TriangleNCT01625234 · OUTCOME
Plasma Tmax on Day 1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- hour
- Interval / dispersion
- Full Range
- Time frame
- 24 hours
What was measured
To characterize the preliminary pharmacokinetics including T max 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 | 3.2 | Not reported | 2.25 | 6.00 | Not reported |
| Phase II: X-396 (Ensartinib) at 225 mg (Fasted) | 3.2 | Not reported | 1.08 | 23.8 | Not reported |
| Phase I: X-396 (Ensartinib) at 50 mg | 2.0 | Not reported | 1.00 | 6.00 | Not reported |
| Phase I: X-396 (Ensartinib) at 100 mg | 3.0 | Not reported | 2.98 | 8.20 | Not reported |
| Phase I: X-396 (Ensartinib) at 200 mg (Fasted) | 3.5 | Not reported | 2.03 | 8.23 | Not reported |
| Phase I: X-396 (Ensartinib) at 250mg | 3.1 | Not reported | 1.00 | 7.17 | Not reported |
| Phase I: X-396 (Ensartinib) at 225mg | 6.0 | Not reported | 2.37 | 8.00 | Not reported |
| Phase II: X-396 (Ensartinib) at 225 mg (Fed) | 4.0 | Not reported | 1.03 | 24.0 | Not reported |
| Phase I: X-396 (Ensartinib) at 200 mg (Fed) | 4.0 | Not reported | 3.00 | 6.00 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.25
- upper Limit
- 6.00
- value
- 3.2
- group Id
- OG001
- lower Limit
- 1.08
- upper Limit
- 23.8
- value
- 3.2
- group Id
- OG002
- lower Limit
- 1.00
- upper Limit
- 6.00
- value
- 2.0
- group Id
- OG003
- lower Limit
- 2.98
- upper Limit
- 8.20
- value
- 3.0
- group Id
- OG004
- lower Limit
- 2.03
- upper Limit
- 8.23
- value
- 3.5
- group Id
- OG005
- lower Limit
- 1.00
- upper Limit
- 7.17
- value
- 3.1
- group Id
- OG006
- lower Limit
- 2.37
- upper Limit
- 8.00
- value
- 6.0
- group Id
- OG007
- lower Limit
- 1.03
- upper Limit
- 24.0
- value
- 4.0
- group Id
- OG008
- lower Limit
- 3.00
- upper Limit
- 6.00
- value
- 4.0
- 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 T max of X-396 given as a single agent
- dispersion Type
- Full Range
- 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
- MEDIAN
- reporting Status
- POSTED
- time Frame
- 24 hours
- title
- Plasma Tmax on Day 1
- type
- SECONDARY
- unit Of Measure
- hour
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice