NCT00425555 · OUTCOME
Area Under the Plasma Concentration AUC0-24, AUC0-48 and AUC 0-infinity of Panobinostat
Study of Oral LBH589 in Adult Patients With Refractory Cutaneous T-Cell Lymphoma · Source last updated 2021-08-20
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- ng*hr/ml
- Interval / dispersion
- Standard Deviation
- Time frame
- Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8
What was measured
AUC is defined as the area under concentration-time curve as a measure of drug exposure. The area under the plasma concentration-time curve from time zero to 24 hours. The area under the plasma concentration-time curve from time zero to 48 hours. AUC (0-inf) is defined as the area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time.
Analysis population: The analysis was performed in PAS population, defined as all participants who provide at least one post-dose PK plasma sample. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.
Groups in this outcome
All Participants
Participants received Panobinostat 20 mg/day capsule orally, OD on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). The treatment duration was not fixed. Participants continued treatment until disease progression or unacceptable toxicity occurred.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| All Participants | 139 |
|---|
Reported measurements
Day 1 - AUC0-24
Analysis denominator · Participants
| Group | Source count |
|---|
| All Participants | 109 |
|---|
Values in ng*hr/ml · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| All Participants | 110.138 | 58.0235 | Not reported | Not reported | Not reported |
|---|
Day 8 - AUC0-24
Analysis denominator · Participants
| Group | Source count |
|---|
| All Participants | 60 |
|---|
Values in ng*hr/ml · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| All Participants | 134.033 | 61.5203 | Not reported | Not reported | Not reported |
|---|
Day 1 - AUC0-48
Analysis denominator · Participants
| Group | Source count |
|---|
| All Participants | 107 |
|---|
Values in ng*hr/ml · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| All Participants | 132.019 | 69.3453 | Not reported | Not reported | Not reported |
|---|
Day 8 - AUC0-48
Analysis denominator · Participants
| Group | Source count |
|---|
| All Participants | 52 |
|---|
Values in ng*hr/ml · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| All Participants | 159.750 | 64.2278 | Not reported | Not reported | Not reported |
|---|
Day 1- AUC (0-inf)
Analysis denominator · Participants
| Group | Source count |
|---|
| All Participants | 93 |
|---|
Values in ng*hr/ml · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| All Participants | 134.828 | 64.9389 | Not reported | Not reported | Not reported |
|---|
Day 8 - AUC (0-inf)
Analysis denominator · Participants
| Group | Source count |
|---|
| All Participants | 52 |
|---|
Values in ng*hr/ml · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| All Participants | 162.673 | 65.0664 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 58.0235
- value
- 110.138
- title
- Day 1 - AUC0-24
- categories
- measurements
- group Id
- OG000
- spread
- 61.5203
- value
- 134.033
- title
- Day 8 - AUC0-24
- categories
- measurements
- group Id
- OG000
- spread
- 69.3453
- value
- 132.019
- title
- Day 1 - AUC0-48
- categories
- measurements
- group Id
- OG000
- spread
- 64.2278
- value
- 159.750
- title
- Day 8 - AUC0-48
- categories
- measurements
- group Id
- OG000
- spread
- 64.9389
- value
- 134.828
- title
- Day 1- AUC (0-inf)
- categories
- measurements
- group Id
- OG000
- spread
- 65.0664
- value
- 162.673
- title
- Day 8 - AUC (0-inf)
- description
- AUC is defined as the area under concentration-time curve as a measure of drug exposure. The area under the plasma concentration-time curve from time zero to 24 hours. The area under the plasma concentration-time curve from time zero to 48 hours. AUC (0-inf) is defined as the area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received Panobinostat 20 mg/day capsule orally, OD on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). The treatment duration was not fixed. Participants continued treatment until disease progression or unacceptable toxicity occurred.
- id
- OG000
- title
- All Participants
- param Type
- MEAN
- population Description
- The analysis was performed in PAS population, defined as all participants who provide at least one post-dose PK plasma sample. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.
- reporting Status
- POSTED
- time Frame
- Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8
- title
- Area Under the Plasma Concentration AUC0-24, AUC0-48 and AUC 0-infinity of Panobinostat
- type
- SECONDARY
- unit Of Measure
- ng*hr/ml
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
Triangle