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NCT01742286 · OUTCOME

Plasma Concentration Time Profiles by Treatment Group in Escalation 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, 2hrs post-dose, 4hrs post-dose, 6hrs post-dose & 24hrs post-dose in Cycle1 Day1 & Cycle 2 day 1; 0hr pre-dose in Cycle 1 Day 15, Cycle 2 Day1, Cycle 2 Day 2, 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	5
Fasted: Ceritinib 450 mg/m2	12
Fasted: Ceritinib 510 mg/m2	6
Fasted: Ceritinib 560 mg/m2	2
Fed: Ceritinib 320 mg/m2	4
Fed: Ceritinib 400 mg/m2	5
Fed: Ceritinib 500 mg/m2	5

Reported measurements

Cycle1 Day1 (C1D1) 0 hr pre-dose

Analysis denominator · Participants

Group	Source count
Fasted: Ceritinib 300 mg/m2	5
Fasted: Ceritinib 450 mg/m2	12
Fasted: Ceritinib 510 mg/m2	6
Fasted: Ceritinib 560 mg/m2	2
Fed: Ceritinib 320 mg/m2	4
Fed: Ceritinib 400 mg/m2	5
Fed: Ceritinib 500 mg/m2	5

Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Fasted: Ceritinib 300 mg/m2	0.0	0.0	Not reported	Not reported	Not reported
Fasted: Ceritinib 450 mg/m2	0.0	0.0	Not reported	Not reported	Not reported
Fasted: Ceritinib 510 mg/m2	0.0	0.0	Not reported	Not reported	Not reported
Fasted: Ceritinib 560 mg/m2	0.0	0.0	Not reported	Not reported	Not reported
Fed: Ceritinib 320 mg/m2	0.0	0.0	Not reported	Not reported	Not reported
Fed: Ceritinib 400 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

C1D1 2 hrs post-dose

Analysis denominator · Participants

Group	Source count
Fasted: Ceritinib 300 mg/m2	5
Fasted: Ceritinib 450 mg/m2	11
Fasted: Ceritinib 510 mg/m2	6
Fasted: Ceritinib 560 mg/m2	2
Fed: Ceritinib 320 mg/m2	4
Fed: Ceritinib 400 mg/m2	5
Fed: Ceritinib 500 mg/m2	5

Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Fasted: Ceritinib 300 mg/m2	104	97.9	Not reported	Not reported	Not reported
Fasted: Ceritinib 450 mg/m2	99.0	94.7	Not reported	Not reported	Not reported
Fasted: Ceritinib 510 mg/m2	112	90.6	Not reported	Not reported	Not reported
Fasted: Ceritinib 560 mg/m2	126	0.6	Not reported	Not reported	Not reported
Fed: Ceritinib 320 mg/m2	52.4	138.1	Not reported	Not reported	Not reported
Fed: Ceritinib 400 mg/m2	197	58.3	Not reported	Not reported	Not reported
Fed: Ceritinib 500 mg/m2	72.5	82.3	Not reported	Not reported	Not reported

C1D1 4 hrs post-dose

Analysis denominator · Participants

Group	Source count
Fasted: Ceritinib 300 mg/m2	5
Fasted: Ceritinib 450 mg/m2	11
Fasted: Ceritinib 510 mg/m2	6
Fasted: Ceritinib 560 mg/m2	2
Fed: Ceritinib 320 mg/m2	4
Fed: Ceritinib 400 mg/m2	5
Fed: Ceritinib 500 mg/m2	5

Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Fasted: Ceritinib 300 mg/m2	216	39.6	Not reported	Not reported	Not reported
Fasted: Ceritinib 450 mg/m2	233	69.0	Not reported	Not reported	Not reported
Fasted: Ceritinib 510 mg/m2	250	93.5	Not reported	Not reported	Not reported
Fasted: Ceritinib 560 mg/m2	350	54.7	Not reported	Not reported	Not reported
Fed: Ceritinib 320 mg/m2	166	92.8	Not reported	Not reported	Not reported
Fed: Ceritinib 400 mg/m2	311	28.1	Not reported	Not reported	Not reported
Fed: Ceritinib 500 mg/m2	153	34.1	Not reported	Not reported	Not reported

C1D1 6 hrs post-dose

Analysis denominator · Participants

Group	Source count
Fasted: Ceritinib 300 mg/m2	5
Fasted: Ceritinib 450 mg/m2	11
Fasted: Ceritinib 510 mg/m2	6
Fasted: Ceritinib 560 mg/m2	2
Fed: Ceritinib 320 mg/m2	4
Fed: Ceritinib 400 mg/m2	5
Fed: Ceritinib 500 mg/m2	4

Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Fasted: Ceritinib 300 mg/m2	227	33.8	Not reported	Not reported	Not reported
Fasted: Ceritinib 450 mg/m2	245	78.1	Not reported	Not reported	Not reported
Fasted: Ceritinib 510 mg/m2	245	97.2	Not reported	Not reported	Not reported
Fasted: Ceritinib 560 mg/m2	423	74.2	Not reported	Not reported	Not reported
Fed: Ceritinib 320 mg/m2	275	35.3	Not reported	Not reported	Not reported
Fed: Ceritinib 400 mg/m2	318	36.7	Not reported	Not reported	Not reported
Fed: Ceritinib 500 mg/m2	168	68.9	Not reported	Not reported	Not reported

C1D1 24 hrs post-dose

Analysis denominator · Participants

Group	Source count
Fasted: Ceritinib 300 mg/m2	5
Fasted: Ceritinib 450 mg/m2	11
Fasted: Ceritinib 510 mg/m2	6
Fasted: Ceritinib 560 mg/m2	2
Fed: Ceritinib 320 mg/m2	4
Fed: Ceritinib 400 mg/m2	5
Fed: Ceritinib 500 mg/m2	4

Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Fasted: Ceritinib 300 mg/m2	130	66.3	Not reported	Not reported	Not reported
Fasted: Ceritinib 450 mg/m2	141	89.9	Not reported	Not reported	Not reported
Fasted: Ceritinib 510 mg/m2	86.4	117.2	Not reported	Not reported	Not reported
Fasted: Ceritinib 560 mg/m2	268	73.6	Not reported	Not reported	Not reported
Fed: Ceritinib 320 mg/m2	98.5	63.7	Not reported	Not reported	Not reported
Fed: Ceritinib 400 mg/m2	126	107.7	Not reported	Not reported	Not reported
Fed: Ceritinib 500 mg/m2	161	111.3	Not reported	Not reported	Not reported

C1D2 0 hr pre-dose

Analysis denominator · Participants

Group	Source count
Fasted: Ceritinib 300 mg/m2	5
Fasted: Ceritinib 450 mg/m2	11
Fasted: Ceritinib 510 mg/m2	6
Fasted: Ceritinib 560 mg/m2	2
Fed: Ceritinib 320 mg/m2	4
Fed: Ceritinib 400 mg/m2	5
Fed: Ceritinib 500 mg/m2	4

Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Fasted: Ceritinib 300 mg/m2	130	66.3	Not reported	Not reported	Not reported
Fasted: Ceritinib 450 mg/m2	141	89.9	Not reported	Not reported	Not reported
Fasted: Ceritinib 510 mg/m2	86.4	117.2	Not reported	Not reported	Not reported
Fasted: Ceritinib 560 mg/m2	268	73.6	Not reported	Not reported	Not reported
Fed: Ceritinib 320 mg/m2	98.5	63.7	Not reported	Not reported	Not reported
Fed: Ceritinib 400 mg/m2	126	107.7	Not reported	Not reported	Not reported
Fed: Ceritinib 500 mg/m2	161	111.3	Not reported	Not reported	Not reported

C1D15 0 hr pre-dose

Analysis denominator · Participants

Group	Source count
Fasted: Ceritinib 300 mg/m2	5
Fasted: Ceritinib 450 mg/m2	12
Fasted: Ceritinib 510 mg/m2	6
Fasted: Ceritinib 560 mg/m2	2
Fed: Ceritinib 320 mg/m2	3
Fed: Ceritinib 400 mg/m2	4
Fed: Ceritinib 500 mg/m2	5

Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Fasted: Ceritinib 300 mg/m2	193	99.6	Not reported	Not reported	Not reported
Fasted: Ceritinib 450 mg/m2	618	64.6	Not reported	Not reported	Not reported
Fasted: Ceritinib 510 mg/m2	537	49.9	Not reported	Not reported	Not reported
Fasted: Ceritinib 560 mg/m2	942	5.1	Not reported	Not reported	Not reported
Fed: Ceritinib 320 mg/m2	262	118.4	Not reported	Not reported	Not reported
Fed: Ceritinib 400 mg/m2	379	119.2	Not reported	Not reported	Not reported
Fed: Ceritinib 500 mg/m2	461	76.3	Not reported	Not reported	Not reported

C2D1 0 hr pre-dose

Analysis denominator · Participants

Group	Source count
Fasted: Ceritinib 300 mg/m2	5
Fasted: Ceritinib 450 mg/m2	12
Fasted: Ceritinib 510 mg/m2	5
Fasted: Ceritinib 560 mg/m2	2
Fed: Ceritinib 320 mg/m2	3
Fed: Ceritinib 400 mg/m2	4
Fed: Ceritinib 500 mg/m2	3

Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Fasted: Ceritinib 300 mg/m2	169	299.5	Not reported	Not reported	Not reported
Fasted: Ceritinib 450 mg/m2	661	53.5	Not reported	Not reported	Not reported
Fasted: Ceritinib 510 mg/m2	672	45.4	Not reported	Not reported	Not reported
Fasted: Ceritinib 560 mg/m2	695	152.7	Not reported	Not reported	Not reported
Fed: Ceritinib 320 mg/m2	218	103.7	Not reported	Not reported	Not reported
Fed: Ceritinib 400 mg/m2	429	73.8	Not reported	Not reported	Not reported
Fed: Ceritinib 500 mg/m2	655	12.4	Not reported	Not reported	Not reported

C2D1 2 hrs post-dose

Analysis denominator · Participants

Group	Source count
Fasted: Ceritinib 300 mg/m2	5
Fasted: Ceritinib 450 mg/m2	12
Fasted: Ceritinib 510 mg/m2	5
Fasted: Ceritinib 560 mg/m2	2
Fed: Ceritinib 320 mg/m2	3
Fed: Ceritinib 400 mg/m2	4
Fed: Ceritinib 500 mg/m2	3

Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Fasted: Ceritinib 300 mg/m2	287	85.4	Not reported	Not reported	Not reported
Fasted: Ceritinib 450 mg/m2	687	61.6	Not reported	Not reported	Not reported
Fasted: Ceritinib 510 mg/m2	801	45.9	Not reported	Not reported	Not reported
Fasted: Ceritinib 560 mg/m2	662	99.6	Not reported	Not reported	Not reported
Fed: Ceritinib 320 mg/m2	196	112.4	Not reported	Not reported	Not reported
Fed: Ceritinib 400 mg/m2	475	96.6	Not reported	Not reported	Not reported
Fed: Ceritinib 500 mg/m2	718	21.1	Not reported	Not reported	Not reported

C2D1 4 hrs post-dose

Analysis denominator · Participants

Group	Source count
Fasted: Ceritinib 300 mg/m2	5
Fasted: Ceritinib 450 mg/m2	12
Fasted: Ceritinib 510 mg/m2	5
Fasted: Ceritinib 560 mg/m2	2
Fed: Ceritinib 320 mg/m2	3
Fed: Ceritinib 400 mg/m2	4
Fed: Ceritinib 500 mg/m2	3

Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Fasted: Ceritinib 300 mg/m2	386	47.6	Not reported	Not reported	Not reported
Fasted: Ceritinib 450 mg/m2	810	51.9	Not reported	Not reported	Not reported
Fasted: Ceritinib 510 mg/m2	1000	30.4	Not reported	Not reported	Not reported
Fasted: Ceritinib 560 mg/m2	1230	30.1	Not reported	Not reported	Not reported
Fed: Ceritinib 320 mg/m2	262	133.9	Not reported	Not reported	Not reported
Fed: Ceritinib 400 mg/m2	631	86.6	Not reported	Not reported	Not reported
Fed: Ceritinib 500 mg/m2	744	13.2	Not reported	Not reported	Not reported

C2D1 6 hrs post-dose

Analysis denominator · Participants

Group	Source count
Fasted: Ceritinib 300 mg/m2	5
Fasted: Ceritinib 450 mg/m2	12
Fasted: Ceritinib 510 mg/m2	5
Fasted: Ceritinib 560 mg/m2	2
Fed: Ceritinib 320 mg/m2	3
Fed: Ceritinib 400 mg/m2	4
Fed: Ceritinib 500 mg/m2	2

Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Fasted: Ceritinib 300 mg/m2	426	38.4	Not reported	Not reported	Not reported
Fasted: Ceritinib 450 mg/m2	852	47.8	Not reported	Not reported	Not reported
Fasted: Ceritinib 510 mg/m2	898	37.6	Not reported	Not reported	Not reported
Fasted: Ceritinib 560 mg/m2	1260	16.4	Not reported	Not reported	Not reported
Fed: Ceritinib 320 mg/m2	300	130.3	Not reported	Not reported	Not reported
Fed: Ceritinib 400 mg/m2	648	105.5	Not reported	Not reported	Not reported
Fed: Ceritinib 500 mg/m2	786	7.7	Not reported	Not reported	Not reported

C2D1 24 hrs post-dose

Analysis denominator · Participants

Group	Source count
Fasted: Ceritinib 300 mg/m2	5
Fasted: Ceritinib 450 mg/m2	12
Fasted: Ceritinib 510 mg/m2	5
Fasted: Ceritinib 560 mg/m2	2
Fed: Ceritinib 320 mg/m2	3
Fed: Ceritinib 400 mg/m2	4
Fed: Ceritinib 500 mg/m2	5

Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Fasted: Ceritinib 300 mg/m2	247	46.9	Not reported	Not reported	Not reported
Fasted: Ceritinib 450 mg/m2	651	53.7	Not reported	Not reported	Not reported
Fasted: Ceritinib 510 mg/m2	714	40.8	Not reported	Not reported	Not reported
Fasted: Ceritinib 560 mg/m2	847	72.2	Not reported	Not reported	Not reported
Fed: Ceritinib 320 mg/m2	194	106.5	Not reported	Not reported	Not reported
Fed: Ceritinib 400 mg/m2	411	147.3	Not reported	Not reported	Not reported
Fed: Ceritinib 500 mg/m2	448	43.9	Not reported	Not reported	Not reported

C2D2 0 hr pre-dose

Analysis denominator · Participants

Group	Source count
Fasted: Ceritinib 300 mg/m2	5
Fasted: Ceritinib 450 mg/m2	12
Fasted: Ceritinib 510 mg/m2	5
Fasted: Ceritinib 560 mg/m2	2
Fed: Ceritinib 320 mg/m2	3
Fed: Ceritinib 400 mg/m2	4
Fed: Ceritinib 500 mg/m2	5

Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Fasted: Ceritinib 300 mg/m2	247	46.9	Not reported	Not reported	Not reported
Fasted: Ceritinib 450 mg/m2	651	53.7	Not reported	Not reported	Not reported
Fasted: Ceritinib 510 mg/m2	714	40.8	Not reported	Not reported	Not reported
Fasted: Ceritinib 560 mg/m2	847	72.2	Not reported	Not reported	Not reported
Fed: Ceritinib 320 mg/m2	194	106.5	Not reported	Not reported	Not reported
Fed: Ceritinib 400 mg/m2	411	147.3	Not reported	Not reported	Not reported
Fed: Ceritinib 500 mg/m2	448	43.9	Not reported	Not reported	Not reported

C3D1 0 hr pre-dose

Analysis denominator · Participants

Group	Source count
Fasted: Ceritinib 300 mg/m2	2
Fasted: Ceritinib 450 mg/m2	8
Fasted: Ceritinib 510 mg/m2	4
Fasted: Ceritinib 560 mg/m2	1
Fed: Ceritinib 320 mg/m2	2
Fed: Ceritinib 400 mg/m2	1
Fed: Ceritinib 500 mg/m2	5

Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Fasted: Ceritinib 300 mg/m2	399	94.4	Not reported	Not reported	Not reported
Fasted: Ceritinib 450 mg/m2	810	34.3	Not reported	Not reported	Not reported
Fasted: Ceritinib 510 mg/m2	415	117.7	Not reported	Not reported	Not reported
Fasted: Ceritinib 560 mg/m2	1320	0.0	Not reported	Not reported	Not reported
Fed: Ceritinib 320 mg/m2	167	218.3	Not reported	Not reported	Not reported
Fed: Ceritinib 400 mg/m2	328	0.0	Not reported	Not reported	Not reported
Fed: Ceritinib 500 mg/m2	433	128.5	Not reported	Not reported	Not reported

C4D1 0 hr pre-dose

Analysis denominator · Participants

Group	Source count
Fasted: Ceritinib 300 mg/m2	2
Fasted: Ceritinib 450 mg/m2	8
Fasted: Ceritinib 510 mg/m2	4
Fasted: Ceritinib 560 mg/m2	1
Fed: Ceritinib 320 mg/m2	1
Fed: Ceritinib 400 mg/m2	1
Fed: Ceritinib 500 mg/m2	3

Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Fasted: Ceritinib 300 mg/m2	503	35.1	Not reported	Not reported	Not reported
Fasted: Ceritinib 450 mg/m2	960	36.2	Not reported	Not reported	Not reported
Fasted: Ceritinib 510 mg/m2	321	874.8	Not reported	Not reported	Not reported
Fasted: Ceritinib 560 mg/m2	857	0.0	Not reported	Not reported	Not reported
Fed: Ceritinib 320 mg/m2	403	0.0	Not reported	Not reported	Not reported
Fed: Ceritinib 400 mg/m2	1320	0.0	Not reported	Not reported	Not reported
Fed: Ceritinib 500 mg/m2	658	27.0	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
0.0
value
0.0
group Id
OG001
spread
0.0
value
0.0
group Id
OG002
spread
0.0
value
0.0
group Id
OG003
spread
0.0
value
0.0
group Id
OG004
spread
0.0
value
0.0
group Id
OG005
spread
0.0
value
0.0
group Id
OG006
spread
0.0
value
0.0
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
12
group Id
OG002
value
6
group Id
OG003
value
2
group Id
OG004
value
4
group Id
OG005
value
5
group Id
OG006
value
5
units
Participants
title
Cycle1 Day1 (C1D1) 0 hr pre-dose
categories
measurements
group Id
OG000
spread
97.9
value
104
group Id
OG001
spread
94.7
value
99.0
group Id
OG002
spread
90.6
value
112
group Id
OG003
spread
0.6
value
126
group Id
OG004
spread
138.1
value
52.4
group Id
OG005
spread
58.3
value
197
group Id
OG006
spread
82.3
value
72.5
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
11
group Id
OG002
value
6
group Id
OG003
value
2
group Id
OG004
value
4
group Id
OG005
value
5
group Id
OG006
value
5
units
Participants
title
C1D1 2 hrs post-dose
categories
measurements
group Id
OG000
spread
39.6
value
216
group Id
OG001
spread
69.0
value
233
group Id
OG002
spread
93.5
value
250
group Id
OG003
spread
54.7
value
350
group Id
OG004
spread
92.8
value
166
group Id
OG005
spread
28.1
value
311
group Id
OG006
spread
34.1
value
153
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
11
group Id
OG002
value
6
group Id
OG003
value
2
group Id
OG004
value
4
group Id
OG005
value
5
group Id
OG006
value
5
units
Participants
title
C1D1 4 hrs post-dose
categories
measurements
group Id
OG000
spread
33.8
value
227
group Id
OG001
spread
78.1
value
245
group Id
OG002
spread
97.2
value
245
group Id
OG003
spread
74.2
value
423
group Id
OG004
spread
35.3
value
275
group Id
OG005
spread
36.7
value
318
group Id
OG006
spread
68.9
value
168
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
11
group Id
OG002
value
6
group Id
OG003
value
2
group Id
OG004
value
4
group Id
OG005
value
5
group Id
OG006
value
4
units
Participants
title
C1D1 6 hrs post-dose
categories
measurements
group Id
OG000
spread
66.3
value
130
group Id
OG001
spread
89.9
value
141
group Id
OG002
spread
117.2
value
86.4
group Id
OG003
spread
73.6
value
268
group Id
OG004
spread
63.7
value
98.5
group Id
OG005
spread
107.7
value
126
group Id
OG006
spread
111.3
value
161
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
11
group Id
OG002
value
6
group Id
OG003
value
2
group Id
OG004
value
4
group Id
OG005
value
5
group Id
OG006
value
4
units
Participants
title
C1D1 24 hrs post-dose
categories
measurements
group Id
OG000
spread
66.3
value
130
group Id
OG001
spread
89.9
value
141
group Id
OG002
spread
117.2
value
86.4
group Id
OG003
spread
73.6
value
268
group Id
OG004
spread
63.7
value
98.5
group Id
OG005
spread
107.7
value
126
group Id
OG006
spread
111.3
value
161
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
11
group Id
OG002
value
6
group Id
OG003
value
2
group Id
OG004
value
4
group Id
OG005
value
5
group Id
OG006
value
4
units
Participants
title
C1D2 0 hr pre-dose
categories
measurements
group Id
OG000
spread
99.6
value
193
group Id
OG001
spread
64.6
value
618
group Id
OG002
spread
49.9
value
537
group Id
OG003
spread
5.1
value
942
group Id
OG004
spread
118.4
value
262
group Id
OG005
spread
119.2
value
379
group Id
OG006
spread
76.3
value
461
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
12
group Id
OG002
value
6
group Id
OG003
value
2
group Id
OG004
value
3
group Id
OG005
value
4
group Id
OG006
value
5
units
Participants
title
C1D15 0 hr pre-dose
categories
measurements
group Id
OG000
spread
299.5
value
169
group Id
OG001
spread
53.5
value
661
group Id
OG002
spread
45.4
value
672
group Id
OG003
spread
152.7
value
695
group Id
OG004
spread
103.7
value
218
group Id
OG005
spread
73.8
value
429
group Id
OG006
spread
12.4
value
655
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
12
group Id
OG002
value
5
group Id
OG003
value
2
group Id
OG004
value
3
group Id
OG005
value
4
group Id
OG006
value
3
units
Participants
title
C2D1 0 hr pre-dose
categories
measurements
group Id
OG000
spread
85.4
value
287
group Id
OG001
spread
61.6
value
687
group Id
OG002
spread
45.9
value
801
group Id
OG003
spread
99.6
value
662
group Id
OG004
spread
112.4
value
196
group Id
OG005
spread
96.6
value
475
group Id
OG006
spread
21.1
value
718
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
12
group Id
OG002
value
5
group Id
OG003
value
2
group Id
OG004
value
3
group Id
OG005
value
4
group Id
OG006
value
3
units
Participants
title
C2D1 2 hrs post-dose
categories
measurements
group Id
OG000
spread
47.6
value
386
group Id
OG001
spread
51.9
value
810
group Id
OG002
spread
30.4
value
1000
group Id
OG003
spread
30.1
value
1230
group Id
OG004
spread
133.9
value
262
group Id
OG005
spread
86.6
value
631
group Id
OG006
spread
13.2
value
744
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
12
group Id
OG002
value
5
group Id
OG003
value
2
group Id
OG004
value
3
group Id
OG005
value
4
group Id
OG006
value
3
units
Participants
title
C2D1 4 hrs post-dose
categories
measurements
group Id
OG000
spread
38.4
value
426
group Id
OG001
spread
47.8
value
852
group Id
OG002
spread
37.6
value
898
group Id
OG003
spread
16.4
value
1260
group Id
OG004
spread
130.3
value
300
group Id
OG005
spread
105.5
value
648
group Id
OG006
spread
7.7
value
786
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
12
group Id
OG002
value
5
group Id
OG003
value
2
group Id
OG004
value
3
group Id
OG005
value
4
group Id
OG006
value
2
units
Participants
title
C2D1 6 hrs post-dose
categories
measurements
group Id
OG000
spread
46.9
value
247
group Id
OG001
spread
53.7
value
651
group Id
OG002
spread
40.8
value
714
group Id
OG003
spread
72.2
value
847
group Id
OG004
spread
106.5
value
194
group Id
OG005
spread
147.3
value
411
group Id
OG006
spread
43.9
value
448
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
12
group Id
OG002
value
5
group Id
OG003
value
2
group Id
OG004
value
3
group Id
OG005
value
4
group Id
OG006
value
5
units
Participants
title
C2D1 24 hrs post-dose

denoms

counts
group Id
OG000
value
5
group Id
OG001
value
12
group Id
OG002
value
6
group Id
OG003
value
2
group Id
OG004
value
4
group Id
OG005
value
5
group Id
OG006
value
5
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, 2hrs post-dose, 4hrs post-dose, 6hrs post-dose & 24hrs post-dose in Cycle1 Day1 & Cycle 2 day 1; 0hr pre-dose in Cycle 1 Day 15, Cycle 2 Day1, Cycle 2 Day 2, Cycle 3 day 1 & Cycle 4 Day 1

title

Plasma Concentration Time Profiles by Treatment Group in Escalation Phase

type

SECONDARY

unit Of Measure

ng/mL

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice