TriangleNCT02717455 · OUTCOME
Area Under the Curve (AUC)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- h*ng/mL
- 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. The area under the curve (AUC) was estimated using a noncompartmental method and calculated from time of dosing to the last measurable concentration.
Analysis population: Patients who had PK samples collected and had AUC data available were included.
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) | 12 |
| Stratum 1, Dose Level 2 (16 mg/m^2) | 6 |
| Stratum 2, Dose Level 1 (16 mg/m^2) | 3 |
| Stratum 2, Dose Level 2 (22 mg/m^2) | 10 |
| Stratum 2, Dose Level 3 (28 mg/m^2) | 11 |
| Stratum 2, Dose Level 4 (36 mg/m^2) | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stratum 1, Dose Level 1 (10 mg/m^2) | 102 | 44 | Not reported | Not reported | Not reported |
| Stratum 1, Dose Level 2 (16 mg/m^2) | 191 | 146 | Not reported | Not reported | Not reported |
| Stratum 2, Dose Level 1 (16 mg/m^2) | 143 | 64 | Not reported | Not reported | Not reported |
| Stratum 2, Dose Level 2 (22 mg/m^2) | 239 | 71 | Not reported | Not reported | Not reported |
| Stratum 2, Dose Level 3 (28 mg/m^2) | 284 | 73 | Not reported | Not reported | Not reported |
| Stratum 2, Dose Level 4 (36 mg/m^2) | 372 | 222 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 44
- value
- 102
- group Id
- OG001
- spread
- 146
- value
- 191
- group Id
- OG002
- spread
- 64
- value
- 143
- group Id
- OG003
- spread
- 71
- value
- 239
- group Id
- OG004
- spread
- 73
- value
- 284
- group Id
- OG005
- spread
- 222
- value
- 372
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 10
- group Id
- OG004
- value
- 11
- group Id
- OG005
- value
- 6
- 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. The area under the curve (AUC) was estimated using a noncompartmental method and calculated from time of dosing to the last measurable concentration.
- 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 AUC data available were included.
- reporting Status
- POSTED
- time Frame
- Up to day 3
- title
- Area Under the Curve (AUC)
- type
- PRIMARY
- unit Of Measure
- h*ng/mL
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Preserved source evidence · Not medical advice