TriangleNCT02780804 · OUTCOME
Half-life of Entinostat
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Hours
- Interval / dispersion
- Full Range
- Time frame
- Plasma concentrations were measured at 0, 0.5, 1, 3, 6, 24, and 48-96 hours post-dose during cycle 1, day 1.
What was measured
The median (min, max) Half-Life of entinostat stratified by study part and dose level. The half-life (t1/2) was calculated using the equation t1/2 = 0.693/λz, where the terminal elimination rate constant (λz) was determined from a least-squares regression of the log-transformed plasma concentration vs. time data for the last 3 - 4 time points.
Analysis population: All eligible enrolled patients.
Groups in this outcome
Stratum 1 With 3 mg/m²
Patients with recurrent or refractory solid tumors, including lymphoma and CSN tumors, treated once weekly with entinostat administered as a single-agent at 3 mg/m2
Stratum 1 With 4 mg/m²
Patients with recurrent or refractory solid tumors, including lymphoma and CSN tumors, treated once weekly with entinostat administered as a single-agent at 4 mg/m2
PK Part With 4 mg/m²
Patients with recurrent or refractory solid tumors without bone marrow involvement, including lymphoma and CSN tumors, treated once weekly with entinostat administered as a single-agent at the RP2D (4 mg/m2)
| Group | Source count |
|---|---|
| Stratum 1 With 3 mg/m² | 6 |
| Stratum 1 With 4 mg/m² | 9 |
| PK Part With 4 mg/m² | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stratum 1 With 3 mg/m² | 50.96 | Not reported | 27.38 | 103.66 | Not reported |
| Stratum 1 With 4 mg/m² | 46.04 | Not reported | 40.51 | 81.32 | Not reported |
| PK Part With 4 mg/m² | 44.23 | Not reported | 29.86 | 103.74 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 27.38
- upper Limit
- 103.66
- value
- 50.96
- group Id
- OG001
- lower Limit
- 40.51
- upper Limit
- 81.32
- value
- 46.04
- group Id
- OG002
- lower Limit
- 29.86
- upper Limit
- 103.74
- value
- 44.23
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 6
- units
- Participants
- description
- The median (min, max) Half-Life of entinostat stratified by study part and dose level. The half-life (t1/2) was calculated using the equation t1/2 = 0.693/λz, where the terminal elimination rate constant (λz) was determined from a least-squares regression of the log-transformed plasma concentration vs. time data for the last 3 - 4 time points.
- dispersion Type
- Full Range
- groups
- description
- Patients with recurrent or refractory solid tumors, including lymphoma and CSN tumors, treated once weekly with entinostat administered as a single-agent at 3 mg/m2
- id
- OG000
- title
- Stratum 1 With 3 mg/m²
- description
- Patients with recurrent or refractory solid tumors, including lymphoma and CSN tumors, treated once weekly with entinostat administered as a single-agent at 4 mg/m2
- id
- OG001
- title
- Stratum 1 With 4 mg/m²
- description
- Patients with recurrent or refractory solid tumors without bone marrow involvement, including lymphoma and CSN tumors, treated once weekly with entinostat administered as a single-agent at the RP2D (4 mg/m2)
- id
- OG002
- title
- PK Part With 4 mg/m²
- param Type
- MEDIAN
- population Description
- All eligible enrolled patients.
- reporting Status
- POSTED
- time Frame
- Plasma concentrations were measured at 0, 0.5, 1, 3, 6, 24, and 48-96 hours post-dose during cycle 1, day 1.
- title
- Half-life of Entinostat
- type
- PRIMARY
- unit Of Measure
- Hours
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice