ReferenceCitation: Sweeney C, Bracarda S, Sternberg CN, Chi KN, Olmos D, Sandhu S, Massard C, Matsubara N, Alekseev B, Parnis F, Atduev V, Buchschacher GL Jr, Gafanov R, Corrales L, Borre M, Stroyakovskiy D, Alves GV, Bournakis E, Puente J, Harle-Yge ML, Gallo J, Chen G, Hanover J, Wongchenko MJ, Garcia J, de Bono JS. Ipatasertib plus abiraterone and prednisolone in metastatic castration-resistant prostate cancer (IPATential150): a multicentre, randomised, double-blind, phase 3 trial. Lancet. 2021 Jul 10;398(10295):131-142. doi: 10.1016/S0140-6736(21)00580-8.

family: Sweeney

full_name: Christopher Sweeney

given: Christopher

family: Bracarda

full_name: Sergio Bracarda

given: Sergio

family: Sternberg

full_name: Cora N Sternberg

given: Cora N

family: Chi

full_name: Kim N Chi

given: Kim N

family: Olmos

full_name: David Olmos

given: David

family: Sandhu

full_name: Shahneen Sandhu

given: Shahneen

family: Massard

full_name: Christophe Massard

given: Christophe

family: Matsubara

full_name: Nobuaki Matsubara

given: Nobuaki

family: Alekseev

full_name: Boris Alekseev

given: Boris

family: Parnis

full_name: Francis Parnis

given: Francis

family: Atduev

full_name: Vagif Atduev

given: Vagif

family: Buchschacher

full_name: Gary L Buchschacher

given: Gary L

suffix: Jr

family: Gafanov

full_name: Rustem Gafanov

given: Rustem

family: Corrales

full_name: Luis Corrales

given: Luis

family: Borre

full_name: Michael Borre

given: Michael

family: Stroyakovskiy

full_name: Daniil Stroyakovskiy

given: Daniil

family: Alves

full_name: Gustavo Vasconcelos Alves

given: Gustavo Vasconcelos

family: Bournakis

full_name: Evangelos Bournakis

given: Evangelos

family: Puente

full_name: Javier Puente

given: Javier

family: Harle-Yge

full_name: Marie-Laurence Harle-Yge

given: Marie-Laurence

family: Gallo

full_name: Jorge Gallo

given: Jorge

family: Chen

full_name: Geng Chen

given: Geng

family: Hanover

full_name: Justin Hanover

given: Justin

family: Wongchenko

full_name: Matthew J Wongchenko

given: Matthew J

family: Garcia

full_name: Josep Garcia

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Greece
Australia
Belgium
Russian Federation
Denmark
Taiwan
Costa Rica
France
Japan
Poland
Thailand
Norway
Canada
Korea, Republic of
Hungary
Ireland
China
Portugal
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
Spain

location_facility: Odense Universitetshospital, Onkologisk Afdeling R

location_facility: Miami Cancer Institute of Baptist Health, Inc.

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1

location_facility: Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital; Oncology Day Unit

location_facility: ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico

location_facility: University Hospital of Patras Medical Oncology

location_facility: Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o.

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc

location_facility: Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie; Klinika Nowotworow Ukladu Moczowego

location_facility: Landeskrankenhaus Salzburg; Universitätsklinik für Urologie und Andrologie der PMU

location_facility: KAOHSIUNG MEDICAL UNI CHUNG-HO HOSPITAL; Dept. Of Urology

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: ICIMED Instituto de Investigación en Ciencias Médicas

location_facility: Kaiser Permanente San Diego - Los Angeles

location_facility: Russian Scientific Center of Roentgenoradiology

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

location_facility: Maharaj Nakorn Chiangmai Hospital; Department of Surgery/ Urology unit

location_facility: Blokhin Cancer Research Center; Urological Dept

location_facility: Urology Cancer Center & GU Research Network

location_facility: Severance Hospital, Yonsei University Health System

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

location_facility: Mount Vernon & Watford Trust Hospital; Dept. of Clinical Oncology

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Chang Gung Memorial Hospital-LinKou; Urology

location_facility: Institut Catala d´Oncologia Hospital Germans Trias i Pujol

location_facility: Sykehuset Østfold Kalnes; Onkologisk seksjon

location_facility: Hospital Clinic i Provincial; Servicio de Urología

location_facility: Hackensack Univ Medical Center; John Theurer Cancer Ctr

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: University Hospital Kyoto Prefectural University of Medicine

location_facility: Ospedale Area Aretina Nord; U.O.C. Oncologia

location_facility: A.O. San Carlo Borromeo; U.O.C. Oncologia

location_facility: Centro Medico Culiacan SA de CV; Consultorio Medico 303 B

location_facility: Royal Marsden Hospital; Institute of Cancer Research

location_facility: Consultorio de Especialidad en Urologia Privado

location_facility: Belinson Medical Center, Division of Oncology

location_facility: Orszagos Onkologiai Intezet; "C" Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály

location_facility: A.O. Istituti Ospitalieri - Cremona; S.C. Oncologia

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Aarhus Universitetshospital, Urologisk Afd. K

location_facility: P.A. Herzen Oncological Inst. ; Oncology

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: HUC; Servico de Urologia e Transplantacao Renal

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Seoul National University Bundang Hospital

location_facility: CHU de Québec - Université Laval - Hôtel-Dieu de Québec

location_facility: Ordensklinikum Linz Elisabethinen; Abteilung für Urologie und Andrologie

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

location_facility: Semmelwies University of Medicine; Urology Dept.

location_facility: Chaim Sheba medical center, Oncology division

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Mater Misericordiae Uni Hospital; Oncology

location_facility: Institut Gustave Roussy; Departement Oncologie Medicale

location_facility: Alexandras Hospital; Dept. of Clin. Therapeutics, Athens Uni School of Medicine

location_facility: University of Colorado Hospital - Anschutz Cancer Pavilion

location_facility: Niigata University Medical & Dental Hospital

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

location_facility: Lynn Cancer Institute/Boca Raton Regional Hospital

location_facility: Woj. Wielospec. Centrum Onkologii i Traumatologii

location_facility: Addenbrookes Nhs Trust; Oncology Clinical Trials Unit

location_facility: SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarawskiego

location_facility: China Medical University Hospital; Urology

location_facility: Institut Mutualiste Montsouris; Oncologie

location_facility: Beijing Friendship Hospital Affiliated of Capital University of Medical Science

location_facility: Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

location_facility: Hospital Universitario Son Espases; Servicio de Oncologia

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie

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

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Papageorgiou General Hospital; Medical Oncology

location_facility: Taichung Veterans General Hospital; Division of Urology

location_facility: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

location_facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

location_facility: Ospedale di Trento-Presidio Ospedaliero Santa Chiara; Oncologia Medica

location_facility: Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica

location_facility: Debreceni Egyetem Klinikai Kozpont ; Department of Oncology

location_facility: Hamilton Health Sciences - Juravinski Cancer Centre

location_facility: Hopital d'Instruction des Armees de Begin

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

location_facility: Royal Wolverhampton hospital; McHale Building

title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial Testing Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Asymptomatic or Mildly Symptomatic, Previously Untreated, Metastatic Castrate-Resistant Prostate Cancer

summary: The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of ipatasertib plus abiraterone and prednisone/prednisolone compared with placebo plus abiraterone and prednisone/prednisolone in participants with metastatic castrate-resistant prostate cancer (mCRPC).


ReferenceType: derived

ReferenceCitation: de Wit R, Wülfing C, Castellano D, Kramer G, Eymard JC, Sternberg CN, Fizazi K, Tombal B, Bamias A, Carles J, Iacovelli R, Melichar B, Sverrisdóttir Á, Theodore C, Feyerabend S, Helissey C, Foster MC, Ozatilgan A, Geffriaud-Ricouard C, de Bono J. Baseline neutrophil-to-lymphocyte ratio as a predictive and prognostic biomarker in patients with metastatic castration-resistant prostate cancer treated with cabazitaxel versus abiraterone or enzalutamide in the CARD study. ESMO Open. 2021 Oct;6(5):100241. doi: 10.1016/j.esmoop.2021.100241. Epub 2021 Aug 24.

family: de Wit

full_name: R. de Wit

given: R.

sequence: first

family: Wülfing

full_name: C. Wülfing

given: C.

sequence: additional

family: Castellano

full_name: D. Castellano

given: D.

family: Kramer

full_name: G. Kramer

given: G.

family: Eymard

full_name: J.-C. Eymard

family: Sternberg

full_name: C.N. Sternberg

family: Fizazi

full_name: K. Fizazi

given: K.

family: Tombal

full_name: B. Tombal

given: B.

family: Bamias

full_name: A. Bamias

given: A.

family: Carles

full_name: J. Carles

given: J.

family: Iacovelli

full_name: R. Iacovelli

family: Melichar

full_name: B. Melichar

family: Sverrisdóttir

full_name: Á. Sverrisdóttir

given: Á.

family: Theodore

full_name: C. Theodore

family: Feyerabend

full_name: S. Feyerabend

given: S.

family: Helissey

full_name: C. Helissey

family: Foster

full_name: M.C. Foster

family: Ozatilgan

full_name: A. Ozatilgan

family: Geffriaud-Ricouard

full_name: C. Geffriaud-Ricouard

family: de Bono

full_name: J. de Bono

bso_classification: Medical research

currency_apc_doaj: EUR

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: ESMO Open

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Sternberg CN, Castellano D, de Bono J, Fizazi K, Tombal B, Wülfing C, Kramer G, Eymard JC, Bamias A, Carles J, Iacovelli R, Melichar B, Sverrisdóttir Á, Theodore C, Feyerabend S, Helissey C, Poole EM, Ozatilgan A, Geffriaud-Ricouard C, de Wit R. Efficacy and Safety of Cabazitaxel Versus Abiraterone or Enzalutamide in Older Patients with Metastatic Castration-resistant Prostate Cancer in the CARD Study. Eur Urol. 2021 Oct;80(4):497-506. doi: 10.1016/j.eururo.2021.06.021. Epub 2021 Jul 15.

ReferenceCitation: Fizazi K, Kramer G, Eymard JC, Sternberg CN, de Bono J, Castellano D, Tombal B, Wülfing C, Liontos M, Carles J, Iacovelli R, Melichar B, Sverrisdóttir Á, Theodore C, Feyerabend S, Helissey C, Oudard S, Facchini G, Poole EM, Ozatilgan A, Geffriaud-Ricouard C, Bensfia S, de Wit R. Quality of life in patients with metastatic prostate cancer following treatment with cabazitaxel versus abiraterone or enzalutamide (CARD): an analysis of a randomised, multicentre, open-label, phase 4 study. Lancet Oncol. 2020 Nov;21(11):1513-1525. doi: 10.1016/S1470-2045(20)30449-6. Epub 2020 Sep 11.

ReferenceCitation: de Wit R, de Bono J, Sternberg CN, Fizazi K, Tombal B, Wülfing C, Kramer G, Eymard JC, Bamias A, Carles J, Iacovelli R, Melichar B, Sverrisdóttir Á, Theodore C, Feyerabend S, Helissey C, Ozatilgan A, Geffriaud-Ricouard C, Castellano D; CARD Investigators. Cabazitaxel versus Abiraterone or Enzalutamide in Metastatic Prostate Cancer. N Engl J Med. 2019 Dec 26;381(26):2506-2518. doi: 10.1056/NEJMoa1911206. Epub 2019 Sep 30.

name: From the Erasmus Medical Center, Rotterdam, the Netherlands (R.W.); the Institute of Cancer Research and the Royal Marsden Hospital, London (J.B.); Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); Institut Gustave Roussy and University of Paris Sud, Villejuif (K.F.), Jean Godinot Institute and Reims Champagne–Ardenne University, Reims (J.-C.E.), Foch Hospital, Suresnes (C.T.), Hôpital d’Instruction des Armées Bégin, Saint Mandé (C.H.), and Sanofi, Europe Medical...

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

location_country:
Italy
Austria
Netherlands
France
Czechia
Greece
Norway
Ireland
Belgium
Spain
Germany
United Kingdom
Iceland

location_facility:
Investigational Site Number 276023
Investigational Site Number 250005
Investigational Site Number 056008
Investigational Site Number 056011
Investigational Site Number 724001
Investigational Site Number 276006
Investigational Site Number 578001
Investigational Site Number 380005
Investigational Site Number 040002
Investigational Site Number 056002
Investigational Site Number 276017
Investigational Site Number 380003
Investigational Site Number 250010
Investigational Site Number 300004
Investigational Site Number 040004
Investigational Site Number 276022
Investigational Site Number 056001
Investigational Site Number 276003
Investigational Site Number 724002
Investigational Site Number 276016
Investigational Site Number 276013
Investigational Site Number 380008
Investigational Site Number 250002
Investigational Site Number 250016
Investigational Site Number 528005
Investigational Site Number 250009
Investigational Site Number 250001
Investigational Site Number 276009
Investigational Site Number 276010
Investigational Site Number 300001
Investigational Site Number 056007
Investigational Site Number 250013
Investigational Site Number 040003
Investigational Site Number 578002
Investigational Site Number 203001
Investigational Site Number 724003
Investigational Site Number 276024
Investigational Site Number 276012
Investigational Site Number 276002
Investigational Site Number 380011
Investigational Site Number 056005
Investigational Site Number 380001
Investigational Site Number 276018
Investigational Site Number 300005
Investigational Site Number 380004
Investigational Site Number 203005
Investigational Site Number 300002
Investigational Site Number 276019
Investigational Site Number 352001
Investigational Site Number 276004
Investigational Site Number 528004
Investigational Site Number 372003
Investigational Site Number 250019
Investigational Site Number 250018
Investigational Site Number 380007
Investigational Site Number 276028
Investigational Site Number 250011
Investigational Site Number 250008
Investigational Site Number 056006
Investigational Site Number 276011
Investigational Site Number 276008
Investigational Site Number 056013
Investigational Site Number 380006
Investigational Site Number 380002
Investigational Site Number 203003
Investigational Site Number 372004
Investigational Site Number 203002
Investigational Site Number 276020
Investigational Site Number 528007
Investigational Site Number 276007
Investigational Site Number 276001
Investigational Site Number 250004
Investigational Site Number 250014
Investigational Site Number 276026
Investigational Site Number 372001
Investigational Site Number 826001
Investigational Site Number 250006
Investigational Site Number 276025
Investigational Site Number 250012
Investigational Site Number 276027
Investigational Site Number 528003
Investigational Site Number 380009
Investigational Site Number 528002
Investigational Site Number 724004
Investigational Site Number 056010
Investigational Site Number 056003
Investigational Site Number 250007

title: A Randomized, Open Label, Multicenter Study of Cabazitaxel Versus an Androgen Receptor (AR)-Targeted Agent (Abiraterone or Enzalutamide) in mCRPC Patients Previously Treated With Docetaxel and Who Rapidly Failed a Prior AR-targeted Agent (CARD)

summary:
Primary Objective:

To compare the radiographic progression-free survival (rPFS) [using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for tumor lesions and Prostate Cancer Working Group 2 (PCWG2) criteria for bone scan lesions or death due to any cause] with chemotherapy (cabazitaxel plus prednisone, Arm A) versus Androgen Receptor (AR)-targeted therapy (enzalutamide or abiraterone acetate plus prednisone, Arm B) in mCRPC patients who have been treated with docetaxel and who had disease progression while receiving AR-targeted therapy within 12 months of AR treatment initiation (≤12 months, either before or after docetaxel).

Secondary Objective:

To compare efficacy for:
Prostate-specific antigen (PSA) response rate and time to PSA progression (TTPP).
Progression-free survival (PFS).
Overall survival (OS).
Tumor response rate and duration of tumor response.
Pain response and time to pain progression.
Symptomatic skeletal event (SSE) rate and time to occurrence of any SSE.
Health status and Health-related Quality of Life (HRQOL).
To evaluate the correlation of a signature of resistance to AR-targeted agents with clinical outcome via the analysis of circulating tumor cell (CTC) phenotypes as well as expression and localization of proteins including AR isoforms in CTCs.
To evaluate safety in the 2 treatment arms.


ReferenceCitation: Ciruelos EM, Rugo HS, Mayer IA, Levy C, Forget F, Delgado Mingorance JI, Safra T, Masuda N, Park YH, Juric D, Conte P, Campone M, Loibl S, Iwata H, Zhou X, Park J, Ridolfi A, Lorenzo I, André F. Patient-Reported Outcomes in Patients With PIK3CA-Mutated Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer From SOLAR-1. J Clin Oncol. 2021 Jun 20;39(18):2005-2015. doi: 10.1200/JCO.20.01139. Epub 2021 Mar 29.

name: Department of Medical Oncology, Breast Cancer Unit, Hospital Universitario 12 de Octubre, Madrid, Spain

family: Ciruelos

full_name: Eva Maria Ciruelos

given: Eva Maria

name: UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA

family: Rugo

full_name: Hope S. Rugo

given: Hope S.

name: Division of Hematology/Oncology, Vanderbilt University Medical Center/Vanderbilt-Ingram Cancer Center, Nashville, TN

family: Mayer

full_name: Ingrid A. Mayer

given: Ingrid A.

name: Responsable de l'Institut Normand du Sein, Centre François Baclesse, Caen, France

family: Levy

full_name: Christelle Levy

given: Christelle

name: Oncologie CHA, Hôpital de Libramont, Vivalia, Libramont-Chevigny, Belgium

family: Forget

full_name: Frédéric Forget

given: Frédéric

name: Oncology Department, University Hospital of Badajoz, Servicio Extremeño de Salud, Badajoz, Spain, and Hospital Infanta Cristina, Badajoz, Spain

family: Delgado Mingorance

full_name: Juan Ignacio Delgado Mingorance

given: Juan Ignacio

name: Medical Oncology and Radiotherapy, Tel Aviv Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel

family: Safra

full_name: Tamar Safra

given: Tamar

name: Department of Surgery and Breast Oncology, National Hospital Organization Osaka National Hospital, Osaka, Japan;

family: Masuda

full_name: Norikazu Masuda

given: Norikazu

name: Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea

family: Park

full_name: Yeon Hee Park

given: Yeon Hee

name: Departments of Hematology/Oncology and Medicine, Massachusetts General Hospital, Boston, MA

family: Juric

full_name: Dejan Juric

given: Dejan

name: Dipartimento Di Scienze Chirurgiche Oncologiche e Gastroenterologiche, Università di Padova and Oncologia Medica 2, Istituto Oncologico Veneto IRCCS, Padova, Italy

family: Conte

full_name: Pierfranco Conte

given: Pierfranco

name: Institut de Cancérologie de l'Ouest, Angers, France

family: Campone

full_name: Mario Campone

given: Mario

name: German Breast Group, GBG Forschungs GmbH, Neu-Isenburg, Germany

name: Center for Haematology and Oncology, Bethanien Hospital, Frankfurt, Germany

family: Loibl

full_name: Sibylle Loibl

given: Sibylle

name: Department of Breast Oncology, Aichi Cancer Center, Nagoya, Japan

family: Iwata

full_name: Hiroji Iwata

given: Hiroji

name: RTI Health Solutions, Research Triangle Park, NC

family: Zhou

full_name: Xiaolei Zhou

given: Xiaolei

name: Novartis Pharmaceuticals Corporation, East Hanover, NJ

full_name: Jinhee Park

given: Jinhee

name: Global Medical Affairs Biostatistics, Novartis Pharma S.A.S., Rueil-Malmaison, France

family: Ridolfi

full_name: Antonia Ridolfi

given: Antonia

family: Lorenzo

full_name: Ines Lorenzo

given: Ines

name: Department of Medical Oncology, Institut Gustave Roussy, Villejuif, France

family: André

full_name: Fabrice André

given: Fabrice

journal_name: Journal of Clinical Oncology

oa_host_type: publisher

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: American Society of Clinical Oncology (ASCO)

title: Patient-Reported Outcomes in Patients With PIK3CA-Mutated Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Advanced Breast Cancer From SOLAR-1

ReferenceCitation: André F, Ciruelos EM, Juric D, Loibl S, Campone M, Mayer IA, Rubovszky G, Yamashita T, Kaufman B, Lu YS, Inoue K, Pápai Z, Takahashi M, Ghaznawi F, Mills D, Kaper M, Miller M, Conte PF, Iwata H, Rugo HS. Alpelisib plus fulvestrant for PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer: final overall survival results from SOLAR-1. Ann Oncol. 2021 Feb;32(2):208-217. doi: 10.1016/j.annonc.2020.11.011. Epub 2020 Nov 25.

full_name: F. André

given: F.

full_name: E.M. Ciruelos

full_name: D. Juric

title: Alpelisib plus fulvestrant for PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor-2–negative advanced breast cancer: final overall survival results from SOLAR-1

ReferenceCitation: Rugo HS, André F, Yamashita T, Cerda H, Toledano I, Stemmer SM, Jurado JC, Juric D, Mayer I, Ciruelos EM, Iwata H, Conte P, Campone M, Wilke C, Mills D, Lteif A, Miller M, Gaudenzi F, Loibl S. Time course and management of key adverse events during the randomized phase III SOLAR-1 study of PI3K inhibitor alpelisib plus fulvestrant in patients with HR-positive advanced breast cancer. Ann Oncol. 2020 Aug;31(8):1001-1010. doi: 10.1016/j.annonc.2020.05.001. Epub 2020 May 13.

ReferenceCitation: André F, Ciruelos E, Rubovszky G, Campone M, Loibl S, Rugo HS, Iwata H, Conte P, Mayer IA, Kaufman B, Yamashita T, Lu YS, Inoue K, Takahashi M, Pápai Z, Longin AS, Mills D, Wilke C, Hirawat S, Juric D; SOLAR-1 Study Group. Alpelisib for PIK3CA-Mutated, Hormone Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2019 May 16;380(20):1929-1940. doi: 10.1056/NEJMoa1813904.

name: From Institut Gustave Roussy, INSERM Unité 981, Université Paris-Sud, Villejuif (F.A.), Institut de Cancérologie de l’Ouest, St. Herblain (M.C.), and Novartis Pharma, Paris (A.-S.L.) — all in France; Hospital Universitario 12 de Octubre, Madrid (E.C.); National Institute of Oncology (G.R.) and Duna Medical Center (Z.P.), Budapest, Hungary; German Breast Group, Neu-Isenburg, and Center for Hematology and Oncology Bethanien, Frankfurt — both in Germany (S.L.); UCSF Helen Diller Family Comprehensive Cancer...

repository_institution: University of Padova - Padua Research Archive

title: Alpelisib for PIK3CA-Mutated, Hormone Receptor–Positive Advanced Breast Cancer

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

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

location_country:
Peru
Greece
Romania
Australia
Belgium
Russian Federation
Taiwan
India
France
Japan
Thailand
Argentina
Canada
Korea, Republic of
Chile
Sweden
Hong Kong
Netherlands
Bulgaria
Hungary
Germany
United States
United Kingdom
Italy
Austria
Brazil
Lebanon
Mexico
Czechia
Israel
Spain

location_facility: Fort Wayne Medical Oncology/Hematology, Inc. Dept.of Fort Wayne Med Onc/Hem

location_facility: Good Samaritan Regional Medical Center Good Samaritan Reg Med Ctr

location_facility: North Shore University Health System NorthShore University

location_facility: Rutgers Cancer Institute of New Jersey SC-2

location_facility: St. Francis Health Comprehensive Cancer Center SC

location_facility: Rush University Medical Center Rush Uni Medical Center

location_facility: Massachusetts General Hospital Updated Regulatory

location_facility: Texas Oncology PA Dallas Presbyterian Hospital SC-1

location_facility: Cancer Therapy and Research Center UT Health Science Center InstituteForDrugDevelopment(4)

location_facility: Ironwood Cancer and Research Centers Chandler 2

location_facility: University Hospitals of Cleveland Seidman Cancer Center SC

location_facility: Florida Cancer Specialists FL Cancer Specialists

title: A Phase III Randomized Double-blind, Placebo Controlled Study of Alpelisib in Combination With Fulvestrant for Men and Postmenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment

summary: To determine whether treatment with alpelisib plus fulvestrant prolongs progression-free survival compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer, who received prior treatment with an Aromatase Inhibitor either as (neo)adjuvant or for advanced disease.


title: A Phase III, Open Label, Randomized Study to Assess the Efficacy and Safety of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment With a New Hormonal Agent and Have Homologous Recombination Repair Gene Mutations (PROfound)

summary: The purpose of this study is to evaluate the efficacy and safety of olaparib versus enzalutamide or abiraterone acetate in subjects with metastatic castration-resistant prostate cancer who have failed prior treatment with a new hormonal agent and have homologous recombination repair gene mutations.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceCitation: Hussain M, Mateo J, Fizazi K, Saad F, Shore N, Sandhu S, Chi KN, Sartor O, Agarwal N, Olmos D, Thiery-Vuillemin A, Twardowski P, Roubaud G, Özgüroğlu M, Kang J, Burgents J, Gresty C, Corcoran C, Adelman CA, de Bono J; PROfound Trial Investigators. Survival with Olaparib in Metastatic Castration-Resistant Prostate Cancer. N Engl J Med. 2020 Dec 10;383(24):2345-2357. doi: 10.1056/NEJMoa2022485. Epub 2020 Sep 20.

name: From the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); Vall d’Hebron Institute of Oncology and Vall d’Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Instituto de Investigación Biomédica de Málaga, Málaga (D.O.) — all in Spain; Institut Gustave Roussy, University of Paris Saclay, Villejuif (K.F.), the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon,...

family: Hussain

full_name: Maha Hussain

given: Maha

family: Mateo

full_name: Joaquin Mateo

given: Joaquin

family: Fizazi

full_name: Karim Fizazi

given: Karim

family: Saad

full_name: Fred Saad

given: Fred

family: Shore

full_name: Neal Shore

given: Neal

family: Sandhu

full_name: Shahneen Sandhu

given: Shahneen

family: Chi

full_name: Kim N. Chi

given: Kim N.

family: Sartor

full_name: Oliver Sartor

given: Oliver

family: Agarwal

full_name: Neeraj Agarwal

given: Neeraj

family: Olmos

full_name: David Olmos

given: David

family: Thiery-Vuillemin

full_name: Antoine Thiery-Vuillemin

given: Antoine

family: Twardowski

full_name: Przemyslaw Twardowski

given: Przemyslaw

family: Roubaud

full_name: Guilhem Roubaud

given: Guilhem

family: Özgüroğlu

full_name: Mustafa Özgüroğlu

given: Mustafa

family: Kang

full_name: Jinyu Kang

given: Jinyu

family: Burgents

full_name: Joseph Burgents

given: Joseph

family: Gresty

full_name: Christopher Gresty

given: Christopher

family: Corcoran

full_name: Claire Corcoran

given: Claire

family: Adelman

full_name: Carrie A. Adelman

given: Carrie A.

family: de Bono

full_name: Johann de Bono

given: Johann

journal_name: New England Journal of Medicine

evidence: open (via free article)

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: de Bono J, Mateo J, Fizazi K, Saad F, Shore N, Sandhu S, Chi KN, Sartor O, Agarwal N, Olmos D, Thiery-Vuillemin A, Twardowski P, Mehra N, Goessl C, Kang J, Burgents J, Wu W, Kohlmann A, Adelman CA, Hussain M. Olaparib for Metastatic Castration-Resistant Prostate Cancer. N Engl J Med. 2020 May 28;382(22):2091-2102. doi: 10.1056/NEJMoa1911440. Epub 2020 Apr 28.

name: From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) — all in the United Kingdom; Vall d’Hebron Institute of Oncology and Vall d’Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) — all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the...

location_country:
Australia
Denmark
Taiwan
France
Japan
Norway
Argentina
Canada
Korea, Republic of
Sweden
Netherlands
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Israel
Spain
Turkey


type: EudraCT Number

title: Edoxaban Versus Standard of Care and Their Effects on Clinical Outcomes in Patients Having Undergone Transcatheter Aortic Valve Implantation (TAVI) - in Atrial Fibrillation

summary:
When the upper chambers of a person's heart receive irregular electrical signals it causes abnormal rhythm in the heart beat. This is called atrial fibrillation.

Atrial fibrillation increases the chance of having a heart attack or stroke. Some patients also get new heart valves using a catheter.

Often doctors give patients a medicine called a vitamin K antagonist (VKA), because it is considered the standard care. This study will see how edoxaban compares to VKA in patients who got a new heart valve by using a catheter.

The study will compare the two drugs for up to three years after heart valve replacement, looking at the drug's overall side effects (called adverse events) and major bleeding.

status: Completed

study_completion_date_type: Actual

ReferenceCitation: Van Mieghem NM, Unverdorben M, Hengstenberg C, Möllmann H, Mehran R, López-Otero D, Nombela-Franco L, Moreno R, Nordbeck P, Thiele H, Lang I, Zamorano JL, Shawl F, Yamamoto M, Watanabe Y, Hayashida K, Hambrecht R, Meincke F, Vranckx P, Jin J, Boersma E, Rodés-Cabau J, Ohlmann P, Capranzano P, Kim HS, Pilgrim T, Anderson R, Baber U, Duggal A, Laeis P, Lanz H, Chen C, Valgimigli M, Veltkamp R, Saito S, Dangas GD; ENVISAGE-TAVI AF Investigators. Edoxaban versus Vitamin K Antagonist for Atrial Fibrillation after TAVR. N Engl J Med. 2021 Aug 28. doi: 10.1056/NEJMoa2111016. [Epub ahead of print]

name: From the Department of Cardiology, Erasmus University Medical Center, Thoraxcenter, Rotterdam, the Netherlands (N.M.V.M., E.B.); Daiichi Sankyo, Basking Ridge, NJ (M.U., J.J., A.D., C.C.); the Department of Internal Medicine II, Division of Cardiology, Vienna General Hospital, Medical University, Vienna (C.H., I.L.); the Department of Internal Medicine, St. Johannes Hospital, Dortmund (H.M.), the Department of Internal Medicine I, University Hospital Würzburg, Würzburg (P.N.), the Department of Internal...

family: Van Mieghem

full_name: Nicolas M. Van Mieghem

given: Nicolas M.

family: Unverdorben

full_name: Martin Unverdorben

given: Martin

family: Hengstenberg

full_name: Christian Hengstenberg

given: Christian

family: Möllmann

full_name: Helge Möllmann

given: Helge

family: Mehran

full_name: Roxana Mehran

given: Roxana

family: López-Otero

full_name: Diego López-Otero

given: Diego

family: Nombela-Franco

full_name: Luis Nombela-Franco

given: Luis

family: Moreno

full_name: Raul Moreno

given: Raul

family: Nordbeck

full_name: Peter Nordbeck

given: Peter

family: Thiele

full_name: Holger Thiele

given: Holger

family: Lang

full_name: Irene Lang

given: Irene

family: Zamorano

full_name: José L. Zamorano

given: José L.

family: Shawl

full_name: Fayaz Shawl

given: Fayaz

family: Yamamoto

full_name: Masanori Yamamoto

given: Masanori

family: Watanabe

full_name: Yusuke Watanabe

given: Yusuke

family: Hayashida

full_name: Kentaro Hayashida

given: Kentaro

family: Hambrecht

full_name: Rainer Hambrecht

given: Rainer

family: Meincke

full_name: Felix Meincke

given: Felix

family: Vranckx

full_name: Pascal Vranckx

given: Pascal

family: Jin

full_name: James Jin

given: James

family: Boersma

full_name: Eric Boersma

given: Eric

family: Rodés-Cabau

full_name: Josep Rodés-Cabau

given: Josep

family: Ohlmann

full_name: Patrick Ohlmann

given: Patrick

ReferenceCitation: Giacoppo D. Anticoagulation After Transcatheter Aortic Valve Replacement: Evolving Answers and Still Unaddressed Questions. JACC Cardiovasc Interv. 2021 Aug 9;14(15):1714-1716. doi: 10.1016/j.jcin.2021.06.004. Epub 2021 Jul 14. Erratum in: JACC Cardiovasc Interv. 2021 Oct 25;14(20):2311-2313.

ReferenceCitation: Van Mieghem NM, Unverdorben M, Valgimigli M, Mehran R, Boersma E, Baber U, Hengstenberg C, Shi M, Chen C, Saito S, Veltkamp R, Vranckx P, Dangas GD. Edoxaban Versus standard of care and their effects on clinical outcomes in patients having undergone Transcatheter Aortic Valve Implantation in Atrial Fibrillation-Rationale and design of the ENVISAGE-TAVI AF trial. Am Heart J. 2018 Nov;205:63-69. doi: 10.1016/j.ahj.2018.07.006. Epub 2018 Aug 29.

title: Edoxaban Versus standard of care and their effects on clinical outcomes in patients having undergone Transcatheter Aortic Valve Implantation in Atrial Fibrillation—Rationale and design of the ENVISAGE-TAVI AF trial

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

location_country:
Italy
Austria
United States
Switzerland
Netherlands
Germany
France
Japan
Poland
Belgium
Spain
Canada
United Kingdom
Korea, Republic of

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: Michigan Heart, St. Joseph Mercy Health System

location_facility: Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

location_facility: University Hospital of Wales, Heath Park

location_facility: Azienda Ospedaliero-Universitaria Policlinico Umberto I

location_facility: Universitätsklinik für Innere Medizin II

location_facility: Penn State Health, Milton S. Hershey Medical Center

location_facility: University Hospitals of Leicester NHS Trust

location_facility: University of Iowa Hospitals and Clinics

location_facility: Newmarket Cardiac Surgery Research Incorporated

location_facility: University of California - San Francisco

location_facility: University of Massachusetts Memorial Medical Center

location_facility: Universitaetsklinik fuer Innere Medizin III

location_facility: Complexo hospitalario universitario de Santiago de Compostela

location_facility: Universitaetsklinik Schleswig-Holstein Campus Kiel

location_facility: Azienda Socio Sanitaria Territoriale di Lecco

location_facility: Oxford University Hospitals, John Radcliffe Hospital

location_facility: Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhugel

location_facility: Hospital Clinico y Provincial de Barcelona

location_facility: Doylestown Health Cardiothoracic Surgery

location_facility: Heart Center Dresden, University Clinic Technical University Dresden

location_facility: University of Texas Health Science Center Houston

location_facility: University of Arizona Sarver Heart Center

location_facility: ASST Spedali Civili di Brescia-UO Cardiologia

location_facility: Hospital Universitario Central de Asturias

location_facility: Universitatsklinikum Essen, Klinik fur Kardiologie

location_facility: Ospedale Sant'Andrea - U.O.S. Emodinamica Cardiologia Interventistica

location_facility: Hospital Universitari Germans Trias I Pujol

location_facility: Klinikum rechts der Isar der Technischen Universitat Munchen

location_facility: Complexo Hospitalario Universitario de A Coruna

location_facility: Providence Sacred Heart Medical Research Center

location_facility: Moses H. Cone Memorial Hospital Operating Corporation d/b/a Cone Health

location_facility: Immanuel Klinikum Bernau Herzzentrum Brandenburg

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: ASST Ovest Milanese - Presidio Ospedallero di Legnana

location_facility: Hospital General Universitario de Alicante

location_facility: NY Presbyterian - Brooklyn Methodist Hospital

location_facility: ZNA - Stuivenberg Ziekenhuis Netwerk Antwerpen

location_facility: AOU Careggi, Interventistica Cardiologica Strutturale

location_facility: Asklepios St. Georg Abteilung fuer Kardiologie

location_facility: Oklahoma Heart Hospital Research Foundation

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Universitatsmedizin Mainz, Zentrum fur Kardiologie

location_facility: Universitaetsklinikum Tuebingen Medizinische Klinik, Abteilung III

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Elisabeth Krankenhaus Essen Klinik fur Kardiologie und Angiologie

location_facility: A.A Dei Colli Monaldi UOC Cardiologia Interventistica

location_facility: Clinique du Millenaire Service de Cardiologie Interventionelle


title: A Randomized Trial Comparing the ELUVIA Drug-eluting Stent Versus Bare Metal Self-expanding Nitinol Stents in the Treatment of Superficial Femoral and/or Proximal Popliteal Arteries

acronym: EMINENT

summary: The EMINENT study is a prospective, multi-center study confirming the superior effectiveness of the ELUVIA stent versus Self-Expanding Bare Nitinol Stents in the treatment of lesions in the femoropopliteal arteries.

ipd_sharing: No

lead_sponsor: Boston Scientific Corporation

location_country:
Italy
Austria
Switzerland
Netherlands
France
Ireland
Belgium
Spain
Germany
United Kingdom

location_facility: Klinikum Nordoberpfalz AG, Klinikum Weiden

location_facility: Manchester University NHS Foundation Trust

location_facility: Krankenhäuser Landkreis Freudenstadt GmbH

location_facility: University Medical Center of Johannes Gutenberg-Mainz

location_facility: University Hospital Schleswig-Holstein Campus Kiel

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Ongoing


title: An Open Label, Randomized, Two Arm Phase III Study of Nivolumab in Combination With Ipilimumab Versus Extreme Study Regimen (Cetuximab + Cisplatin/Carboplatin + Fluorouracil) as First Line Therapy in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

acronym: CheckMate 651

summary: The main purpose of this study is to compare nivolumab and ipilimumab with the extreme regimen as first line treatment in patients with recurrent or metastatic squamous cell of the head and neck cancer

ReferenceCitation: Hwang M, Seiwert TY. Are taxanes the future for head and neck cancer? Pragmatism in the immunotherapy era. Lancet Oncol. 2021 Apr;22(4):413-415. doi: 10.1016/S1470-2045(21)00121-2. Epub 2021 Mar 5. Erratum in: Lancet Oncol. 2021 Apr;22(4):e134.

family: Hwang

full_name: Michael Hwang

given: Michael

family: Seiwert

full_name: Tanguy Y Seiwert

given: Tanguy Y

journal_name: The Lancet Oncology

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Austria
Brazil
Switzerland
Mexico
Germany
France
Japan
Greece
Israel
Poland
Ireland
Australia
Spain
United States
United Kingdom
Korea, Republic of
Taiwan

location_facility: Board of Trustees of the Leland Stanford Junior University

location_facility: General Oncology Hospital of Kifissia Agioi Anargyroi

location_facility: Klinikum rechts der Isar der Technischen Universitat Munchen

location_facility: ONCOSITE - Centro de Pesquisa Clinica em Oncologia

location_facility: Instituto De Assistencia Medica Ao Servidor Publico Estadual

location_facility: Azienda Ospedaliera Universitaria Di Modena

location_facility: PERSONAL Oncologia de Precisao e Personalizada

location_facility: Hospital De Base De Sao Jose Do Rio Preto

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

location_facility: Hospital de Clinicas de Porto Alegre HCPA

location_facility: Istituto Nazionale Tumori Fondazione Pascale

location_facility: Fundacao Pio Xii Hosp Cancer De Barretos

location_facility: Anticancer Hospital Of Thessaloniki "Theageneion"

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza

location_facility: Hopital Albert Michallon - Chu De Grenoble

location_facility: Universitaetsmedizin Der Johannes Gutenberg-Universitaet

location_facility: Fondazione Policlinico Universitario A. Gemelli

intervention_type: Drug


title: A Dose Frequency Optimization, Phase IIIB/IV Trial of Nivolumab 240 mg Every 2 Weeks vs Nivolumab 480 mg Every 4 Weeks in Subjects With Advanced or Metastatic Non-small Cell Lung Cancer Who Received up to 12 Months of Nivolumab at 3 mg/kg or 240 mg Every 2 Weeks

acronym: CheckMate 384

summary: The primary objective of this study is to compare PFS (progression-free survival) rate at 6 months and at 1 year after randomization, of Nivolumab 480 mg every 4 weeks with nivolumab 240 mg every 2 weeks in subjects with advanced/metastatic (Stage IIIb/IV) NSCLC (non-Sq and Sq).

location_country:
Italy
Austria
United States
Germany
France
Australia
Spain
Canada

location_facility: Memorial Cancer Institute at Memorial Regional Hospital

location_facility: Tri-County Hematology & Oncology Associates, Inc

location_facility: Texas Oncology-Midland Allison Cancer Center

location_facility: Charleston Hematology Oncology Associates, Pa

location_facility: Southern California Permanente Medical Group

location_facility: Yakima Valley Memorial Hospital/North Star Lodge

location_facility: Kaiser Permanente Medical Center (clinic+DSL)

intervention_type: Biological


lead_sponsor: Eisai Inc.

location_country:
Italy
United States
Sweden
Germany
France
Poland
Israel
Romania
Belgium
Australia
Russian Federation
Spain
Denmark
Canada
United Kingdom
Korea, Republic of

location_facility:
Facility#1
Facility #4
Facility #2
Royal Brisbane and Women's Hospital
Facility #1
Facility #5
Facility #6
Facility #3
Facility #7
Facility#2

source: euctr

title: A Multicenter, Randomized, Double-Blind Phase 2 Trial of Lenvatinib (E7080) in Subjects With 131I-Refractory Differentiated Thyroid Cancer to Evaluate Whether an Oral Starting Dose of 18 mg Daily Will Provide Comparable Efficacy to a 24-mg Starting Dose, But Have a Better Safety Profile

summary: This is a multicenter, randomized, double-blind study being conducted as a postmarketing requirement to the US Food and Drug Administration (FDA) to evaluate whether there is a lower starting dosage of lenvatinib 24 mg once daily (QD) that provides comparable efficacy but has a better safety profile in participants with radioiodine-refractory differentiated thyroid cancer RR-DTC with radiographic evidence of disease progression within the prior 12 months.

status_simplified: Completed


ReferenceType: background

ReferenceCitation: Ocran-Appiah J, Boutry C, Hervé C, Soni J, Schuind A; ZOSTER-056 Study Group. Safety of the adjuvanted recombinant zoster vaccine in adults aged 50 years or older. A phase IIIB, non-randomized, multinational, open-label study in previous ZOE-50 and ZOE-70 placebo recipients. Vaccine. 2021 Jan 3;39(1):6-10. doi: 10.1016/j.vaccine.2020.10.029. Epub 2020 Dec 1.

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

lead_sponsor: GlaxoSmithKline

primary_purpose: Prevention

location_country:
Italy
Brazil
United States
Sweden
Hong Kong
Mexico
Germany
Finland
France
Czechia
Japan
Australia
Spain
Estonia
Canada
United Kingdom
Korea, Republic of
Taiwan

ipd_sharing: Yes

title: Cross-vaccination Study of GSK Biologicals' Lyophilized Formulation of the Herpes Zoster Subunit (HZ/su) Vaccine (GSK 1437173A) in Subjects Who Previously Received Placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) Studies

summary: The purpose of this study is to cross-vaccinate and collect safety data in terms of unsolicited Adverse Events (AEs), Serious Adverse Events (SAEs) and potential Immune Mediated Disease (pIMD) from subjects >= 50 Years of age (YOA) who previously received placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229).


ReferenceCitation: Rini BI, Atkins MB, Choueiri TK, Thomaidou D, Rosbrook B, Thakur M, Hutson TE. Time to Resolution of Axitinib-Related Adverse Events After Treatment Interruption in Patients With Advanced Renal Cell Carcinoma. Clin Genitourin Cancer. 2021 Oct;19(5):e306-e312. doi: 10.1016/j.clgc.2021.03.019. Epub 2021 Apr 5.

family: Rini

full_name: Brian I. Rini

given: Brian I.

family: Atkins

full_name: Michael B. Atkins

given: Michael B.

family: Choueiri

full_name: Toni K. Choueiri

given: Toni K.

family: Thomaidou

full_name: Despina Thomaidou

given: Despina

family: Rosbrook

full_name: Brad Rosbrook

given: Brad

family: Thakur

full_name: Maghull Thakur

given: Maghull

family: Hutson

full_name: Thomas E. Hutson

given: Thomas E.

journal_name: Clinical Genitourinary Cancer

evidence: open (via crossref license)

ReferenceCitation: Choueiri TK, Larkin J, Pal S, Motzer RJ, Rini BI, Venugopal B, Alekseev B, Miyake H, Gravis G, Bilen MA, Hariharan S, Chudnovsky A, Ching KA, Mu XJ, Mariani M, Robbins PB, Huang B, di Pietro A, Albiges L. Efficacy and correlative analyses of avelumab plus axitinib versus sunitinib in sarcomatoid renal cell carcinoma: post hoc analysis of a randomized clinical trial. ESMO Open. 2021 Jun;6(3):100101. doi: 10.1016/j.esmoop.2021.100101. Epub 2021 Apr 23. Erratum in: ESMO Open. 2021 Aug;6(4):100177.

full_name: T.K. Choueiri

family: Larkin

full_name: J. Larkin

given: J.

family: Pal

full_name: S. Pal

given: S.

family: Motzer

full_name: R.J. Motzer

full_name: B.I. Rini

family: Venugopal

full_name: B. Venugopal

given: B.

family: Alekseev

full_name: B. Alekseev

family: Miyake

full_name: H. Miyake

given: H.

family: Gravis

full_name: G. Gravis

given: G.

family: Bilen

full_name: M.A. Bilen

family: Hariharan

full_name: S. Hariharan

family: Chudnovsky

full_name: A. Chudnovsky

given: A.

family: Ching

full_name: K.A. Ching

family: Mu

full_name: X.J. Mu

family: Mariani

full_name: M. Mariani

given: M.

family: Robbins

repository_institution: The University of Glasgow - Enlighten: Publications

repositories_institution: The University of Glasgow - Enlighten: Publications

ReferenceCitation: Motzer RJ, Robbins PB, Powles T, Albiges L, Haanen JB, Larkin J, Mu XJ, Ching KA, Uemura M, Pal SK, Alekseev B, Gravis G, Campbell MT, Penkov K, Lee JL, Hariharan S, Wang X, Zhang W, Wang J, Chudnovsky A, di Pietro A, Donahue AC, Choueiri TK. Avelumab plus axitinib versus sunitinib in advanced renal cell carcinoma: biomarker analysis of the phase 3 JAVELIN Renal 101 trial. Nat Med. 2020 Nov;26(11):1733-1741. doi: 10.1038/s41591-020-1044-8. Epub 2020 Sep 7.

ReferenceCitation: Choueiri TK, Motzer RJ, Rini BI, Haanen J, Campbell MT, Venugopal B, Kollmannsberger C, Gravis-Mescam G, Uemura M, Lee JL, Grimm MO, Gurney H, Schmidinger M, Larkin J, Atkins MB, Pal SK, Wang J, Mariani M, Krishnaswami S, Cislo P, Chudnovsky A, Fowst C, Huang B, di Pietro A, Albiges L. Updated efficacy results from the JAVELIN Renal 101 trial: first-line avelumab plus axitinib versus sunitinib in patients with advanced renal cell carcinoma. Ann Oncol. 2020 Aug;31(8):1030-1039. doi: 10.1016/j.annonc.2020.04.010. Epub 2020 Apr 25.

ReferenceCitation: Motzer RJ, Penkov K, Haanen J, Rini B, Albiges L, Campbell MT, Venugopal B, Kollmannsberger C, Negrier S, Uemura M, Lee JL, Vasiliev A, Miller WH Jr, Gurney H, Schmidinger M, Larkin J, Atkins MB, Bedke J, Alekseev B, Wang J, Mariani M, Robbins PB, Chudnovsky A, Fowst C, Hariharan S, Huang B, di Pietro A, Choueiri TK. Avelumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma. N Engl J Med. 2019 Mar 21;380(12):1103-1115. doi: 10.1056/NEJMoa1816047. Epub 2019 Feb 16.

name: From Memorial Sloan Kettering Cancer Center (R.J.M.) and Pfizer (S.H.), New York; Private Medical Institution Euromedservice (K.P.) and Nonstate Health Institution Road Clinical Hospital–Russian Railways (A.V.), St. Petersburg, and the Moscow Scientific Research Oncology Institute, Moscow (B.A.) — all in Russia; the Netherlands Cancer Institute, Amsterdam (J.H.); the Cleveland Clinic, Cleveland (B.R.); Institut Gustave Roussy, Villejuif (L.A.), and Centre Léon Bérard, University of Lyon, Lyon (S.N.) —...

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:
Romania
Australia
Belgium
Russian Federation
Denmark
France
Japan
Canada
Korea, Republic of
Sweden
Netherlands
Hungary
United States
Germany
United Kingdom
Italy
Austria
Mexico
Israel
New Zealand
Spain

location_facility: Oaxaca Site Management Organization S.C.

location_facility: Novant Health Clinical Research Onocolgy

location_facility: Barnes-Jewish Hospital, Siteman Cancer Center - West County

location_facility: "Prof. Dr. Ion Chiricuta" Oncology Institute

location_facility: Krankenhaus der Barmherzigen Schwestern Wien

location_facility: Oncology Investigational Drug Services- The Sidney Kimmel Cancer Center at Johns Hopkins Hospital

location_facility: SBIH of Nizhegorodskaya region "Clinical-Diagnostics center"

location_facility: Clinical Hospital #122 n.a. L. G. Sokolov

location_facility: Netherlands Cancer Institute / Apotheek MC Slotervaart

location_facility: Anschutz Cancer Center Pavilion Pharmacy

location_facility: Clinical Trial Pharmacy, National Cancer Center

location_facility: Monash Health Translational Precinct, Monash Medical Centre

location_facility: Pharmacy - clinical unit, Tel Aviv Sourasky Medical Center

location_facility: Nottingham University Hospitals, Nottingham City Hospital, Nottingham Trials Pharmacy

location_facility: Seattle Cancer Care Alliance / University of Washington

location_facility: Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital

location_facility: Centre Eugene Marquis Service Pharmacie - Essais Cliniques

location_facility: Washington University Infusion Center Pharmacy

location_facility: Investigational Drug Service, University of Pennsylvania

location_facility: CIUSSS de l'Estrie-Centre hospitalier universitaire de Sherbrooke

location_facility: Hospital of the University of Pennsylvania

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez, Centro Universitario Contra el Cancer

location_facility: Barnes-Jewish Hospital, Siteman Cancer Center

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: MedStar Health Cardiology Associates, LLC.

location_facility: FSBI "Research Institute of Oncology n.a. N.N. Petrov" MoH RF

location_facility: FBIH "Privolzhskiy Regional Medical Center" of FMBA

location_facility: Beatson West of Scotland Cancer Centre, Gartnavel General Hospital,

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

location_facility: University of Colorado Cancer Center Anschutz Cancer Pavilion

location_facility: Severance Hospital, Yonsei University Health System

location_facility: LLC "Clinical Diagnostic Center "Medex-pert"

location_facility: Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute

location_facility: Scientific Research Institute of Urology named after N.A.Lopatkin of the Hersten Federal

location_facility: Moffitt Cancer Center and Research Institute

location_facility: Laura & Isaac Perlmutter Cancer Center at NYU Langone

location_facility: Massachusetts General Hospital Clinical Trials Pharmacy

location_facility: Addenbrooke's Hospital, Central Pharmacy, Level 1

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Sidney Kimmel Center for Prostate and Urologic Cancers

location_facility: British Columbia Cancer Agency - Kelowna

location_facility: RBHI "Kursk Regional Clinical Oncology Dispensary" of HCKR (legal address)

location_facility: US Oncology Investigational Products Center (IPC)

location_facility: Seoul National University Hospital, Clinical Pharmacy

location_facility: Kyungpook National University Medical Center

location_facility: James Cancer Hospital and Solove Research Institute

location_facility: Universitaetsklinikum Jena Klinik und Poliklinik fuer Urologie

location_facility: Chungnam National University Hospital, Clinical Pharmacy

location_facility: Winship Cancer Institute, Emory University

location_facility: Moscow Scientific Research Oncology Institute n.a. P.A. Hertzen

location_facility: R.S. McLaughlin Durham Regional Cancer Centre, Lakeridge Health

location_facility: London Regional Cancer Program, London Health Sciences Centre

location_facility: Tauranga Hospital, Bay of Plenty Clinical Trials Unit

location_facility: Washington University School of Medicine

location_facility: Hamamatsu University School of Medicine, University Hospital

location_facility: Seoul National University Bundang Hospital

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: SHI YR Regional Clinical Oncology Hospital

location_facility: Cleveland Clinic Investigational Pharmacy

location_facility: Beth Israel Deaconess Medical Center Pharmacy - BIDMC

location_facility: Private medical institution "Euromedservice"

location_facility: Samsung Medical Center Clinical Trial Pharmacy

location_facility: Ballarat Oncology & Haematology Services

location_facility: Niigata University Medical & Dental Hospital

location_facility: Cambridge University Hospital NHS Foundation Trust, Addenbrooke's Hospital

location_facility: Institut de Cancerologie de Lorraine (ICL)

location_facility: St Bartholomew's Hospital, Barts Health NHS Trust

location_facility: Department of Medical Oncology, The Christie NHS Foundation Trust

location_facility: Barnes-Jewish Hospital, Siteman Cancer Center - South County

location_facility: Dél.pesti Centrumkórház-OHII Szent Lálszló Kórház telephely

location_facility: Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy

location_facility: BC Cancer GU Clinic - Fairmont Medical Building

location_facility: Centro di Riferimento Oncologico - IRCCS

location_facility: Russian Research Center for Radiology and Surgical Technologies

location_facility: Sahlgrenska University Hospital, Dept of Oncology

location_facility: Mount Vernon Cancer Centre, East & North Herts NHS Trust

location_facility: NS HI "Road Clinical Hospital of JSC "Russian Railways""

location_facility: Alberta Health Services - Cancer Care, Tom Baker Cancer Centre

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

location_facility: Kyungpook National University Medical Center, Clinical Pharmacy

location_facility: Hirosaki University School of Medicine & Hospital

location_facility: Beth Israel Deaconess Medical Center (BIDMC)

location_facility: East Jefferson Hematology-Oncology Metairie Physician Service Inc.

location_facility: Barnes-Jewish Hospital, Siteman Cancer Center - St. Peters

location_facility: Joe Arrington Cancer Research and Treatment Center

location_facility: Seoul National University Bundang Hospital, Clinical Pharmacy

location_facility: Investigational Drug Service- Emory University

location_facility: Academic Unit of Oncology, Nottingham University Hospitals NHS Trust-City Campus

location_facility: Tokyo Women's Medical University Hospital

location_facility: SBIH of Nizhegorodskaya region "Nizhniy Novgorod Regional Clinical Oncology Dispensary"

location_facility: The Sidney Kimmel Comprehensive Cancer Center

title: A PHASE 3, MULTINATIONAL, RANDOMIZED, OPEN-LABEL, PARALLEL-ARM STUDY OF AVELUMAB (MSB0010718C) IN COMBINATION WITH AXITINIB (INLYTA(REGISTERED)) VERSUS SUNITINIB (SUTENT(REGISTERED)) MONOTHERAPY IN THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED RENAL CELL CARCINOMA

summary: This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of avelumab in combination with axitinib and of sunitinib monotherapy, administered as first-line treatment, in patients with advanced renal cell carcinoma


type: Registry Identifier

title: A Phase 3, Double-Blind, Placebo-controlled Study of Quizartinib Administered in Combination With Induction and Consolidation Chemotherapy, and Administered as Continuation Therapy in Subjects 18 to 75 Years Old With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (QuANTUM First)

acronym: QuANTUM-First

summary:
Quizartinib is an experimental drug. It is not approved for regular use. It can only be used in medical research.

Adults might be able to join this study after bone marrow tests show they have a certain kind of blood cancer (FLT3-ITD AML).

Participants will have an equal chance of receiving quizartinib or placebo along with their chemotherapy.

ReferenceCitation: Cortes J, Perl AE, Döhner H, Kantarjian H, Martinelli G, Kovacsovics T, Rousselot P, Steffen B, Dombret H, Estey E, Strickland S, Altman JK, Baldus CD, Burnett A, Krämer A, Russell N, Shah NP, Smith CC, Wang ES, Ifrah N, Gammon G, Trone D, Lazzaretto D, Levis M. Quizartinib, an FLT3 inhibitor, as monotherapy in patients with relapsed or refractory acute myeloid leukaemia: an open-label, multicentre, single-arm, phase 2 trial. Lancet Oncol. 2018 Jul;19(7):889-903. doi: 10.1016/S1470-2045(18)30240-7. Epub 2018 May 31.

family: Cortes

full_name: Jorge Cortes

given: Jorge

family: Perl

full_name: Alexander E Perl

given: Alexander E

family: Döhner

full_name: Hartmut Döhner

given: Hartmut

family: Kantarjian

full_name: Hagop Kantarjian

given: Hagop

family: Martinelli

full_name: Giovanni Martinelli

given: Giovanni

family: Kovacsovics

full_name: Tibor Kovacsovics

given: Tibor

family: Rousselot

full_name: Philippe Rousselot

given: Philippe

family: Steffen

full_name: Björn Steffen

given: Björn

family: Dombret

full_name: Hervé Dombret

given: Hervé

family: Estey

full_name: Elihu Estey

given: Elihu

family: Strickland

full_name: Stephen Strickland

given: Stephen

family: Altman

full_name: Jessica K Altman

given: Jessica K

family: Baldus

full_name: Claudia D Baldus

given: Claudia D

family: Burnett

full_name: Alan Burnett

given: Alan

family: Krämer

full_name: Alwin Krämer

given: Alwin

family: Russell

full_name: Nigel Russell

given: Nigel

family: Shah

full_name: Neil P Shah

given: Neil P

family: Smith

full_name: Catherine C Smith

given: Catherine C

family: Wang

full_name: Eunice S Wang

given: Eunice S

family: Ifrah

full_name: Norbert Ifrah

given: Norbert

family: Gammon

full_name: Guy Gammon

given: Guy

family: Trone

full_name: Denise Trone

given: Denise

family: Lazzaretto

location_country:
Romania
Belgium
Australia
Russian Federation
Taiwan
Ukraine
Croatia
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Hong Kong
Bulgaria
Singapore
Hungary
China
Portugal
Germany
United States
United Kingdom
Italy
Brazil
Serbia
Czechia
Israel
Spain

location_facility: Chang Gung Medical Foundation - Kaohsiung Branch

location_facility: Spitalul Clinic Judetean de Urgenta Târgu-Mureş (4008)

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Hospital Universitari Joan XXIII de Tarragona

location_facility: The University of Chicago Medical Center

location_facility: Kameda Medical Center - Kameda General Hospital

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Azienda Ospedaliero Universitaria Maggiore della Carità di Novara

location_facility: Azienda Ospedaliera Ordine Mauriziano di Torino

location_facility: Azienda Sanitaria Locale 13 - Ospedale "C. e G. Mazzoni"- Ascoli Piceno

location_facility: Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino - Ospedale Molinette

location_facility: Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara

location_facility: Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka

location_facility: Santa Casa de Misericórdia de Porto Alegre

location_facility: Instituto do Cancer do Estado de São Paulo

location_facility: Nizhny Novgorod Regional Clinical Hospital

location_facility: Institutul Oncologic "Prof. Dr. Ion Chiricuţă" Cluj Napoca

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Hospital of the University of Pennsylvania

location_facility: Azienda Ospedaliera Universitaria "Federico II"

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

location_facility: Spitalul Universitar de Urgenta Bucuresti

location_facility: Daegu Catholic University Medical Center

location_facility: Azienda Ospedaliero - Universitaria San Luigi Gonzaga

location_facility: Centro Hospitalar de São João, EPE - Hospital de São João

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

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr. 1 we Wrocławiu

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

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

location_facility: Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan

location_facility: Maidstone and Tunbridge Wells NHS Trust - Maidstone Hospital

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Saratov State Medical University named after V.I. Razumovsky

location_facility: Complexo Hospitalario Universitario A Coruña

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Centre Henri Becquerel - Centre de Lutte Contre le Cancer

location_facility: Chonnam National University Hwasun Hospital

location_facility: Hospital Universitario Central de Asturias

location_facility: University Hospitals Seidman Cancer Center

location_facility: Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School

location_facility: Azienda Ospedaliera Nazionale SS.Antonio e Biagio e Cesare Arrigo

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Franciscan St. Francis Health Indianapolis

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Instituto Português Oncologia do Porto Francisco Gentil, EPE

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: The General Hospital of People's Liberation Army (301 Hospital)

location_facility: Hospital Regional Universitario de Málaga - Hospital General

location_facility: Hospital Universitari de Girona Doctor Josep Trueta

location_facility: University Multiprofile Hospital for Active Treatment "Dr. G. Stranski" EAD

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: Complejo Hospitalario Universitario de Albacete - Hospital General Universitario

location_facility: Chang Gung Medical Foundation - Linkou Branch

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Centro Hospitalar e Universitário de Coimbra, EPE - Hospitais da Universidade de Coimbra

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

location_facility: Vseobecna Fakultni Nemocnice, Ustav hematologie a krevni transfuze (UHKT)

location_facility: Seoul National University Bundang Hospital

location_facility: University of Florida (UF) Health Shands Hospital

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Centre Hospitalier de Versailles - Hôpital André Mignot

location_facility: Vinnitsa Regional Clinical Hospital im. N.I. Pirogov

location_facility: Hospital General Universitario de Alicante

location_facility: NY Medical College - Hudson Valley Hematology Oncology Associates

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: Azienda Ospedaliera Universitaria OO.RR. San Giovanni di Dio Ruggi d'Aragona

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: ASST dei Sette Laghi - Ospedale di Circolo e Fondazione Macchi Varese

location_facility: University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD

location_facility: West Virginia University Hospitals, Inc.

location_facility: Poltava Regional Clinical Hospital named after M. V. Sklifosovskoho

location_facility: Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez

location_facility: Spitalul Clinic Municipal Filantropia Craiova

location_facility: Centro Hospitalar do Porto, EPE - Hospital Geral de Santo António

location_facility: Kobe City Medical Center General Hospital

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Russian Research Institute of Hematology and Blood Transfusion

location_facility: University of Kentucky Chandler Medical Center

location_facility: Complexo Hospitalario Universitario de Santiago (CHUS) - Hospital Clínico Universitario

location_facility: National Hospital Organization Kagoshima Medical Center

location_facility: Spitalul Clinic Judetean de Urgenta Târgu-Mureş (4005)

location_facility: Tang Du Hospital, Fourth Military Medical University

location_facility: Almazov Federal North-West Medical Research Centre

location_facility: National University Hospital (S) Pte Ltd

location_facility: Fujian Medical University Union Hospital

location_facility: Hospital Clínico Universitario "Lozano Blesa"

location_facility: Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital

location_facility: Azienda Ospedaliero - Universitaria Consorziale Policlinico di Bari

location_facility: Complejo Hospitalario Universitario Granada


type: Other Identifier

title: Assessment of STELARA® (Ustekinumab) and Tumor Necrosis Factor Alpha Inhibitor Therapies in Patients With Psoriatic Arthritis in Standard Health-Care Practice; A Prospective, Observational Cohort

acronym: PsaBio

summary: The purpose of this study is to evaluate treatment retention in psoriatic arthritis participants with STELARA or tumor necrosis factor alpha inhibitor (TNFi) therapies in relation to effectiveness, safety, benefit/risk and to examine clinical response.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Janssen Pharmaceutica N.V., Belgium

location_country:
Netherlands
France
Greece
Russian Federation
Belgium
Spain
United Kingdom


title: Phase 3 Randomized, Double-Blind, Placebo Controlled, Multicenter Study to Compare the Efficacy and Safety of Lenalidomide (CC-5013) Plus R-CHOP Chemotherapy (R2-CHOP) Versus Placebo Plus R-CHOP Chemotherapy in Subjects With Previously Untreated Activated B-cell Type Diffuse Large B-cell Lymphoma

acronym: ROBUST

summary: To evaluate the efficacy and safety of lenalidomide, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R2-CHOP) chemotherapy versus placebo, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (placebo-R-CHOP) chemotherapy in patients who have previously untreated ABC type DLBCL.

ReferenceCitation: Nowakowski GS, Chiappella A, Witzig TE, Spina M, Gascoyne RD, Zhang L, Flament J, Repici J, Vitolo U. ROBUST: Lenalidomide-R-CHOP versus placebo-R-CHOP in previously untreated ABC-type diffuse large B-cell lymphoma. Future Oncol. 2016 Jul;12(13):1553-63. doi: 10.2217/fon-2016-0130. Epub 2016 Apr 18.

ReferenceCitation: Nowakowski GS, Chiappella A, Gascoyne RD, Scott DW, Zhang Q, Jurczak W, Özcan M, Hong X, Zhu J, Jin J, Belada D, Bergua JM, Piazza F, Mócikova H, Molinari AL, Yoon DH, Cavallo F, Tani M, Yamamoto K, Izutsu K, Kato K, Czuczman M, Hersey S, Kilcoyne A, Russo J, Hudak K, Zhang J, Wade S, Witzig TE, Vitolo U. ROBUST: A Phase III Study of Lenalidomide Plus R-CHOP Versus Placebo Plus R-CHOP in Previously Untreated Patients With ABC-Type Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2021 Apr 20;39(12):1317-1328. doi: 10.1200/JCO.20.01366. Epub 2021 Feb 23.

name: Division of Hematology, Mayo Clinic, Rochester, MN

family: Nowakowski

full_name: Grzegorz S. Nowakowski

given: Grzegorz S.

name: Division of Hematology, A.O.U. Città della Salute e della Scienza Hospital and University, Torino, Italy

family: Chiappella

full_name: Annalisa Chiappella

given: Annalisa

name: Centre for Lymphoid Cancer, British Columbia Cancer, Vancouver, British Columbia, Canada

family: Gascoyne

full_name: Randy D. Gascoyne

given: Randy D.

family: Scott

full_name: David W. Scott

given: David W.

name: Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China

family: Zhang

full_name: Qingyuan Zhang

given: Qingyuan

name: Maria Sklodowska-Curie Institute—Oncology Centre, Cracow, Poland

family: Jurczak

full_name: Wojciech Jurczak

given: Wojciech

name: Department of Hematology, Ankara University, Ankara, Turkey

family: Özcan

full_name: Muhit Özcan

given: Muhit

name: Cancer Hospital, Fudan University, Shanghai, China

family: Hong

full_name: Xiaonan Hong

given: Xiaonan

family: Zhu

full_name: Jun Zhu

given: Jun

name: The First Affiliated Hospital of Medical School of Zhejiang University, First Hospital of Zhejiang Province, Hangzhou, Zhejiang, China

family: Jin

full_name: Jie Jin

given: Jie

name: Fourth Department of Internal Medicine-Hematology, Charles University Hospital and Faculty of Medicine, Hradec Králové, Czech Republic

family: Belada

full_name: David Belada

given: David

name: Servicio de Hematologia, Hospital Universitario San Pedro de Alcántara, Cáceres, Spain

family: Bergua

full_name: Juan Miguel Bergua

given: Juan Miguel

name: Division of Hematology, Department of Medicine, University of Padova and Azienda Ospedaliera di Padova, Padova, Italy

family: Piazza

full_name: Francesco Piazza

given: Francesco

name: Department of Internal Medicine and Haematology, Faculty Hospital Kralovske Vinohrady, Prague, Czech Republic

family: Mócikova

full_name: Heidi Mócikova

given: Heidi

name: UO Ematologia, Ospedale Degli Infermi, Rimini, Italy

family: Molinari

full_name: Anna Lia Molinari

given: Anna Lia

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

family: Yoon

full_name: Dok Hyun Yoon

given: Dok Hyun

name: AOU Città della Salute e della Scienza di Torino, Turin, Italy

family: Cavallo

full_name: Federica Cavallo

given: Federica

name: U.O. Ematologia, Dipartimento Oncologia e Ematologia, Ospedale Santa Maria delle Croci, Ravenna, Italy

family: Tani

full_name: Monica Tani

given: Monica

name: Department of Hematology and Cell Therapy, Aichi Cancer Center Hospital, Nagoya, Japan

family: Yamamoto

full_name: Kazuhito Yamamoto

given: Kazuhito

name: National Cancer Center Hospital, Tokyo, Japan

family: Izutsu

full_name: Koji Izutsu

given: Koji

name: Department of Medicine and Biosystemic Science, Kyushu University Faculty of Medicine, Fukuoka City, Japan

family: Kato

full_name: Koji Kato

name: Clinical Research and Development, Celgene Corporation, Summit, NJ

family: Czuczman

full_name: Myron Czuczman

given: Myron

name: Translational Development, Precision Medicine and Companion Diagnostics, Celgene Corporation, Summit, NJ

family: Hersey

name: Department of Statistical Programming, Celgene Corporation, Overland Park, KS

repository_institution: University of Turin - Institutional Research Information System University of Turin

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:
Belgium
Australia
Russian Federation
Taiwan
France
Japan
Poland
Canada
Korea, Republic of
Switzerland
Netherlands
Ireland
Puerto Rico
China
Portugal
United States
Italy
Czechia
Israel
New Zealand
Spain
Turkey

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Centre Hospitalier Departemental de Vendee

location_facility: Regional Cancer Care Associates - Somerset Division

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Fakultni nemocnice Kralovske Vinohrady, Interni hematologicka klinika

location_facility: Azienda Ospedaliero Universitaria Ospedali

location_facility: Centro Hospitalar do Porto - Hospital de Santo António

location_facility: Centre Hospitalier de Saint Brieuc Hopital Yves le Foll

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)

location_facility: VU University Medical Center VU Medisch Centrum

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: Chang Gung Medical Foundation, Kaohsiung Memorial Hospital

location_facility: Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale

location_facility: Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Siouxland Hematology-Oncology Associates, LLP

location_facility: Centre Hospitalier Universitaire de Sherbrooke CHUS

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: Severance Hospital, Yonsei University Health System

location_facility: California Cancer Associates for Research and Excellence cCARE

location_facility: Hospital Universitario Madrid Sanchinarro

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: H. Hartziekenhuis Roeselare-Menen vzw campus Wilgenstraat

location_facility: Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest

location_facility: Regional Cancer Care Associates/Cherry Hill Division, LLC.

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza di Torino

location_facility: Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

location_facility: Instituto Portugues de Oncologia de Lisboa, Francisco Gentil

location_facility: Russian Cancer Research Center n.a. Blokhin, Chemotherapy Department

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Koc Universitesi Tip Fakultesi Amerikan Hastanesi

location_facility: Hospital Universitario Central de Asturias

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

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

location_facility: Centro Hospitalar E Universitario de Coimbra EPE

location_facility: Nanfang Hospital of Southern medicine university in Guangzhou

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Centre Hospitalier Universitaire de Liege

location_facility: Presidio Ospedaliero Di Treviso Ca' Foncello

location_facility: Azienda Ospedaliera Universitaria Integrata di Verona

location_facility: Azienda Sanitaria Ospedaliera S. Croce e Carle

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Xinqiao Hospital, Third Military Medical University

location_facility: Cukurova Universitesi Tip Fakultesi Balcali Hastanesi

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Chang Gung Medical Foundation-Linkou Branch

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

location_facility: Harbin Medical University Tumor Hospital

location_facility: Research Oncology Institute of Rosmed Technologies n.a. prof. N.N. Petrov

location_facility: Zaklad Opieki Zdrowotnej MSW z Warminsko-Mazurskim Centrum Onkologii

location_facility: First Affiliated Hospital of Soochow University

location_facility: University Hospital, Kyoto Prefectural University of Medicine

location_facility: Azienda Ospedaliero Universitaria Di Modena Policlinico

location_facility: Ankara University Medical Faculty Cebeci Hospital

location_facility: Policlinico Universitario Campus Biomedico Di Roma

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: West China Medical School West China Hospital Sichuan University

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe

location_facility: The Cancer Institute Hospital of Japanese Foundation For Cancer Research

location_facility: Complejo Hospitalario Nuestra Senora de Valme

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi

location_facility: Azienda Ospedaliera Universitaria Federico II

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

location_facility: Cancer Treatment Centers of America - Southeastern Regional Medical Center

location_facility: Cliniques Universitaires UCL de Mont-Godine

location_facility: Samodz.Pub.Zaklad Opieki Zdrow-ej Min-wa Spraw Wewnetrznych w Poznaniu im Prof.Ludwika Bierkowskiego

location_facility: Azienda Ospedaliera Santi Antonio Biagio E Cesare Arrigo

location_facility: Azienda Ospedaliero-Universitaria Santa Maria della Misericordia die Udine

location_facility: Trakya Universitesi Tip Fakultesi Hastanesi

location_facility: University of Texas Southwestern Medical Center

location_facility: Azienda Ospedaliero Universitaria Di Bologna Policlinico Sorsola Malpighi


title: A Post-authorization, Non-interventional, Safety Study Study of Patients With Myelodysplastic Syndromes (MDS) Treated With Lenalidomide.

acronym: PASS MDS del5q

summary:
This registry is a prospective, non-interventional, post authorisation safety study for patients diagnosed with Transfusion Dependent, IPSS low or intermediate-1-Risk Myelodysplastic Syndrome (MDS), associated to a single abnormality of the chromosome 5 [del(5q)].

The purpose of this study is to collect additional data about the safety of an oral drug (lenalidomide, Revlimid®) that may have been prescribed to relieve anemia and decrease the need of blood transfusions. However, also patients affected by the MDS del(5q) who receive other treatments different from lenalidomide can be included in this study, if they agree.

lead_sponsor: Celgene

location_country:
Italy
Luxembourg
Sweden
France
Greece
Norway
Belgium
Spain
Denmark
Germany
United Kingdom

location_facility: Gemeinschaftspraxis fur Hamatologie und Onkologie, Onkologisches zentrum Lebach

location_facility: H.U.Marq.Valdecilla, Hospital Universitario Marqués de Valdecilla. Hematología

location_facility: Centre Hospitalier Universitaire De Limoges - Hopital Dupuyt

location_facility: Hämatologie und Onkologie, Klinikum Chemnitz gGmbH International Patient Center

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: Institut für Versorgungsforschung in der Onkologie

location_facility: Uniklinikum Düsseldorf, Klinik für Hämatologie, Onkologie und Klinische Immunologie

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Centre Hospitalier D'Avignon - Hopital Henri Duffaut

location_facility: Hospital Universitario fundacion Jiminez Diaz

location_facility: Kreiskrankenhaus St. Elisabeth - Von Werth-Str.

location_facility: Azienda Ospedaliera Papa Giovanni XX111 Piazza OMS

location_facility: Innere Medizin II - Onkologie, Hämatologie, Univesitatklinikum Tubingen

location_facility: Azienda Ospedaliera Universitaria di Sassari

location_facility: III. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München

location_facility: Hospital Universitario central de Asturias

location_facility: Gemeinschaftspraxis für Hämatologie und Onkologie

location_facility: Lund University Hospital - Lasarettsgatan 23

location_facility: CHRU De Lille - Hôpital Claude - Rue Michel Polonovski

location_facility: Hopital de Hautepierre CHRU de Strasbourg

location_facility: III. Medizinische Klinik, Hämatologie und internistische Onkologie , Univesitatsmedizin Mannheim

location_facility: AOU Ospedali Riuniti Umberto I G.M. Lancisi G. Salesi

location_facility: Aberdeen Royal Infirmary - Foresterhill Road

location_facility: Hospital Universitario de Gran Canaria Servicio de Hematología y

location_facility: Broomfield Hospital - Mid-Essex Hospitals NHS Trust

location_facility: Hospital del Mar,Hematologia Hemotheropia

location_facility: Department of Hematology, Hospital Duran i Reynals

location_facility: Abteilung Hämatologie, Internistische Onkologie, Universitatklinikum Leipzig

location_facility: Policlinico S.Orsola Malpighi, AOU di Bologna

location_facility: AOU Policlinico Tor Vergata, Università Roma Tor Vergata

location_facility: CHU Nancy Brabois Adultes - 58 Allee dy morvan

location_facility: Praxis, Onkologische Schwerpunktpraxis Dres. Verpoort

location_facility: ZENTRUM FÜR INNERE MEDIZIN, Universitatklinikum Wurzburg

location_facility: Radcliffe Hospitals and University - Headley Way, Headington


ReferenceCitation: Lee YA, Lee H, Im SW, Song YS, Oh DY, Kang HJ, Won JK, Jung KC, Kwon D, Chung EJ, Hah JH, Paeng JC, Kim JH, Choi J, Kim OH, Oh JM, Ahn BC, Wirth LJ, Shin CH, Kim JI, Park YJ. NTRK and RET fusion-directed therapy in pediatric thyroid cancer yields a tumor response and radioiodine uptake. J Clin Invest. 2021 Sep 15;131(18). pii: 144847. doi: 10.1172/JCI144847.

family: Lee

full_name: Young Ah Lee

given: Young Ah

full_name: Hyunjung Lee

given: Hyunjung

family: Im

full_name: Sun-Wha Im

given: Sun-Wha

family: Song

full_name: Young Shin Song

given: Young Shin

family: Oh

full_name: Do-Youn Oh

given: Do-Youn

family: Kang

full_name: Hyoung Jin Kang

given: Hyoung Jin

family: Won

full_name: Jae-Kyung Won

given: Jae-Kyung

family: Jung

full_name: Kyeong Cheon Jung

given: Kyeong Cheon

family: Kwon

full_name: Dohee Kwon

given: Dohee

family: Chung

full_name: Eun-Jae Chung

given: Eun-Jae

family: Hah

full_name: J. Hun Hah

given: J. Hun

family: Paeng

full_name: Jin Chul Paeng

given: Jin Chul

family: Kim

full_name: Ji-hoon Kim

given: Ji-hoon

family: Choi

full_name: Jaeyong Choi

given: Jaeyong

full_name: Ok-Hee Kim

given: Ok-Hee

full_name: Ji Min Oh

given: Ji Min

family: Ahn

full_name: Byeong-Cheol Ahn

given: Byeong-Cheol

family: Wirth

full_name: Lori J. Wirth

given: Lori J.

family: Shin

full_name: Choong Ho Shin

given: Choong Ho

full_name: Jong-Il Kim

given: Jong-Il

family: Park

full_name: Young Joo Park

given: Young Joo

journal_name: Journal of Clinical Investigation

evidence: open (via free pdf)

publisher: American Society for Clinical Investigation

publisher_group: American Society for Clinical Investigation

publisher_normalized: American Society for Clinical Investigation

title: NTRK- and RET-fusion-directed therapy in pediatric thyroid cancer yields a tumor response and radioiodine uptake

ReferenceCitation: Bebb DG, Banerji S, Blais N, Desmeules P, Gill S, Grin A, Feilotter H, Hansen AR, Hyrcza M, Krzyzanowska M, Melosky B, Noujaim J, Purgina B, Ruether D, Simmons CE, Soulieres D, Torlakovic EE, Tsao MS. Canadian Consensus for Biomarker Testing and Treatment of TRK Fusion Cancer in Adults. Curr Oncol. 2021 Jan 15;28(1):523-548. doi: 10.3390/curroncol28010053.

family: Bebb

full_name: D. Gwyn Bebb

given: D. Gwyn

ReferenceCitation: Perreault S, Chami R, Deyell RJ, El Demellawy D, Ellezam B, Jabado N, Morgenstern DA, Narendran A, Sorensen PHB, Wasserman JD, Yip S. Canadian Consensus for Biomarker Testing and Treatment of TRK Fusion Cancer in Pediatric Patients. Curr Oncol. 2021 Jan 9;28(1):346-366. doi: 10.3390/curroncol28010038.

ReferenceCitation: Hong DS, DuBois SG, Kummar S, Farago AF, Albert CM, Rohrberg KS, van Tilburg CM, Nagasubramanian R, Berlin JD, Federman N, Mascarenhas L, Geoerger B, Dowlati A, Pappo AS, Bielack S, Doz F, McDermott R, Patel JD, Schilder RJ, Tahara M, Pfister SM, Witt O, Ladanyi M, Rudzinski ER, Nanda S, Childs BH, Laetsch TW, Hyman DM, Drilon A. Larotrectinib in patients with TRK fusion-positive solid tumours: a pooled analysis of three phase 1/2 clinical trials. Lancet Oncol. 2020 Apr;21(4):531-540. doi: 10.1016/S1470-2045(19)30856-3. Epub 2020 Feb 24.

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

ReferenceCitation: Drilon A, Laetsch TW, Kummar S, DuBois SG, Lassen UN, Demetri GD, Nathenson M, Doebele RC, Farago AF, Pappo AS, Turpin B, Dowlati A, Brose MS, Mascarenhas L, Federman N, Berlin J, El-Deiry WS, Baik C, Deeken J, Boni V, Nagasubramanian R, Taylor M, Rudzinski ER, Meric-Bernstam F, Sohal DPS, Ma PC, Raez LE, Hechtman JF, Benayed R, Ladanyi M, Tuch BB, Ebata K, Cruickshank S, Ku NC, Cox MC, Hawkins DS, Hong DS, Hyman DM. Efficacy of Larotrectinib in TRK Fusion-Positive Cancers in Adults and Children. N Engl J Med. 2018 Feb 22;378(8):731-739. doi: 10.1056/NEJMoa1714448.

name: From Memorial Sloan Kettering Cancer Center (A. Drilon, J.F.H., R.B., M.L., D.M.H.) and Weill Cornell Medical College (A. Drilon, D.M.H.), New York; University of Texas Southwestern Medical Center–Children’s Health, Dallas (T.W.L.); Stanford Cancer Center, Stanford University, Palo Alto (S.K.), Children’s Hospital Los Angeles, Keck School of Medicine, University of Southern California (L.M.), and UCLA David Geffen School of Medicine (N.F.), Los Angeles, and Loxo Oncology, South San Francisco (B.B.T., K.E...

title: Efficacy of Larotrectinib inTRKFusion–Positive Cancers in Adults and Children

ReferenceCitation: Shi E, Chmielecki J, Tang CM, Wang K, Heinrich MC, Kang G, Corless CL, Hong D, Fero KE, Murphy JD, Fanta PT, Ali SM, De Siena M, Burgoyne AM, Movva S, Madlensky L, Heestand GM, Trent JC, Kurzrock R, Morosini D, Ross JS, Harismendy O, Sicklick JK. FGFR1 and NTRK3 actionable alterations in "Wild-Type" gastrointestinal stromal tumors. J Transl Med. 2016 Dec 14;14(1):339.

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

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

location_country:
Greece
Belgium
Australia
Russian Federation
Denmark
Taiwan
Ukraine
India
France
Japan
Poland
Slovakia
Norway
Argentina
Canada
Korea, Republic of
Colombia
Sweden
Singapore
Hungary
Ireland
China
Portugal
Germany
United States
United Kingdom
Italy
Brazil
Czechia
Spain
Turkey

location_facility: Hôpital Guillaume et René Laennec - Nantes

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Hospital Universitario "Marqués de Valdecilla"

location_facility: Fundación Cenit para la Investigación en Neurociencias

location_facility: A.O.U. di Bologna Policlinico S.Orsola Malpighi

location_facility: Moscow Scient. Res. Institute of Oncology n.a P.A. Hertzen

location_facility: ICANS - Institut de Cancérologie de Strasbourg Europe

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

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: 1st Moscow State Medical University n.a. I.M.Sechenov

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: Hospital de Base da Fundação F M S J Rio Preto

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Fundação Pio XII - Hospital de Câncer de Barretos

location_facility: London Regional Cancer Program, London Health Sciences Ctr

location_facility: Cenantron Centro Avançado de Tratamento Oncológico, Ltda.

location_facility: Clín. de Pesq. e Centro de Estudos em Onco Gineco Mamária

location_facility: General Oncology Hospital of Kifissia AGIOI ANARGYROI

location_facility: Institut Bergonié - Unicancer Nouvelle Aquitaine

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi

location_facility: IRCCS Istituti Fisioterapici Ospitalieri - IFO

location_facility: Instituto Nacional do Câncer - INCA - HC II

location_facility: Instituto do Câncer do Estado de São Paulo

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: IBCC - Instituto Brasileiro de Controle do Cancer

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

location_facility: Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.

location_facility: Hospital General Universitario de Valencia

location_facility: Onkologicky Ustav Svatej Alzbety, s.r.o.

location_facility: Real e Benemérita Associação Portuguesa de Beneficência

location_facility: Arkhangelsk Clinical Oncology Dispensary

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Charité Comprehensive Cancer Center (CCCC)

location_facility: Karolinska Universitetssjukhuset i Solna

location_facility: Fundacion Jimenez Diaz (Clinica de la Concepcion)

location_facility: Hospital Clínic i Provincial de Barcelona

location_facility: Oslo universitetssykehus HF Radiumhospitalet

location_facility: Fundación Oftalmológica de Santander Carlos Ardila Lule

location_facility: Russian Oncological Scientific Center n.a. N.N. Blokhin RAMS

location_facility: Institute Of Cancer-Barts and The London School of Medicine

location_facility: Hosp. Araujo Jorge da Associação de Combate ao Câncer

location_facility: Sir Mortimer B. Davis Jewish General Hospital

location_facility: Jawaharlal Institute Of Postgraduate Medical Education and R

location_facility: TC Saglik Bakanligi Goztepe ProfDr Suleyman Yalcin Sehir Has

location_facility: AGIOS SAVVAS Anticancer Hospital of Athens

location_facility: Kokilaben Dhirubhai Ambani Hospital & Medical Research Insti

location_facility: Moscow Clinical Scientific Centre n.a.Loginov

location_facility: Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma

location_facility: St. Petersburg Clinical Onc. Cent. of Spec. Types of Care

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

location_facility: Centro Estudios Médicos e Invest. Clínicas "Dr. N. Quirno"

location_facility: Institut Jules Bordet/Jules Bordet Instituut

location_facility: A.S.U. Friuli Centrale - A. Regionale Coordinamento Salute

title: A Phase 2 Basket Study of the Oral TRK Inhibitor Larotrectinib in Subjects With NTRK Fusion-positive Tumors

summary: This research study is done to test how well different types of cancer respond to the drug called larotrectinib. The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3). Larotrectinib is a drug that blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer.


lead_sponsor: SillaJen, Inc.

location_country:
Italy
United States
Hong Kong
Germany
France
Thailand
Israel
Singapore
Australia
New Zealand
China
Canada
United Kingdom
Korea, Republic of
Taiwan
Portugal

acronym: PHOCUS

location_facility: Hospital of The University of Pennsylvania

location_facility: Washington University School of Medicine

location_facility: Benaroya Research Institute at Virginia Mason Hospital

location_facility: Tulane University Health Sciences Center

location_facility: University of Texas Southwestern Medical Center

title: A Phase 3 Randomized, Open-Label Study Comparing Pexa Vec (Vaccinia GM CSF / Thymidine Kinase-Deactivated Virus) Followed by Sorafenib Versus Sorafenib in Patients With Advanced Hepatocellular Carcinoma (HCC) Without Prior Systemic Therapy

summary: This is a randomized Phase 3 study to determine whether treatment with vaccinia virus based immunotherapy (Pexa-Vec) followed by sorafenib increases survival compared to treatment with sorafenib in patients with advanced hepatocellular carcinoma who have not received prior systemic therapy.