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NCT02564900 · OUTCOME

Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) 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
MEAN
Unit
days
Interval / dispersion
Standard Deviation
Time frame
Post first dose up to Day 147

What was measured

The serum PK parameters of Terminal elimination half-life for DS-8201a and its analytes was 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/kg49
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg19
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg17
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg17
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg22
Dose Expansion: HER2-expressing Other Solid Tumors58
Dose Expansion: HER2-expressing Breast Cancer21

Reported measurements

Source class 1
Values in days · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dose Escalation: Cohort 1, 0.8 mg/kg2.180.671Not reportedNot reportedNot reported
Dose Escalation: Cohort 2, 1.6 mg/kg3.071.22Not reportedNot reportedNot reported
Dose Escalation: Cohort 3, 3.2 mg/kg4.231.24Not reportedNot reportedNot reported
Dose Escalation: Cohort 4, 5.4 mg/kg6.030.603Not reportedNot reportedNot reported
Dose Escalation: Cohort 5, 6.4 mg/kg7.331.64Not reportedNot reportedNot reported
Dose Escalation: Cohort 6, 8.0 mg/kg6.440.793Not reportedNot reportedNot reported
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg5.521.23Not reportedNot reportedNot reported
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg6.001.22Not reportedNot reportedNot reported
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg5.281.49Not reportedNot reportedNot reported
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg5.791.01Not reportedNot reportedNot reported
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg6.181.18Not reportedNot reportedNot reported
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg5.901.57Not reportedNot reportedNot reported
Dose Expansion: HER2-expressing Other Solid Tumors5.611.29Not reportedNot reportedNot reported
Dose Expansion: HER2-expressing Breast Cancer5.461.02Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.671
        value
        2.18
      2. group Id
        OG001
        spread
        1.22
        value
        3.07
      3. group Id
        OG002
        spread
        1.24
        value
        4.23
      4. group Id
        OG003
        spread
        0.603
        value
        6.03
      5. group Id
        OG004
        spread
        1.64
        value
        7.33
      6. group Id
        OG005
        spread
        0.793
        value
        6.44
      7. group Id
        OG006
        spread
        1.23
        value
        5.52
      8. group Id
        OG007
        spread
        1.22
        value
        6.00
      9. group Id
        OG008
        spread
        1.49
        value
        5.28
      10. group Id
        OG009
        spread
        1.01
        value
        5.79
      11. group Id
        OG010
        spread
        1.18
        value
        6.18
      12. group Id
        OG011
        spread
        1.57
        value
        5.90
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
      49
    9. group Id
      OG008
      value
      19
    10. group Id
      OG009
      value
      17
    11. group Id
      OG010
      value
      17
    12. group Id
      OG011
      value
      22
    units
    Participants
description
The serum PK parameters of Terminal elimination half-life for DS-8201a and its analytes was estimated using standard non-compartmental methods.
dispersion Type
Standard Deviation
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
MEAN
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: Terminal Elimination Half-life (t1/2) of Serum DS-8201a Following First Dose
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice