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(QuANTUM-R): An Open-label Study of Quizartinib Monotherapy vs. Salvage Chemotherapy in Acute Myeloid Leukemia (AML) Subjects Who Are FLT3-ITD Positive

Sponsor
Daiichi Sankyo, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02039726
Collaborator
(none)
367
Enrollment
131
Locations
2
Arms
76.3
Actual Duration (Months)
2.8
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of the study is to determine whether quizartinib monotherapy prolongs overall survival (OS) compared to salvage chemotherapy in subjects with FMS-like tyrosine kinase 3 - Internal Tandem Duplication (FLT3-ITD) positive AML who are refractory to or have relapsed within 6 months, after first-line AML therapy.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
367 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3 Open-label Randomized Study of Quizartinib (AC220) Monotherapy Versus Salvage Chemotherapy in Subjects With Tyrosine Kinase 3 - Internal Tandem Duplication (FLT3-ITD) Positive Acute Myeloid Leukemia (AML) Refractory to or Relapsed After First-line Treatment With or Without Hematopoietic Stem Cell Transplantation (HSCT) Consolidation
Actual Study Start Date :
May 1, 2014
Actual Primary Completion Date :
Feb 22, 2018
Actual Study Completion Date :
Sep 8, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Quizartinib

Participants who were randomized to receive 20 or 30 mg quizartinib tablets administered orally once daily.

Drug: Quizartinib
20 or 30 mg quizartinib tablets administered orally once daily
Other Names:
  • AC220

    		•
    Active Comparator: Salvage chemotherapy

    Participants who were randomized to receive salvage chemotherapy, such as low dose cytarabine (LoDAC); mitoxantrone, etoposide, and intermediate-dose cytarabine (MEC); or fludarabine, cytarabine, and granulocyte colony stimulating factor (G-CSF) with idarubicin (FLAG-IDA), were administered during 28-day cycles.

    Drug: Salvage Chemotherapy
    Low dose cytarabine (LoDAC); mitoxantrone, etoposide, and intermediate-dose cytarabine (MEC); or fludarabine, cytarabine, and granulocyte colony stimulating factor (G-CSF) with idarubicin (FLAG-IDA) administered during 28-day cycles
    Other Names:
  • Standard of Care

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall Survival in Participants That Received Quizartinib Versus Salvage Chemotherapy [At approximately 3 years 9 months]

      Overall Survival is defined as the time (in weeks) from the date of randomization to the date of death due to any cause. Median and quartiles are calculated using the Kaplan-Meier method.

    Secondary Outcome Measures

    1. Event-free Survival in Participants That Received Quizartinib Versus Salvage Chemotherapy [At approximately 3 years 9 months]

      Event-free survival is defined as the time (in weeks) from randomization until documented refractory disease, relapse after complete composite remission (CRc), or death from any cause, whichever is observed first.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Provision of written informed consent approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) with privacy language in accordance with national regulations (e.g., Health Insurance Portability and Accountability Act [HIPAA] authorization for United States [US] sites) prior to any study related procedures, including withdrawal of prohibited medications if applicable.

    2. Age ≥ 18 years or the minimum legal adult age (whichever is greater) at the time of Informed consent.

    3. Morphologically documented primary Acute Myeloid Leukemia (AML) or AML secondary to Myelodysplastic Syndrome (MDS), as defined by World Health Organization (WHO) criteria, as determined by pathology review at the study site.

    4. In first relapse (with duration of remission of 6 months or less) or refractory after prior therapy, with or without HSCT. Induction therapy must have included at least 1 cycle of an anthracycline/mitoxantrone-containing induction block at a standard dose.

    5. Presence of the FLT3-ITD activating mutation in bone marrow or peripheral blood (allelic ratio as determined by a central laboratory with a cutoff of ≥3% FLT3-ITD/total FLT3). If a specimen has been sent for FLT3-ITD testing at the central laboratory but the subject requires treatment for AML before the central FLT3-ITD test result is available, a local test result may be acceptable for randomization after consultation with the Medical Monitor.

    6. Eligibility for pre-selected salvage chemotherapy, according to the Investigator's assessment.

    7. Eastern Cooperative Oncology Group (ECOG) performance score 0-2.

    8. Discontinuation of prior AML treatment before the start of study treatment (except hydroxyurea or other treatment to control leukocytosis) for at least 2 weeks for cytotoxic agents, or for at least 5 half-lives for non cytotoxic agents.

    9. Serum creatinine ≤1.5×upper limit of normal (ULN), or glomerular filtration rate >25 mL/min, as calculated with the Cockcroft-Gault formula.

    10. Serum potassium, magnesium, and calcium (serum calcium corrected for hypoalbuminemia) within institutional normal limits. Subjects with electrolytes outside the normal range will be eligible if these values are corrected upon retesting following any necessary supplementation.

    11. Total serum bilirubin ≤1.5×ULN.

    12. Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) ≤2.5×ULN.

    Exclusion Criteria:

    1. Acute Promyelocytic Leukemia (AML subtype M3).

    2. AML secondary to prior chemotherapy for other neoplasms, except AML secondary to prior Myelodysplastic Syndrome (MDS).

    3. History of another malignancy, unless the candidate has been disease-free for at least 5 years.

    4. Persistent, clinically significant > Grade 1 non-hematologic toxicity from prior AML therapy.

    5. Clinically significant graft versus host disease (GVHD) or GVHD requiring initiation of treatment or treatment escalation within 21 days, and/or > Grade 1 persistent or clinically significant non hematologic toxicity related to HSCT.

    6. History of or current, central nervous system involvement with AML.

    7. Clinically significant coagulation abnormality, such as disseminated intravascular coagulation.

    8. Prior treatment with quizartinib or participated in a prior quizartinib study.

    9. Prior treatment with a FLT3 targeted therapy including sorafenib or investigational FLT3 inhibitors (not including the multi-kinase inhibitor, midostaurin).

    10. Major surgery within 4 weeks prior to screening.

    11. Radiation therapy within 4 weeks prior to screening.

    12. Uncontrolled or significant cardiovascular disease

    13. Active infection not well controlled by antibacterial or antiviral therapy.

    14. Known infection with human immunodeficiency virus, or active hepatitis B or C, or other active clinically relevant liver disease.

    15. Unwillingness to receive infusion of blood products according to the protocol.

    16. In a man whose sexual partner is a woman of childbearing potential, unwillingness or inability of the man or woman to use a highly effective contraceptive method for the entire study treatment period for at least 3 months after study completion. Male subjects must not freeze or donate sperm starting at Screening and throughout the study period, and 105 days after the final study drug administration.

    17. In a heterosexually active woman of childbearing potential, unwillingness or inability to use a highly effective contraceptive method for the entire study treatment period and for at least 3 months after study treatment completion. Additionally, for women randomized to chemotherapy, unwillingness to adhere to the restrictions in the respective locally established guidelines and local approved label (prescribing information, Summary of Product Characteristics, or US product insert) from the manufacturer and the Patient Information Leaflet (package insert) as instructed by the Investigator.

    18. Pregnancy.

    19. Female Subjects must agree to not breastfeed from the time of Screening and throughout the study period, and for 25 days after the final study drug administration.

    20. Medical condition, serious intercurrent illness, or other circumstance that, in the Investigator's judgment, could jeopardize the candidate's safety as a study subject, or that could interfere with study objectives.

    21. For subjects in the United Kingdom only: Refusal of permission to allow the subject's General Practitioner to be notified of their participation in the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 City of Hope National Medical Center Duarte California United States 91010
    2 University of Southern California, Norris Comprehensive Cancer Center Los Angeles California United States 90033
    3 UCLA Medical Center Los Angeles California United States 90095
    4 UC Davis Cancer Center Sacramento California United States 95817
    5 Stanford University Medical Center Stanford Comprehensive Cancer Center Stanford California United States 94305
    6 Yale University New Haven Connecticut United States 06520
    7 Emory Winship Cancer Institute Atlanta Georgia United States 30322
    8 University of Illinois at Chicago Chicago Illinois United States 60607
    9 University of Chicago Chicago Illinois United States 60637
    10 Franciscan Alliance Indianapolis Indiana United States 46237
    11 University of Kansas Medical Center Research Institute Inc Westwood Kansas United States 66205
    12 LSU Health Sciences Center Feist Weiller Cancer Center Shreveport Louisiana United States 71103
    13 University of Maryland Baltimore Maryland United States 21201
    14 Dana Farber Cancer Institute Boston Massachusetts United States 02215
    15 University of Michigan Health System Ann Arbor Michigan United States 48109
    16 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201
    17 Mayo Clinic Rochester Minnesota United States 55905
    18 Washington University School of Medicine Saint Louis Missouri United States 63110
    19 University of Nebraska Medical Center Omaha Nebraska United States 68198
    20 John Theurer Cancer Center at Hackensack University Medical Center Hackensack New Jersey United States 07601
    21 Roswell Park Cancer Institute Buffalo New York United States 14263
    22 Columbia University Medical Center New York New York United States 10032
    23 University of Rochester Rochester New York United States 14642
    24 NY Medical College Valhalla New York United States 10595
    25 UNC Linebreger Comprehensive Cancer Center Chapel Hill North Carolina United States 27599
    26 Duke Cancer Institute at Duke University Health System Durham North Carolina United States 27710
    27 Wake Forest University Baptist Health Winston-Salem North Carolina United States 27157
    28 University of Cincinnati Cincinnati Ohio United States 45267
    29 Oregon Health and Science University Knight Cancer Institute Portland Oregon United States 97239
    30 Geisinger Medical Center Danville Pennsylvania United States 17822
    31 Penn State Milton S Hershey Medical Center Hershey Pennsylvania United States 17033
    32 University of Pennsylvania Health System Philadelphia Pennsylvania United States 19104
    33 Avera Cancer Institute Sioux Falls South Dakota United States 57105
    34 Vanderbilt-Ingram Cancer Center Nashville Tennessee United States 37232
    35 MD Anderson Center, The University of Texas Houston Texas United States 77030
    36 Swedish Cancer Institute Seattle Washington United States 98104
    37 The Canbera Hospital Garran New South Wales Australia 2605
    38 Westmead Hospital Westmead New South Wales Australia 2145
    39 The Princess Alexandra Hospital Brisbane Queensland Australia
    40 Royal Adelaide Hospital Adelaide South Australia Australia 5000
    41 The Queen Elizabeth Hospital Woodville South Australia Australia 5011
    42 Alfred Hospital Melbourne Victoria Australia 3004
    43 ZNA Stuivenberg Antwerpen BE Belgium 2060
    44 UCL St Luc Brussels BE Belgium 1200
    45 Leuven UZ Gasthuisberg Leuven BE Belgium 3000
    46 University of Alberta Hospital Edmonton Alberta Canada T6G 2B7
    47 Vancouver General Hospital Vancouver British Columbia Canada V5Z 1M9
    48 Princess Margaret Cancer Centre Princess Margaret Hospital Toronto Ontario Canada M5G2M9
    49 Klinička Bolinca Merkur Zagreb Croatia 10000
    50 Kliničko Bolnički Centar Zagreb Zagreb Croatia 10000
    51 Fakultni nemocnice Brno Brno Czechia 62500
    52 Fakultni nemocnice Hradec Kralove Hradec Králové Czechia 50005
    53 Fakultni nemocnice Olomouc Olomouc Czechia 77900
    54 CHU de Caen Caen France 14000
    55 Centre Hospitalier Universitaire Grenoble Hopital Michalon Grenoble France 38043
    56 Centre Hospitalier de Versailles Le Chesnay France 78157
    57 Hopital de la Conception Marseille France 13385
    58 Centre Hospitalier Universitaire Nantes Nantes France 44035
    59 Hôpital Saint Louis Paris France 75010
    60 Hopital Saint-Antoine Paris France 75571
    61 Hopital Haut Leveque Centre Francois Magendie Pessac France 33604
    62 Centre Henri-Becquerel Rouen France 76038
    63 Centre Hospitalier Universitaire Purpan Toulouse France 31059
    64 Charité Universitätsmedizin Berlin Berlin Germany 12200
    65 Charité Campus Virchow Klinikum Berlin Germany 13353
    66 Klinikum Braunschweig Braunschweig Germany 38114
    67 Universitatsklinikum Dresden Dresden Germany 01307
    68 Klinikum der Johann Wolfgang-Goethe-Universität Frankfurt Germany 60590
    69 Universitätsklinikum Halle Halle Germany 06120
    70 Medizinische Hochschule Hannover Hanover Germany 30625
    71 Uniklinik Heidelberg Medizinische Klinik und Poliklinik V Heidelberg Germany 69120
    72 Universitätsklinikum Jena Jena Germany 07743
    73 Universitätsklinikum Leipzig Leipzig Germany 04103
    74 University Mainz Mainz Germany 55131
    75 Universitätsklinikum Giessen und Marburg GmbH Marburg Germany 35043
    76 LMU München Klinikum Großhadern Munchen Germany 81377
    77 Medizinische Klinik A Hämatologie Hämostaseologie Internistische Onkologie und Pneumologie Münster Germany 48149
    78 The Chinese University of Hong Kong, Prince of Wales Hospital Hong Kong Hong Kong
    79 The University of Hong Kong, Queen Mary Hospital Hong Kong Hong Kong
    80 Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Szent Gyorgyi Albert Klinikai Kozpont Szeged Csongrad Hungary 6725
    81 Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Intezet Debrecen Hajdu Bihar Hungary 4032
    82 Semmelweis Egyetem Altalanos Orvostudomanyi Kar I. Belgyogyaszati Klinika Budapest Pest Hungary 1083
    83 AOU Policlinico Consorziale di Bari Bari Italy 70124
    84 Università di Bologna Bologna Italy 40138
    85 Unità Operativa di Ematologia e Unità Operativa CTMO Cagliari Italy
    86 Arcispedale S Anna Ferrara Italy 44124
    87 AOU Careggi Firenze Italy 50134
    88 IRCCS Azienda Ospedaliera Universitaria San Martino Genova Italy 16132
    89 Opsedale San Martino di Genova Genova Italy 16132
    90 Ospedale San Raffaele Milan Italy 20132
    91 Azienda Ospedaliera Universitaria Federico II Napoli Italy 80131
    92 Azienda Ospedaliero Universitaria San Luigi Gonzaga Orbassano Italy 10043
    93 L'UOC di Ematologia del Policlinico Tor Vergata Rome Italy 00133
    94 Policlinico Universitario Agostino Gemelli Rome Italy 00168
    95 Azienda Ospedaliero Universitaria Senese, Policlinico S. Maria alle Scotte Siena Italy 53100
    96 Ospedale di Circolo-a Fondazione Macchi Varese Italy 21100
    97 Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do Korea, Republic of 463-707
    98 Kyungpook National University Hospital Daegu Korea, Republic of 700-721
    99 Seoul National University Hospital Seoul Korea, Republic of 110-744
    100 Samsung Medical Center Seoul Korea, Republic of 135-710
    101 The Catholic University of Korea Seoul St. Mary's Hospital Seoul Korea, Republic of 137-701
    102 Asan Medical Center Seoul Korea, Republic of 138-736
    103 VU Medisch Centrum Amsterdam Netherlands 1081 HV
    104 Universitair Medisch Centrum Groningen Groningen Netherlands 9713 GZ
    105 Erasmus Medical Center Rotterdam Netherlands 3015 CE
    106 Uniwersytecki Szpital Kliniczny w Biatymstoku, Klinika Hematologii z Pododzialem Chorob Naczyn Bialystok Poland 15276
    107 Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach Oddzial Hematologii i Transplantacji Szpiku Katowice Poland 40032
    108 Samodzielny Publiczny Szpital Kliniczny Nr 1, Klinika Hematoonkologii i Transplantacji Szpiku Lublin Poland 20081
    109 Klinicki Centar Srbije Belgrade Serbia 11000
    110 Klinicki Centar Vojvodine Novi Sad Serbia 21000
    111 National University of Singapore Singapore Singapore 119228
    112 Singapore General Hospital Singapore Singapore 169608
    113 Hospital Son Espases Palma De Mallorca Spain 07120
    114 Hospital La Fe Valencia SP Spain 46026
    115 Hospital Clinic I Provincial de Barcelona Barcelona Spain 08036
    116 Hospital Universitari Germans Trias i Pujol Barcelona Spain 08916
    117 Hospital General Universitario Gregorio Marañon Madrid Spain 28007
    118 Complejo Hospitalario de Navarra Pamplona Spain 31008
    119 Hospital Clínico Universitario de Salamanca Salamanca Spain 37007
    120 Hospital Universitario Virgen del Rocio Sevilla Spain 41013
    121 China Medical University Hospital Taichung Taiwan 404
    122 National Cheng Kung University Hospital Tainan Taiwan 704
    123 National Taiwan University Hospital Taipei Taiwan 100
    124 Taipei Veterans General Hospital Taipei Taiwan 112
    125 Bristol Haematology and Oncology Centre Bristol England United Kingdom BS2 8ED
    126 Saint James University Hospital Leeds England United Kingdom LS9 7TF
    127 King's College Hospital London England United Kingdom SE5 9RS
    128 Nottingham City Hospital NHS Trust Nottingham England United Kingdom NG51PB
    129 Royal Marsden Hospital Sutton Sutton England United Kingdom SM2 5PT
    130 Aberdeen Royal Infirmary Aberdeen Scotland United Kingdom AB25 2ZN
    131 University Hospital of Wales Cardiff South Glamorgan United Kingdom CF14 4XW

    Sponsors and Collaborators

    • Daiichi Sankyo, Inc.

    Investigators

    • Principal Investigator: Jorge E. Cortes, MD, M.D. Anderson Cancer Center
    • Study Director: Global Clinical Leader, Daiichi Sankyo, Inc.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Daiichi Sankyo, Inc.
    ClinicalTrials.gov Identifier:
    NCT02039726
    Other Study ID Numbers:
    • AC220-007
    • EudraCT Number 2013-004890-28
    First Posted:
    Jan 20, 2014
    Last Update Posted:
    Feb 24, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Daiichi Sankyo, Inc.
    Acute Myeloid Leukemia
    AML
    FMS-like tyrosine kinase 3
    FLT3-ITD
    Quizartinib
    Leukemia
    Tablets
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Myeloid
    Leukemia, Myeloid, Acute

    Study Results

    Participant Flow

    Recruitment Details A total of 367 participants who met the inclusion and none of the exclusion criteria were randomized (intent-to-treat population); 335 received study drug (safety analysis set).
    Pre-assignment Detail Prior to randomization, the investigator was required to pre-select 1 of the 3 salvage chemotherapy regimens for each participant. Randomization was stratified by response to prior therapy (relapsed in ≤6 months [with or without HSCT] or refractory) and pre-selected salvage chemotherapy (high or low intensity chemotherapy) for all participants.
    Arm/Group Title Quizartinib Salvage Chemotherapy
    Arm/Group Description Participants who were randomized to receive 20 or 30 mg Quizartinib tablets administered orally once daily. Participants who were randomized to receive salvage chemotherapy, such as low dose cytarabine (LoDAC); mitoxantrone, etoposide, and intermediate-dose cytarabine (MEC); or fludarabine, cytarabine, and granulocyte colony stimulating factor (G-CSF) with idarubicin (FLAG-IDA), were administered during 28-day cycles.
    Period Title: Overall Study
    STARTED 245 122
    Ongoing (as of Data Cutoff) 45 16
    Did Not Receive Treatment 4 28
    COMPLETED 200 106
    NOT COMPLETED 45 16

    Baseline Characteristics

    Arm/Group Title Quizartinib Salvage Chemotherapy Total
    Arm/Group Description Participants who were randomized to receive 20 or 30 mg Quizartinib tablets administered orally once daily. Participants who were randomized to receive salvage chemotherapy, such as low dose cytarabine (LoDAC); mitoxantrone, etoposide, and intermediate-dose cytarabine (MEC); or fludarabine, cytarabine, and granulocyte colony stimulating factor (G-CSF) with idarubicin (FLAG-IDA), were administered during 28-day cycles. Total of all reporting groups
    Overall Participants 245 122 367
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    180
    73.5%
    89
    73%
    269
    73.3%
    >=65 years
    65
    26.5%
    33
    27%
    98
    26.7%
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    55.0
    57.5
    56.0
    Sex: Female, Male (Count of Participants)
    Female
    132
    53.9%
    58
    47.5%
    190
    51.8%
    Male
    113
    46.1%
    64
    52.5%
    177
    48.2%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    1
    0.4%
    0
    0%
    1
    0.3%
    Asian
    24
    9.8%
    16
    13.1%
    40
    10.9%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    9
    3.7%
    3
    2.5%
    12
    3.3%
    White
    184
    75.1%
    93
    76.2%
    277
    75.5%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    27
    11%
    10
    8.2%
    37
    10.1%
    Region of Enrollment (participants) [Number]
    Singapore
    0
    0%
    2
    1.6%
    2
    0.5%
    Hong Kong
    5
    2%
    3
    2.5%
    8
    2.2%
    Hungary
    1
    0.4%
    0
    0%
    1
    0.3%
    United States
    82
    33.5%
    36
    29.5%
    118
    32.2%
    Czechia
    2
    0.8%
    0
    0%
    2
    0.5%
    United Kingdom
    21
    8.6%
    14
    11.5%
    35
    9.5%
    Spain
    15
    6.1%
    6
    4.9%
    21
    5.7%
    Canada
    18
    7.3%
    5
    4.1%
    23
    6.3%
    Netherlands
    2
    0.8%
    1
    0.8%
    3
    0.8%
    South Korea
    11
    4.5%
    7
    5.7%
    18
    4.9%
    Belgium
    1
    0.4%
    0
    0%
    1
    0.3%
    Taiwan
    2
    0.8%
    1
    0.8%
    3
    0.8%
    Poland
    2
    0.8%
    0
    0%
    2
    0.5%
    Italy
    34
    13.9%
    19
    15.6%
    53
    14.4%
    Australia
    3
    1.2%
    3
    2.5%
    6
    1.6%
    France
    20
    8.2%
    7
    5.7%
    27
    7.4%
    Serbia
    1
    0.4%
    0
    0%
    1
    0.3%
    Germany
    25
    10.2%
    18
    14.8%
    43
    11.7%

    Outcome Measures

    1. Primary Outcome
    Title Overall Survival in Participants That Received Quizartinib Versus Salvage Chemotherapy
    Description Overall Survival is defined as the time (in weeks) from the date of randomization to the date of death due to any cause. Median and quartiles are calculated using the Kaplan-Meier method.
    Time Frame At approximately 3 years 9 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Quizartinib Salvage Chemotherapy
    Arm/Group Description Participants who were randomized to receive 20 or 30 mg quizartinib tablets administered orally once daily. Participants who were randomized to receive salvage chemotherapy, such as low dose cytarabine (LoDAC); mitoxantrone, etoposide, and intermediate-dose cytarabine (MEC); or fludarabine, cytarabine, and granulocyte colony stimulating factor (G-CSF) with idarubicin (FLAG-IDA), were administered during 28-day cycles.
    Measure Participants 245 122
    Median (Inter-Quartile Range) [weeks]
    27.0
    20.4
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Quizartinib, Salvage Chemotherapy
    Comments Stratified analysis - stratification factors include prior therapy and response (Relapsed in ≤6 months (not post-HSCT), Refractory, or relapsed in ≤6 months post allogeneic HSCT), and pre-selected chemotherapy (High intensity chemotherapy [MEC or FLAG-IDA], or low intensity chemotherapy [LoDAC]).
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0185
    Comments
    Method P-value for HR=1 (1-sided)
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.758
    Confidence Interval (2-Sided) 95%
    0.584 to 0.983
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title Event-free Survival in Participants That Received Quizartinib Versus Salvage Chemotherapy
    Description Event-free survival is defined as the time (in weeks) from randomization until documented refractory disease, relapse after complete composite remission (CRc), or death from any cause, whichever is observed first.
    Time Frame At approximately 3 years 9 months

    Outcome Measure Data

    Analysis Population Description
    Event-free survival was assessed in the intent-to-treat (ITT) analysis set.
    Arm/Group Title Quizartinib Salvage Chemotherapy
    Arm/Group Description Participants who were randomized to receive 20 or 30 mg quizartinib tablets administered orally once daily. Participants who were randomized to receive salvage chemotherapy, such as low dose cytarabine (LoDAC); mitoxantrone, etoposide, and intermediate-dose cytarabine (MEC); or fludarabine, cytarabine, and granulocyte colony stimulating factor (G-CSF) with idarubicin (FLAG-IDA), were administered during 28-day cycles.
    Measure Participants 245 122
    Median (Inter-Quartile Range) [weeks]
    6.0
    3.7
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Quizartinib, Salvage Chemotherapy
    Comments Stratified analysis - stratification factors include prior therapy and response (Relapsed in ≤6 months (not post-HSCT), Refractory, or relapsed in ≤6 months post allogeneic HSCT), and pre-selected chemotherapy (High intensity chemotherapy [MEC or FLAG-IDA], or low intensity chemotherapy [LoDAC]).
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2034
    Comments
    Method P value for HR=1 (1-sided)
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.898
    Confidence Interval (2-Sided) 95%
    0.697 to 1.157
    Parameter Dispersion Type:
    Value:
    Estimation Comments

    Adverse Events

    Time Frame Treatment-emergent adverse events (TEAEs) were collected from the first dose of study drug to 30 days after the last dose (or longer if assessed as treatment related). All safety events are reported for participants in the Safety Analysis Set who received at least 1 dose of study drug or salvage chemotherapy.
    Adverse Event Reporting Description Differences in treatment regimens make the Treatment-emergent adverse events (TEAE) collection period span multiple 28-day cycles in the Quizartinib arm and only 1-2 weeks in the salvage chemotherapy arm.
    Arm/Group Title Quizartinib Salvage Chemotherapy
    Arm/Group Description Participants who were randomized to receive 20 or 30 mg quizartinib tablets administered orally once daily. Participants who were randomized to receive salvage chemotherapy, such as low dose cytarabine (LoDAC); mitoxantrone, etoposide, and intermediate-dose cytarabine (MEC); or fludarabine, cytarabine, and granulocyte colony stimulating factor (G-CSF) with idarubicin (FLAG-IDA), were administered during 28-day cycles.
    All Cause Mortality
    Quizartinib Salvage Chemotherapy
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 80/241 (33.2%) 16/94 (17%)
    Serious Adverse Events
    Quizartinib Salvage Chemotherapy
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 168/241 (69.7%) 37/94 (39.4%)
    Blood and lymphatic system disorders
    Anemia 6/241 (2.5%) 0/94 (0%)
    Disseminated intravascular coagulation 1/241 (0.4%) 0/94 (0%)
    Febrile bone marrow aplasia 1/241 (0.4%) 0/94 (0%)
    Febrile neutropenia 50/241 (20.7%) 9/94 (9.6%)
    Leukocytosis 2/241 (0.8%) 1/94 (1.1%)
    Neutropenia 4/241 (1.7%) 0/94 (0%)
    Pancytopenia 3/241 (1.2%) 0/94 (0%)
    Thrombocytopenia 3/241 (1.2%) 0/94 (0%)
    Cardiac disorders
    Acute myocardial infarction 0/241 (0%) 1/94 (1.1%)
    Angina pectoris 1/241 (0.4%) 0/94 (0%)
    Atrial fibrillation 2/241 (0.8%) 0/94 (0%)
    Cardiac failure 1/241 (0.4%) 0/94 (0%)
    Cardiomyopathy 0/241 (0%) 1/94 (1.1%)
    Myocardial infarction 1/241 (0.4%) 0/94 (0%)
    Pericarditis 2/241 (0.8%) 0/94 (0%)
    Stress cardiomyopathy 1/241 (0.4%) 0/94 (0%)
    Gastrointestinal disorders
    Abdominal pain 1/241 (0.4%) 0/94 (0%)
    Colitis 1/241 (0.4%) 0/94 (0%)
    Diarrhea 2/241 (0.8%) 0/94 (0%)
    Gastric hemorrhage 1/241 (0.4%) 0/94 (0%)
    Gastritis 1/241 (0.4%) 0/94 (0%)
    Gastrointestinal hemorrhage 1/241 (0.4%) 0/94 (0%)
    Hematemesis 1/241 (0.4%) 0/94 (0%)
    Ileus 0/241 (0%) 1/94 (1.1%)
    Large intestinal obstruction 1/241 (0.4%) 0/94 (0%)
    Melena 1/241 (0.4%) 0/94 (0%)
    Nausea 5/241 (2.1%) 0/94 (0%)
    Esophagitis 1/241 (0.4%) 0/94 (0%)
    Stomatitis 1/241 (0.4%) 0/94 (0%)
    Upper gastrointestinal hemorrhage 1/241 (0.4%) 0/94 (0%)
    Vomiting 5/241 (2.1%) 0/94 (0%)
    General disorders
    Chills 1/241 (0.4%) 0/94 (0%)
    Multi-organ failure 1/241 (0.4%) 1/94 (1.1%)
    Non-cardiac chest pain 1/241 (0.4%) 0/94 (0%)
    Edema peripheral 1/241 (0.4%) 0/94 (0%)
    Pain 1/241 (0.4%) 0/94 (0%)
    Performance status decreased 1/241 (0.4%) 0/94 (0%)
    Pyrexia 8/241 (3.3%) 2/94 (2.1%)
    Vascular complication associated with device 1/241 (0.4%) 0/94 (0%)
    Hepatobiliary disorders
    Cholecystitis 0/241 (0%) 1/94 (1.1%)
    Hepatic failure 1/241 (0.4%) 0/94 (0%)
    Hepatitis toxic 1/241 (0.4%) 0/94 (0%)
    Hepatocellular injury 1/241 (0.4%) 0/94 (0%)
    Immune system disorders
    Graft versus host disease in intestine 4/241 (1.7%) 0/94 (0%)
    Graft versus host disease in liver 1/241 (0.4%) 0/94 (0%)
    Graft versus host disease in skin 3/241 (1.2%) 0/94 (0%)
    Infections and infestations
    Acarodermatitis 1/241 (0.4%) 0/94 (0%)
    Anal abscess 0/241 (0%) 1/94 (1.1%)
    Anal infection 1/241 (0.4%) 0/94 (0%)
    Appendicitis 1/241 (0.4%) 0/94 (0%)
    Aspergillus infection 1/241 (0.4%) 0/94 (0%)
    Bacteremia 4/241 (1.7%) 1/94 (1.1%)
    Bronchitis 1/241 (0.4%) 0/94 (0%)
    Bronchopulmonary aspergillosis 1/241 (0.4%) 0/94 (0%)
    Candida infection 1/241 (0.4%) 0/94 (0%)
    Cellulitis 6/241 (2.5%) 0/94 (0%)
    Clostridium difficile colitis 1/241 (0.4%) 0/94 (0%)
    Clostridium difficile infection 2/241 (0.8%) 0/94 (0%)
    Device related infection 3/241 (1.2%) 1/94 (1.1%)
    Device related sepsis 1/241 (0.4%) 0/94 (0%)
    Ear infection 1/241 (0.4%) 0/94 (0%)
    Enteritis infectious 1/241 (0.4%) 0/94 (0%)
    Enterobacter bacteremia 1/241 (0.4%) 0/94 (0%)
    Enterobacter infection 3/241 (1.2%) 0/94 (0%)
    Enterococcal sepsis 1/241 (0.4%) 0/94 (0%)
    Enterocolitis infectious 1/241 (0.4%) 0/94 (0%)
    Escherichia bacteremia 0/241 (0%) 1/94 (1.1%)
    Escherichia sepsis 2/241 (0.8%) 3/94 (3.2%)
    Fungal skin infection 0/241 (0%) 1/94 (1.1%)
    Gastroenteritis 3/241 (1.2%) 0/94 (0%)
    Gastroenteritis rotavirus 1/241 (0.4%) 0/94 (0%)
    Hepatitis A 1/241 (0.4%) 0/94 (0%)
    Infection 2/241 (0.8%) 0/94 (0%)
    Influenza 1/241 (0.4%) 0/94 (0%)
    Klebsiella sepsis 2/241 (0.8%) 0/94 (0%)
    Lower respiratory tract infection 1/241 (0.4%) 1/94 (1.1%)
    Lung infection 3/241 (1.2%) 0/94 (0%)
    Lymph gland infection 1/241 (0.4%) 0/94 (0%)
    Necrotizing fascitis 0/241 (0%) 1/94 (1.1%)
    Neutropenic infection 2/241 (0.8%) 0/94 (0%)
    Neutropenic sepsis 7/241 (2.9%) 2/94 (2.1%)
    Peritonitis 1/241 (0.4%) 0/94 (0%)
    Pharyngitis 1/241 (0.4%) 0/94 (0%)
    Pneumococcal sepsis 1/241 (0.4%) 0/94 (0%)
    Pneumonia 22/241 (9.1%) 3/94 (3.2%)
    Pneumonia fungal 3/241 (1.2%) 2/94 (2.1%)
    Pneumonia staphylococcal 1/241 (0.4%) 0/94 (0%)
    Pseudomonas infection 1/241 (0.4%) 0/94 (0%)
    Pulmonary mycosis 1/241 (0.4%) 0/94 (0%)
    Pyelonephritis acute 1/241 (0.4%) 0/94 (0%)
    Respiratory tract infection 1/241 (0.4%) 0/94 (0%)
    Respiratory tract infection viral 1/241 (0.4%) 0/94 (0%)
    Sepsis 16/241 (6.6%) 4/94 (4.3%)
    Septic shock 5/241 (2.1%) 1/94 (1.1%)
    Sinusitis 1/241 (0.4%) 0/94 (0%)
    Skin infection 2/241 (0.8%) 0/94 (0%)
    Soft tissue infection 1/241 (0.4%) 0/94 (0%)
    Staphylococcal bacteremia 2/241 (0.8%) 0/94 (0%)
    Staphylococcal infection 4/241 (1.7%) 0/94 (0%)
    Staphylococcal sepsis 1/241 (0.4%) 0/94 (0%)
    Staphylococcal skin infection 1/241 (0.4%) 0/94 (0%)
    Stenotrophomonas infection 1/241 (0.4%) 0/94 (0%)
    Upper respiratory tract infection 5/241 (2.1%) 0/94 (0%)
    Urinary tract infection 6/241 (2.5%) 0/94 (0%)
    Urinary tract infection bacterial 1/241 (0.4%) 0/94 (0%)
    Urosepsis 1/241 (0.4%) 0/94 (0%)
    Viral upper respiratory tract infection 1/241 (0.4%) 0/94 (0%)
    Vulval cellulitis 1/241 (0.4%) 0/94 (0%)
    Wound infection 1/241 (0.4%) 0/94 (0%)
    Injury, poisoning and procedural complications
    Allergic transfusion reaction 1/241 (0.4%) 0/94 (0%)
    Fall 1/241 (0.4%) 0/94 (0%)
    Lumbar vertebral fracture 1/241 (0.4%) 0/94 (0%)
    Overdose 1/241 (0.4%) 0/94 (0%)
    Patella fracture 1/241 (0.4%) 0/94 (0%)
    Post procedural hematoma 1/241 (0.4%) 0/94 (0%)
    Pubis fracture 1/241 (0.4%) 0/94 (0%)
    Subdural hemorrhage 1/241 (0.4%) 1/94 (1.1%)
    Transfusion reaction 1/241 (0.4%) 0/94 (0%)
    Investigations
    Electrocardiogram QT prolonged 5/241 (2.1%) 0/94 (0%)
    Liver function test abnormal 1/241 (0.4%) 0/94 (0%)
    Neutrophil count decreased 2/241 (0.8%) 0/94 (0%)
    Platelet count decreased 1/241 (0.4%) 0/94 (0%)
    Metabolism and nutrition disorders
    Decreased appetite 1/241 (0.4%) 0/94 (0%)
    Diabetic ketoacidosis 1/241 (0.4%) 0/94 (0%)
    Hypokalemia 1/241 (0.4%) 0/94 (0%)
    Hyponatremia 1/241 (0.4%) 0/94 (0%)
    Tumor lysis syndrome 1/241 (0.4%) 0/94 (0%)
    Musculoskeletal and connective tissue disorders
    Chondrocalcinosis pyrophosphate 0/241 (0%) 1/94 (1.1%)
    Myositis 1/241 (0.4%) 0/94 (0%)
    Osteoarthritis 1/241 (0.4%) 0/94 (0%)
    Nervous system disorders
    Cerebral hemorrhage 2/241 (0.8%) 0/94 (0%)
    Cognitive disorder 1/241 (0.4%) 0/94 (0%)
    Depressed level of consciousness 1/241 (0.4%) 0/94 (0%)
    Hemorrhage intracranial 5/241 (2.1%) 2/94 (2.1%)
    Headache 1/241 (0.4%) 0/94 (0%)
    Horner's syndrome 1/241 (0.4%) 0/94 (0%)
    Lethargy 1/241 (0.4%) 0/94 (0%)
    Syncope 5/241 (2.1%) 0/94 (0%)
    Transient ischaemic attack 1/241 (0.4%) 0/94 (0%)
    Psychiatric disorders
    Depression 1/241 (0.4%) 0/94 (0%)
    Psychotic disorder 0/241 (0%) 1/94 (1.1%)
    Renal and urinary disorders
    Hematuria 2/241 (0.8%) 0/94 (0%)
    Renal failure 1/241 (0.4%) 0/94 (0%)
    Renal failure acute 1/241 (0.4%) 0/94 (0%)
    Urinary retention 1/241 (0.4%) 0/94 (0%)
    Reproductive system and breast disorders
    Vaginal hemorrhage 1/241 (0.4%) 0/94 (0%)
    Respiratory, thoracic and mediastinal disorders
    Cough 1/241 (0.4%) 0/94 (0%)
    Dyspnea 2/241 (0.8%) 0/94 (0%)
    Hemoptysis 1/241 (0.4%) 0/94 (0%)
    Hypoxia 1/241 (0.4%) 1/94 (1.1%)
    Lung disorder 1/241 (0.4%) 1/94 (1.1%)
    Pleural effusion 1/241 (0.4%) 0/94 (0%)
    Pleurisy 1/241 (0.4%) 0/94 (0%)
    Pneumonia aspiration 0/241 (0%) 1/94 (1.1%)
    Pneumonitis 2/241 (0.8%) 0/94 (0%)
    Pulmonary embolism 1/241 (0.4%) 1/94 (1.1%)
    Respiratory distress 1/241 (0.4%) 0/94 (0%)
    Respiratory failure 2/241 (0.8%) 0/94 (0%)
    Skin and subcutaneous tissue disorders
    Acute febrile neutrophilic dermatosis 2/241 (0.8%) 0/94 (0%)
    Petechiae 1/241 (0.4%) 0/94 (0%)
    Pyoderma gangrenosum 1/241 (0.4%) 0/94 (0%)
    Rash generalized 2/241 (0.8%) 0/94 (0%)
    Vascular disorders
    Phlebitis 1/241 (0.4%) 0/94 (0%)
    Venous thrombosis 1/241 (0.4%) 0/94 (0%)
    Other (Not Including Serious) Adverse Events
    Quizartinib Salvage Chemotherapy
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 238/241 (98.8%) 91/94 (96.8%)
    Blood and lymphatic system disorders
    Anemia 86/241 (35.7%) 131 29/94 (30.9%) 35
    Febrile neutropenia 41/241 (17%) 47 19/94 (20.2%) 28
    Leukocytosis 14/241 (5.8%) 14 3/94 (3.2%) 3
    Leukopenia 13/241 (5.4%) 17 2/94 (2.1%) 2
    Neutropenia 48/241 (19.9%) 77 11/94 (11.7%) 11
    Thrombocytopenia 62/241 (25.7%) 84 20/94 (21.3%) 21
    Cardiac disorders
    Sinus tachycardia 8/241 (3.3%) 8 5/94 (5.3%) 5
    Eye disorders
    Dry eye 13/241 (5.4%) 13 1/94 (1.1%) 1
    Gastrointestinal disorders
    Abdominal distension 11/241 (4.6%) 13 5/94 (5.3%) 5
    Abdominal pain 30/241 (12.4%) 33 15/94 (16%) 16
    Abdominal pain upper 18/241 (7.5%) 21 0/94 (0%) 0
    Constipation 47/241 (19.5%) 54 22/94 (23.4%) 29
    Diarrhea 68/241 (28.2%) 98 34/94 (36.2%) 42
    Dry mouth 13/241 (5.4%) 14 3/94 (3.2%) 3
    Dyspepsia 20/241 (8.3%) 20 6/94 (6.4%) 6
    Gingival bleeding 16/241 (6.6%) 16 3/94 (3.2%) 3
    Nausea 114/241 (47.3%) 164 39/94 (41.5%) 47
    Proctalgia 8/241 (3.3%) 9 5/94 (5.3%) 5
    Stomatitis 39/241 (16.2%) 39 18/94 (19.1%) 18
    Vomiting 80/241 (33.2%) 116 20/94 (21.3%) 25
    General disorders
    Asthenia 34/241 (14.1%) 38 10/94 (10.6%) 11
    Chills 15/241 (6.2%) 15 7/94 (7.4%) 8
    Fatigue 67/241 (27.8%) 81 18/94 (19.1%) 22
    Edema peripheral 51/241 (21.2%) 58 22/94 (23.4%) 26
    Pain 19/241 (7.9%) 21 8/94 (8.5%) 8
    Pyrexia 88/241 (36.5%) 130 42/94 (44.7%) 69
    Immune system disorders
    Graft versus host disease 14/241 (5.8%) 14 0/94 (0%) 0
    Graft versus host disease in skin 16/241 (6.6%) 18 0/94 (0%) 0
    Infections and infestations
    Bacteremia 2/241 (0.8%) 2 5/94 (5.3%) 5
    Device related infection 9/241 (3.7%) 9 7/94 (7.4%) 7
    Enterococcal infection 1/241 (0.4%) 1 5/94 (5.3%) 5
    Pneumonia 11/241 (4.6%) 11 6/94 (6.4%) 6
    Upper respiratory tract infection 17/241 (7.1%) 17 1/94 (1.1%) 1
    Urinary tract infection 18/241 (7.5%) 26 0/94 (0%) 0
    Injury, poisoning and procedural complications
    Contusion 15/241 (6.2%) 17 2/94 (2.1%) 2
    Investigations
    Alanine aminotransferase increased 32/241 (13.3%) 46 4/94 (4.3%) 5
    Aspartate aminotransferase increased 26/241 (10.8%) 41 1/94 (1.1%) 1
    Blood alkaline phosphatase increased 18/241 (7.5%) 24 4/94 (4.3%) 5
    Blood bilirubin increased 24/241 (10%) 30 3/94 (3.2%) 6
    Blood creatinine increased 16/241 (6.6%) 22 2/94 (2.1%) 2
    Electrocardiogram QT prolonged 63/241 (26.1%) 90 2/94 (2.1%) 2
    Neutrophil count decreased 31/241 (12.9%) 46 14/94 (14.9%) 21
    Platelet count decreased 33/241 (13.7%) 39 12/94 (12.8%) 20
    Weight decreased 27/241 (11.2%) 31 5/94 (5.3%) 5
    White blood cell count decreased 35/241 (14.5%) 45 14/94 (14.9%) 17
    Metabolism and nutrition disorders
    Decreased appetite 48/241 (19.9%) 62 10/94 (10.6%) 10
    Hyperglycemia 15/241 (6.2%) 17 7/94 (7.4%) 10
    Hypoalbuminemia 17/241 (7.1%) 33 7/94 (7.4%) 10
    Hypocalcemia 27/241 (11.2%) 36 10/94 (10.6%) 10
    Hypokalemia 76/241 (31.5%) 124 25/94 (26.6%) 45
    Hypomagnesemia 36/241 (14.9%) 56 7/94 (7.4%) 12
    Hyponatremia 21/241 (8.7%) 36 6/94 (6.4%) 6
    Hypophosphatemia 23/241 (9.5%) 31 10/94 (10.6%) 12
    Musculoskeletal and connective tissue disorders
    Arthralgia 20/241 (8.3%) 24 3/94 (3.2%) 3
    Back pain 26/241 (10.8%) 29 9/94 (9.6%) 9
    Muscle spasms 19/241 (7.9%) 22 0/94 (0%) 0
    Musculoskeletal pain 19/241 (7.9%) 20 6/94 (6.4%) 8
    Myalgia 15/241 (6.2%) 16 2/94 (2.1%) 2
    Pain in extremity 25/241 (10.4%) 26 6/94 (6.4%) 6
    Nervous system disorders
    Dizziness 36/241 (14.9%) 41 10/94 (10.6%) 10
    Dysgeusia 22/241 (9.1%) 22 1/94 (1.1%) 1
    Headache 51/241 (21.2%) 64 16/94 (17%) 19
    Psychiatric disorders
    Anxiety 19/241 (7.9%) 21 4/94 (4.3%) 4
    Confusional state 7/241 (2.9%) 7 5/94 (5.3%) 5
    Insomnia 22/241 (9.1%) 24 13/94 (13.8%) 13
    Renal and urinary disorders
    Dysuria 15/241 (6.2%) 16 39/94 (41.5%) 39
    Respiratory, thoracic and mediastinal disorders
    Cough 56/241 (23.2%) 64 13/94 (13.8%) 14
    Dyspnea 48/241 (19.9%) 61 8/94 (8.5%) 11
    Epistaxis 28/241 (11.6%) 34 8/94 (8.5%) 9
    Nasal congestion 9/241 (3.7%) 9 5/94 (5.3%) 5
    Oropharyngeal pain 25/241 (10.4%) 26 6/94 (6.4%) 7
    Pleural effusion 14/241 (5.8%) 14 2/94 (2.1%) 2
    Skin and subcutaneous tissue disorders
    Petechiae 27/241 (11.2%) 31 6/94 (6.4%) 8
    Pruritis 15/241 (6.2%) 15 6/94 (6.4%) 8
    Rash 36/241 (14.9%) 41 9/94 (9.6%) 10
    Skin lesion 14/241 (5.8%) 14 1/94 (1.1%) 1
    Vascular disorders
    Hypertension 9/241 (3.7%) 9 8/94 (8.5%) 8
    Hypotension 32/241 (13.3%) 39 10/94 (10.6%) 10

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Daiichi Sankyo
    Organization Contact for Clinical Trial Information
    Phone 1-908-992-6400
    Email CTRinfo@dsi.com
    Responsible Party:
    Daiichi Sankyo, Inc.
    ClinicalTrials.gov Identifier:
    NCT02039726
    Other Study ID Numbers:
    • AC220-007
    • EudraCT Number 2013-004890-28
    First Posted:
    Jan 20, 2014
    Last Update Posted:
    Feb 24, 2021
    Last Verified:
    Feb 1, 2021