TriangleNCT01915498 · OUTCOME
Phase 1: AUC From Time Zero to 10 Hours Postdose (AUC0-10) of AGI-16903 After Multiple Oral Doses of Enasidenib
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, 8, and 10 hours post-dose.
What was measured
AGI-16903 is a primary metabolite of enasidenib. Plasma AGI-16903 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 10 hours post-dose (AUC0-10) 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 | 2 |
| Enasidenib 150 mg BID | 4 |
| Enasidenib 50 mg QD | 4 |
| Phase 1 Dose Escalation: Enasidenib 75 mg QD | 4 |
| Phase 1 Dose Escalation: Enasidenib 100 mg QD | 94 |
| Phase 1 Dose Escalation: Enasidenib 150 mg QD | 3 |
| 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 | 3 |
| Phase 1 Dose Escalation: Enasidenib 650 mg QD | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enasidenib 30 mg BID | 4830 | 82.9 | Not reported | Not reported | Not reported |
| Enasidenib 50 mg BID | 9437 | 46.8 | Not reported | Not reported | Not reported |
| Enasidenib 75 mg BID | 9002 | 60.0 | Not reported | Not reported | Not reported |
| Enasidenib 100 mg BID | 13463 | NA | Not reported | Not reported | Percent coefficient of variation could not be calculated due to small sample size |
| Enasidenib 150 mg BID | 20705 | 16.1 | Not reported | Not reported | Not reported |
| Enasidenib 50 mg QD | 6502 | 132.7 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 75 mg QD | 3954 | 80.6 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 100 mg QD | 9502 | 42.0 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 150 mg QD | 13263 | 40.1 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 200 mg QD | 14303 | 47.2 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 300 mg QD | 12448 | 35.0 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 450 mg QD | 17963 | 18.7 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 650 mg QD | 22102 | NA | Not reported | Not reported | Percent coefficient of variation could not be calculated due to small sample size |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 82.9
- value
- 4830
- group Id
- OG001
- spread
- 46.8
- value
- 9437
- group Id
- OG002
- spread
- 60.0
- value
- 9002
- comment
- Percent coefficient of variation could not be calculated due to small sample size
- group Id
- OG003
- spread
- NA
- value
- 13463
- group Id
- OG004
- spread
- 16.1
- value
- 20705
- group Id
- OG005
- spread
- 132.7
- value
- 6502
- group Id
- OG006
- spread
- 80.6
- value
- 3954
- group Id
- OG007
- spread
- 42.0
- value
- 9502
- group Id
- OG008
- spread
- 40.1
- value
- 13263
- group Id
- OG009
- spread
- 47.2
- value
- 14303
- group Id
- OG010
- spread
- 35.0
- value
- 12448
- group Id
- OG011
- spread
- 18.7
- value
- 17963
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 94
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 11
- group Id
- OG010
- value
- 7
- group Id
- OG011
- value
- 3
- units
- Participants
- description
- AGI-16903 is a primary metabolite of enasidenib. Plasma AGI-16903 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 10 hours post-dose (AUC0-10) 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, 8, and 10 hours post-dose.
- title
- Phase 1: AUC From Time Zero to 10 Hours Postdose (AUC0-10) of AGI-16903 After Multiple Oral Doses of Enasidenib
- type
- SECONDARY
- unit Of Measure
- ng*h/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice