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NCT02099539 · OUTCOME

Characterization of the Pharmacokinetic Profile - Area Under the Plasma Concentration Curve

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
hr x ng/mL
Interval / dispersion
Full Range
Time frame
Samples were collected and the AUC was determined at 24 hours and at time t (last measurable concentration). The AUC was calculated for 168 hours and time to infinity.

What was measured

Area under the plasma concentration curve from time 0 through the last measurable concentration (AUC0-t). PK samples were obtained from the start of treatment until 72 hours. The AUC0-168 and AUC0-inf were calculated with noncompartmental pharmacokinetic analysis equations.

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

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 3: N-803 - IV 6 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 4: N-803 - IV 10 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 5: N-803 - SQ 10 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 6: N-803 - SQ 15 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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Cohort 1: N-803 - IV 1 ug/kg3
Cohort 2: N-803 - IV 3 ug/kg3
Cohort 3: N-803 - IV 6 ug/kg3
Cohort 4: N-803 - IV 10 ug/kg3
Cohort 5: N-803 - SQ 10 ug/kg4
Cohort 6: N-803 - SQ 15 ug/kg3

Reported measurements

AUC0-t

Analysis denominator · Participants

GroupSource count
Cohort 1: N-803 - IV 1 ug/kg3
Cohort 2: N-803 - IV 3 ug/kg3
Cohort 3: N-803 - IV 6 ug/kg3
Cohort 4: N-803 - IV 10 ug/kg3
Cohort 5: N-803 - SQ 10 ug/kg4
Cohort 6: N-803 - SQ 15 ug/kg3
Values in hr x ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Cohort 1: N-803 - IV 1 ug/kg10.5Not reported7.5813.7Not reported
Cohort 2: N-803 - IV 3 ug/kg129Not reported105166Not reported
Cohort 3: N-803 - IV 6 ug/kg634Not reported439845Not reported
Cohort 4: N-803 - IV 10 ug/kg808Not reported5771200Not reported
Cohort 5: N-803 - SQ 10 ug/kg13.6Not reported6.0021.2Not reported
Cohort 6: N-803 - SQ 15 ug/kg60.4Not reported9.61135Not reported
AUC0-24

Analysis denominator · Participants

GroupSource count
Cohort 1: N-803 - IV 1 ug/kg3
Cohort 2: N-803 - IV 3 ug/kg2
Cohort 3: N-803 - IV 6 ug/kg2
Cohort 4: N-803 - IV 10 ug/kg3
Cohort 5: N-803 - SQ 10 ug/kg4
Cohort 6: N-803 - SQ 15 ug/kg3
Values in hr x ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Cohort 1: N-803 - IV 1 ug/kg10.6Not reported7.6213.8Not reported
Cohort 2: N-803 - IV 3 ug/kg141Not reported116166Not reported
Cohort 3: N-803 - IV 6 ug/kg731Not reported618845Not reported
Cohort 4: N-803 - IV 10 ug/kg811Not reported5771220Not reported
Cohort 5: N-803 - SQ 10 ug/kg5.01Not reported2.916.69Not reported
Cohort 6: N-803 - SQ 15 ug/kg31.1Not reported11.765.5Not reported
AUC0-168

Analysis denominator · Participants

GroupSource count
Cohort 1: N-803 - IV 1 ug/kg3
Cohort 2: N-803 - IV 3 ug/kg2
Cohort 3: N-803 - IV 6 ug/kg2
Cohort 4: N-803 - IV 10 ug/kg3
Cohort 5: N-803 - SQ 10 ug/kg0
Cohort 6: N-803 - SQ 15 ug/kg1
Values in hr x ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Cohort 1: N-803 - IV 1 ug/kg10.6Not reported7.6213.8Not reported
Cohort 2: N-803 - IV 3 ug/kg141Not reported116166Not reported
Cohort 3: N-803 - IV 6 ug/kg732Not reported618846Not reported
Cohort 4: N-803 - IV 10 ug/kg813Not reported5781220Not reported
Cohort 6: N-803 - SQ 15 ug/kg31.4Not reported31.431.4Not reported
AUC0-inf

Analysis denominator · Participants

GroupSource count
Cohort 1: N-803 - IV 1 ug/kg3
Cohort 2: N-803 - IV 3 ug/kg2
Cohort 3: N-803 - IV 6 ug/kg2
Cohort 4: N-803 - IV 10 ug/kg3
Cohort 5: N-803 - SQ 10 ug/kg0
Cohort 6: N-803 - SQ 15 ug/kg1
Values in hr x ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Cohort 1: N-803 - IV 1 ug/kg10.6Not reported7.6113.7Not reported
Cohort 2: N-803 - IV 3 ug/kg141Not reported116166Not reported
Cohort 3: N-803 - IV 6 ug/kg732Not reported618846Not reported
Cohort 4: N-803 - IV 10 ug/kg814Not reported5781220Not reported
Cohort 6: N-803 - SQ 15 ug/kg32.5Not reported32.532.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.58
        upper Limit
        13.7
        value
        10.5
      2. group Id
        OG001
        lower Limit
        105
        upper Limit
        166
        value
        129
      3. group Id
        OG002
        lower Limit
        439
        upper Limit
        845
        value
        634
      4. group Id
        OG003
        lower Limit
        577
        upper Limit
        1200
        value
        808
      5. group Id
        OG004
        lower Limit
        6.00
        upper Limit
        21.2
        value
        13.6
      6. group Id
        OG005
        lower Limit
        9.61
        upper Limit
        135
        value
        60.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        4
      6. group Id
        OG005
        value
        3
      units
      Participants
    title
    AUC0-t
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.62
        upper Limit
        13.8
        value
        10.6
      2. group Id
        OG001
        lower Limit
        116
        upper Limit
        166
        value
        141
      3. group Id
        OG002
        lower Limit
        618
        upper Limit
        845
        value
        731
      4. group Id
        OG003
        lower Limit
        577
        upper Limit
        1220
        value
        811
      5. group Id
        OG004
        lower Limit
        2.91
        upper Limit
        6.69
        value
        5.01
      6. group Id
        OG005
        lower Limit
        11.7
        upper Limit
        65.5
        value
        31.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        4
      6. group Id
        OG005
        value
        3
      units
      Participants
    title
    AUC0-24
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.62
        upper Limit
        13.8
        value
        10.6
      2. group Id
        OG001
        lower Limit
        116
        upper Limit
        166
        value
        141
      3. group Id
        OG002
        lower Limit
        618
        upper Limit
        846
        value
        732
      4. group Id
        OG003
        lower Limit
        578
        upper Limit
        1220
        value
        813
      5. group Id
        OG005
        lower Limit
        31.4
        upper Limit
        31.4
        value
        31.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        1
      units
      Participants
    title
    AUC0-168
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.61
        upper Limit
        13.7
        value
        10.6
      2. group Id
        OG001
        lower Limit
        116
        upper Limit
        166
        value
        141
      3. group Id
        OG002
        lower Limit
        618
        upper Limit
        846
        value
        732
      4. group Id
        OG003
        lower Limit
        578
        upper Limit
        1220
        value
        814
      5. group Id
        OG005
        lower Limit
        32.5
        upper Limit
        32.5
        value
        32.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        1
      units
      Participants
    title
    AUC0-inf
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      4
    6. group Id
      OG005
      value
      3
    units
    Participants
description
Area under the plasma concentration curve from time 0 through the last measurable concentration (AUC0-t). PK samples were obtained from the start of treatment until 72 hours. The AUC0-168 and AUC0-inf were calculated with noncompartmental pharmacokinetic analysis equations.
dispersion Type
Full Range
groups
  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
Samples were collected and the AUC was determined at 24 hours and at time t (last measurable concentration). The AUC was calculated for 168 hours and time to infinity.
title
Characterization of the Pharmacokinetic Profile - Area Under the Plasma Concentration Curve
type
SECONDARY
unit Of Measure
hr x ng/mL

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Preserved source evidence · Not medical advice