TriangleNCT00697346 · OUTCOME
Cmax: Maximum Observed Concentration for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) Dosing at Day 7
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 7 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. Here number of participants analyzed were participants evaluable for this outcome measure.
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 | 8 |
| Alisertib 50 mg ECT BID 7D | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Alisertib 30 mg ECT BID 7D | 2025 | 29.6 | Not reported | Not reported | Not reported |
| Alisertib 40 mg ECT BID 7D | 2586 | 35.7 | Not reported | Not reported | Not reported |
| Alisertib 50 mg ECT BID 7D | 2058 | 44.6 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 29.6
- value
- 2025
- group Id
- OG001
- spread
- 35.7
- value
- 2586
- group Id
- OG002
- spread
- 44.6
- value
- 2058
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 7
- 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. Here number of participants analyzed were participants evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 7 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 7
- type
- PRIMARY
- unit Of Measure
- nM
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice