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NCT03329690 · OUTCOME

Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) 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/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 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

Cmax: 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/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
DS-8201a12.14.79Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a13.38.52Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a13.37.37Not reportedNot reportedNot reported
Cmax: 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 ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
DS-8201a9.083.81Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a7.621.86Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a9.833.75Not reportedNot reportedNot reported
Ctrough: 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/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
DS-8201a0.3160.294Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a0.2900.237Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a0.7722.28Not reportedNot reportedNot reported
Ctrough: 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 ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
DS-8201a0.7142.19Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a0.3780.138Not reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a1.101.95Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.79
        value
        12.1
      2. group Id
        OG001
        spread
        8.52
        value
        13.3
      3. group Id
        OG002
        spread
        7.37
        value
        13.3
    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: MAAA-1181a, Cycle 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.81
        value
        9.08
      2. group Id
        OG001
        spread
        1.86
        value
        7.62
      3. group Id
        OG002
        spread
        3.75
        value
        9.83
    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: MAAA-1181a, Cycle 3
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.294
        value
        0.316
      2. group Id
        OG001
        spread
        0.237
        value
        0.290
      3. group Id
        OG002
        spread
        2.28
        value
        0.772
    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: MAAA-1181a, Cycle 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.19
        value
        0.714
      2. group Id
        OG001
        spread
        0.138
        value
        0.378
      3. group Id
        OG002
        spread
        1.95
        value
        1.10
    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: 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 maximum serum concentration (Cmax) and the trough serum concentration (Ctrough) of DS-8201a were assessed. 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.
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 MAAA-1181 Following Treatment With DS-8201a
type
SECONDARY
unit Of Measure
ng/mL

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Preserved source evidence · Not medical advice