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NCT02004028 · OUTCOME

To Evaluate the Tumor Response to VS-6063 (Defactinib)

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Cohort 1, 40 days; Cohort 2, 42 days; Cohort 3, 28 days; Cohort 4, 28 days.

What was measured

Modified RECIST criteria for assessment of response in malignant pleural mesothelioma Ann Oncol 2004. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the in the volume of target lesions; Progressive Disease (PD) at least a 20% increase in the volume of target lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter.

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

Complete Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 10Not reportedNot reportedNot reportedNot reported
Cohort 20Not reportedNot reportedNot reportedNot reported
Cohort 30Not reportedNot reportedNot reportedNot reported
Cohort 40Not reportedNot reportedNot reportedNot reported
Partial Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 11Not reportedNot reportedNot reportedNot reported
Cohort 22Not reportedNot reportedNot reportedNot reported
Cohort 31Not reportedNot reportedNot reportedNot reported
Cohort 40Not reportedNot reportedNot reportedNot reported
Stable Disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 19Not reportedNot reportedNot reportedNot reported
Cohort 24Not reportedNot reportedNot reportedNot reported
Cohort 37Not reportedNot reportedNot reportedNot reported
Cohort 42Not reportedNot reportedNot reportedNot reported
Progressive Disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 10Not reportedNot reportedNot reportedNot reported
Cohort 23Not reportedNot reportedNot reportedNot reported
Cohort 32Not reportedNot reportedNot reportedNot reported
Cohort 43Not reportedNot reportedNot reportedNot reported
Non-Evaluable
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 10Not reportedNot reportedNot reportedNot reported
Cohort 21Not reportedNot reportedNot reportedNot reported
Cohort 30Not reportedNot reportedNot reportedNot reported
Cohort 40Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    title
    Complete Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        0
    title
    Partial Response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        7
      4. group Id
        OG003
        value
        2
    title
    Stable Disease
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        3
    title
    Progressive Disease
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    title
    Non-Evaluable
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
Modified RECIST criteria for assessment of response in malignant pleural mesothelioma Ann Oncol 2004. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the in the volume of target lesions; Progressive Disease (PD) at least a 20% increase in the volume of target lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter.
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
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Cohort 1, 40 days; Cohort 2, 42 days; Cohort 3, 28 days; Cohort 4, 28 days.
title
To Evaluate the Tumor Response to VS-6063 (Defactinib)
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice