TriangleNCT01915498 · OUTCOME
Phase 1: Minimum Percent Change From Baseline Response Value Post-dose Over 10 Hours (%BRmin) for 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. Minimum percent change from Baseline response value post-dose over 10 hours was calculated as: (minimum observed concentration post-dose over 10 hours \[Rmin\] - Baseline) / Baseline \* 100. 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 | 6 |
| Enasidenib 150 mg BID | 4 |
| Enasidenib 50 mg QD | 5 |
| Phase 1 Dose Escalation: Enasidenib 75 mg QD | 7 |
| Phase 1 Dose Escalation: Enasidenib 100 mg QD | 102 |
| Phase 1 Dose Escalation: Enasidenib 150 mg QD | 6 |
| Phase 1 Dose Escalation: Enasidenib 200 mg QD | 12 |
| 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
Cycle 1, Day 15
| Group | Source count |
|---|---|
| Enasidenib 30 mg BID | 6 |
| Enasidenib 50 mg BID | 7 |
| Enasidenib 75 mg BID | 6 |
| Enasidenib 100 mg BID | 6 |
| Enasidenib 150 mg BID | 4 |
| Enasidenib 50 mg QD | 5 |
| Phase 1 Dose Escalation: Enasidenib 75 mg QD | 7 |
| Phase 1 Dose Escalation: Enasidenib 100 mg QD | 81 |
| Phase 1 Dose Escalation: Enasidenib 150 mg QD | 6 |
| Phase 1 Dose Escalation: Enasidenib 200 mg QD | 12 |
| Phase 1 Dose Escalation: Enasidenib 300 mg QD | 4 |
| 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 | -69.0 | 42.0 | Not reported | Not reported | Not reported |
| Enasidenib 50 mg BID | -76.5 | 56.4 | Not reported | Not reported | Not reported |
| Enasidenib 75 mg BID | -89.2 | 18.9 | Not reported | Not reported | Not reported |
| Enasidenib 100 mg BID | -88.6 | 12.3 | Not reported | Not reported | Not reported |
| Enasidenib 150 mg BID | -81.4 | 11.6 | Not reported | Not reported | Not reported |
| Enasidenib 50 mg QD | -63.3 | 40.7 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 75 mg QD | -79.3 | 22.0 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 100 mg QD | -71.0 | 57.1 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 150 mg QD | -80.4 | 45.7 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 200 mg QD | -86.0 | 25.3 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 300 mg QD | -91.2 | 4.0 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 450 mg QD | -71.3 | 31.5 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 650 mg QD | -23.1 | 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 | 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 | 8 |
| 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 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enasidenib 30 mg BID | -54.8 | 94.7 | Not reported | Not reported | Not reported |
| Enasidenib 50 mg BID | -54.5 | 192.9 | Not reported | Not reported | Not reported |
| Enasidenib 75 mg BID | -68.9 | 63.3 | Not reported | Not reported | Not reported |
| Enasidenib 100 mg BID | -89.5 | 12.5 | Not reported | Not reported | Not reported |
| Enasidenib 150 mg BID | -80.7 | 14.5 | Not reported | Not reported | Not reported |
| Enasidenib 50 mg QD | -84.8 | 18.5 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 75 mg QD | -70.6 | 61.8 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 100 mg QD | -65.6 | 94.7 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 150 mg QD | -47.2 | 224.0 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 200 mg QD | -35.6 | 422.0 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 300 mg QD | -89.8 | 8.0 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 450 mg QD | -60.6 | 83.8 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation: Enasidenib 650 mg QD | -53.5 | 120.5 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 42.0
- value
- -69.0
- group Id
- OG001
- spread
- 56.4
- value
- -76.5
- group Id
- OG002
- spread
- 18.9
- value
- -89.2
- group Id
- OG003
- spread
- 12.3
- value
- -88.6
- group Id
- OG004
- spread
- 11.6
- value
- -81.4
- group Id
- OG005
- spread
- 40.7
- value
- -63.3
- group Id
- OG006
- spread
- 22.0
- value
- -79.3
- group Id
- OG007
- spread
- 57.1
- value
- -71.0
- group Id
- OG008
- spread
- 45.7
- value
- -80.4
- group Id
- OG009
- spread
- 25.3
- value
- -86.0
- group Id
- OG010
- spread
- 4.0
- value
- -91.2
- group Id
- OG011
- spread
- 31.5
- value
- -71.3
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 7
- group Id
- OG007
- value
- 81
- group Id
- OG008
- value
- 6
- group Id
- OG009
- value
- 12
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 4
- units
- Participants
- title
- Cycle 1, Day 15
- categories
- measurements
- group Id
- OG000
- spread
- 94.7
- value
- -54.8
- group Id
- OG001
- spread
- 192.9
- value
- -54.5
- group Id
- OG002
- spread
- 63.3
- value
- -68.9
- group Id
- OG003
- spread
- 12.5
- value
- -89.5
- group Id
- OG004
- spread
- 14.5
- value
- -80.7
- group Id
- OG005
- spread
- 18.5
- value
- -84.8
- group Id
- OG006
- spread
- 61.8
- value
- -70.6
- group Id
- OG007
- spread
- 94.7
- value
- -65.6
- group Id
- OG008
- spread
- 224.0
- value
- -47.2
- group Id
- OG009
- spread
- 422.0
- value
- -35.6
- group Id
- OG010
- spread
- 8.0
- value
- -89.8
- group Id
- OG011
- spread
- 83.8
- value
- -60.6
- 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
- 5
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 102
- group Id
- OG008
- value
- 5
- group Id
- OG009
- value
- 8
- group Id
- OG010
- value
- 7
- group Id
- OG011
- value
- 5
- 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
- 6
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 7
- group Id
- OG007
- value
- 102
- group Id
- OG008
- value
- 6
- group Id
- OG009
- value
- 12
- group Id
- OG010
- value
- 7
- group Id
- OG011
- value
- 5
- units
- Participants
- description
- Plasma 2-HG was measured using qualified LC-MS/MS, the LLOQ was 30.0 ng/mL. Minimum percent change from Baseline response value post-dose over 10 hours was calculated as: (minimum observed concentration post-dose over 10 hours \[Rmin\] - Baseline) / Baseline \* 100. 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: Minimum Percent Change From Baseline Response Value Post-dose Over 10 Hours (%BRmin) for 2-HG After Multiple Oral Doses of Enasidenib
- type
- SECONDARY
- unit Of Measure
- percent change
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice