Trial · NCT02418000
A Study of E6201 for the Treatment of Advanced Hematologic Malignancies With FLT3 and/or Ras Mutations
NCT02418000, Phase 1, Phase 2, Terminated, Spirita Oncology, LLC; results first posted 2019-03-05
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. A Study of E6201 for the Treatment of Advanced Hematologic Malignancies With FLT3 and/or Ras Mutations. Trials, record NCT02418000. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02418000
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of E6201 for the Treatment of Advanced Hematologic Malignancies With FLT3 and/or Ras Mutations
- NCT number
- NCT02418000
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 27 participants, actual
- Lead sponsor
- Spirita Oncology, LLC
- Conditions
- AML, MDS, CMML
- Interventions
- E6201
- First posted
- 2015-04-16
- Last updated
- 2019-03-20
- Results first posted
- 2019-03-05
- Limitations and caveats
Although E6201 exhibited an acceptable safety profile when administered at doses up to the MTD of 320 mg/m\^2 IV twice weekly, insufficient efficacy was observed during the Phase 1 portion of the study. Thus, the Phase 2a portion was not initiated.
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of E6201 | Up to 6 weeks for each dose cohort | 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. |
| Primary | Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | Up to 6 weeks for each dose cohort | 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. |
| Secondary | Overall Response Rate | At the end of C1 and every 2 cycles thereafter through 6 months following last dose of study drug | 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%. |
| Secondary | Duration of Response | At the end of C1 and every 2 cycles thereafter through 6 months following last dose of study drug | Length of time from the first evidence of objective response to the first evidence of progression |
| Secondary | Progression-Free Survival | From Cycle 1 Day 1 (C1D1) until death or study closure, up to 26 months | Length of time from the date of first administration of study drug to the first evidence of disease progression or death, whichever is earlier |
| Secondary | Overall Survival | From C1D1 until death or study closure, up to 26 months | Length of time from the date of first administration of study drug to the date of death from any cause |
| Secondary | Pharmacokinetic Profile of E6201 in Plasma: Cmax | Assessed at Cycle 1 Days 1 and 15, Cycle 2 Day 1, pre-dose, 5 minutes following the end of the 2-hour infusion, 2, 4, 8 and 24 hours post-infusion. Summary PK parameters for Cycle 1 Day 1 reported. | Cmax: Maximum measured plasma concentration over the collection period |
| Secondary | Pharmacokinetics of E6201 in Plasma: Tmax | Assessed at Cycle 1 Days 1 and 15, Cycle 2 Day 1, pre-dose, 5 minutes following the end of the 2-hour infusion, 2, 4, 8 and 24 hours post-infusion. Summary PK parameters for Cycle 1 Day 1 reported. | Tmax: Time to maximum measured plasma concentration |
| Secondary | Pharmacokinetic Profile of E6201 in Plasma: AUCT | Assessed at Cycle 1 Days 1 and 15, Cycle 2 Day 1, pre-dose, 5 minutes following the end of the 2-hour infusion, 2, 4, 8 and 24 hours post-infusion. Summary PK parameters for Cycle 1 Day 1 reported. | Area under the plasma concentration versus time curve (AUC) to the last measurable concentration over the sampling time-interval. |
| Secondary | Pharmacokinetic Profile of E6201 in Plasma: AUCI | Assessed at Cycle 1 Days 1 and 15, Cycle 2 Day 1, pre-dose, 5 minutes following the end of the 2-hour infusion, 2, 4, 8 and 24 hours post-infusion. Summary PK parameters for Cycle 1 Day 1 reported. | AUCI: The area under the concentration versus time curve from time 0 to infinity |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD) of E6201 | Up to 6 weeks for each dose cohort | Full analysis set (FAS): All subjects who were administered any fraction of a dose of study medication | E6201 MTD (mg/m^2) IV twice weekly | NUMBER |
| PRIMARY | Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | Up to 6 weeks for each dose cohort | Full analysis set (FAS): All subjects who were administered any fraction of a dose of study medication. | Number of Participants with DLTs | NUMBER |
| SECONDARY | Overall Response Rate | At the end of C1 and every 2 cycles thereafter through 6 months following last dose of study drug | 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. | Objective Responses | NUMBER |
| SECONDARY | Duration of Response | At the end of C1 and every 2 cycles thereafter through 6 months following last dose of study drug | 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 | Progression-Free Survival | From Cycle 1 Day 1 (C1D1) until death or study closure, up to 26 months | 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 | Overall Survival | From C1D1 until death or study closure, up to 26 months | 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. | Days | MEDIAN |
| SECONDARY | Pharmacokinetic Profile of E6201 in Plasma: Cmax | Assessed at Cycle 1 Days 1 and 15, Cycle 2 Day 1, pre-dose, 5 minutes following the end of the 2-hour infusion, 2, 4, 8 and 24 hours post-infusion. Summary PK parameters for Cycle 1 Day 1 reported. | All subjects in the FAS who completed at least 1 pharmacokinetic (PK) assessment. | ng/mL | MEAN |
| SECONDARY | Pharmacokinetics of E6201 in Plasma: Tmax | Assessed at Cycle 1 Days 1 and 15, Cycle 2 Day 1, pre-dose, 5 minutes following the end of the 2-hour infusion, 2, 4, 8 and 24 hours post-infusion. Summary PK parameters for Cycle 1 Day 1 reported. | All subjects in the FAS who completed at least 1 pharmacokinetic (PK) assessment. | h | MEAN |
| SECONDARY | Pharmacokinetic Profile of E6201 in Plasma: AUCT | Assessed at Cycle 1 Days 1 and 15, Cycle 2 Day 1, pre-dose, 5 minutes following the end of the 2-hour infusion, 2, 4, 8 and 24 hours post-infusion. Summary PK parameters for Cycle 1 Day 1 reported. | All subjects in the FAS who completed at least 1 pharmacokinetic (PK) assessment. | h.ng/mL | MEAN |
| SECONDARY | Pharmacokinetic Profile of E6201 in Plasma: AUCI | Assessed at Cycle 1 Days 1 and 15, Cycle 2 Day 1, pre-dose, 5 minutes following the end of the 2-hour infusion, 2, 4, 8 and 24 hours post-infusion. Summary PK parameters for Cycle 1 Day 1 reported. | All subjects in the FAS who completed at least 1 pharmacokinetic (PK) assessment. | h.ng/mL | MEAN |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group101
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) of E6201 | All Participants | 320 | E6201 MTD (mg/m^2) IV twice weekly | ||
| Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | E6201 240 mg/m^2 Weekly | 1 | Number of Participants with DLTs | ||
| Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | E6201 320 mg/m^2 Weekly | 1 | Number of Participants with DLTs | ||
| Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | E6201 160 mg/m^2 Twice Weekly | 0 | Number of Participants with DLTs | ||
| Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | E6201 240 mg/m^2 Twice Weekly | 0 | Number of Participants with DLTs | ||
| Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | E6201 320 mg/m^2 IV Twice Weekly | 0 | Number of Participants with DLTs | ||
| Overall Response Rate | E6201 240 mg/m^2 Weekly | 0 | Objective Responses | ||
| Overall Response Rate | E6201 320 mg/m^2 Weekly | 0 | Objective Responses | ||
| Overall Response Rate | E6201 160 mg/m^2 Twice Weekly | 0 | Objective Responses | ||
| Overall Response Rate | E6201 240 mg/m^2 Twice Weekly | 0 | Objective Responses |
1 to 10 of 101Source ClinicalTrials.gov
See all 101 results by groupParticipant flow75
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Cohort 1: E6201 240 mg/m^2 Weekly | STARTED | E6201 240 mg/m^2 Weekly | 7 | |
| Cohort 1: E6201 240 mg/m^2 Weekly | STARTED | E6201 320 mg/m^2 Weekly | 0 | |
| Cohort 1: E6201 240 mg/m^2 Weekly | STARTED | E6201 160 mg/m^2 Twice Weekly | 0 | |
| Cohort 1: E6201 240 mg/m^2 Weekly | STARTED | E6201 240 mg/m^2 Twice Weekly | 0 | |
| Cohort 1: E6201 240 mg/m^2 Weekly | STARTED | E6201 320 mg/m^2 Twice Weekly | 0 | |
| Cohort 1: E6201 240 mg/m^2 Weekly | COMPLETED | E6201 240 mg/m^2 Weekly | 0 | |
| Cohort 1: E6201 240 mg/m^2 Weekly | COMPLETED | E6201 320 mg/m^2 Weekly | 0 | |
| Cohort 1: E6201 240 mg/m^2 Weekly | COMPLETED | E6201 160 mg/m^2 Twice Weekly | 0 | |
| Cohort 1: E6201 240 mg/m^2 Weekly | COMPLETED | E6201 240 mg/m^2 Twice Weekly | 0 | |
| Cohort 1: E6201 240 mg/m^2 Weekly | COMPLETED | E6201 320 mg/m^2 Twice Weekly | 0 |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 participant flowAdverse events345
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Febrile neutropenia | Blood and lymphatic system disorders | E6201 240 mg/m^2 Weekly | 1 | 7 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | E6201 320 mg/m^2 Weekly | 3 | 10 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | E6201 160 mg/m^2 Twice Weekly | 0 | 3 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | E6201 240 mg/m^2 Twice Weekly | 2 | 3 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | E6201 320 mg/m^2 Twice Weekly | 1 | 4 | |
| other | Leucocytosis | Blood and lymphatic system disorders | E6201 240 mg/m^2 Weekly | 1 | 7 | |
| other | Leucocytosis | Blood and lymphatic system disorders | E6201 320 mg/m^2 Weekly | 3 | 10 | |
| other | Leucocytosis | Blood and lymphatic system disorders | E6201 160 mg/m^2 Twice Weekly | 0 | 3 | |
| other | Leucocytosis | Blood and lymphatic system disorders | E6201 240 mg/m^2 Twice Weekly | 1 | 3 | |
| other | Leucocytosis | Blood and lymphatic system disorders | E6201 320 mg/m^2 Twice Weekly | 0 | 4 |
1 to 10 of 345Source ClinicalTrials.gov
See all 345 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | E6201 240 mg/m^2 Weekly | 3 | 7 |
| Total, all-cause mortality | E6201 320 mg/m^2 Weekly | 4 | 10 |
| Total, all-cause mortality | E6201 160 mg/m^2 Twice Weekly | 1 | 3 |
| Total, all-cause mortality | E6201 240 mg/m^2 Twice Weekly | 0 | 3 |
| Total, all-cause mortality | E6201 320 mg/m^2 Twice Weekly | 1 | 4 |
| Total, other adverse events | E6201 240 mg/m^2 Weekly | 7 | 7 |
| Total, other adverse events | E6201 320 mg/m^2 Weekly | 10 | 10 |
| Total, other adverse events | E6201 160 mg/m^2 Twice Weekly | 3 | 3 |
| Total, other adverse events | E6201 240 mg/m^2 Twice Weekly | 3 | 3 |
| Total, other adverse events | E6201 320 mg/m^2 Twice Weekly | 4 | 4 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02418000
GET https://conductscience.org/api/trials/v1/NCT02418000/registered?page=2