Acute Myeloid Leukemia, Leukemia, Myelodysplastic Syndrome, AML, MDS
Conditions
Keywords
RTK, kinase, inhibitor, tyrosine, acute, FLT3, AC220, pharmacokinetic, pharmacokinetics, PK, pharmacodynamic, pharmacodynamics, mutations, PD, receptor, class III, relapsed, refractory, t(8;21), q22;q22, AML1/ETO, t(16;16, p13;q22, CBFbeta/MYH11, inv(16), p13q22, 11q23, dysplasia, myeloid, myelomonocytic, monoblastic, monocytic, erythroid, erythroleukemia, megakaryoblastic, basophilic, panmyelosis, myelofibrosis
Brief summary
Patients received oral AC220 daily for 14 days to study the side effects, tolerability and best dose for treating relapsed or refractory acute myeloid leukemia, regardless of FLT3 status.
Detailed description
This is a multi-center clinical study conducted in the USA and two international sites. This open-label, dose escalation study was designed to characterize the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of orally administered AC220 as a single agent given daily for 14 days. Cohorts of 3 patients received AC220 until dose limiting toxicity was noted (DLT). At that point cohorts expanded to 6 patients until MTD was determined. Patients not experiencing DLT or significant disease progression at Day 15 may have continued receiving AC220 at the discretion of the Investigator and Sponsor. FLT3 positive and negative patients were allowed to participate.
Interventions
DRUGAC220
Powder in bottle formulation supplied as 50mg or 350 mg in glass, crimped serum vials. Requires reconstitution by a pharmacist, and must be stored securely and protected from light.
Sponsors
Daiichi Sankyo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males and females age ≥ 18 years; 2. Histopathologically documented primary or secondary AML, as defined by WHO criteria (Jaffe et al, 2001), confirmed by pathology review at treating institution, meeting at least one of the following: 1. Refractory to at least 1 cycle of induction chemotherapy, or 2. Relapsed after at least 1 cycle of induction chemotherapy, or 3. Patient is not, according to the clinical judgment of the Principal Investigator, a candidate for induction chemotherapy due to age, comorbidity, or other factors; 3. Patients for whom no standard therapies are anticipated to result in a durable remission, or who have failed potentially curative therapy, or who refuse standard therapy or patients for whom there is no known therapy of documented treatment benefit; 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-3; 5. In the absence of rapidly progressing disease, the interval from prior treatment to time of AC220 administration should be at least 2 weeks for cytotoxic agents (other than hydroxyurea, per Section 8.8), or at least 5 half-lives for noncytotoxic agents; 6. Persistent chronic clinically significant toxicities from prior chemotherapy or surgery must be less than Grade 2; 7. Serum creatinine ≤ 2.0 mg/dL; 8. Total serum bilirubin ≤ 1.5 × ULN unless considered due to Gilbert's syndrome or leukemic organ involvement; 9. Serum AST or ALT ≤ 3.0 × ULN unless considered due to leukemic organ involvement; 10. Females of childbearing potential must have a negative pregnancy test (urine β-hCG); 11. Females of childbearing potential and sexually mature males must agree to use a medically accepted method of contraception throughout the study; 12. Written informed consent must be provided.
Exclusion criteria
1. Histologic diagnosis of acute promyelocytic leukemia; 2. Clinically active central nervous system leukemia; 3. Persistent clinically significant toxicity from prior chemotherapy that is Grade 2 or higher by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3); 4. Bone marrow transplant within 2 months prior to study; 5. Active, uncontrolled infection; 6. Major surgery within 4 weeks prior to study; 7. Radiation therapy within 4 weeks prior to, or concurrent with, study; 8. Human immunodeficiency virus positivity; 9. Active hepatitis B or C or other active liver disease; 10. Women who are pregnant, lactating, or unwilling to use contraception if of childbearing potential; 11. Medical condition, serious intercurrent illness, or other extenuating circumstance that, in the judgment of the Principal Investigator, could jeopardize patient safety or interfere with the objectives of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Baseline up to 30 days post last dose |
| Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Baseline up to 30 days post last dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Progressive Disease Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Baseline up to 28 days after the last dose, up to approximately 3 years | Progressive disease response criteria included doubling of blast count % in bone marrow (biopsy or aspirate) from baseline; considering measurements starting on Study Day 15, doubling of blast count % in blood from baseline; death determined to be related to disease or disease progression; and investigator reported disease progression. |
| Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Baseline up to 28 days after the last dose, up to approximately 3 years | Complete Response (CR) response criteria included either a post-baseline bone marrow (BM) biopsy or aspiration % blasts \<5%, absolute neutrophil count (ANC) \>1×10\^9/L and platelet count \>100×10\^9/L on the same date as the qualifying BM assessment. CRp response included all CR criteria met, except participant did not experience a platelet recovery (ANC recovery required). CRi response included a qualifying BM result, but not an ANC recovery. Participants may or may not have had a platelet recovery and were not required to be transfusion independent. Partial remission (PR) response included a decrease of ≥50% in % blasts in the BM aspirate or biopsy from baseline to a post-baseline result between 5% to 25% in the bone marrow aspirate or biopsy. Nonresponders (NR) had a pre- and 1 or more post-baseline BM assessment carried out, but results did not meet any response criteria. Participants who were not evaluable (NE) did not have at least 14 days of treatment and were not assessed. |
| Number of Participants With Hematologic Improvement Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Baseline up to 28 days after the last dose, up to approximately 3 years | Hematologic improvement is summarized in terms of Erythroid Response (HI-E), Platelet Response (HI-P), Neutrophil Response (HI-N), and Hematologic Improvement (HI). For post-treatment results, HI-E major responders had \>2 g/dL increase in hemoglobin for at least 1 result after first treatment and transfusion independent; minor responders 1 to 2 g/dL increase in hemoglobin for at least 1 result post first treatment and a 50% decrease in red blood cell transfusion requirements. For HI-P, major responders had ≥30 × 10\^9/L increase in platelet count and transfusion independent; minor responders had 50% or more increase in platelet count with a net increase between 10 to 30 × 10\^9/L and 50% decrease in platelet transfusion requirements. For HI-N, major responders had an increase in absolute neutrophil count (ANC) of 100% or an absolute increase of more than 0.5 × 10\^9/L (whichever is greater); minor responders had an increase in ANC of 100% but an absolute increase of \<0.5 × 10\^9/L. |
Countries
Georgia, United States
Participant flow
Recruitment details
A total of 76 participants who met all inclusion and no exclusion criteria were enrolled and treated in the study at 4 clinical sites in the United States and 2 sites in the Republic of Georgia.
Participants by arm
| Arm | Count |
|---|---|
| Quizartinib Participants initially received quizartinib (AC220) on an intermittent dosing (ID) schedule (14 days on treatment followed by 14 days off treatment) up to a maximum of 200 mg/day.
Following a protocol amendment, participants then received a starting dose of 300 mg/day quizartinib on an ID regimen or received a starting dose of 200 mg/day quizartinib for 28 days (1 cycle) on a continuous dosing schedule. | 76 |
| Total | 76 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 6 |
| Overall Study | Death | 12 |
| Overall Study | Disease progression | 43 |
| Overall Study | Other | 1 |
| Overall Study | Physician Decision | 5 |
| Overall Study | Withdrawal by Subject | 9 |
Baseline characteristics
| Characteristic | Quizartinib |
|---|---|
| Age, Continuous | 56.0 years STANDARD_DEVIATION 17.1 |
| Age, Customized 18 to 60 years | 39 Participants |
| Age, Customized <18 years | 0 Participants |
| Age, Customized 61 to 75 years | 31 Participants |
| Age, Customized >75 years | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 68 Participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 3 | 8 / 8 | 6 / 6 | 5 / 5 | 5 / 5 | 3 / 3 | 5 / 5 | 5 / 6 | 4 / 4 | 6 / 6 | 16 / 17 | 8 / 8 |
| other Total, other adverse events | 3 / 3 | 8 / 8 | 5 / 6 | 5 / 5 | 5 / 5 | 3 / 3 | 5 / 5 | 6 / 6 | 4 / 4 | 6 / 6 | 15 / 17 | 8 / 8 |
| serious Total, serious adverse events | 1 / 3 | 4 / 8 | 1 / 6 | 3 / 5 | 4 / 5 | 2 / 3 | 4 / 5 | 3 / 6 | 3 / 4 | 5 / 6 | 9 / 17 | 8 / 8 |
Outcome results
Primary
Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia
Time frame: Baseline up to 30 days post last dose
Population: Safety events were assessed in the Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | At Least 1 Treatment-Related Adverse Event | 39 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | General disorders & administration site conditions | 11 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Malaise | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Gastrointestinal disorders | 21 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Dyspnoea exertional | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Blood and Lymphatic System Disorders | 4 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Anaemia | 3 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Thrombocytopenia | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Pancytopenia | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Skin and Subcutaneous Tissue Disorders | 8 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Periorbital odema | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Swelling face | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Alopecia | 2 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Dry skin | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Hyperglycaemia | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Hypoalbuminaemia | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Nervous System Disorders | 12 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Psychiatric Disorders | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Insomnia | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Cardiac Disorders | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Right ventricular dysfunction | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Pyrexia | 2 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Fatigue | 4 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Oedema peripheral | 6 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Asthenia | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Chills | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Nausea | 12 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Diarrhoea | 6 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Vomiting | 8 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Abdominal pain | 3 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Abdominal pain upper | 2 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Dyspepsia | 3 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Constipation | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Abdominal distension | 2 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Gastrointestinal haemorrhage | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Gastrooesophageal reflux disease | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Abdominal discomfort | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Oral mucosal blistering | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Epigastric discomfort | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Retching | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Respiratory, Thoracic, and Mediastinal Disorders | 2 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Haemoptysis | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Increased tendency to bruise | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Hair colour changes | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Hidradenitis | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Photosensitivity reaction | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Infections and Infestations | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Pneumonia | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Lung infection | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Metabolism and Nutrition Disorders | 7 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Hypokalaemia | 2 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Anorexia | 5 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Headache | 2 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Dizziness | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Dysgeusia | 8 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Hypoaesthesia | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Neuropathy peripheral | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Dysarthria | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Investigations | 11 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Electrocardiogram QT prolonged | 9 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Blood bilirubin increased | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Hepatic enzyme increased | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Injury, Poisoning, and Procedural Complications | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Contusion | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Eye Disorders | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Eyelid oedema | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Hepatobiliary Disorders | 3 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Hyperbilirubinaemia | 3 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Jaundice | 1 Participants |
Primary
Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia
Time frame: Baseline up to 30 days post last dose
Population: Safety events were assessed in the Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Quizartinib 12 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Anorexia : Grade 3-4 | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Dysgeusia : Grade 3-4 | 0 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Fatigue : Grade 3-4 | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Eyelid oedema : Grade 3-4 | 0 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Hypoalbuminaemia : Grade 3-4 | 0 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Thrombocytopenia : Grade 3-4 | 0 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Nausea : Grade 3-4 | 0 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Pancytopenia : All Grades | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Photosensitivity reaction : Grade 3-4 | 0 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Photosensitivity reaction : All Grades | 0 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Thrombocytopenia : All Grades | 0 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Nausea : All Grades | 6 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Eyelid oedema : All Grades | 0 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Hypoalbuminaemia : All Grades | 0 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Electrocardiogram QT prolonged : All Grades | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Hypokalaemia : All Grades | 2 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Anaemia : All Grades | 2 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Lung infection : Grade 3-4 | 0 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Electrocardiogram QT prolonged : Grade 3-4 | 0 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Hypokalaemia : Grade 3-4 | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Fatigue : All Grades | 2 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Lung infection : All Grades | 0 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Dysgeusia : All Grades | 4 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Anaemia : Grade 3-4 | 2 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Pancytopenia : Grade 3-4 | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Vomiting : All Grades | 3 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Pyrexia : All Grades | 2 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Anorexia : All Grades | 3 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Pyrexia : Grade 3-4 | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Vomiting : Grade 3-4 | 1 Participants |
| Quizartinib 18 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Pyrexia : Grade 3-4 | 0 Participants |
| Quizartinib 18 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Anorexia : Grade 3-4 | 0 Participants |
| Quizartinib 18 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Hypoalbuminaemia : All Grades | 1 Participants |
| Quizartinib 18 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Fatigue : Grade 3-4 | 0 Participants |
| Quizartinib 18 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Fatigue : All Grades | 1 Participants |
| Quizartinib 18 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Anaemia : All Grades | 1 Participants |
| Quizartinib 18 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Eyelid oedema : Grade 3-4 | 1 Participants |
| Quizartinib 18 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Anaemia : Grade 3-4 | 1 Participants |
| Quizartinib 18 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Pyrexia : All Grades | 0 Participants |
| Quizartinib 18 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Eyelid oedema : All Grades | 1 Participants |
| Quizartinib 18 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Pancytopenia : Grade 3-4 | 0 Participants |
| Quizartinib 18 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Hypokalaemia : All Grades | 0 Participants |
| Quizartinib 18 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Hypokalaemia : Grade 3-4 | 0 Participants |
| Quizartinib 18 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Thrombocytopenia : All Grades | 0 Participants |
| Quizartinib 18 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Anorexia : All Grades | 1 Participants |
| Quizartinib 18 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Lung infection : All Grades | 1 Participants |
| Quizartinib 18 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Dysgeusia : Grade 3-4 | 0 Participants |
| Quizartinib 18 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Pancytopenia : All Grades | 0 Participants |
| Quizartinib 18 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Photosensitivity reaction : All Grades | 0 Participants |
| Quizartinib 18 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Thrombocytopenia : Grade 3-4 | 0 Participants |
| Quizartinib 18 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Nausea : All Grades | 3 Participants |
| Quizartinib 18 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Lung infection : Grade 3-4 | 1 Participants |
| Quizartinib 18 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Electrocardiogram QT prolonged : All Grades | 0 Participants |
| Quizartinib 18 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Vomiting : Grade 3-4 | 0 Participants |
| Quizartinib 18 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Electrocardiogram QT prolonged : Grade 3-4 | 0 Participants |
| Quizartinib 18 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Nausea : Grade 3-4 | 0 Participants |
| Quizartinib 18 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Dysgeusia : All Grades | 1 Participants |
| Quizartinib 18 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Photosensitivity reaction : Grade 3-4 | 0 Participants |
| Quizartinib 18 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Vomiting : All Grades | 3 Participants |
| Quizartinib 18 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Hypoalbuminaemia : Grade 3-4 | 1 Participants |
| Quizartinib 27 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Pancytopenia : All Grades | 0 Participants |
| Quizartinib 27 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Nausea : Grade 3-4 | 0 Participants |
| Quizartinib 27 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Dysgeusia : Grade 3-4 | 0 Participants |
| Quizartinib 27 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Vomiting : Grade 3-4 | 0 Participants |
| Quizartinib 27 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Anaemia : Grade 3-4 | 0 Participants |
| Quizartinib 27 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Hypokalaemia : Grade 3-4 | 0 Participants |
| Quizartinib 27 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Pyrexia : Grade 3-4 | 0 Participants |
| Quizartinib 27 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Lung infection : All Grades | 0 Participants |
| Quizartinib 27 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Photosensitivity reaction : All Grades | 1 Participants |
| Quizartinib 27 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Thrombocytopenia : Grade 3-4 | 1 Participants |
| Quizartinib 27 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Electrocardiogram QT prolonged : All Grades | 8 Participants |
| Quizartinib 27 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Electrocardiogram QT prolonged : Grade 3-4 | 4 Participants |
| Quizartinib 27 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Dysgeusia : All Grades | 3 Participants |
| Quizartinib 27 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Vomiting : All Grades | 2 Participants |
| Quizartinib 27 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Anorexia : All Grades | 1 Participants |
| Quizartinib 27 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Anorexia : Grade 3-4 | 0 Participants |
| Quizartinib 27 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Fatigue : All Grades | 1 Participants |
| Quizartinib 27 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Fatigue : Grade 3-4 | 1 Participants |
| Quizartinib 27 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Anaemia : All Grades | 0 Participants |
| Quizartinib 27 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Hypokalaemia : All Grades | 0 Participants |
| Quizartinib 27 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Pyrexia : All Grades | 0 Participants |
| Quizartinib 27 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Eyelid oedema : All Grades | 0 Participants |
| Quizartinib 27 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Eyelid oedema : Grade 3-4 | 0 Participants |
| Quizartinib 27 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Hypoalbuminaemia : All Grades | 0 Participants |
| Quizartinib 27 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Hypoalbuminaemia : Grade 3-4 | 0 Participants |
| Quizartinib 27 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Lung infection : Grade 3-4 | 0 Participants |
| Quizartinib 27 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Nausea : All Grades | 3 Participants |
| Quizartinib 27 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Pancytopenia : Grade 3-4 | 0 Participants |
| Quizartinib 27 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Photosensitivity reaction : Grade 3-4 | 1 Participants |
| Quizartinib 27 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Thrombocytopenia : All Grades | 1 Participants |
| Quizartinib 40 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Fatigue : All Grades | 4 Participants |
| Quizartinib 40 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Photosensitivity reaction : Grade 3-4 | 1 Participants |
| Quizartinib 40 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Hypoalbuminaemia : All Grades | 1 Participants |
| Quizartinib 40 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Anorexia : All Grades | 5 Participants |
| Quizartinib 40 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Vomiting : All Grades | 8 Participants |
| Quizartinib 40 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Dysgeusia : Grade 3-4 | 0 Participants |
| Quizartinib 40 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Hypoalbuminaemia : Grade 3-4 | 1 Participants |
| Quizartinib 40 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Electrocardiogram QT prolonged : Grade 3-4 | 4 Participants |
| Quizartinib 40 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Electrocardiogram QT prolonged : All Grades | 9 Participants |
| Quizartinib 40 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Nausea : Grade 3-4 | 0 Participants |
| Quizartinib 40 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Dysgeusia : All Grades | 8 Participants |
| Quizartinib 40 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Lung infection : Grade 3-4 | 1 Participants |
| Quizartinib 40 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Photosensitivity reaction : All Grades | 1 Participants |
| Quizartinib 40 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Lung infection : All Grades | 1 Participants |
| Quizartinib 40 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Thrombocytopenia : Grade 3-4 | 1 Participants |
| Quizartinib 40 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Pancytopenia : All Grades | 1 Participants |
| Quizartinib 40 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Hypokalaemia : Grade 3-4 | 1 Participants |
| Quizartinib 40 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Anaemia : Grade 3-4 | 3 Participants |
| Quizartinib 40 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Thrombocytopenia : All Grades | 1 Participants |
| Quizartinib 40 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Pancytopenia : Grade 3-4 | 1 Participants |
| Quizartinib 40 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Anorexia : Grade 3-4 | 1 Participants |
| Quizartinib 40 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Pyrexia : Grade 3-4 | 1 Participants |
| Quizartinib 40 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Pyrexia : All Grades | 2 Participants |
| Quizartinib 40 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Vomiting : Grade 3-4 | 1 Participants |
| Quizartinib 40 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Eyelid oedema : All Grades | 1 Participants |
| Quizartinib 40 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Hypokalaemia : All Grades | 2 Participants |
| Quizartinib 40 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Anaemia : All Grades | 3 Participants |
| Quizartinib 40 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Nausea : All Grades | 12 Participants |
| Quizartinib 40 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Eyelid oedema : Grade 3-4 | 1 Participants |
| Quizartinib 40 mg ID | Number of Participants With Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Fatigue : Grade 3-4 | 2 Participants |
Secondary
Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia
Complete Response (CR) response criteria included either a post-baseline bone marrow (BM) biopsy or aspiration % blasts \<5%, absolute neutrophil count (ANC) \>1×10\^9/L and platelet count \>100×10\^9/L on the same date as the qualifying BM assessment. CRp response included all CR criteria met, except participant did not experience a platelet recovery (ANC recovery required). CRi response included a qualifying BM result, but not an ANC recovery. Participants may or may not have had a platelet recovery and were not required to be transfusion independent. Partial remission (PR) response included a decrease of ≥50% in % blasts in the BM aspirate or biopsy from baseline to a post-baseline result between 5% to 25% in the bone marrow aspirate or biopsy. Nonresponders (NR) had a pre- and 1 or more post-baseline BM assessment carried out, but results did not meet any response criteria. Participants who were not evaluable (NE) did not have at least 14 days of treatment and were not assessed.
Time frame: Baseline up to 28 days after the last dose, up to approximately 3 years
Population: Disease response was assessed in the Intent-to-Treat Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Quizartinib 12 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Nonresponder (NR) | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Overall response | 0 Participants |
| Quizartinib 12 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Not evaluable (NE) | 0 Participants |
| Quizartinib 12 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Partial remission (PR) | 0 Participants |
| Quizartinib 12 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete hematologic recovery | 0 Participants |
| Quizartinib 12 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | composite CR (CR+CRp+CRi) | 0 Participants |
| Quizartinib 12 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete platelet recovery | 0 Participants |
| Quizartinib 12 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Complete response (CR) | 0 Participants |
| Quizartinib 18 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete hematologic recovery | 0 Participants |
| Quizartinib 18 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Overall response | 1 Participants |
| Quizartinib 18 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Nonresponder (NR) | 2 Participants |
| Quizartinib 18 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Partial remission (PR) | 1 Participants |
| Quizartinib 18 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete platelet recovery | 0 Participants |
| Quizartinib 18 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Complete response (CR) | 0 Participants |
| Quizartinib 18 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Not evaluable (NE) | 3 Participants |
| Quizartinib 18 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | composite CR (CR+CRp+CRi) | 0 Participants |
| Quizartinib 27 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | composite CR (CR+CRp+CRi) | 0 Participants |
| Quizartinib 27 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Overall response | 2 Participants |
| Quizartinib 27 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Not evaluable (NE) | 1 Participants |
| Quizartinib 27 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Complete response (CR) | 0 Participants |
| Quizartinib 27 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete hematologic recovery | 0 Participants |
| Quizartinib 27 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete platelet recovery | 0 Participants |
| Quizartinib 27 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Partial remission (PR) | 2 Participants |
| Quizartinib 27 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Nonresponder (NR) | 0 Participants |
| Quizartinib 40 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Partial remission (PR) | 1 Participants |
| Quizartinib 40 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Not evaluable (NE) | 0 Participants |
| Quizartinib 40 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | composite CR (CR+CRp+CRi) | 1 Participants |
| Quizartinib 40 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Overall response | 2 Participants |
| Quizartinib 40 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete hematologic recovery | 0 Participants |
| Quizartinib 40 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete platelet recovery | 1 Participants |
| Quizartinib 40 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Nonresponder (NR) | 0 Participants |
| Quizartinib 40 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Complete response (CR) | 0 Participants |
| Quizartinib 60 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Complete response (CR) | 0 Participants |
| Quizartinib 60 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Not evaluable (NE) | 0 Participants |
| Quizartinib 60 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | composite CR (CR+CRp+CRi) | 1 Participants |
| Quizartinib 60 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete platelet recovery | 0 Participants |
| Quizartinib 60 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Partial remission (PR) | 1 Participants |
| Quizartinib 60 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Overall response | 2 Participants |
| Quizartinib 60 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete hematologic recovery | 1 Participants |
| Quizartinib 60 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Nonresponder (NR) | 1 Participants |
| Quizartinib 90 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Nonresponder (NR) | 1 Participants |
| Quizartinib 90 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete platelet recovery | 0 Participants |
| Quizartinib 90 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | composite CR (CR+CRp+CRi) | 0 Participants |
| Quizartinib 90 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Complete response (CR) | 0 Participants |
| Quizartinib 90 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete hematologic recovery | 0 Participants |
| Quizartinib 90 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Partial remission (PR) | 1 Participants |
| Quizartinib 90 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Not evaluable (NE) | 0 Participants |
| Quizartinib 90 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Overall response | 1 Participants |
| Quizartinib 135 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Complete response (CR) | 0 Participants |
| Quizartinib 135 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete hematologic recovery | 0 Participants |
| Quizartinib 135 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Partial remission (PR) | 1 Participants |
| Quizartinib 135 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | composite CR (CR+CRp+CRi) | 0 Participants |
| Quizartinib 135 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Not evaluable (NE) | 1 Participants |
| Quizartinib 135 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete platelet recovery | 0 Participants |
| Quizartinib 135 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Overall response | 1 Participants |
| Quizartinib 135 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Nonresponder (NR) | 2 Participants |
| Quizartinib 200 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Partial remission (PR) | 1 Participants |
| Quizartinib 200 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Complete response (CR) | 0 Participants |
| Quizartinib 200 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Nonresponder (NR) | 3 Participants |
| Quizartinib 200 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Overall response | 2 Participants |
| Quizartinib 200 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | composite CR (CR+CRp+CRi) | 1 Participants |
| Quizartinib 200 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Not evaluable (NE) | 0 Participants |
| Quizartinib 200 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete hematologic recovery | 0 Participants |
| Quizartinib 200 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete platelet recovery | 1 Participants |
| Quizartinib 300 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Partial remission (PR) | 1 Participants |
| Quizartinib 300 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete platelet recovery | 0 Participants |
| Quizartinib 300 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Complete response (CR) | 0 Participants |
| Quizartinib 300 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Not evaluable (NE) | 0 Participants |
| Quizartinib 300 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete hematologic recovery | 1 Participants |
| Quizartinib 300 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Overall response | 2 Participants |
| Quizartinib 300 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Nonresponder (NR) | 0 Participants |
| Quizartinib 300 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | composite CR (CR+CRp+CRi) | 1 Participants |
| Quizartinib 450 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Nonresponder (NR) | 2 Participants |
| Quizartinib 450 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete hematologic recovery | 0 Participants |
| Quizartinib 450 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | composite CR (CR+CRp+CRi) | 0 Participants |
| Quizartinib 450 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Overall response | 2 Participants |
| Quizartinib 450 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete platelet recovery | 0 Participants |
| Quizartinib 450 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Complete response (CR) | 0 Participants |
| Quizartinib 450 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Partial remission (PR) | 2 Participants |
| Quizartinib 450 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Not evaluable (NE) | 0 Participants |
| Quizartinib 200 mg CD | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Partial remission (PR) | 1 Participants |
| Quizartinib 200 mg CD | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | composite CR (CR+CRp+CRi) | 5 Participants |
| Quizartinib 200 mg CD | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Complete response (CR) | 2 Participants |
| Quizartinib 200 mg CD | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete platelet recovery | 1 Participants |
| Quizartinib 200 mg CD | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Nonresponder (NR) | 5 Participants |
| Quizartinib 200 mg CD | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Overall response | 6 Participants |
| Quizartinib 200 mg CD | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete hematologic recovery | 2 Participants |
| Quizartinib 200 mg CD | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Not evaluable (NE) | 2 Participants |
| Quizartinib 300 mg CD | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Nonresponder (NR) | 2 Participants |
| Quizartinib 300 mg CD | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete platelet recovery | 0 Participants |
| Quizartinib 300 mg CD | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Partial remission (PR) | 1 Participants |
| Quizartinib 300 mg CD | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Complete response (CR) | 0 Participants |
| Quizartinib 300 mg CD | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Not evaluable (NE) | 1 Participants |
| Quizartinib 300 mg CD | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | composite CR (CR+CRp+CRi) | 1 Participants |
| Quizartinib 300 mg CD | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete hematologic recovery | 1 Participants |
| Quizartinib 300 mg CD | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Overall response | 2 Participants |
| All Participants | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete platelet recovery | 3 Participants |
| All Participants | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Nonresponder (NR) | 19 Participants |
| All Participants | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Partial remission (PR) | 13 Participants |
| All Participants | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete hematologic recovery | 5 Participants |
| All Participants | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Not evaluable (NE) | 8 Participants |
| All Participants | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Complete response (CR) | 2 Participants |
| All Participants | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | composite CR (CR+CRp+CRi) | 10 Participants |
| All Participants | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Overall response | 23 Participants |
Secondary
Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia
Complete Response (CR) response criteria included either a post-baseline bone marrow biopsy or aspiration % blasts \<5%, absolute neutrophil count (ANC) \>1×10\^9/L and platelet count \>100×10\^9/L on the same date as the qualifying bone marrow assessment. CRp response included all CR criteria met except participant did not experience a platelet recovery. Participants must have experienced an ANC Recovery. CRi response included a qualifying bone marrow result, but did not experience an ANC recovery. Participants may or may not have experienced a platelet recovery and were not required to be transfusion independent. Partial remission (PR) response included a decrease of ≥50% in % blasts in the bone marrow aspirate or biopsy from baseline to a post-baseline result between 5% to 25% in the bone marrow aspirate or biopsy. Nonresponders (NR) had a pre- and 1 or more post-baseline bone marrow assessment carried out, but results did not meet any of the CR or PR or progressive disease criteria.
Time frame: Baseline up to 28 days after the last dose, up to approximately 3 years
Population: Disease response was assessed in the Evaluable Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Quizartinib 12 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete hematologic recovery | 0 Participants |
| Quizartinib 12 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete platelet recovery | 0 Participants |
| Quizartinib 12 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Complete response (CR) | 0 Participants |
| Quizartinib 12 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Partial remission | 0 Participants |
| Quizartinib 12 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Overall response | 0 Participants |
| Quizartinib 12 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Nonresponder | 1 Participants |
| Quizartinib 12 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Composite CR (CR+CRp+CRi) | 0 Participants |
| Quizartinib 18 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete hematologic recovery | 0 Participants |
| Quizartinib 18 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Partial remission | 1 Participants |
| Quizartinib 18 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Overall response | 1 Participants |
| Quizartinib 18 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete platelet recovery | 0 Participants |
| Quizartinib 18 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Composite CR (CR+CRp+CRi) | 0 Participants |
| Quizartinib 18 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Complete response (CR) | 0 Participants |
| Quizartinib 18 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Nonresponder | 2 Participants |
| Quizartinib 27 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Nonresponder | 0 Participants |
| Quizartinib 27 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Overall response | 2 Participants |
| Quizartinib 27 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Composite CR (CR+CRp+CRi) | 0 Participants |
| Quizartinib 27 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Partial remission | 2 Participants |
| Quizartinib 27 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Complete response (CR) | 0 Participants |
| Quizartinib 27 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete hematologic recovery | 0 Participants |
| Quizartinib 27 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete platelet recovery | 0 Participants |
| Quizartinib 40 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete hematologic recovery | 0 Participants |
| Quizartinib 40 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Nonresponder | 0 Participants |
| Quizartinib 40 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Overall response | 2 Participants |
| Quizartinib 40 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Partial remission | 1 Participants |
| Quizartinib 40 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Complete response (CR) | 0 Participants |
| Quizartinib 40 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Composite CR (CR+CRp+CRi) | 1 Participants |
| Quizartinib 40 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete platelet recovery | 1 Participants |
| Quizartinib 60 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete hematologic recovery | 1 Participants |
| Quizartinib 60 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete platelet recovery | 0 Participants |
| Quizartinib 60 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Overall response | 2 Participants |
| Quizartinib 60 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Composite CR (CR+CRp+CRi) | 1 Participants |
| Quizartinib 60 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Nonresponder | 1 Participants |
| Quizartinib 60 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Complete response (CR) | 0 Participants |
| Quizartinib 60 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Partial remission | 1 Participants |
| Quizartinib 90 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Partial remission | 1 Participants |
| Quizartinib 90 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Overall response | 1 Participants |
| Quizartinib 90 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete platelet recovery | 0 Participants |
| Quizartinib 90 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Complete response (CR) | 0 Participants |
| Quizartinib 90 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete hematologic recovery | 0 Participants |
| Quizartinib 90 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Nonresponder | 1 Participants |
| Quizartinib 90 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Composite CR (CR+CRp+CRi) | 0 Participants |
| Quizartinib 135 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete platelet recovery | 0 Participants |
| Quizartinib 135 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Overall response | 1 Participants |
| Quizartinib 135 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Composite CR (CR+CRp+CRi) | 0 Participants |
| Quizartinib 135 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Complete response (CR) | 0 Participants |
| Quizartinib 135 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete hematologic recovery | 0 Participants |
| Quizartinib 135 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Partial remission | 1 Participants |
| Quizartinib 135 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Nonresponder | 2 Participants |
| Quizartinib 200 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Composite CR (CR+CRp+CRi) | 1 Participants |
| Quizartinib 200 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Partial remission | 1 Participants |
| Quizartinib 200 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Complete response (CR) | 0 Participants |
| Quizartinib 200 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete hematologic recovery | 0 Participants |
| Quizartinib 200 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete platelet recovery | 1 Participants |
| Quizartinib 200 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Nonresponder | 3 Participants |
| Quizartinib 200 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Overall response | 2 Participants |
| Quizartinib 300 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Complete response (CR) | 0 Participants |
| Quizartinib 300 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Composite CR (CR+CRp+CRi) | 1 Participants |
| Quizartinib 300 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete platelet recovery | 0 Participants |
| Quizartinib 300 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Overall response | 2 Participants |
| Quizartinib 300 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete hematologic recovery | 1 Participants |
| Quizartinib 300 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Nonresponder | 0 Participants |
| Quizartinib 300 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Partial remission | 1 Participants |
| Quizartinib 450 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete platelet recovery | 0 Participants |
| Quizartinib 450 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Overall response | 1 Participants |
| Quizartinib 450 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Composite CR (CR+CRp+CRi) | 0 Participants |
| Quizartinib 450 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Complete response (CR) | 0 Participants |
| Quizartinib 450 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Partial remission | 1 Participants |
| Quizartinib 450 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete hematologic recovery | 0 Participants |
| Quizartinib 450 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Nonresponder | 2 Participants |
| Quizartinib 200 mg CD | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Partial remission | 1 Participants |
| Quizartinib 200 mg CD | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Complete response (CR) | 2 Participants |
| Quizartinib 200 mg CD | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Nonresponder | 5 Participants |
| Quizartinib 200 mg CD | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete hematologic recovery | 2 Participants |
| Quizartinib 200 mg CD | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Composite CR (CR+CRp+CRi) | 5 Participants |
| Quizartinib 200 mg CD | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete platelet recovery | 1 Participants |
| Quizartinib 200 mg CD | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Overall response | 6 Participants |
| Quizartinib 300 mg CD | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete platelet recovery | 0 Participants |
| Quizartinib 300 mg CD | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Nonresponder | 2 Participants |
| Quizartinib 300 mg CD | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete hematologic recovery | 1 Participants |
| Quizartinib 300 mg CD | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Complete response (CR) | 0 Participants |
| Quizartinib 300 mg CD | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Composite CR (CR+CRp+CRi) | 1 Participants |
| Quizartinib 300 mg CD | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Overall response | 2 Participants |
| Quizartinib 300 mg CD | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Partial remission | 1 Participants |
| All Participants | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Nonresponder | 19 Participants |
| All Participants | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Overall response | 22 Participants |
| All Participants | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Composite CR (CR+CRp+CRi) | 10 Participants |
| All Participants | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Partial remission | 12 Participants |
| All Participants | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete hematologic recovery | 5 Participants |
| All Participants | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Complete response (CR) | 2 Participants |
| All Participants | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | CR with incomplete platelet recovery | 3 Participants |
Secondary
Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Progressive Disease Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia
Progressive disease response criteria included doubling of blast count % in bone marrow (biopsy or aspirate) from baseline; considering measurements starting on Study Day 15, doubling of blast count % in blood from baseline; death determined to be related to disease or disease progression; and investigator reported disease progression.
Time frame: Baseline up to 28 days after the last dose, up to approximately 3 years
Population: Disease response was assessed in the Evaluable Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Quizartinib 12 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Progressive Disease Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | 2 Participants |
| Quizartinib 18 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Progressive Disease Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | 2 Participants |
| Quizartinib 27 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Progressive Disease Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | 2 Participants |
| Quizartinib 40 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Progressive Disease Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | 2 Participants |
| Quizartinib 60 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Progressive Disease Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | 2 Participants |
| Quizartinib 90 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Progressive Disease Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | 0 Participants |
| Quizartinib 135 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Progressive Disease Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | 1 Participants |
| Quizartinib 200 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Progressive Disease Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | 0 Participants |
| Quizartinib 300 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Progressive Disease Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | 2 Participants |
| Quizartinib 450 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Progressive Disease Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | 1 Participants |
| Quizartinib 200 mg CD | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Progressive Disease Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | 1 Participants |
| Quizartinib 300 mg CD | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Progressive Disease Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | 3 Participants |
| All Participants | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Progressive Disease Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | 18 Participants |
Secondary
Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Progressive Disease Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia
Progressive disease response criteria included doubling of blast count % in bone marrow (biopsy or aspirate) from baseline; considering measurements starting on Study Day 15, doubling of blast count % in blood from baseline; death determined to be related to disease or disease progression; and investigator reported disease progression.
Time frame: Baseline up to 28 days after the last dose, up to approximately 3 years
Population: Disease response was assessed in the Intent-to-Treat Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Quizartinib 12 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Progressive Disease Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | 2 Participants |
| Quizartinib 18 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Progressive Disease Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | 2 Participants |
| Quizartinib 27 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Progressive Disease Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | 3 Participants |
| Quizartinib 40 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Progressive Disease Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | 3 Participants |
| Quizartinib 60 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Progressive Disease Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | 2 Participants |
| Quizartinib 90 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Progressive Disease Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | 1 Participants |
| Quizartinib 135 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Progressive Disease Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | 1 Participants |
| Quizartinib 200 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Progressive Disease Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | 1 Participants |
| Quizartinib 300 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Progressive Disease Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | 2 Participants |
| Quizartinib 450 mg ID | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Progressive Disease Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | 2 Participants |
| Quizartinib 200 mg CD | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Progressive Disease Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | 4 Participants |
| Quizartinib 300 mg CD | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Progressive Disease Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | 3 Participants |
| All Participants | Number of Participants Achieving a Best Disease Response by Dose Cohort in Terms of Progressive Disease Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | 26 Participants |
Secondary
Number of Participants With Hematologic Improvement Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia
Hematologic improvement is summarized in terms of Erythroid Response (HI-E), Platelet Response (HI-P), Neutrophil Response (HI-N), and Hematologic Improvement (HI). For post-treatment results, HI-E major responders had \>2 g/dL increase in hemoglobin for at least 1 result after first treatment and transfusion independent; minor responders 1 to 2 g/dL increase in hemoglobin for at least 1 result post first treatment and a 50% decrease in red blood cell transfusion requirements. For HI-P, major responders had ≥30 × 10\^9/L increase in platelet count and transfusion independent; minor responders had 50% or more increase in platelet count with a net increase between 10 to 30 × 10\^9/L and 50% decrease in platelet transfusion requirements. For HI-N, major responders had an increase in absolute neutrophil count (ANC) of 100% or an absolute increase of more than 0.5 × 10\^9/L (whichever is greater); minor responders had an increase in ANC of 100% but an absolute increase of \<0.5 × 10\^9/L.
Time frame: Baseline up to 28 days after the last dose, up to approximately 3 years
Population: Hematologic improvement was assessed in the Intent-to-Treat Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Quizartinib 12 mg ID | Number of Participants With Hematologic Improvement Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Erythroid Response (HI-E) Responders | 35 Participants |
| Quizartinib 12 mg ID | Number of Participants With Hematologic Improvement Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Erythroid Response (HI-E) Major Responders | 15 Participants |
| Quizartinib 12 mg ID | Number of Participants With Hematologic Improvement Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Erythroid Response (HI-E) Minor Responders | 20 Participants |
| Quizartinib 12 mg ID | Number of Participants With Hematologic Improvement Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Erythroid Response (HI-E) No Response | 34 Participants |
| Quizartinib 12 mg ID | Number of Participants With Hematologic Improvement Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | HI-E Participants excluded | 7 Participants |
| Quizartinib 12 mg ID | Number of Participants With Hematologic Improvement Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Platelet Response (HI-P) Responders | 39 Participants |
| Quizartinib 12 mg ID | Number of Participants With Hematologic Improvement Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Platelet Response (HI-P) Major Responders | 18 Participants |
| Quizartinib 12 mg ID | Number of Participants With Hematologic Improvement Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Platelet Response (HI-P) Minor Responders | 21 Participants |
| Quizartinib 12 mg ID | Number of Participants With Hematologic Improvement Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Platelet Response (HI-P) No Response | 29 Participants |
| Quizartinib 12 mg ID | Number of Participants With Hematologic Improvement Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | HI-P Participants excluded | 8 Participants |
| Quizartinib 12 mg ID | Number of Participants With Hematologic Improvement Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Neutrophil Response (HI-N) Responders | 26 Participants |
| Quizartinib 12 mg ID | Number of Participants With Hematologic Improvement Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Neutrophil Response (HI-N) Major Responders | 19 Participants |
| Quizartinib 12 mg ID | Number of Participants With Hematologic Improvement Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Neutrophil Response (HI-N) Minor Responders | 7 Participants |
| Quizartinib 12 mg ID | Number of Participants With Hematologic Improvement Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Neutrophil Response (HI-N) No Response | 24 Participants |
| Quizartinib 12 mg ID | Number of Participants With Hematologic Improvement Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | HI-N Participants excluded | 26 Participants |
| Quizartinib 12 mg ID | Number of Participants With Hematologic Improvement Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Hematologic Improvement (HI) Responders | 60 Participants |
| Quizartinib 12 mg ID | Number of Participants With Hematologic Improvement Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Hematologic Improvement (HI) Any Major Response | 38 Participants |
| Quizartinib 12 mg ID | Number of Participants With Hematologic Improvement Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Hematologic Improvement (HI) Any Minor Response | 22 Participants |
| Quizartinib 12 mg ID | Number of Participants With Hematologic Improvement Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | HI Participants excluded | 1 Participants |