TriangleNCT01625234 · OUTCOME
Plasma Concentrations AUC on Day 1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- h·ng/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- 0, 0.5h, 1.0h , 2.0 h, 4.0h, 6.0h, 8.0h, 24.0h,
What was measured
To characterize the preliminary pharmacokinetics including AUC of X-396 given as a single agent
Groups in this outcome
Phase I: X-396 (Ensartinib) at 25mg
Dose escalation starting at 25 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor
Phase II: X-396 (Ensartinib) at 225 mg (Fasted)
RP2D 225 mg (fasted) For the expanded cohort portion of the study, patients must have NSCLC with ALK genomic alterations. Phase II: X-396 (ensartinib): Expanded Cohort
Phase I: X-396 (Ensartinib) at 50 mg
Dose escalation starting at 50 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor
Phase I: X-396 (Ensartinib) at 100 mg
Dose escalation starting at 100 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor
Phase I: X-396 (Ensartinib) at 200 mg (Fasted)
Dose escalation starting at 200 mg (fasted), oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor
Phase I: X-396 (Ensartinib) at 250mg
Dose escalation starting at 250 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor
Phase I: X-396 (Ensartinib) at 225mg
Dose escalation starting at 225 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor
Phase II: X-396 (Ensartinib) at 225 mg (Fed)
RP2D 225 mg (fed) For the expanded cohort portion of the study, patients must have NSCLC with ALK genomic alterations. Phase II: X-396 (ensartinib): Expanded Cohort
Phase I: X-396 (Ensartinib) at 200 mg (Fed)
Dose escalation starting at 200 mg (fed), oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor
| Group | Source count |
|---|---|
| Phase I: X-396 (Ensartinib) at 25mg | 4 |
| Phase II: X-396 (Ensartinib) at 225 mg (Fasted) | 18 |
| Phase I: X-396 (Ensartinib) at 50 mg | 3 |
| Phase I: X-396 (Ensartinib) at 100 mg | 5 |
| Phase I: X-396 (Ensartinib) at 200 mg (Fasted) | 8 |
| Phase I: X-396 (Ensartinib) at 250mg | 10 |
| Phase I: X-396 (Ensartinib) at 225mg | 3 |
| Phase II: X-396 (Ensartinib) at 225 mg (Fed) | 17 |
| Phase I: X-396 (Ensartinib) at 200 mg (Fed) | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I: X-396 (Ensartinib) at 25mg | 31 | 39.0 | Not reported | Not reported | Not reported |
| Phase II: X-396 (Ensartinib) at 225 mg (Fasted) | 756 | 43.3 | Not reported | Not reported | Not reported |
| Phase I: X-396 (Ensartinib) at 50 mg | 134 | 71.2 | Not reported | Not reported | Not reported |
| Phase I: X-396 (Ensartinib) at 100 mg | 250 | 84.1 | Not reported | Not reported | Not reported |
| Phase I: X-396 (Ensartinib) at 200 mg (Fasted) | 614 | 66.8 | Not reported | Not reported | Not reported |
| Phase I: X-396 (Ensartinib) at 250mg | 973 | 42.6 | Not reported | Not reported | Not reported |
| Phase I: X-396 (Ensartinib) at 225mg | 394 | 74.9 | Not reported | Not reported | Not reported |
| Phase II: X-396 (Ensartinib) at 225 mg (Fed) | 664 | 66.3 | Not reported | Not reported | Not reported |
| Phase I: X-396 (Ensartinib) at 200 mg (Fed) | 513 | 28.3 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 39.0
- value
- 31
- group Id
- OG001
- spread
- 43.3
- value
- 756
- group Id
- OG002
- spread
- 71.2
- value
- 134
- group Id
- OG003
- spread
- 84.1
- value
- 250
- group Id
- OG004
- spread
- 66.8
- value
- 614
- group Id
- OG005
- spread
- 42.6
- value
- 973
- group Id
- OG006
- spread
- 74.9
- value
- 394
- group Id
- OG007
- spread
- 66.3
- value
- 664
- group Id
- OG008
- spread
- 28.3
- value
- 513
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 18
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 8
- group Id
- OG005
- value
- 10
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 17
- group Id
- OG008
- value
- 3
- units
- Participants
- description
- To characterize the preliminary pharmacokinetics including AUC of X-396 given as a single agent
- dispersion Type
- Standard Deviation
- groups
- description
- Dose escalation starting at 25 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor
- id
- OG000
- title
- Phase I: X-396 (Ensartinib) at 25mg
- description
- RP2D 225 mg (fasted) For the expanded cohort portion of the study, patients must have NSCLC with ALK genomic alterations. Phase II: X-396 (ensartinib): Expanded Cohort
- id
- OG001
- title
- Phase II: X-396 (Ensartinib) at 225 mg (Fasted)
- description
- Dose escalation starting at 50 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor
- id
- OG002
- title
- Phase I: X-396 (Ensartinib) at 50 mg
- description
- Dose escalation starting at 100 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor
- id
- OG003
- title
- Phase I: X-396 (Ensartinib) at 100 mg
- description
- Dose escalation starting at 200 mg (fasted), oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor
- id
- OG004
- title
- Phase I: X-396 (Ensartinib) at 200 mg (Fasted)
- description
- Dose escalation starting at 250 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor
- id
- OG005
- title
- Phase I: X-396 (Ensartinib) at 250mg
- description
- Dose escalation starting at 225 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor
- id
- OG006
- title
- Phase I: X-396 (Ensartinib) at 225mg
- description
- RP2D 225 mg (fed) For the expanded cohort portion of the study, patients must have NSCLC with ALK genomic alterations. Phase II: X-396 (ensartinib): Expanded Cohort
- id
- OG007
- title
- Phase II: X-396 (Ensartinib) at 225 mg (Fed)
- description
- Dose escalation starting at 200 mg (fed), oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor
- id
- OG008
- title
- Phase I: X-396 (Ensartinib) at 200 mg (Fed)
- param Type
- GEOMETRIC_MEAN
- reporting Status
- POSTED
- time Frame
- 0, 0.5h, 1.0h , 2.0 h, 4.0h, 6.0h, 8.0h, 24.0h,
- title
- Plasma Concentrations AUC on Day 1
- type
- SECONDARY
- unit Of Measure
- h·ng/mL
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Preserved source evidence · Not medical advice