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NCT03329690 · OUTCOME

Pharmacokinetic Parameter Terminal Elimination Half-life (t1/2) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a

DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Gastric Cancer [DESTINY-Gastric01] · Source last updated 2022-03-18

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

Measure
MEAN
Unit
days
Interval / dispersion
Standard Deviation
Time frame
Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days)

What was measured

Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. Terminal elimination half-life (t1/2) of DS-8201a was assessed. This serum PK parameter for DS-8201a, total anti-HER2 antibody, and MAAA-1181a were estimated in each participant using standard noncompartmental methods.

Analysis population: Pharmacokinetic parameters were assessed in patients with available data in the Pharmacokinetic Analysis Set.

Groups in this outcome

DS-8201a

Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.

Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a

Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.

Exploratory: Naïve HER2 IHC 1+, DS-8201a

Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.

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

Analysis denominator · Participants

GroupSource count
DS-8201a124
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a20
Exploratory: Naïve HER2 IHC 1+, DS-8201a23

Reported measurements

DS-8201a, Cycle 1

Analysis denominator · Participants

GroupSource count
DS-8201a124
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a20
Exploratory: Naïve HER2 IHC 1+, DS-8201a23
Values in days · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
DS-8201a5.771.37Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a5.541.08Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a5.521.17Not reportedNot reportedNot reported
DS-8201a, Cycle 3

Analysis denominator · Participants

GroupSource count
DS-8201a66
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a10
Exploratory: Naïve HER2 IHC 1+, DS-8201a10
Values in days · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
DS-8201a7.461.82Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a6.401.00Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a6.351.73Not reportedNot reportedNot reported
Total Anti-HER2 antibody, Cycle 1

Analysis denominator · Participants

GroupSource count
DS-8201a121
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a20
Exploratory: Naïve HER2 IHC 1+, DS-8201a22
Values in days · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
DS-8201a6.202.22Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a5.541.01Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a5.651.51Not reportedNot reportedNot reported
Total Anti-HER2 antibody, Cycle 3

Analysis denominator · Participants

GroupSource count
DS-8201a66
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a11
Exploratory: Naïve HER2 IHC 1+, DS-8201a9
Values in days · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
DS-8201a8.002.04Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a7.902.10Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a6.171.15Not reportedNot reportedNot reported
MAAA-1181a, Cycle 1

Analysis denominator · Participants

GroupSource count
DS-8201a98
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a17
Exploratory: Naïve HER2 IHC 1+, DS-8201a22
Values in days · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
DS-8201a5.501.11Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a5.210.939Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a5.611.19Not reportedNot reportedNot reported
MAAA-1181a, Cycle 3

Analysis denominator · Participants

GroupSource count
DS-8201a50
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a10
Exploratory: Naïve HER2 IHC 1+, DS-8201a7
Values in days · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
DS-8201a7.011.65Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a6.181.02Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a5.801.10Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.37
        value
        5.77
      2. group Id
        OG001
        spread
        1.08
        value
        5.54
      3. group Id
        OG002
        spread
        1.17
        value
        5.52
    denoms
    1. counts
      1. group Id
        OG000
        value
        124
      2. group Id
        OG001
        value
        20
      3. group Id
        OG002
        value
        23
      units
      Participants
    title
    DS-8201a, Cycle 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.82
        value
        7.46
      2. group Id
        OG001
        spread
        1.00
        value
        6.40
      3. group Id
        OG002
        spread
        1.73
        value
        6.35
    denoms
    1. counts
      1. group Id
        OG000
        value
        66
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        10
      units
      Participants
    title
    DS-8201a, Cycle 3
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.22
        value
        6.20
      2. group Id
        OG001
        spread
        1.01
        value
        5.54
      3. group Id
        OG002
        spread
        1.51
        value
        5.65
    denoms
    1. counts
      1. group Id
        OG000
        value
        121
      2. group Id
        OG001
        value
        20
      3. group Id
        OG002
        value
        22
      units
      Participants
    title
    Total Anti-HER2 antibody, Cycle 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.04
        value
        8.00
      2. group Id
        OG001
        spread
        2.10
        value
        7.90
      3. group Id
        OG002
        spread
        1.15
        value
        6.17
    denoms
    1. counts
      1. group Id
        OG000
        value
        66
      2. group Id
        OG001
        value
        11
      3. group Id
        OG002
        value
        9
      units
      Participants
    title
    Total Anti-HER2 antibody, Cycle 3
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.11
        value
        5.50
      2. group Id
        OG001
        spread
        0.939
        value
        5.21
      3. group Id
        OG002
        spread
        1.19
        value
        5.61
    denoms
    1. counts
      1. group Id
        OG000
        value
        98
      2. group Id
        OG001
        value
        17
      3. group Id
        OG002
        value
        22
      units
      Participants
    title
    MAAA-1181a, Cycle 1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.65
        value
        7.01
      2. group Id
        OG001
        spread
        1.02
        value
        6.18
      3. group Id
        OG002
        spread
        1.10
        value
        5.80
    denoms
    1. counts
      1. group Id
        OG000
        value
        50
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        7
      units
      Participants
    title
    MAAA-1181a, Cycle 3
denoms
  1. counts
    1. group Id
      OG000
      value
      124
    2. group Id
      OG001
      value
      20
    3. group Id
      OG002
      value
      23
    units
    Participants
description
Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. Terminal elimination half-life (t1/2) of DS-8201a was assessed. This serum PK parameter for DS-8201a, total anti-HER2 antibody, and MAAA-1181a were estimated in each participant using standard noncompartmental methods.
dispersion Type
Standard Deviation
groups
  1. description
    Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
    id
    OG000
    title
    DS-8201a
  2. description
    Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
    id
    OG001
    title
    Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
  3. description
    Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
    id
    OG002
    title
    Exploratory: Naïve HER2 IHC 1+, DS-8201a
param Type
MEAN
population Description
Pharmacokinetic parameters were assessed in patients with available data in the Pharmacokinetic Analysis Set.
reporting Status
POSTED
time Frame
Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days)
title
Pharmacokinetic Parameter Terminal Elimination Half-life (t1/2) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a
type
SECONDARY
unit Of Measure
days

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Preserved source evidence · Not medical advice