TriangleNCT01915498 · OUTCOME
Phase 1: Percent Change From Baseline for Area Under the Effect Concentration Time Curve From Time 0 to 10 Hours Postdose of 2-HG 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
- MEAN
- Unit
- percent change
- Interval / dispersion
- Standard Deviation
- Time frame
- Cycle 1, Day 15 and Cycle 2, Day 1 at predose and 0.5, 1, 2, 3, 4, 6, 8, and 10 hours post-dose.
What was measured
Plasma 2-HG was measured using qualified LC-MS/MS, the LLOQ was 30.0 ng/mL. Area under the effect concentration time curve from time point zero (predose) up to 10 hours postdose (AUEC0-10) was calculated using the linear trapezoid rule. Percent change from baseline for AUEC0-10 was calculated as: (AUEC0-10 minus \[Baseline\*Tlast\]) / (Baseline\*Tlast) \* 100, where Tlast corresponded to 10 hours and Baseline was equal to the average of the Screening and Day -3 (predose) 2-HG values. Data reported are the arithmetic mean and relative standard deviation expressed as a percentage.
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 | 6 |
| Enasidenib 50 mg BID | 7 |
| Enasidenib 75 mg BID | 6 |
| Enasidenib 100 mg BID | 5 |
| Enasidenib 150 mg BID | 4 |
| Enasidenib 50 mg QD | 5 |
| Phase 1 Dose Escalation: Enasidenib 75 mg QD | 6 |
| Phase 1 Dose Escalation: Enasidenib 100 mg QD | 89 |
| Phase 1 Dose Escalation: Enasidenib 150 mg QD | 5 |
| Phase 1 Dose Escalation: Enasidenib 200 mg QD | 10 |
| Phase 1 Dose Escalation: Enasidenib 300 mg QD | 7 |
| Phase 1 Dose Escalation: Enasidenib 450 mg QD | 4 |
| Phase 1 Dose Escalation: Enasidenib 650 mg QD | 2 |
Reported measurements
Cycle 1, Day 15
| Group | Source count |
|---|---|
| Enasidenib 30 mg BID | 6 |
| Enasidenib 50 mg BID | 5 |
| Enasidenib 75 mg BID | 6 |
| Enasidenib 100 mg BID | 5 |
| Enasidenib 150 mg BID | 4 |
| Enasidenib 50 mg QD | 5 |
| Phase 1 Dose Escalation: Enasidenib 75 mg QD | 6 |
| Phase 1 Dose Escalation: Enasidenib 100 mg QD | 77 |
| Phase 1 Dose Escalation: Enasidenib 150 mg QD | 5 |
| Phase 1 Dose Escalation: Enasidenib 200 mg QD | 10 |
| Phase 1 Dose Escalation: Enasidenib 300 mg QD | 3 |
| Phase 1 Dose Escalation: Enasidenib 450 mg QD | 4 |
| Phase 1 Dose Escalation: Enasidenib 650 mg QD | 1 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enasidenib 30 mg BID | -62.18 | 48.9 | Not reported | Not reported | Not reported |
| Enasidenib 50 mg BID | -62.60 | 113.1 | Not reported | Not reported | Not reported |
| Enasidenib 75 mg BID | -87.19 | 21.4 | Not reported | Not reported | Not reported |
| Enasidenib 100 mg BID | -84.24 | 14.2 | Not reported | Not reported | Not reported |
| Enasidenib 150 mg BID | -79.40 | 13.7 | Not reported | Not reported | Not reported |
| Enasidenib 50 mg QD | -58.76 | 44.9 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 75 mg QD | -69.00 | 38.8 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 100 mg QD | -64.23 | 80.3 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 150 mg QD | -71.67 | 72.6 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 200 mg QD | -79.34 | 34.1 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 300 mg QD | -87.74 | 5.7 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 450 mg QD | -62.89 | 48.8 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 650 mg QD | 2.54 | NA | Not reported | Not reported | Could not be calculated for N = 1 |
Cycle 2, Day 1
| Group | Source count |
|---|---|
| Enasidenib 30 mg BID | 4 |
| Enasidenib 50 mg BID | 7 |
| Enasidenib 75 mg BID | 5 |
| Enasidenib 100 mg BID | 3 |
| 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 | 89 |
| Phase 1 Dose Escalation: Enasidenib 150 mg QD | 5 |
| Phase 1 Dose Escalation: Enasidenib 200 mg QD | 8 |
| Phase 1 Dose Escalation: Enasidenib 300 mg QD | 7 |
| Phase 1 Dose Escalation: Enasidenib 450 mg QD | 4 |
| Phase 1 Dose Escalation: Enasidenib 650 mg QD | 2 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enasidenib 30 mg BID | -49.01 | 115.4 | Not reported | Not reported | Not reported |
| Enasidenib 50 mg BID | -35.49 | 430.9 | Not reported | Not reported | Not reported |
| Enasidenib 75 mg BID | -64.63 | 74.7 | Not reported | Not reported | Not reported |
| Enasidenib 100 mg BID | -83.93 | 19.0 | Not reported | Not reported | Not reported |
| Enasidenib 150 mg BID | -78.07 | 17.2 | Not reported | Not reported | Not reported |
| Enasidenib 50 mg QD | -81.51 | 25.9 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 75 mg QD | -66.41 | 70.5 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 100 mg QD | -53.46 | 190.7 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 150 mg QD | -37.70 | 317.5 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 200 mg QD | -27.70 | 599.5 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 300 mg QD | -87.88 | 9.4 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 450 mg QD | -76.98 | 40.2 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 650 mg QD | -82.28 | 24.9 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 48.9
- value
- -62.18
- group Id
- OG001
- spread
- 113.1
- value
- -62.60
- group Id
- OG002
- spread
- 21.4
- value
- -87.19
- group Id
- OG003
- spread
- 14.2
- value
- -84.24
- group Id
- OG004
- spread
- 13.7
- value
- -79.40
- group Id
- OG005
- spread
- 44.9
- value
- -58.76
- group Id
- OG006
- spread
- 38.8
- value
- -69.00
- group Id
- OG007
- spread
- 80.3
- value
- -64.23
- group Id
- OG008
- spread
- 72.6
- value
- -71.67
- group Id
- OG009
- spread
- 34.1
- value
- -79.34
- group Id
- OG010
- spread
- 5.7
- value
- -87.74
- group Id
- OG011
- spread
- 48.8
- value
- -62.89
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 6
- group Id
- OG007
- value
- 77
- group Id
- OG008
- value
- 5
- group Id
- OG009
- value
- 10
- group Id
- OG010
- value
- 3
- group Id
- OG011
- value
- 4
- units
- Participants
- title
- Cycle 1, Day 15
- categories
- measurements
- group Id
- OG000
- spread
- 115.4
- value
- -49.01
- group Id
- OG001
- spread
- 430.9
- value
- -35.49
- group Id
- OG002
- spread
- 74.7
- value
- -64.63
- group Id
- OG003
- spread
- 19.0
- value
- -83.93
- group Id
- OG004
- spread
- 17.2
- value
- -78.07
- group Id
- OG005
- spread
- 25.9
- value
- -81.51
- group Id
- OG006
- spread
- 70.5
- value
- -66.41
- group Id
- OG007
- spread
- 190.7
- value
- -53.46
- group Id
- OG008
- spread
- 317.5
- value
- -37.70
- group Id
- OG009
- spread
- 599.5
- value
- -27.70
- group Id
- OG010
- spread
- 9.4
- value
- -87.88
- group Id
- OG011
- spread
- 40.2
- value
- -76.98
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 89
- group Id
- OG008
- value
- 5
- group Id
- OG009
- value
- 8
- group Id
- OG010
- value
- 7
- group Id
- OG011
- value
- 4
- units
- Participants
- title
- Cycle 2, Day 1
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 6
- group Id
- OG007
- value
- 89
- group Id
- OG008
- value
- 5
- group Id
- OG009
- value
- 10
- group Id
- OG010
- value
- 7
- group Id
- OG011
- value
- 4
- units
- Participants
- description
- Plasma 2-HG was measured using qualified LC-MS/MS, the LLOQ was 30.0 ng/mL. Area under the effect concentration time curve from time point zero (predose) up to 10 hours postdose (AUEC0-10) was calculated using the linear trapezoid rule. Percent change from baseline for AUEC0-10 was calculated as: (AUEC0-10 minus \[Baseline\*Tlast\]) / (Baseline\*Tlast) \* 100, where Tlast corresponded to 10 hours and Baseline was equal to the average of the Screening and Day -3 (predose) 2-HG values. Data reported are the arithmetic mean and relative standard deviation expressed as a percentage.
- dispersion Type
- Standard Deviation
- 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
- 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 1, Day 15 and Cycle 2, Day 1 at predose and 0.5, 1, 2, 3, 4, 6, 8, and 10 hours post-dose.
- title
- Phase 1: Percent Change From Baseline for Area Under the Effect Concentration Time Curve From Time 0 to 10 Hours Postdose of 2-HG After Multiple Oral Doses of Enasidenib
- type
- SECONDARY
- unit Of Measure
- percent change
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Preserved source evidence · Not medical advice