Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2)
Study of Brentuximab Vedotin (SGN-35) in Pediatric Participants With Relapsed or Refractory (r/r) Systemic Anaplastic Large-Cell Lymphoma or Hodgkin Lymphoma · Source last updated 2024-05-30
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
MEAN
Unit
ug/mL
Interval / dispersion
Standard Deviation
Time frame
Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose
What was measured
Blood samples were collected and tested for serum concentrations of brentuximab vedotin antibody-drug conjugate.
Analysis population: PK-evaluable population was defined as participants with sufficient dosing and PK data to reliably estimate PK parameters. Cycle 2 Day 2 values are collected in phase 1 participants only. Here, number analyzed is number of participants assessed at given time-point. Data summarized together for all participants in brentuximab vedotin 1.8 mg/kg arm.
Groups in this outcome
Brentuximab Vedotin 1.4 mg/kg: Phase 1
Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
Brentuximab Vedotin 1.8 mg/kg: Phase 1
Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
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
Brentuximab Vedotin 1.4 mg/kg: Phase 1
3
Brentuximab Vedotin 1.8 mg/kg: Phase 1
33
Reported measurements
Cycle 1 Day 1, Pre-Dose
Analysis denominator · Participants
Group
Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1
0
Brentuximab Vedotin 1.8 mg/kg: Phase 1
33
Values in ug/mL · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1
NA
NA
Not reported
Not reported
Data was below the limit of quantification.
Cycle 1 Day 1, 5 Minutes Post-Dose
Analysis denominator · Participants
Group
Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1
3
Brentuximab Vedotin 1.8 mg/kg: Phase 1
33
Values in ug/mL · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1
23.1
3.46
Not reported
Not reported
Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1
31.8
12.4
Not reported
Not reported
Not reported
Cycle 1 Day 2, 24 Hours Post-Dose
Analysis denominator · Participants
Group
Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1
3
Brentuximab Vedotin 1.8 mg/kg: Phase 1
32
Values in ug/mL · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1
9.50
1.73
Not reported
Not reported
Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1
13.0
5.34
Not reported
Not reported
Not reported
Cycle 1 Day 3, 48 Hours Post-Dose
Analysis denominator · Participants
Group
Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1
3
Brentuximab Vedotin 1.8 mg/kg: Phase 1
31
Values in ug/mL · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1
5.67
0.924
Not reported
Not reported
Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1
12.0
16.3
Not reported
Not reported
Not reported
Cycle 1 Day 5, 96 Hours Post-Dose
Analysis denominator · Participants
Group
Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1
3
Brentuximab Vedotin 1.8 mg/kg: Phase 1
31
Values in ug/mL · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1
3.50
1.41
Not reported
Not reported
Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1
8.68
13.4
Not reported
Not reported
Not reported
Cycle 1 Day 14, 312 Hours Post-Dose
Analysis denominator · Participants
Group
Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1
3
Brentuximab Vedotin 1.8 mg/kg: Phase 1
31
Values in ug/mL · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1
0.844
0.309
Not reported
Not reported
Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1
2.19
3.44
Not reported
Not reported
Not reported
Cycle 2 Day 1, Pre-Dose
Analysis denominator · Participants
Group
Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1
3
Brentuximab Vedotin 1.8 mg/kg: Phase 1
32
Values in ug/mL · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1
0.149
0.128
Not reported
Not reported
Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1
0.395
0.322
Not reported
Not reported
Not reported
Cycle 2 Day 1, 5-minutes Post-Dose
Analysis denominator · Participants
Group
Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1
3
Brentuximab Vedotin 1.8 mg/kg: Phase 1
30
Values in ug/mL · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1
25.3
7.56
Not reported
Not reported
Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1
32.9
9.80
Not reported
Not reported
Not reported
Cycle 2 Day 2, 24 Hours Post-Dose
Analysis denominator · Participants
Group
Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1
3
Brentuximab Vedotin 1.8 mg/kg: Phase 1
10
Values in ug/mL · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1
8.80
6.19
Not reported
Not reported
Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1
10.4
8.05
Not reported
Not reported
Not reported
Cycle 2 Day 3, 48 Hours Post-Dose
Analysis denominator · Participants
Group
Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1
3
Brentuximab Vedotin 1.8 mg/kg: Phase 1
29
Values in ug/mL · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1
3.70
1.95
Not reported
Not reported
Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1
11.4
16.8
Not reported
Not reported
Not reported
Cycle 2 Day 5, 96 Hours Post-Dose
Analysis denominator · Participants
Group
Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1
3
Brentuximab Vedotin 1.8 mg/kg: Phase 1
27
Values in ug/mL · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1
2.04
1.26
Not reported
Not reported
Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1
9.61
17.9
Not reported
Not reported
Not reported
Cycle 3 Day 1, Pre-Dose
Analysis denominator · Participants
Group
Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1
2
Brentuximab Vedotin 1.8 mg/kg: Phase 1
26
Values in ug/mL · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1
0.116
0.163
Not reported
Not reported
Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1
0.491
0.387
Not reported
Not reported
Not reported
Cycle 3 Day 1, 5 minutes Post-Dose
Analysis denominator · Participants
Group
Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1
2
Brentuximab Vedotin 1.8 mg/kg: Phase 1
26
Values in ug/mL · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1
23.9
2.83
Not reported
Not reported
Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1
31.3
9.79
Not reported
Not reported
Not reported
Cycle 4 Day 1, Pre-dose
Analysis denominator · Participants
Group
Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1
2
Brentuximab Vedotin 1.8 mg/kg: Phase 1
21
Values in ug/mL · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1
0.218
0.271
Not reported
Not reported
Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1
0.691
0.492
Not reported
Not reported
Not reported
Cycle 4 Day 1, 5 minutes Post-Dose
Analysis denominator · Participants
Group
Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1
2
Brentuximab Vedotin 1.8 mg/kg: Phase 1
21
Values in ug/mL · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1
22.9
4.60
Not reported
Not reported
Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1
30.0
12.2
Not reported
Not reported
Not reported
Cycle 5 Day 1, Pre-Dose
Analysis denominator · Participants
Group
Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1
2
Brentuximab Vedotin 1.8 mg/kg: Phase 1
21
Values in ug/mL · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1
0.264
0.321
Not reported
Not reported
Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1
0.845
0.564
Not reported
Not reported
Not reported
Cycle 5 Day 1, 5 minutes Post-Dose
Analysis denominator · Participants
Group
Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1
2
Brentuximab Vedotin 1.8 mg/kg: Phase 1
21
Values in ug/mL · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1
22.5
3.32
Not reported
Not reported
Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1
30.6
15.1
Not reported
Not reported
Not reported
Cycle 6 Day 1, Pre-Dose
Analysis denominator · Participants
Group
Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1
2
Brentuximab Vedotin 1.8 mg/kg: Phase 1
17
Values in ug/mL · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1
0.312
0.351
Not reported
Not reported
Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1
1.06
0.699
Not reported
Not reported
Not reported
Cycle 6 Day 1, 5 minutes Post-Dose
Analysis denominator · Participants
Group
Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1
2
Brentuximab Vedotin 1.8 mg/kg: Phase 1
17
Values in ug/mL · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1
20.3
4.38
Not reported
Not reported
Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1
33.2
16.1
Not reported
Not reported
Not reported
Cycle 7 Day 1, Pre-Dose
Analysis denominator · Participants
Group
Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1
2
Brentuximab Vedotin 1.8 mg/kg: Phase 1
17
Values in ug/mL · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1
0.327
0.337
Not reported
Not reported
Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1
1.04
0.618
Not reported
Not reported
Not reported
Cycle 7 Day 1, 5 minutes Post-Dose
Analysis denominator · Participants
Group
Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1
2
Brentuximab Vedotin 1.8 mg/kg: Phase 1
17
Values in ug/mL · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Brentuximab Vedotin 1.4 mg/kg: Phase 1
17.9
2.40
Not reported
Not reported
Not reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1
32.3
15.4
Not reported
Not reported
Not reported
Cycle 8 Day 1, Pre-Dose
Analysis denominator · Participants
Group
Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1
0
Brentuximab Vedotin 1.8 mg/kg: Phase 1
14
Values in ug/mL · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1
1.25
0.565
Not reported
Not reported
Not reported
Cycle 8 Day 1, 5 minutes Post-Dose
Analysis denominator · Participants
Group
Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1
0
Brentuximab Vedotin 1.8 mg/kg: Phase 1
14
Values in ug/mL · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1
35.2
10.5
Not reported
Not reported
Not reported
Cycle 8 Day 2, 24 Hours Post-Dose
Analysis denominator · Participants
Group
Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1
0
Brentuximab Vedotin 1.8 mg/kg: Phase 1
13
Values in ug/mL · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1
14.0
4.55
Not reported
Not reported
Not reported
Cycle 8 Day 3, 48 Hours Post-Dose
Analysis denominator · Participants
Group
Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1
0
Brentuximab Vedotin 1.8 mg/kg: Phase 1
13
Values in ug/mL · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1
9.53
2.96
Not reported
Not reported
Not reported
Cycle 8 Day 5, 96 Hours Post-Dose
Analysis denominator · Participants
Group
Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1
0
Brentuximab Vedotin 1.8 mg/kg: Phase 1
12
Values in ug/mL · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1
6.44
2.35
Not reported
Not reported
Not reported
Cycle 8 Day 14, 312 Hours Post-Dose
Analysis denominator · Participants
Group
Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1
0
Brentuximab Vedotin 1.8 mg/kg: Phase 1
13
Values in ug/mL · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1
3.30
4.63
Not reported
Not reported
Not reported
Cycle 9 Day 1, Pre-Dose
Analysis denominator · Participants
Group
Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1
0
Brentuximab Vedotin 1.8 mg/kg: Phase 1
14
Values in ug/mL · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1
4.37
11.7
Not reported
Not reported
Not reported
Cycle 9 Day 1, 5 Minutes Post-Dose
Analysis denominator · Participants
Group
Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1
0
Brentuximab Vedotin 1.8 mg/kg: Phase 1
13
Values in ug/mL · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1
29.6
11.3
Not reported
Not reported
Not reported
Cycle 10 Day 1, Pre-Dose
Analysis denominator · Participants
Group
Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1
0
Brentuximab Vedotin 1.8 mg/kg: Phase 1
11
Values in ug/mL · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1
1.20
0.455
Not reported
Not reported
Not reported
Cycle 10 Day 1, 5 minutes Post-Dose
Analysis denominator · Participants
Group
Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1
0
Brentuximab Vedotin 1.8 mg/kg: Phase 1
12
Values in ug/mL · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1
35.7
9.50
Not reported
Not reported
Not reported
Cycle 11 Day 1, Pre-Dose
Analysis denominator · Participants
Group
Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1
0
Brentuximab Vedotin 1.8 mg/kg: Phase 1
8
Values in ug/mL · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1
1.84
1.57
Not reported
Not reported
Not reported
Cycle 11 Day 1, 5 minutes Post-Dose
Analysis denominator · Participants
Group
Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1
0
Brentuximab Vedotin 1.8 mg/kg: Phase 1
8
Values in ug/mL · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1
35.7
10.8
Not reported
Not reported
Not reported
Cycle 12 Day 1, Pre-Dose
Analysis denominator · Participants
Group
Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1
0
Brentuximab Vedotin 1.8 mg/kg: Phase 1
6
Values in ug/mL · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1
1.47
0.665
Not reported
Not reported
Not reported
Cycle 12 Day 1, 5 minutes Post-Dose
Analysis denominator · Participants
Group
Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1
0
Brentuximab Vedotin 1.8 mg/kg: Phase 1
6
Values in ug/mL · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1
40.0
10.4
Not reported
Not reported
Not reported
Cycle 13 Day 1, Pre-Dose
Analysis denominator · Participants
Group
Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1
0
Brentuximab Vedotin 1.8 mg/kg: Phase 1
6
Values in ug/mL · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1
6.28
11.5
Not reported
Not reported
Not reported
Cycle 13 Day 1, 5 minutes Post-Dose
Analysis denominator · Participants
Group
Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1
0
Brentuximab Vedotin 1.8 mg/kg: Phase 1
6
Values in ug/mL · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1
33.3
16.1
Not reported
Not reported
Not reported
Cycle 14 Day 1, Pre-Dose
Analysis denominator · Participants
Group
Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1
0
Brentuximab Vedotin 1.8 mg/kg: Phase 1
6
Values in ug/mL · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1
1.60
0.600
Not reported
Not reported
Not reported
Cycle 14 Day 1, 5 minutes Post-Dose
Analysis denominator · Participants
Group
Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1
0
Brentuximab Vedotin 1.8 mg/kg: Phase 1
6
Values in ug/mL · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1
37.0
7.92
Not reported
Not reported
Not reported
Cycle 15 Day 1, Pre-Dose
Analysis denominator · Participants
Group
Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1
0
Brentuximab Vedotin 1.8 mg/kg: Phase 1
6
Values in ug/mL · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1
1.48
0.542
Not reported
Not reported
Not reported
Cycle 15 Day 1, 5 minutes Post-Dose
Analysis denominator · Participants
Group
Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1
0
Brentuximab Vedotin 1.8 mg/kg: Phase 1
6
Values in ug/mL · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1
40.3
10.6
Not reported
Not reported
Not reported
Cycle 16 Day 1, Pre-Dose
Analysis denominator · Participants
Group
Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1
0
Brentuximab Vedotin 1.8 mg/kg: Phase 1
6
Values in ug/mL · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1
1.52
0.361
Not reported
Not reported
Not reported
Cycle 16 Day 1, 5 minutes Post-Dose
Analysis denominator · Participants
Group
Source count
Brentuximab Vedotin 1.4 mg/kg: Phase 1
0
Brentuximab Vedotin 1.8 mg/kg: Phase 1
6
Values in ug/mL · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Brentuximab Vedotin 1.8 mg/kg: Phase 1
41.5
4.70
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
comment
Data was below the limit of quantification.
group Id
OG001
spread
NA
value
NA
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
33
units
Participants
title
Cycle 1 Day 1, Pre-Dose
categories
measurements
group Id
OG000
spread
3.46
value
23.1
group Id
OG001
spread
12.4
value
31.8
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
33
units
Participants
title
Cycle 1 Day 1, 5 Minutes Post-Dose
categories
measurements
group Id
OG000
spread
1.73
value
9.50
group Id
OG001
spread
5.34
value
13.0
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
32
units
Participants
title
Cycle 1 Day 2, 24 Hours Post-Dose
categories
measurements
group Id
OG000
spread
0.924
value
5.67
group Id
OG001
spread
16.3
value
12.0
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
31
units
Participants
title
Cycle 1 Day 3, 48 Hours Post-Dose
categories
measurements
group Id
OG000
spread
1.41
value
3.50
group Id
OG001
spread
13.4
value
8.68
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
31
units
Participants
title
Cycle 1 Day 5, 96 Hours Post-Dose
categories
measurements
group Id
OG000
spread
0.309
value
0.844
group Id
OG001
spread
3.44
value
2.19
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
31
units
Participants
title
Cycle 1 Day 14, 312 Hours Post-Dose
categories
measurements
group Id
OG000
spread
0.128
value
0.149
group Id
OG001
spread
0.322
value
0.395
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
32
units
Participants
title
Cycle 2 Day 1, Pre-Dose
categories
measurements
group Id
OG000
spread
7.56
value
25.3
group Id
OG001
spread
9.80
value
32.9
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
30
units
Participants
title
Cycle 2 Day 1, 5-minutes Post-Dose
categories
measurements
group Id
OG000
spread
6.19
value
8.80
group Id
OG001
spread
8.05
value
10.4
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
10
units
Participants
title
Cycle 2 Day 2, 24 Hours Post-Dose
categories
measurements
group Id
OG000
spread
1.95
value
3.70
group Id
OG001
spread
16.8
value
11.4
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
29
units
Participants
title
Cycle 2 Day 3, 48 Hours Post-Dose
categories
measurements
group Id
OG000
spread
1.26
value
2.04
group Id
OG001
spread
17.9
value
9.61
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
27
units
Participants
title
Cycle 2 Day 5, 96 Hours Post-Dose
categories
measurements
group Id
OG000
spread
0.163
value
0.116
group Id
OG001
spread
0.387
value
0.491
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
26
units
Participants
title
Cycle 3 Day 1, Pre-Dose
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
33
units
Participants
description
Blood samples were collected and tested for serum concentrations of brentuximab vedotin antibody-drug conjugate.
dispersion Type
Standard Deviation
groups
description
Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
id
OG000
title
Brentuximab Vedotin 1.4 mg/kg: Phase 1
description
Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
id
OG001
title
Brentuximab Vedotin 1.8 mg/kg: Phase 1
param Type
MEAN
population Description
PK-evaluable population was defined as participants with sufficient dosing and PK data to reliably estimate PK parameters. Cycle 2 Day 2 values are collected in phase 1 participants only. Here, number analyzed is number of participants assessed at given time-point. Data summarized together for all participants in brentuximab vedotin 1.8 mg/kg arm.
reporting Status
POSTED
time Frame
Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose
title
Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2)
Triangle