TriangleNCT00697346 · OUTCOME
Tmax: Time of First Occurrence of Cmax for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) 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
- hours (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. Here number of participants analyzed were participants evaluable for this outcome measure.
Groups in this outcome
Alisertib 25mg PIC QD 21D
Alisertib 25 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days (D) followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 35 mg PIC QD 21D
Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 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 25mg PIC QD 21D | 6 |
| Alisertib 35 mg PIC QD 21D | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Alisertib 25mg PIC QD 21D | 2.0 | Not reported | 2.0 | 3.3 | Not reported |
| Alisertib 35 mg PIC QD 21D | 2.0 | Not reported | 1.1 | 5.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.0
- upper Limit
- 3.3
- value
- 2.0
- group Id
- OG001
- lower Limit
- 1.1
- upper Limit
- 5.2
- value
- 2.0
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 4
- units
- Participants
- dispersion Type
- Full Range
- groups
- description
- Alisertib 25 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days (D) followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 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 25mg PIC QD 21D
- description
- Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 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 35 mg PIC QD 21D
- 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. Here number of participants analyzed were participants evaluable for this outcome measure.
- 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 21 Days (QD21D) Dosing at Day 1
- type
- PRIMARY
- unit Of Measure
- hours (h)
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice