TriangleNCT00697346 · OUTCOME
Cmax: Maximum Observed Concentration for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 14
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- nM
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Cycle 1 Day 14 predose and at multiple timepoints (up to 8 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. Here number of participants analyzed were participants evaluable for this outcome measure.
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).
| Group | Source count |
|---|---|
| Alisertib 35 mg PIC QD 14D | 2 |
| Alisertib 45 mg PIC QD 14D | 5 |
| Alisertib 65 mg PIC QD 14D | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Alisertib 35 mg PIC QD 14D | 2193.5 | NA | Not reported | Not reported | Geometric Coefficient of Variation was not calculated for 2 participants. |
| Alisertib 45 mg PIC QD 14D | 1634.4 | 52.5 | Not reported | Not reported | Not reported |
| Alisertib 65 mg PIC QD 14D | 2300.2 | 40.3 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Geometric Coefficient of Variation was not calculated for 2 participants.
- group Id
- OG000
- spread
- NA
- value
- 2193.5
- group Id
- OG001
- spread
- 52.5
- value
- 1634.4
- group Id
- OG002
- spread
- 40.3
- value
- 2300.2
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 6
- units
- Participants
- dispersion Type
- Geometric Coefficient of Variation
- 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
- param Type
- GEOMETRIC_MEAN
- 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. Here number of participants analyzed were participants evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose
- title
- Cmax: Maximum Observed Concentration for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 14
- type
- PRIMARY
- unit Of Measure
- nM
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice