TriangleNCT00697346 · OUTCOME
Tmax: Time of First Occurrence of Cmax for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- h
- Interval / dispersion
- Full Range
- Time frame
- Cycle 1 Day 1 predose and at multiple timepoints (up to 24 hours) postdose
Analysis population: PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis.
Groups in this outcome
Alisertib 35 mg PIC QD 14D
Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 45 mg PIC QD 14D
Alisertib 45 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity to (up 4 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 65 mg PIC QD 14D
Alisertib 65 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 90 mg PIC QD 14D
Alisertib 90 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 5 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
| Group | Source count |
|---|---|
| Alisertib 35 mg PIC QD 14D | 3 |
| Alisertib 45 mg PIC QD 14D | 6 |
| Alisertib 65 mg PIC QD 14D | 7 |
| Alisertib 90 mg PIC QD 14D | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Alisertib 35 mg PIC QD 14D | 2.0 | 34.8 | 1.9 | 4.0 | Not reported |
| Alisertib 45 mg PIC QD 14D | 3.0 | 58.0 | 1.1 | 4.0 | Not reported |
| Alisertib 65 mg PIC QD 14D | 2.0 | 44.3 | 1.9 | 6.0 | Not reported |
| Alisertib 90 mg PIC QD 14D | 2.9 | 24.3 | 1.5 | 4.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.9
- spread
- 34.8
- upper Limit
- 4.0
- value
- 2.0
- group Id
- OG001
- lower Limit
- 1.1
- spread
- 58.0
- upper Limit
- 4.0
- value
- 3.0
- group Id
- OG002
- lower Limit
- 1.9
- spread
- 44.3
- upper Limit
- 6.0
- value
- 2.0
- group Id
- OG003
- lower Limit
- 1.5
- spread
- 24.3
- upper Limit
- 4.3
- value
- 2.9
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 2
- units
- Participants
- dispersion Type
- Full Range
- groups
- description
- Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
- id
- OG000
- title
- Alisertib 35 mg PIC QD 14D
- description
- Alisertib 45 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity to (up 4 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
- id
- OG001
- title
- Alisertib 45 mg PIC QD 14D
- description
- Alisertib 65 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
- id
- OG002
- title
- Alisertib 65 mg PIC QD 14D
- description
- Alisertib 90 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 5 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
- id
- OG003
- title
- Alisertib 90 mg PIC QD 14D
- param Type
- MEDIAN
- population Description
- PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 1 predose and at multiple timepoints (up to 24 hours) postdose
- title
- Tmax: Time of First Occurrence of Cmax for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 1
- type
- PRIMARY
- unit Of Measure
- h
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Preserved source evidence · Not medical advice