NCT01742286 · OUTCOME
Plasma Concentration Time Profiles by Treatment Group in Expansion Phase
Phase I Study of LDK378 in Pediatric, Malignancies With a Genetic Alteration in Anaplastic Lymphoma Kinase (ALK) · Source last updated 2020-06-09
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
- 0hr pre-dose Cycle 1 Day 1, cycle 1 Day 15; 0hr pre-dose, 2hrs post-dose, 4hrs post-dose, 6hrs post-dose & 24hrs post-dose in Cycle2 Day1; 0hr pre-dose in Cycle2 Day2, Cycle 3 Day 1 & Cycle 4 Day 1
What was measured
Characterize single and multiple-dose PK of LDK378 in pediatric patients. Only PK plasma concentrations with non-missing sampling date and time, and for which the last dose date and time prior to the PK sample draw are non-missing, were included in the PK analysis.
Analysis population: The PK analysis set (PAS) consisted of all patients who received at least one dose of ceritinib and had at least one evaluable PK sample.
Groups in this outcome
Fasted: Ceritinib 300 mg/m2
Participants in the fasted group who took 300 mg of ceritinib
Fasted: Ceritinib 450 mg/m2
Participants in the fasted group who took 450 mg of ceritinib
Fasted: Ceritinib 510 mg/m2
Participants in the fasted group who took 510 mg of ceritinib
Fasted: Ceritinib 560 mg/m2
Participants in the fasted group who took 560 mg of ceritinib
Fed: Ceritinib 320 mg/m2
Participants in the fed group who took 320 mg of ceritinib
Fed: Ceritinib 400 mg/m2
Participants in the fed group who took 400 mg of ceritinib
Fed: Ceritinib 500 mg/m2
Participants in the fed group who took 500 mg of ceritinib
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Fasted: Ceritinib 300 mg/m2 | 0 |
|---|
| Fasted: Ceritinib 450 mg/m2 | 0 |
|---|
| Fasted: Ceritinib 510 mg/m2 | 7 |
|---|
| Fasted: Ceritinib 560 mg/m2 | 0 |
|---|
| Fed: Ceritinib 320 mg/m2 | 0 |
|---|
| Fed: Ceritinib 400 mg/m2 | 0 |
|---|
| Fed: Ceritinib 500 mg/m2 | 16 |
|---|
Reported measurements
C1D1 0 hr pre-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Fasted: Ceritinib 300 mg/m2 | 0 |
|---|
| Fasted: Ceritinib 450 mg/m2 | 0 |
|---|
| Fasted: Ceritinib 510 mg/m2 | 6 |
|---|
| Fasted: Ceritinib 560 mg/m2 | 0 |
|---|
| Fed: Ceritinib 320 mg/m2 | 0 |
|---|
| Fed: Ceritinib 400 mg/m2 | 0 |
|---|
| Fed: Ceritinib 500 mg/m2 | 9 |
|---|
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Fasted: Ceritinib 510 mg/m2 | 0.0 | 0.0 | Not reported | Not reported | Not reported |
|---|
| Fed: Ceritinib 500 mg/m2 | 0.0 | 0.0 | Not reported | Not reported | Not reported |
|---|
C1D15 0 hr post-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Fasted: Ceritinib 300 mg/m2 | 0 |
|---|
| Fasted: Ceritinib 450 mg/m2 | 0 |
|---|
| Fasted: Ceritinib 510 mg/m2 | 1 |
|---|
| Fasted: Ceritinib 560 mg/m2 | 0 |
|---|
| Fed: Ceritinib 320 mg/m2 | 0 |
|---|
| Fed: Ceritinib 400 mg/m2 | 0 |
|---|
| Fed: Ceritinib 500 mg/m2 | 0 |
|---|
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Fasted: Ceritinib 510 mg/m2 | 1190 | 0.0 | Not reported | Not reported | Not reported |
|---|
C2D1 0 hr pre-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Fasted: Ceritinib 300 mg/m2 | 0 |
|---|
| Fasted: Ceritinib 450 mg/m2 | 0 |
|---|
| Fasted: Ceritinib 510 mg/m2 | 7 |
|---|
| Fasted: Ceritinib 560 mg/m2 | 0 |
|---|
| Fed: Ceritinib 320 mg/m2 | 0 |
|---|
| Fed: Ceritinib 400 mg/m2 | 0 |
|---|
| Fed: Ceritinib 500 mg/m2 | 16 |
|---|
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Fasted: Ceritinib 510 mg/m2 | 529 | 365.4 | Not reported | Not reported | Not reported |
|---|
| Fed: Ceritinib 500 mg/m2 | 627 | 93.6 | Not reported | Not reported | Not reported |
|---|
C2D1 2 hrs post-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Fasted: Ceritinib 300 mg/m2 | 0 |
|---|
| Fasted: Ceritinib 450 mg/m2 | 0 |
|---|
| Fasted: Ceritinib 510 mg/m2 | 7 |
|---|
| Fasted: Ceritinib 560 mg/m2 | 0 |
|---|
| Fed: Ceritinib 320 mg/m2 | 0 |
|---|
| Fed: Ceritinib 400 mg/m2 | 0 |
|---|
| Fed: Ceritinib 500 mg/m2 | 15 |
|---|
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Fasted: Ceritinib 510 mg/m2 | 798 | 69.0 | Not reported | Not reported | Not reported |
|---|
| Fed: Ceritinib 500 mg/m2 | 729 | 72.3 | Not reported | Not reported | Not reported |
|---|
C2D1 4 hrs post-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Fasted: Ceritinib 300 mg/m2 | 0 |
|---|
| Fasted: Ceritinib 450 mg/m2 | 0 |
|---|
| Fasted: Ceritinib 510 mg/m2 | 7 |
|---|
| Fasted: Ceritinib 560 mg/m2 | 0 |
|---|
| Fed: Ceritinib 320 mg/m2 | 0 |
|---|
| Fed: Ceritinib 400 mg/m2 | 0 |
|---|
| Fed: Ceritinib 500 mg/m2 | 14 |
|---|
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Fasted: Ceritinib 510 mg/m2 | 863 | 65.2 | Not reported | Not reported | Not reported |
|---|
| Fed: Ceritinib 500 mg/m2 | 828 | 47.9 | Not reported | Not reported | Not reported |
|---|
C2D1 6 hrs post-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Fasted: Ceritinib 300 mg/m2 | 0 |
|---|
| Fasted: Ceritinib 450 mg/m2 | 0 |
|---|
| Fasted: Ceritinib 510 mg/m2 | 7 |
|---|
| Fasted: Ceritinib 560 mg/m2 | 0 |
|---|
| Fed: Ceritinib 320 mg/m2 | 0 |
|---|
| Fed: Ceritinib 400 mg/m2 | 0 |
|---|
| Fed: Ceritinib 500 mg/m2 | 15 |
|---|
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Fasted: Ceritinib 510 mg/m2 | 939 | 71.4 | Not reported | Not reported | Not reported |
|---|
| Fed: Ceritinib 500 mg/m2 | 870 | 52.6 | Not reported | Not reported | Not reported |
|---|
C2D1 24 hrs post-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Fasted: Ceritinib 300 mg/m2 | 0 |
|---|
| Fasted: Ceritinib 450 mg/m2 | 0 |
|---|
| Fasted: Ceritinib 510 mg/m2 | 6 |
|---|
| Fasted: Ceritinib 560 mg/m2 | 0 |
|---|
| Fed: Ceritinib 320 mg/m2 | 0 |
|---|
| Fed: Ceritinib 400 mg/m2 | 0 |
|---|
| Fed: Ceritinib 500 mg/m2 | 14 |
|---|
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Fasted: Ceritinib 510 mg/m2 | 615 | 119.9 | Not reported | Not reported | Not reported |
|---|
| Fed: Ceritinib 500 mg/m2 | 596 | 75.5 | Not reported | Not reported | Not reported |
|---|
C2D2 0 hr pre-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Fasted: Ceritinib 300 mg/m2 | 0 |
|---|
| Fasted: Ceritinib 450 mg/m2 | 0 |
|---|
| Fasted: Ceritinib 510 mg/m2 | 6 |
|---|
| Fasted: Ceritinib 560 mg/m2 | 0 |
|---|
| Fed: Ceritinib 320 mg/m2 | 0 |
|---|
| Fed: Ceritinib 400 mg/m2 | 0 |
|---|
| Fed: Ceritinib 500 mg/m2 | 14 |
|---|
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Fasted: Ceritinib 510 mg/m2 | 615 | 119.9 | Not reported | Not reported | Not reported |
|---|
| Fed: Ceritinib 500 mg/m2 | 596 | 75.5 | Not reported | Not reported | Not reported |
|---|
C3D1 0 hr pre-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Fasted: Ceritinib 300 mg/m2 | 0 |
|---|
| Fasted: Ceritinib 450 mg/m2 | 0 |
|---|
| Fasted: Ceritinib 510 mg/m2 | 5 |
|---|
| Fasted: Ceritinib 560 mg/m2 | 0 |
|---|
| Fed: Ceritinib 320 mg/m2 | 0 |
|---|
| Fed: Ceritinib 400 mg/m2 | 0 |
|---|
| Fed: Ceritinib 500 mg/m2 | 14 |
|---|
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Fasted: Ceritinib 510 mg/m2 | 836 | 60.4 | Not reported | Not reported | Not reported |
|---|
| Fed: Ceritinib 500 mg/m2 | 573 | 134.2 | Not reported | Not reported | Not reported |
|---|
C4D1 0 hr pre-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Fasted: Ceritinib 300 mg/m2 | 0 |
|---|
| Fasted: Ceritinib 450 mg/m2 | 0 |
|---|
| Fasted: Ceritinib 510 mg/m2 | 5 |
|---|
| Fasted: Ceritinib 560 mg/m2 | 0 |
|---|
| Fed: Ceritinib 320 mg/m2 | 0 |
|---|
| Fed: Ceritinib 400 mg/m2 | 0 |
|---|
| Fed: Ceritinib 500 mg/m2 | 12 |
|---|
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Fasted: Ceritinib 510 mg/m2 | 834 | 78.8 | Not reported | Not reported | Not reported |
|---|
| Fed: Ceritinib 500 mg/m2 | 622 | 96.5 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG002
- spread
- 0.0
- value
- 0.0
- group Id
- OG006
- spread
- 0.0
- value
- 0.0
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 9
- units
- Participants
- title
- C1D1 0 hr pre-dose
- categories
- measurements
- group Id
- OG002
- spread
- 0.0
- value
- 1190
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- units
- Participants
- title
- C1D15 0 hr post-dose
- categories
- measurements
- group Id
- OG002
- spread
- 365.4
- value
- 529
- group Id
- OG006
- spread
- 93.6
- value
- 627
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 16
- units
- Participants
- title
- C2D1 0 hr pre-dose
- categories
- measurements
- group Id
- OG002
- spread
- 69.0
- value
- 798
- group Id
- OG006
- spread
- 72.3
- value
- 729
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 15
- units
- Participants
- title
- C2D1 2 hrs post-dose
- categories
- measurements
- group Id
- OG002
- spread
- 65.2
- value
- 863
- group Id
- OG006
- spread
- 47.9
- value
- 828
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 14
- units
- Participants
- title
- C2D1 4 hrs post-dose
- categories
- measurements
- group Id
- OG002
- spread
- 71.4
- value
- 939
- group Id
- OG006
- spread
- 52.6
- value
- 870
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 15
- units
- Participants
- title
- C2D1 6 hrs post-dose
- categories
- measurements
- group Id
- OG002
- spread
- 119.9
- value
- 615
- group Id
- OG006
- spread
- 75.5
- value
- 596
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 14
- units
- Participants
- title
- C2D1 24 hrs post-dose
- categories
- measurements
- group Id
- OG002
- spread
- 119.9
- value
- 615
- group Id
- OG006
- spread
- 75.5
- value
- 596
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 14
- units
- Participants
- title
- C2D2 0 hr pre-dose
- categories
- measurements
- group Id
- OG002
- spread
- 60.4
- value
- 836
- group Id
- OG006
- spread
- 134.2
- value
- 573
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 14
- units
- Participants
- title
- C3D1 0 hr pre-dose
- categories
- measurements
- group Id
- OG002
- spread
- 78.8
- value
- 834
- group Id
- OG006
- spread
- 96.5
- value
- 622
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 12
- units
- Participants
- title
- C4D1 0 hr pre-dose
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 16
- units
- Participants
- description
- Characterize single and multiple-dose PK of LDK378 in pediatric patients. Only PK plasma concentrations with non-missing sampling date and time, and for which the last dose date and time prior to the PK sample draw are non-missing, were included in the PK analysis.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants in the fasted group who took 300 mg of ceritinib
- id
- OG000
- title
- Fasted: Ceritinib 300 mg/m2
- description
- Participants in the fasted group who took 450 mg of ceritinib
- id
- OG001
- title
- Fasted: Ceritinib 450 mg/m2
- description
- Participants in the fasted group who took 510 mg of ceritinib
- id
- OG002
- title
- Fasted: Ceritinib 510 mg/m2
- description
- Participants in the fasted group who took 560 mg of ceritinib
- id
- OG003
- title
- Fasted: Ceritinib 560 mg/m2
- description
- Participants in the fed group who took 320 mg of ceritinib
- id
- OG004
- title
- Fed: Ceritinib 320 mg/m2
- description
- Participants in the fed group who took 400 mg of ceritinib
- id
- OG005
- title
- Fed: Ceritinib 400 mg/m2
- description
- Participants in the fed group who took 500 mg of ceritinib
- id
- OG006
- title
- Fed: Ceritinib 500 mg/m2
- param Type
- GEOMETRIC_MEAN
- population Description
- The PK analysis set (PAS) consisted of all patients who received at least one dose of ceritinib and had at least one evaluable PK sample.
- reporting Status
- POSTED
- time Frame
- 0hr pre-dose Cycle 1 Day 1, cycle 1 Day 15; 0hr pre-dose, 2hrs post-dose, 4hrs post-dose, 6hrs post-dose & 24hrs post-dose in Cycle2 Day1; 0hr pre-dose in Cycle2 Day2, Cycle 3 Day 1 & Cycle 4 Day 1
- title
- Plasma Concentration Time Profiles by Treatment Group in Expansion Phase
- type
- SECONDARY
- unit Of Measure
- ng/mL
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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