TriangleNCT01915498 · OUTCOME
Phase 1: AUC From Time Zero to 8 Hours Postdose (AUC0-8) of Enasidenib After Multiple Oral Doses
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ng*h/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Cycle 2 Day 1 at predose and 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose.
What was measured
Plasma enasidenib was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. Area under the plasma concentration-time curve from time 0 to 8 hours post-dose (AUC0-8) was calculated using the linear trapezoidal rule.
Analysis population: Participants who received enasidenib on Cycle 2, Day 1 with sufficient data to determine PK parameters. Participants who took less than 80% of their planned continuous dosing regimen were excluded from the analysis. Participants in the Phase 1 Escalation and Expansion Enasidenib 100 mg QD cohorts were combined for analysis.
Groups in this outcome
Enasidenib 30 mg BID
Participants received enasidenib 30 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
Enasidenib 50 mg BID
Participants received enasidenib 50 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
Enasidenib 75 mg BID
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
Enasidenib 100 mg BID
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity
Enasidenib 150 mg BID
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
Enasidenib 50 mg QD
Participants received enasidenib 50 mg tablets every day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
Phase 1 Dose Escalation: Enasidenib 75 mg QD
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
Phase 1 Dose Escalation: Enasidenib 100 mg QD
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
Phase 1 Dose Escalation: Enasidenib 150 mg QD
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
Phase 1 Dose Escalation: Enasidenib 200 mg QD
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
Phase 1 Dose Escalation: Enasidenib 300 mg QD
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
Phase 1 Dose Escalation: Enasidenib 450 mg QD
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
Phase 1 Dose Escalation: Enasidenib 650 mg QD
Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
| Group | Source count |
|---|---|
| Enasidenib 30 mg BID | 4 |
| Enasidenib 50 mg BID | 7 |
| Enasidenib 75 mg BID | 5 |
| Enasidenib 100 mg BID | 4 |
| Enasidenib 150 mg BID | 4 |
| Enasidenib 50 mg QD | 5 |
| Phase 1 Dose Escalation: Enasidenib 75 mg QD | 4 |
| Phase 1 Dose Escalation: Enasidenib 100 mg QD | 102 |
| Phase 1 Dose Escalation: Enasidenib 150 mg QD | 5 |
| Phase 1 Dose Escalation: Enasidenib 200 mg QD | 11 |
| Phase 1 Dose Escalation: Enasidenib 300 mg QD | 7 |
| Phase 1 Dose Escalation: Enasidenib 450 mg QD | 5 |
| Phase 1 Dose Escalation: Enasidenib 650 mg QD | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enasidenib 30 mg BID | 34338 | 62.5 | Not reported | Not reported | Not reported |
| Enasidenib 50 mg BID | 81775 | 35.2 | Not reported | Not reported | Not reported |
| Enasidenib 75 mg BID | 103364 | 34.1 | Not reported | Not reported | Not reported |
| Enasidenib 100 mg BID | 135649 | 31.4 | Not reported | Not reported | Not reported |
| Enasidenib 150 mg BID | 162308 | 18.0 | Not reported | Not reported | Not reported |
| Enasidenib 50 mg QD | 43407 | 106.5 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 75 mg QD | 44360 | 57.2 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 100 mg QD | 83444 | 48.9 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 150 mg QD | 101462 | 37.7 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 200 mg QD | 108404 | 53.1 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 300 mg QD | 105098 | 40.9 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 450 mg QD | 181186 | 21.5 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 650 mg QD | 219708 | 14.6 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 62.5
- value
- 34338
- group Id
- OG001
- spread
- 35.2
- value
- 81775
- group Id
- OG002
- spread
- 34.1
- value
- 103364
- group Id
- OG003
- spread
- 31.4
- value
- 135649
- group Id
- OG004
- spread
- 18.0
- value
- 162308
- group Id
- OG005
- spread
- 106.5
- value
- 43407
- group Id
- OG006
- spread
- 57.2
- value
- 44360
- group Id
- OG007
- spread
- 48.9
- value
- 83444
- group Id
- OG008
- spread
- 37.7
- value
- 101462
- group Id
- OG009
- spread
- 53.1
- value
- 108404
- group Id
- OG010
- spread
- 40.9
- value
- 105098
- group Id
- OG011
- spread
- 21.5
- value
- 181186
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 102
- group Id
- OG008
- value
- 5
- group Id
- OG009
- value
- 11
- group Id
- OG010
- value
- 7
- group Id
- OG011
- value
- 5
- units
- Participants
- description
- Plasma enasidenib was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. Area under the plasma concentration-time curve from time 0 to 8 hours post-dose (AUC0-8) was calculated using the linear trapezoidal rule.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants received enasidenib 30 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
- id
- OG000
- title
- Enasidenib 30 mg BID
- description
- Participants received enasidenib 50 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
- id
- OG001
- title
- Enasidenib 50 mg BID
- description
- Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
- id
- OG002
- title
- Enasidenib 75 mg BID
- description
- Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity
- id
- OG003
- title
- Enasidenib 100 mg BID
- description
- Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
- id
- OG004
- title
- Enasidenib 150 mg BID
- description
- Participants received enasidenib 50 mg tablets every day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
- id
- OG005
- title
- Enasidenib 50 mg QD
- description
- Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
- id
- OG006
- title
- Phase 1 Dose Escalation: Enasidenib 75 mg QD
- description
- Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
- id
- OG007
- title
- Phase 1 Dose Escalation: Enasidenib 100 mg QD
- description
- Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
- id
- OG008
- title
- Phase 1 Dose Escalation: Enasidenib 150 mg QD
- description
- Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
- id
- OG009
- title
- Phase 1 Dose Escalation: Enasidenib 200 mg QD
- description
- Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
- id
- OG010
- title
- Phase 1 Dose Escalation: Enasidenib 300 mg QD
- description
- Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
- id
- OG011
- title
- Phase 1 Dose Escalation: Enasidenib 450 mg QD
- param Type
- GEOMETRIC_MEAN
- population Description
- Participants who received enasidenib on Cycle 2, Day 1 with sufficient data to determine PK parameters. Participants who took less than 80% of their planned continuous dosing regimen were excluded from the analysis. Participants in the Phase 1 Escalation and Expansion Enasidenib 100 mg QD cohorts were combined for analysis.
- reporting Status
- POSTED
- time Frame
- Cycle 2 Day 1 at predose and 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose.
- title
- Phase 1: AUC From Time Zero to 8 Hours Postdose (AUC0-8) of Enasidenib After Multiple Oral Doses
- type
- SECONDARY
- unit Of Measure
- ng*h/mL
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Preserved source evidence · Not medical advice