TriangleNCT02717455 · OUTCOME
Elimination Rate (Kel)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- per hour
- Interval / dispersion
- Standard Deviation
- Time frame
- Up to day 3
What was measured
Plasma samples for pharmacokinetic (PK) analysis were drawn at pre-dose and at 0.5, 1, 2, 4, 8 (±1), 24 (±4) hours after the first dose of panobinostat, as well as prior to the second dose on Course 1 Day 3. Elimination rate (Kel) was estimated using a noncompartmental method.
Analysis population: Patients who had PK samples collected and had Kel data available were included in this analysis.
Groups in this outcome
Stratum 1, Dose Level 1 (10 mg/m^2)
Recurrent or progressive DIPG patients received panobinostat orally every other day, 3 times per week at 10 mg/m\^2/day for three weeks on, one week off (1 course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Stratum 1, Dose Level 2 (16 mg/m^2)
Recurrent or progressive DIPG patients received panobinostat orally every other day, 3 times per week at 16 mg/m\^2/day for three weeks on, one week off (1 course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Stratum 2, Dose Level 1 (16 mg/m^2)
Non-progressed DIPG or H3K27M+ thalamic DMG patients received panobinostat orally every other day, 3 times per week at 16 mg/m\^2/day for every other week (1 course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Stratum 2, Dose Level 2 (22 mg/m^2)
Non-progressed DIPG or H3K27M+ thalamic DMG patients received panobinostat orally every other day, 3 times per week at 22 mg/m\^2/day for every other week (1 course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Stratum 2, Dose Level 3 (28 mg/m^2)
Non-progressed DIPG or H3K27M+ thalamic DMG patients received panobinostat orally every other day, 3 times per week at 28 mg/m\^2/day for every other week (1course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Stratum 2, Dose Level 4 (36 mg/m^2)
Non-progressed DIPG or H3K27M+ thalamic DMG patients received panobinostat orally every other day, 3 times per week at 36 mg/m\^2/day for every other week (1course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Stratum 1, Dose Level 1 (10 mg/m^2) | 10 |
| Stratum 1, Dose Level 2 (16 mg/m^2) | 5 |
| Stratum 2, Dose Level 1 (16 mg/m^2) | 3 |
| Stratum 2, Dose Level 2 (22 mg/m^2) | 7 |
| Stratum 2, Dose Level 3 (28 mg/m^2) | 7 |
| Stratum 2, Dose Level 4 (36 mg/m^2) | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stratum 1, Dose Level 1 (10 mg/m^2) | 0.059 | 0.024 | Not reported | Not reported | Not reported |
| Stratum 1, Dose Level 2 (16 mg/m^2) | 0.065 | 0.013 | Not reported | Not reported | Not reported |
| Stratum 2, Dose Level 1 (16 mg/m^2) | 0.047 | 0.003 | Not reported | Not reported | Not reported |
| Stratum 2, Dose Level 2 (22 mg/m^2) | 0.057 | 0.012 | Not reported | Not reported | Not reported |
| Stratum 2, Dose Level 3 (28 mg/m^2) | 0.047 | 0.006 | Not reported | Not reported | Not reported |
| Stratum 2, Dose Level 4 (36 mg/m^2) | 0.066 | 0.017 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.024
- value
- 0.059
- group Id
- OG001
- spread
- 0.013
- value
- 0.065
- group Id
- OG002
- spread
- 0.003
- value
- 0.047
- group Id
- OG003
- spread
- 0.012
- value
- 0.057
- group Id
- OG004
- spread
- 0.006
- value
- 0.047
- group Id
- OG005
- spread
- 0.017
- value
- 0.066
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 4
- units
- Participants
- description
- Plasma samples for pharmacokinetic (PK) analysis were drawn at pre-dose and at 0.5, 1, 2, 4, 8 (±1), 24 (±4) hours after the first dose of panobinostat, as well as prior to the second dose on Course 1 Day 3. Elimination rate (Kel) was estimated using a noncompartmental method.
- dispersion Type
- Standard Deviation
- groups
- description
- Recurrent or progressive DIPG patients received panobinostat orally every other day, 3 times per week at 10 mg/m\^2/day for three weeks on, one week off (1 course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Stratum 1, Dose Level 1 (10 mg/m^2)
- description
- Recurrent or progressive DIPG patients received panobinostat orally every other day, 3 times per week at 16 mg/m\^2/day for three weeks on, one week off (1 course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- Stratum 1, Dose Level 2 (16 mg/m^2)
- description
- Non-progressed DIPG or H3K27M+ thalamic DMG patients received panobinostat orally every other day, 3 times per week at 16 mg/m\^2/day for every other week (1 course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
- id
- OG002
- title
- Stratum 2, Dose Level 1 (16 mg/m^2)
- description
- Non-progressed DIPG or H3K27M+ thalamic DMG patients received panobinostat orally every other day, 3 times per week at 22 mg/m\^2/day for every other week (1 course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
- id
- OG003
- title
- Stratum 2, Dose Level 2 (22 mg/m^2)
- description
- Non-progressed DIPG or H3K27M+ thalamic DMG patients received panobinostat orally every other day, 3 times per week at 28 mg/m\^2/day for every other week (1course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
- id
- OG004
- title
- Stratum 2, Dose Level 3 (28 mg/m^2)
- description
- Non-progressed DIPG or H3K27M+ thalamic DMG patients received panobinostat orally every other day, 3 times per week at 36 mg/m\^2/day for every other week (1course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
- id
- OG005
- title
- Stratum 2, Dose Level 4 (36 mg/m^2)
- param Type
- MEAN
- population Description
- Patients who had PK samples collected and had Kel data available were included in this analysis.
- reporting Status
- POSTED
- time Frame
- Up to day 3
- title
- Elimination Rate (Kel)
- type
- PRIMARY
- unit Of Measure
- per hour
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice