A Study of E6201 for the Treatment of Advanced Hematologic Malignancies With FLT3 and/or Ras Mutations

Draft scope assessment: unclear. Attached because the study's own record names FLT3. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Phase 1 (Safety Run-In) was conducted in 5 dose cohorts in up to 30 subjects in a standard 3+3 dose-escalation design to establish an MTD and recommended Phase 2 dose (RP2D). Safety assessed through the monitoring of adverse events (AEs), serious adverse events (SAEs), clinical laboratory parameters (hematology and serum chemistry), vital sign measurements, electrocardiograms (ECGs) and physical examinations.

Full analysis set (FAS): All subjects who were administered any fraction of a dose of study medication

→

primary · POSTED

A DLT was defined as any one of the following events: prolonged myelosuppression (as defined by the National Cancer Institute \[NCI\] criteria specific for leukemia, i.e., marrow cellularity \< 5% at ≥ 6 weeks from start of therapy without evidence of leukemia); ≥ Grade 3 non-hematologic toxicity (excluding Grade 3 nausea, vomiting or diarrhea that is adequately controlled with supportive care and resolves to ≤ Grade 2 within 48 hours, or Grade 3 electrolyte disturbances responsive to correction within 24 hours); ≥ Grade 3 liver function tests (LFTs) lasting \> 7 days; treatment interruption \> 14 days due to toxicity; or other important medical event. DLTs were collected to determine the MTD which is defined as the dose level below the dose at which ≥ 2 of 6 patients in a dose cohort experienced a DLT.

Full analysis set (FAS): All subjects who were administered any fraction of a dose of study medication.

→

secondary · POSTED

For acute myeloid leukemia (AML): Revised Recommendations of the International Working Group (IWG) Response Criteria for AML: CR: Free of leukemia-related symptoms, absolute neutrophil count (ANC) \> 1.0 x 10\^9/L, platelet count ≥ 100 x 10\^9/L, normal bone marrow with \< 5% blasts and no Auer rods. CRi: As per CR but w/ residual thrombocytopenia (platelet count \<100 x 10\^9/L) or residual neutropenia (ANC \<1.0 x 10\^9/L). PR: ≥50% decrease bone marrow blasts to 5 - 25% abnormal cells, or CR w/ ≤ 5% blasts if Auer rods present. For myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML): Modified IWG Response Criteria for MDS: CR: Free of leukemia-related symptoms, ANC ≥1.0 x 10\^9/L, platelet count ≥100 x 10\^9/L, bone marrow ≤5% myeloblasts, normal maturation of all cell lines, hemoglobin ≥ 11g/dL, no blasts in the peripheral blood. PR: All CR criteria w/ ≥50% decrease in bone marrow blasts over pre-treatment, but still \> 5%.

The analysis population was the per-protocol set (PPS). The PPS included all subjects in the FAS who had a valid baseline and one or more post-treatment assessments for a specified measure.

→

secondary · POSTED

Length of time from the first evidence of objective response to the first evidence of progression

The analysis population was the per-protocol set (PPS). The PPS included all subjects in the FAS who had a valid baseline and one or more post-treatment assessments for a specified measure. No objective responses were observed. Therefore, duration of response could not be calculated.

→

secondary · POSTED

Length of time from the date of first administration of study drug to the first evidence of disease progression or death, whichever is earlier

The analysis population was the per-protocol set (PPS). The PPS included all subjects in the FAS who had a valid baseline and one or more post-treatment assessments for a specified measure. For AML, MDS and CMML, progression was defined by relevant IWG criteria as failure to achieve at least a PR. No responses; PFS could not be calculated.

→

secondary · POSTED

Length of time from the date of first administration of study drug to the date of death from any cause

The analysis population was the per-protocol set (PPS). The PPS included all subjects in the FAS who had a valid baseline and one or more post-treatment assessments for a specified endpoint.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id: NCT02418000
trial label: A Study of E6201 for the Treatment of Advanced Hematologic Malignancies With FLT3 and/or Ras Mutations
applicability: unclear
applicability note: Attached because the study's own record names FLT3. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 5
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id
NCT02418000
outcome key
om-0000
source section id
NCT02418000-om-0000
source outcome index
0
endpoint
Maximum Tolerated Dose (MTD) of E6201
endpoint definition
Phase 1 (Safety Run-In) was conducted in 5 dose cohorts in up to 30 subjects in a standard 3+3 dose-escalation design to establish an MTD and recommended Phase 2 dose (RP2D). Safety assessed through the monitoring of adverse events (AEs), serious adverse events (SAEs), clinical laboratory parameters (hematology and serum chemistry), vital sign measurements, electrocardiograms (ECGs) and physical examinations.
time origin
Up to 6 weeks for each dose cohort
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Full analysis set (FAS): All subjects who were administered any fraction of a dose of study medication
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id
NCT02418000
outcome key
om-0001
source section id
NCT02418000-om-0001
source outcome index
1
endpoint
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
endpoint definition
A DLT was defined as any one of the following events: prolonged myelosuppression (as defined by the National Cancer Institute \[NCI\] criteria specific for leukemia, i.e., marrow cellularity \< 5% at ≥ 6 weeks from start of therapy without evidence of leukemia); ≥ Grade 3 non-hematologic toxicity (excluding Grade 3 nausea, vomiting or diarrhea that is adequately controlled with supportive care and resolves to ≤ Grade 2 within 48 hours, or Grade 3 electrolyte disturbances responsive to correction within 24 hours); ≥ Grade 3 liver function tests (LFTs) lasting \> 7 days; treatment interruption \> 14 days due to toxicity; or other important medical event. DLTs were collected to determine the MTD which is defined as the dose level below the dose at which ≥ 2 of 6 patients in a dose cohort experienced a DLT.
time origin
Up to 6 weeks for each dose cohort
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Full analysis set (FAS): All subjects who were administered any fraction of a dose of study medication.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id
NCT02418000
outcome key
om-0002
source section id
NCT02418000-om-0002
source outcome index
2
endpoint
Overall Response Rate
endpoint definition
For acute myeloid leukemia (AML): Revised Recommendations of the International Working Group (IWG) Response Criteria for AML: CR: Free of leukemia-related symptoms, absolute neutrophil count (ANC) \> 1.0 x 10\^9/L, platelet count ≥ 100 x 10\^9/L, normal bone marrow with \< 5% blasts and no Auer rods. CRi: As per CR but w/ residual thrombocytopenia (platelet count \<100 x 10\^9/L) or residual neutropenia (ANC \<1.0 x 10\^9/L). PR: ≥50% decrease bone marrow blasts to 5 - 25% abnormal cells, or CR w/ ≤ 5% blasts if Auer rods present. For myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML): Modified IWG Response Criteria for MDS: CR: Free of leukemia-related symptoms, ANC ≥1.0 x 10\^9/L, platelet count ≥100 x 10\^9/L, bone marrow ≤5% myeloblasts, normal maturation of all cell lines, hemoglobin ≥ 11g/dL, no blasts in the peripheral blood. PR: All CR criteria w/ ≥50% decrease in bone marrow blasts over pre-treatment, but still \> 5%.
time origin
At the end of C1 and every 2 cycles thereafter through 6 months following last dose of study drug
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The analysis population was the per-protocol set (PPS). The PPS included all subjects in the FAS who had a valid baseline and one or more post-treatment assessments for a specified measure.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id
NCT02418000
outcome key
om-0003
source section id
NCT02418000-om-0003
source outcome index
3
endpoint
Duration of Response
endpoint definition
Length of time from the first evidence of objective response to the first evidence of progression
time origin
At the end of C1 and every 2 cycles thereafter through 6 months following last dose of study drug
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The analysis population was the per-protocol set (PPS). The PPS included all subjects in the FAS who had a valid baseline and one or more post-treatment assessments for a specified measure. No objective responses were observed. Therefore, duration of response could not be calculated.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id
NCT02418000
outcome key
om-0004
source section id
NCT02418000-om-0004
source outcome index
4
endpoint
Progression-Free Survival
endpoint definition
Length of time from the date of first administration of study drug to the first evidence of disease progression or death, whichever is earlier
time origin
From Cycle 1 Day 1 (C1D1) until death or study closure, up to 26 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The analysis population was the per-protocol set (PPS). The PPS included all subjects in the FAS who had a valid baseline and one or more post-treatment assessments for a specified measure. For AML, MDS and CMML, progression was defined by relevant IWG criteria as failure to achieve at least a PR. No responses; PFS could not be calculated.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id
NCT02418000
outcome key
om-0005
source section id
NCT02418000-om-0005
source outcome index
5
endpoint
Overall Survival
endpoint definition
Length of time from the date of first administration of study drug to the date of death from any cause
time origin
From C1D1 until death or study closure, up to 26 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The analysis population was the per-protocol set (PPS). The PPS included all subjects in the FAS who had a valid baseline and one or more post-treatment assessments for a specified endpoint.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id
NCT02418000
outcome key
om-0000
arm key
OG000
arm label
All Participants
regimen
All study participants who received at least 1 dose of E6201 at 240 or 320 mg/m\^2 IV weekly, or at 160, 240 or 320 mg/m\^2 IV twice weekly
analyzed count
27
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02418000-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id
NCT02418000
outcome key
om-0001
arm key
OG000
arm label
E6201 240 mg/m^2 Weekly
regimen
E6201 240 mg/m\^2 IV over 2 hours once weekly, on Days 1, 8, 15, and 22, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02418000-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id
NCT02418000
outcome key
om-0001
arm key
OG001
arm label
E6201 320 mg/m^2 Weekly
regimen
E6201 320 mg/m\^2 IV over 2 hours once weekly, on Days 1, 8, 15, and 22, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02418000-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id
NCT02418000
outcome key
om-0001
arm key
OG002
arm label
E6201 160 mg/m^2 Twice Weekly
regimen
E6201 160 mg/m\^2 IV over 2 hours twice weekly, on Days 1, 4, 8, 11, 15, 18, 22 and 25, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02418000-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id
NCT02418000
outcome key
om-0001
arm key
OG003
arm label
E6201 240 mg/m^2 Twice Weekly
regimen
E6201 240 mg/m\^2 IV over 2 hours twice weekly, on Days 1, 4, 8, 11, 15, 18, 22 and 25, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02418000-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id
NCT02418000
outcome key
om-0001
arm key
OG004
arm label
E6201 320 mg/m^2 IV Twice Weekly
regimen
E6201 320 mg/m\^2 IV over 2 hours twice weekly, on Days 1, 4, 8, 11, 15, 18, 22 and 25, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02418000-om-0001#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id
NCT02418000
outcome key
om-0002
arm key
OG000
arm label
E6201 240 mg/m^2 Weekly
regimen
E6201 240 mg/m\^2 IV over 2 hours once weekly, on Days 1, 8, 15, and 22, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02418000-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id
NCT02418000
outcome key
om-0002
arm key
OG001
arm label
E6201 320 mg/m^2 Weekly
regimen
E6201 320 mg/m\^2 IV over 2 hours once weekly, on Days 1, 8, 15, and 22, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02418000-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id
NCT02418000
outcome key
om-0002
arm key
OG002
arm label
E6201 160 mg/m^2 Twice Weekly
regimen
E6201 160 mg/m\^2 IV over 2 hours twice weekly, on Days 1, 4, 8, 11, 15, 18, 22 and 25, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02418000-om-0002#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id
NCT02418000
outcome key
om-0002
arm key
OG003
arm label
E6201 240 mg/m^2 Twice Weekly
regimen
E6201 240 mg/m\^2 IV over 2 hours twice weekly, on Days 1, 4, 8, 11, 15, 18, 22 and 25, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02418000-om-0002#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id
NCT02418000
outcome key
om-0002
arm key
OG004
arm label
E6201 320 mg/m^2 Twice Weekly
regimen
E6201 320 mg/m\^2 IV over 2 hours twice weekly, on Days 1, 4, 8, 11, 15, 18, 22 and 25, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02418000-om-0002#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id
NCT02418000
outcome key
om-0003
arm key
OG000
arm label
E6201 240 mg/m^2 Weekly
regimen
E6201 240 mg/m\^2 IV over 2 hours once weekly, on Days 1, 8, 15, and 22, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for discontinuation of study drug, and followed for up to 6 months after the last dose.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02418000-om-0003#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id
NCT02418000
harm key
EG000
source section id
NCT02418000-ae
event group key
EG000
event group label
E6201 240 mg/m^2 Weekly
serious affected
4
serious at risk
7
other affected
7
other at risk
7
frequency threshold
4
collection period
Adverse event data were collected for each subject from C1D1 to 6 months after the last dose of study drug. The total duration of the study was 26 months.
event definition
Adverse events were reported for all study participants who were administered any fraction of a dose of study medication.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id
NCT02418000
harm key
EG001
source section id
NCT02418000-ae
event group key
EG001
event group label
E6201 320 mg/m^2 Weekly
serious affected
10
serious at risk
10
other affected
10
other at risk
10
frequency threshold
4
collection period
Adverse event data were collected for each subject from C1D1 to 6 months after the last dose of study drug. The total duration of the study was 26 months.
event definition
Adverse events were reported for all study participants who were administered any fraction of a dose of study medication.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id
NCT02418000
harm key
EG002
source section id
NCT02418000-ae
event group key
EG002
event group label
E6201 160 mg/m^2 Twice Weekly
serious affected
3
serious at risk
3
other affected
3
other at risk
3
frequency threshold
4
collection period
Adverse event data were collected for each subject from C1D1 to 6 months after the last dose of study drug. The total duration of the study was 26 months.
event definition
Adverse events were reported for all study participants who were administered any fraction of a dose of study medication.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id
NCT02418000
harm key
EG003
source section id
NCT02418000-ae
event group key
EG003
event group label
E6201 240 mg/m^2 Twice Weekly
serious affected
2
serious at risk
3
other affected
3
other at risk
3
frequency threshold
4
collection period
Adverse event data were collected for each subject from C1D1 to 6 months after the last dose of study drug. The total duration of the study was 26 months.
event definition
Adverse events were reported for all study participants who were administered any fraction of a dose of study medication.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id
NCT02418000
harm key
EG004
source section id
NCT02418000-ae
event group key
EG004
event group label
E6201 320 mg/m^2 Twice Weekly
serious affected
2
serious at risk
4
other affected
4
other at risk
4
frequency threshold
4
collection period
Adverse event data were collected for each subject from C1D1 to 6 months after the last dose of study drug. The total duration of the study was 26 months.
event definition
Adverse events were reported for all study participants who were administered any fraction of a dose of study medication.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice