TriangleNCT02255461 · OUTCOME
Single Dose 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 3
What was measured
On day 1 of course 1, series blood samples for palbociclib pharmacokinetic studies were collected at pre-dose, 0.5, 1, 2, 4, 8 (±1), 10 (±0.5) optional, 24 (±4), 48 (±4) hours after the oral dose of palbociclib. Apparent oral clearance (CL/F) was estimated using a non-compartmental method.
Analysis population: Patients with blood samples collected for pharmacokinetic studies on days 1-3 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) | 3 |
| Stratum I, Dose Level 2 (75 mg/m2) | 12 |
| Stratum I, Dose Level 3 (95 mg/m2) | 6 |
| Stratum II, Dose Level 1 (50 mg/m2) | 4 |
| Stratum II, Dose Level 2 (75mg/m2) | 9 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stratum I, Dose Level 1 (50 mg/m2) | 35.8 | Not reported | 34.4 | 53.1 | Not reported |
| Stratum I, Dose Level 2 (75 mg/m2) | 38.4 | Not reported | 29.3 | 72.0 | Not reported |
| Stratum I, Dose Level 3 (95 mg/m2) | 33.7 | Not reported | 17.3 | 63.3 | Not reported |
| Stratum II, Dose Level 1 (50 mg/m2) | 37.2 | Not reported | 16.9 | 64.3 | Not reported |
| Stratum II, Dose Level 2 (75mg/m2) | 24.4 | Not reported | 11.7 | 355.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 34.4
- upper Limit
- 53.1
- value
- 35.8
- group Id
- OG001
- lower Limit
- 29.3
- upper Limit
- 72.0
- value
- 38.4
- group Id
- OG002
- lower Limit
- 17.3
- upper Limit
- 63.3
- value
- 33.7
- group Id
- OG003
- lower Limit
- 16.9
- upper Limit
- 64.3
- value
- 37.2
- group Id
- OG004
- lower Limit
- 11.7
- upper Limit
- 355.0
- value
- 24.4
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 9
- units
- Participants
- description
- On day 1 of course 1, series blood samples for palbociclib pharmacokinetic studies were collected at pre-dose, 0.5, 1, 2, 4, 8 (±1), 10 (±0.5) optional, 24 (±4), 48 (±4) hours after the oral dose of palbociclib. 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 1-3 of course 1 were included.
- reporting Status
- POSTED
- time Frame
- Up to day 3
- title
- Single Dose 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