TriangleNCT02255461 · OUTCOME
Steady State Elimination Rate Constant (Ke)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- per hour
- Interval / dispersion
- Full Range
- Time frame
- Up to day 22
What was measured
On day 21 of course 1, series blood samples for palbociclib pharmacokinetic studies were collected at pre-dose, 1, 2, 4, 8 (±1), 10 (±0.5) optional, and 24 (±4) hours after the dose. Elimination rate constant (Ke) was estimated using a non-compartmental method.
Analysis population: Patients with blood samples collected for pharmacokinetic studies on days 21-22 of course 1 were included.
Groups in this outcome
Stratum I, Dose Level 1 (50 mg/m2)
Less-heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Stratum I, Dose Level 2 (75 mg/m2)
Less-heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Stratum I, Dose Level 3 (95 mg/m2)
Less-heavily pre-treated patients received oral palbociclib daily at 95 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Stratum II, Dose Level 1 (50 mg/m2)
Heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Stratum II, Dose Level 2 (75mg/m2)
Heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Stratum I, Dose Level 1 (50 mg/m2) | 2 |
| Stratum I, Dose Level 2 (75 mg/m2) | 10 |
| Stratum I, Dose Level 3 (95 mg/m2) | 3 |
| Stratum II, Dose Level 1 (50 mg/m2) | 4 |
| Stratum II, Dose Level 2 (75mg/m2) | 8 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stratum I, Dose Level 1 (50 mg/m2) | 0.052 | Not reported | 0.041 | 0.066 | Not reported |
| Stratum I, Dose Level 2 (75 mg/m2) | 0.050 | Not reported | 0.017 | 0.110 | Not reported |
| Stratum I, Dose Level 3 (95 mg/m2) | 0.062 | Not reported | 0.054 | 0.071 | Not reported |
| Stratum II, Dose Level 1 (50 mg/m2) | 0.032 | Not reported | 0.024 | 0.049 | Not reported |
| Stratum II, Dose Level 2 (75mg/m2) | 0.039 | Not reported | 0.032 | 0.074 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.041
- upper Limit
- 0.066
- value
- 0.052
- group Id
- OG001
- lower Limit
- 0.017
- upper Limit
- 0.110
- value
- 0.050
- group Id
- OG002
- lower Limit
- 0.054
- upper Limit
- 0.071
- value
- 0.062
- group Id
- OG003
- lower Limit
- 0.024
- upper Limit
- 0.049
- value
- 0.032
- group Id
- OG004
- lower Limit
- 0.032
- upper Limit
- 0.074
- value
- 0.039
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 8
- units
- Participants
- description
- On day 21 of course 1, series blood samples for palbociclib pharmacokinetic studies were collected at pre-dose, 1, 2, 4, 8 (±1), 10 (±0.5) optional, and 24 (±4) hours after the dose. Elimination rate constant (Ke) was estimated using a non-compartmental method.
- dispersion Type
- Full Range
- groups
- description
- Less-heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Stratum I, Dose Level 1 (50 mg/m2)
- description
- Less-heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- Stratum I, Dose Level 2 (75 mg/m2)
- description
- Less-heavily pre-treated patients received oral palbociclib daily at 95 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
- id
- OG002
- title
- Stratum I, Dose Level 3 (95 mg/m2)
- description
- Heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
- id
- OG003
- title
- Stratum II, Dose Level 1 (50 mg/m2)
- description
- Heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
- id
- OG004
- title
- Stratum II, Dose Level 2 (75mg/m2)
- param Type
- MEDIAN
- population Description
- Patients with blood samples collected for pharmacokinetic studies on days 21-22 of course 1 were included.
- reporting Status
- POSTED
- time Frame
- Up to day 22
- title
- Steady State Elimination Rate Constant (Ke)
- type
- PRIMARY
- unit Of Measure
- per hour
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice