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NCT02004028 · OUTCOME

Percentage of pFAK Inhibition in Tumor Tissue

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
percentage of pFAK inhibition in a tumor
Interval / dispersion
Full Range
Time frame
Cohort 1, From Baseline to Day 12; Cohort 2, From Baseline to Day 35; Cohorts 3, From Baseline to Day 21; Cohorts 3, From Baseline to day 21 day.

What was measured

percentage VS-6063 (defactinib)

Groups in this outcome

Cohort 1

Defactinib 400 mg BID for 12 Days

Cohort 2

Defactinib 400 mg BID for 35 Days

Cohort 3

Defactinib 400 mg BID for 21 Days

Cohort 4

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 210
Cohort 310
Cohort 45

Reported measurements

Source class 1
Values in percentage of pFAK inhibition in a tumor · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Cohort 1NANot reportedNANATrue baseline sample were not available so post-treatment samples were compared with post-study surgical specimens which was not an accurate baseline measure.
Cohort 2NANot reportedNANATrue baseline sample were not available so post-treatment samples were compared with post-study surgical specimens which was not an accurate baseline measure.
Cohort 385.6Not reported-12.57100Not reported
Cohort 4NANot reportedNANAInhibition of tumor FAK was not included in Cohort 4, as per the protocol.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        True baseline sample were not available so post-treatment samples were compared with post-study surgical specimens which was not an accurate baseline measure.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        True baseline sample were not available so post-treatment samples were compared with post-study surgical specimens which was not an accurate baseline measure.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      3. group Id
        OG002
        lower Limit
        -12.57
        upper Limit
        100
        value
        85.6
      4. comment
        Inhibition of tumor FAK was not included in Cohort 4, as per the protocol.
        group Id
        OG003
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      10
    4. group Id
      OG003
      value
      5
    units
    Participants
description
percentage VS-6063 (defactinib)
dispersion Type
Full Range
groups
  1. description
    Defactinib 400 mg BID for 12 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 BID for 21 Days
    id
    OG002
    title
    Cohort 3
  4. description
    Defactinib 100 mg BID for 21 Days
    id
    OG003
    title
    Cohort 4
param Type
MEDIAN
reporting Status
POSTED
time Frame
Cohort 1, From Baseline to Day 12; Cohort 2, From Baseline to Day 35; Cohorts 3, From Baseline to Day 21; Cohorts 3, From Baseline to day 21 day.
title
Percentage of pFAK Inhibition in Tumor Tissue
type
PRIMARY
unit Of Measure
percentage of pFAK inhibition in a tumor

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

Preserved source evidence · Not medical advice