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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02039726
Recruitment Status : Active, not recruiting
First Posted : January 20, 2014
Results First Posted : January 27, 2020
Last Update Posted : February 10, 2020
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition AML
Interventions Drug: Quizartinib
Drug: Salvage Chemotherapy
Enrollment 367
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 Details 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
Hide 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
Arm/Group Title Quizartinib Salvage Chemotherapy Total
Hide 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 Number of Baseline Participants 245 122 367
Hide Baseline Analysis Population Description
Participants received standard of care salvage chemotherapy (administered subcutaneously [LoDac] or intravenously [MEC and FLAG-IDA]).
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 245 participants 122 participants 367 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
180
  73.5%
89
  73.0%
269
  73.3%
>=65 years
65
  26.5%
33
  27.0%
98
  26.7%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 245 participants 122 participants 367 participants
55.0
(19 to 81)
57.5
(18 to 78)
56.0
(18 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 245 participants 122 participants 367 participants
Female
132
  53.9%
58
  47.5%
190
  51.8%
Male
113
  46.1%
64
  52.5%
177
  48.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 245 participants 122 participants 367 participants
American Indian or Alaska Native
1
   0.4%
0
   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%
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%
0
   0.0%
Unknown or Not Reported
27
  11.0%
10
   8.2%
37
  10.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 245 participants 122 participants 367 participants
Singapore 0 2 2
Hong Kong 5 3 8
Hungary 1 0 1
United States 82 36 118
Czechia 2 0 2
United Kingdom 21 14 35
Spain 15 6 21
Canada 18 5 23
Netherlands 2 1 3
South Korea 11 7 18
Belgium 1 0 1
Taiwan 2 1 3
Poland 2 0 2
Italy 34 19 53
Australia 3 3 6
France 20 7 27
Serbia 1 0 1
Germany 25 18 43
1.Primary Outcome
Title Overall Survival in Participants That Received Quizartinib Versus Salvage Chemotherapy
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quizartinib Salvage Chemotherapy
Hide 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.
Overall Number of Participants Analyzed 245 122
Median (Inter-Quartile Range)
Unit of Measure: weeks
27.0
(15.4 to 62.6)
20.4
(8.3 to 39.6)
Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.0185
Comments [Not Specified]
Method P-value for HR=1 (1-sided)
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.758
Confidence Interval (2-Sided) 95%
0.584 to 0.983
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Event-free Survival in Participants That Received Quizartinib Versus Salvage Chemotherapy
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Event-free survival was assessed in the intent-to-treat (ITT) analysis set.
Arm/Group Title Quizartinib Salvage Chemotherapy
Hide 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.
Overall Number of Participants Analyzed 245 122
Median (Inter-Quartile Range)
Unit of Measure: weeks
6.0
(0.1 to 19.7)
3.7
(0.1 to 17.0)
Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.2034
Comments [Not Specified]
Method P value for HR=1 (1-sided)
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.898
Confidence Interval (2-Sided) 95%
0.697 to 1.157
Estimation Comments [Not Specified]
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
Hide 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 (%) Affected / at Risk (%)
Total   80/241 (33.20%)      16/94 (17.02%)    
Hide Serious Adverse Events
Quizartinib Salvage Chemotherapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   168/241 (69.71%)      37/94 (39.36%)    
Blood and lymphatic system disorders     
Anemia  1  6/241 (2.49%)  0/94 (0.00%) 
Disseminated intravascular coagulation  1  1/241 (0.41%)  0/94 (0.00%) 
Febrile bone marrow aplasia  1  1/241 (0.41%)  0/94 (0.00%) 
Febrile neutropenia  1  50/241 (20.75%)  9/94 (9.57%) 
Leukocytosis  1  2/241 (0.83%)  1/94 (1.06%) 
Neutropenia  1  4/241 (1.66%)  0/94 (0.00%) 
Pancytopenia  1  3/241 (1.24%)  0/94 (0.00%) 
Thrombocytopenia  1  3/241 (1.24%)  0/94 (0.00%) 
Cardiac disorders     
Acute myocardial infarction  1  0/241 (0.00%)  1/94 (1.06%) 
Angina pectoris  1  1/241 (0.41%)  0/94 (0.00%) 
Atrial fibrillation  1  2/241 (0.83%)  0/94 (0.00%) 
Cardiac failure  1  1/241 (0.41%)  0/94 (0.00%) 
Cardiomyopathy  1  0/241 (0.00%)  1/94 (1.06%) 
Myocardial infarction  1  1/241 (0.41%)  0/94 (0.00%) 
Pericarditis  1  2/241 (0.83%)  0/94 (0.00%) 
Stress cardiomyopathy  1  1/241 (0.41%)  0/94 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  1/241 (0.41%)  0/94 (0.00%) 
Colitis  1  1/241 (0.41%)  0/94 (0.00%) 
Diarrhea  1  2/241 (0.83%)  0/94 (0.00%) 
Gastric hemorrhage  1  1/241 (0.41%)  0/94 (0.00%) 
Gastritis  1  1/241 (0.41%)  0/94 (0.00%) 
Gastrointestinal hemorrhage  1  1/241 (0.41%)  0/94 (0.00%) 
Hematemesis  1  1/241 (0.41%)  0/94 (0.00%) 
Ileus  1  0/241 (0.00%)  1/94 (1.06%) 
Large intestinal obstruction  1  1/241 (0.41%)  0/94 (0.00%) 
Melena  1  1/241 (0.41%)  0/94 (0.00%) 
Nausea  1  5/241 (2.07%)  0/94 (0.00%) 
Esophagitis  1  1/241 (0.41%)  0/94 (0.00%) 
Stomatitis  1  1/241 (0.41%)  0/94 (0.00%) 
Upper gastrointestinal hemorrhage  1  1/241 (0.41%)  0/94 (0.00%) 
Vomiting  1  5/241 (2.07%)  0/94 (0.00%) 
General disorders     
Chills  1  1/241 (0.41%)  0/94 (0.00%) 
Multi-organ failure  1  1/241 (0.41%)  1/94 (1.06%) 
Non-cardiac chest pain  1  1/241 (0.41%)  0/94 (0.00%) 
Edema peripheral  1  1/241 (0.41%)  0/94 (0.00%) 
Pain  1  1/241 (0.41%)  0/94 (0.00%) 
Performance status decreased  1  1/241 (0.41%)  0/94 (0.00%) 
Pyrexia  1  8/241 (3.32%)  2/94 (2.13%) 
Vascular complication associated with device  1  1/241 (0.41%)  0/94 (0.00%) 
Hepatobiliary disorders     
Cholecystitis  1  0/241 (0.00%)  1/94 (1.06%) 
Hepatic failure  1  1/241 (0.41%)  0/94 (0.00%) 
Hepatitis toxic  1  1/241 (0.41%)  0/94 (0.00%) 
Hepatocellular injury  1  1/241 (0.41%)  0/94 (0.00%) 
Immune system disorders     
Graft versus host disease in intestine  1  4/241 (1.66%)  0/94 (0.00%) 
Graft versus host disease in liver  1  1/241 (0.41%)  0/94 (0.00%) 
Graft versus host disease in skin  1  3/241 (1.24%)  0/94 (0.00%) 
Infections and infestations     
Acarodermatitis  1  1/241 (0.41%)  0/94 (0.00%) 
Anal abscess  1  0/241 (0.00%)  1/94 (1.06%) 
Anal infection  1  1/241 (0.41%)  0/94 (0.00%) 
Appendicitis  1  1/241 (0.41%)  0/94 (0.00%) 
Aspergillus infection  1  1/241 (0.41%)  0/94 (0.00%) 
Bacteremia  1  4/241 (1.66%)  1/94 (1.06%) 
Bronchitis  1  1/241 (0.41%)  0/94 (0.00%) 
Bronchopulmonary aspergillosis  1  1/241 (0.41%)  0/94 (0.00%) 
Candida infection  1  1/241 (0.41%)  0/94 (0.00%) 
Cellulitis  1  6/241 (2.49%)  0/94 (0.00%) 
Clostridium difficile colitis  1  1/241 (0.41%)  0/94 (0.00%) 
Clostridium difficile infection  1  2/241 (0.83%)  0/94 (0.00%) 
Device related infection  1  3/241 (1.24%)  1/94 (1.06%) 
Device related sepsis  1  1/241 (0.41%)  0/94 (0.00%) 
Ear infection  1  1/241 (0.41%)  0/94 (0.00%) 
Enteritis infectious  1  1/241 (0.41%)  0/94 (0.00%) 
Enterobacter bacteremia  1  1/241 (0.41%)  0/94 (0.00%) 
Enterobacter infection  1  3/241 (1.24%)  0/94 (0.00%) 
Enterococcal sepsis  1  1/241 (0.41%)  0/94 (0.00%) 
Enterocolitis infectious  1  1/241 (0.41%)  0/94 (0.00%) 
Escherichia bacteremia  1  0/241 (0.00%)  1/94 (1.06%) 
Escherichia sepsis  1  2/241 (0.83%)  3/94 (3.19%) 
Fungal skin infection  1  0/241 (0.00%)  1/94 (1.06%) 
Gastroenteritis  1  3/241 (1.24%)  0/94 (0.00%) 
Gastroenteritis rotavirus  1  1/241 (0.41%)  0/94 (0.00%) 
Hepatitis A  1  1/241 (0.41%)  0/94 (0.00%) 
Infection  1  2/241 (0.83%)  0/94 (0.00%) 
Influenza  1  1/241 (0.41%)  0/94 (0.00%) 
Klebsiella sepsis  1  2/241 (0.83%)  0/94 (0.00%) 
Lower respiratory tract infection  1  1/241 (0.41%)  1/94 (1.06%) 
Lung infection  1  3/241 (1.24%)  0/94 (0.00%) 
Lymph gland infection  1  1/241 (0.41%)  0/94 (0.00%) 
Necrotizing fascitis  1  0/241 (0.00%)  1/94 (1.06%) 
Neutropenic infection  1  2/241 (0.83%)  0/94 (0.00%) 
Neutropenic sepsis  1  7/241 (2.90%)  2/94 (2.13%) 
Peritonitis  1  1/241 (0.41%)  0/94 (0.00%) 
Pharyngitis  1  1/241 (0.41%)  0/94 (0.00%) 
Pneumococcal sepsis  1  1/241 (0.41%)  0/94 (0.00%) 
Pneumonia  1  22/241 (9.13%)  3/94 (3.19%) 
Pneumonia fungal  1  3/241 (1.24%)  2/94 (2.13%) 
Pneumonia staphylococcal  1  1/241 (0.41%)  0/94 (0.00%) 
Pseudomonas infection  1  1/241 (0.41%)  0/94 (0.00%) 
Pulmonary mycosis  1  1/241 (0.41%)  0/94 (0.00%) 
Pyelonephritis acute  1  1/241 (0.41%)  0/94 (0.00%) 
Respiratory tract infection  1  1/241 (0.41%)  0/94 (0.00%) 
Respiratory tract infection viral  1  1/241 (0.41%)  0/94 (0.00%) 
Sepsis  1  16/241 (6.64%)  4/94 (4.26%) 
Septic shock  1  5/241 (2.07%)  1/94 (1.06%) 
Sinusitis  1  1/241 (0.41%)  0/94 (0.00%) 
Skin infection  1  2/241 (0.83%)  0/94 (0.00%) 
Soft tissue infection  1  1/241 (0.41%)  0/94 (0.00%) 
Staphylococcal bacteremia  1  2/241 (0.83%)  0/94 (0.00%) 
Staphylococcal infection  1  4/241 (1.66%)  0/94 (0.00%) 
Staphylococcal sepsis  1  1/241 (0.41%)  0/94 (0.00%) 
Staphylococcal skin infection  1  1/241 (0.41%)  0/94 (0.00%) 
Stenotrophomonas infection  1  1/241 (0.41%)  0/94 (0.00%) 
Upper respiratory tract infection  1  5/241 (2.07%)  0/94 (0.00%) 
Urinary tract infection  1  6/241 (2.49%)  0/94 (0.00%) 
Urinary tract infection bacterial  1  1/241 (0.41%)  0/94 (0.00%) 
Urosepsis  1  1/241 (0.41%)  0/94 (0.00%) 
Viral upper respiratory tract infection  1  1/241 (0.41%)  0/94 (0.00%) 
Vulval cellulitis  1  1/241 (0.41%)  0/94 (0.00%) 
Wound infection  1  1/241 (0.41%)  0/94 (0.00%) 
Injury, poisoning and procedural complications     
Allergic transfusion reaction  1  1/241 (0.41%)  0/94 (0.00%) 
Fall  1  1/241 (0.41%)  0/94 (0.00%) 
Lumbar vertebral fracture  1  1/241 (0.41%)  0/94 (0.00%) 
Overdose  1  1/241 (0.41%)  0/94 (0.00%) 
Patella fracture  1  1/241 (0.41%)  0/94 (0.00%) 
Post procedural hematoma  1  1/241 (0.41%)  0/94 (0.00%) 
Pubis fracture  1  1/241 (0.41%)  0/94 (0.00%) 
Subdural hemorrhage  1  1/241 (0.41%)  1/94 (1.06%) 
Transfusion reaction  1  1/241 (0.41%)  0/94 (0.00%) 
Investigations     
Electrocardiogram QT prolonged  1  5/241 (2.07%)  0/94 (0.00%) 
Liver function test abnormal  1  1/241 (0.41%)  0/94 (0.00%) 
Neutrophil count decreased  1  2/241 (0.83%)  0/94 (0.00%) 
Platelet count decreased  1  1/241 (0.41%)  0/94 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  1/241 (0.41%)  0/94 (0.00%) 
Diabetic ketoacidosis  1  1/241 (0.41%)  0/94 (0.00%) 
Hypokalemia  1  1/241 (0.41%)  0/94 (0.00%) 
Hyponatremia  1  1/241 (0.41%)  0/94 (0.00%) 
Tumor lysis syndrome  1  1/241 (0.41%)  0/94 (0.00%) 
Musculoskeletal and connective tissue disorders     
Chondrocalcinosis pyrophosphate  1  0/241 (0.00%)  1/94 (1.06%) 
Myositis  1  1/241 (0.41%)  0/94 (0.00%) 
Osteoarthritis  1  1/241 (0.41%)  0/94 (0.00%) 
Nervous system disorders     
Cerebral hemorrhage  1  2/241 (0.83%)  0/94 (0.00%) 
Cognitive disorder  1  1/241 (0.41%)  0/94 (0.00%) 
Depressed level of consciousness  1  1/241 (0.41%)  0/94 (0.00%) 
Hemorrhage intracranial  1  5/241 (2.07%)  2/94 (2.13%) 
Headache  1  1/241 (0.41%)  0/94 (0.00%) 
Horner's syndrome  1  1/241 (0.41%)  0/94 (0.00%) 
Lethargy  1  1/241 (0.41%)  0/94 (0.00%) 
Syncope  1  5/241 (2.07%)  0/94 (0.00%) 
Transient ischaemic attack  1  1/241 (0.41%)  0/94 (0.00%) 
Psychiatric disorders     
Depression  1  1/241 (0.41%)  0/94 (0.00%) 
Psychotic disorder  1  0/241 (0.00%)  1/94 (1.06%) 
Renal and urinary disorders     
Hematuria  1  2/241 (0.83%)  0/94 (0.00%) 
Renal failure  1  1/241 (0.41%)  0/94 (0.00%) 
Renal failure acute  1  1/241 (0.41%)  0/94 (0.00%) 
Urinary retention  1  1/241 (0.41%)  0/94 (0.00%) 
Reproductive system and breast disorders     
Vaginal hemorrhage  1  1/241 (0.41%)  0/94 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/241 (0.41%)  0/94 (0.00%) 
Dyspnea  1  2/241 (0.83%)  0/94 (0.00%) 
Hemoptysis  1  1/241 (0.41%)  0/94 (0.00%) 
Hypoxia  1  1/241 (0.41%)  1/94 (1.06%) 
Lung disorder  1  1/241 (0.41%)  1/94 (1.06%) 
Pleural effusion  1  1/241 (0.41%)  0/94 (0.00%) 
Pleurisy  1  1/241 (0.41%)  0/94 (0.00%) 
Pneumonia aspiration  1  0/241 (0.00%)  1/94 (1.06%) 
Pneumonitis  1  2/241 (0.83%)  0/94 (0.00%) 
Pulmonary embolism  1  1/241 (0.41%)  1/94 (1.06%) 
Respiratory distress  1  1/241 (0.41%)  0/94 (0.00%) 
Respiratory failure  1  2/241 (0.83%)  0/94 (0.00%) 
Skin and subcutaneous tissue disorders     
Acute febrile neutrophilic dermatosis  1  2/241 (0.83%)  0/94 (0.00%) 
Petechiae  1  1/241 (0.41%)  0/94 (0.00%) 
Pyoderma gangrenosum  1  1/241 (0.41%)  0/94 (0.00%) 
Rash generalized  1  2/241 (0.83%)  0/94 (0.00%) 
Vascular disorders     
Phlebitis  1  1/241 (0.41%)  0/94 (0.00%) 
Venous thrombosis  1  1/241 (0.41%)  0/94 (0.00%) 
1
Term from vocabulary, MedDRA 16.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Quizartinib Salvage Chemotherapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   238/241 (98.76%)      91/94 (96.81%)    
Blood and lymphatic system disorders     
Anemia  1  86/241 (35.68%)  131 29/94 (30.85%)  35
Febrile neutropenia  1  41/241 (17.01%)  47 19/94 (20.21%)  28
Leukocytosis  1  14/241 (5.81%)  14 3/94 (3.19%)  3
Leukopenia  1  13/241 (5.39%)  17 2/94 (2.13%)  2
Neutropenia  1  48/241 (19.92%)  77 11/94 (11.70%)  11
Thrombocytopenia  1  62/241 (25.73%)  84 20/94 (21.28%)  21
Cardiac disorders     
Sinus tachycardia  1  8/241 (3.32%)  8 5/94 (5.32%)  5
Eye disorders     
Dry eye  1  13/241 (5.39%)  13 1/94 (1.06%)  1
Gastrointestinal disorders     
Abdominal distension  1  11/241 (4.56%)  13 5/94 (5.32%)  5
Abdominal pain  1  30/241 (12.45%)  33 15/94 (15.96%)  16
Abdominal pain upper  1  18/241 (7.47%)  21 0/94 (0.00%)  0
Constipation  1  47/241 (19.50%)  54 22/94 (23.40%)  29
Diarrhea  1  68/241 (28.22%)  98 34/94 (36.17%)  42
Dry mouth  1  13/241 (5.39%)  14 3/94 (3.19%)  3
Dyspepsia  1  20/241 (8.30%)  20 6/94 (6.38%)  6
Gingival bleeding  1  16/241 (6.64%)  16 3/94 (3.19%)  3
Nausea  1  114/241 (47.30%)  164 39/94 (41.49%)  47
Proctalgia  1  8/241 (3.32%)  9 5/94 (5.32%)  5
Stomatitis  1  39/241 (16.18%)  39 18/94 (19.15%)  18
Vomiting  1  80/241 (33.20%)  116 20/94 (21.28%)  25
General disorders     
Asthenia  1  34/241 (14.11%)  38 10/94 (10.64%)  11
Chills  1  15/241 (6.22%)  15 7/94 (7.45%)  8
Fatigue  1  67/241 (27.80%)  81 18/94 (19.15%)  22
Edema peripheral  1  51/241 (21.16%)  58 22/94 (23.40%)  26
Pain  1  19/241 (7.88%)  21 8/94 (8.51%)  8
Pyrexia  1  88/241 (36.51%)  130 42/94 (44.68%)  69
Immune system disorders     
Graft versus host disease  1  14/241 (5.81%)  14 0/94 (0.00%)  0
Graft versus host disease in skin  1  16/241 (6.64%)  18 0/94 (0.00%)  0
Infections and infestations     
Bacteremia  1  2/241 (0.83%)  2 5/94 (5.32%)  5
Device related infection  1  9/241 (3.73%)  9 7/94 (7.45%)  7
Enterococcal infection  1  1/241 (0.41%)  1 5/94 (5.32%)  5
Pneumonia  1  11/241 (4.56%)  11 6/94 (6.38%)  6
Upper respiratory tract infection  1  17/241 (7.05%)  17 1/94 (1.06%)  1
Urinary tract infection  1  18/241 (7.47%)  26 0/94 (0.00%)  0
Injury, poisoning and procedural complications     
Contusion  1  15/241 (6.22%)  17 2/94 (2.13%)  2
Investigations     
Alanine aminotransferase increased  1  32/241 (13.28%)  46 4/94 (4.26%)  5
Aspartate aminotransferase increased  1  26/241 (10.79%)  41 1/94 (1.06%)  1
Blood alkaline phosphatase increased  1  18/241 (7.47%)  24 4/94 (4.26%)  5
Blood bilirubin increased  1  24/241 (9.96%)  30 3/94 (3.19%)  6
Blood creatinine increased  1  16/241 (6.64%)  22 2/94 (2.13%)  2
Electrocardiogram QT prolonged  1  63/241 (26.14%)  90 2/94 (2.13%)  2
Neutrophil count decreased  1  31/241 (12.86%)  46 14/94 (14.89%)  21
Platelet count decreased  1  33/241 (13.69%)  39 12/94 (12.77%)  20
Weight decreased  1  27/241 (11.20%)  31 5/94 (5.32%)  5
White blood cell count decreased  1  35/241 (14.52%)  45 14/94 (14.89%)  17
Metabolism and nutrition disorders     
Decreased appetite  1  48/241 (19.92%)  62 10/94 (10.64%)  10
Hyperglycemia  1  15/241 (6.22%)  17 7/94 (7.45%)  10
Hypoalbuminemia  1  17/241 (7.05%)  33 7/94 (7.45%)  10
Hypocalcemia  1  27/241 (11.20%)  36 10/94 (10.64%)  10
Hypokalemia  1  76/241 (31.54%)  124 25/94 (26.60%)  45
Hypomagnesemia  1  36/241 (14.94%)  56 7/94 (7.45%)  12
Hyponatremia  1  21/241 (8.71%)  36 6/94 (6.38%)  6
Hypophosphatemia  1  23/241 (9.54%)  31 10/94 (10.64%)  12
Musculoskeletal and connective tissue disorders     
Arthralgia  1  20/241 (8.30%)  24 3/94 (3.19%)  3
Back pain  1  26/241 (10.79%)  29 9/94 (9.57%)  9
Muscle spasms  1  19/241 (7.88%)  22 0/94 (0.00%)  0
Musculoskeletal pain  1  19/241 (7.88%)  20 6/94 (6.38%)  8
Myalgia  1  15/241 (6.22%)  16 2/94 (2.13%)  2
Pain in extremity  1  25/241 (10.37%)  26 6/94 (6.38%)  6
Nervous system disorders     
Dizziness  1  36/241 (14.94%)  41 10/94 (10.64%)  10
Dysgeusia  1  22/241 (9.13%)  22 1/94 (1.06%)  1
Headache  1  51/241 (21.16%)  64 16/94 (17.02%)  19
Psychiatric disorders     
Anxiety  1  19/241 (7.88%)  21 4/94 (4.26%)  4
Confusional state  1  7/241 (2.90%)  7 5/94 (5.32%)  5
Insomnia  1  22/241 (9.13%)  24 13/94 (13.83%)  13
Renal and urinary disorders     
Dysuria  1  15/241 (6.22%)  16 39/94 (41.49%)  39
Respiratory, thoracic and mediastinal disorders     
Cough  1  56/241 (23.24%)  64 13/94 (13.83%)  14
Dyspnea  1  48/241 (19.92%)  61 8/94 (8.51%)  11
Epistaxis  1  28/241 (11.62%)  34 8/94 (8.51%)  9
Nasal congestion  1  9/241 (3.73%)  9 5/94 (5.32%)  5
Oropharyngeal pain  1  25/241 (10.37%)  26 6/94 (6.38%)  7
Pleural effusion  1  14/241 (5.81%)  14 2/94 (2.13%)  2
Skin and subcutaneous tissue disorders     
Petechiae  1  27/241 (11.20%)  31 6/94 (6.38%)  8
Pruritis  1  15/241 (6.22%)  15 6/94 (6.38%)  8
Rash  1  36/241 (14.94%)  41 9/94 (9.57%)  10
Skin lesion  1  14/241 (5.81%)  14 1/94 (1.06%)  1
Vascular disorders     
Hypertension  1  9/241 (3.73%)  9 8/94 (8.51%)  8
Hypotension  1  32/241 (13.28%)  39 10/94 (10.64%)  10
1
Term from vocabulary, MedDRA 16.1
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Daiichi Sankyo
Organization: Contact for Clinical Trial Information
Phone: 1-908-992-6400
EMail: CTRinfo@dsi.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT02039726    
Other Study ID Numbers: AC220-007
EudraCT Number 2013-004890-28 ( Other Identifier: Universal Trial Number (UTN) U1111-1151-8078 )
First Submitted: January 15, 2014
First Posted: January 20, 2014
Results First Submitted: September 25, 2019
Results First Posted: January 27, 2020
Last Update Posted: February 10, 2020