSELICA). Eur Urol. 2018 Sep;74(3):283-291. doi: 10.1016/j.eururo.2018.02.013. Epub 2018 Feb 28.

apc_source: openAPC

family: Mehra

full_name: Niven Mehra

given: Niven

family: Dolling

full_name: David Dolling

given: David

family: Sumanasuriya

full_name: Semini Sumanasuriya

given: Semini

family: Christova

full_name: Rossitza Christova

given: Rossitza

family: Pope

full_name: Lorna Pope

given: Lorna

family: Carreira

full_name: Suzanne Carreira

given: Suzanne

family: Seed

full_name: George Seed

ReferenceCitation: Oudard S, Fizazi K, Sengeløv L, Daugaard G, Saad F, Hansen S, Hjälm-Eriksson M, Jassem J, Thiery-Vuillemin A, Caffo O, Castellano D, Mainwaring PN, Bernard J, Shen L, Chadjaa M, Sartor O. Cabazitaxel Versus Docetaxel As First-Line Therapy for Patients With Metastatic Castration-Resistant Prostate Cancer: A Randomized Phase III Trial-FIRSTANA. J Clin Oncol. 2017 Oct 1;35(28):3189-3197. doi: 10.1200/JCO.2016.72.1068. Epub 2017 Jul 28.

name: Stéphane Oudard, Georges Pompidou European Hospital, Rene Descartes University; Mustapha Chadjaa; Sanofi, Paris; Karim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif; Antoine Thiery-Vuillemin, Centre Hospitalier Universitaire Minjoz Besançon, Besançon, France; Lisa Sengeløv, Herlev Hospital, Herlev; Gedske Daugaard, Copenhagen University Hospital, Rigshospitalet, Copenhagen; Steinbjørn Hansen, Odense University Hospital, Odense, Denmark; Fred Saad, Centre Hospitalier de l’Université...

title: Cabazitaxel Versus Docetaxel As First-Line Therapy for Patients With Metastatic Castration-Resistant Prostate Cancer: A Randomized Phase III Trial—FIRSTANA

ReferenceCitation: de Liaño AG, Reig O, Mellado B, Martin C, Rull EU, Maroto JP. Prognostic and predictive value of plasma testosterone levels in patients receiving first-line chemotherapy for metastatic castrate-resistant prostate cancer. Br J Cancer. 2014 Apr 29;110(9):2201-8. doi: 10.1038/bjc.2014.189. Epub 2014 Apr 10.

ReferenceCitation: Winquist E, Rodrigues G. Open clinical uro-oncology trials in Canada. Can J Urol. 2012 Dec;19(6):6587-91.

location_country:
Peru
Finland
Romania
Australia
Russian Federation
Denmark
Taiwan
Ukraine
France
Japan
Poland
Canada
Sweden
China
Portugal
United States
Germany
Italy
Brazil
Mexico
Czechia
Israel
Belarus
Spain
Turkey

location_facility:
Investigational Site Number 376003
Investigational Site Number 124007
Investigational Site Number 112001
Investigational Site Number 250005
Investigational Site Number 840016
Investigational Site Number 642004
Investigational Site Number 616002
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Investigational Site Number 124004
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Investigational Site Number 250001
Investigational Site Number 484003
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Investigational Site Number 158003
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Investigational Site Number 392001
Investigational Site Number 620005
Investigational Site Number 643002
Investigational Site Number 250003
Investigational Site Number 840001
Investigational Site Number 124002
Investigational Site Number 203001
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Investigational Site Number 840018
Investigational Site Number 076004
Investigational Site Number 156005
Investigational Site Number 112004
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Investigational Site Number 804004
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Investigational Site Number 392006
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Investigational Site Number 792001
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Investigational Site Number 604005
Investigational Site Number 804010
Investigational Site Number 642003
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Investigational Site Number 380004
Investigational Site Number 392005
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Investigational Site Number 643001
Investigational Site Number 158001
Investigational Site Number 840138
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Investigational Site Number 158002
Investigational Site Number 752003
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Investigational Site Number 643004
Investigational Site Number 484006
Investigational Site Number 203004
Investigational Site Number 380002
Investigational Site Number 804006
Investigational Site Number 246002
Investigational Site Number 484005
Investigational Site Number 203003
Investigational Site Number 124006
Investigational Site Number 620004
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type: Registry Identifier

title: A Phase II, Single-arm Study of Orally Administered BEZ235 as Second-line Therapy in Patients With Advanced or Metastatic Endometrial Carcinoma

summary: This is an open label and single arm study to investigate the safety and efficacy of BEZ235 in adult women with endometrial carcinoma whose disease progressed (or recurred) while on or after first-line antineoplastic treatment for advanced endometrial carcinoma.

status: Withdrawn

location_country:
Italy
Brazil
Germany
France
Japan
Poland
Singapore
Russian Federation
Spain
Turkey
United States
Canada

location_facility: University of Oklahoma Health Sciences Center

location_facility: University of Texas Southwestern Medical Center

status_simplified: Unknown