Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03329690 · OUTCOME

Percentage of Participants With Objective Response Rate Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Baseline to date of first documented objective response (CR or PR), up to 36 months postdose

What was measured

The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR), assessed by independent central imaging review (ICR) based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Unconfirmed ORR (not confirmed by ICR) and confirmed ORR (confirmed by ICR) are reported.

Analysis population: Objective response rate was assessed in the Primary Cohort in the Intent-to-Treat 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.

Physician's Choice Irinotecan

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 irinotecan monotherapy as prescribed by the physician before enrollment.

Physician's Choice Paclitaxel

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 paclitaxel monotherapy as prescribed by the physician before enrollment.

Physician's Choice Overall

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 either irinotecan or paclitaxel monotherapy as prescribed by the physician before enrollment.

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-8201a126
Physician's Choice Irinotecan55
Physician's Choice Paclitaxel7
Physician's Choice Overall62

Reported measurements

Unconfirmed ORR, 25 months (DCO: Nov 8, 2019)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
DS-8201a61Not reportedNot reportedNot reportedNot reported
Physician's Choice Irinotecan7Not reportedNot reportedNot reportedNot reported
Physician's Choice Paclitaxel1Not reportedNot reportedNot reportedNot reported
Physician's Choice Overall8Not reportedNot reportedNot reportedNot reported
Unconfirmed ORR, 36 months (DCO: Dec 11, 2020)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
DS-8201a61Not reportedNot reportedNot reportedNot reported
Physician's Choice Irinotecan7Not reportedNot reportedNot reportedNot reported
Physician's Choice Paclitaxel1Not reportedNot reportedNot reportedNot reported
Physician's Choice Overall8Not reportedNot reportedNot reportedNot reported
Confirmed ORR, 25 months (DCO: Nov 8, 2019)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
DS-8201a51Not reportedNot reportedNot reportedNot reported
Physician's Choice Irinotecan6Not reportedNot reportedNot reportedNot reported
Physician's Choice Paclitaxel1Not reportedNot reportedNot reportedNot reported
Physician's Choice Overall7Not reportedNot reportedNot reportedNot reported
Confirmed ORR, 36 months (DCO: Dec 11, 2020)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
DS-8201a50Not reportedNot reportedNot reportedNot reported
Physician's Choice Irinotecan6Not reportedNot reportedNot reportedNot reported
Physician's Choice Paclitaxel1Not reportedNot reportedNot reportedNot reported
Physician's Choice Overall7Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    2. OG003
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    statistical Comment
    CMH test with region as a stratification factor
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG003
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    statistical Comment
    CMH test with region as a stratification factor
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        61
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        8
    title
    Unconfirmed ORR, 25 months (DCO: Nov 8, 2019)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        61
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        8
    title
    Unconfirmed ORR, 36 months (DCO: Dec 11, 2020)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        51
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        7
    title
    Confirmed ORR, 25 months (DCO: Nov 8, 2019)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        50
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        7
    title
    Confirmed ORR, 36 months (DCO: Dec 11, 2020)
denoms
  1. counts
    1. group Id
      OG000
      value
      126
    2. group Id
      OG001
      value
      55
    3. group Id
      OG002
      value
      7
    4. group Id
      OG003
      value
      62
    units
    Participants
description
The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR), assessed by independent central imaging review (ICR) based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Unconfirmed ORR (not confirmed by ICR) and confirmed ORR (confirmed by ICR) are reported.
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
    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 irinotecan monotherapy as prescribed by the physician before enrollment.
    id
    OG001
    title
    Physician's Choice Irinotecan
  3. 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 paclitaxel monotherapy as prescribed by the physician before enrollment.
    id
    OG002
    title
    Physician's Choice Paclitaxel
  4. 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 either irinotecan or paclitaxel monotherapy as prescribed by the physician before enrollment.
    id
    OG003
    title
    Physician's Choice Overall
param Type
COUNT_OF_PARTICIPANTS
population Description
Objective response rate was assessed in the Primary Cohort in the Intent-to-Treat Analysis Set.
reporting Status
POSTED
time Frame
Baseline to date of first documented objective response (CR or PR), up to 36 months postdose
title
Percentage of Participants With Objective Response Rate Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice