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This is a phase 1b, dose escalation, study of quizartinib to evaluate the safety profile, the pharmacokinetics, and the recommended dose of quizartinib for subsequent clinical studies of the combination of quizartinib and induction and consolidation chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quizartinib 20 mg/day | Experimental | Participants who received 20 mg quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m^2/day IV) and either idarubicin (12 mg/m^2/day IV infusion) or daunorubicin (60 mg/m^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m^2/12 hours IV) was co-administered with quizartinib. |
|
| Quizartinib 40 mg/day | Experimental | Participants who received 40 mg quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m^2/day IV) and either idarubicin (12 mg/m^2/day IV infusion) or daunorubicin (60 mg/m^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m^2/12 hours IV) was co-administered with quizartinib. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quizartinib | Drug | [Induction period, Cycle 1] Once-daily repeated oral administration Day 8 to Day 21. [Induction period, Cycle 2] Once-daily repeated oral administration Day 6 to Day 19. [Consolidation period] Once-daily repeated oral administration Day 6 to Day 19. |
| Measure | Description | Time Frame |
|---|---|---|
| Summary of Best Responses After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) | Best response was defined as the best measured complete remission (CR), CR with incomplete hematological recovery (CRi), CR with incomplete platelet recovery (CRp), Partial remission (PR), or No response (NR) in the overall response assessments at all time points after the first dose. CR is defined as absence of leukemia cells morphologically; bone marrow blasts <5 %; neutrophil count ≥ 1000 /mm 3; platelet count ≥ 100 ,000 /mm 3, independence of RBC transfusions for 4 weeks; independence of platelet transfusions for 1 week; absence of extramedullary leukemia. | Day 0 to Day 21 of last completed cycle (each cycle 28 days), up to approximately 1 year |
| Summary of Best Response Rates After the First Oral Dose of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Best response was defined as the best measured complete remission (CR), CR with incomplete hematological recovery (CRi), CR with incomplete platelet recovery (CRp), Partial remission (PR), or No response (NR) in the overall response assessments at all time points after the first dose. | Day 0 to Day 21 of last completed cycle (each cycle 28 days), up to approximately 1 year |
| Pharmacokinetic Parameter Maximum Serum Concentration (Cmax) of Geometric Means of Quizartinib and Active Metabolite (AC886) After Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia | The maximum serum plasma concentration (Cmax) is reported at Induction phase Cycle 1, Day 9 and the maximum serum plasma concentration at steady state (Cmax,ss) is reported at Induction phase Cycle 1, Day 21 for quizartinib, active metabolite AC886, and quizartinib and AC886. | Induction phase Cycle 1, Day 8 to Cycle 1, Day 21 (each cycle 28 days) |
| Pharmacokinetic Parameter Area Under the Concentration-Time Curve During Dosing Interval of Quizartinib and Metabolite (AC886) After Daily Dose of 20 mg or 40 mg With Chemotherapy to Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Leader | Daiichi Sankyo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo | Japan |
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
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A total of 7 participants who met all inclusion and no exclusion criteria were enrolled and received treatment in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Quizartinib 20 mg/Day | Participants who received 20 mg quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m^2/day IV) and either idarubicin (12 mg/m^2/day IV infusion) or daunorubicin (60 mg/m^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m^2/12 hours IV) was co-administered with quizartinib. |
| FG001 | Quizartinib 40 mg/Day | Participants who received 40 mg/day quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m^2/day IV) and either idarubicin (12 mg/m^2/day IV infusion) or daunorubicin (60 mg/m^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m^2/12 hours IV) was co-administered with quizartinib. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Induction Phase |
|
| |||||||||||||||||||||
| Consolidation Phase |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Quizartinib 20 mg/Day | Participants who received 20 mg quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m^2/day IV) and either idarubicin (12 mg/m^2/day IV infusion) or daunorubicin (60 mg/m^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m^2/12 hours IV) was co-administered with quizartinib. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Summary of Best Responses After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) | Best response was defined as the best measured complete remission (CR), CR with incomplete hematological recovery (CRi), CR with incomplete platelet recovery (CRp), Partial remission (PR), or No response (NR) in the overall response assessments at all time points after the first dose. CR is defined as absence of leukemia cells morphologically; bone marrow blasts <5 %; neutrophil count ≥ 1000 /mm 3; platelet count ≥ 100 ,000 /mm 3, independence of RBC transfusions for 4 weeks; independence of platelet transfusions for 1 week; absence of extramedullary leukemia. | Best response was assessed in the Efficacy Analysis Set. | Posted | Count of Participants | Participants | Day 0 to Day 21 of last completed cycle (each cycle 28 days), up to approximately 1 year |
|
Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year.
A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Quizartinib 20 mg/Day | Participants who received 20 mg quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m^2/day IV) and either idarubicin (12 mg/m^2/day IV infusion) or daunorubicin (60 mg/m^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m^2/12 hours IV) was co-administered with quizartinib. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Contact for Clinical Trial Information | Daiichi Sankyo, Inc. | 908-992-6400 | CTRinfo@dsi.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 17, 2016 | Jul 12, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| C544967 | quizartinib |
| D003561 | Cytarabine |
| D015255 | Idarubicin |
| D003630 | Daunorubicin |
| ID | Term |
|---|---|
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Cytarabine | Drug | [Induction period, Cycle 1] Once-daily intravenous injection of 100 mg/m^2 cytarabine on Day 1 to 7. [Induction period, Cycle 2] Once-daily intravenous injection of 100 mg/m^2 cytarabine on Day 1 to 5. [Consolidation period] Twice-daily intravenous injection of 3.0 g/m^2 cytarabine at 12-hour intervals on Days 1, 3, and 5. |
|
| Idarubicin | Drug | Either Idarubicin or Daunorubicin will be used [Induction period, Cycle 1] Once-daily intravenous injection of 12 mg/m^2 idarubicin on Day 1 to 3. [Induction period, Cycle 2] Once-daily intravenous injection of 12 mg/m^2 idarubicin on Day 1 and 2. |
|
| Daunorubicin | Drug | Either Idarubicin or Daunorubicin will be used [Induction period, Cycle 1] Once-daily intravenous injection of 60mg/m^2 daunorubicin on Day 1 to 3. [Induction period, Cycle 2] Once-daily intravenous injection of 60mg/m^2 daunorubicin on Day 1 and 2. |
|
The area under the plasma concentration-time curve during dosing interval (AUCtau) of geometric means is reported at Induction phase Cycle 1, Day 9 and the area under the plasma concentration-time curve during dosing interval at steady state (AUCtauss) of geometric means are reported at Induction phase Cycle 1, Day 21 for quizartinib, active metabolite AC886, and quizartinib and AC886. |
| Induction phase Cycle 1, Day 8 to Cycle 1, Day 21 (each cycle 28 days) |
| Pharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Quizartinib and the Active Metabolite (AC886) After a Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) | The time of maximum plasma concentration (Tmax) of geometric means is reported at Induction phase Cycle 1, Day 9 and the time of maximum plasma concentration at steady state (Tmax,ss) of geometric means is reported at Induction phase Cycle 1, Day 21 for quizartinib, active metabolite AC886, and quizartinib and AC886. | Induction phase Cycle 1, Day 8 to Cycle 1, Day 21 (each cycle 28 days) |
| Pharmacokinetic Parameter Metabolite to Parent Ratio (MR) of Active Metabolite (AC886) After a Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) | The metabolite to parent ratio of geometric means for Cmax and AUCtau is reported at Induction phase Cycle 1, Day 9 for active metabolite AC886 is reported. | Induction phase Cycle 1, Day 8 (each cycle 28 days) |
| Pharmacokinetic Parameter Trough Plasma Concentration (Ctrough) of Quizartinib and Active Metabolite (AC886) After a Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) | The trough plasma concentration (Ctrough) of geometric means is reported at Induction phase Cycle 1, Day 21 for serum quizartinib, active metabolite AC886, and quizartinib and AC886. | Induction phase Cycle 1, Day 21 (each cycle 28 days) |
| Pharmacokinetic Parameter Accumulation Ratio (AR) of Quizartinib and Active Metabolite (AC886) After a Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) | The accumulation ratio of geometric means for Cmax and AUCtau is reported at Induction phase Cycle 1, Day 21 for serum quizartinib, active metabolite AC886, and quizartinib and AC886. | Induction phase Cycle 1, Day 21 (each cycle 28 days) |
| Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) | A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and coadministered drugs, or the start date of new AML post-treatment, whichever was earlier. | Induction phase Cycle 1, Day 1 up to 35 days after last dose in Cycle 2 (each cycle 28 days), up to approximately 1 year |
| Number of Participants Treatment-Emergent Adverse Events Reported During Consolidation Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) | A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and coadministered drugs, or the start date of new AML post-treatment, whichever was earlier. | Consolidation phase Cycle 1, Day 1 up to 35 days after last dose (each cycle 28 days), up to approximately 1 year |
| Relapse after CR, CRp, or CRi |
|
| NOT COMPLETED |
|
|
| BG001 | Quizartinib 40 mg/Day | Participants who received 40 mg/day quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m^2/day IV) and either idarubicin (12 mg/m^2/day IV infusion) or daunorubicin (60 mg/m^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m^2/12 hours IV) was co-administered with quizartinib. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Participants who received 20 mg quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m^2/day IV) and either idarubicin (12 mg/m^2/day IV infusion) or daunorubicin (60 mg/m^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m^2/12 hours IV) was co-administered with quizartinib. |
| OG001 | Quizartinib 40 mg/Day | Participants who received 40 mg/day quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m^2/day IV) and either idarubicin (12 mg/m^2/day IV infusion) or daunorubicin (60 mg/m^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m^2/12 hours IV) was co-administered with quizartinib. |
|
|
| Primary | Summary of Best Response Rates After the First Oral Dose of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia | Best response was defined as the best measured complete remission (CR), CR with incomplete hematological recovery (CRi), CR with incomplete platelet recovery (CRp), Partial remission (PR), or No response (NR) in the overall response assessments at all time points after the first dose. | Best response was assessed in the Efficacy Analysis Set. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 0 to Day 21 of last completed cycle (each cycle 28 days), up to approximately 1 year |
|
|
|
| Primary | Pharmacokinetic Parameter Maximum Serum Concentration (Cmax) of Geometric Means of Quizartinib and Active Metabolite (AC886) After Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia | The maximum serum plasma concentration (Cmax) is reported at Induction phase Cycle 1, Day 9 and the maximum serum plasma concentration at steady state (Cmax,ss) is reported at Induction phase Cycle 1, Day 21 for quizartinib, active metabolite AC886, and quizartinib and AC886. | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Induction phase Cycle 1, Day 8 to Cycle 1, Day 21 (each cycle 28 days) |
|
|
|
| Primary | Pharmacokinetic Parameter Area Under the Concentration-Time Curve During Dosing Interval of Quizartinib and Metabolite (AC886) After Daily Dose of 20 mg or 40 mg With Chemotherapy to Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia | The area under the plasma concentration-time curve during dosing interval (AUCtau) of geometric means is reported at Induction phase Cycle 1, Day 9 and the area under the plasma concentration-time curve during dosing interval at steady state (AUCtauss) of geometric means are reported at Induction phase Cycle 1, Day 21 for quizartinib, active metabolite AC886, and quizartinib and AC886. | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Induction phase Cycle 1, Day 8 to Cycle 1, Day 21 (each cycle 28 days) |
|
|
|
| Primary | Pharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Quizartinib and the Active Metabolite (AC886) After a Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) | The time of maximum plasma concentration (Tmax) of geometric means is reported at Induction phase Cycle 1, Day 9 and the time of maximum plasma concentration at steady state (Tmax,ss) of geometric means is reported at Induction phase Cycle 1, Day 21 for quizartinib, active metabolite AC886, and quizartinib and AC886. | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | Posted | Median | Full Range | hour | Induction phase Cycle 1, Day 8 to Cycle 1, Day 21 (each cycle 28 days) |
|
|
|
| Primary | Pharmacokinetic Parameter Metabolite to Parent Ratio (MR) of Active Metabolite (AC886) After a Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) | The metabolite to parent ratio of geometric means for Cmax and AUCtau is reported at Induction phase Cycle 1, Day 9 for active metabolite AC886 is reported. | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | Posted | Geometric Mean | Geometric Coefficient of Variation | metabolite to parent ratio | Induction phase Cycle 1, Day 8 (each cycle 28 days) |
|
|
|
| Primary | Pharmacokinetic Parameter Trough Plasma Concentration (Ctrough) of Quizartinib and Active Metabolite (AC886) After a Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) | The trough plasma concentration (Ctrough) of geometric means is reported at Induction phase Cycle 1, Day 21 for serum quizartinib, active metabolite AC886, and quizartinib and AC886. | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Induction phase Cycle 1, Day 21 (each cycle 28 days) |
|
|
|
| Primary | Pharmacokinetic Parameter Accumulation Ratio (AR) of Quizartinib and Active Metabolite (AC886) After a Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) | The accumulation ratio of geometric means for Cmax and AUCtau is reported at Induction phase Cycle 1, Day 21 for serum quizartinib, active metabolite AC886, and quizartinib and AC886. | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | Posted | Geometric Mean | Geometric Coefficient of Variation | accumulation ratio | Induction phase Cycle 1, Day 21 (each cycle 28 days) |
|
|
|
| Primary | Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) | A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and coadministered drugs, or the start date of new AML post-treatment, whichever was earlier. | Adverse events were assessed in the Safety Analysis Set. | Posted | Count of Participants | Participants | Induction phase Cycle 1, Day 1 up to 35 days after last dose in Cycle 2 (each cycle 28 days), up to approximately 1 year |
|
|
|
| Primary | Number of Participants Treatment-Emergent Adverse Events Reported During Consolidation Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) | A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and coadministered drugs, or the start date of new AML post-treatment, whichever was earlier. | Adverse events were assessed in the Safety Analysis Set. | Posted | Count of Participants | Participants | Consolidation phase Cycle 1, Day 1 up to 35 days after last dose (each cycle 28 days), up to approximately 1 year |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 4 |
| 4 |
| EG001 | Quizartinib 40 mg/Day | Participants who received 40 mg/day quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m^2/day IV) and either idarubicin (12 mg/m^2/day IV infusion) or daunorubicin (60 mg/m^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m^2/12 hours IV) was co-administered with quizartinib. | 0 | 3 | 2 | 3 | 3 | 3 |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hypouricaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA 20.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dermatitis bullous | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Urinary tract pain | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Aspartate aminotransferase | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
Not provided
Not provided
| D006425 |
| Hemic and Lymphatic Diseases |
| D006571 |
| Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| Cycle 1, Day 8: AC886, Cmax |
|
|
| Cycle 1, Day 8: Quizartinib + AC886, Cmax |
|
|
| Cycle 1, Day 21: Quizartinib, Cmax, ss |
|
|
| Cycle 1, Day 21: AC886, Cmax, ss |
|
|
| Cycle 1, Day 21: Quizartinib + AC886, Cmax |
|
|
| Cycle 1, Day 8: AC886, AUCtau |
|
|
| Cycle 1, Day 8: Quizartinib + AC886, AUCtau |
|
|
| Cycle 1, Day 21: Quizartinib, AUCtau,ss |
|
|
| Cycle 1, Day 21: AC886, AUCtau, ss |
|
|
| Cycle 1, Day 21: Quizartinib + AC886, AUCtau |
|
|
| Cycle 1, Day 8: AC886, Tmax |
|
|
| Cycle 1, Day 8: Quizartinib + AC886, Tmax |
|
|
| Cycle 1, Day 21: Quizartinib, Tmax,ss |
|
|
| Cycle 1, Day 21: AC886, Tmax,ss |
|
|
| Cycle 1, Day 21: Quizartinib + AC886, Tmax |
|
|
| Cycle 1, Day 21: Quizartinib + AC886 |
|
| Cycle 1, Day 21: Quizartinib + AC886 AR (Cmax) |
|
| Cycle 1, Day 21: Quizartinib AR (AUCtau) |
|
| Cycle 1, Day 21: AC886 AR (AUCtau) |
|
| Cycle 1, Day 21: Quizartinib + AC886 AR (AUCtau) |
|
| Pneumonia |
|
| Skin infection |
|
| Staphylococcal bacteraemia |
|
| Blood and Lymphatic System Disorders |
|
| Febrile neutropenia |
|
| Anaemia |
|
| Leukopenia |
|
| Neutropenia |
|
| Thrombocytopenia |
|
| Immune Disorders |
|
| Hypersensitivity |
|
| Metabolism and Nutrition Disorders |
|
| Decreased appetite |
|
| Hypoalbuminaemia |
|
| Hypokalaemia |
|
| Hypomagnesaemia |
|
| Hyponatraemia |
|
| Hypophosphataemia |
|
| Hypouricaemia |
|
| Tumour lysis syndrome |
|
| Nervous System Disorders |
|
| Dysgeusia |
|
| Dizziness |
|
| Eye Disorders |
|
| Photophobia |
|
| Cardiac Disorders |
|
| Palpitations |
|
| Vascular Disorders |
|
| Hypotension |
|
| Respiratory, Thoracic, and Mediastinal Disorders |
|
| Epistaxis |
|
| Oropharyngeal pain |
|
| Respiratory disorder |
|
| Gastrointestinal Disorders |
|
| Abdominal pain upper |
|
| Nausea |
|
| Constipation |
|
| Diarrhoea |
|
| Stomatitis |
|
| Cheilitis |
|
| Vomiting |
|
| Melaena |
|
| Hepatobiliary Disorders |
|
| Hepatic function abnormal |
|
| Skin and Subcutaneous Tissue Disorders |
|
| Alopecia |
|
| Rash |
|
| Rash maculo-papular |
|
| Dermatitis bullous |
|
| Dry skin |
|
| Musculoskeletal and Connective Tissue Disorders |
|
| Arthralgia |
|
| Musculoskeletal pain |
|
| Myalgia |
|
| Pain in extremity |
|
| Renal and Urinary Disorders |
|
| Haematuria |
|
| Proteinuria |
|
| Urinary tract pain |
|
| Reproductive System and Breast Disorders |
|
| Menorrhagia |
|
| General Disorders & Administration Site Conditions |
|
| Oedema peripheral |
|
| Pyrexia |
|
| Investigations |
|
| Gamma-glutamyltransferase increased |
|
| Alanine aminotransferase increased |
|
| Blood alkaline phosphatase increased |
|
| Electrocardiogram QT prolonged |
|
| Platelet count decreased |
|
| Weight decreased |
|
| White blood cell count decreased |
|
| Aspartate aminotransferase |
|
| Aspartate aminotransferase increased |
|
| Blood bilirubin increased |
|
| Blood lactate dehydrogenase increased |
|
| Blood pressure decreased |
|
| Lipase increased |
|
| Lung infection |
|
| Skin infection |
|
| Upper respiratory tract infection |
|
| Blood and Lymphatic System Disorders |
|
| Febrile neutropenia |
|
| Nervous System Disorders |
|
| Dysgeusia |
|
| Gastrointestinal Disorders |
|
| Diarrhoea |
|
| Nausea |
|
| Stomatitis |
|
| Skin and Subcutaneous Tissue Disorders |
|
| Rash |
|
| Rash maculo-papular |
|
| General Disorders & Administration Site Conditions |
|
| Oedema peripheral |
|
| Investigations |
|
| Platelet count decreased |
|
| White blood cell count decreased |
|
| Alanine aminotransferase increased |
|
| Electrocardiogram QT prolonged |
|
| Injury, Poisoning, and Procedural Complications |
|
| Contusion |
|
| Fall |
|