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NCT03329690 · OUTCOME

Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve 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*d/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. Area under the concentration versus time curve (AUC) from Time 0 to the Last Quantifiable Concentration (AUClast) and Area Under the Concentration versus-Time Curve up to 21 days (AUC21d) are reported. 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. No patient samples were collected or analyzed for AUClast DS-8201a and total anti-HER2 antibody for Cycle 3 as AUClast was planned to be assessed only for Cycle 1.

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

AUClast: 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*d/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
DS-8201a611150Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a572143Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a545160Not reportedNot reportedNot reported
AUClast: DS-8201a, Cycle 3

Analysis denominator · Participants

GroupSource count
DS-8201a0
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a0
Exploratory: Naïve HER2 IHC 1+, DS-8201a0
AUClast: 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*d/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
DS-8201a667241Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a570126Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a547167Not reportedNot reportedNot reported
AUClast: Total Anti-HER2 antibody, Cycle 3

Analysis denominator · Participants

GroupSource count
DS-8201a0
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a0
Exploratory: Naïve HER2 IHC 1+, DS-8201a0
AUC21d: 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 ug*d/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
DS-8201a612150Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a572143Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a569114Not reportedNot reportedNot reported
AUC21d: 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 ug*d/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
DS-8201a867213Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a746197Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a72471.9Not reportedNot reportedNot reported
AUC21d: 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 ug*d/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
DS-8201a651210Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a570126Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a582104Not reportedNot reportedNot reported
AUC21d: 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 ug*d/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
DS-8201a888244Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a775210Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a737110Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        150
        value
        611
      2. group Id
        OG001
        spread
        143
        value
        572
      3. group Id
        OG002
        spread
        160
        value
        545
    denoms
    1. counts
      1. group Id
        OG000
        value
        125
      2. group Id
        OG001
        value
        20
      3. group Id
        OG002
        value
        24
      units
      Participants
    title
    AUClast: DS-8201a, Cycle 1
  2. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    AUClast: DS-8201a, Cycle 3
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        241
        value
        667
      2. group Id
        OG001
        spread
        126
        value
        570
      3. group Id
        OG002
        spread
        167
        value
        547
    denoms
    1. counts
      1. group Id
        OG000
        value
        125
      2. group Id
        OG001
        value
        20
      3. group Id
        OG002
        value
        24
      units
      Participants
    title
    AUClast: Total Anti-HER2 antibody, Cycle 1
  4. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    AUClast: Total Anti-HER2 antibody, Cycle 3
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        150
        value
        612
      2. group Id
        OG001
        spread
        143
        value
        572
      3. group Id
        OG002
        spread
        114
        value
        569
    denoms
    1. counts
      1. group Id
        OG000
        value
        124
      2. group Id
        OG001
        value
        20
      3. group Id
        OG002
        value
        23
      units
      Participants
    title
    AUC21d: DS-8201a, Cycle 1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        213
        value
        867
      2. group Id
        OG001
        spread
        197
        value
        746
      3. group Id
        OG002
        spread
        71.9
        value
        724
    denoms
    1. counts
      1. group Id
        OG000
        value
        66
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        10
      units
      Participants
    title
    AUC21d: DS-8201a, Cycle 3
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        210
        value
        651
      2. group Id
        OG001
        spread
        126
        value
        570
      3. group Id
        OG002
        spread
        104
        value
        582
    denoms
    1. counts
      1. group Id
        OG000
        value
        121
      2. group Id
        OG001
        value
        20
      3. group Id
        OG002
        value
        22
      units
      Participants
    title
    AUC21d: Total Anti-HER2 antibody, Cycle 1
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        244
        value
        888
      2. group Id
        OG001
        spread
        210
        value
        775
      3. group Id
        OG002
        spread
        110
        value
        737
    denoms
    1. counts
      1. group Id
        OG000
        value
        66
      2. group Id
        OG001
        value
        11
      3. group Id
        OG002
        value
        9
      units
      Participants
    title
    AUC21d: 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. Area under the concentration versus time curve (AUC) from Time 0 to the Last Quantifiable Concentration (AUClast) and Area Under the Concentration versus-Time Curve up to 21 days (AUC21d) are reported. 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. No patient samples were collected or analyzed for AUClast DS-8201a and total anti-HER2 antibody for Cycle 3 as AUClast was planned to be assessed only for Cycle 1.
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 Parameters of Area Under the Concentration Versus-Time Curve of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a
type
SECONDARY
unit Of Measure
ug*d/mL

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Preserved source evidence · Not medical advice