Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02004028 · OUTCOME

Evaluate the Pharmacokinetics of VS-6063 (Defactinib), Median Tmax (h)

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
MEDIAN
Unit
hour
Interval / dispersion
Full Range
Time frame
0-24 hours

What was measured

Time to Maximum concentration (Tmax)

Groups in this outcome

Cohort 1

Cohort 1: Defactinib 400 mg BID for 12 days Cohort 2: Defactinib 400 mg BID for 35 days

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 hour · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Cohort 11Not reported14Not reported
Cohort 21Not reported14Not reported
Cohort 3 (Fed)4Not reported28Not reported
Cohort 4 (Fasted)1Not reported12Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1
        upper Limit
        4
        value
        1
      2. group Id
        OG001
        lower Limit
        1
        upper Limit
        4
        value
        1
      3. group Id
        OG002
        lower Limit
        2
        upper Limit
        8
        value
        4
      4. group Id
        OG003
        lower Limit
        1
        upper Limit
        2
        value
        1
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
Time to Maximum concentration (Tmax)
dispersion Type
Full Range
groups
  1. description
    Cohort 1: Defactinib 400 mg BID for 12 days Cohort 2: Defactinib 400 mg BID for 35 days
    id
    OG000
    title
    Cohort 1
  2. description
    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
MEDIAN
reporting Status
POSTED
time Frame
0-24 hours
title
Evaluate the Pharmacokinetics of VS-6063 (Defactinib), Median Tmax (h)
type
PRIMARY
unit Of Measure
hour

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

Preserved source evidence · Not medical advice