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NCT02564900 · OUTCOME

Pharmacokinetic Analysis: Time of Maximum Plasma Concentration (Tmax) of Serum DS-8201a Following First Dose

Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors · Source last updated 2024-01-22

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
hours
Interval / dispersion
Full Range
Time frame
Post first dose up to Day 147

What was measured

The serum PK parameters of Time of maximum plasma concentration (Tmax) for DS-8201a and its analytes were estimated using standard non-compartmental methods.

Analysis population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.

Groups in this outcome

Dose Escalation: Cohort 1, 0.8 mg/kg

Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).

Dose Escalation: Cohort 2, 1.6 mg/kg

Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).

Dose Escalation: Cohort 3, 3.2 mg/kg

Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).

Dose Escalation: Cohort 4, 5.4 mg/kg

Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).

Dose Escalation: Cohort 5, 6.4 mg/kg

Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).

Dose Escalation: Cohort 6, 8.0 mg/kg

Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).

Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg

Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).

Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg

Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).

Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg

Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).

Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg

Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).

Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg

Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).

Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg

Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).

Dose Expansion: HER2-expressing Other Solid Tumors

Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).

Dose Expansion: HER2-expressing Breast Cancer

Japan only: Participants with HER2-expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP2).

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Dose Escalation: Cohort 1, 0.8 mg/kg3
Dose Escalation: Cohort 2, 1.6 mg/kg3
Dose Escalation: Cohort 3, 3.2 mg/kg3
Dose Escalation: Cohort 4, 5.4 mg/kg6
Dose Escalation: Cohort 5, 6.4 mg/kg6
Dose Escalation: Cohort 6, 8.0 mg/kg5
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg48
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg50
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg20
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg19
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg17
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg23
Dose Expansion: HER2-expressing Other Solid Tumors59
Dose Expansion: HER2-expressing Breast Cancer21

Reported measurements

Source class 1
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Dose Escalation: Cohort 1, 0.8 mg/kg1.95Not reported1.621.98Not reported
Dose Escalation: Cohort 2, 1.6 mg/kg4.03Not reported1.874.08Not reported
Dose Escalation: Cohort 3, 3.2 mg/kg4.12Not reported1.956.88Not reported
Dose Escalation: Cohort 4, 5.4 mg/kg2.02Not reported1.872.07Not reported
Dose Escalation: Cohort 5, 6.4 mg/kg2.06Not reported1.503.97Not reported
Dose Escalation: Cohort 6, 8.0 mg/kg1.97Not reported1.706.80Not reported
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg2.00Not reported1.506.85Not reported
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg2.08Not reported1.537.05Not reported
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg2.16Not reported1.507.07Not reported
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg2.00Not reported1.506.67Not reported
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg2.03Not reported1.584.08Not reported
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg1.95Not reported1.537.00Not reported
Dose Expansion: HER2-expressing Other Solid Tumors2.02Not reported1.507.20Not reported
Dose Expansion: HER2-expressing Breast Cancer2.05Not reported1.627.23Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.62
        upper Limit
        1.98
        value
        1.95
      2. group Id
        OG001
        lower Limit
        1.87
        upper Limit
        4.08
        value
        4.03
      3. group Id
        OG002
        lower Limit
        1.95
        upper Limit
        6.88
        value
        4.12
      4. group Id
        OG003
        lower Limit
        1.87
        upper Limit
        2.07
        value
        2.02
      5. group Id
        OG004
        lower Limit
        1.50
        upper Limit
        3.97
        value
        2.06
      6. group Id
        OG005
        lower Limit
        1.70
        upper Limit
        6.80
        value
        1.97
      7. group Id
        OG006
        lower Limit
        1.50
        upper Limit
        6.85
        value
        2.00
      8. group Id
        OG007
        lower Limit
        1.53
        upper Limit
        7.05
        value
        2.08
      9. group Id
        OG008
        lower Limit
        1.50
        upper Limit
        7.07
        value
        2.16
      10. group Id
        OG009
        lower Limit
        1.50
        upper Limit
        6.67
        value
        2.00
      11. group Id
        OG010
        lower Limit
        1.58
        upper Limit
        4.08
        value
        2.03
      12. group Id
        OG011
        lower Limit
        1.53
        upper Limit
        7.00
        value
        1.95
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      6
    5. group Id
      OG004
      value
      6
    6. group Id
      OG005
      value
      5
    7. group Id
      OG006
      value
      48
    8. group Id
      OG007
      value
      50
    9. group Id
      OG008
      value
      20
    10. group Id
      OG009
      value
      19
    11. group Id
      OG010
      value
      17
    12. group Id
      OG011
      value
      23
    units
    Participants
description
The serum PK parameters of Time of maximum plasma concentration (Tmax) for DS-8201a and its analytes were estimated using standard non-compartmental methods.
dispersion Type
Full Range
groups
  1. description
    Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
    id
    OG000
    title
    Dose Escalation: Cohort 1, 0.8 mg/kg
  2. description
    Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
    id
    OG001
    title
    Dose Escalation: Cohort 2, 1.6 mg/kg
  3. description
    Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
    id
    OG002
    title
    Dose Escalation: Cohort 3, 3.2 mg/kg
  4. description
    Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
    id
    OG003
    title
    Dose Escalation: Cohort 4, 5.4 mg/kg
  5. description
    Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
    id
    OG004
    title
    Dose Escalation: Cohort 5, 6.4 mg/kg
  6. description
    Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
    id
    OG005
    title
    Dose Escalation: Cohort 6, 8.0 mg/kg
  7. description
    Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
    id
    OG006
    title
    Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
  8. description
    Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
    id
    OG007
    title
    Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
  9. description
    Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
    id
    OG008
    title
    Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
  10. description
    Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
    id
    OG009
    title
    Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
  11. description
    Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
    id
    OG010
    title
    Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
  12. description
    Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
    id
    OG011
    title
    Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
param Type
MEDIAN
population Description
Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
reporting Status
POSTED
time Frame
Post first dose up to Day 147
title
Pharmacokinetic Analysis: Time of Maximum Plasma Concentration (Tmax) of Serum DS-8201a Following First Dose
type
SECONDARY
unit Of Measure
hours

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Preserved source evidence · Not medical advice