TriangleNCT02418000 · OUTCOME
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Number of Participants with DLTs
- Interval / dispersion
- Not reported
- Time frame
- Up to 6 weeks for each dose cohort
What was measured
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.
Analysis population: Full analysis set (FAS): All subjects who were administered any fraction of a dose of study medication.
Groups in this outcome
E6201 240 mg/m^2 Weekly
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
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
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
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 IV Twice Weekly
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 IV Twice Weekly | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| E6201 240 mg/m^2 Weekly | 1 | Not reported | Not reported | Not reported | Not reported |
| E6201 320 mg/m^2 Weekly | 1 | Not reported | Not reported | Not reported | Not reported |
| E6201 160 mg/m^2 Twice Weekly | 0 | Not reported | Not reported | Not reported | Not reported |
| E6201 240 mg/m^2 Twice Weekly | 0 | Not reported | Not reported | Not reported | Not reported |
| E6201 320 mg/m^2 IV Twice Weekly | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- 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
- 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.
- groups
- description
- 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
- 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
- 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
- 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
- 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 IV Twice Weekly
- param Type
- NUMBER
- population Description
- Full analysis set (FAS): All subjects who were administered any fraction of a dose of study medication.
- reporting Status
- POSTED
- time Frame
- Up to 6 weeks for each dose cohort
- title
- Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
- type
- PRIMARY
- unit Of Measure
- Number of Participants with DLTs
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice