TriangleNCT01625234 · OUTCOME
Plasma Concentrations Cmax for Day 1
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
- Standard Deviation
- Time frame
- 24 hours
What was measured
To characterize the preliminary pharmacokinetics including Cmax f X-396 given as a single agent
Analysis population: Histologically or cytologically confirmed diagnosis of advanced solid tumor malignancy that is not responsive to at least 1 prior standard regimen for advanced disease or for which there is no approved therapy or for patients that decline standard therapy.For Phase II of the study, patients must have NSCLC with ALK genomic alterations.
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 | 5 | 81.9 | Not reported | Not reported | Not reported |
| Phase II: X-396 (Ensartinib) at 225 mg (Fasted) | 136 | 40.0 | Not reported | Not reported | Not reported |
| Phase I: X-396 (Ensartinib) at 50 mg | 29 | 86.5 | Not reported | Not reported | Not reported |
| Phase I: X-396 (Ensartinib) at 100 mg | 53 | 57.7 | Not reported | Not reported | Not reported |
| Phase I: X-396 (Ensartinib) at 200 mg (Fasted) | 114 | 79.8 | Not reported | Not reported | Not reported |
| Phase I: X-396 (Ensartinib) at 250mg | 182 | 44.4 | Not reported | Not reported | Not reported |
| Phase I: X-396 (Ensartinib) at 225mg | 94 | 44.0 | Not reported | Not reported | Not reported |
| Phase II: X-396 (Ensartinib) at 225 mg (Fed) | 125 | 52.7 | Not reported | Not reported | Not reported |
| Phase I: X-396 (Ensartinib) at 200 mg (Fed) | 109 | 44.5 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 81.9
- value
- 5
- group Id
- OG001
- spread
- 40.0
- value
- 136
- group Id
- OG002
- spread
- 86.5
- value
- 29
- group Id
- OG003
- spread
- 57.7
- value
- 53
- group Id
- OG004
- spread
- 79.8
- value
- 114
- group Id
- OG005
- spread
- 44.4
- value
- 182
- group Id
- OG006
- spread
- 44.0
- value
- 94
- group Id
- OG007
- spread
- 52.7
- value
- 125
- group Id
- OG008
- spread
- 44.5
- value
- 109
- 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 Cmax f 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
- population Description
- Histologically or cytologically confirmed diagnosis of advanced solid tumor malignancy that is not responsive to at least 1 prior standard regimen for advanced disease or for which there is no approved therapy or for patients that decline standard therapy.For Phase II of the study, patients must have NSCLC with ALK genomic alterations.
- reporting Status
- POSTED
- time Frame
- 24 hours
- title
- Plasma Concentrations Cmax for Day 1
- type
- SECONDARY
- unit Of Measure
- ng/ml
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Preserved source evidence · Not medical advice