TriangleNCT01915498 · OUTCOME
Phase 1 and 2: Maximum Concentration (Cmax) After Single and Multiple Oral Doses of Enasidenib 100 mg QD
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ng/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Day -3 (Phase 1 only) predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 24, 48, and 72 hours post-dose or Cycle 1 Day 1 (Phase 2) and Cycle 2 Day 1 (Phase 1 & 2) at predose and 2, 4, 6, 8, and 24 hours post-dose.
What was measured
The first 3 participants enrolled in each cohort of the dose escalation phase and the first 15 participants enrolled in each arm of Phase 1 Expansion received a single dose of enasidenib three days prior to starting the 28-day dosing regimen (Day -3) for single dose PK analysis, and underwent PK assessments on Cycle 2, Day 1 for multiple dose (steady-state) PK analysis. Participants in Phase 2 underwent PK assessments on Cycle 1, Day 1 for single dose analysis and on Cycle 2, Day 1 for multiple dose (steady-state) analysis. 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.
Analysis population: Participants who received enasidenib on Day -3 or Cycle 1, Day 1 and Cycle 2, Day 1 with sufficient data to determine PK parameters. Participants who took \< 80% of their planned continuous dosing regimen were excluded from the analysis of Cycle 2, Day 1. Participants in Phase 1 and 2 who received enasidenib 100 mg QD are combined for the analysis.
Groups in this outcome
Phase 1 and 2: Enasidenib 100 mg QD
Participants in Phase 1 and 2 who received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
| Group | Source count |
|---|---|
| Phase 1 and 2: Enasidenib 100 mg QD | 176 |
Reported measurements
Day -3 / Cycle 1, Day 1
| Group | Source count |
|---|---|
| Phase 1 and 2: Enasidenib 100 mg QD | 150 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 and 2: Enasidenib 100 mg QD | 1423 | 50.2 | Not reported | Not reported | Not reported |
Cycle 2, Day 1
| Group | Source count |
|---|---|
| Phase 1 and 2: Enasidenib 100 mg QD | 176 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 and 2: Enasidenib 100 mg QD | 13057 | 44.8 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 50.2
- value
- 1423
- denoms
- counts
- group Id
- OG000
- value
- 150
- units
- Participants
- title
- Day -3 / Cycle 1, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 44.8
- value
- 13057
- denoms
- counts
- group Id
- OG000
- value
- 176
- units
- Participants
- title
- Cycle 2, Day 1
- denoms
- counts
- group Id
- OG000
- value
- 176
- units
- Participants
- description
- The first 3 participants enrolled in each cohort of the dose escalation phase and the first 15 participants enrolled in each arm of Phase 1 Expansion received a single dose of enasidenib three days prior to starting the 28-day dosing regimen (Day -3) for single dose PK analysis, and underwent PK assessments on Cycle 2, Day 1 for multiple dose (steady-state) PK analysis. Participants in Phase 2 underwent PK assessments on Cycle 1, Day 1 for single dose analysis and on Cycle 2, Day 1 for multiple dose (steady-state) analysis. 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.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants in Phase 1 and 2 who received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
- id
- OG000
- title
- Phase 1 and 2: Enasidenib 100 mg QD
- param Type
- GEOMETRIC_MEAN
- population Description
- Participants who received enasidenib on Day -3 or Cycle 1, Day 1 and Cycle 2, Day 1 with sufficient data to determine PK parameters. Participants who took \< 80% of their planned continuous dosing regimen were excluded from the analysis of Cycle 2, Day 1. Participants in Phase 1 and 2 who received enasidenib 100 mg QD are combined for the analysis.
- reporting Status
- POSTED
- time Frame
- Day -3 (Phase 1 only) predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 24, 48, and 72 hours post-dose or Cycle 1 Day 1 (Phase 2) and Cycle 2 Day 1 (Phase 1 & 2) at predose and 2, 4, 6, 8, and 24 hours post-dose.
- title
- Phase 1 and 2: Maximum Concentration (Cmax) After Single and Multiple Oral Doses of Enasidenib 100 mg QD
- type
- SECONDARY
- unit Of Measure
- ng/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice