TriangleNCT02418000 · OUTCOME
Number of Participants With Suppression of pFLT3 by PIA at 4 Hours Post-dose
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Cycle 1 Day 1, 4 hours post-dose.
What was measured
Blood assay: Plasma inhibitory assay (PIA) measuring pFLT3 in blood at 4 hours post-dose
Analysis population: All subjects in the FAS who completed at least 1 PD assessment. Data obtained were not quantitative.
Groups in this outcome
E6201 240 mg/m^2 Weekly
Cohort 1: Participants were administered 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.
E6201 320 mg/m^2 Weekly
Cohort 2: Participants were administered 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.
E6201 160 mg/m^2 Twice Weekly
Cohort 3: Participants were administered 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.
E6201 240 mg/m^2 Twice Weekly
Cohort 4: Participants were administered 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.
E6201 320 mg/m^2 Twice Weekly
Cohort 5: Participants were administered 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.
| Group | Source count |
|---|---|
| E6201 240 mg/m^2 Weekly | 7 |
| E6201 320 mg/m^2 Weekly | 10 |
| E6201 160 mg/m^2 Twice Weekly | 3 |
| E6201 240 mg/m^2 Twice Weekly | 3 |
| E6201 320 mg/m^2 Twice Weekly | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| E6201 240 mg/m^2 Weekly | 6 | Not reported | Not reported | Not reported | Not reported |
| E6201 320 mg/m^2 Weekly | 5 | Not reported | Not reported | Not reported | Not reported |
| E6201 160 mg/m^2 Twice Weekly | 2 | Not reported | Not reported | Not reported | Not reported |
| E6201 240 mg/m^2 Twice Weekly | 3 | Not reported | Not reported | Not reported | Not reported |
| E6201 320 mg/m^2 Twice Weekly | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 4
- units
- Participants
- description
- Blood assay: Plasma inhibitory assay (PIA) measuring pFLT3 in blood at 4 hours post-dose
- groups
- description
- Cohort 1: Participants were administered 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.
- id
- OG000
- title
- E6201 240 mg/m^2 Weekly
- description
- Cohort 2: Participants were administered 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.
- id
- OG001
- title
- E6201 320 mg/m^2 Weekly
- description
- Cohort 3: Participants were administered 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.
- id
- OG002
- title
- E6201 160 mg/m^2 Twice Weekly
- description
- Cohort 4: Participants were administered 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.
- id
- OG003
- title
- E6201 240 mg/m^2 Twice Weekly
- description
- Cohort 5: Participants were administered 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.
- id
- OG004
- title
- E6201 320 mg/m^2 Twice Weekly
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All subjects in the FAS who completed at least 1 PD assessment. Data obtained were not quantitative.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 1, 4 hours post-dose.
- title
- Number of Participants With Suppression of pFLT3 by PIA at 4 Hours Post-dose
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice