Clinical trial NCT06578247: Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML
Official title: Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial Of Quizartinib Administered in Combination With Induction and Consolidation Chemotherapy and Administered as Maintenance Therapy in Adult Patients With Newly Diagnosed FLT3-ITD Negative Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Leukemia
Keywords: acute myeloid leukemia
quizartinib
FLT3
FLT3-ITD
Chemotherapy
FLT3-WT
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2024-08-29
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare the effects of Quizartinib versus placebo in combination with chemotherapy in participants with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukemia (AML).

Detailed description: This is a clinical trial to compare the effect of quizartinib versus placebo (administered with standard induction and consolidation chemotherapy, then administered as maintenance therapy for up to 36 cycles) on the primary endpoint of overall survival (OS) in adult patients with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukemia (AML). Participants will be tested for FLT3-ITD mutation status in a central laboratory using a validated assay.

Eligibility criteria: Key Inclusion Criteria:

* Must be competent and able to comprehend, sign, and date an Ethics Committee (EC)- or Institutional Review Board (IRB)-approved Informed Consent Form (ICF) before performance of any trial-specific procedures or tests.
* ≥18 years or the minimum legal adult age (whichever is greater) and 70 years (at Screening).
* Newly diagnosed, morphologically documented primary AML based on the World Health Organization (WHO) 2016 classification (at Screening)
* Eastern Cooperative Oncology Group (ECOG) performance status (at the time the participant signs their ICF) of 0-2.
* Participant is receiving standard "7+3" induction chemotherapy regimen as specified in the protocol

Key Exclusion Criteria:

* Diagnosis of acute promyelocytic leukemia (APL), French-American-British classification M3 or WHO classification of APL with translocation, t(15;17)(q22;q12), or BCR-ABL positive leukemia (ie, chronic myelogenous leukemia in blast crisis); participants who undergo diagnostic workup for APL and treatment with all-trans retinoic acid (ATRA), but who are found not to have APL, are eligible (treatment with ATRA must be discontinued before starting induction chemotherapy).
* Diagnosis of AML secondary to prior chemotherapy or radiotherapy for other neoplasms or autoimmune/rheumatologic conditions.
* Diagnosis of AML secondary to myelodysplastic syndrome (MDS) or a myeloproliferative neoplasm (MPN) or MDS/MPNs including CMML, aCML, JMML and others.
* Participants with newly diagnosed AML with FLT3-ITD mutations (FLT3-ITD \[+\]) present at ≥5% VAF (or ≥0.05 SR) based on a validated FLT3 mutation assay.
* Prior treatment for AML, except for the following allowances:

  1. Leukapheresis;
  2. Treatment for hyperleukocytosis with hydroxyurea;
  3. Cranial radiotherapy for central nervous system (CNS) leukostasis;
  4. Prophylactic intrathecal chemotherapy;
  5. Growth factor/cytokine support.

Primary outcomes:
measure: Overall Survival (Arm A vs Arm B)
timeFrame: Date of first patient randomized to the target number of deaths reached, up to approximately 42 months
Secondary outcomes:
measure: Event-free survival (Arm A vs. Arm B)
timeFrame: Date of randomization up to approximately 42 months
measure: Duration of complete response (Arm A vs. Arm B)
timeFrame: Date of randomization up to approximately 42 months
measure: Relapse-free survival (Arm A vs. Arm B)
timeFrame: Date of randomization up to approximately 42 months
measure: Complete remission rate (Arm A vs. Arm B)
timeFrame: At end of Induction Phase, up to approximately 120 days
measure: Complete remission rate with minimal or measurable residual disease (Arm A vs. Arm B)
timeFrame: At end of Induction Phase (Cycle 1 or Cycles 1 and 2) and at the end of 2 cycles (2 cycles of induction or 1 cycle induction and 1 cycle consolidation)(1 Induction cycle is up to 60 days, 1 Consolidation cycle is 28 days), up to approximately 120 days
measure: Number of Participants With Treatment-emergent Adverse Events (Arm A vs. Arm B)
timeFrame: Date of first dose up to 30 days after last dose, up to approximately 42 months
Other outcomes:
Locations:
city: Goodyear
country: United States
facility: City of Hope Phoenix
state: Arizona
city: Phoenix
country: United States
facility: Mayo Clinic - Phoenix
state: Arizona
city: Tucson
country: United States
facility: University of Arizona Cancer Center
state: Arizona
city: San Francisco
country: United States
facility: Ucsf - School of Medicine
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine- Parent
state: California
city: Denver
country: United States
facility: Colorado Blood Cancer Institute
state: Colorado
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Jacksonville
country: United States
facility: Mayo Clinic Hospital
state: Florida
city: Kissimmee
country: United States
facility: Florida Hospital Cancer Institute - Kissimmee
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Tampa
country: United States
facility: Moffit Cancer Center
state: Florida
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Chicago
country: United States
facility: University of Illinois Hospital & Health Sciences System
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago Medical Center
state: Illinois
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Medical Center - New Orleans
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center Michigan Medicine
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Medical School - Twin Cities Campus
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Haddonfield
country: United States
facility: Thomas Jefferson Univ Hosp
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Comprehensive Cancer Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center - Main
state: New York
city: Syracuse
country: United States
facility: Upstate University Hospital
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Hospitals
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Center
state: Ohio
city: Columbus
country: United States
facility: The James Cancer Hospital and Solove Research Institute
state: Ohio
city: Columbus
country: United States
facility: Ohio Health Marion Area Physicians
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University (Ohsu)
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Upmc Hillman Cancer Center
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Nashville
country: United States
facility: Tristar Bone Marrow Transplant
state: Tennessee
city: Austin
country: United States
facility: South Austin Medical Center
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Houston
country: United States
facility: The University of Texas Md Anderson Cancer Center
state: Texas
city: Charlottesville
country: United States
facility: Uva Health System
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University (Vcu) Massey Cancer Center
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
city: Bedford Park
country: Australia
facility: Flinders Medical Centre (Fmc)
city: Box Hill
country: Australia
facility: Box Hill Hospital
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
city: Darlinghurst
country: Australia
facility: St Vincent'S Hospital Melbourne
city: Douglas
country: Australia
facility: Townsville University Hospital
city: Liverpool
country: Australia
facility: Liverpool Hospital
city: Melbourne
country: Australia
facility: The Alfred Hospital
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
city: Perth
country: Australia
facility: Sir Charles Gairdner Hospital
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
city: Linz
country: Austria
facility: Ordensklinikum Linz Gmbh - Elisabethinen
city: Salzburg
country: Austria
facility: Lkh - Universită"Tsklinikum Der Pmu Salzburg
city: Wien
country: Austria
facility: Hanusch Krankenhaus Der Wgkk Wien
city: Anderlecht
country: Belgium
facility: Institut Jules Bordet
city: Antwerpen
country: Belgium
facility: ZNA
city: Brugge
country: Belgium
facility: Az Sint-Jan
city: Leuven
country: Belgium
facility: Uz Leuven
city: Liege
country: Belgium
facility: Chu de Liă Ge
city: Roeselare
country: Belgium
facility: AZ DELTA
city: Botucatu
country: Brazil
facility: Unesp - Faculdade de Medicina Da Universidade Estadual Paulista - Campus Botucatu
city: Campinas
country: Brazil
facility: Centro de Hematologia E Hemoterapia - Hemocentro de Campinas - Unicamp
city: Campinas
country: Brazil
facility: Centro de Hematologia e Hemoterapia - Hemocentro de Campinas - UNICAMP
city: Curitiba
country: Brazil
facility: Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer
city: Curitiba
country: Brazil
facility: Hospital Erasto Gaertner - Liga Paranaense de Combate Ao Că'Ncer
city: FlorianĂłpolis
country: Brazil
facility: Cepon - Centro de Pesquisas Oncolă"Gicas de Santa Catarina
city: Fortaleza
country: Brazil
facility: Huwc - Ufc - Hospital Universită Rio Walter Cantă Dio - Universidade Federal Do Ceară
city: Goiania
country: Brazil
facility: HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
city: Goiania
country: Brazil
facility: Hc-Ufg - Hospital Das Clă Nicas Da Universidade Federal de Goiă S
city: Jau
country: Brazil
facility: Fundacao Doutor Amaral Carvalho
city: Jaú
country: Brazil
facility: Fundaã§Ã£O Doutor Amaral Carvalho
city: Passo Fundo
country: Brazil
facility: Hospital de Clínicas de Passo Fundo
city: Passo Fundo
country: Brazil
facility: Hospital de Clă Nicas de Passo Fundo
city: Porto Alegre
country: Brazil
facility: Santa Casa de Misericórdia de Porto Alegre
city: Porto Alegre
country: Brazil
facility: Santa Casa de Miserică"Rdia de Porto Alegre
city: Porto Alegre
country: Brazil
facility: Hospital de Clă Nicas de Porto Alegre
city: Porto Alegre
country: Brazil
facility: Hospital Ernesto Dornelles
city: Rio de Janeiro
country: Brazil
facility: Inca - Instituto Nacional de Că'Ncer
city: Sao Jose Rio Preto
country: Brazil
facility: Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
city: Sao Paulo
country: Brazil
facility: ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
city: SĂŁo Paulo
country: Brazil
facility: Icesp - Instituto Do Câncer Do Estado de São Paulo Octavio Frias de Oliveira
city: SĂŁo Paulo
country: Brazil
facility: Hospital Benefică Ncia Portuguesa de Să O Paulo
city: SĂŁo Paulo
country: Brazil
facility: Hospital Nove de Julho
city: Pleven
country: Bulgaria
facility: Umhat 'Dr. Georgi Stranski', Ead
city: Plovdiv
country: Bulgaria
facility: Umhat 'Sv. Georgi', Ead
city: Sofia
country: Bulgaria
facility: Umhat Â Sv. Ivan Rilskiâ , Ead
city: Sofia
country: Bulgaria
facility: Military Medical Academy - Mhat - Sofia
city: Sofia
country: Bulgaria
facility: 'Shathd' Ead Sofia
city: Stara Zagora
country: Bulgaria
facility: Umhat Prof. Dr. Stoyan Kirkovich Ad
city: London
country: Canada
facility: London Health Sciences Centre
city: Ottawa
country: Canada
facility: The Ottawa Hospital - General Campus
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Centre
city: Toronto
country: Canada
facility: Princess Margaret Cancer Center
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Peking University Third Hospital
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Changchun
country: China
facility: The First Hospital of Jilin University
city: Changsha
country: China
facility: Xiangya Hospital, Central South University
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
city: Guangzhou
country: China
facility: Sun Yat-Sen University, Cancer Center
city: Guangzhou
country: China
facility: Guangdong Provincial People'S Hospital
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
city: Nanjing
country: China
facility: Zhong Da Hospital, Southeast University
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
city: Shanghai
country: China
facility: Shanghai Tongren Hospital
city: Shengyang
country: China
facility: Shengjing Hospital of China Medical University
city: Shenzhen
country: China
facility: Shenzhen Second People'S Hospital
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
city: Tianjin
country: China
facility: Institute of Hematology and Hospital of Blood Disease
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
city: Wuxi
country: China
facility: Wuxi People'S Hospital
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xiâ An Jiaotong University
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Rijeka
country: Croatia
facility: Clinical Hospital Centre Rijeka
city: Zagreb
country: Croatia
facility: Clinical Hospital Centar Zagreb
city: Zagreb
country: Croatia
facility: Clinical Hospital Dubrava
city: Brno
country: Czechia
facility: Fakultni Nemocnice Brno
city: Hradec Kralove
country: Czechia
facility: Fakultni Nemocnice Hradec Kralove
city: Ostrava - Poruba
country: Czechia
facility: Fakultni Nemocnice Ostrava
city: Plzen
country: Czechia
facility: Fakultni Nemocnice Plzen
city: Praha 10
country: Czechia
facility: Fakultni Nemocnice Kralovske Vinohrady
city: Praha 2
country: Czechia
facility: Ustav Hematologie A Krevni Transfuze
city: Angers
country: France
facility: Chu Angers - Hă"Pital Hă"Tel Dieu
city: Caen
country: France
facility: Chu de Caen
city: Grenoble
country: France
facility: Chu de Grenoble - Hă"Pital Albert Michallon
city: Le Chesnay Cedex
country: France
facility: Centre Hospitalier de Versailles
city: Lille cedex
country: France
facility: Hopital Claude Huriez - Chru Lille
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille Cedex 05
country: France
facility: Hopital de La Conception - Aphm
city: Nantes cedex 1
country: France
facility: Chu de Nantes - Hotel Dieu
city: Nice
country: France
facility: Chu Nice - Hă"Pital de L'Archet 1
city: Paris cedex 10
country: France
facility: Hă"Pital Saint-Louis
city: Pessac cedex
country: France
facility: Chu de Bordeaux - Hă"Pital Haut-Lă Vă Que
city: Pierre BĂŠnite
country: France
facility: Centre Hospitalier Lyon Sud
city: Rennes cedex 09
country: France
facility: Chu Rennes - Hopital Pontchaillou
city: Salouel
country: France
facility: Chu Amiens - Hopital Sud
city: Strasbourg
country: France
facility: Institut de Cancă Rologie de Strasbourg Europe - Icans
city: Toulouse
country: France
facility: Institut Universitaire Du Cancer de Toulouse- Iuct-O
city: Alzenau
country: Germany
facility: Klinikum Aschaffenburg-Alzenau
city: Braunschweig
country: Germany
facility: Staedtisches Klinikum Braunschweig Ggmbh
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus Tu Dresden
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Hannover
country: Germany
facility: Krh Klinikum Siloah
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein
city: Leipzig
country: Germany
facility: Universită"Tsklinikum Leipzig Klinik Fă R Hă"Matologie Internistische Onkologie Hă"Mostaseol
city: Münster
country: Germany
facility: Universitaetsklinikum Muenster
city: Hong kong
country: Hong Kong
facility: The University of Hong Kong
city: Shatin
country: Hong Kong
facility: The Chinese University of Hong Kong (Cuhk)
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Debrecen
country: Hungary
facility: Debreceni Egyetem
city: Gyor
country: Hungary
facility: Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
city: Bari
country: Italy
facility: Azienda Ospedaliero Universitaria Consorziale Policlinico Di Bari
city: Brescia
country: Italy
facility: Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia (Presidio Spedali Civili)
city: Meldola
country: Italy
facility: Irccs Istituto Scientifico Romagnolo Per Lo Studio Dei Tumori 'Dino Amadori' - Irst
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Milano
country: Italy
facility: Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
city: Novara
country: Italy
facility: Ospedale Maggiore Di Novara
city: Palermo
country: Italy
facility: Azienda Ospedaliera Vincenzo Cervello
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli Irccs
city: Rome
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: San Giovanni Rotondo
country: Italy
facility: Irccs Ospedale Casa Sollievo Della Sofferenza
city: Torino
country: Italy
facility: Azienda Ospedaliero-Universitaria Cittă Della Salute E Della Scienza Di Torino
city: Torino
country: Italy
facility: Ospedale Mauriziano Umberto I
city: Varese
country: Italy
facility: Asst Dei Sette Laghi Ospedale Di Circolo E Fondazione Macchi Varese
city: Akita
country: Japan
facility: Akita University Hospital
city: Aomori
country: Japan
facility: Aomori Prefetural Central Hospital
city: Bunkyo-ku
country: Japan
facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
city: Chiba-shi
country: Japan
facility: Chiba Aoba Municipal Hospital
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Fukuyama
country: Japan
facility: Chugoku Central Hospital
city: Gifu
country: Japan
facility: Gifu Municipal Hospital
city: Hamamatsu
country: Japan
facility: Hamamatsu University School of Medicine, University Hospital
city: Kamogawa-shi
country: Japan
facility: Tesshokai Kameda General Hospital
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
city: Kumamoto
country: Japan
facility: National Hospital Organization Kumamoto Medical Center
city: Maebashi
country: Japan
facility: Saiseikai Maebashi Hospital
city: Matsuyama
country: Japan
facility: Ehime Prefectural Central Hospital
city: Nagoya
country: Japan
facility: Nagoya University Hospital
city: Osakar
country: Japan
facility: Japan RED CROSS OSAKA HOSPITAL
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
city: Sapporo
country: Japan
facility: Sapporo Hokuyu Hospital
city: Tenri
country: Japan
facility: Tenri Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Hwasun-gun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Jeonju-si
country: Korea, Republic of
facility: Jeonbuk National University Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary'S Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Bergen
country: Norway
facility: Haukeland Universitetssykehus
city: Oslo
country: Norway
facility: Oslo University Hospital
city: TromsĂ¸
country: Norway
facility: University Hospital of North Norway
city: Lublin
country: Poland
facility: Klinika Hematoonkologii I Transplantacji Szpiku
city: Olsztyn
country: Poland
facility: Spzoz Msw Zwarmiĺ Sko-Mazurskimcen.Onko.Wolsztynie
city: Torun
country: Poland
facility: Wojewodzki Szpital Zespolony Im. L. Rydygiera W Toruniu
city: Warszawa
country: Poland
facility: Instytut Hematologii I Transfuzjologii
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
city: Porto
country: Portugal
facility: Instituto Português de Oncologia Do Porto Francisco Gentil, Epe
city: Bucuresti
country: Romania
facility: Spitalul Clinic Colentina
city: Bucuresti
country: Romania
facility: Institutul Clinic Fundeni
city: Bucuresti
country: Romania
facility: Spitalul Clinic Coltea
city: Cluj-Napoca
country: Romania
facility: Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
city: Craiova
country: Romania
facility: Spitalul Clinic Municipal Filantropia Craiova
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Belgrade
country: Serbia
facility: University Clinical Center of Serbia
city: Nis
country: Serbia
facility: University Clinical Center Nis
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Curie Oncology Pte Ltd
city: Albacete
country: Spain
facility: Complejo Hospitalario Universitario de Albacete
city: Barcelona
country: Spain
facility: Hospital de La Santa Creu I Sant Pau
city: Caceres
country: Spain
facility: Hospital San Pedro de Alcantara
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Las Palmas
country: Spain
facility: Hospital Universitario de Gran Canaria Dr. Negrin
city: Madrid
country: Spain
facility: Clinica Universidad de Navarra
city: Madrid
country: Spain
facility: Md Anderson Cancer Centre
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Malaga
city: Murcia
country: Spain
facility: Hospital General Universitario Morales Meseguer
city: Palma de Mallorca
country: Spain
facility: Hospital Universitari Son Espases
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Universitario Quironsalud Madrid
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago
city: Seville
country: Spain
facility: Hospital Universitario Virgen Del Rocio
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitario Dr. Peset
city: Valencia
country: Spain
facility: Hospital Universitari I Politecnic La Fe
city: GĂśteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset
city: Lund
country: Sweden
facility: Skă Nes Universitetssjukhus, Lund
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset
city: Bern
country: Switzerland
facility: Inselspital - Universitaetsspital Bern
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospitalx
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan County
country: Taiwan
facility: Chang Gung Memorial Hospital
city: London
country: United Kingdom
facility: King'S College Hospital
city: London
country: United Kingdom
facility: Hammersmith Hospital
city: Maidstone
country: United Kingdom
facility: Maidstone Hospital
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
city: Oxford
country: United Kingdom
facility: Churchill Hospital
city: Torquay
country: United Kingdom
facility: Torbay Hospital
Study officials:
affiliation: Daiichi Sankyo
name: Global Clinical Leader
role: STUDY_DIRECTOR
References: