TriangleNCT02717455 · OUTCOME
Clearance (CL/F)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- L/h
- 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. Clearance (CL/F) was estimated using a noncompartmental method.
Analysis population: Patients who had PK samples collected and had CL/F 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) | 87 | 19 | Not reported | Not reported | Not reported |
| Stratum 1, Dose Level 2 (16 mg/m^2) | 146 | 104 | Not reported | Not reported | Not reported |
| Stratum 2, Dose Level 1 (16 mg/m^2) | 156 | 44 | Not reported | Not reported | Not reported |
| Stratum 2, Dose Level 2 (22 mg/m^2) | 115 | 34 | Not reported | Not reported | Not reported |
| Stratum 2, Dose Level 3 (28 mg/m^2) | 93 | 26 | Not reported | Not reported | Not reported |
| Stratum 2, Dose Level 4 (36 mg/m^2) | 129 | 109 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 19
- value
- 87
- group Id
- OG001
- spread
- 104
- value
- 146
- group Id
- OG002
- spread
- 44
- value
- 156
- group Id
- OG003
- spread
- 34
- value
- 115
- group Id
- OG004
- spread
- 26
- value
- 93
- group Id
- OG005
- spread
- 109
- value
- 129
- 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. Clearance (CL/F) 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 CL/F data available were included in this analysis.
- reporting Status
- POSTED
- time Frame
- Up to day 3
- title
- Clearance (CL/F)
- type
- PRIMARY
- unit Of Measure
- L/h
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Preserved source evidence · Not medical advice