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NCT03329690 · OUTCOME

Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of 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
ng*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 MAAA-1181a 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 MAAA-1181a 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: 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 ng*d/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
DS-8201a46.716.3Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a53.442.7Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a44.522.5Not reportedNot reportedNot reported
AUClast: MAAA-1181a, 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: MAAA-1181a, Cycle 1

Analysis denominator · Participants

GroupSource count
DS-8201a107
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a19
Exploratory: Naïve HER2 IHC 1+, DS-8201a22
Values in ng*d/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
DS-8201a46.416.1Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a44.920.1Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a44.522.5Not reportedNot reportedNot reported
AUC21d: MAAA-1181a, Cycle 3

Analysis denominator · Participants

GroupSource count
DS-8201a54
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a10
Exploratory: Naïve HER2 IHC 1+, DS-8201a8
Values in ng*d/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
DS-8201a42.015.1Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a39.48.36Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a44.617.8Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.3
        value
        46.7
      2. group Id
        OG001
        spread
        42.7
        value
        53.4
      3. group Id
        OG002
        spread
        22.5
        value
        44.5
    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: MAAA-1181a, 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: MAAA-1181a, Cycle 3
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.1
        value
        46.4
      2. group Id
        OG001
        spread
        20.1
        value
        44.9
      3. group Id
        OG002
        spread
        22.5
        value
        44.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        107
      2. group Id
        OG001
        value
        19
      3. group Id
        OG002
        value
        22
      units
      Participants
    title
    AUC21d: MAAA-1181a, Cycle 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.1
        value
        42.0
      2. group Id
        OG001
        spread
        8.36
        value
        39.4
      3. group Id
        OG002
        spread
        17.8
        value
        44.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        54
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        8
      units
      Participants
    title
    AUC21d: 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. 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 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 the Pharmacokinetic Analysis Set. No patient samples were collected or analyzed for MAAA-1181a 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 MAAA-1181 Following Treatment With DS-8201a
type
SECONDARY
unit Of Measure
ng*d/mL

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Preserved source evidence · Not medical advice