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NCT03329690 · FLOW

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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.

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
    FG000
    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
    FG001
    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
    FG002
    title
    Physician's Choice Paclitaxel
  4. description
    Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
    id
    FG003
    title
    Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
  5. description
    Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
    id
    FG004
    title
    Exploratory: Naïve HER2 IHC 1+, DS-8201a
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        85
      2. group Id
        FG001
        num Subjects
        44
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        16
      5. group Id
        FG004
        num Subjects
        20
      type
      Progressive disease per RECIST
    2. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        1
      type
      Clinical progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        22
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        2
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      type
      Physician Decision
    7. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Miscellaneous
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      type
      Did not receive treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        126
      2. group Id
        FG001
        num Subjects
        55
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        21
      5. group Id
        FG004
        num Subjects
        24
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        125
      2. group Id
        FG001
        num Subjects
        55
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        20
      5. group Id
        FG004
        num Subjects
        24
      type
      Received Treatment
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        126
      2. group Id
        FG001
        num Subjects
        55
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        21
      5. group Id
        FG004
        num Subjects
        24
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
In the Primary Cohort, participants with HER2 overexpressing gastric of GEJ adenocarcinoma were randomized (2:1) to either DS-8201a or physician's choice (irinotecan or paclitaxel). In the Exploratory Cohorts, participants with HER2 IHC 2+/ISH negative advanced gastric or GEJ adenocarcinoma who were naïve to HER2 treatment received DS-8201a.
recruitment Details
In the Primary Cohort, a total of 188 participants who met all inclusion criteria and no exclusion criteria were enrolled and randomized to treatment. In the Exploratory Cohorts, a total of 45 non-randomized participants were enrolled and 44 patients received treatment. Study participants for all cohorts were enrolled at clinic sites in South Korea and Japan. Participants took part of the study from November 2, 2017 to Data Cut-Off (DCO) date of December 11, 2020.
Complete source fields
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
    FG000
    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
    FG001
    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
    FG002
    title
    Physician's Choice Paclitaxel
  4. description
    Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
    id
    FG003
    title
    Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
  5. description
    Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
    id
    FG004
    title
    Exploratory: Naïve HER2 IHC 1+, DS-8201a
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        85
      2. group Id
        FG001
        num Subjects
        44
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        16
      5. group Id
        FG004
        num Subjects
        20
      type
      Progressive disease per RECIST
    2. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        1
      type
      Clinical progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        22
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        2
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      type
      Physician Decision
    7. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Miscellaneous
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      type
      Did not receive treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        126
      2. group Id
        FG001
        num Subjects
        55
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        21
      5. group Id
        FG004
        num Subjects
        24
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        125
      2. group Id
        FG001
        num Subjects
        55
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        20
      5. group Id
        FG004
        num Subjects
        24
      type
      Received Treatment
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        126
      2. group Id
        FG001
        num Subjects
        55
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        21
      5. group Id
        FG004
        num Subjects
        24
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
In the Primary Cohort, participants with HER2 overexpressing gastric of GEJ adenocarcinoma were randomized (2:1) to either DS-8201a or physician's choice (irinotecan or paclitaxel). In the Exploratory Cohorts, participants with HER2 IHC 2+/ISH negative advanced gastric or GEJ adenocarcinoma who were naïve to HER2 treatment received DS-8201a.
recruitment Details
In the Primary Cohort, a total of 188 participants who met all inclusion criteria and no exclusion criteria were enrolled and randomized to treatment. In the Exploratory Cohorts, a total of 45 non-randomized participants were enrolled and 44 patients received treatment. Study participants for all cohorts were enrolled at clinic sites in South Korea and Japan. Participants took part of the study from November 2, 2017 to Data Cut-Off (DCO) date of December 11, 2020.

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

Preserved source evidence · Not medical advice