NCT02099539 · OUTCOME

Characterization of the Pharmacokinetic Profile - Half-life (t½)

QUILT-3.005: A Study of N-803 in Patients With Relapsed or Refractory Multiple Myeloma · Source last updated 2024-09-26

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEAN
Unit: Hours
Interval / dispersion: Full Range
Time frame: PK timepoint up to 72 hours +/- 6 hours

What was measured

Half-life (t½) - The period of time required for the concentration or amount of drug in the body to be reduced by one-half.

Analysis population: Cohort 7: N-803 - SQ 20 ug/kg did not enroll any subjects. In addition, 6 out of 7 SC patients (Cohorts 5 and 6) had insufficient measurable post-tmax sampling to allow for evaluation of the terminal phase-dependent PK parameters (ie, t½, CL/F, Vz/F, AUC0-168, AUC0-∞).

Groups in this outcome

Cohort 1: N-803 - IV 1 ug/kg

N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles

Cohort 2: N-803 - IV 3 ug/kg

Cohort 3: N-803 - IV 6 ug/kg

Cohort 4: N-803 - IV 10 ug/kg

Cohort 5: N-803 - SQ 10 ug/kg

Cohort 6: N-803 - SQ 15 ug/kg

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
Cohort 1: N-803 - IV 1 ug/kg	3
Cohort 2: N-803 - IV 3 ug/kg	2
Cohort 3: N-803 - IV 6 ug/kg	2
Cohort 4: N-803 - IV 10 ug/kg	3
Cohort 5: N-803 - SQ 10 ug/kg	0
Cohort 6: N-803 - SQ 15 ug/kg	1

Reported measurements

Source class 1

Values in Hours · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Cohort 1: N-803 - IV 1 ug/kg	0.773	Not reported	0.734	0.826	Not reported
Cohort 2: N-803 - IV 3 ug/kg	2.41	Not reported	2.40	2.41	Not reported
Cohort 3: N-803 - IV 6 ug/kg	2.21	Not reported	2.02	2.39	Not reported
Cohort 4: N-803 - IV 10 ug/kg	3.07	Not reported	2.33	4.14	Not reported
Cohort 6: N-803 - SQ 15 ug/kg	35.3	Not reported	35.3	35.3	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
0.734
upper Limit
0.826
value
0.773
group Id
OG001
lower Limit
2.40
upper Limit
2.41
value
2.41
group Id
OG002
lower Limit
2.02
upper Limit
2.39
value
2.21
group Id
OG003
lower Limit
2.33
upper Limit
4.14
value
3.07
group Id
OG005
lower Limit
35.3
upper Limit
35.3
value
35.3

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
2
group Id
OG002
value
2
group Id
OG003
value
3
group Id
OG004
value
0
group Id
OG005
value
1
units
Participants

description

Half-life (t½) - The period of time required for the concentration or amount of drug in the body to be reduced by one-half.

dispersion Type

Full Range

groups

description
N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles
id
OG000
title
Cohort 1: N-803 - IV 1 ug/kg
description
N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles
id
OG001
title
Cohort 2: N-803 - IV 3 ug/kg
description
N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles
id
OG002
title
Cohort 3: N-803 - IV 6 ug/kg
description
N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles
id
OG003
title
Cohort 4: N-803 - IV 10 ug/kg
description
N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles
id
OG004
title
Cohort 5: N-803 - SQ 10 ug/kg
description
N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles
id
OG005
title
Cohort 6: N-803 - SQ 15 ug/kg

param Type

MEAN

population Description

Cohort 7: N-803 - SQ 20 ug/kg did not enroll any subjects. In addition, 6 out of 7 SC patients (Cohorts 5 and 6) had insufficient measurable post-tmax sampling to allow for evaluation of the terminal phase-dependent PK parameters (ie, t½, CL/F, Vz/F, AUC0-168, AUC0-∞).

reporting Status

POSTED

time Frame

PK timepoint up to 72 hours +/- 6 hours

title

Characterization of the Pharmacokinetic Profile - Half-life (t½)

type

SECONDARY

unit Of Measure

Hours

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Preserved source evidence · Not medical advice