TriangleNCT02255461 · OUTCOME
Steady State Apparent Oral Clearance (CL/F)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- L/h/m^2
- 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. Apparent oral clearance (CL/F) 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) | 26.6 | Not reported | 19.0 | 34.2 | Not reported |
| Stratum I, Dose Level 2 (75 mg/m2) | 25.8 | Not reported | 12.3 | 101.0 | Not reported |
| Stratum I, Dose Level 3 (95 mg/m2) | 28.1 | Not reported | 20.8 | 35.3 | Not reported |
| Stratum II, Dose Level 1 (50 mg/m2) | 17.0 | Not reported | 9.7 | 64.0 | Not reported |
| Stratum II, Dose Level 2 (75mg/m2) | 16.1 | Not reported | 12.1 | 62.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 19.0
- upper Limit
- 34.2
- value
- 26.6
- group Id
- OG001
- lower Limit
- 12.3
- upper Limit
- 101.0
- value
- 25.8
- group Id
- OG002
- lower Limit
- 20.8
- upper Limit
- 35.3
- value
- 28.1
- group Id
- OG003
- lower Limit
- 9.7
- upper Limit
- 64.0
- value
- 17.0
- group Id
- OG004
- lower Limit
- 12.1
- upper Limit
- 62.4
- value
- 16.1
- 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. Apparent oral clearance (CL/F) 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 Apparent Oral Clearance (CL/F)
- type
- PRIMARY
- unit Of Measure
- L/h/m^2
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice