TriangleNCT00697346 · OUTCOME
Maximum Tolerated Dose (MTD) of Alisertib
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- mg BID for 7 days
- Interval / dispersion
- Not reported
- Time frame
- From first dose of study drug to 30 days after the last dose (up to 422 days)
What was measured
MTD was defined as the highest dose at which DLT occurred in 0/3 or 1/6 participants.
Analysis population: DLT evaluable population included all participants who received at least 75% of their planned alisertib doses for their first cycle of treatment (unless interrupted by DLT) and had sufficient follow up data to allow the investigators and sponsor to determine whether DLT occurred.
Groups in this outcome
Alisertib
Alisertib 25 or 35 mg, PIC formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles or alisertib 35, 45, 65 or 90 mg PIC, orally, 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 14 cycles) followed by alisertib 50 mg ECT, orally, BID for 7 days followed by a 14-day recovery period in 21-day cycles or alisertib 40 mg, ECT formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, or alisertib 30, 40 or 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 alisertib 50 mg ECT, orally, BID for 7 days followed by a 14-day recovery period in 21-day cycles (up to 14 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 | 58 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Alisertib | 50 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 50
- denoms
- counts
- group Id
- OG000
- value
- 58
- units
- Participants
- description
- MTD was defined as the highest dose at which DLT occurred in 0/3 or 1/6 participants.
- groups
- description
- Alisertib 25 or 35 mg, PIC formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles or alisertib 35, 45, 65 or 90 mg PIC, orally, 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 14 cycles) followed by alisertib 50 mg ECT, orally, BID for 7 days followed by a 14-day recovery period in 21-day cycles or alisertib 40 mg, ECT formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, or alisertib 30, 40 or 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 alisertib 50 mg ECT, orally, BID for 7 days followed by a 14-day recovery period in 21-day cycles (up to 14 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
- param Type
- NUMBER
- population Description
- DLT evaluable population included all participants who received at least 75% of their planned alisertib doses for their first cycle of treatment (unless interrupted by DLT) and had sufficient follow up data to allow the investigators and sponsor to determine whether DLT occurred.
- reporting Status
- POSTED
- time Frame
- From first dose of study drug to 30 days after the last dose (up to 422 days)
- title
- Maximum Tolerated Dose (MTD) of Alisertib
- type
- PRIMARY
- unit Of Measure
- mg BID for 7 days
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice