Trial Outcomes & Findings for Phase 2 Study of Quizartinib in Participants With Acute Myeloid Leukemia (AML) FLT3 Internal Tandem Duplication (FLT3/ITD) Mutation (NCT NCT02984995)
NCT ID: NCT02984995
Last Updated: 2020-02-17
Results Overview
The composite complete remission (CRc) rate is defined as the proportion of participants whose best response is complete remission \[CR\], CR with incomplete platelet recovery \[CRp\], or CR with incomplete hematological recovery \[CRi\]) after treatment with quizartinib.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
Baseline, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1 up until the end of treatment, except for responses from any subsequent AML therapy including transplantation
Results posted on
2020-02-17
Participant Flow
A total of 37 participants who met all inclusion and no exclusion criteria were enrolled in the study.
Quizartinib initial dose was 30 mg/day and escalated to 60 mg/day. For subjects receiving strong cytochrome P450 (CYP) 3A4 inhibitors, the initial dose was 20 mg/day. An increase from the initial dose of 30 mg/day to 60 mg/day or 20 mg/day to 30 mg/day was determined on Day 16 of Cycle 1 and Day 1 of Cycle 2 based on dose increase criteria.
Participant milestones
| Measure |
Initial Dose 30 mg/Day Quizartinib
Participants who received an initial dose of 30 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 60 mg/day at Day 15.
|
Initial Dose 20 mg/Day Quizartinib
Participants who received a CYP3A4 strong inhibitor received an initial dose of 20 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 30 mg/day at Day 15.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
3
|
|
Overall Study
COMPLETED
|
9
|
0
|
|
Overall Study
NOT COMPLETED
|
25
|
3
|
Reasons for withdrawal
| Measure |
Initial Dose 30 mg/Day Quizartinib
Participants who received an initial dose of 30 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 60 mg/day at Day 15.
|
Initial Dose 20 mg/Day Quizartinib
Participants who received a CYP3A4 strong inhibitor received an initial dose of 20 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 30 mg/day at Day 15.
|
|---|---|---|
|
Overall Study
Required stem cell transplant
|
13
|
2
|
|
Overall Study
Progressive disease
|
11
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Phase 2 Study of Quizartinib in Participants With Acute Myeloid Leukemia (AML) FLT3 Internal Tandem Duplication (FLT3/ITD) Mutation
Baseline characteristics by cohort
| Measure |
Initial Dose 30 mg/Day Quizartinib
n=34 Participants
Participants who received an initial dose of 30 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 60 mg/day at Day 15.
|
Initial Dose 20 mg/Day Quizartinib
n=3 Participants
Participants who received a CYP3A4 strong inhibitor received an initial dose of 20 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 30 mg/day at Day 15.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Age, Continuous
|
60.2 years
STANDARD_DEVIATION 14.51 • n=99 Participants
|
58.0 years
STANDARD_DEVIATION 9.92 • n=107 Participants
|
60.0 years
STANDARD_DEVIATION 14.68 • n=206 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Japan
|
34 participants
n=99 Participants
|
3 participants
n=107 Participants
|
37 participants
n=206 Participants
|
|
BMI
|
20.72 kg/m^2
STANDARD_DEVIATION 2.53 • n=99 Participants
|
22.25 kg/m^2
STANDARD_DEVIATION 3.37 • n=107 Participants
|
20.84 kg/m^2
STANDARD_DEVIATION 2.58 • n=206 Participants
|
|
FLT3-ITD Status
Positive
|
29 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
FLT3-ITD Status
Negative
|
5 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Response to Prior Therapy
Relapse
|
21 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Response to Prior Therapy
Refractory
|
13 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1 up until the end of treatment, except for responses from any subsequent AML therapy including transplantationPopulation: All participants with FLT3-ITD positive relapsed or refractory AML who achieved CR, CRp, or CRi, discontinued the study treatment, or completed response assessment at Cycle 4 Day 1.
The composite complete remission (CRc) rate is defined as the proportion of participants whose best response is complete remission \[CR\], CR with incomplete platelet recovery \[CRp\], or CR with incomplete hematological recovery \[CRi\]) after treatment with quizartinib.
Outcome measures
| Measure |
Initial Dose 30 mg/Day Quizartinib
n=23 Participants
Participants who received an initial dose of 30 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 60 mg/day at Day 15.
|
Initial Dose 20 mg/Day Quizartinib
n=3 Participants
Participants who received a CYP3A4 strong inhibitor received an initial dose of 20 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 30 mg/day at Day 15.
|
Total
n=26 Participants
All participants who received either 30 mg/day or 20 mg/day quizartinib as an initial dose.
|
Quizartinib 60 mg/Day (With No Use of Strong CYP3A4 Inhibitor)
Patients who did not receive a CYP3A4 strong inhibitor received quizartinib 60 mg/day.
|
|---|---|---|---|---|
|
Composite Complete Remission (CRc) Rate After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML
|
56.5 percentage of participants
Interval 37.5 to 74.2
|
33.3 percentage of participants
Interval 1.7 to 86.5
|
53.8 percentage of participants
Interval 36.2 to 70.8
|
—
|
SECONDARY outcome
Timeframe: Baseline, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1 until the end of treatment, except for responses from any subsequent AMLPopulation: All participants with FLT3-ITD positive relapsed or refractory AML who achieved CR, CRp, CRi, or PR, discontinued the study treatment, or completed response assessment at Cycle 4 Day 1.
Best response is defined as the best measured response over all response assessments (complete response \[CR\], CR with incomplete platelet recovery \[CRp\], CR with incomplete hematological recovery \[CRi\], partial remission \[PR\], no response \[NR\], or Unknown) at all time points after the first dose of the study drug to the end of treatment (does not include response from any subsequent AML therapy including transplantation).
Outcome measures
| Measure |
Initial Dose 30 mg/Day Quizartinib
n=24 Participants
Participants who received an initial dose of 30 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 60 mg/day at Day 15.
|
Initial Dose 20 mg/Day Quizartinib
n=3 Participants
Participants who received a CYP3A4 strong inhibitor received an initial dose of 20 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 30 mg/day at Day 15.
|
Total
n=27 Participants
All participants who received either 30 mg/day or 20 mg/day quizartinib as an initial dose.
|
Quizartinib 60 mg/Day (With No Use of Strong CYP3A4 Inhibitor)
Patients who did not receive a CYP3A4 strong inhibitor received quizartinib 60 mg/day.
|
|---|---|---|---|---|
|
Best Response After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML
Complete response (CR)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Best Response After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML
Complete response with incomplete platelet (CRp)
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Best Response After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML
Complete response with incomplete hematologic(CRi)
|
12 Participants
|
1 Participants
|
13 Participants
|
—
|
|
Best Response After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML
Partial remission (PR)
|
6 Participants
|
1 Participants
|
7 Participants
|
—
|
|
Best Response After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML
No response (NR)
|
5 Participants
|
1 Participants
|
6 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1 until the end of treatment, except for responses from any subsequent AMLPopulation: All participants with FLT3-ITD positive relapsed or refractory AML who achieved CR, CRp, CRi, or PR, discontinued the study treatment, or completed response assessment at Cycle 4 Day 1.
Outcome measures
| Measure |
Initial Dose 30 mg/Day Quizartinib
n=24 Participants
Participants who received an initial dose of 30 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 60 mg/day at Day 15.
|
Initial Dose 20 mg/Day Quizartinib
n=3 Participants
Participants who received a CYP3A4 strong inhibitor received an initial dose of 20 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 30 mg/day at Day 15.
|
Total
n=27 Participants
All participants who received either 30 mg/day or 20 mg/day quizartinib as an initial dose.
|
Quizartinib 60 mg/Day (With No Use of Strong CYP3A4 Inhibitor)
Patients who did not receive a CYP3A4 strong inhibitor received quizartinib 60 mg/day.
|
|---|---|---|---|---|
|
Response Rate After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML
|
79.2 percentage of participants
Interval 57.8 to 92.9
|
66.7 percentage of participants
Interval 9.4 to 99.2
|
77.8 percentage of participants
Interval 57.7 to 91.4
|
—
|
SECONDARY outcome
Timeframe: Baseline, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1 up until the end of treatment, except for responses from any subsequent AML therapy including transplantationPopulation: All participants with FLT3-ITD positive relapsed or refractory AML who had a documented best response of CRc.
Duration from the date of first composite complete remission (CRc) (complete remission \[CR\], CR with incomplete platelet recovery \[CRp\], or CR with incomplete hematological recovery \[CRi\]) observed to the date of documented relapse was assessed.
Outcome measures
| Measure |
Initial Dose 30 mg/Day Quizartinib
n=13 Participants
Participants who received an initial dose of 30 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 60 mg/day at Day 15.
|
Initial Dose 20 mg/Day Quizartinib
n=1 Participants
Participants who received a CYP3A4 strong inhibitor received an initial dose of 20 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 30 mg/day at Day 15.
|
Total
n=14 Participants
All participants who received either 30 mg/day or 20 mg/day quizartinib as an initial dose.
|
Quizartinib 60 mg/Day (With No Use of Strong CYP3A4 Inhibitor)
Patients who did not receive a CYP3A4 strong inhibitor received quizartinib 60 mg/day.
|
|---|---|---|---|---|
|
Duration of Composite Complete Remission (CRc) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML
|
16.1 weeks
Interval 4.7 to 24.6
|
NA weeks
A median value was not reached due to \<50% of participants experiencing the event. In a Kaplan-Meier analysis, the curve would never fall below the 50% mark, and would continue to the largest observed censored time value.
|
16.1 weeks
Interval 4.7 to 24.6
|
—
|
SECONDARY outcome
Timeframe: Baseline, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1 until the end of treatment, except for responses from any subsequent AML therapy including transplantation up to 1 yearPopulation: All participants with FLT3-ITD positive relapsed or refractory AML.
OS is defined as the time from registration (enrollment) until death from any cause.
Outcome measures
| Measure |
Initial Dose 30 mg/Day Quizartinib
n=29 Participants
Participants who received an initial dose of 30 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 60 mg/day at Day 15.
|
Initial Dose 20 mg/Day Quizartinib
n=3 Participants
Participants who received a CYP3A4 strong inhibitor received an initial dose of 20 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 30 mg/day at Day 15.
|
Total
n=32 Participants
All participants who received either 30 mg/day or 20 mg/day quizartinib as an initial dose.
|
Quizartinib 60 mg/Day (With No Use of Strong CYP3A4 Inhibitor)
Patients who did not receive a CYP3A4 strong inhibitor received quizartinib 60 mg/day.
|
|---|---|---|---|---|
|
Overall Survival (OS) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML
|
34.1 weeks
Interval 27.1 to
Upper limit was expressed as NA since the upper limit was not reached. The upper limit was not estimated because of the small number of events after the median OS time.
|
NA weeks
Interval 22.6 to
There were not enough events to estimate a standard error for the median survival time"
|
34.1 weeks
Interval 27.1 to
Upper limit was expressed as NA since the upper limit was not reached. The upper limit was not estimated because of the small number of events after the median OS time.
|
—
|
SECONDARY outcome
Timeframe: Baseline, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1 until the end of treatment, except for responses from any subsequent AML therapy including transplantation up to 32 weeksPopulation: All participants with FLT3-ITD positive relapsed or refractory AML.
Event-free survival is defined as the time from date of registration until documented refractory disease, relapse after response of composite complete remission (CRc = complete remission \[CR\], CR with incomplete platelet recovery \[CRp\], or CR with incomplete hematological recovery \[CRi\]), or death from any cause, whichever occurs first.
Outcome measures
| Measure |
Initial Dose 30 mg/Day Quizartinib
n=29 Participants
Participants who received an initial dose of 30 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 60 mg/day at Day 15.
|
Initial Dose 20 mg/Day Quizartinib
n=3 Participants
Participants who received a CYP3A4 strong inhibitor received an initial dose of 20 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 30 mg/day at Day 15.
|
Total
n=32 Participants
All participants who received either 30 mg/day or 20 mg/day quizartinib as an initial dose.
|
Quizartinib 60 mg/Day (With No Use of Strong CYP3A4 Inhibitor)
Patients who did not receive a CYP3A4 strong inhibitor received quizartinib 60 mg/day.
|
|---|---|---|---|---|
|
Event-free Survival (EFS) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML
|
12.7 weeks
Interval 0.1 to 24.7
|
0.1 weeks
Interval 0.1 to
The missing upper bound is related to right-censored data. The last time point censored and estimate is essentially infinity, therefore it is N/A.
|
12.7 weeks
Interval 0.1 to 24.7
|
—
|
SECONDARY outcome
Timeframe: Baseline, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1 until the end of treatment, except for responses from any subsequent AML therapy including transplantation up to 28 weeksPopulation: All participants with FLT3-ITD positive relapsed or refractory AML and documented best response of CRc.
Leukemia-free survival (LFS) is the time from the first documented response of CRc until documented relapse or death from any cause. The analysis for LFS will be conditional on the participant having a documented best response of CRc.
Outcome measures
| Measure |
Initial Dose 30 mg/Day Quizartinib
n=29 Participants
Participants who received an initial dose of 30 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 60 mg/day at Day 15.
|
Initial Dose 20 mg/Day Quizartinib
n=3 Participants
Participants who received a CYP3A4 strong inhibitor received an initial dose of 20 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 30 mg/day at Day 15.
|
Total
n=32 Participants
All participants who received either 30 mg/day or 20 mg/day quizartinib as an initial dose.
|
Quizartinib 60 mg/Day (With No Use of Strong CYP3A4 Inhibitor)
Patients who did not receive a CYP3A4 strong inhibitor received quizartinib 60 mg/day.
|
|---|---|---|---|---|
|
Leukemia-free Survival (LFS) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML
|
16.1 weeks
Interval 4.7 to 24.6
|
NA weeks
Lack of a median value is due to less than 50% of the participants experiencing the event. In a Kaplan-Meier analysis, the curve would never fall below the 50% mark, and would continue to the largest observed censored time value.
|
16.1 weeks
Interval 4.7 to 24.6
|
—
|
SECONDARY outcome
Timeframe: Up to new AML treatment or 1 year post treatmentPopulation: All participants with FLT3-ITD positive relapsed or refractory AML who underwent HSCT after treatment.
Proportion of participants who start hematopoietic stem cell transplantation (HSCT) immediately after the end of treatment with the study drug without receiving other treatment for AML, except for conditioning regiment for HSCT, was assessed.
Outcome measures
| Measure |
Initial Dose 30 mg/Day Quizartinib
n=29 Participants
Participants who received an initial dose of 30 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 60 mg/day at Day 15.
|
Initial Dose 20 mg/Day Quizartinib
n=3 Participants
Participants who received a CYP3A4 strong inhibitor received an initial dose of 20 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 30 mg/day at Day 15.
|
Total
n=32 Participants
All participants who received either 30 mg/day or 20 mg/day quizartinib as an initial dose.
|
Quizartinib 60 mg/Day (With No Use of Strong CYP3A4 Inhibitor)
Patients who did not receive a CYP3A4 strong inhibitor received quizartinib 60 mg/day.
|
|---|---|---|---|---|
|
Hematopoietic Stem Cell Transplantation Rate After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML
|
37.9 Percentage of participants
Interval 20.7 to 57.7
|
33.3 Percentage of participants
Interval 0.8 to 90.6
|
37.5 Percentage of participants
Interval 21.1 to 56.3
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Days 1 and 15; Cycle 2, Day 1Population: Pharmacokinetic (PK) parameters were assessed in the PK Analysis Set.
Outcome measures
| Measure |
Initial Dose 30 mg/Day Quizartinib
n=3 Participants
Participants who received an initial dose of 30 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 60 mg/day at Day 15.
|
Initial Dose 20 mg/Day Quizartinib
n=34 Participants
Participants who received a CYP3A4 strong inhibitor received an initial dose of 20 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 30 mg/day at Day 15.
|
Total
n=2 Participants
All participants who received either 30 mg/day or 20 mg/day quizartinib as an initial dose.
|
Quizartinib 60 mg/Day (With No Use of Strong CYP3A4 Inhibitor)
n=21 Participants
Patients who did not receive a CYP3A4 strong inhibitor received quizartinib 60 mg/day.
|
|---|---|---|---|---|
|
Change in the Area Under the Plasma Concentration Time Curve (AUC) of Quizartinib and Its Active Metabolite After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML
Cycle 1, Day 1; Quizartinib (n=3,34,0,0)
|
877 ng*h/mL
Standard Deviation 489
|
1170 ng*h/mL
Standard Deviation 716
|
—
|
—
|
|
Change in the Area Under the Plasma Concentration Time Curve (AUC) of Quizartinib and Its Active Metabolite After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML
Cycle 1, Day 1; Active Metabolite (n=3,34,0,0)
|
75.1 ng*h/mL
Standard Deviation 80.6
|
560 ng*h/mL
Standard Deviation 391
|
—
|
—
|
|
Change in the Area Under the Plasma Concentration Time Curve (AUC) of Quizartinib and Its Active Metabolite After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML
Cycle 1, Day 15; Quizartinib (n=3,32,0,0)
|
2610 ng*h/mL
Standard Deviation 693
|
3970 ng*h/mL
Standard Deviation 2610
|
—
|
—
|
|
Change in the Area Under the Plasma Concentration Time Curve (AUC) of Quizartinib and Its Active Metabolite After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML
Cycle 1, Day 15; Active Metabolite (n=3,32,0,0)
|
430 ng*h/mL
Standard Deviation 276
|
3120 ng*h/mL
Standard Deviation 1300
|
—
|
—
|
|
Change in the Area Under the Plasma Concentration Time Curve (AUC) of Quizartinib and Its Active Metabolite After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML
Cycle 2, Day 1; Quizartinib (n=0,0,2,21)
|
—
|
—
|
2960 ng*h/mL
Standard Deviation 749
|
9240 ng*h/mL
Standard Deviation 6090
|
|
Change in the Area Under the Plasma Concentration Time Curve (AUC) of Quizartinib and Its Active Metabolite After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML
Cycle 2, Day 1; Active Metabolite (n=0,0,2,21)
|
—
|
—
|
983 ng*h/mL
Standard Deviation 389
|
6530 ng*h/mL
Standard Deviation 2630
|
SECONDARY outcome
Timeframe: Cycle 1, Days 1 and 15; Cycle 2, Day 1Population: Pharmacokinetic (PK) parameters were assessed in the PK Analysis Set.
Outcome measures
| Measure |
Initial Dose 30 mg/Day Quizartinib
n=3 Participants
Participants who received an initial dose of 30 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 60 mg/day at Day 15.
|
Initial Dose 20 mg/Day Quizartinib
n=34 Participants
Participants who received a CYP3A4 strong inhibitor received an initial dose of 20 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 30 mg/day at Day 15.
|
Total
n=2 Participants
All participants who received either 30 mg/day or 20 mg/day quizartinib as an initial dose.
|
Quizartinib 60 mg/Day (With No Use of Strong CYP3A4 Inhibitor)
n=21 Participants
Patients who did not receive a CYP3A4 strong inhibitor received quizartinib 60 mg/day.
|
|---|---|---|---|---|
|
Change in the Maximum Plasma Concentration (Cmax) of Quizartinib and Its Metabolite (AC886) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML
Cycle 1, Day 1; Quizartinib (n=3,34,0,0)
|
48.1 ng/mL
Standard Deviation 25.9
|
76.9 ng/mL
Standard Deviation 46.8
|
—
|
—
|
|
Change in the Maximum Plasma Concentration (Cmax) of Quizartinib and Its Metabolite (AC886) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML
Cycle 1, Day 1; Active Metabolite (n=3,34,0,0)
|
3.92 ng/mL
Standard Deviation 4.49
|
29.1 ng/mL
Standard Deviation 20.9
|
—
|
—
|
|
Change in the Maximum Plasma Concentration (Cmax) of Quizartinib and Its Metabolite (AC886) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML
Cycle 1, Day 15; Quizartinib (n=3,32,0,0)
|
127 ng/mL
Standard Deviation 35.9
|
211 ng/mL
Standard Deviation 132
|
—
|
—
|
|
Change in the Maximum Plasma Concentration (Cmax) of Quizartinib and Its Metabolite (AC886) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML
Cycle 1, Day 15; Active Metabolite (n=3,32,0,0)
|
18.9 ng/mL
Standard Deviation 12.1
|
146 ng/mL
Standard Deviation 60.4
|
—
|
—
|
|
Change in the Maximum Plasma Concentration (Cmax) of Quizartinib and Its Metabolite (AC886) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML
Cycle 2, Day 1; Quizartinib (n=0,0,2,21)
|
—
|
—
|
149 ng/mL
Standard Deviation 38.2
|
480 ng/mL
Standard Deviation 296
|
|
Change in the Maximum Plasma Concentration (Cmax) of Quizartinib and Its Metabolite (AC886) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML
Cycle 2, Day 1; Active Metabolite (n=0,0,2,21)
|
—
|
—
|
43.7 ng/mL
Standard Deviation 17.7
|
298 ng/mL
Standard Deviation 118
|
SECONDARY outcome
Timeframe: Cycle 1, Day 15Population: Pharmacokinetic (PK) parameters were assessed in the PK Analysis Set.
Outcome measures
| Measure |
Initial Dose 30 mg/Day Quizartinib
n=3 Participants
Participants who received an initial dose of 30 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 60 mg/day at Day 15.
|
Initial Dose 20 mg/Day Quizartinib
n=32 Participants
Participants who received a CYP3A4 strong inhibitor received an initial dose of 20 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 30 mg/day at Day 15.
|
Total
All participants who received either 30 mg/day or 20 mg/day quizartinib as an initial dose.
|
Quizartinib 60 mg/Day (With No Use of Strong CYP3A4 Inhibitor)
Patients who did not receive a CYP3A4 strong inhibitor received quizartinib 60 mg/day.
|
|---|---|---|---|---|
|
Change in the Trough Plasma Concentration (Ctrough) of Quizartinib and Its Metabolite (AC886) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML
Cycle 1, Day 15; Quizartinib
|
98.2 ng/mL
Standard Deviation 19.7
|
128 ng/mL
Standard Deviation 92.5
|
—
|
—
|
|
Change in the Trough Plasma Concentration (Ctrough) of Quizartinib and Its Metabolite (AC886) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML
Cycle 1, Day 15; Active Metabolite
|
17.8 ng/mL
Standard Deviation 11.3
|
112 ng/mL
Standard Deviation 47.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Days 1 and 15; Cycle 2, Day 1Population: Pharmacokinetic (PK) parameters were assessed in the PK Analysis Set.
Outcome measures
| Measure |
Initial Dose 30 mg/Day Quizartinib
n=3 Participants
Participants who received an initial dose of 30 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 60 mg/day at Day 15.
|
Initial Dose 20 mg/Day Quizartinib
n=34 Participants
Participants who received a CYP3A4 strong inhibitor received an initial dose of 20 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 30 mg/day at Day 15.
|
Total
n=2 Participants
All participants who received either 30 mg/day or 20 mg/day quizartinib as an initial dose.
|
Quizartinib 60 mg/Day (With No Use of Strong CYP3A4 Inhibitor)
n=21 Participants
Patients who did not receive a CYP3A4 strong inhibitor received quizartinib 60 mg/day.
|
|---|---|---|---|---|
|
Change in the Time to Reach Maximum Plasma Concentration (Tmax) of Quizartinib and Its Metabolite (AC886) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML
Cycle 1, Day 1; Quizartinib (n=3,34,0,0)
|
4.08 h
Interval 2.17 to 6.17
|
4.03 h
Interval 1.85 to 24.2
|
—
|
—
|
|
Change in the Time to Reach Maximum Plasma Concentration (Tmax) of Quizartinib and Its Metabolite (AC886) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML
Cycle 1, Day 1; Active Metabolite (n=2,33,0,0)
|
24.33 h
Interval 24.25 to 24.42
|
24.32 h
Interval 3.93 to 24.67
|
—
|
—
|
|
Change in the Time to Reach Maximum Plasma Concentration (Tmax) of Quizartinib and Its Metabolite (AC886) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML
Cycle 1, Day 15; Quizartinib (n=3,32,0,0)
|
4.08 h
Interval 4.08 to 6.25
|
3.06 h
Interval 1.42 to 6.08
|
—
|
—
|
|
Change in the Time to Reach Maximum Plasma Concentration (Tmax) of Quizartinib and Its Metabolite (AC886) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML
Cycle 1, Day 15; Active Metabolite (n=3,32,0,0)
|
4.08 h
Interval 0.0 to 6.25
|
5.82 h
Interval 0.83 to 24.5
|
—
|
—
|
|
Change in the Time to Reach Maximum Plasma Concentration (Tmax) of Quizartinib and Its Metabolite (AC886) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML
Cycle 2, Day 1; Quizartinib (n=0,0,2,21)
|
—
|
—
|
6.17 h
Interval 6.08 to 6.24
|
3.87 h
Interval 0.0 to 6.23
|
|
Change in the Time to Reach Maximum Plasma Concentration (Tmax) of Quizartinib and Its Metabolite (AC886) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML
Cycle 2, Day 1; Active Metabolite (n=0,0,2,21)
|
—
|
—
|
14.17 h
Interval 4.25 to 24.08
|
5.65 h
Interval 0.0 to 24.02
|
Adverse Events
Initial Dose 30 mg/Day Quizartinib
Serious events: 14 serious events
Other events: 34 other events
Deaths: 13 deaths
Initial 20 mg/Day Quizartinib
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
Total
Serious events: 17 serious events
Other events: 37 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
Initial Dose 30 mg/Day Quizartinib
n=34 participants at risk
Participants who received an initial dose of 30 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 60 mg/day at Day 15.
|
Initial 20 mg/Day Quizartinib
n=3 participants at risk
Participants who received a CYP3A4 strong inhibitor received an initial dose of 20 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 30 mg/day at Day 15.
|
Total
n=37 participants at risk
All participants who received either 30 mg/day or 20 mg/day quizartinib as an initial dose.
|
|---|---|---|---|
|
Infections and infestations
Bacteremia
|
5.9%
2/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
5.4%
2/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Infections and infestations
Sepsis
|
2.9%
1/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
33.3%
1/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
5.4%
2/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Infections and infestations
Cellulitis
|
2.9%
1/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
2.7%
1/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Infections and infestations
Encephalitis
|
2.9%
1/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
2.7%
1/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Infections and infestations
Pneumonia
|
2.9%
1/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
2.7%
1/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
11.8%
4/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
66.7%
2/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
16.2%
6/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
2.9%
1/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
2.7%
1/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
2.9%
1/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
2.7%
1/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
33.3%
1/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
2.7%
1/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Vascular disorders
Hematoma
|
2.9%
1/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
2.7%
1/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Vascular disorders
Shock hemorrhagic
|
2.9%
1/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
2.7%
1/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
2.9%
1/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
2.7%
1/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Organizing pneumonia
|
2.9%
1/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
2.7%
1/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.9%
1/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
2.7%
1/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.9%
1/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
2.7%
1/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.9%
1/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
2.7%
1/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
1/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
2.7%
1/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Skin and subcutaneous tissue disorders
Pyoderma gangrenosum
|
2.9%
1/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
2.7%
1/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
General disorders
Disease progression
|
2.9%
1/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
2.7%
1/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
General disorders
Non-cardiac chest pain
|
2.9%
1/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
2.7%
1/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
General disorders
Edema peripheral
|
2.9%
1/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
2.7%
1/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Investigations
Platelet count decreased
|
2.9%
1/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
2.7%
1/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
Other adverse events
| Measure |
Initial Dose 30 mg/Day Quizartinib
n=34 participants at risk
Participants who received an initial dose of 30 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 60 mg/day at Day 15.
|
Initial 20 mg/Day Quizartinib
n=3 participants at risk
Participants who received a CYP3A4 strong inhibitor received an initial dose of 20 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 30 mg/day at Day 15.
|
Total
n=37 participants at risk
All participants who received either 30 mg/day or 20 mg/day quizartinib as an initial dose.
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.8%
4/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
33.3%
1/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
13.5%
5/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.8%
4/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
10.8%
4/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Nervous system disorders
Headache
|
11.8%
4/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
10.8%
4/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Nervous system disorders
Dysgeusia
|
8.8%
3/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
8.1%
3/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.8%
3/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
8.1%
3/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Infections and infestations
Acarodermatitis
|
8.8%
3/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
8.1%
3/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Infections and infestations
Pneumonia
|
8.8%
3/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
8.1%
3/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Infections and infestations
Bacteremia
|
5.9%
2/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
5.4%
2/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Infections and infestations
Cellulitis
|
5.9%
2/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
5.4%
2/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Infections and infestations
Device-related infections
|
5.9%
2/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
5.4%
2/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
29.4%
10/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
27.0%
10/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
23.5%
8/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
33.3%
1/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
24.3%
9/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.8%
3/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
33.3%
1/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
10.8%
4/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.9%
1/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
33.3%
1/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
5.4%
2/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Vascular disorders
Hypotension
|
2.9%
1/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
33.3%
1/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
5.4%
2/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Vascular disorders
Phlebitis
|
5.9%
2/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
5.4%
2/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.9%
2/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
5.4%
2/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Gastrointestinal disorders
Nausea
|
26.5%
9/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
66.7%
2/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
29.7%
11/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Gastrointestinal disorders
Vomiting
|
17.6%
6/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
16.2%
6/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
11.8%
4/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
10.8%
4/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Gastrointestinal disorders
Constipation
|
5.9%
2/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
33.3%
1/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
8.1%
3/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
8.8%
3/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
8.1%
3/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Gastrointestinal disorders
Proctalgia
|
5.9%
2/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
5.4%
2/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Hepatobiliary disorders
Liver disorder
|
5.9%
2/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
5.4%
2/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.8%
3/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
33.3%
1/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
10.8%
4/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
8.8%
3/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
8.1%
3/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.9%
2/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
5.4%
2/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.9%
2/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
5.4%
2/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.8%
3/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
33.3%
1/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
10.8%
4/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.8%
3/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
8.1%
3/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
General disorders
Pyrexia
|
11.8%
4/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
33.3%
1/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
13.5%
5/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
General disorders
Edema
|
5.9%
2/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
33.3%
1/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
8.1%
3/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
General disorders
Malaise
|
5.9%
2/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
5.4%
2/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
General disorders
Edema peripheral
|
5.9%
2/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
5.4%
2/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Investigations
Electrocardiogram QT prolonged
|
35.3%
12/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
33.3%
1/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
35.1%
13/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Investigations
Platelet count decreased
|
38.2%
13/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
35.1%
13/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Investigations
Neutrophil count decreased
|
23.5%
8/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
21.6%
8/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Investigations
White blood cell count decreased
|
23.5%
8/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
21.6%
8/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Investigations
Alanine aminotransferase increased
|
11.8%
4/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
10.8%
4/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
8.8%
3/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
8.1%
3/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Investigations
Liver function test increased
|
8.8%
3/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
8.1%
3/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
5.9%
2/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
5.4%
2/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Investigations
Blood uric acid increased
|
5.9%
2/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
0.00%
0/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
5.4%
2/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
5.9%
2/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
33.3%
1/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
8.1%
3/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/34 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
66.7%
2/3 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
5.4%
2/37 • Adverse events were collected from the signing of the informed consent form through 45 days after last dose of study drug up to approximately 2 years.
Adverse events that emerge (or worsen) from the first dose of study drug to the follow-up visit, 45 days after the last dose of study drug, or start date of new AML post treatment.
|
Additional Information
Contact for Clinical Trial Information
Daiichi Sankyo Co., Ltd.
Phone: 908-992-6400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place