Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03329690 · OUTCOME

Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of DS-8201a and Total Anti-HER2 Antibody 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
ug/mL
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. The maximum serum concentration (Cmax) and the trough serum concentration (Ctrough) of DS-8201a were assessed. These serum PK parameters for DS-8201a and total anti-HER2 antibody 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

Cmax: 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 ug/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
DS-8201a12728.4Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a11929.1Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a12724.5Not reportedNot reportedNot reported
Cmax: 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 ug/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
DS-8201a13731.1Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a12825.6Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a12323.2Not reportedNot reportedNot reported
Cmax: 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 ug/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
DS-8201a11630.6Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a10526.1Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a11019.6Not reportedNot reportedNot reported
Cmax: 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 ug/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
DS-8201a12128.4Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a11524.2Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a11221.9Not reportedNot reportedNot reported
Ctrough: 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 ug/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
DS-8201a5.563.08Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a4.522.42Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a9.5123.4Not reportedNot reportedNot reported
Ctrough: 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 ug/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
DS-8201a13.417.3Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a8.843.09Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a13.218.6Not reportedNot reportedNot reported
Ctrough: 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 ug/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
DS-8201a8.568.60Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a5.332.97Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a10.020.5Not reportedNot reportedNot reported
Ctrough: 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 ug/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
DS-8201a15.613.6Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a12.25.76Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a14.617.6Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        28.4
        value
        127
      2. group Id
        OG001
        spread
        29.1
        value
        119
      3. group Id
        OG002
        spread
        24.5
        value
        127
    denoms
    1. counts
      1. group Id
        OG000
        value
        125
      2. group Id
        OG001
        value
        20
      3. group Id
        OG002
        value
        24
      units
      Participants
    title
    Cmax: DS-8201a, Cycle 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        31.1
        value
        137
      2. group Id
        OG001
        spread
        25.6
        value
        128
      3. group Id
        OG002
        spread
        23.2
        value
        123
    denoms
    1. counts
      1. group Id
        OG000
        value
        69
      2. group Id
        OG001
        value
        11
      3. group Id
        OG002
        value
        11
      units
      Participants
    title
    Cmax: DS-8201a, Cycle 3
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        30.6
        value
        116
      2. group Id
        OG001
        spread
        26.1
        value
        105
      3. group Id
        OG002
        spread
        19.6
        value
        110
    denoms
    1. counts
      1. group Id
        OG000
        value
        125
      2. group Id
        OG001
        value
        20
      3. group Id
        OG002
        value
        24
      units
      Participants
    title
    Cmax: Total Anti-HER2 antibody, Cycle 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        28.4
        value
        121
      2. group Id
        OG001
        spread
        24.2
        value
        115
      3. group Id
        OG002
        spread
        21.9
        value
        112
    denoms
    1. counts
      1. group Id
        OG000
        value
        69
      2. group Id
        OG001
        value
        11
      3. group Id
        OG002
        value
        11
      units
      Participants
    title
    Cmax: Total Anti-HER2 antibody, Cycle 3
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.08
        value
        5.56
      2. group Id
        OG001
        spread
        2.42
        value
        4.52
      3. group Id
        OG002
        spread
        23.4
        value
        9.51
    denoms
    1. counts
      1. group Id
        OG000
        value
        125
      2. group Id
        OG001
        value
        20
      3. group Id
        OG002
        value
        24
      units
      Participants
    title
    Ctrough: DS-8201a, Cycle 1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.3
        value
        13.4
      2. group Id
        OG001
        spread
        3.09
        value
        8.84
      3. group Id
        OG002
        spread
        18.6
        value
        13.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        69
      2. group Id
        OG001
        value
        11
      3. group Id
        OG002
        value
        11
      units
      Participants
    title
    Ctrough: DS-8201a, Cycle 3
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.60
        value
        8.56
      2. group Id
        OG001
        spread
        2.97
        value
        5.33
      3. group Id
        OG002
        spread
        20.5
        value
        10.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        125
      2. group Id
        OG001
        value
        20
      3. group Id
        OG002
        value
        24
      units
      Participants
    title
    Ctrough: Total Anti-HER2 antibody, Cycle 1
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.6
        value
        15.6
      2. group Id
        OG001
        spread
        5.76
        value
        12.2
      3. group Id
        OG002
        spread
        17.6
        value
        14.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        69
      2. group Id
        OG001
        value
        11
      3. group Id
        OG002
        value
        11
      units
      Participants
    title
    Ctrough: Total Anti-HER2 antibody, 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 maximum serum concentration (Cmax) and the trough serum concentration (Ctrough) of DS-8201a were assessed. These serum PK parameters for DS-8201a and total anti-HER2 antibody 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 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 Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a
type
SECONDARY
unit Of Measure
ug/mL

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice