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NCT03329690 · OUTCOME

Pharmacokinetic Parameter of Time to Maximum Serum Concentration (Tmax) 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
MEDIAN
Unit
hours
Interval / dispersion
Full Range
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. The time to maximum serum concentration (Tmax) 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 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-8201a125
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a20
Exploratory: Naïve HER2 IHC 1+, DS-8201a24

Reported measurements

DS-8201a, Cycle 1

Analysis denominator · Participants

GroupSource count
DS-8201a125
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a20
Exploratory: Naïve HER2 IHC 1+, DS-8201a24
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DS-8201a3.93Not reported07.15Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a3.90Not reported1.587.12Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a3.89Not reported1.537.08Not reported
DS-8201a, Cycle 3

Analysis denominator · Participants

GroupSource count
DS-8201a69
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a11
Exploratory: Naïve HER2 IHC 1+, DS-8201a11
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DS-8201a4.00Not reported0.587.25Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a4.00Not reported0.586.82Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a4.00Not reported0.687.02Not reported
Total Anti-HER2 antibody, Cycle 1

Analysis denominator · Participants

GroupSource count
DS-8201a125
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a20
Exploratory: Naïve HER2 IHC 1+, DS-8201a24
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DS-8201a3.83Not reported07.15Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a3.83Not reported1.587.08Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a3.87Not reported1.537.08Not reported
Total Anti-HER2 antibody, Cycle 3

Analysis denominator · Participants

GroupSource count
DS-8201a69
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a11
Exploratory: Naïve HER2 IHC 1+, DS-8201a11
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DS-8201a3.98Not reported0.537.17Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a4.00Not reported0.576.83Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a3.75Not reported0.537.03Not reported
MAAA-1181a, Cycle 1

Analysis denominator · Participants

GroupSource count
DS-8201a125
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a20
Exploratory: Naïve HER2 IHC 1+, DS-8201a24
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DS-8201a6.85Not reported3.757.25Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a6.83Not reported3.83141.73Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a6.81Not reported3.837.08Not reported
MAAA-1181a, Cycle 3

Analysis denominator · Participants

GroupSource count
DS-8201a69
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a11
Exploratory: Naïve HER2 IHC 1+, DS-8201a11
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DS-8201a6.80Not reported3.787.25Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a6.82Not reported3.887.10Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a6.77Not reported3.987.07Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        7.15
        value
        3.93
      2. group Id
        OG001
        lower Limit
        1.58
        upper Limit
        7.12
        value
        3.90
      3. group Id
        OG002
        lower Limit
        1.53
        upper Limit
        7.08
        value
        3.89
    denoms
    1. counts
      1. group Id
        OG000
        value
        125
      2. group Id
        OG001
        value
        20
      3. group Id
        OG002
        value
        24
      units
      Participants
    title
    DS-8201a, Cycle 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.58
        upper Limit
        7.25
        value
        4.00
      2. group Id
        OG001
        lower Limit
        0.58
        upper Limit
        6.82
        value
        4.00
      3. group Id
        OG002
        lower Limit
        0.68
        upper Limit
        7.02
        value
        4.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        69
      2. group Id
        OG001
        value
        11
      3. group Id
        OG002
        value
        11
      units
      Participants
    title
    DS-8201a, Cycle 3
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        7.15
        value
        3.83
      2. group Id
        OG001
        lower Limit
        1.58
        upper Limit
        7.08
        value
        3.83
      3. group Id
        OG002
        lower Limit
        1.53
        upper Limit
        7.08
        value
        3.87
    denoms
    1. counts
      1. group Id
        OG000
        value
        125
      2. group Id
        OG001
        value
        20
      3. group Id
        OG002
        value
        24
      units
      Participants
    title
    Total Anti-HER2 antibody, Cycle 1
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.53
        upper Limit
        7.17
        value
        3.98
      2. group Id
        OG001
        lower Limit
        0.57
        upper Limit
        6.83
        value
        4.00
      3. group Id
        OG002
        lower Limit
        0.53
        upper Limit
        7.03
        value
        3.75
    denoms
    1. counts
      1. group Id
        OG000
        value
        69
      2. group Id
        OG001
        value
        11
      3. group Id
        OG002
        value
        11
      units
      Participants
    title
    Total Anti-HER2 antibody, Cycle 3
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.75
        upper Limit
        7.25
        value
        6.85
      2. group Id
        OG001
        lower Limit
        3.83
        upper Limit
        141.73
        value
        6.83
      3. group Id
        OG002
        lower Limit
        3.83
        upper Limit
        7.08
        value
        6.81
    denoms
    1. counts
      1. group Id
        OG000
        value
        125
      2. group Id
        OG001
        value
        20
      3. group Id
        OG002
        value
        24
      units
      Participants
    title
    MAAA-1181a, Cycle 1
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.78
        upper Limit
        7.25
        value
        6.80
      2. group Id
        OG001
        lower Limit
        3.88
        upper Limit
        7.10
        value
        6.82
      3. group Id
        OG002
        lower Limit
        3.98
        upper Limit
        7.07
        value
        6.77
    denoms
    1. counts
      1. group Id
        OG000
        value
        69
      2. group Id
        OG001
        value
        11
      3. group Id
        OG002
        value
        11
      units
      Participants
    title
    MAAA-1181a, Cycle 3
denoms
  1. counts
    1. group Id
      OG000
      value
      125
    2. group Id
      OG001
      value
      20
    3. group Id
      OG002
      value
      24
    units
    Participants
description
Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. The time to maximum serum concentration (Tmax) 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
Full Range
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
MEDIAN
population Description
Pharmacokinetic parameters were assessed 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 of Time to Maximum Serum Concentration (Tmax) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a
type
SECONDARY
unit Of Measure
hours

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Preserved source evidence · Not medical advice