TriangleNCT01915498 · OUTCOME
Phase 1: Time of Minimum Observed Concentration Over 10 Hours Postdose (Tmin) 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
- MEDIAN
- Unit
- hours
- Interval / dispersion
- Full Range
- 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.
Analysis population: Participants who received enasidenib on Cycle 1, Day 15 or Cycle 2, Day 1 with sufficient data to determine PD 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 | 4.00 | Not reported | 2.15 | 10.00 | Not reported |
| Enasidenib 50 mg BID | 5.90 | Not reported | 1.00 | 10.00 | Not reported |
| Enasidenib 75 mg BID | 3.03 | Not reported | 0.50 | 10.00 | Not reported |
| Enasidenib 100 mg BID | 4.44 | Not reported | 1.10 | 10.00 | Not reported |
| Enasidenib 150 mg BID | 1.00 | Not reported | 0.50 | 2.00 | Not reported |
| Enasidenib 50 mg QD | 3.00 | Not reported | 0.50 | 6.05 | Not reported |
| Phase 1 Dose Escalation: Enasidenib 75 mg QD | 5.85 | Not reported | 0.42 | 10.00 | Not reported |
| Phase 1 Dose Escalation: Enasidenib 100 mg QD | 3.10 | Not reported | 0.35 | 10.00 | Not reported |
| Phase 1 Dose Escalation: Enasidenib 150 mg QD | 6.50 | Not reported | 1.00 | 10.02 | Not reported |
| Phase 1 Dose Escalation: Enasidenib 200 mg QD | 1.53 | Not reported | 0.50 | 8.00 | Not reported |
| Phase 1 Dose Escalation: Enasidenib 300 mg QD | 7.08 | Not reported | 3.00 | 10.00 | Not reported |
| Phase 1 Dose Escalation: Enasidenib 450 mg QD | 4.00 | Not reported | 0.50 | 8.07 | Not reported |
| Phase 1 Dose Escalation: Enasidenib 650 mg QD | 2.87 | Not reported | 2.87 | 2.87 | Not reported |
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 | 0.98 | Not reported | 0.42 | 4.00 | Not reported |
| Enasidenib 50 mg BID | 3.00 | Not reported | 1.00 | 10.00 | Not reported |
| Enasidenib 75 mg BID | 6.17 | Not reported | 2.00 | 8.08 | Not reported |
| Enasidenib 100 mg BID | 6.00 | Not reported | 0.97 | 6.00 | Not reported |
| Enasidenib 150 mg BID | 2.00 | Not reported | 0.50 | 9.97 | Not reported |
| Enasidenib 50 mg QD | 2.95 | Not reported | 0.48 | 10.08 | Not reported |
| Phase 1 Dose Escalation: Enasidenib 75 mg QD | 6.96 | Not reported | 2.00 | 10.02 | Not reported |
| Phase 1 Dose Escalation: Enasidenib 100 mg QD | 3.65 | Not reported | 0.30 | 10.32 | Not reported |
| Phase 1 Dose Escalation: Enasidenib 150 mg QD | 4.00 | Not reported | 0.97 | 10.03 | Not reported |
| Phase 1 Dose Escalation: Enasidenib 200 mg QD | 5.95 | Not reported | 1.00 | 7.93 | Not reported |
| Phase 1 Dose Escalation: Enasidenib 300 mg QD | 7.92 | Not reported | 0.98 | 9.87 | Not reported |
| Phase 1 Dose Escalation: Enasidenib 450 mg QD | 6.00 | Not reported | 1.00 | 9.83 | Not reported |
| Phase 1 Dose Escalation: Enasidenib 650 mg QD | 2.00 | Not reported | 0.53 | 4.00 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.15
- upper Limit
- 10.00
- value
- 4.00
- group Id
- OG001
- lower Limit
- 1.00
- upper Limit
- 10.00
- value
- 5.90
- group Id
- OG002
- lower Limit
- 0.50
- upper Limit
- 10.00
- value
- 3.03
- group Id
- OG003
- lower Limit
- 1.10
- upper Limit
- 10.00
- value
- 4.44
- group Id
- OG004
- lower Limit
- 0.50
- upper Limit
- 2.00
- value
- 1.00
- group Id
- OG005
- lower Limit
- 0.50
- upper Limit
- 6.05
- value
- 3.00
- group Id
- OG006
- lower Limit
- 0.42
- upper Limit
- 10.00
- value
- 5.85
- group Id
- OG007
- lower Limit
- 0.35
- upper Limit
- 10.00
- value
- 3.10
- group Id
- OG008
- lower Limit
- 1.00
- upper Limit
- 10.02
- value
- 6.50
- group Id
- OG009
- lower Limit
- 0.50
- upper Limit
- 8.00
- value
- 1.53
- group Id
- OG010
- lower Limit
- 3.00
- upper Limit
- 10.00
- value
- 7.08
- group Id
- OG011
- lower Limit
- 0.50
- upper Limit
- 8.07
- value
- 4.00
- 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
- lower Limit
- 0.42
- upper Limit
- 4.00
- value
- 0.98
- group Id
- OG001
- lower Limit
- 1.00
- upper Limit
- 10.00
- value
- 3.00
- group Id
- OG002
- lower Limit
- 2.00
- upper Limit
- 8.08
- value
- 6.17
- group Id
- OG003
- lower Limit
- 0.97
- upper Limit
- 6.00
- value
- 6.00
- group Id
- OG004
- lower Limit
- 0.50
- upper Limit
- 9.97
- value
- 2.00
- group Id
- OG005
- lower Limit
- 0.48
- upper Limit
- 10.08
- value
- 2.95
- group Id
- OG006
- lower Limit
- 2.00
- upper Limit
- 10.02
- value
- 6.96
- group Id
- OG007
- lower Limit
- 0.30
- upper Limit
- 10.32
- value
- 3.65
- group Id
- OG008
- lower Limit
- 0.97
- upper Limit
- 10.03
- value
- 4.00
- group Id
- OG009
- lower Limit
- 1.00
- upper Limit
- 7.93
- value
- 5.95
- group Id
- OG010
- lower Limit
- 0.98
- upper Limit
- 9.87
- value
- 7.92
- group Id
- OG011
- lower Limit
- 1.00
- upper Limit
- 9.83
- value
- 6.00
- 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.
- dispersion Type
- Full Range
- 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
- MEDIAN
- population Description
- Participants who received enasidenib on Cycle 1, Day 15 or Cycle 2, Day 1 with sufficient data to determine PD 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: Time of Minimum Observed Concentration Over 10 Hours Postdose (Tmin) of 2-HG After Multiple Oral Doses of Enasidenib
- type
- SECONDARY
- unit Of Measure
- hours
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice