TriangleNCT00697346 · OUTCOME
Cmax: Maximum Observed Concentration for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) Dosing at Day 1
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 1 predose and at multiple timepoints (up to 12 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 30 mg ECT BID 7D
Alisertib 30 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-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 40 mg ECT BID 7D
alisertib 40 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-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 50 mg ECT BID 7D
Alisertib 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-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 30 mg ECT BID 7D | 3 |
| Alisertib 40 mg ECT BID 7D | 9 |
| Alisertib 50 mg ECT BID 7D | 10 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Alisertib 30 mg ECT BID 7D | 886 | 39.7 | Not reported | Not reported | Not reported |
| Alisertib 40 mg ECT BID 7D | 1114 | 37.1 | Not reported | Not reported | Not reported |
| Alisertib 50 mg ECT BID 7D | 1531 | 58.4 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 39.7
- value
- 886
- group Id
- OG001
- spread
- 37.1
- value
- 1114
- group Id
- OG002
- spread
- 58.4
- value
- 1531
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 10
- units
- Participants
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Alisertib 30 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-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 30 mg ECT BID 7D
- description
- alisertib 40 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-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
- OG001
- title
- Alisertib 40 mg ECT BID 7D
- description
- Alisertib 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-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 50 mg ECT BID 7D
- 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.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 1 predose and at multiple timepoints (up to 12 hours) postdose
- title
- Cmax: Maximum Observed Concentration for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) Dosing at Day 1
- type
- PRIMARY
- unit Of Measure
- nM
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice