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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02668653




Registration number
NCT02668653
Ethics application status
Date submitted
22/01/2016
Date registered
29/01/2016

Titles & IDs
Public title
Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML)
Scientific 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)
Secondary ID [1] 0 0
2015-004856-24
Secondary ID [2] 0 0
AC220-A-U302
Universal Trial Number (UTN)
Trial acronym
QuANTUM-First
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukemia 0 0
Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Chemotherapy plus quizartinib - Induction: up to 2 cycles with cytarabine and daunorubicin/idarubicin, followed by the experimental drug quizartinib

Consolidation: up to 4 cycles of cytarabine followed by the experimental drug quizartinib and/or hematopoeitic stem cell transplant

Continuation: up to 36 cycles with the experimental drug quizartinib

Active comparator: Chemotherapy plus placebo - Induction: up to 2 cycles with cytarabine and daunorubicin/idarubicin, followed by placebo

Consolidation: up to 4 cycles of cytarabine followed by placebo and/or hematopoeitic stem cell transplant

Continuation: up to 36 cycles with placebo
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
Timepoint [1] 0 0
Date of randomization to the date of death due to any cause, up to approximately 3 years after enrollment
Secondary outcome [1] 0 0
Event-free Survival in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
Timepoint [1] 0 0
Date of randomization to the date of refractory disease, relapse, or death, up to approximately 3 years after enrollment
Secondary outcome [2] 0 0
Complete Remission (CR) Rate at the End of Induction in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
Timepoint [2] 0 0
Approximately Cycle 1 Day 21 (Induction) to end of Induction, up to approximately 120 days (each Induction cycle is up to 60 days)
Secondary outcome [3] 0 0
Composite CR Rate at the End of Induction in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
Timepoint [3] 0 0
Approximately Cycle 1 Day 21 (Induction) to end of Induction, up to approximately 120 days (each Induction cycle is up to 60 days)
Secondary outcome [4] 0 0
Number of Participants With Treatment-emergent Adverse Events Occurring in =10% Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
Timepoint [4] 0 0
Date of first dose up to 30 days after last dose, up to 36 cycles following continuation (approximately 6 years 11 months, each cycle is 28 days)
Secondary outcome [5] 0 0
Number of Participants Achieving CR With FLT3-ITD Minimal Residual Disease Negativity at the End of Induction in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
Timepoint [5] 0 0
Approximately Cycle 1 Day 21 (Induction phase) to end of Induction phase, up to approximately 120 days (each Induction cycle is up to 60 days)
Secondary outcome [6] 0 0
Number of Participants Achieving Composite CR With FLT3-ITD Minimal Residual Disease Negativity at the End of Induction in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
Timepoint [6] 0 0
Approximately Cycle 1 Day 21 (Induction phase) to end of Induction phase, up to approximately 120 days (each Induction cycle is up to 60 days)
Secondary outcome [7] 0 0
Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve at Steady State
Timepoint [7] 0 0
Induction Cycle 1: Day 8, predose, 2-4 hours (hr) postdose on Days 8, 15, 21; Consolidation Cycle 1: Day 6, predose, 2-4 hr postdose on Days 6, 13, 19; Continuation Cycle 1: 2-4 hr postdose, Days 1, 8, 15; Cycle 2 Days 1 and 15 (each cycle, 28 days)
Secondary outcome [8] 0 0
Pharmacokinetic Parameter Steady State, Maximum Plasma Concentration (Css,Max)
Timepoint [8] 0 0
Induction Cycle 1: Day 8, predose, 2-4 hours (hr) postdose on Days 8, 15, 21; Consolidation Cycle 1: Day 6, predose, 2-4 hr postdose on Days 6, 13, 19; Continuation Cycle 1: 2-4 hr postdose, Days 1, 8, 15; Cycle 2 Days 1 and 15 (each cycle, 28 days)
Secondary outcome [9] 0 0
Pharmacokinetic Parameter Time to Maximum Plasma Concentration Steady State (Tmax,ss)
Timepoint [9] 0 0
Induction Cycle 1: Day 8, predose, 2-4 hours (hr) postdose on Days 8, 15, 21; Consolidation Cycle 1: Day 6, predose, 2-4 hr postdose on Days 6, 13, 19; Continuation Cycle 1: 2-4 hr postdose, Days 1, 8, 15; Cycle 2 Days 1 and 15 (each cycle, 28 days)

Eligibility
Key inclusion criteria
1. Must be competent and able to comprehend, sign, and date an Ethics Committee (EC) or Institutional Review Board approved Informed Consent Form (ICF) before performance of any study-specific procedures or tests;
2. Is =18 years or the minimum legal adult age (whichever is greater) and =75 years (at Screening);
3. Newly diagnosed, morphologically documented primary AML or AML secondary to myelodysplastic syndrome or a myeloproliferative neoplasm, based on the World Health Organization (WHO) 2008 classification (at Screening);
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (at the time the participant signs their first ICF);
5. Presence of FLT3-ITD activating mutation in bone marrow (allelic ratio of =3% FLT3-ITD/total FLT3);
6. Participant is receiving standard "7+3" induction chemotherapy regimen as specified in the protocol;
7. Adequate renal function defined as:

a. Creatinine clearance >50 mL/min, as calculated with the modified Cockcroft Gault equation
8. Adequate hepatic function defined as:

1. Total serum bilirubin (TBL) =1.5 × upper limit of normal (ULN) unless the participant has documented Gilbert's syndrome or the increase is related to increased unconjugated (indirect) bilirubin due to hemolysis;
2. Serum alkaline phosphatase, aspartate transaminase (AST) and alanine transaminase (ALT) =2.5 × ULN;
9. Serum electrolytes within normal limits: potassium, calcium (total, or corrected for serum albumin in case of hypoalbuminemia or ionized calcium) and magnesium. If outside of normal limits, participant will be eligible when electrolytes are corrected;
10. If a woman of childbearing potential, must have a negative serum pregnancy test upon entry into this study and must be willing to use highly effective birth control upon enrollment, during the treatment period and for 6 months following the last dose of investigational drug or cytarabine, whichever is later. A woman is considered of childbearing potential following menarche and until becoming postmenopausal (no menstrual period for a minimum of 12 months);
11. If male, must be surgically sterile or willing to use highly effective birth control upon enrollment, during the treatment period, and for 6 months following the last dose of investigational drug or cytarabine, whichever is later.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Diagnosis of acute promyelocytic leukemia (APL), French-American-British classification M3 or WHO classification of APL with translocation, t(15;17)(q22;q12), or breakpoint cluster region-Abelson murine leukemia viral oncogene homolog 1 (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).
2. Diagnosis of AML secondary to prior chemotherapy or radiotherapy for other neoplasms;
3. Prior treatment for AML, except for the following allowances:

* Leukapheresis;
* Treatment for hyperleukocytosis with hydroxyurea;
* Cranial radiotherapy for central nervous system (CNS) leukostasis;
* Prophylactic intrathecal chemotherapy;
* Growth factor/cytokine support;
4. Prior treatment with quizartinib or other FLT3-ITD inhibitors;
5. Prior treatment with any investigational drug or device within 30 days prior to Randomization (within 2 weeks for investigational or approved immunotherapy) or currently participating in other investigational procedures;
6. History of known CNS leukemia, including cerebrospinal fluid positive for AML blasts; lumbar puncture is recommended for participants with symptoms of CNS leukemia to rule out extramedullary CNS involvement;
7. History of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease for at least 2 years;
8. Uncontrolled or significant cardiovascular disease, including any of the following:

* Bradycardia of less than 50 beats per minute, unless the participant has a pacemaker;
* Fridericia's Heart Rate Correction Formula (QTcF) interval >450 msec;
* Diagnosis of or suspicion of long QT syndrome (including family history of long QT syndrome);
* Systolic blood pressure =180 mmHg or diastolic blood pressure =110 mmHg;
* History of clinically relevant ventricular arrhythmias (eg, ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes);
* History of second (Mobitz II) or third degree heart block (participants with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker);
* History of uncontrolled angina pectoris or myocardial infarction within 6 months prior to Screening;
* History of New York Heart Association Class 3 or 4 heart failure;
* Known history of left ventricular ejection fraction (LVEF) =45% or less than the institutional lower limit of normal;
* Complete left bundle branch block;
9. Active acute or chronic systemic fungal, bacterial, or viral infection not well controlled by antifungal, antibacterial or antiviral therapy;
10. Known active clinically relevant liver disease (eg, active hepatitis B, or active hepatitis C);
11. Known history of human immunodeficiency virus (HIV). Participants should be tested for HIV prior to Randomization if required by local regulations or EC;
12. History of hypersensitivity to any excipients in the quizartinib/placebo tablets;
13. Females who are pregnant or breastfeeding;
14. Otherwise considered inappropriate for the study by the Investigator.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/06/2023
Sample size
Target
Accrual to date
Final
539
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [2] 0 0
Townsville Hospital (TTH) - Douglas
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [4] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2298 - Waratah
Recruitment postcode(s) [2] 0 0
4814 - Douglas
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
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United States of America
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Indiana
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United States of America
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Kentucky
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United States of America
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New Jersey
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Pennsylvania
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United States of America
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West Virginia
Country [11] 0 0
Argentina
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Santa Fe
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Argentina
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Córdoba
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Belgium
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Brugge
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Belgium
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Gent
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Belgium
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Yvoir
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Brazil
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Brasília
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Brazil
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Passo Fundo
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Brazil
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Porto Alegre
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Pleven
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Sofia
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Alberta
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Wenzhou
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Xi'an
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China
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Zhengzhou
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Croatia
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Zagreb
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Czechia
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Hradec Kralove
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Olomouc
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Ostrava
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Plzen
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Toulouse
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Essen
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Frankfurt am Main
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Halle
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Hamm
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Hannöver
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Heidelberg
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Leipzig
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Germany
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Mutlangen
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Germany
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Wuppertal
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Hong Kong
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Shatin
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Pécs
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Szombathely
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Israel
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Tsifrin
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Peta? Tiqwa
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Israel
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Ramat-Gan
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Israel
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Tel Aviv
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Italy
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Alessandria
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Ascoli Piceno
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Bari
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Bologna
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Genova
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Napoli
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Italy
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Palermo
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Italy
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Ravenna
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Italy
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Roma
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Italy
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Rozzano
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Salerno
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Italy
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Siena
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Torino
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Italy
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Varese
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Japan
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Aichi
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Hokkaido
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Miagi
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Nara
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Tokyo
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Aomori
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Chiba
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Gifu
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Kobe
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Kumamoto
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Nagasaki
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Hwasun
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Incheon
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Seongnam-si
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Seoul
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Sowon
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Ulsan
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Kraków
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Portugal
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Coimbra
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Lisboa
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Portugal
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Porto
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Romania
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Bucuresti
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Cluj-Napoca
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Romania
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Craiova
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Romania
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Târgu-Mures
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Russian Federation
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Nizhny Novgorod
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Russian Federation
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Penza
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Russian Federation
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Petrozavodsk
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Russian Federation
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Ryazan'
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Russian Federation
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Saint Petersburg
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Russian Federation
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Saratov
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Russian Federation
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St. Petersburg
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Russian Federation
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Tula
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Serbia
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Belgrade
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Serbia
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Nis
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Serbia
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Novi Sad
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Singapore
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Singapore
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Alicante
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Badalona
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Spain
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Barcelona
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Spain
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Bilbao
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Spain
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Cáceres
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Spain
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Córdoba
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Spain
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Girona
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Spain
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Granada
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Spain
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La Coruña
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Spain
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Las Palmas De Gran Canaria
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Spain
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Madrid
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Majadahonda
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Spain
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Málaga
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Spain
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Oviedo
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Spain
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Pamplona
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Spain
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Salamanca
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Spain
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Santander
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Spain
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Santiago de Compostela
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Sevilla
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Spain
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Tarragona
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Spain
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Valencia
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Taiwan
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Niaosong District
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Taiwan
State/province [168] 0 0
Taichung
Country [169] 0 0
Taiwan
State/province [169] 0 0
Tainan
Country [170] 0 0
Taiwan
State/province [170] 0 0
Taipei
Country [171] 0 0
Taiwan
State/province [171] 0 0
Taoyuan
Country [172] 0 0
Ukraine
State/province [172] 0 0
Cherkasy
Country [173] 0 0
Ukraine
State/province [173] 0 0
Poltava
Country [174] 0 0
Ukraine
State/province [174] 0 0
Vinnytsia
Country [175] 0 0
Ukraine
State/province [175] 0 0
Zhytomyr
Country [176] 0 0
United Kingdom
State/province [176] 0 0
Maidstone

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Daiichi Sankyo
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Global Clinical Leader
Address 0 0
Daiichi Sankyo
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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/

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF)
When will data be available (start and end dates)?
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Available to whom?
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/daiichi-sankyo/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02668653