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NCT02004028 · OUTCOME

Evaluate the Pharmacokinetics of VS-6063 (Defactinib), CMax

Window of Opportunity Study of VS-6063 (Defactinib) in Surgical Resectable Malignant Pleural Mesothelioma Participants · Source last updated 2024-02-20

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

Measure
GEOMETRIC_MEAN
Unit
ng/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
0-24 hours

What was measured

Maximum observed plasma concentration

Groups in this outcome

Cohort 1

Cohort 1: Defactinib 400 mg BID for 12 days

Cohort 2

Cohort 2: Defactinib 400 mg BID for 35 days

Cohort 3 (Fed)

Defactinib 400 mg for 21 days

Cohort 4 (Fasted)

Defactinib 100 mg BID for 21 days

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

Analysis denominator · Participants

GroupSource count
Cohort 110
Cohort 29
Cohort 3 (Fed)9
Cohort 4 (Fasted)5

Reported measurements

Source class 1
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Cohort 11052126Not reportedNot reportedNot reported
Cohort 21052126Not reportedNot reportedNot reported
Cohort 3 (Fed)513180Not reportedNot reportedNot reported
Cohort 4 (Fasted)51776Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        126
        value
        1052
      2. group Id
        OG001
        spread
        126
        value
        1052
      3. group Id
        OG002
        spread
        180
        value
        513
      4. group Id
        OG003
        spread
        76
        value
        517
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      9
    3. group Id
      OG002
      value
      9
    4. group Id
      OG003
      value
      5
    units
    Participants
description
Maximum observed plasma concentration
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Cohort 1: Defactinib 400 mg BID for 12 days
    id
    OG000
    title
    Cohort 1
  2. description
    Cohort 2: Defactinib 400 mg BID for 35 days
    id
    OG001
    title
    Cohort 2
  3. description
    Defactinib 400 mg for 21 days
    id
    OG002
    title
    Cohort 3 (Fed)
  4. description
    Defactinib 100 mg BID for 21 days
    id
    OG003
    title
    Cohort 4 (Fasted)
param Type
GEOMETRIC_MEAN
reporting Status
POSTED
time Frame
0-24 hours
title
Evaluate the Pharmacokinetics of VS-6063 (Defactinib), CMax
type
PRIMARY
unit Of Measure
ng/mL

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice